bioihbjkbjnl/mcl2 huggingface dataset:
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of an aqueous nasal spray investigational
      compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system
      in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study
      can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include
      physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and
      allergy skin testing. You will need to complete a daily diary card and spend the night in the
      clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
    

Detailed description: 
      A randomized, double-blind, parallel group, placebo and active (prednisone) controlled,
      6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic
      pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with
      perennial allergic rhinitis (PAR).
    

Intervention name(s): GW685698X aqueous nasal spray
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: perennial allergic rhinitis; intranasal corticosteroid; HPA axis function; GW685698X
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma
      challenged with an inhaled allergen.
    


Intervention name(s): AZD5423; Budesonide 200 microgram; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Suspension for nebulisation once daily 7 days; Dry powder for inhalation twice daily 7 days; Solution for nebulisation once daily 7 days; Solution for nebulisation once daily 7 days
Other intervention name(s): Pulmicort
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergen Challenge; Asthma; Inhaled selective glucocorticoid receptor agonist (iSEGRA)
A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with
      stage 1 or stage 2 hypertension after the withdrawal of active medication.
    


Intervention name(s): Nebivolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration; Matching placebo tablets, oral administration
Other intervention name(s): Bystolic® (nebivolol)
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nebivolol; Bystolic®; Hypertension; blood pressure; withdrawal
A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities,
      of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed
      diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered
      twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of
      radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard
      dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week
      break. The anticipated time on study treatment is 3-12 months, and the target sample size
      will not exceed 30 evaluable patients.
    


Intervention name(s): capecitabine [Xeloda]
Intervention type(s): Drug
Intervention description(s): 500mg/m2 po bid (starting dose)
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Downhill Training on Ankle Joint
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Downhill training help to improve musculoskeletal condition. Applying downhill training could
      help obese children by improving their muscular strength.
    

Detailed description: 
      the current study aimed to find the effect of downhill training on the ankle isokinetic
      parameters of obese children. There were two experimental groups, the first received level
      walking while the second received downhill training. The ankle isokinetic parameters were
      assessed pre and post-intervention for 6 weeks.
    

Intervention name(s): Level walking exercise; Downhill exercise
Intervention type(s): Other; Other
Intervention description(s): treadmill exercise with 0 inclination; treadmill exercise with -20 inclination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout
Condition: Glycogen Depletion
Study type: Interventional

Summary: 
      The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy
      stores and energy metabolism during recovery after an acute exercise bout. To achieve this,
      30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody)
      combined with a 2-hour exercise bout. Stable isotope tracers will be infused to determine
      substrate kinetics. Indirect calorimetry will be applied to determine substrate oxidation,
      and muscle biopsies will be taken to determine substrate uptake and storage.
    


Intervention name(s): Tocilizumab/Actemra® (Roche); Saline 9%
Intervention type(s): Drug; Drug
Intervention description(s): The infusion of tocilizumab will antagonize IL-6 signaling for the duration of the study, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise; The infusion of saline will serve as placebo for tocilizumab, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables
Condition: Acupressure; Pain; Hemodynamic Instability; Angiopathy, Peripheral
MeSH terms: Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional

Summary: 
      This randomized controlled study evaluates the effect of acupressure application on the pain
      level patients after angioography. The hypothesis of this study is that acupressure reduces
      pain levels and stabilizes hemodynamic variables.
    

Detailed description: 
      In the study, 124 patients will randomly assigned to acupressure/experimental group and
      control group. To the acupressure/experimental group (n = 62), an average of 15 minutes will
      be applied to the LI4 (liver, between thumb and forefinger), P6 (pericardium, three fingers
      above the wrist) and LI 11 is located the area where the elbow bend. On the other hand, no
      other intervention will be applied to the control group other than routine treatment and
      nursing care. The primary outcome of the research is the effect of acupressure on the pain of
      patients. The secondary outcome of the study is to determine the effect of acupressure on the
      hemodynamic variables. The pain and hemodynamic variables will be collected before,
      immediately after the application, 10th, 20th and 30th minutes after the application. Data
      will also be collected from the control group at the same time.
    

Intervention name(s): Acupressure
Intervention type(s): Other
Intervention description(s): The experimental group will start with LI4 points and continue P6 and LI11 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.
Other intervention name(s): Acupress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, three-arm randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Condition: Alopecia, Androgenetic
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in
      participants with androgenetic alopecia.
    


Intervention name(s): P-3074; Finasteride; P-3074 Vehicle; Finasteride Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): finasteride topical solution; Propecia; Vehicle of P-3074; Placebo of Finasteride
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Using Online Food Retail "Nudges" to Promote Healthier Beverage Intake Among Low-Income Children
Condition: Obesity
Study type: Interventional

Summary: 
      The specific aims of this proposal are to 1) develop online food retail nudges to discourage
      sugary drink purchases and promote healthier substitutes; 2) examine the impact of online
      store nudges on purchases of sugary drinks in an online randomized controlled experiment with
      low-income parents, including Supplemental Nutrition Assistance Program (SNAP) and Women,
      Infants, and Children (WIC)-participating parents, of children age 1-5 years; and 3)
      disseminate findings to retailers, including those participating in the SNAP Online
      Purchasing Pilot.
    


Intervention name(s): "Nudges" in Web-Based Supermarket
Intervention type(s): Behavioral
Intervention description(s): While shopping in the web-based supermarket, participants assigned to the "nudge" arm will see retail nudges to discourage sugary drink purchases and promote healthier substitutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Fear of Hypoglycemia and Glycemic Variability
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a
      blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions
      in a 2 week time period, in addition to the filling of 5 questionnaires including fear of
      hypoglycemia-2 questionnaire.
    

Detailed description: 
      Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a
      blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions
      in a 2 week time period, in addition to the filling of questionnaires including fear of
      hypoglycemia-2 questionnaire.

      Biobanking of urine/blood Collection of key medical informations by investigators

      Questionnaires :

        -  socio-economic status

        -  Fear of hypoglycemia-2

        -  Anxiety Depression scale (HAD)

        -  Health survey (SF36, SF12)

        -  Satisfaction to treatment (DHP-18)

        -  Dutch Eating Behavior Questionnaire (DEBQ)

        -  Pittsburgh quality of sleep (PSQI)

        -  Blood Glucose diary
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetes
      
Biospecimen description: 
      -  blood (whole blood + plasma + serum)

        -  urines
    
Keywords: diabetes
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of combined treatment
      with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with
      HER2-positive metastatic breast cancer.
    

Detailed description: 
      Based on preclinical experiments conducted in our laboratories, we hypothesize that the
      aggressive behavior of HER2-overexpressing breast cancers is due in part to increased
      angiogenesis resulting from HER2-induced increases in vascular endothelial growth factor
      (VEGF) expression. In vivo experiments suggest that combined blockade of the HER2 receptor
      and VEGF results in superior anti-tumor efficacy compared with either treatment alone.

      The current clinical trial, for which the phase I portion has been completed, will examine
      the efficacy and safety of trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in
      the treatment of HER2-overexpressing metastatic breast cancer.
    

Intervention name(s): Bevacizumab (drug), Herceptin (drug)
Intervention type(s): Drug
Intervention MeSH terms: Bevacizumab; Trastuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer; HER2; Trastuzumab; Herceptin; VEGF; Bevacizumab; Avastin
Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      This single-blinded, randomized controlled was aimed to compare the efficacy of Frenkel's and
      Conventional Balance Exercises in improving balance and quality of life in patients with
      subacute ischemic stroke. The participants of Group A received 'Frenkel's Exercises'. In
      contrast, Group B participants received 'Conventional Balance Exercise' interventions three
      days/week for 30-60 minutes for four weeks. The data was collected pre and post-treatment on
      the Berg Balance Scale and Stroke Specific-Quality of Life.
    


Intervention name(s): Stroke Rehabilitation
Intervention type(s): Other
Intervention description(s): Both the groups received interventions three days/week for 30-60 minutes for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stroke; Disability; Exercise; Balance; Quality of Life.
A Study to Evaluate Central Nervous System (CNS) Pharmacodynamic Activity of TAK-653 in Healthy Participants Using Transcranial Magnetic Stimulation (TMS)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether TAK-653, in comparison to placebo,
      increases CNS excitability, assessed with TMS-evoked motor-evoked potential (MEP) in healthy
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-653. This study is designed to evaluate the
      central pharmacodynamic activity of TAK-653 using TMS. The study will enroll approximately 24
      participants to yield 22 participants that complete treatment periods 1, 2, and 3.
      Participants will be randomly assigned to 1 of the 6 sequences to receive TAK-653 0.5 mg low
      dose or TAK-653 6 mg high dose or Placebo in double-blind treatment periods 1, 2, and 3,
      followed by Ketamine 0.5 mg/kg in open-label Treatment period 4.

      All participants will receive one dose of TAK-653 (0.5 or 6 mg), or Placebo or Ketamine on
      Day 1 of each treatment period.

      This single center trial will be conducted in the Netherlands. The overall time to
      participate in this study is 15 weeks. Participants will make 5 visits to the clinic. A
      washout period of minimum 10 days will be maintained between the doses in treatment periods 1
      to 3. Follow-up phone call will be made on Day 14.
    

Intervention name(s): TAK-653; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-653 tablets.; TAK-653 placebo-matching tablets.; Ketamine intravenous infusion.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a randomized, crossover 6 sequence study in Treatment Periods 1, 2, and 3.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy
The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The aim of the intervention is to gain insight into the long term effect of dietary fatty
      acid quality on insulin sensitivity and health parameters in healthy men.

      Whole body and peripheral insulin sensitivity were measured, together with analyses of plasma
      hormones and metabolites. The plasma proteome was also analyzed. Molecular adaptations in
      skeletal muscle and adipose tissue were subject for investigation. Furthermore, gut
      microbiota population number and diversity will be analyzed from faeces samples obtained
      before and after the intervention.
    

Detailed description: 
      Two experimental diets with a high fat content (65 E% fat), enriched in either saturated or
      polyunsaturated fatty acids, were provided for 6 weeks to healthy men, in a randomized
      controlled intervention study with two arms.

      Healthy, untrained, non-obese male subjects (27-45 years) were included in the study. The
      experimental diets are eucaloric, and thus provided so the subjects remains weight stable.

      Before and after the intervention, two experimental days was conducted (2 experiments before
      and 2 experiments after the intervention).

      At pre-intervention, subjects completed a high-fat meal test and insulin sensitivity was
      measured by the hyperinsulinemic-euglycemic clamp. On both days, blood and tissue biopsies
      were obtained. These two experimental days were repeated at the end of the 6 weeks
      intervention.

      The hyperinsulinemic-euglycemic clamp was combined with stable isotope infusion (deuterium
      labelled glucose) in order to measure hepatic glucose production. Before the clamp, a
      catheter is inserted into the femoral vein, to enable measurement of insulin stimulated
      glucose uptake across the leg. Biopsies are obtained by the needle biopsy method from the
      vastus lateralis muscle and peri-umbilical subcutaneous adipose tissue. Blood samples were
      analyzed for glucose, insulin, inflammatory markers, gut hormones, adipokines, plasma fatty
      acid composition, and lipoprotein profile. Indirect calorimetric was also applied to measure
      substrate oxidation during the experimental days.
    

Intervention name(s): High-fat diet
Intervention type(s): Behavioral
Intervention description(s): The aim of the intervention is to evaluate whether insulin sensitivity and selected Health parameters is affected, when the intake of saturated fatty acids or polyunsaturated fatty acids are highly increased, even when subjects are in energy balance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: insulin sensitivity; high-fat diet
Prevention of Falls and Injurious Falls Among Elderly People
Condition: Falls; Accidental Falls
Study type: Interventional

Summary: 
      The aim of this study is to describe and analyse the effects of multifactorial trial on the
      incidence of falls and injurious falls and on different risk factors of falling among the
      home-dwelling aged.
    

Detailed description: 
      The aims of the study:

        1. To implement a program for the prevention of falls and injurious falls.

        2. To describe the structure and activities of the fall prevention program implemented
           among the aged who are living in their own home, have at least moderate cognitive
           abilities, have fallen during previous 12 months and are 65 years of age or older. A
           further aim is to describe the frequency of participation according to age, gender,
           residence, health and physical condition.

        3. To describe the effects of prevention on primary risk factors of falling such as muscle
           strength, balance, eye sight, medications, depression and home hazards in relation to
           age, gender, health and physical condition.

        4. To describe and assess the effects of prevention on the incidence of falls and injurious
           falls.

        5. To assess the effects of prevention on physical, cognitive and psychosocial functional
           abilities, quality of life and use of health and social services and deaths.
    

Intervention name(s): Multifactorial prevention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Falls; Accidental falls; Prevention; Aged; Multifactorial trial
Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study objective is to check the non-inferiority of the 2 formulations produced by EMS
      when compared with the same substances and pharmaceuticals forms of the product Condroflex
      (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and
      functional capacity that will be periodically measured by using the "Visual Analog Scale" of
      pain (VAS) and the questionnaire of Lequesne.
    


Intervention name(s): EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder); EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules); Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder); Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg; Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg; Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg; Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment