bioihbjkbjnl/mcl2 huggingface dataset:
Midazolam Sedation in Dentally Anxious Patients
Condition: Dental Anxiety
Study type: Interventional
Phase: Phase 3

Summary: 
      Use lay language.

      To compare patient level of cooperation during dental care under conscious sedation with
      midazolam according to the administration route
    

Detailed description: 
      The progress of the study is described below:

      Session 1: intravenous administration of midazolam. Establishment of the individual dose.

      Randomisation.

      Session 2 :

      Group A : oral administration of midazolam : the dose administered is twice the individual
      dose determined in session 1.

      Group B : intravenous administration of midazolam at the individual dose determined in
      session 1.

      Session 3 : reversal of the procedures :

      Group A : intravenous administration of midazolam at the individual dose determined in
      session 1.

      Group B : oral administration of midazolam : the dose administered is twice the individual
      dose determined in session 1.
    

Intervention name(s): Conscious sedation for dental care; midazolam
Intervention type(s): Other; Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Conscious sedation; Dental anxiety; Oral midazolam; Intravenous midazolam; Behaviour
Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
Condition: Cardiovascular Risk Factor; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This study will evaluate the effect of low level laser blood radiation applied to all
      participants for prevention of coronary artery disease in patients with high risk
      (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)
    

Detailed description: 
      The areas of low - intensity laser use have expanded in several conditions by different
      mechanisms and ways. Hypertension as one of coronary artery disease risk factors and early
      indicator of future cardiovascular events with high blood viscosity and elevated blood
      cholesterol levels with immune-pathological basis became necessary issue to be handled. Low
      Level Laser irradiation effects on blood is very essential way in revealing the mechanisms of
      the action of laser radiation on biological tissues by means of changes in metabolism,
      leading to molecular, cellular and systemic changes.
    

Intervention name(s): low level laser hemotherapy
Intervention type(s): Device
Intervention description(s): semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity
Other intervention name(s): Watch laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; high blood viscosity; hypercholesterolemia
Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open label, single group study that is being performed to assess the
      safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single
      dose of spesolimab in adult patients with active Generalized Pustular Psoriasis (GPP).
    


Intervention name(s): Spesolimab
Intervention type(s): Drug
Intervention description(s): Solution for infusion
Other intervention name(s): BI 655130
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH
      antagonist IVF cycles. The investigators performed this study to compare such a protocol with
      the gold-standard still today, which is the long-agonist protocol with no previous use of the
      pill.
    


Intervention name(s): levonorgestrel and ethynilestradiol
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility patients requiring IVF; good prognosis
Mindfulness Training for Small Teams
Condition: Cognitive Change
Study type: Interventional

Summary: 
      The purpose of this study is to look at how mindfulness training may influence how the
      participant thinks, feels, and acts.
    


Intervention name(s): MBAT-T; MBAT-I
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The MBAT-Team program builds on the basic 4-week, 8-hour MBAT-Soldier program. In addition to the basic program, MBAT-Team includes exercises promoting the cultivation of attention and emotion regulation in the service of effective team interactions (e.g., mindful communication and listening; monitoring and attention to the activities and emotional states of others, and additional practices to promote collective mindfulness).; The MBAT-Individual program is based on the basic 4-week, 8-hour MBAT-Soldier curriculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: attentional performance; psychological well-being; operational performance
Antioxidant Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study examines whether an antioxidant taken orally will improve glucose tolerance and
      insulin secretion in type 2 diabetic subjects.
    


Intervention name(s): Placebo; n-aceylcysteine
Intervention type(s): Drug; Drug
Intervention description(s): one capsule BID; 450 mgm BID
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 diabetes
Carpal Tunnel Syndrome in Pregnant Women
Condition: Carpal Tunnel Syndrome; Exercise
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The purpose of our study is to evaluate the effectiveness of the home exercise program in
      patients who develop Carpal tunnel syndrome (CTS).
    

Detailed description: 
      Materials and Method: Thirty-three patients with CTS (mild to moderate) were included to
      randomized, single-blind, controlled clinical trial. Based on EMG results and clinical
      examination, patient group was divided two part as mild and moderate CTS (group 1) and normal
      (group 2). The Sick Boston Carpal Tunnel Syndrome Questionnaire form was filled in
      face-to-face method.

      Cases in this study: Patients who had pain and numbness problems at the hands of the
      Bezmiâlem Vakif University Polyclinic for Women and Obstetrics were then directed to the
      Bezmiâlem Vakif University Physical Therapy Rehabilitation Policlinic. After the examination
      and clinical testing of each patient (Tinel test, Phalen's test, Reverse Phalen's and
      Durkan's Carpal Compression test), the patients were directed to Bezmiâlem Vakif University
      Neurology Policlinic. Based on electromyography (EMG) results and clinical examination, the
      group was classified as mild and moderate CTS (group 1) and normal (group 2). A disease
      exercise form was distributed for all patients to do exercises.
    

Intervention name(s): Tendon and Nerve Gliding Exercises
Intervention type(s): Behavioral
Intervention description(s): Tendon and Nerve Gliding Exercises: The tendon slip exercises used in this study were performed in five different positions, namely flexion, flat, hook, punch, table top and flat punch positions. Nerve-gliding exercises were performed by moving the fingers and wrists in six different positions, focusing on the median nerve consisting of all the disease grip, finger lengthening, wrist extension, thumb extension, forearm supination and gentle gentle gait. Instructions were given to make 10 sets of exercises in 3 sets, written and verbal, in order to have e exercises for all patient's tendons and nerves shifting exercises. Brochures were also provided explaining the exercises.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-Probability Sample: Any of a variety of other sampling processes, such as convenience
        sampling or invitation to volunteer
      
Keywords: Carpal tunnel syndrome; home exercise; pregnant women
Ixabepilone in Treating Young Patients With Refractory Solid Tumors
Condition: Adult Rhabdomyosarcoma; Adult Synovial Sarcoma; Alveolar Childhood Rhabdomyosarcoma; Childhood Synovial Sarcoma; Embryonal Childhood Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Rhabdomyosarcoma, Embryonal; Neuroectodermal Tumors, Primitive, Peripheral; Sarcoma, Synovial; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying how well ixabepilone works in treating young patients with
      refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the response rate to ixabepilone in various strata of recurrent solid malignant
      tumors of childhood and young adulthood, including all of the following: Embryonal or
      alveolar rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/peripheral neuroectodermal tumor,
      synovial sarcoma or malignant peripheral nerve sheath tumor, Wilms' tumor, and neuroblastoma.

      II. Determine the time to progression for each tumor stratum. III. Prospectively evaluate the
      feasibility and utility of automated volumetric tumor measurement in patients with measurable
      pulmonary metastases, and descriptively compare volumetric measurements to 1-dimensional
      (RECIST criteria) and 2-dimensional (WHO criteria) measurements.

      IV. Define and describe the toxicities of ixabepilone.

      OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's
      sarcoma/ peripheral neuroectodermal tumor vs osteosarcoma vs alveolar or embryonal
      rhabdomyosarcoma vs Wilms' tumor vs neuroblastoma vs synovial sarcoma/malignant peripheral
      nerve sheath tumor).

      Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the
      absence of unacceptable toxicity or disease progression.

      After completion of study treatment, patients are followed up every year for 5 years.

      PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
    

Intervention name(s): ixabepilone
Intervention type(s): Drug
Intervention description(s): Given IV
Other intervention name(s): BMS-247550; epothilone B lactam; Ixempra
Intervention MeSH terms: Epothilones; Epothilone B
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intranasal Anti-IgE Antibodies on IgE Production
Condition: Allergy
Study type: Interventional

Summary: 
      In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or
      intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before
      nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples,
      specific and total IgE levels will be assessed.
    

Detailed description: 
      The intranasal challenge study will be performed over 8 weeks outside of the birch pollen
      season (November to January) as a randomized, double blind and placebo-controlled study.
      During a screening visit, 15 individuals will be recruited according to eligibility criteria.
      They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or
      placebo). Intranasal administration will take place on three consecutive days and serum
      samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of
      total and specific IgE levels
    

Intervention name(s): anti-IgE; intranasal allergen; intranasal saline
Intervention type(s): Drug; Other; Other
Intervention description(s): intranasal anti-IgE; intranasal allergen; intranasal placebo
Other intervention name(s): Omalizumab; GMP produced recombinant Bet v 1; sodium chloride 0.9%
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
Condition: Obstructive Sleep Apnea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Weight Loss
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition
      and energy expenditure. The objective of this study is to evaluate the influence of OSA in
      energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both
      genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary
      intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN
      with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein
      / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS
      obese standard diet. All groups will be instructed to perform a restricted energy diet (less
      30% of daily energy expenditure). At baseline and one month after the beginning of the
      program the following evaluations will be conducted: total energy expenditure measured by
      doubly labeled water method, resting energy expenditure and thermic effect of food by
      calorimetry, polysomnography analysis, body composition by pletysmography, food consumption
      by three days of food diary, blood collection for analysis of lipid profile, visceral
      proteins, hormones related to control of body weight and inflammation. As hypothesis we
      believe that apneic obese individuals have greater difficult in weight loss and loss more
      free fat mass than the obese no apneic and that diets with more protein can contribute to
      greater weight loss, better body composition and energy expenditure in these population.
    


Intervention name(s): Diet
Intervention type(s): Behavioral
Intervention description(s): Reduction of energy intake in order to weight loss
Other intervention name(s): Energy restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; obesity; diet; energy expenditure
NI-0401 in Patients With Acute Renal Allograft Rejection
Condition: Acute Renal Transplant Rejection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine the safety and tolerability of NI-0401 and whether
      NI-0401 can reverse BpACR.
    


Intervention name(s): NI-0401
Intervention type(s): Drug
Intervention description(s): 5 daily infusions with escalating doses of NI-0401
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several
      studies have indicated that appropriate pain treatment protocols reduce postoperative
      morbidity, improve the results of the surgery, and decrease hospital costs
    

Detailed description: 
      Forty four patients were randomly allocated into two groups of equal size to receive either
      lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).

      Randomization: was performed using Lidocaine group and Control group registers, which was
      placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a
      physician who prepared the intravenous solution and identified it with the patient number,
      according to the envelope drawn. The solution was handed to another physician, blind to the
      prepared solutions' content, who was responsible for the anesthesia. The solution volume was
      equal. The responsible investigator was remained blind to the chosen group until the end of
      the study.
    

Intervention name(s): Lidocaine; 0.9% Sodium-chloride
Intervention type(s): Drug; Drug
Intervention description(s): patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.; patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.
Other intervention name(s): Xylocaine; Normal saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the tolerability, and effect on quality of life, in patients
      receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic
      renal anemia. The anticipated time on study treatment is 10 months, and the target sample
      size is 60 individuals.
    


Intervention name(s): Epoetin Beta
Intervention type(s): Drug
Intervention description(s): Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.
Other intervention name(s): NeoRecormon
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study determined the safety of ASP1941 after a single and multiple once-daily doses for
      10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD)
      of ASP1941 were assessed.
    


Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ASP1941; Diabetes Mellitus; Multiple ascending doses; Healthy subjects
Metformin Treatment, Renal Function and Lactic Acidosis
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Acidosis; Acidosis, Lactic
Study type: Observational

Summary: 
      From a central registry at the National Board of Health and Welfare in Sweden collect all
      patients in the city of Malmö prescribed metformin during two years. Glomerular filtration
      rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control
      material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU
      admission were also sought. The study hypothesis is that metformin is prescribed to patients
      with lower GFR than anticipated with very few cases of lactic acidosis registered.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients irrespective of age prescribed metformin according to a registry for the city
        of Malmö
      
Keywords: metformin; type 2 diabetes; e-GFR; creatinine; lactic acidosis
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug
      interaction between rosuvastatin and fenofibric acid in healthy adult subjects
    


Intervention name(s): Cresto 20mg; Fenofibric acid 135mg; Cresto 20mg, Fenofibric acid 135mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, rosuvastatin 20mg; capsule, fenofibric acid 135mg; rosuvastatin 20mg, Fenofibric acid 135mg
Intervention MeSH terms: Fenofibric acid; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Unilateral Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold
      (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast
      cancer radiation therapy, can reduce side effects to the heart.
    

Detailed description: 
      The primary objective of this study is to estimate the rate of radiation-associated regional
      myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH
      for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac
      perfusion scans pre- and 6 months post-radiation.
    

Intervention name(s): Cardiac SPECT perfusion scan
Intervention type(s): Other
Intervention description(s): A SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with left-sided breast cancer