bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this study, the effects of 4-week aromatherapy massage on pain, functionality, sleep
      quality and menopausal symptoms will be examined in individuals diagnosed with knee
      osteoarthritis during menopause.
    

Detailed description: 
      The aim of this study is to investigate the effect of aromatherapy massage performed with
      bergamot oil for 4 weeks on pain, function, sleep and menopausal symptoms in menopausal women
      with knee osteoarthritis. Participants will be randomly divided into 3 groups as Bergamot,
      placebo and control. In addition to the conventional treatment, the Bergamot group will
      receive 2 sessions of Bergamot oil per week for 4 weeks, and the placebo group will be
      massaged with 2 sessions of sweet almond oil for 4 weeks. the control group will continue
      conventional treatment for 4 weeks. All assessments will be performed before starting
      treatment and at the end of 4 weeks of treatment. Participants' pain will be evaluated by
      VAS, Functions by WOMAC, Sleep quality by PSQI, menopausal symptoms by Menopause Symptoms
      Evaluation scale. At the end of the study, the satisfaction of the participants will be
      evaluated with VAS.
    

Intervention name(s): Bergamot; Placebo
Intervention type(s): Other; Other
Intervention description(s): The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.; The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer
Condition: Cancer
Study type: Observational

Summary: 
      This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance
      Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil
      has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS
      Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI
      at 3T can be used to differentiate different histological characteristics within whole
      tumours and so determine if the technique could be of prognostic value.

      The study hypothesis is that this technique will be able to differentiate tumours with
      histological features known to be associated with poor prognosis (tumour type, grade and
      lymphovascular space invasion).
    


Intervention name(s): Magnetic Resonance Imaging using an endovaginal receiver coil
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: Magnetic Resonance Imaging
Evaluating Progression of and Diagnostic Tools for Primary Ciliary Dyskinesia in Children and Adolescents
Condition: Primary Ciliary Dyskinesia
MeSH terms: Ciliary Motility Disorders; Dyskinesias
Study type: Observational

Summary: 
      Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is
      the primary defense mechanism for the lungs. Inhaled particles, including microbes that can
      cause infections, are normally entrapped in mucus on the airway surfaces and then cleared out
      by the coordinated action of tiny hair-like structures called cilia. Individuals with primary
      ciliary dyskinesia (PCD) have defective mucociliary clearance, which in turn leads to lung
      infections and disease. The purpose of this study is to determine how lung disease progresses
      over time in children and adolescents with PCD.
    

Detailed description: 
      PCD is a rare genetic disorder in which impaired mucus clearance commonly results in chronic
      cough and infections in the airways, sinuses, and middle ears. Long lasting airway infection
      ultimately leads to structural damage to the airways, known as bronchiectasis, and, in turn,
      loss of lung function. While PCD shares some similarities with the disease cystic fibrosis,
      it is important to distinguish PCD from cystic fibrosis. In particular, the age of onset and
      progression of PCD's clinical lung disease, including timing of specific microbial pathogen
      infections and bronchiectasis, remain poorly defined. The purpose of this study is to
      determine how lung disease progresses over time in children and adolescents with PCD.
      Specific attention will be directed toward determining whether certain factors play a role in
      lung disease progression. The study will also evaluate diagnostic tools and quality of life
      among individuals with PCD. Filling these gaps of knowledge may help to improve the clinical
      management of PCD in the future.

      This longitudinal study will last 5 years. There will be a total of 5 study visits, and these
      visits will occur yearly. Each study visit will last 3 to 4 hours. All study visits will
      include a medical history review; physical exam; height, weight, and vital sign measurements;
      sampling of respiratory fluids and mucus; lung function tests; and questionnaires. The
      initial visit may also include using a probe to measure nasal nitric oxide levels and blood
      collection for genetic testing. Study visits 1, 3, and 5 will also include blood collection
      for pregnancy testing and a high resolution computed tomography (HRCT) scan of the chest to
      image the lungs. At the end of each month, participants will report any use of oral, inhaled,
      or intravenous antibiotics.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with primary ciliary dyskinesia
      
Biospecimen description: 
      Blood samples
    
Keywords: Kartagener Syndrome
Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO
Condition: Plasmodium Falciparum; Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      Phase IV, single center, 2 arms randomized controlled, open label study. Study will be
      conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics
      and efficacy of ARCO.
    

Detailed description: 
      Evaluation of safety and tolerability of the administration of ARCO and Eurartesim in terms
      of blood biochemistry, full blood count, ECG assessments, vital signs and adverse events
      profile in patients with uncomplicated P. falciparum malaria. Dihydroartemisinin/piperaquine
      will be used as comparator.
    

Intervention name(s): artemisinin/naphthoquine; dihydroartemisinin/piperaquine phosphate
Intervention type(s): Drug; Drug
Intervention description(s): Each tablet of ARCO (artemisinin/naphthoquine) contains 125 mg artemisinin and 50 mg of naphthoquine. The total dose for adults will be 1000mg of artemisinin and 400mg of naphthoquine in a fixed oral dose (ARCO tablet).
The regimen for children will be calculated according to the body weight (20mg artemisinin + 8mg naphthoquine per kg body weight in a fixed oral dose(ARCO tablet)).; Eurartesim (dihydroartemisinin/piperaquine phosphate) is a fixed dose preparation with two dose-strengths (20 mg dihydroartemisinin and 160mg of piperaquine phosphate and 40mg dihydroartemisinin and 320mg of piperaquine phosphate. The regimen for patients with body weight of 36-75kg is three tablets of 40mg dihydroartemisinin and 320mg of piperaquine phosphate once daily for three consecutive days. Those beyond or below this range the regimen will be calculated based on the body weight.
Other intervention name(s): ARCO®; Eurartesim®
Intervention MeSH terms: Piperaquine; Artenimol; Artemisinins; Artemisinin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncomplicated Plasmodium falciparum Malaria
PENTA Fosamprenavir Study
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated
      for the treatment of HIV-infected adults, adolescents and children of 6 years of age and
      above for use in combination with other anti-HIV medicines. Safety data from two
      GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or
      without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated
      that gastrointestinal events were the most commonly reported AEs, but that the majority of
      events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was
      reported in 20% of children in the APV20003 trial; and neutropenia was identified as a
      potential safety concern by the European Medicines Agency (EMEA). The objectives of this
      study were to conduct an observational cohort study of the usage and safety of FPV/RTV in
      children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV
      paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
Intervention type(s): Drug
Intervention description(s): HIV-1 infected children currently or having ever been exposed to FPV (+/- 20% of 18mg/kg BID + RTV)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Seven paediatric HIV cohorts participating in the European Pregnancy and Paediatric HIV
        Cohort Collaboration (EPPICC) as follows: French Perinatal Cohort Study / Enquête
        Périnatale Français; Hospital St.Pierre Cohort, Brussels; Italian Register for
        HIV-infection in Children; Madrid Cohort of HIV-infected Children; Spanish Perinatal Cohort
        Study [NENEXP], Catalonia, Spain; UK National Study of HIV in Pregnancy and Childhood
        [NSHPC] & Collaborative HIV Paediatric Study [CHIPS]; and the "Victor Babes" Hospital
        Cohort, Romania.
      
Keywords: HIV; Antiretroviral therapy; protease inbitor; fosamprenavir; paediatrics
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of
      invasive depth of colorectal neoplasia.
    

Detailed description: 
      NBI could be used in stratifying patients for endoscopic resection or surgery and got an
      accurate evaluation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive adult patients undergo colonoscopy and find out more than one lesion ≧ 6mm from
        Jan 2009 to Dec 2010
      
Biospecimen description: 
      All the lesions will be removed endoscopically or surgically and examined histologically by
      an independent gastrointestinal pathologist.

      Histological diagnosis is determined according to the World Health Organization (WHO)
      criteria.Pedunculated lesions are categorized according to Haggitt's classification.
    
Keywords: narrow band imaging（NBI）; colorectal lesions; predicting histology
Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Single site study involving Biological Mothers and their children approximately 8-10 years
      old to assess the predominant microflora and skin physiology.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and their biological mothers
      
Keywords: microflora; microbiome; bacteria taxa
Alternate-Day Buprenorphine Administration. Phase VII - 8
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if four times a subjects daily maintenance dose
      will hold for 96 hours without changes in agonist and antagonist effects under open dosing
      conditions.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction
Condition: Low Level Laser Therapy; Temporomandibular Joint Dysfunction
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      This study was to determine the effect of conventional therapy and low level laser therapy on
      pain and function in patients with temporomandibular joint dysfunction. sixty patients with
      myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients
      in each group; Group I received traditional exercise. Group II received low level laser
      therapy in addition to traditional exercise. All outcome measures including Pain and
      function, were evaluated before and after the treatment program.
    

Detailed description: 
      METHODOLOGY

      Subjects: This prospective study was conducted on thirty patients of both genders with
      myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university
      Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into
      this study according to the following criteria:
    

Intervention name(s): conventional therapy; low level laser therapy
Intervention type(s): Other; Other
Intervention description(s): Exercise therapeutic Ultrasound; LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.
Other intervention name(s): I; II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: conventional therapy
Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398
      using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.
    

Detailed description: 
      This is a 2-part, single center, double-blind study (neither physician nor participant knows
      the treatment that the participant receives). Part 1 is designed to evaluate the safety,
      tolerability, and pharmacokinetics (level of drug in the blood) of a dosing regimen of an
      investigational drug (JNJ-26528398) prior to its use in Part 2. In Part 1, participants will
      be assigned by chance to receive either 3 mg/day JNJ-26528398 (6 participants) or placebo (3
      participants) for 7 consecutive days while staying in the clinic for 10 days. Placebo is an
      inactive substance that is compared with a drug to test whether the drug has a real effect.
      Part 2 is designed to evaluate the anti-inflammatory properties of JNJ-26528398 by measuring
      markers of inflammation in the blood after intravenous (IV) administration of a substance
      (endotoxin) which activates the immune system and temporarily causes flu-like symptoms. In
      Part 2, participants will be assigned by chance to receive up to 3 mg/day JNJ-26528398 (6
      participants) or placebo (4 participants) for up to 7 consecutive days while staying in the
      clinic for 10 days. Endotoxin will be given on the last day of study drug administration.
      Participants will remain in bed for at least 6 hours after endotoxin administration and will
      be closely monitored by study personnel.
    

Intervention name(s): JNJ-26528398; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In Study Part 1, the participant will receive an oral solution of JNJ-26528398 3 mg once daily for 7 days. The same dosing regimen is planned for Part 2, but may be adjusted (lower dose and/or fewer dosing days) based on the data from Part 1.; In both Study Part 1 and Part 2, the participant will receive an oral solution of matching placebo once daily for up to 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy participants; Pharmacodynamic; Pharmacokinetics; Intravenous Endotoxin-Induced Model; Acute Inflammation; JNJ-26528398; Anti-inflammatory
Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery
Condition: Pain; Postoperative
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effectiveness of pre-emptive Quadratus
      lumborum block on intra, postoperative pain assessment and opioid requirements in
      laparoscopic bariatric procedures.
    


Intervention name(s): US-guided Quadratus lumborum block.; Bupivacaine; Saline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery; Bupivacaine; normal saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Quadratus lumborum block; laparoscopic bariatric surgery
A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the clinical tablet formulation of prasugrel taken orally with an orally
      disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel
      active metabolite circulating in the blood for each treatment.
    


Intervention name(s): Prasugrel (clinical formulation); Prasugrel (Orally Disintegrating Tablet [ODT])
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY640315; Effient®; Efient®; LY640315; Effient®; Efient®
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fat Layer Reduction in the Lateral Thighs Using CoolSculpting
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the performance of a cryolipolysis system using a colder treatment parameter for
      non-invasive reduction of subcutaneous fat in the lateral thighs.
    

Detailed description: 
      Evaluation of the Zeltiq CoolSculpting System for non-invasive subcutaneous fat reduction in
      the lateral thighs.
    

Intervention name(s): The Zeltiq CoolSculpting System
Intervention type(s): Device
Intervention description(s): The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
Condition: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a 10-week, placebo-controlled, randomized study to investigate the effect of
      injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or
      Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
    


Intervention name(s): Canakinumab 150 mg; Placebo to Canakinumab
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous injection of Canakinumab 150 mg.; Single subcutaneous injection of Placebo to Canakinumab.
Other intervention name(s): ACZ885; Glucophage; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Orinase; Glipizide; Glucotrol; Glimepiride; Amaryl; Glyburide; DiaBeta; Micronase; Glynase PresTab; Troglitazone; Rezulin; Insulin; Iletin; Novolin; Velosulin; Humalog; Humulin; Lente; Ultralente; NPH Iletin; ACZ885; Glucophage; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Orinase; Glipizide; Glucotrol; Glimepiride; Amaryl; Glyburide; DiaBeta; Micronase; Glynase PresTab; Troglitazone; Rezulin; Insulin; Iletin; Novolin; Velosulin; Humalog; Humulin; Lente; Ultralente; NPH Iletin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Glimepiride; Insulin Lispro; Insulin, Isophane; Glyburide; Glipizide; Troglitazone; Tolbutamide; Acetohexamide; Insulin, Regular, Pork; Tolazamide; Chlorpropamide; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; canakinumab; Pre diabetic; glucose intolerant; oral anti diabetic medication; insulin treatment; metabolic syndrome
To Explore the Changes of Nutritional Status, Immune Function, Intestinal Motility and Intestinal Flora in Patients With Constipation Before and After Surgical Treatment
Condition: Constipation; Surgical Treatment
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Chronic constipation is a heterogeneous disease with multiple symptoms, and its incidence is
      on the rise in many countries. It has become a common disease affecting the quality of life.
      When these patients fail to respond to standardized and systematic non-surgical treatment,
      and the relevant examination suggests that there are surgical indications, surgical treatment
      should be considered. The cure rate of surgical treatment can reach 95%. The purpose of this
      study was to evaluate the intestinal motility, nutritional status, immune function and
      intestinal environment of patients by measuring BMI, biochemical tests and nutritional risk
      related questionnaires.
    


Intervention name(s): Subtotal colectomy was performed
Intervention type(s): Procedure
Intervention description(s): Colonic subtotal resection, also known as subtotal colectomy, is a surgical procedure used to treat colonic diseases such asconstipation, colon cancer, ulcerative colitis, and others.
The purpose of this surgery is to remove a portion of the colon in the patient's body. Unlike a total colectomy, which involves removing the entire colon, a subtotal colectomy only removes a portion of the colon. The procedure typically involves removing the diseased part of the colon and reconnecting the remaining colon. This allows for the preservation of some normal colonic function, enabling the patient to have regular bowel movements.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment