bioihbjkbjnl/mcl2 huggingface dataset:
Drug Treatment for Alcoholics With Bipolar Disorder
Condition: Alcoholism; Bipolar Disorder
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in
      treating individuals with alcohol dependence and comorbid bipolar disorder.
    

Detailed description: 
      The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in
      individuals with alcohol dependence and bipolar disorder, in a double-blind,
      placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with
      treatment as usual, which include lithium carbonate and individual dual recovery counseling
      and are randomized to either sodium valproate or placebo.
    

Intervention name(s): sodium valproate
Intervention type(s): Drug
Intervention description(s): subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.
Other intervention name(s): Depakote, Divalproex sodium, Depacon
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over
      single-dose study employing administration of two oral formulations of crizotinib (OLF and
      FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled
      to obtain at least 20 evaluable subjects who complete the study. Each subject will receive
      two treatments (A and B) with a washout period of at least 14 days between each treatment.
    


Intervention name(s): crizotinib
Intervention type(s): Drug
Intervention description(s): Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days.
Intervention MeSH terms: Crizotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: relative bioavailability; pharmacokinetics; crizotinib; oral liquid formulation; formulated capsule
The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled clinical study. The investigators screen of eligible
      patients, randomized divide into the following two groups: corticosteroids + azathioprine
      group, corticosteroids + leflunomide group. The investigators treat the enrolled patients,
      estimate efficacy and observed the side effects according to the requirements of program. The
      investigators establish a clinical database for recording patients date and statistical
      analysis. Evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis
      patients in the different group prove that what kind of treatment can improve the cure rate.
      The investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and
      kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when the
      investigators apply these therapy in the treatment of different clinical types of myasthenia
      gravis.
    


Intervention name(s): Azathioprine; Leflunomide
Intervention type(s): Drug; Drug
Intervention description(s): The basic therapy of each group is cholinesterase inhibitors (pyridostigmine 36mg / kg / d). Group 1 glucocorticoid + Azathioprine: Glucocorticoid (0.25mg/kg/d )plus Azathioprine at a starting dose of 50mg/d for 14 days, then increase up to 2mg/kg in 2 weeks.If no adverse events occurred , maintain the dose until 48 weeks.; The basic therapy of each group is cholinesterase inhibitors (pyridostigmine 36mg / kg / d). Group 2 glucocorticoid + Leflunomide: Glucocorticoid (0.25mg/kg/d )plus Leflunomide 20mg/d for adult, 10mg/d for child. if no adverse events occurred , maintain the dose until 48 weeks.
Intervention MeSH terms: Azathioprine; Leflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myasthenia gravis; leflunomide
Integrated Management of Pronation Deformity in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy; Congenital Abnormalities
Study type: Interventional
Phase: Phase 3

Summary: 
      Pronation deformity is a very common problem in children with cerebral palsy. This deformity
      is usually has neural and non-neural aspects. In this clinical trial the aim is to show the
      importance of combine treatment approach with pharmacological and non-pharmacological
      modalities. .
    

Detailed description: 
      Spasticity is not only the most common motor disorder but also the main cause of slowly
      developing contractures in children with cerebral palsy. Pronation deformity which is a very
      common problem in children with cerebral palsy is primarily due to spasticity of the pronator
      muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and
      joint contractures usually coexist with spasticity of pronator muscles. There is very limited
      information about how to treat this deformity in the current literature.

      In this prospective, randomized, controlled clinical trial the aim is to show the
      effectiveness of twister, and home exercise program in an integrated approach with BoNT-A
      injections on spasticity, and passive range of motion (pROM) of children with CP having
      pronation deformity.
    

Intervention name(s): Botulinum toxin type A; Upper extremity orthoses; Home exercise program
Intervention type(s): Drug; Other; Other
Intervention description(s): Dysport; Twister; Specific exercises for pronation deformity
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cerebral palsy; botulinum toxin-A; pronator deformity
MK0686 in Postsurgery Dental Pain (0686-002)
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the pain relieving effect of MK0686 to placebo or ibuprofen after dental surgery.
    


Intervention name(s): MK0686
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain
Condition: Anterior Knee Pain Syndrome; Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in
      comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength
      on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded
      cross-over study design. Patients with anterior knee pain and signs of impaired hip function
      will be recruited in Vienna and surrounding area, measurements/data collection will be
      conducted by two experienced physiotherapists in a physiotherapy group practice in 1150
      Vienna.
    


Intervention name(s): Joint Mobilization; Laying on of Hands
Intervention type(s): Other; Other
Intervention description(s): Manual Therapy Intervention, commonly used by physiotherapists; Sham Hip Joint Mobilization
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mobilization; muscle strength; hip abductors; hip external rotators
Diet, Nutrient Status, and Food Insecurity
Condition: Food Insecurity
Study type: Interventional

Summary: 
      Arkansas has one of the highest rates for food insecurity and 27.7% of children in the
      University of Arkansas area are food insecure. In addition, more than 14% of children ages
      2-4 are obese and 20% of children ages 10-17 are obese. In Northwest Arkansas, the area
      surrounding the University of Arkansas in Fayetteville (Washington County), the food
      insecurity rate for adults is 17.9% (an estimated 34,730 individuals) and the food insecurity
      rate for children under 17 years of age is 24.4% (12,150 individuals). In addition, the
      surrounding counties have similar food insecurity rates (This makes Northwest Arkansas an
      ideal location to conduct a pilot study focusing on egg supplementation, childhood obesity,
      and food insecurity
      (http://www.feedingamerica.org/hunger-in-america/our-research/map-the-meal-gap).
    


Intervention name(s): Egg supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Pulsed Radiofrequency for Emotional Stress
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The objective of the study is to assess the short-term and long-term effects of
      transcutaneous pulsed radio frequency treatment on the physiological status, subjective
      well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is
      a method that is widely used for control of pain. There are no known complications. In this
      study a Radiofrequency generator will be used that has a separate outlet for transcutaneous
      use. Patients will be recruited within the clinic population of patients.
    

Detailed description: 
      Data will be assessed in at three times, the baseline testing, the first and the second
      follow-up meeting (+2-4 days of intervention; as well as + 40 days via post/email)

      The inclusion criteria are: Inclusion:

        -  age 18 - 65

        -  chronic pain (Duration of three Months or more) patients of the Pain Center Nottwil,
           Swiss Paraplegic Center

      The following criteria will lead to an exclusion of the study:

        -  severe medical issues, such as cancer or comparable diseases

        -  severe mental disorders such as severe depression or schizophrenia

        -  patients with pacemakers or with atrial fibrillation

        -  Women who are pregnant or breast-feeding The primary outcome assessed is the
           physiological status, assessed by the heart rate variability (HRV). Secondary outcomes
           are the subjective well-being, as assessed by the "Marburger questionnaire regarding
           habitual well-being" (FW-7) questionnaire as well as the intensity of pain, as assessed
           by the numeric rating scale for pain intensity (NRS) score and by a 7-point Likert
           scale.
    

Intervention name(s): TcPRF; Placebo
Intervention type(s): Device; Device
Intervention description(s): Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. It is used in the daily clinical practice in the Pain Center of the Swiss Paraplegic Center.; In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
Other intervention name(s): TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan); TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effect of a Weight-Loss Diet in Women Doing Reformer Pilates: A 12-Week Evaluation
Condition: Pilates; Diet; Women
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a weight-loss diet on body
      composition in women who practice reformer pilates for 12 weeks. It compares dietary habits
      and macro and micronutrient intakes in subjects with and without a weight-loss diet at the
      start and end of the study.
    

Detailed description: 
      The effect of a weight-loss diet on body composition in women reformer pilates for 12 weeks
      was compared in this study. It compares dietary habits and macro and micronutrient intakes in
      subjects with and without a weight-loss diet at the start and end of the study.

      A total of 49 women (18 years old) were randomly assigned to one of two groups: control (CG:
      reformer pilates; n=23) or study (SG: reformer pilates + weight-loss diet; n=26). Subjects in
      both groups did pilates for 45 minutes three times a week for a total of 12 weeks. At the
      start and end of the study, their body weight (kg), waist circumference (cm), hip
      circumference (cm), neck circumference (cm), mid-upper arm circumference (cm), and body
      composition [body fat (% ), body water (% ), body muscle (% )] were all measured. Their
      waist/height ratio and body mass index (kg/m2) were also measured at the start and end of the
      study. All subjects' dietary habits were questioned, their 24-hour retrospective food
      consumption was recorded, and their physical activity levels were assessed using the
      International Physical Activity Questionnaire (Short Form).
    

Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): In accordance with Turkey Dietary Guidelines, these diet plans were designed to provide 45-60% of energy from carbohydrates, 10-20% from protein, and 20-35 percent from fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For a period of 12 weeks, subjects in the Study Group (SG) and Control Group (CG) groups received three 45-minute sessions of Pilates exercises per week.
Study Group: In addition to Pilates, she followed a three-month weight-loss diet based on Turkey Dietary Guidelines, as prescribed by the dietician. These diet plans were designed to ensure that carbohydrates provided 45-60% of the energy, protein provided 10-20%, and fat provided 20-35 percent.
Control Group: The women in the control group did only reformer pilates for three months. They were followed up for not applying any diet.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pilates-based exercises; Weight Loss; Diet; Women; Body composition
Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat
Condition: Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Absorption, metabolism and excretion of linerixibat have been studied in previous clinical
      trials. However, no dedicated clinical studies of drug absorption, metabolism, and excretion
      have been conducted for linerixibat. The purpose of this study is to determine the PK,
      balance/excretion, and metabolism of radiolabeled 14 Carbon [14C]-linerixibat following a
      single intravenous (IV) radiolabeled microtracer dose (concomitant with a non-radiolabeled
      oral dose) and a single oral radiolabeled dose. This is a single group, two period, single
      sequence, and mass balance study will enroll 6 healthy male subjects. Each subject will be
      involved in the study for up to 10 weeks which includes screening period, two treatment
      periods (treatment Periods 1 and 2), separated by about 7 days (at least 13 days between oral
      doses), and a follow-up visit 1-2 weeks after the last assessment in treatment Period 2.
    


Intervention name(s): Linerixibat tablet; [14C]-linerixibat intravenous infusion; Linerixibat oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Linerixibat will be available as white to slightly colored film-coated round tablet to be administered as two tablets taken in the fasted state in the morning with 240 milliliter (mL) of room temperature water.; [14C]-linerixibat will be available as clear, colorless solution free from visible particulates to be administered 25 mL IV over 3 hours immediately after the oral dose.; Linerixibat will be available as clear, colorless solution free from visible particulates to be administered 60 mL solution in the fasted state in the morning.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive linerixibat tablets concomitantly with [14C]-linerixibat IV infusion in treatment Period 1 and [14C]-linerixibat oral solution in treatment Period 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: [14C]-linerixibat; GSK2330672; Microtracer dose
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is
      associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to
      patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety
      and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)
    


Intervention name(s): PH-797804; PH-797804; PH-797804; PH-797804; PH-797804; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks; 1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks; 3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks; 6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks; 10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks; Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity
Condition: Lax Skin; Knee
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.
    

Detailed description: 
      Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left
      side treated". All subjects will receive three, single-sided injections of PLLA, performed 1
      month apart. Treatments will be provided to one randomly assigned knee. The non-treatment
      knee will receive bacteriostatic water, injected in the same manner as PLLA. Up to one (1)
      syringe of PLLA, diluted at 16 mL, will be used per session.

      Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial.
      Prior to receiving any study treatment, mandatory photography using 2D photography and Vectra
      will be obtained of each subject's treatment area. All photographs may be used for research
      and/or commercial use.
    

Intervention name(s): poly-L-lactic acid to right knee; poly-L-lactic acid to left knee
Intervention type(s): Device; Device
Intervention description(s): Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.; Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
Other intervention name(s): Sculptra Aesthetic; Sculptra Aesthetic
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of PLLA, performed 1 month apart. Treatments will be provided to one randomly assigned knee. The non-treatment knee will receive bacteriostatic water, injected in the same manner as PLLA. Up to one (1) syringe of PLLA, diluted at 16 mL, will be used per session
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Delayed Language Development in Children With Cleft Palate at Sohag University Hospital
Condition: Delayed Language in Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      This is a retrospective study on children with cleft palate who came to the multidisciplinary
      cleft clinic at Sohag University Hospital from September 2017 to September 2023
    


Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Data collection
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        cleft palate children
Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR)
      Procedure for the treatment of Type 2 Diabetes.
    


Intervention name(s): DMR Procedure (Fractyl)
Intervention type(s): Device
Intervention description(s): Endoscopic procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Conducted Over 3 Periods to Look at the Drug in the Body
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study conducted over 3 periods to look at the drug in the body.
    


Intervention name(s): AZD8329; AZD8329
Intervention type(s): Drug; Drug
Intervention description(s): tablet; Solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Healthy