bioihbjkbjnl/mcl2 huggingface dataset:
Vedic Counselling for Women Victims of Domestic Abuse
Condition: Intimate Partner Violence; Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The Vedic Counselling is the whole person approach, system of total life style counselling
      based on 'Vedic Laws of right living, right actions, right relationship and right
      awareness'.Vedic Counselling was developed as trauma focused therapy for this study to treat
      female victims of domestic abuse.
    


Intervention name(s): Vedic Counselling; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trauma focused Vedic Counselling intervention was delivered by trained and experienced therapist of Yoga and Vedanta.12-week sessions were provided on one to one bases on personalised approach.; The active control group received standard psychosocial care provided by the participating psychologists and psychiatrists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-finding Study With Lu AA24530 in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess the efficacy in treating patients with Major
      Depressive Disorder of one or more doses of Lu AA24530 relative to placebo
    

Detailed description: 
      According to the World Health Organisation, Major Depressive Disorder is the leading cause of
      disability and the 4th leading contributor to the global burden of disease. There are unmet
      medical needs in the treatment of depressive disorders in terms of insufficient effectiveness
      and unpleasant side-effects of current therapies. The overall prognosis of the disorder is
      positive for the majority of patients, but as many as 30% of patients will develop a chronic
      and treatment-resistant depression. In the study, patients with depression are treated for 6
      weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks
      and again after 6 weeks of treatment.
    

Intervention name(s): Lu AA24530; Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): per oral, once daily for 6 weeks; per oral, once daily for 6 weeks; per oral, once daily for 6 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug therapy; Depressive disorder; Antidepressive agents; Depressive symptoms; Affective disorders; Randomized controlled trial; Placebo-controlled; Double-blind; Active reference; Multicenter study
Single-dose and Multiple-dose X842 Phase 1 Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of X842 after
      administration of single and multiple doses in healthy subjects
    

Detailed description: 
      This is a single-center, open label, First-In-human (FIH), Phase I clinical study to evaluate
      the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of
      single dose and multiple doses of X842 capsules in healthy subjects.

      The study comprises a Single Ascending Dose (SAD) part, a Multiple Ascending Dose (MAD) part,
      and a Food Effect (FE) study.
    

Intervention name(s): Single ascending dose of X842; Multiple ascending dose of X842; Food Effect
Intervention type(s): Drug; Drug; Other
Intervention description(s): A total of 7 dose groups will be set for the ascending dose: 5.6 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 225 mg. In the 5.6 mg dose group, 4 subjects will receive X842; in the 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 225 mg dose groups, 8 subjects in each group will receive X842. Each subject can only receive a certain dose level and cannot enter in multiple dose groups repeatedly.; Two dose groups will be set, including the groups receiving the recommended phase II dose and a higher dose; Eight subjects will be enrolled in each group, with half male and half female, who will receive X842 once daily for 5 consecutive days. Each subject can only receive a certain dose level and cannot enter in multiple dose groups repeatedly.; Twelve subjects (appropriate ratio of male to female) screened for eligibility will be randomized into Group A and B. The 6 subjects in Group A will take the study drug (X842) in fasted condition and subject in Group B will take the study drug in fed condition in the 1st cycle. In the 2nd Cycle, subjects in Group A will take the study drug in fed condition, and subjects in Group B will take the study drug in fasted condition. The interval between the two cycles is at least 7 days.
Other intervention name(s): X842; X842; X842
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: SAD, MAD and FE study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Potassium competitive acid blocker; Esophagitis; X842; Intragastric pH; Gastroesophageal reflux disease; GERD; Acid inhibition
Dairy Macronutrient Effects on the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The investigators examined the effects of 4-week dietary protein intake in mixed meals at two
      levels of protein amount on whole body glucose metabolisms in older adults with metabolic
      syndrome.
    

Detailed description: 
      The investigators investigated changes in insulin sensitivity before and after 4 weeks of
      dietary intervention and control in subjects with metabolic syndrome. Two groups of subjects
      were studied before and after a weight maintenance diet. Group 1 was fed a common American
      diet with a macronutrient distribution of 10% protein, 55% carbohydrates, and 35% fat. Group
      2 consumed a higher protein diet (20%; 1.4 g/kg/d of protein). Carbohydrate intake was lower
      in Group 2 (45%), with fat intake (largely derived from dairy sources) similar between
      groups. Glucose utilization and endogenous glucose production were determined during an oral
      glucose tolerance test (OGTT) with a novel double-tracer approach. The secondary aim was to
      determine the effect of a diet high in dairy consumption on blood lipid profiles. The
      investigators measured blood lipids before and after dietary intervention in each group.
    

Intervention name(s): Recommended protein intake; Elevated protein intake
Intervention type(s): Other; Other
Intervention description(s): Recommended protein intake diet contained 10% protein, 55% carbohydrate,and 35 % fat.; Recommended protein intake diet contained 20% protein, 45% carbohydrate,and 35 % fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Effects in Cervical Spinal Mobilization and Oscillation Mobilization in Neck Pain
Condition: Manual Therapy; Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to compare the clinical effects of spinal mobilization versus
      vertebral resonant oscillation (POLD) in patients with bilateral mechanical neck pain on pain
      sensitivity and neck pain intensity.
    

Detailed description: 
      The clinical practice guidelines for manual therapy management the neck pain including the
      spine mobilization.

      The vertebral resonant oscillation using the POLD method is similar to spine mobilizations,
      but there are some differens; the oscillatory movement has a sinusoidal waveform, the
      frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to
      described by Panjabi 1992.

      The spinal mobilizations has a posterior-anterior vertebral movement for spinous process,
      described by Maitland 2000.
    

Intervention name(s): Spine Mobilizations; Vertebral Resonant Oscillation
Intervention type(s): Other; Other
Intervention description(s): Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000; The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens ; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mobilization; resonant oscillation
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 48-week study to collect additional information on the safety, tolerability,
      pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy)
      including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.
    

Detailed description: 
      A 48 Week, Phase II, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety,
      Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir QD and
      GW433908/Ritonavir BID when Administered to HIV-1 Infected, Antiretroviral Naive and
      Experience Pediatric Subjects 2 to 18 Years Old

      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): ritonavir; fosamprenavir
Intervention type(s): Drug; Drug
Intervention description(s): ritonavir oral capsules or oral solution; fosamprenavir oral suspension or tablet
Other intervention name(s): fosamprenavir
Intervention MeSH terms: Ritonavir; Fosamprenavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; HIV; protease inhibitors; ritonavir; fosamprenavir; LEXIVA; AGENERASE; amprenavir
Single and Multiple Dose Study to Explore the Safety and Pharmacokinetics of JNJ-39758979 In Healthy Male Volunteers of Either Caucasian or Japanese Descent
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics
      (how the drug is absorbed in the body, how it is distributed within the body and it is
      removed from the body over time) of single doses of JNJ-39758979 in healthy Japanese
      volunteers and multiple doses of JNJ-39758979 in healthy Japanese and Caucasian volunteers.
    

Detailed description: 
      This study will assess the safety and pharmacokinetics of JNJ-39758979 or placebo (which
      looks like the drug being studied but has no active ingredients) in healthy volunteers. This
      study is being conducted in two parts. Part 1 is a randomized (study drug will be assigned by
      chance), double-blind (neither the physician nor volunteer knows the identity of the assigned
      drug) study evaluating the safety, tolerability and pharmacokinetics of single doses of
      JNJ-39758979 and placebo in 36 healthy Japanese male volunteers. Part 2 is a randomized,
      double-blind study evaluating the safety, tolerability, and pharmacokinetics of multiple
      doses of JNJ-39758979 and placebo in 24 healthy Japanese males and 24 healthy Caucasian
      males. For Part 1, the participation period is a maximum of 56 days, including a screening
      visit, a 7-day in-clinic period and two follow-up visits. For Part 2, the participation
      period is a maximum of 202 days, including a screening visit, a 17-day in-clinic period and
      two follow-up visits. For both parts of the study, safety evaluations, which will include ECG
      (a cardiac function test), vital signs and monitoring of side-effects will be performed.
      Additionally, blood and urine samples will be collected for evaluation. Part 1: volunteers
      will receive a single oral (by mouth) dose of JNJ-39758979 (50, 100, 300, or 600mg) or
      placebo; Part 2: volunteers will receive an oral dose of JNJ-39758979 (300 mg) or placebo
      once a day for 14 days.
    

Intervention name(s): single dose NJ-39758979/ matching placebo; multi-dose JNJ-39758979 /matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of JNJ-39758979 (either 50, 100, 300, 600mg) or Placebo; JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: JNJ 39758979; Japanese descent
The Role of Leptin Receptors in NASH
Condition: Nonalcoholic Steatohepatitis; Metabolic Syndrome
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Observational

Summary: 
      NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis,
      inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics,
      but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the
      morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily
      secreted by adipose tissue. The production of serum leptin increases with progressive
      obesity. Because of this observation, there has been significant interest in potential role
      of leptin in NAFLD.

      Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression
      as the degree of hepatic injury worsens in NAFLD.
    


Intervention name(s): no interventions, only regular blood-draw
Intervention type(s): Other
Intervention description(s): No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for bariatric surgery
      
Biospecimen description: 
      Liver biopsy specimes, serum
    
Keywords: leptin, leptin receptors, adiponectin
Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome
Condition: Overactive Bladder; Obstructive Sleep Apnea; Overactive Bladder Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Urinary Bladder, Overactive; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, we aim to determine whether combined tolterodine and CPAP therapy is a more
      effective treatment for patients with OSAS than CPAP treatment only.
    


Intervention name(s): Tolterodine Tartrate 4 MG; Continuous positive airway pressure therapy (CPAP)
Intervention type(s): Drug; Other
Intervention description(s): Tolterodine is actively being used in the treatment of over active bladder symptoms today; The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile
      imaging both before and after surgery for the repair of the POP. Surgical repair will be
      performed by a single surgeon who will perform either a laparoscopic or vaginal repair.
    

Detailed description: 
      Patients will be recruited and sign a consent form. The patients included are patients with
      POP that are candidates for either laparoscopic or vaginal repair.

      Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different
      points:

        -  The day of surgery before surgery.

        -  The day after surgery.

        -  3 months post-operational. Every patient will serve as her own control. Demographic,
           gynecologic and obstetric history will be obtained from patients' electronic files.
    

Intervention name(s): vaginal tactile imager
Intervention type(s): Device
Intervention description(s): Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to assess the performance of the subcutaneous glucose sensor
      over an extended sensor life. The sensor is currently approved for 3 days of use and this
      study will examine sensor safety and accuracy when used for six days. This study will also
      test sensor safety and accuracy when inserted in an alternate body location (buttock area in
      addition to abdomen area). The study hypothesis is that the sensor performance will not
      greatly diminish when used for six days, or in an alternate insertion area.
    

Detailed description: 
      The Medtronic MiniMed Subcutaneous Glucose Sensor was originally approved by the FDA for
      commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999
      (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose
      oxidase beneath several layers of biocompatible membrane. This same sensor is used as part of
      the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is
      based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for
      use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received
      regulatory approval from the FDA in 2006.

      As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of
      72 hours, using only the abdomen area as an insertion site. Recent studies have shown that
      the useful sensor life could extend beyond three days, and it is reasonable to expect a
      significant percentage of sensors to last six days. It is the goal of this study to confirm
      sensor performance accuracy data from one of these recent studies. The sensor is also
      commonly worn in body areas other than the abdomen (such as the buttock). This study will
      also demonstrate sensor accuracy when used in an alternate site.
    

Intervention name(s): MMT-7003 subcutaneous glucose sensor
Intervention type(s): Device
Intervention description(s): All subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy.
Other intervention name(s): Glucose sensor; Blood sugar sensor; glucose monitor; blood sugar monitor; MiniMed sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood sugar; glucose; sensor
Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia

      Secondary Objective:

      To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.
    

Detailed description: 
      The study duration by subject will include a 8-week treatment period with 3 follow-up visits.
    

Intervention name(s): AMISULPRIDE
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: tablet Route of administration: oral
Other intervention name(s): Solian
Intervention MeSH terms: Amisulpride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to estimate the relative potency for bronchoprotective effect of
      formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).
    


Intervention name(s): Formatris 24µg; Formatris 12µg; Foradil P 24µg; Foradil P 12µg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2; 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2; Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2; Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment