bioihbjkbjnl/mcl2 huggingface dataset:
HIV Risk Reduction in Subutex Injectors in Tbilisi
Condition: HIV
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will obtain pilot data on the acceptability of a 12-week course of daily observed
      suboxone and methadone, followed by a dose taper or referral to a local treatment program for
      80 opioid dependent patients (40 group) who have been injecting subutex or other
      buprenorphine preparations 10 or more days in the past 30, and on the impact of each
      medication on HIV risk and on subutex and opioid use during treatment and a followup at week
      20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research
      Center, Union Alternative of Georgia in Tbilisi.
    


Intervention name(s): methadone; buprenorphine-naloxone (Suboxone) for 12 weeks
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks of methadone maintenance with counseling; 12 weeks of maintenance with counseling
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: buprenorphine injecting; opiate dependence; HIV risk; treatment outcome; opiate dependence with buprenorphine injecting
Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis
Condition: Primary Glomerulonephritis
MeSH terms: Glomerulonephritis
Study type: Interventional

Summary: 
      we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1
      production in human glomerulonephritis.
    

Detailed description: 
      Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment
      of peripheral vascular occlusive disorders. In addition, PTX has shown its ability to
      attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis,
      and to reduce subnephrotic proteinuria due to early and advanced diabetic nephropathy.
      However, data with respect to its effect on non-nephrotic primary glomerular diseases are
      lacking. Moreover, while the anti-proteinuric effect of PTX has been largely attributed to
      down-regulation of TNF-a, it remains unknown whether other mediators, especially MCP-1, are
      also affected by PTX. Because our previous works have shown that PTX attenuates proteinuria
      and suppresses renal MCP-1 mRNA expression in experimental glomerulonephritis in rats, we
      hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1
      production in human glomerulonephritis. This study was thereby conducted to investigate the
      potential anti-proteinuric and anti-MCP-1 effects of PTX in subnephrotic patients with
      primary glomerular diseases.
    

Intervention name(s): pentoxifylline
Intervention type(s): Drug
Intervention MeSH terms: Pentoxifylline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glomerulonephritis
Effect of OSA on RV Heamodynamics and Function
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Correlation of severity of obstructive sleep apnea and function of the right ventricle by
      means of 2D echocardiography and cardiac MRI
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a frequently under diagnosed condition that has emerged as
      an increasing medical problem with important social and financial implications worldwide. OSA
      is a well established risk factor for systemic hypertension , myocardial infarction or
      stroke.

      Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive collapse of the upper
      airway during sleep .The obstructive apneic event is associated with considerable breathing
      efforts against a totally or partially occluded upper airway, and apnea is terminated by an
      arousal and heavy snoring as airflow is restored. Severity of OSAS is described according to
      total number of apneas and hyperpneas per hour of sleep, which is named as the apnea-hypopnea
      index (AHI).

      Cardiovascular disturbances are the most serious complications of OSAS. These complications
      include heart failure, acute myocardial infarction, nocturnal arrhythmias, stroke, systemic
      and pulmonary hypertension. All these cardiovascular complications increase morbidity and
      mortality of OSAS.

      Currently, sleep apnea is accepted as one of the identifiable causes of hypertension. Also,
      OSAS is closely associated with obesity and ageing.

      There is conclusive evidence that OSAS influences right heart function (the
      pathophysiological consequences of sleep apnea-hypopnea might result in an imbalance in
      myocardial oxygen delivery/consumption ratio, activation of sympathetic and other
      neurohormonal systems, and increased right and left ventricular after load )
    

Intervention name(s): 2D Echocardiography and cardiac MRI
Intervention type(s): Diagnostic Test
Intervention description(s): imaging of right ventricle by both modalities to assess right ventricle function accurately
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will include 90 patients who are diagnosed as obstructive sleep apnea by sleep
        study and 10 healthy volunteers
Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
Condition: Mental Health Issue; Body Image
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat
      cognitive distortion for body image. Then, validate its efficacy to make an improvement in
      both physical and mental health.
    


Intervention name(s): Liposuction; Cognitive Behavioral Therapy
Intervention type(s): Procedure; Behavioral
Intervention description(s): This is a type of fat removal procedure used in plastic surgery.; This is a psycho-social intervention that aims to improve mental health.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Body Image Satisfaction; Liposuction; Psychological Therapy
Lansoprazole Versus Mosapride for Functional Dyspepsia
Condition: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome
MeSH terms: Syndrome; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      Functional dyspepsia is a common symptom complex with significant impact on quality of life.
      There is no standard treatment for functional dyspepsia but therapeutic efficacy of proton
      pump inhibitor (PPI) and prokinetic agent have been proved in subsets of patients. This study
      has two aims:

        -  first is to compare the therapeutic efficacy of lansoprazole (a PPI) and mosapride (a
           prokinetic agent) for functional dyspepsia

        -  second is to investigate whether different subgroups of functional dyspepsia (e.g.,
           epigastric pain syndrome and postprandial distress syndrome) respond differently to PPI
           and prokinetic agent.
    

Detailed description: 
      Eligible outpatients with presentation of dyspepsia are enrolled if they fulfilled the
      criteria of ROME III criteria. A trained assistant helps the eligible patients to complete
      the ROME III standard questionaire, brief symptom rating scale (BSRS), and Maudsley
      Personality Inventory (MPI). The enrolled patients are then randomized into either
      lansoprazole or mosapride group for 14-day treatment. Before starting medication, right after
      completing the medication, and 1 month after the medication, the enrolled patients complete
      standardized severity questionnaire (Hong-Kong Index) to evaluate severity of dyspeptic
      symptoms. Symptom improvement is then determined.
    

Intervention name(s): lansoprazole; mosapride
Intervention type(s): Drug; Drug
Intervention description(s): lansoprazole, 30 mg, once daily for 14 days; mosapride, 5 mg, thrice daily for 14 days
Other intervention name(s): Takepron (brand name); Mopride (brand name)
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Mosapride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: functional dyspepsia; epigastric pain syndrome; postprandial distress syndrome; proton pump inhibitor; 5 HT-4 receptor agonist
Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage
Condition: Depression; Anxiety Depression; Pregnancy Early
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar
      pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the
      parity on depression and anxiety.
    

Detailed description: 
      The beck depression and anxiety scale consists of questionnaire questions asked to the
      patient, and the value on 17 indicates advanced depression.

      The BDI inventory has maximum of 63 and minimum of 0 scores:

      (0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20):
      Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over
      40: Extreme depression. A persistent score of !17, requires psychiatric treatment
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Comparison of beck depression and anxiety values of nulliparous and multiparous pregnants
        who underwent optional abortion below 12 weeks and the effect of parity on depression and
        anxiety.
      
Keywords: Beck Depression; Beck Anxiety; parite; curettage
Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438)
      and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult
      participants
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of ALVAC-HIV
      and bivalent gp120 protein/MF59 or bivalent gp120 protein/AS01(B). This study will also
      compare HIV-specific CD4+ T-cell response rates at the Month 6.5 timepoint (2 weeks after the
      fourth vaccination) of ALVAC-HIV and bivalent gp120 protein/MF59 to each of the bivalent
      gp120 protein/AS01(B) vaccine regimens. Additionally, this study will compare HIV-specific
      Env-gp120 binding antibody response magnitudes at the Month 12 timepoint (6 months after the
      fourth vaccination) of ALVAC-HIV and bivalent gp120 protein/MF59 to each of the bivalent
      gp120 protein/AS01(B) vaccine regimens.

      The study will enroll 160 healthy, HIV-uninfected volunteers aged 18 to 40 years. Groups 1 to
      3 will consist of a total of 150 participants who will receive the vaccines at Months 0, 1,
      3, and 6, while 10 participants in Group 4 will receive placebos at Months 0, 1, 3, 6.

      Study visits will include a physical examination, an interview and/or questionnaire, HIV
      testing and HIV risk-reduction counseling, and urine and blood collection. Participants may
      optionally choose to provide rectal fluid, cervical fluid, semen, and/or stool samples.
    

Intervention name(s): ALVAC-HIV (vCP2438); Bivalent subtype C gp120/MF59; Bivalent subtype C gp120/AS01(B); Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): expresses the gene products 96ZM651 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and Gag and Pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a viral titer greater than or equal to 1 × 10^6 cell culture infectious dose (CCID)50 and less than 1 × 10^8 CCID50 (nominal dose of 10^7 CCID50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%), administered IM as a single 1 mL dose.; clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered IM as a single 0.5 mL dose.; clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 20 mcg or 100 mcg, mixed with AS01B adjuvant, administered IM as a single 0.75 mL dose.; Sodium Chloride for Injection, 0.9%, administered IM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV
Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
Condition: Muscular Dystrophy, Facioscapulohumeral
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine whether albuterol increases strength in patients with
      facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction
      testing.

      II. Determine whether albuterol increases muscle mass in this patient population as
      determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry
      (DEXA).

      III. Examine the long term safety of albuterol in this patient population.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
      randomized into one of three treatment groups. The first group receives placebo. The second
      group receives low dose albuterol orally every 12 hours. The third group receives high dose
      albuterol orally every 12 hours. Treatment continues for 52 weeks unless unacceptable side
      effects occur.

      All patients return for follow up assessments at weeks 4, 12, 24, and 52.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): albuterol
Intervention type(s): Drug
Intervention MeSH terms: Albuterol
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: genetic diseases and dysmorphic syndromes; muscular dystrophy; neurologic and psychiatric disorders; rare disease
Evaluation of Risk Factors of Sleep Quality in Intensive Care Unit
Condition: Sleep Disorders; Delirium
MeSH terms: Delirium; Sleep Wake Disorders
Study type: Observational

Summary: 
      The aim of this study was to investigate the relationship between sleep disturbances and
      delirium in surgical ICU patients. The study set up to test the hypothesis that the
      occurrence of delirium is associated to the alteration of sleep quality and quantity observed
      in the critically ill patients.
    

Detailed description: 
      Sleep disorders are an important clinical entity affecting outcome in respiratory,
      cardiovascular, metabolic and psychiatric disorders and exacting a potentially significant
      toll on patients at both a personal and socio-economic level.Delirium is a common organ
      dysfunction in the critically ill patients characterized by an acute onset of impaired
      cognitive function [REF] associated with prolonged ICU and hospital stay, nosocomial
      pneumonia, and death.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ICU postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to
        the general ICU
      
Keywords: Sleep; ICU; Delirium; Post surgical ventilated patients; ICU patients
Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib
      administered to participants with impaired renal/kidney function to those of a healthy
      matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in
      participants with impaired renal function is similar to that in matched healthy participants
      following a single 50 mg oral dose.
    


Intervention name(s): MK-0822
Intervention type(s): Drug
Intervention description(s): A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Other intervention name(s): odanacatib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Maribavir Pediatric Formulation in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one
      part.

      The main aim of Part 1 of this study is to check the ability of a single dose of maribavir
      pediatric formulation to be absorbed in the digestive tract compared to commercial tablet
      formulation and to check how a high-fat, high-calorie meal affects absorption, distribution,
      and elimination of maribavir pediatric formulation given orally as water suspension.

      The main aim of Part 2 of this study is to assess the stomach acid reducing effect of
      multiple doses of rabeprazole on absorption, distribution, and elimination of maribavir
      pediatric formulation given orally as water suspension.

      Each participant will stay in the study clinic from the day before the first treatment until
      the day after the last treatment.
    

Detailed description: 
      Part 1 is a crossover design with three treatments (Treatments A, B, and C), six sequences,
      and three periods.

      The relative bioavailability of 200 milligrams (mg) maribavir pediatric formulation
      administered orally as water suspension under fasting conditions (Treatment B) will be
      compared to 200 mg maribavir commercial tablet administered orally under fasting conditions
      (Treatment A). In addition, the effect of food on the pharmacokinetics (PK) of 200 mg
      maribavir pediatric formulation administered orally as water suspension under fasting
      conditions (Treatment B) and fed conditions (Treatment C) will be assessed. In each sequence,
      participants will receive three treatments (Treatments A, B, and C) per schedule.

        -  Sequence 1: Treatment A + Treatment B + Treatment C

        -  Sequence 2: Treatment A + Treatment C + Treatment B

        -  Sequence 3: Treatment B + Treatment A + Treatment C

        -  Sequence 4: Treatment B + Treatment C + Treatment A

        -  Sequence 5: Treatment C + Treatment A + Treatment B

        -  Sequence 6: Treatment C + Treatment B + Treatment A

      Part 2 is a single fixed-sequence design with two treatments (Treatments D and E). The two
      treatments will be administered to evaluate the gastric acid-reducing effect of multiple
      doses of rabeprazole on the PK of a single dose of 200 mg maribavir pediatric formulation
      administered orally as water suspension.
    

Intervention name(s): Maribavir Commercial Tablet Formulation; Maribavir Pediatric Powder-for-oral Suspension Formulation; Rabeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Maribavir commercial tablet.; Maribavir pediatric powder-for-oral suspension.; Rabeprazole tablet.
Other intervention name(s): TAK-620; TAK-620
Intervention MeSH terms: Maribavir; Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1/2 Study of Durvalumab(MEDI4736) and Tremelimumab in Chinese Patients With Advanced Malignancies
Condition: Advanced Malignancy
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability,
      Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with
      tremelimumab in Chinese Patients with Advanced Malignancies
    


Intervention name(s): durvalumab; tremelimumab + durvalumab
Intervention type(s): Drug; Drug
Intervention description(s): durvalumab (MEDI4736) 20mg/kg via IV infusion every 4 weeks until confirmed disease progression or unacceptable toxicity; 20 mg/kg durvalumab (MEDI4736) via IV infusion q4w and 1 mg/kg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 20 mg/kg durvalumab (MEDI4736) q4w starting on Week 16 for up to confirmed disease progression
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms
      to evaluate contact lens related dry eye symptoms and subjective comfort.
    


Intervention name(s): ACUVUE Oasys 1-Day; Habitual Lens
Intervention type(s): Device; Device
Intervention description(s): TEST; Subjects' own Habitual Lenses
Other intervention name(s): CONTROL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be performed to evaluate the safety, tolerability and pharmacokinetics of
      single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male
      volunteers.
    


Intervention name(s): AZD0328
Intervention type(s): Drug
Intervention description(s): Oral solution A single dose Day 1 followed by once daily doses on Day 3-7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: AZD0328; Japanese; Caucasian; pharmacokinetics; safety; tolerability