bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Chronic Low Back Pain Study
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study was to evaluate the analgesic effect and safety of
      hydrocodone/acetaminophen extended release compared to placebo.
    

Detailed description: 
      This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study
      compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to
      placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP).
      Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration
      Period to proceed to randomization into the double-blind (DB) Maintenance Period of the
      study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in
      OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing
      doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice
      daily. During the DB period, participants in the hydrocodone/acetaminophen extended release
      group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2
      weeks, while participants in the placebo group took 1 placebo tablet twice daily.
    

Intervention name(s): hydrocodone/acetaminophen extended release; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): ABT-712
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor
Condition: Vasomotor Symptoms (VMS)
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of
      Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all
      eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2
      treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be
      followed for a 2-week, drug-free, follow-up period after their last dose of blinded
      Q-122/placebo before termination from the study.
    

Detailed description: 
      Vasomotor symptoms (VMS) are significant in postmenopausal women with the most effective
      medications for relief being hormonal preparations. Non-hormonal medications have
      demonstrated efficacy but at a far lower level than estrogen replacement therapy. For women
      with a history of breast cancer, hormone replacement therapy is often contraindicated and is
      not an option for women receiving endocrine therapy including tamoxifen (TAM) and aromatase
      inhibitors (AI). Breast cancer survivors, and women receiving endocrine therapy in
      particular, have a high rate of problematic hot flashes. In an open label Phase 1 study of
      the safety and activity of Q-122 in breast cancer patients taking TAM or an AI, 8 of 9 women
      who received at least 1 dose of 100 mg and 10 of 11 women who received at least 1 dose of 200
      mg had a reduction in hot flashes of 2 or more per day, the FDA criteria for anti-VMS
      activity. This study will define the effect of Q-122 versus placebo in a population of women
      with a history of or current breast cancer who have an average of 50 or more moderate to
      severe hot flashes per week.
    

Intervention name(s): Q-122; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule of Q-122; oral capsule of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical,
      gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a
      single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2
      diabetes mellitus and obesity class I. In order to compare the effect of weight loss on
      glycemic control among medical and surgical groups, and after 2 years of follow up, the
      results of efficacy, safety and maintenance will be compared between the three groups.
    


Intervention name(s): Gastric bypass surgery; Surgical ileal transposition with sleeve; Clinical
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Gastric bypass surgery performed laparoscopically; Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.; The study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes mellitus; Grade I obesity; Inadequate glycemic control
Study to Learn More About the Effect of Itraconazole (ITZ) Given Repeatedly by Mouth on the Way How the Study Drug BAY1902607 Given One Time by Mouth Acts in the Human Body of Healthy Male Participants
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      BAY1902607 is a new type of drug under clinical development for different conditions
      including the treatment of endometriosis, i.e. a condition where the tissue that usually
      grows inside the womb grows outside of the womb.

      Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and
      possibly inhibits the breakdown of BAY1902607. In this clinical study, BAY1902607 is given
      alone by mouth or in combination with ITZ. Researchers want to learn more how quickly and to
      what extent the study drug BAY1902607 given by mouth to healthy male participants is absorbed
      by the human body, reaches the blood stream and is excreted again. In addition they want to
      find out whether the elimination of the study drug BAY1902607 is influenced by ITZ given at
      the same time.
    


Intervention name(s): BAY1902607; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.; Itraconazole is administered at a dose of 200 mg once a day (oral solution of 10 mg mL-1) on Day 1 to Day 14 of study period 2.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug-drug interaction; Itraconazole (ITZ); Cytochrom P450 3A4 (CYP3A4) metabolism; P2X3-inhibitor
A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Condition: Alcohol Dependence; Anxiety; Depression
MeSH terms: Alcoholism; Depression
Study type: Interventional

Summary: 
      There is a high rate of psychological comorbidity in people suffering from alcohol
      dependence. There is a need for an effective integrated treatment for alcohol dependence and
      comorbid anxiety or depression. This study will test the efficacy of a novel integrated
      intervention for comorbid alcohol dependence and anxiety or mood disorder.
    

Detailed description: 
      In summary, the specific aims of this project are:

        1. To assess the effectiveness of a novel stepped care intervention for alcohol dependent
           patients with co-morbid anxiety and/or depression compared to usual treatment for
           alcohol dependence in promoting abstinence from alcohol and increased quality of life
           and in reducing symptoms of anxiety and depression.

        2. To describe important factors relating to the maintenance of alcohol-related psychiatric
           comorbidity.

      Step 1: All subjects will complete 12 weeks of pharmacotherapy (n = 120) on naltexone (50 mg,
      1 tablet daily), acamprosate (333 mg, 2 tablets 3 times daily, reduced to 4/day for women
      <65kg), or a combination of the two. After a 3 week stabilization period, subjects will
      undergo complete formal assessment for anxiety and depression. Those subjects with a
      diagnosis of anxiety or depressive disorder regardless of drinking outcome will be offered
      the next step of care and followed up at 12-16 weeks.

      Step 2: Subjects to undergo the next step of care (n = 30 per group, 60 in total) will be
      randomized by referring to the consecutively assigned subject identification number to a
      matched numbered envelope containing a random assignment card. Randomization will be
      stratified according to concomitant SSRI use. The treatment groups will be:

        1. Intervention for comorbid anxiety or depression, and

        2. Usual counseling care.
    

Intervention name(s): Integrated care; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.; Counselling for all subjects will continue in accord with standard practice. Currently, programs of brief individualized motivation enhancement therapy (feedback of assessment findings, reinforcement, empathy, client's own motivation) are available.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol; anxiety; depression; comorbidity; CBT
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Condition: Colon Cancer; Lung Cancer; Tobacco Use Cessation; Obesity; Pneumonia, Bacterial; Shingles; Hepatitis C
MeSH terms: Hepatitis C; Pneumonia, Bacterial; Lung Neoplasms; Colonic Neoplasms; Liver Neoplasms; Obesity
Study type: Interventional

Summary: 
      The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United
      States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention
      (CDC) recommendations in adults age 50 and older.
    


Intervention name(s): Epic Healthy Planet Population Health Module
Intervention type(s): Other
Intervention description(s): Electronic population health module which is tailored to increased adherence to USPSTF and CDC recommendations
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Diaphragmatic Function in Stroke Patients.
Condition: Paralytic Stroke; Cough
MeSH terms: Cough; Stroke
Study type: Observational

Summary: 
      -  This study attempts to elucidate whether stroke patients with dysphagia have reduced
           diaphragm movement during voluntary coughing, and also during deep inspiration and
           expiration than stroke patients without dysphagia.

        -  This study will also compare various spirometric measurements with the diaphragmatic
           motions.
    

Detailed description: 
      Stroke is a debilitating condition that can impair multiple functions, including swallowing.
      Stroke patients with dysphagia, are known to have reduced cough due to multiple mechanisms
      and this can impair their expectorate function. This can lead to accumulation of sputum and
      mucoid, ultimately resulting in aspiration pneumonia. Stroke patients, especially those with
      dysphagia, are also known to have expiratory muscle weakness and weak cough than healthy
      controls. Stroke patients are also known to have reduced diaphragm movement than healthy
      subjects. Sonography is a useful tool that can easily and reliability measure diaphragm
      movement. Whether stroke patients with dysphagia have reduced diaphragm movement than those
      without dysphagia and whether this affects voluntary cough have not been reported yet.

      This study attempts to evaluate diaphragm movements during voluntary cough in stroke patients
      with dysphagia and determine whether this reduced diaphragm movement correlates to their peak
      flow meters during voluntary cough.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Stroke patients from a university affiliated medical center
      
Keywords: dysphagia,diaphragm, ultrasonography, inspiration, expiration,
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to demonstrate that V221 may be administered concomitantly with
      pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles,
      mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
    


Intervention name(s): Comparator: ProQuad™ (V221); Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV); 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Other intervention name(s): ProQuad™; V221; PREVNAR™
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time PF-07242813 will be given to humans. The purpose of the study is to
      evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses
      of PF-07242813 in healthy participants and in participants with moderate to severe atopic
      dermatitis. An additional goal is to assess the pharmacodynamics of PF-07242813 in
      participants with moderate to severe AD, including potential effects on clinical signs and
      symptoms.
    


Intervention name(s): PF-07242813; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-07242813 given intravenously or subcutaneous; Placebo given intravenously or subcutaneous
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Atopic Dermatitis; inflammatory skin disease
The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
Condition: Phthalate Exposure; Preeclampsia; Estrogen; Progestin
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and
      neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure
      to phthalates causes. There is increasing evidence concerning the potential endocrine
      disrupting for phthalate exposure during pregnancy. Prenatal exposure phthalates would
      disrupt the level of sex hormone in pregnant women, which results in preeclampsia. The
      relationship of prenatal phthalate exposure with maternal and neonatal outcomes in human
      beings was often sex-specific associations. Because of the potentially harmful influence of
      prenatal phthalate exposure, steps should be taken to prevent or reduce phthalate exposure
      during pregnancy.
    


Intervention name(s): test Phthalates, estrogen and progesterone
Intervention type(s): Other
Intervention description(s): test mothers Phthalates in their urine, and test estrogen and progesterone receptor in placental tissue
Intervention MeSH terms: Progesterone; Estrogens
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The participants include pregnant women meeting the inclusion criteria.
A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.
Condition: Smoking; Vaccines
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of multiple doses of
      PF-05402536 and PF-06413367 in healthy adult smokers.
    


Intervention name(s): NIC7-001; NIC7-003; Saline
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular, multiple dose; Intramuscular, multiple dose; Saline (0.9% sodium chloride)
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking cessation; vaccine; Phase 1
Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the
      bioequivalence of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical
      Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
    

Detailed description: 
      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. 24 healthy subjects will participate in the study. All dosed subject
      samples will be analyzed and their data will be included in the final study report Primary
      Pharmacokinetic Parameters: Cmax ,AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke,
      tmax and t1/2e. ANOVA using 5% significance level for log transformed (with the 90%
      confidence intervals) and untransformed data of Cmax,, AUC0→t and AUC0→∞and for untransformed
      data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for AUC0→t,
      AUC0→∞and Cmax to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Bravamax 200 mg (Modafinil); Vigil 200 mg (Modafinil)
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Other intervention name(s): Vigil; Vigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Condition: Environmental Enteric Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of PTM202 in treating environmental
      enteric dysfunction.
    


Intervention name(s): PTM202; micro-nutrient sprinkles
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PTM202 given twice daily for 30 days.; Micro-nutrient sprinkles will be given twice daily for 30 days.
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nutrition
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Condition: Prophylaxis: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunologic equivalence of three consecutive
      lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess
      immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit
      influenza vaccine (TIVf).

      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.
      Female subjects of childbearing potential were tested for pregnancy before the administration
      of the vaccine and included only if using and agreeing to continue to use contraception
      during the course of the study.

      The total study participation time per subject is about 3 weeks.
    


Intervention name(s): TIVc_LOT A; TIVc_LOT B; TIVc_LOT C; TIVf
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single IM (Intramuscular) administration dose of 0.5 mL of TIVc; Single IM administration dose of 0.5 mL of TIVc; Single IM administration dose of 0.5 mL of TIVc; Single IM administration dose of 0.5 mL of TIVf
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effects of High Protein Intake With Intense Exercise and Energy Deficit
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      A four week intervention will take place with the participants. They will undergo 6 days a
      week of high intensity training. They will also be at a 40% energy deficiency. One group will
      have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis
      that the participants with the higher protein will retain more lean mass.
    


Intervention name(s): High Protein; Low Protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2.4g/kg of protein; 1.2g/kg of protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Muscle; Protein; Diet; Exercise
Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery
Condition: Short Term Pre-habilitation Before Bariatric Surgery
Study type: Observational

Summary: 
      Observational study is conducted in patient under short term pre-habilitation before
      bariatric surgery.
    

Detailed description: 
      Observational study is conducted in patient under short term pre-habilitation before
      bariatric surgery. Data on anthropometry (waist circumference), body compositions (weight,
      muscle mass, fat free mass, fat mass, fat percentage and basal metabolic rate (BMR)), and
      functional status (handgrips strength) are collected.
    

Intervention name(s): prehabilitation
Intervention type(s): Other
Intervention description(s): very low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        morbidly obese patients
      
Keywords: obesity