bioihbjkbjnl/mcl2 huggingface dataset:
Waterpipe Warnings Aim 2: Text Versus Pictorial Warning Survey
Condition: Waterpipe Tobacco Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young
      adults' intentions to smoke waterpipe in the future.
    

Detailed description: 
      Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco
      smoking, which increases their risk of a variety of pulmonary, neurological, and oncological
      health conditions, among many others. This trial will randomly assign young adult waterpipe
      users or those susceptible to use to view waterpipe tobacco packages with text warning,
      pictorial warnings, or no warnings in a one-time online study. Participants will answer a
      series of questions regarding each package.
    

Intervention name(s): Pictorial Warnings; Text Warnings; No Warnings (Control)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.; Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.; Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized to the text-only condition will see six packages with different text warnings. Participants randomized to the pictorial condition will see six packages with different pictorial warnings. Participants in the control condition will see a single package without a warning.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Waterpipe Tobacco Smoking
Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries
Condition: Flexor Tendon Rupture; Hand Therapy
MeSH terms: Rupture; Tendon Injuries
Study type: Interventional

Summary: 
      Aim: The aim of the study was to investigate the effect of electromyographic (EMG)
      biofeedback training applied in addition to early passive motion protocol on electrical
      muscle activity (EMA) and functional status in zone I-III flexor tendon injuries.

      Materials and Methods: Cases who underwent surgery for flexor tendon injuries in zone I-III
      were included in this prospective randomized controlled trial. Cases were randomly divided
      into two groups of 11 cases each by block randomization. In the first group, EMG biofeedback
      training was applied in addition to the early passive motion method (modified Duran
      protocol), while the second group was followed only by early passive motion method. The
      treatment program was performed by the same physiotherapist three times a week, for 12 weeks.
      At the postoperative 5th, 12th and 24th weeks, joint range of motion (ROM) and EMA were
      evaluated, and the Michigan Hand Outcome Questionnaire (MHQ) was administered to the
      patients. The grip strength at 12th and 24th weeks were also assessed. The Mann-Whitney U
      Test was used to compare the two groups.
    


Intervention name(s): EMG biofeedback training
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single and Repeated Dose Escalation Study of GSK2838232
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for
      the treatment of HIV in combination with other antiretroviral therapy (ART). The primary
      objectives of this study are to investigate the safety, tolerability, and pharmacokinetics
      (PK) of single and repeat doses of GSK2838232. This study will be a double-blind,
      placebo-controlled, single and repeat dose escalation study. This study will be conducted in
      two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD)
      doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of
      GSK2838232 (as of active pharmaceutical ingredient-powder in bottle [API PiB]) 50 milligrams
      (mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative
      bioavailability of single doses of crystalline active pharmaceutical ingredient (API)
      Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In
      Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days as
      sequential dose cohorts. Maximum duration of study participation will be approximately 10
      weeks.
    


Intervention name(s): GSK2838232 PIB; GSK2838232 IR1; GSK2838232 IR2; Placebo PIB; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK2838232 will be available as oral suspension for reconstitution, will be administered as 50, 100 and 200 mg in Part A and as 20, 50, 100 or 200 mg in Part B.; GSK2838232 will be available as film-coated tablet for oral use; GSK2838232 will be available as film-coated tablet for oral use; Oral suspension of hydromellulose acetate succinate will be supplied as powder-in-bottle for reconstitution.; It is to be purchased by site. It will be white film-coated ovaloid tablets for oral administration.
Intervention MeSH terms: Ritonavir; GSK-2838232
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2838232; HIV; repeated dose escalation; immediate release tablet; single dose escalation
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
Condition: Opioid-induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211
      in patients with opioid-induced constipation.
    


Intervention name(s): TD-1211; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses; Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: constipation; opioid induced
Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy
      male volunteers.
    


Intervention name(s): DKF-310; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Donepezil
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C
Condition: Hepatitis; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to demonstrate the noninferiority of Algeron in combination with
      ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic
      hepatitis C.
    

Detailed description: 
      The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of
      rapid (after the 4th week) and early (after the 12th week) virologic response will be based
      on PCR data. For patients with treatment failure after the 12th week the antiviral therapy
      shall be discontinued. All patients who require further anti-viral treatment will receive a
      combination treatment with Algeron / Pegasys and ribavirin for another 12 or 36 weeks
      (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after
      last dose of study treatment.
    

Intervention name(s): Algeron; Pegasys
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 µg/kg of body weight subcutaneously, once a week; 180 µg subcutaneously, once a week
Other intervention name(s): Cepeginterferon alfa-2b; Peginterferon alfa-2a
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Cepeginterferon alfa; Peginterferon; Treatment
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
Condition: Multiple Myeloma; Stem Cell Transplantation
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed
      by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and
      HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete
      remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used
      to upgrade remission.
    


Intervention name(s): allogeneic hematopoietic SCT
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Plasmocytoma; Stem Cell Transplantation
Hypercapnia During Shoulder Arthroscopy
Condition: Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia; Hypercapnia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and
      cerebral oxygenation during shoulder arthroscopy.
    

Detailed description: 
      The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º
      sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen
      saturation (rSO2).
    

Intervention name(s): hypercapnia; normocapnia
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg; Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Other intervention name(s): ETCO2-45; ETCO2-35
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to test the combination of Plerixafor with G-CSF for
      chemosensitization in patients with relapsed or refractory AML.
    

Detailed description: 
      In this study, we are seeking to target the leukemia microenvironment to overcome disease
      resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the
      bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic
      chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through the
      following:

        1. Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with
           plerixafor in stem cell mobilization

        2. Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of
           administration.

        3. Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4 blockade.
    

Intervention name(s): G-CSF; Plerixafor; Mitoxantrone; Etoposide; Cytarabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): filgrastim; Neupogen; AMD3100; Mozobil; Novantrone; VP-16; Vepesid; Etopophos; Ara-C; Cytosar
Intervention MeSH terms: Cytarabine; Plerixafor; Etoposide; Mitoxantrone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stem cell mobilization; chemosensitization; CXCR4; SDF-1; CXCL-12
Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes
Condition: Polycystic Ovary Syndrome; Obesity
MeSH terms: Polycystic Ovary Syndrome; Obesity; Syndrome
Study type: Observational

Summary: 
      The study aimed to explore the impact of obesity on both body composition and ovarian Doppler
      parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome
      (PCOS). Additionally, the investigation seeked to establish correlations between these
      parameters and their prevalence concerning the clinical criteria of PCOS.
    

Detailed description: 
      Polycystic ovarian syndrome (PCOS) is a complex and multifactorial condition characterized by
      endocrinological, reproductive, metabolic, and biochemical abnormalities, affecting 12% to
      21% of reproductive-aged females. It has emerged as a significant global public health
      concern. However, variations in diagnostic criteria and patient selection have led to
      considerable discrepancies in the absolute prevalence of PCOS and its temporal trends.
      Previous studies have examined ovarian volume and blood flow indices in both obese and
      non-obese females with PCOS, albeit employing different criteria for obesity classification.
      Notably, none have compared these parameters across normal weight, overweight, and obese PCOS
      females. Therefore, the current study aims to explore the impact of obesity on body
      composition and ovarian Doppler parameters within distinct PCOS phenotypes. An additional
      objective is to assess correlations between anthropometric, body composition, and ovarian
      Doppler parameters and the prevalence of PCOS symptoms.
    

Intervention name(s): Evaluation
Intervention type(s): Other
Intervention description(s): Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        They were recruited from the gynecology and infertility clinic, for Doppler sonographic
        examination and body composition analysis.
      
Keywords: Polycystic Ovary Syndrome; Obesity; Body composition; Ovarian Doppler
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to
      investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in
      adult subjects with moderate to severe chronic plaque psoriasis
    


Intervention name(s): Bimekizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Based on their randomization subjects will receive a combination of several injections of Bimekizumab.; Subjects will receive injections of Placebo.
Other intervention name(s): UCB4940
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab
Nitrate Supplementation on Motor Unit Activity
Condition: Dietary Supplements; Healthy
Study type: Interventional

Summary: 
      This study aimed to assess if nitrate supplementation influence motor unit (MU) activity
      following a sustained ischemic contraction and whether this is affected by blood flow
      restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6
      years) completed two experimental trials following 5-days of supplementation with either
      nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded,
      cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size
      and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with
      BFR. These variables were also assessed during a 90 s recovery period with the first half
      completed with, and the second half completed without, BFR. Nitrate supplementation can
      expedite the recovery of MUP duration following a sustained ischemic contraction in healthy
      adults. These novel observations improve understanding of the effects of nitrate on the
      recovery of neuromuscular function post-exercise and might have implications for recovery of
      muscle contractile function.
    


Intervention name(s): Nitrate supplementation; Placebo supplementtaion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants ingested 2 × 70 mL/day shots of concentrate nitrate-rich (~12.8 mmol/day nitrate) or nitrate-depleted (~0.08 mmol/day nitrite) beetroot juice (Beet It, James White Drinks Ltd., Ipswich, UK). Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.; 2 × 70 mL/day shots of concentrate nitrate-depleted (~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is to investigate whether novel soft contact lens optical designs can slow myopia
      progression
    


Intervention name(s): Soft Contact Test Lens A; Soft Contact Test Lens C
Intervention type(s): Device; Device
Intervention description(s): FDA-approved, non-marketed daily disposable soft contact lens, conventional design; Daily disposable soft contact lens with new optical design
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma
Condition: Unresectable Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine safety profile, initial response rates and
      progression free survival for the combination therapy of neoadjuvant system ipilimumab
      followed by ILI with melphalan in patients with in transit melanoma.

      Hypothesis:

      The combination of regional LPAm plus systemic ipilimumab will lead to a larger response rate
      than either therapy alone.

      The combination of regional LPAm plus systemic ipilimumab will cause larger changes in immune
      cell populations than are seen with either therapy along.

      Changes in immune cell populations will predict progression free survival.
    


Intervention name(s): Ipilimumab
Intervention type(s): Drug
Intervention MeSH terms: Ipilimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the catechol-O-methyltransferase (COMT)
      inhibitor tolcapone, relative to placebo, reduces alcohol drinking and alcohol cue-elicited
      brain activation and increases brain activation associated with cognitive control as a
      function of a participant's genotype at a polymorphism in the COMT gene.
    


Intervention name(s): Tolcapone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Tasmar
Intervention MeSH terms: Tolcapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study is a three-arm randomized controlled trial to implement and evaluate the relative
      effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused
      intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in
      primary care clinics. The study will also examine the relative effects of the intervention
      conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC
      screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social
      influence surrounding CRC screening among patients, clinicians, and clinical staff. The
      target population includes average-risk patients aged 50-75 years, clinicians, and clinical
      staff within the primary care setting. The intervention will be implemented within primary
      care clinics in two managed care organizations (MCOs). The intervention targets the following
      CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy,
      colonoscopy, and double contrast barium enema.
    


Intervention name(s): Usual care; Clinic-focused intervention; Clinic- and patient-focused
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): No intervention will be conducted in this arm of the study.; The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff. The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based. The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.; This arm will combine the clinic-focused intervention and the patient-focused intervention. The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cancer; Colorectal cancer; Patient education; Physician education