bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives
Condition: Contraception
Study type: Observational

Summary: 
      Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives
      efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral
      treatment. The aim of the study is to evaluate in everyday practice the relation between
      dosage errors and indicated factors, potentially influencing the compliance with the dosing
      scheme.
    


Intervention name(s): EE/DRSP (Yasmin Product Family)
Intervention type(s): Drug
Intervention description(s): One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.
Intervention MeSH terms: Drospirenone and ethinyl estradiol combination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Gynecological practices patients - starters or current users.
      
Keywords: Contraception; Compliance
Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
Condition: Chronic Widespread Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The aim is to evaluate a novel treatment routine where contact through a smart phone/computer
      is used for online support for patients suffering from chronic widespread pain (CWP). The
      outline is that patients are encouraged to perform physical activity during a period of 12
      months with online support from a physical therapist.
    

Detailed description: 
      The intervention follows principles from the theories of person-centered care and
      self-efficacy. The examinations performed at baseline and after six months were conducted by
      blinded examiners at a visit at the primary health care centers. All participants developed a
      person-centered health plan for physical activity together with a physiotherapist. The
      intervention group was supported with a digital platform for six months.
    

Intervention name(s): Physical exercise and online support; Physical exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.; Person-centered design of health care plan individually adjusted physical exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™
      Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment
      office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8
      weeks when compared to a masked procedure (renal angiogram).
    

Detailed description: 
      Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will
      be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).
    

Intervention name(s): Renal Denervation (Vessix); Renal Angiography
Intervention type(s): Device; Device
Intervention description(s): Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator; Percutaneous renal angiography
Other intervention name(s): Vessix Reduce™ Catheter and Vessix™ Generator; Vessix Renal Denervation System; Renal Angiogram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypertension; Renal Denervation
Computer Assisted Cognitive Remediation Program in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether computer-assisted cognitive remediation
      therapy is effective in the treatment of cognitive deficits in schizophrenia.
    

Detailed description: 
      Schizophrenia can be considered a chronic illness that affects all aspects of daily life.
      Cognitive deficits seems to play a key role that interferes directly in the functional
      adaptation.

      Cognitive remediation therapy (CRT) emerges as a psychological intervention that target
      cognitive impairment. But, the use of computerized or papel an pencil procedures for
      remediation cognitive deficits remains controversial. Nonetheless, computer tasks offer a
      number of advantages compared to those of paper and pencil. The most noteworthy advantages
      are to enhance patient's motivation just because the sensory variety that the exercises
      presented or the possibility to provide immediate feedback. Furthermore, the possibility to
      present custom-tailored and adapted tasks taking into accounts the patients deficits and
      their evolution in the process of the psychological therapy is another important feature of
      computer-assisted cognitive remediation therapy.
    

Intervention name(s): Computer-assisted cognitive remediation therapy; attentional task
Intervention type(s): Behavioral; Other
Intervention description(s): Comparison of two groups:
The experimental group performs 48 sessions of computer exercices designed to remedy cognitive domains(attention, speed of processing, working memory,reasoning and problem solving) frequently affected in schizophrenia.
The intervention has a period 6 months , two sessions a week. All exercises provided a visual or verbal feedback to immediately terminate the execution.In addition to, the therapist after the sessions interactively explain the results and the strategies employed by the patient.; The Control group performs 48 sessions of watching videos and answer questions about these videos, in a period of 6 months , two sessions a week.
Other intervention name(s): cognitive remediation therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: schizophrenia; cognitive remediation therapy; cognition; quality of life
BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects
Condition: Obesity; Cardiovascular Disease; Hypertension; Diabetes
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to collect data to help researchers better understand the
      various causes of obesity, which may lead to the development of new obesity treatment
      options.
    

Detailed description: 
      Obesity is major metabolic health concern and the potential beneficial effects of natriuretic
      peptides, specifically B-type natriuretic peptide (BNP) on adipocyte biology, energy
      expenditure and body weight could be of great significance. This study will provide insight
      into the mechanisms of dysregulation of the natriuretic peptides system in obesity and will
      contribute to delineate the roles and the clinical importance of BNP in the treatment of
      obesity.
    

Intervention name(s): Nesiritide; Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Natriuretic Peptide, Brain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: B-type Natriuretic Peptide; Metabolism; Insulin infusion
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
Condition: Threatened Premature Labor
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      Eligible patients will be informed and asked to enroll in the study at hospital admission. A
      transvaginal ultrasound examination will be performed to determine cervical length. If an
      eligible woman accepts to participate, patient will be randomized to one of the study arms
      assigned in a double blind basis. Patient will receive the medication (vaginal capsule of
      progesterone or placebo). The patient will administer herself one vaginal capsule in a daily
      basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate
      that the use of a maintenance treatment with vaginal progesterone is able to reduce the
      incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal
      and neonatal data will be collected.
    


Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days; 1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Hib Diseases; Neisseria Meningitidis Serogroups A & C Diseases
MeSH terms: Hepatitis B; Diphtheria
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with
      that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™
      vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly
      administered with Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), with
      respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP)
      after a three-dose primary vaccination course.
    

Detailed description: 
      Randomized study with five groups to receive one of the following vaccination regimens: One
      of the three formulations of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals'
      Tritanrix™-HepB (3 different groups) GSK Biologicals' Tritanrix™-HepB + GSK Biologicals'
      Hiberix™ GSK Biologicals' Tritanrix™-HepB mixed with GSK Biologicals' Hiberix™ + Wyeth
      Lederle's Meningitec™
    

Intervention name(s): DTPw-HBV/Hib-MenAC conjugate vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence and adhesion properties of transdermal clonidine prepared
      with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with
      VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.
    


Intervention name(s): Catapres-TTS-1; Intervention 1: Catapres-TTS-3; Intervention 1: Catapres-TTS-3; Intervention 2: Catapres-TTS-3; Catapres-TTS-1; Intervention 2: Catapres-TTS-3
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Catapres-TTS-1 Oppanol; Catapres-TTS-3 Oppanol; Catapres-TTS-3 Oppanol; Catapres-TTS-3 Vistanex; Catapres-TTS-1 Vistanex; Catapres-TTS-3 Vistanex
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence Study of Anastrozole 1 mg Tablet
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole
      [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].
    

Detailed description: 
      This study was conducted to characterize and compare the pharmacokinetic and safety profiles
      and the bioequivalence of a newly developed new generation aromatase inhibitor (CJ
      anastrozole) with existing anastrozole formulation (Arimidex®) in healthy Korean volunteers.
      This study is designed as single-dose, randomized, double-blind, 2-way crossover trial.
      Participants were randomized to receive 1 mg of either the CJ anastrozole or Arimidex,
      followed by a 3-week washout period. And then the alternate formulation was administered.
      After 10-hour overnight fast drug was administered. For analysis of pharmacokinetic
      properties, including Cmax and AUClast, blood samples were obtained at 0.33, 0.67, 1, 1.5, 2,
      3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours after drug administration.
    

Intervention name(s): CJ anastrozole 1 mg tablet
Intervention type(s): Drug
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence; anastrozole; Healthy subjects; Antineoplastic Agents; Therapeutic Uses; Enzyme Inhibitors
Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to assess the blood pressure lowering effects of two doses of telmisartan over a
      four-week treatment period; to determine potentially effective doses for pediatric patients
      for future studies; to assess the safety and tolerability of two doses of telmisartan.

      Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of
      telmisartan in children and adolescents aged 6 to <18 years, and to determine if age-related
      differences exist
    


Intervention name(s): Telmisartan; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal Subjects
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed to assess the safety, tolerability, pharmacokinetics (PK),
      gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses
      of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized,
      double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be
      randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.
    


Intervention name(s): GSK3179106; Matched Placebo
Intervention type(s): Drug; Drug
Intervention description(s): It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally; It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: REarranged during Transfection Growth Factor Receptor Tyrosine Kinase Inhibitor
Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of IV administration of
      VX15/2503 in patients with multiple sclerosis. The escalation part of the study will
      determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is
      found.
    

Detailed description: 
      VX15/2503-N-101 is a single ascending dose-escalation, randomized, double-blinded,
      placebo-controlled study to evaluate the safety and tolerability of IV-administered VX15/2503
      in patients with multiple sclerosis. This will be accomplished by using a dose escalation
      procedure starting at a low dose of VX15/2503 and will continue based on predefined
      parameters until the maximum tolerated dose is identified. Patients will be randomized at a
      4:1 ratio to receive VX15/2503 to placebo. The patients and the study team will be blinded to
      the treatment that each patient receives.

      The study drug, VX15/2503, is a humanized monoclonal antibody that binds to the semaphorin 4D
      (SEMA4D; CD100) antigen. Experimental evidence suggest that antibody neutralization of SEMA4D
      may represent a new therapeutic strategy for treating multiple sclerosis.
    

Intervention name(s): VX15/2503; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose intravenous administration; single dose intravenous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VX15/2503; Semaphorin 4D; SEMA4D; CD100; safety; tolerability; pharmacokinetics; immunogenicity; multiple sclerosis; monoclonal antibody
Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults
Condition: Intermittent Fasting; Overweight; Time Restricted Feeding
MeSH terms: Overweight
Study type: Interventional

Summary: 
      LIMITFOOD is a randomized clinical intervention study that investigates the effects of two
      different intermittent fasting protocols compared to a control group on the health of normal-
      and overweight adults. A total of 72 participants will be randomized into three equally sized
      groups: an alternate day fasting, a time-restricted feeding and a control group.
    

Detailed description: 
      The prevalence of overweight has risen considerably all over the world in the past century.
      Epidemiological studies have shown that, starting from a body mass index of 20-21 kg/m2,
      increasing BMI levels are associated with progressively increased risks of developing
      diabetes, cardiovascular disease, several types of cancer and other diseases. The problem is
      pronounced by the unlimited and constant availability of food. Treatment of overweight is
      still difficult and finding effective and more personalized strategies to manage these
      conditions is crucial.

      Intermittent fasting has been suggested as an alternative way to address these problems.
      Intermittent fasting is an eating pattern that involves rotating periods of eating and
      fasting. Animal studies and previous human clinical trials have provided evidence that
      various types of intermittent fasting lead to weight loss and improved health markers not
      only in obese, but also in healthy, non-obese adults.There are several types of intermittent
      fasting. The most popular version is time-restricted feeding (TRF), which allows ad libitum
      (at one's pleasure) energy intake within a defined period of time each day (6-12h). Another
      subtype of IF is called alternate day fasting (ADF). ADF is defined as 'feast days' on which
      food is consumed ad libitum, which alternate with 'fast days' on which food is withheld or
      reduced.

      However, despite the growing popularity of intermittent fasting, it is not clear which type
      of IF is most effective and what fasting window is needed to induce beneficial effects.
      Additionally, tools to longitudinally track personal progress of dieting are lacking.
      Therefore, the main objective of this study is to compare the effects of each of two
      different intermittent fasting protocols (TRF and ADF) on metabolic parameters to a control
      group. Furthermore, a new dynamic measurement technique, using breath analysis, will allow to
      better monitor the progress of individual participants.
    

Intervention name(s): Time-Restricted Feeding; Alternate Day Fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are instructed to limit food intake to maximum 8 hours per day.; Participants are instructed to fast every other day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability and Pharmacokinetics of FTP-198 Tablet in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-dose escalation clinical trial for FTP-198 conducted in chinese
      healthy volunteers. The safety, tolerability, food-impact and pharmacokinetics of FTP-198
      tablet in healthy volunteers will be evaluated using a randomized, double-blind,
      placebo-controlled trial design.
    


Intervention name(s): Placebo
Intervention type(s): Drug
Intervention description(s): Placebo is a tablet with the same appearance as FTP-198
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: FTP-198; IPF; health; phase I
The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
Condition: Premenstrual Dysphoric Disorder; Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome; Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the
      pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring
      cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance
      spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and
      post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®,
      Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid
      levels with cortical GABA levels at these same time points. Neurosteroids to be measured
      include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with
      PMDD will be compared to those of healthy subjects.
    


Intervention name(s): fluoxetine
Intervention type(s): Drug
Intervention description(s): Fluoxetine 20 mg daily by mouth for 2-3 months.
Other intervention name(s): Prozac; Sarafem
Intervention MeSH terms: Fluoxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hormones; menses; PMS; PMDD