bioihbjkbjnl/mcl2 huggingface dataset:
The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF
Condition: Endometrial Injury; Hysteroscopy; Repeated Implantation Failures
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators checked the hypothesis whether endometrial injury performed during the
      cycle before a frozen embryo transfer in women with RIF can improve pregnancy rates
    

Detailed description: 
      After a freeze all cycle, participants were divided in two groups: an intervention group
      (n=30), who underwent endometrial injury before the transfer, and a control group (n=30), who
      underwent no other intervention. The primary outcome was clinical pregnancy rate, while
      secondary clinical and laboratory parameters. Baseline and cycle characteristics were also
      compared between groups.
    

Intervention name(s): Endometrial injury
Intervention type(s): Procedure
Intervention description(s): Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer
Intervention model: Single Group Assignment
Intervention model description: Endometrial injury in RIF patients
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrial injury; Hysteroscopy; RIF; IVF; ART
Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of
      moderately to severely active Crohn's disease
    

Detailed description: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study in adult subjects with moderately to severely active Crohn's disease.

      Eligible subjects include males and females aged 18-75 years with moderately to severely
      active CD for at least 3 months. Each subject will receive the assigned treatment over 12
      weeks, followed by a 4-week safety follow-up period.
    

Intervention name(s): PRV-6527; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment; Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
Condition: Common Variable Immunodeficiency; Agammaglobulinemia
MeSH terms: Agammaglobulinemia; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to assess the efficacy and safety of Vivaglobin in previously
      untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation
      period. The purpose is to investigate whether PUPs will respond to subcutaneous
      immunoglobulin (SCIG) treatment with adequate trough levels without first receiving
      immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg
      body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of
      500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG
      therapy.
    


Intervention name(s): Vivaglobin
Intervention type(s): Drug
Intervention description(s): Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Previously Untreated Patient (PUP); Primary Immunodeficiency (PID); CVID; XLA; Subcutaneous immunoglobulin (SCIG); IgG trough level; Quality of life; Common variable immunodeficiency (CVID); X-linked agammaglobulinemia (XLA)
A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063
      compared with placebo in treatment of acutely exacerbated schizophrenia.
    

Detailed description: 
      The drug being tested in this study is called TAK-063. TAK-063 is being tested to treat
      people who have schizophrenia. This study will look at the different symptoms associated with
      schizophrenia including cognitive symptoms, personal and social functioning and functional
      capacity (ability to perform tasks associated with real, everyday life such as household
      chores, communication, finance, transportation, and planning recreational activities) in
      people who take TAK-063.

      The study enrolled 164 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the two treatment groups-which will remain undisclosed to the
      patient and study doctor during the study (unless there is an urgent medical need):

        -  TAK-063 20 mg

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient.

      All participants will be asked to take the tablets once daily at nighttime. All participants
      will initially receive TAK-063, 20 mg/day. The dose may be titrated down to 10 mg/day, if
      intolerable.

      The multi-center trial will be conducted in the United States. The overall time to
      participate in this study is 6 weeks. Participants will be hospitalized until the Week 3
      visit. Participants will make 11 visits to the clinic during the treatment and 1 visit during
      the follow-up.
    

Intervention name(s): TAK-063 20 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-063 tablet.; TAK-063 matching-placebo tablet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Antacid Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential effects of calcium carbonate and aluminum/magnesium
      hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of
      lesinurad in healthy, adult male subjects.
    

Detailed description: 
      In this study, lesinurad and antacid will be administered in the fed state, antacid doses
      will be attenuated to reflect the more commonly used doses, baseline PD assessments will be
      performed both in presence and absence of antacid treatment, and the sequence of treatments
      (lesinurad +/- antacid) will be randomized.
    

Intervention name(s): Lesinurad 400 mg; Tums 500 mg and 750 mg; MINTOX 10 mL
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Subcutaneous Pharmacokinetics of Belatacept
Condition: Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept
      Administered Subcutaneously to Healthy Subjects
    


Intervention name(s): belatacept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose, 116 days; Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status
Condition: Cobalamin Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with
      vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome
      variable is the difference in the change of methylmalonic acid after 3 months between the two
      study arms.
    


Intervention name(s): Placebo; Cyanocobalamin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Toothpaste not containing the vitamin.; Toothpaste containing100 µg cyanocobalamin/g.
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cobalamin biomarkers; Anemia; Vegan diet; Subclinical; Metabolic functional markers; Holotranscobalamin; Methylmalonic acid
Effectiveness of Assertive Continuing Care for Youth
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Following discharge from residential treatment 324 adolescents are randomly assigned to
      Assertive Continuing Care with and without motivational incentives in a 2 x 2 factorial
      design. Clinical outcomes are assessed at 3, 6, 9, and 12 months post discharge.
    


Intervention name(s): ACC; CM; UCC
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Weekly community based behavioral counseling and case management; Weekly community based prize drawing opportunities contingent upon completed verifiable pro-social activities and clean urine and breath alcohol test results; recommendation made by discharge counselor upon leaving residential treatment to attend nearest outpatient clinic.
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Treatment
Increased Physical Activity Through Mindfulness
Condition: Physical Activity; Life Style; Mindfulness
Study type: Interventional

Summary: 
      In a pilot study 90 physically inactive patients will be randomized to three different
      intervention groups; mindfulness training, mindfulness training and Physical Activity on
      Prescription (PAP) or only PAP Follow-up will be done at baseline, three and six months with
      questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether
      mindfulness may increase physical activity and decrease physical inactivity.
    

Detailed description: 
      All patients between 40 and 65 years of age who fulfills the inclusion criteria will be asked
      to participate in the study. Posters with information about the study will be put in the
      waiting room and on other strategic places. Patients who accept to participate will get both
      written and orally information, after the information they will sign a informed consent. The
      patients will estimate their level of physical activity in minutes per week to control
      inclusion criteria. The patients will return a morning for fasting blood samples and get an
      accelerometer attached to them to wear during 7 days. During this time randomization will be
      preformed. They will also get to answer a couple of different surveys. The results from the
      surveys and blood samples will be the study baseline.

      All patients with abnormal test results will follow specific flow diagram for the usual care.
    

Intervention name(s): Mindfulness; PAP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day; Physical Activity on Prescription, after 3 months a new prescription
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the cervical muscular force control , taking into
      account the proprioceptive signals, in patients with and without cervical dystonia.
    


Intervention name(s): Electromyogram
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment
Condition: Breast Cancer; Breast Neoplasm; Breast Malignant Tumor; Resilience; Self-efficacy
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study was to develop and evaluate the self-efficacy and resilience of the Breast Cancer
      Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy.
    

Detailed description: 
      This study was to develop and evaluate the self-efficacy and resilience of the Breast Cancer
      Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy. In the first
      phase of this study, develop a prototype the Breast Cancer Self-Care App by conducting
      patients interviews. In the second phase, an experimental two-group pretest-posttest
      quantitative study design to evaluate the self-efficacy and resilience of the Breast Cancer
      Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy. The patients
      were randomized to the experimental and control groups. Patients in the control group
      received general routine care and patients in the experimental group received general routine
      care plus the Breast Cancer Self-Care App intervention. Both groups completed a basic
      demographics, self-efficacy and resilience questionnaires at the pre-test and after four
      weeks.
    

Intervention name(s): The Breast Cancer Self-Care App
Intervention type(s): Device
Intervention description(s): The Breast Cancer Self-Care App includes several parts- introduction to breast cancer, types of treatment, side effects care, nutrition, relaxation videos, insurance, medical news and recording side effects, etc. The researcher assisted in installing the App on the patient's mobile phone, entered the personal account, and asked the patient to fill in questionnaires. Patients were given individual health education task in the Breast Cancer Self-Care App every week according to the type of chemotherapy drugs. After four weeks, they filled in questionnaires again.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Breast cancer; mobile application; Resilience; self-efficacy
Intravitreal Bevacizumab for Neovascular Glaucoma
Condition: Neovascular; Glaucoma
MeSH terms: Glaucoma; Glaucoma, Neovascular
Study type: Interventional

Summary: 
      Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in
      eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other
      neovascular disorders such as wet-type age-related macular degeneration and diabetic macular
      edema has been described. We aim to evaluate the effect of three intravitreal injections of
      bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures
      include intraocular pressure and extent of iris neovascularization. Both study arms will
      receive conventional treatment for NVG.
    


Intervention name(s): subconjunctival normal saline; Avastin
Intervention type(s): Other; Drug
Intervention description(s): 0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals; intravitreal injection of avastin 2.5mg repeated twice at monthly intervals
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neovascular; Glaucoma; Bevacizumab; Avastin; Intravitreal; IOP
Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
Condition: Sleep Apnea; Hypertension; Cardiovascular Diseases
MeSH terms: Apnea; Sleep Apnea Syndromes; Disorders of Excessive Somnolence; Hypertension; Cardiovascular Diseases; Sleepiness
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the effect of CPAP over the incidence of
      cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.

      The hypothesis of the study is the following: The existence of sleep disordered breathing in
      the general population is associated to an increased incidence of arterial hypertension and
      to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders
      during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime
      sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular
      complications.

      The end points of the study are new diagnosis of arterial hypertension and new cardiovascular
      events.

      All patients, after randomization, will be followed for three years.
    


Intervention name(s): CPAP (Continuous Positive Airway Pressure)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
Condition: Post-Stroke Spasticity; Cerebrovascular Accident
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over
      placebo in patients with post-stroke upper limb spasticity of both the wrist and finger
      flexors using the Modified Ashworth Scale (MAS) wrist score.
    

Detailed description: 
      This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over
      placebo in patients with post-stroke upper limb spasticity of both the wrist and finger
      flexors using the Modified Ashworth Scale (MAS) wrist score.
    

Intervention name(s): GSK1358820; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): botulinum toxin type A; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spasticity; Post-Stroke; botulinum toxin type A; Upper Limb
Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability
Condition: Healthy; Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the short-term effect of a nutritional program
      consisting of a yerba mate supplement, fiber supplement, and intermittent fasting on glycemic
      variability in men and women with risk factors for impaired fasting glucose.
    

Detailed description: 
      The purpose of this study is to determine the effect of a nutritional program which combines
      two different supplements (a yerba mate extract supplement and a fiber-based, vitamin-rich
      nutritional supplement) and intermittent fasting on glycemic variability and glycemic control
      in men and women with risk factors for impaired fasting glucose.

      This study will be an exploratory pilot study with one screening visit, one baseline visit
      followed by a baseline phase, two intervention phases, and one follow-up visit. During the
      baseline phase, subjects will follow their regular dietary routines. During the 4-day Phase
      1, subjects will take the yerba mate supplement once per day and the fiber supplement twice
      per day. During the 4-day Phase 2, subjects will continue the supplement regimen from Phase
      1, while incorporating daily intermittent fasting for approximately 16 hours and eating for 8
      hours. A continuous glucose monitor will be worn by each subject to continuously measure
      glucose throughout the study period.
    

Intervention name(s): Dietary supplement regimen; Dietary supplement and intermittent fasting regimen
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The powdered, soluble fiber-based supplement contains soluble fibers, phytosterols, plant-derived polysaccharides, flavor, maltodextrin, orange juice powder, citric acid, vitamin and mineral blend, and sweetener. This is prepared in water and consumed twice per day, prior to a meal.
The yerba mate-based supplement (containing green yerba mate leaf extract, sweeteners, and flavor) is a powdered supplement prepared in water and consumed in the morning.; The dietary supplement regimen is the same as in Phase 1. The intermittent fasting protocol consists of a 16-hour fasting period and an 8-hour eating window.
Other intervention name(s): Balance; Unimate; Feel Great
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Baseline (no supplements or intermittent fasting requirements) and two interventional phases (Phase 1: supplements only; Phase 2: supplements and intermittent fasting)
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Intermittent fasting; Yerba mate; Continuous glucose monitoring; Dietary supplements; Soluble fiber
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
Condition: Concussion; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      This is an open-label, non-randomized, prospective, multi-site, parallel group (segment),
      hypothesis-generating study designed to collect data that will aid in future scientific and
      engineering exploration of correlations between clinical neuropsychological assessments and
      GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended
      for scientific inquiry and engineering development purposes, and may be used in future
      regulatory submissions.
    

Detailed description: 
      This data-driven study is being conducted for hypothesis generation in population of mild
      traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance
      imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical
      neuropsychological assessments. This data is intended for future use in development of
      specialized MR acquisition, reconstruction, and processing software intended to identify mTBI
      biomarkers.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): MRI scanning
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: TBI; MR; mTBI; NFL; MRI