bioihbjkbjnl/mcl2 huggingface dataset:
Creating Live Interactions to Mitigate Barriers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study is a validation study to evaluate the acceptability, feasibility and impact of a
      mobile psychosocial intervention to enhance social functioning in people with schizophrenia.
    

Detailed description: 
      The goal of this study is to employ an innovative and evidence-based mobile intervention that
      includes a neuroscience-informed computerized social cognition training program, a Health
      Insurance Portability and Accountability Act-compliant videoconferencing tool that we will
      use for psychoeducational group therapy, and peer-to-peer secure social networking for
      individuals with schizophrenia, in a parallel arm, double-blind, randomized, controlled
      clinical trial to assess feasibility and initial efficacy, to investigate the intervention's
      effects on symptoms, social cognition, and quality of life, and to prepare for a large-scale
      efficacy trial in adults with schizophrenia.
    

Intervention name(s): Computerized Plasticity-Based Adaptive Cognitive Training; Commercially available computerized training; Optimized social skills training; Unstructured support group sessions
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Training on computerized exercises that targets social cognition for 2 hours per week.; Training on computerized, casual video games for 2 hours per week.; Group-video calls with Specialist for 1 hour per week where participants can interact with Specialist individually or as a group. Specialist will provide guidance, support and feedback, and send links and articles about information and topics discussed during the video calls.; Unstructured support group-video calls for 1 hour per week. The Specialist will not engage with participants (eg. providing participants with links to articles and additional support) or provide guidance for the group discussion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
Condition: Fertility Issues
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The present study is aimed to explore the treatment effect from the intake of probiotic
      Lactobacillus crispatus M247 in the improvement of clinical and psychological aspects in
      women undergoing homologous level 2 ART procedures.
    

Detailed description: 
      The use of assisted reproductive technology (ART) has increased dramatically worldwide due to
      the continuous rise in infertility rates; for these reasons an increasing number of couples
      undertake the path of ART, even though this is difficult journey, with uncertain outcomes and
      possible medical risks, both physical and psychological.

      In this study the investigators aim to explore the hypothesis that recreating a favorable
      vaginotype through the intake of the probiotic Lactobacillus crispatus M247 can have a
      positive effect in achieving pregnancy in cryopreserved cycles as well as a positive
      relationship between vaginal, endometrial (still unknown), gut and oral microbiota.
    

Intervention name(s): Probiotic Lactobacillus crispatus M247
Intervention type(s): Dietary Supplement
Intervention description(s): Patient who have received probiotic Lactobacillus crispatus M247
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to
      be replaced by another formulation (principle) in future clinical trials and on the market.
      This trial intends to bridge pharmacokinetics (PK) between the two formulation principles.
      For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the
      trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on
      the PK of BI 1810631 after administration as NF in order to inform management of food and
      concomitant medications.
    


Intervention name(s): BI 1810631 - trial formulation 1 (TF1); BI 1810631 - new formulation (NF); Rabeprazole sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1810631 - trial formulation 1 (TF1); BI 1810631 - new formulation (NF); Rabeprazole sodium
Other intervention name(s): Pariet®
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-way crossover
Masking: None (Open Label)
Primary purpose: Treatment
The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A two-part study for NAFLD subjects with normal liver functions and in general good health to
      be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are
      in general good health and have normal liver functions to be treated with CM-101.
    

Detailed description: 
      This study is designed to assess the safety and preliminary pharmacodynamics of repeated
      administrations of CM-101 in two subject populations. The objective of part one of this study
      is to demonstrate that repeated treatment with CM-101 will be safe and well tolerated in
      NAFLD subjects that have normal liver functions and are in general good health. A second
      expansion part will be carried out that will include patients with NAFLD/NASH Activity Score
      (NAS) < 3 that are in general good health and have normal liver functions.
    

Intervention name(s): Anti-human CCL24 monoclonal antibody (CM-101) - Part One; Anti-human CCL24 monoclonal antibody (CM-101) - Part Two; Placebo - Study Part One; Placebo - Study Part Two
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Anti-human CCL24 monoclonal antibody (CM-101) - Part One; Anti-human CCL24 monoclonal antibody (CM-101) - Part Two; Placebo Comparator; Placebo Comparator
Intervention MeSH terms: Antineoplastic Agents, Immunological; Streptococcal polysaccharide type III group B; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gestational Age Specific Thyroid Function Reference Range
Condition: Thyroid; Reference Values; Pregnancy
MeSH terms: Thyroid Diseases
Study type: Observational

Summary: 
      It has been well accepted that maternal thyroid dysfunction has adverse affects on both
      mothers and fetuses. However, the dramatical changes during pregnancy make the interpretation
      of thyroid function test (TFT, i.e. free triiodothyronine [FT3], free thyroxine [FT4] and
      thyrotropin [TSH]) very difficult. Previous studies have shown that the level of thyroid
      hormones differs from non-pregnant population and varies from gestational ages. Moreover,
      studies have shown the agreement among different instrument platforms was quite low. This
      study is aimed to determine gestational age specific TFT reference ranges of the local
      pregnant population for all available platforms currently used under Hospital Authority and
      Department of Health.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hong Kong women
      
Biospecimen description: 
      Cord blood
    
Keywords: Thyroid; Reference values; Pregnancy
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Patient presenting to chronic pain clinics frequently undergo diagnostic and therapeutic
      spinal injections as part of their treatment. These procedures can cause significant level of
      apprehension in patients, which can lead to increased procedural times, increased procedural
      pain and reluctance to continue with the treatment program. It appears that certain
      interventions could reduce the anxiety and catastrophization levels and modify pain
      perception during medical procedures. The investigators therefore sought to evaluate the
      effect of a single 30 minutes information session which includes relaxation training
      administered 5 to 6 days before the nerve block procedure on patient's anxiety and
      catastrophization levels prior to the procedure and pain scores during the procedure, as well
      as the overall level of satisfaction with care received.
    


Intervention name(s): Relaxation and information session
Intervention type(s): Behavioral
Intervention description(s): Relaxation and information session before the medial branch block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: chronic pain; anxiety; intervention; information; relaxation
The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate which combination therapy is more effective for
      improving the blood pressure (BP) and reducing target organ damage in Japanese hypertensive
      patients: Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB
      plus diuretics.
    

Detailed description: 
      Renin-angiotensin (RA) inhibitors have been demonstrated to be the most effective drugs for
      reducing subclinical target organ damage in hypertensive patients. In several patients,
      however, BP control is not sufficiently achieved by RA inhibitors alone, and a combination of
      two drugs is frequently required. It is unclear whether a combination of RA inhibitors and
      diuretics or CCB is more effective in reducing hypertensive target organ damage. Control of
      central BP has been shown to be more effective than peripheral BP in predicting
      cardiovascular events and target organ damage associated with hypertension. The J-CORE study
      is active controlled, 2-arm parallel group comparison, prospective randomized open blinded
      end-point (PROBE) design study. The ARB plus CCB combination therapy group is administered
      olmesartan 20 mg/day and azelnidipine 16 mg/day and the ARB plus diuretics combination
      therapy group receives olmesartan 20 mg/day and hydrochlorothiazide (HCTZ) 12.5 mg/day. At
      least 100 patients will be enrolled in each group and the follow up duration will be 24
      weeks. The primary endpoint is to compare the changes in the central aortic BP and the
      ambulatory BP between the two groups. The secondary endpoint is to compare the changes in
      office BP, home BP, and hypertensive target organ damage between the two groups.
    

Intervention name(s): Olmesartan medoxomil ＋Azelnidipine; Olmesartan medoxomil + Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day for 6 months.; The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.
Other intervention name(s): arm A; arm H
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 894416 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 894416
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test,T) as compared to when given alone as oral single dose (Reference, R).
    


Intervention name(s): Itraconazole; BI 894416
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Tablet
Intervention MeSH terms: Itraconazole
Intervention model: Crossover Assignment
Intervention model description: Open-label, one-way crossover design
Masking: None (Open Label)
Primary purpose: Treatment
Maximal Exercise Capacity, Physical Activity and Respiratory Muscle Strength in Peripheral Artery Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Observational

Summary: 
      The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in
      patients with peripheral artery disease (PAD). The secondary aim of the study is assessment
      of physical activity level, respiratory function, peripheral and respiratory muscle strength,
      respiratory muscle endurance, depression, quality of life, intermittent claudication and
      cardiovascular risk factors in patients with PAD.
    

Detailed description: 
      Peripheral artery disease is characterized by reduced exercise capacity, physical activity
      level and intermittent claudication. The number of studies investigating maximal and
      submaximal exercise capacity and physical activity level in PAD is limited. There is also no
      study investigated pulmonary functions, respiratory muscle strength and endurance in this
      patient population. According to the sample size analysis 15 patients and 15 healthy
      individuals with similar demographic characteristics will be included the study. Patients and
      healthy individuals will be selected according to predetermined inclusion and exclusion
      criteria. The assessments will be completed in two days.Maximal exercise capacity will be
      assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using
      six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary
      function using spirometry, respiratory muscle strength using mouth pressure device,
      peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using
      incremental threshold loading test, depression using Beck depression inventory (Turkish
      version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication
      using Walking Impairment Questionnaire (Turkish version)
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        At least 15 patients with PAD will be included in patients group and 15 healthy individuals
        will be included in control group
      
Keywords: Peripheral Arterial Disease; Exercise capacity; Physical activity; Respiratory muscle strength; Peripheric muscle strength
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This single arm study will assess the efficacy and safety of treatment with Xeloda plus
      standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible
      participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for
      5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated
      time on study treatment is < 3 months, and the target sample size is < 100 individuals.
    


Intervention name(s): Standard radiotherapy; Capecitabine [Xeloda]
Intervention type(s): Radiation; Drug
Intervention description(s): Administered as prescribed according to normal clinical practice.; 825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks.
Other intervention name(s): Xeloda®
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      This study investigates the impact of endometrial scratching on endometrial secretion, when
      correlated to pregnancy.
    


Intervention name(s): Pipelle de Cornier
Intervention type(s): Other
Intervention description(s): RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching
Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
Condition: Osteoporosis; Breast Cancer
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Interventional

Summary: 
      Chemotherapy can damage bone marrow and therefore impair the production of white blood cells,
      platelets and red blood cells with the resulting anemia and osteoporosis.
    

Detailed description: 
      Purposes of this study were:

        1. To determine the therapeutic efficacy of the whole-body vibration (WBV) in improving
           osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

        2. To determine the therapeutic efficacy of the weight bearing exercise in improving
           osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

        3. To gain knowledge about the whole-body vibration (WBV) and the weight bearing exercise
           in improving osteoporosis in breast cancer patients after receiving chemotherapy within
           3-6 months.

        4. To share in designing an ideal protocol for the treatment of the osteoporosis in breast
           cancer patients after receiving chemotherapy within 3-6 months.
    

Intervention name(s): Whole body vibration group; Weight bearing exercises; vitamin D supplements and calcium
Intervention type(s): Other; Other; Drug
Intervention description(s): Whole body vibration apparatus (model Power plate -my5tm, made in United States) with frequency 30 - 40 Hz was used for the whole body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.; Electronic treadmill Kettler- marathon model No 7899-800, made in Germany (as form of weight bearing exercises), which was adjusted to the subject's comfortable walking speed. Generally, during the treadmill training, its speed and inclination are electronically adjusted, and it is also provided with a control panel to display the exercise parameters. It allows for the comfortable running without joint or back pains through a perfect combination between aluminium-pertinax running deck, shock absorbers and overall shock-damping design.; vitamin D supplements and calcium
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women
Condition: Depression; Insomnia; Cognitive Behavioral Therapy; Menopausal Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Considering physical and psychological problems that threaten women during the menopausal
      period, it seems that therapies that can help women cope with these problems, especially
      psychological ones, will be useful. The community mental health nurse is usually the first
      health professional whom women rely on to relieve their menopause symptoms. It is essential
      for the primary health care nurse to know how to properly approach women at this stage of
      their life and how to provide them the best and safe treatment. Because only limited
      interventional studies have been done to manage insomnia and depression among menopausal
      women in Egypt, the present study focused on reducing and insomnia and depression of
      menopausal women by using group Cognitive behavioral therapy. The current study aimed to
      examine the efficiency of group Cognitive Behavioral Therapy for insomnia and depression
      among menopausal women.
    


Intervention name(s): Cognitive Behavioral Therapy Program
Intervention type(s): Behavioral
Intervention description(s): Brief description of the Cognitive Behavioral Therapy program is given below:
Session 1: Mutual understanding and rapprochement
Session 2: Sleep hygiene education
Session 3: Psychoeducation about stimulus control strategies; monitoring sleep environments, and identification of behavioral habits at bedtime, dysfunctional beliefs, and attitudes about sleep.
Session 4: Training on relaxation techniques
Session 5: Psycho education about depression
Session 6: Cognitive restructuring
Session 7: The terminating session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical
      study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4)
      eligible subjects will be dispensed Test Lens 2 based on their responses to the CLDEQ-8
      questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2
    


Intervention name(s): AquaComfort Plus; Acuvue Oasys 1-Day
Intervention type(s): Device; Device
Intervention description(s): Test Lens 1; Test Lens 2
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment