bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      M2951 is an investigational drug under evaluation for treatment of autoimmune and
      inflammatory disorders. The purpose of the study is to assess the efficacy of M2951 in
      participants with rheumatoid arthritis (RA) currently treated with stable dose of
      methotrexate (MTX).
    


Intervention name(s): Placebo; M2951; M2951
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.; Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.; Participants who received placebo matched to M2951 or M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open label extension period.
Other intervention name(s): Evobrutinib; Evobrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; M2951; Bruton's Tyrosine Kinase (BTK)
Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
Condition: Polycystic Ovary Syndrome; Obesity
MeSH terms: Polycystic Ovary Syndrome; Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS)
      is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an
      anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.

      We investigates short term interventions with low dose liraglutide in combination with
      metformin and high dose liraglutide alone influence on significant weight reduction in obese
      women with PCOS.
    


Intervention name(s): liraglutide; metformin and liraglutide
Intervention type(s): Drug; Drug
Other intervention name(s): Victoza; Glucophage and Victoza
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Overlap FGIDs and Genetic Polymorphism
Condition: Functional Gastrointestinal Disorders; Overlap Syndromes
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Undifferentiated Connective Tissue Diseases; Syndrome
Study type: Observational

Summary: 
      1. To analyze the prevalence of overlap syndromes among NERD or RH, FD, and IBS patients,
           and to identify and to compare the differences in their characteristics and symptoms,
           and to determine their risk factors.

        2. To identify the differences in clinical features according to sex and gender.

        3. To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up
           period.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient who were diagnosed with NERD/RH, FD, IBS and their overlaps (NERD/RH-FD,
        NERD/RH-IBS, FD-IBS, NERD/RH-FD-IBS) and healthy controls.
      
Keywords: functional gastrointestinal disorder; overlap syndromes; functional dyspepsia; irritable bowel syndrome; non-erosive reflux disease; reflux hypersensitivity
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Condition: Postmenopause; Hypertension; Pre-Hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to compare the effects of treatment of two different
      formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with
      prehypertension.
    

Detailed description: 
      This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
      HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the
      trial.
    

Intervention name(s): Drospirenone/17ß-estradiol (Angeliq, BAY86-4891); Drospirenone/17ß-estradiol (Angeliq, BAY86-4891); SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SH K 00641 A -Active study medication encapsulated tablet; SH K 00641 B - Active study medication encapsulated tablet; Active control encapsulated tablet
Intervention MeSH terms: Medroxyprogesterone Acetate; Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pre-Hypertension in Postmenopausal Women
A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders
Condition: Anxiety; Neurasthenia; Adjustment Disorders
MeSH terms: Anxiety Disorders; Adjustment Disorders; Neurasthenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at
      a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in
      neurasthenia and adjustment disorder.

      An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a
      dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment
      disorder.
    


Intervention name(s): Ranquilon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two 1 mg tablets 3 times per day for 28 days; Two tablets 3 times per day for 28 days
Other intervention name(s): GB-115; 6-phenylhexanoyl)glycyl-L-tryptophan amide
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia
Condition: Functional Dyspepsia; H. Pylori Infection
MeSH terms: Dyspepsia
Study type: Observational

Summary: 
      The pathophysiology of functional dyspepsia is still unclear but several peptides have been
      indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of
      appetite and gut motility and serotonin is a typical neurotransmitter related with sensory
      and motor functions of gut. On the other hand, transient receptor potential vanilloid
      receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal
      disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or
      glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine
      whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric
      mucosa of FD patients are different from those in healthy controls, and whether some changes
      of their expression correlate with certain dyspeptic symptoms. The investigators also
      investigated the effect of H. pylori infection by comparing their expressions before and one
      year after H. pylori eradication.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had epigastric pain or discomfort with normal upper endoscopy and no evidence
        for explaining these symptoms were prospectively enrolled in Seoul National University
        Bundang Hospital. All participants underwent esophagogastroduodenoscopy. During endoscopy,
        biopsies were taken from both antrum and body for histological evaluation, determining H.
        pylori infection status.

        Participants were divided into control and patients according to the Rome III criteria.
        Patients group were subclassified into 3 categories; PDS (postprandial distress syndrome),
        EPS(epigastric pain syndrome) or mixed (PDS+EPS)
      
Biospecimen description: 
      Blood sample (plasma and serum), samples with DNA and paraffin-embedded tissue. During the
      endoscopic examination, one pair of biopsies was obtained from the greater curvature of high
      body. Biopsies are taken using standard biopsy forceps.
Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System for Thoracoabdominal and Para-renal Aortic Aneurysms.(E-nside Study)
Condition: Aortic Aneurysm, Thoracoabdominal; Para-renal Aortic Aneurysms
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal
Study type: Observational

Summary: 
      The study was created to evaluate the theoretical anatomical feasibility of the new E-nside
      Multibranch Stent Graft System (JOTEC GmbH, Hechingen) in patients with thoracoabdominal and
      para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of
      the patients treated with other techniques for this pathology in the vascular Unit of San
      Raffaele Hospital, in the past ten years. With this study, investigators want to analyze in
      how many cases the new prosthesis would be usable.

      E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) is in the pre-CE marking
      stage. At present, the certifying organism is evaluating the documentation for the release
      the CE mark certification and Declaration of Conformity.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patient with thoracoabdominal or para-renal aortic aneurysm
Bilateral Oophorectomy Versus Ovarian Conservation
Condition: Oophorectomy; Hysterectomy
Study type: Interventional

Summary: 
      This is a pilot study to assess the feasibility of conducting a randomized, blinded,
      controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and
      fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and
      greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be
      randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to
      group assignment. The primary goal of this pilot is to determine the feasibility of
      recruiting and retaining study participants in anticipation of conducting a larger,
      multi-centered trial. However, the investigators will also obtain baseline data and follow-up
      measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains
      that the investigators hypothesize may be effected by oophorectomy: cardiovascular health,
      skeletal health, sexual functioning, and health-related quality-of-life.
    


Intervention name(s): Bilateral salpingo-oophorectomy; Ovarian conservation
Intervention type(s): Procedure; Procedure
Intervention description(s): Removal of both ovaries and fallopian tubes at the time of hysterectomy; Both ovaries and fallopian tubes not removed at the time of hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Photoplethysmography for Diagnose Incipient Hypovolemia
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Observational

Summary: 
      Hypovolemia caused by acute bleeding increased morbi-mortality in emergency and operatin
      rooms. Precise real-time diagnosis of incipient acute hypovolemia is lacking at the bedside.
      We hypothesize that the infrared-red signals of pulse oximetry are sensitive to acute changes
      in patient's volemia. We aimed to test this hypothesis in a cohort of healthy blood donors as
      a model of simulated acute hypovolemia.
    

Detailed description: 
      This is a prospective and observational study designed to determine if the changes observed
      in finger photoplethysmographic waveform can detect incipient hypovolemia. The investigators
      will studied 60 blood donor volunteers as a model of slight hypovolemia (8-10% of the
      volemia). Vital signs and photoplethysmography will be recorded in the thumb of the tested
      hand during a standard blood donation protocol. Recorded data will be analyzed and compared
      before and after blood donation .
    

Intervention name(s): Finger photoplethysmography
Intervention type(s): Diagnostic Test
Intervention description(s): Finger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy blood donor volunteers.
      
Keywords: Photoplethysmography; Vital signs; Hemodynamics
Aquatic Exercises for Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic
      exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain
      in patients with specific chronic low back pain.
    

Detailed description: 
      In general, the population will have at least one episode of low back pain during their
      lifetime, with recurrence in most cases. Several treatments have been proposed for these
      patients and the evidence is still not clear about the effectiveness of aquatic exercises
      when compared to other modalities of exercises in the water. This study will be a randomized
      controlled trial following the Consort-Statement principles. The subjects, aged between 20
      and 50 years, after signing the informed consent will be randomly allocated to one group
      treatment: aquatic exercises (AEG) or aquatic exercises associated to deep-water running
      (AEDWRG). The duration of the protocol will be set at 12 weeks, 3x-week.
    

Intervention name(s): Aquatic Exercises; Deep-water running
Intervention type(s): Other; Other
Intervention description(s): Exercises performed in the water.; It is a non-impact form of running executed in place in (higher than 2 meters) the water wearing a flotation belt. Heart rate is controlled by heart rate watch
Other intervention name(s): Aquatic Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hydrotherapy; aquatic
ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      The investigators examined whether there was a difference in the occurrence of ST depressions
      after injection of five or ten units of oxytocin, in preeclamptic patients delivered by
      caesarean section (CS) under regional anesthesia.
    

Detailed description: 
      ST depression on electrocardiograms has been reported in healthy women undergoing cesarean
      section in regional anesthesia. The investigators examined whether there was a difference in
      the occurrence of electrocardiogram changes suggestive of myocardial ischemia (ST
      depressions) in preeclamptic patients randomized to five or ten units of oxytocin during
      cesarean section with regional anesthesia.

      In a double-blind randomized controlled study preeclamptic patients undergoing cesarean
      section under spinal anesthesia were randomized to 5 or 10 units of oxytocin, given as an
      intravenous bolus. A Holter monitor was used to record electrocardiograms. Non-invasive blood
      pressure and heart rate were monitored.
    

Intervention name(s): oxytocin
Intervention type(s): Drug
Intervention description(s): Intravenous bolus dose given during 1 minute after clamping of the umbilical cord
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: cesarean section; electrocardiography; heart; hypotension; ischemia; oxytocin; preeclampsia; regional anesthesia; ECG changes suggestive of myocardial ischemia
Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have
      weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost
      the immune system's responses against many HIV-1 proteins. The main purposes of this study
      are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can
      stimulate immune system responses in people who have HIV-1 infection.
    

Detailed description: 
      Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL)
      responses contribute to the control and potential clearance of the virus. Vaccines designed
      specifically to induce CTL responses are likely to be well suited for treatment of HIV
      infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL
      epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer
      that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies
      have shown that the vaccine induces strong CTL responses in animal models. This study will
      evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in
      HIV-1-infected individuals who are being treated with highly active antiretroviral therapy
      (HAART) and have a CD4 count of 350 cells/mm3 or more and fully suppressed viral replication
      on stable HAART.

      Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4,
      8, and 16. Participants will be randomly assigned to receive either vaccine or placebo. Ten
      patients will be assigned to each dose group; eight will receive active vaccine and two will
      receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In
      addition to undergoing standard safety exams, patients will have blood drawn for use in
      evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and
      patient will be followed for safety and immune responses for an additional 24 weeks after
      they complete vaccination; the total study is estimated to take 18 months.
    

Intervention name(s): EP HIV-1090
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV Therapeutic Vaccine; CTL Epitope; Treatment Experienced
Women's Lifestyle Balance Study
Condition: PreDiabetes; Metabolic Syndrome; Overweight
MeSH terms: Overweight; Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Syndrome
Study type: Interventional

Summary: 
      This pilot study aims to determine whether adding a sleep extension and sleep hygiene
      intervention to an existing lifestyle improvement program improves its efficacy for weight
      loss in those at risk for diabetes and cardiovascular disease. Half of the participants will
      receive the Centers for Disease Control's standard PreventT2 program and half of the
      participants will receive the same program with an additional sleep intervention.
    

Detailed description: 
      The goal of this pilot study is to determine whether the efficacy of an existing lifestyle
      improvement program can be increased by adding a sleep extension and sleep hygiene
      intervention. Improved sleep can improve weight loss through two possible routes: lessening
      fatigue may potentiate physical activity (PA), and decreasing appetite may potentiate diet
      improvements. A sample of 24-30 women will be assigned to either the Centers for Disease
      Control's (CDC's) standard PreventT2 program or the same program with an additional
      integrated sleep intervention. Both programs will involve 8 group sessions administered over
      3 months, and all women will be followed for a total of 6 months. The primary outcome is
      weight loss, and secondary outcomes include sleep quality and duration, physical activity,
      caloric intake, and physiological indicators of cardiovascular and diabetes risk (HbA1c,
      HOMA-IR, lipids, blood pressure). The combined program has the potential to significantly
      improve weight loss in those at risk for diabetes and cardiovascular disease (CVD).
    

Intervention name(s): CDC's PreventT2 Program; CDC's PreventT2 Program with Added Sleep Content
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The PreventT2 program will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving nutritional intake and increasing physical activity. It will also include individual biweekly phone calls for 6 months.; The CDC's PreventT2 program with added sleep content will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving sleep quality and nutritional intake and increasing sleep duration and physical activity. It will also include individual biweekly phone calls for 6 months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to one of two groups.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Weight loss; Women; Sleep; Intervention; Diet; Physical activity; Fitbit