bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
Condition: Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapse Free
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day
      versus placebo in the treatment of patients with primary progressive multiple sclerosis or
      relapse-free secondary progressive multiple sclerosis.
    

Detailed description: 
      Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective
      effect through its activity on mast cells and other non-neuronal cells of the central nervous
      system, with subsequent modulation of inflammatory and neurodegenerative processes. The
      objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day
      versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day
      after 3 months of treatment versus matched placebo, in the treatment of patients with primary
      progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.
      Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1
      design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96
      weeks of treatment in the overall study population with subgroup analysis performed in
      stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).
    

Intervention name(s): Masitinib; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): AB1010; Placebo Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; primary progressive; relapse-free; secondary progressive
IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting
Condition: Heart Failure; Heart Attack; Coronary Artery Bypass Surgery
MeSH terms: Myocardial Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Following myocardial infarct, cellular therapy is a potential approach to repopulate the
      injured myocardium, to treat heart failure and restore cardiac function. The purpose of this
      study is to assess the safety, feasibility and efficacy of intramyocardial delivery of
      selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass
      grafting in patients with chronic ischemic cardiomyopathy.
    

Detailed description: 
      CD133+ are well characterized distinct early progenitor group of stem cells that possess high
      engraftment, pluripotent and angiogenic capacity and proved to be valuable for cardiac repair
      by promoting neovascularization, inhibition of apoptosis and cardiomyogenesis.

      The investigators proposed research protocol involves patients with chronic ischemic heart
      disease and left ventricular dysfunction undergoing coronary artery bypass grafting (CABG).
      In this phase II clinical trial, prospective, randomized, 2 arm, double-blind,
      placebo-controlled study, the investigators will assess the safety, feasibility and
      functional effect of intra-myocardial injection of highly selected autologous CD133+ bone
      marrow stem cells to placebo.
    

Intervention name(s): Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting; Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Intervention type(s): Biological; Biological
Intervention description(s): Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium.; Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium
Other intervention name(s): Autologous CD133+ stem cells or placebo solution containing autologous plasma without CD133+; Autologous CD133+ stem cells or placebo solution containing autologous plasma without CD133+.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study's primary objective is to compare the efficacy and tolerability of switching
      patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new
      treatment (quetiapine) to the participants' existing treatment with people diagnosed with
      depression (major depression disorder).

      The secondary objective is to examine the response and remission rates following the switch
      from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with
      examining changes in neurocognitive and apathy measures after the switch.
    

Detailed description: 
      1. Study Design 1) An 8-week, randomized rater blinded parallel group, 2-arm trial 2) Trial
           duration - 9 weeks 3) Drug doses

             -  Levomilnacipran ER; Switching to a flexible dose regime of levomilnacipran ER
                40-120 mg/day after initial dose of 20mg.

             -  Quetiapine XR; Adjunct a flexible dose regimen of quetiapine XR 150-300 mg/day
                after initial dose of 50mg.

        2. Objective 1) To compare the efficacy and tolerability of switching to levomilnacipran ER
           (40-120 mg/d) versus augmentation with quetiapine XR 150-300 mg/day to the patients'
           existing treatment for patients with inadequate relief on generic SSRIs in patients with
           MDD.

      2) To examine the response following the switch from generic SSRI to levomilnacipran ER and
      augmentation with quetiapine XR.

      3) To examine changes in neurocognitive and apathy measures after switching from SSRI to
      levomilnacipran ER and after augmentation with quetiapine XR in MDD
    

Intervention name(s): Levomilnacipran; Quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): treating major depression. A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8; Quetiapine will be started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current antidepressant.
Other intervention name(s): Fetzima; Seroquel
Intervention MeSH terms: Milnacipran; Quetiapine Fumarate; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
HIV Prevention in Haitian American Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There has not been a great deal of research involving Haitian American adolescents and HIV
      risk reduction. The purpose of the study is to learn better ways to teach teenagers about
      living healthy by educating these children about how to make good choices about things like
      eating healthy, exercise, and sexual behavior. The primary focus of the proposed study is to
      understand the mechanisms of adopting safer sex practices among Haitian American (H-A)
      adolescents. We will enroll 160 male and 160 female participants to achieve the target sample
      of 272 participants at the 12-month follow-up time point.
    

Detailed description: 
      The primary focus of the study is to understand the mechanisms of adopting safer sex
      practices among Haitian American (H-A) adolescents. We replicated a Cognitive-Behavioral HIV
      transmission risk reduction (CB-HIV-TRR) intervention entitled "Becoming A Responsible Teen"
      (BART, St. Lawrence, et al, 1995; St. Lawrence, 1998). This approach, which emphasizes
      building skills and self-efficacy in the process of risk reduction, was demonstrated to be
      highly effective with African American male and female adolescents in Mississippi. In a
      meta-analysis of published CB-HIV-RR intervention outcome studies (Kalichman, et al., 1996),
      the BART intervention was shown to have produced the highest effect not only for the
      published studies with adolescents, but also for HIV prevention interventions of all other
      populations studied. Based on its promising effects, the BART intervention has been
      officially designed as one of only four HIV risk "Programs that Work" by CDC Division of
      Adolescent and School Health (DASH). CDC designates programs as such based on reviewing
      programs in the literature using rigorous criteria. The proposed work focused on delineating
      theoretically important conditions associated with HIV transmission risk reduction (HIV-TRR)
      to address issues of mechanism of action and generalizability, respectively. Specifically,
      this 5 year study evaluates the effects of a version of the BART intervention that has been
      adapted to be appropriate to Haitian adolescents in Miami) as compared to a standard care
      (SC) condition among 160 male and 160 female high risk Haitian adolescents.
    

Intervention name(s): Cognitive Behavioral and Standard Care with Healthy Living
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Haitian American Adolescents; HIV Prevention; Cognitive Behavioral Intervention
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Respiratory Aspiration; Bronchiectasis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for
      Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
    


Intervention name(s): Ciprofloxacin for Inhalation; Ciprofloxacin for Inhalation; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg once daily by inhalation for 28 days; 150 mg once daily by inhalation for 28 days; Placebo once daily by inhalation for 28 days
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pseudomonas aeruginosa; antimicrobial; inhalation; ciprofloxacin; Non-Cystic Fibrosis Bronchiectasis
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene
      procedures in pregnant women.

      Patients consenting to participate to the study will undergo periodontal evaluation at the
      baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly
      assigned to:

        -  Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair
           Peribioma mousse twice a day

        -  Control group: home oral application of Biorepair Peribioma Toothpaste

      Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.
    

Detailed description: 
      The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene
      procedures in pregnant women.

      Patients consenting to participate to the study will undergo periodontal evaluation at the
      baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly
      assigned to:

        -  Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair
           Peribioma mousse twice a day

        -  Control group: home oral application of Biorepair Peribioma Toothpaste

      Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following
      indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical
      Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index,
      Papillary Marginal Gingival Index.
    

Intervention name(s): Biorepair Toothpaste + Mousse; Biorepair Toothpaste
Intervention type(s): Other; Other
Intervention description(s): Domiciliary application of the products twice a day.; Domiciliary application of the product twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy
In Vitro Human Embryo Culture System
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the development of human embryos grown in a
      conventional culture dish to those grown in a new embryo culture device known as the SMART
      System.
    

Detailed description: 
      This study is a multi-center, randomized, performance study.
    

Intervention name(s): SMART System; Culture dish
Intervention type(s): Device; Device
Intervention description(s): microfluidic embryo culture system; Standard IVF culture dish
Other intervention name(s): System for Microfluidically-Assisted Reproductive Technology; dish
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: infertility; embryo development
Walking Exercise on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of 6-month aerobic walking program on
      memory, subjective cognitive complaints, and brain-derived neurotrophic factor for older
      hypertensive women. Participants will be randomly assigned to the experimental group and the
      control group. The intervention group will last for 24 weeks. The outcome measurements
      included memory, subjective cognitive complaints, and brain-derived neurotrophic factor.
    

Detailed description: 
      The purpose of this study is to explore an aerobic walking program on memory, subjective
      cognitive complaints, and brain-derived neurotrophic factor. In quantitative study with
      experimental design, qualified subjects will be randomly assigned to experimental or control
      group. Experimental subjects will perform six-month aerobic walking program and control group
      receive routine care. The outcome measurements included memory, subjective cognitive
      complaints, and brain-derived neurotrophic factor. Data will be collected at baseline, the
      end of the six-month intervention. Data will be analyzed using Generalized Estimation
      Equation evaluate the effect of the intervention program.
    

Intervention name(s): Aerobic exercise; control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down. The program included individualized education, telephone and social media counselling, and booklet guidance; control group received routine care and a manual on healthy living
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Walking exercise; Memory; Hypertension; Brain-derived neurotrophic factor; Subjective Cognitive Complaint; Women
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely
      demonstrated. The success of this procedure requires that the patient is awake and
      cooperative. The conditions of this intervention can be difficult to tolerate by the patient
      for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly
      the head in the stereotactic frame), stress related to the localization of the DBS. It is
      therefore important to improve the comfort as well as the cooperation of the patient, during
      implantation of the DBS electrodes, in order to optimize the conditions of the intervention.
      In addition to analgesia, acupuncture should allow sedation without affecting alertness and
      should contribute to the regulation of any vegetative reactions during the procedure.
      Therefore, we hypothesize that acupuncture could improve the quality of care of the patient
      during a DBS procedure. In practice, this is electroacupuncture that will be used in this
      research to maintain the stimulation of acupuncture points to an optimal level during the
      time of the intervention.
    


Intervention name(s): Electroacupuncture; Local Anesthesia (lidocaine hydrochloride)
Intervention type(s): Procedure; Drug
Intervention description(s): Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.; All patients will receive injectable paracetamol for pain relief, a mix of nitrous oxide 50% and oxygen 50% for analgesia and lidocaine hydrochloride for local anesthesia.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women
Condition: Anovulation; Obesity
MeSH terms: Anovulation
Study type: Interventional

Summary: 
      This study aims to investigate the role of the weight reduction agent, Orlistat compared to
      the Metformin for the management of women who are obese and do not ovulate or have difficulty
      conceiving. Patients will receive either one of these medications and will be monitored at
      regular intervals with hormone blood tests and ultrasound scans in order to study the effect
      of the medications on the reproductive functions. Patients will receive the medications for
      three months and the study will end if the patient becomes pregnant. The study also aims to
      investigate the dose of metformin that should be used as there is no consensus to date
      regarding the optimum dosage for this drug
    

Detailed description: 
      We aim to recruit 40 patients suffering from anovulatory obesity with a BMI of 30 or more.
      Patients will be included from all ethnic groups.

      Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH,
      fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and
      ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including
      Doppler blood flow study (ovarian stromal velocity, PI, RI, SD ratio and power Doppler)
      Participants will then be randomised to receive either metformin or orlistat. Patients
      receiving orlistat will receive the standard dose of the drug as recommended in the BNF.
      Metformin will be given in an incremental dose starting at 1000mg per day and increased at 4
      weekly intervals to 2000mg/d, depending on the occurrence of any gastrointestinal
      intolerance. The endocrinological and ultrasound investigations will be repeated at 4 weekly
      intervals. Both groups will be given a standard exercise and diet program in conjunction with
      medical treatment.

      The clinical endpoint will be the achievement of conception, a Body Mass Index of less than
      30, or completion of a 3-month course of treatment.

      Study design:

      A randomised controlled open label clinical trial. Participants be randomised using a
      computer generated randomisation program available at the pharmacy of the Jessop Wing, into
      either one of two arms: metformin or orlistat. The randomisation will be stratified in order
      to achieve a homogenous distribution of PCOS and non-PCOS patients in both arms of the study.
    

Intervention name(s): Orlistat Vs Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; Obesity; metformin; orlistat
Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary purpose of this study is to compare renal function between subjects receiving
      optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving
      standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf®
      over 52 weeks after kidney transplantation will also be obtained.
    


Intervention name(s): Advagraf®
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): FK506; tacrolimus
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute rejection; Advagraf; Renal function