bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod
      compared to placebo on efficacy parameters in patients with relapsing-remitting multiple
      sclerosis (RRMS).
    

Detailed description: 
      This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month
      double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an
      Extension phase which consisted of a dose-blinded period and an open-label period.

      In the Core phase, patients were randomized to receive a fixed dose of fingolimod (0.5
      mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months.

      For the Extension phase, patients who were treated with fingolimod during the Core phase
      continued treatment at the assigned dose level, while those previously treated with placebo
      during the Core phase were re-randomized in a 1:1 ratio to receive one of the two doses of
      fingolimod (1.25 mg or 0.5 mg). All patients in the extension received blinded
      investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once
      daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and
      subsequently all patients were switched to open-label fingolimod 0.5 mg.

      With the implementation of Amendment 11, the 1.25 mg dose was discontinued and all patients
      were switched to fingolimod 0.5 mg dose. With the implementation of Amendment 12, all
      patients treated with Placebo in the fingolimod Core phase were switched to treatment with
      0.5 mg fingolimod per day. The Extension phase continued until all patients either
      discontinued or transferred to Study CFTY720D2399 (NCT01201356; initiated in September 2010).
    

Intervention name(s): Fingolimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fingolimod capsules for oral administration; Matching placebo capsules for oral administration.
Other intervention name(s): FTY720; Gilenya®
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fingolimod; FTY720; relapsing-remitting multiple sclerosis; MS; RRMS
Glucagon Use in Colonoscopies
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators believe that glucagon therapy will have a positive impact on key parameters
      of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma
      detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort,
      and patient's willingness to undergo a repeat colonoscopy.
    

Detailed description: 
      Glucagon transiently decreases peristalsis of smooth muscle in the gastrointestinal tract. It
      is widely used by radiologists to improve diagnostic yields of upper and lower GI barium
      contrast examinations. Glucagon is also routinely administered intravenously for all
      endoscopic retrograde cholangiopancreatography (ERCP) throughout the United States to
      facilitate canulation of the duodenal papilla and sphincterotomy. Glucagon has been used at
      the dose of 1-3 mg intravenously by Dr. John Cello in over 5000 ERCP examinations. The role
      of glucagon in facilitating colonoscopy remains controversial however and is not considered
      "routine". Several studies have evaluated the effect of glucagon on colonoscopy with varying
      results. No large scale randomized controlled trial has been performed to conclusively
      establish the effect of routine glucagon administration prior to colonoscopy. The
      investigators plan to carry out a randomized double blind, placebo controlled trial that
      studies key parameters of a colonoscopy such as cecal intubation time, withdrawal time, total
      procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the
      procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.
    

Intervention name(s): Glucagon
Intervention type(s): Drug
Intervention description(s): glucagon (hormone produced by the body)
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: glucagon, screening colonoscopy
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy,
      safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of
      women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having
      participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in
      the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects
      were aged 15-25 years at the time of entry into the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      In this extension study, women who were vaccinated in the primary study, and participated in
      the follow-up study, will be followed with visits every 6 months.
    

Intervention name(s): Blood sampling; Collection of cervical specimen; Cervarix
Intervention type(s): Procedure; Procedure; Biological
Intervention description(s): Blood sampling at Visit 3, 5 and 7.; Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.; Three doses administered intramuscularly at 0, 1 and 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Component Analysis for Motivational Interviewing
Condition: Alcohol-Related Disorders; Alcohol Use Disorders; Alcohol Drinking; Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism; Alcohol-Related Disorders; Alcohol Drinking
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the critical components of motivational
      interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic
      drinking. The study will disaggregate MI into its component parts and test full MI compared
      to MI without its directive strategies. This study will test whether the directive elements
      of MI are critical or whether MI effects may be attributable solely to its Rogerian,
      non-directive components. For more information, go to http://caspirnyc.org/p_motion.html
    

Detailed description: 
      Project Motion is a clinical research study for people seeking to reduce, but not stop their
      drinking. Individuals who qualify will receive a comprehensive assessment and brief
      individual psychotherapy at no cost. The study is being conducted by a team of scientists at
      Columbia University College of Physicians and Surgeons and the New York State Psychiatric
      Institute and is funded by the National Institutes of Health (NIH). Our offices are located
      next to Columbus Circle and we offer convenient hours for appointments.

      The purpose of our study is to understand how brief psychotherapy helps people reduce alcohol
      consumption and drinking problems. For example, we know that some people can reduce drinking
      with little or no treatment, whereas others benefit from one-on-one psychotherapy. However,
      we do not know why this happens. Individuals who qualify and decide to participate will be
      assigned by chance to one of three conditions. Individuals assigned to the first two
      conditions will receive brief psychotherapy, beginning the first week of their participation
      in the study. Individuals in the third condition will receive feedback on their drinking and
      be asked to reduce their drinking with the aid of telephone self-monitoring for a period of 8
      weeks. Individuals in the third condition will then receive psychotherapy as well. The delay
      of 8 weeks will allow us to understand how the psychotherapy works compared to how people
      change without counseling.
    

Intervention name(s): Full Motivational Interviewing ("FMI"); Spirit Only Motivational Interviewing ("SOMI")
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking.; Empathic and non-directive counselling based on Rogerian psychotherapy model.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drinking; Alcohol Problems; Alcoholism; Moderation-Oriented Treatment; Controlled Drinking; Reduced Drinking; Heavy Drinking; Problematic Drinking; Non-Abstinence-based Drinking
Study of Safety and Efficacy of an Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a non-comparative study. the primary objective of the study is to assess the efficacy
      of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are
      to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of
      the product.
    


Intervention name(s): Norethindrone/ethinyl estradiol
Intervention type(s): Drug
Intervention description(s): 1 tablet per day
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception
Learned Resourcefulness Intervention
Condition: Self-Control; Caregiver Burden; Quality of Life
MeSH terms: Caregiver Burden
Study type: Interventional

Summary: 
      This study aimed to test the effects of a learned resourcefulness interveniton program on the
      learned resourcefulness, caregiver burden, quality of life for older family caregivers.
    

Detailed description: 
      A quasi-experimental trail will be used to test the effects of a learned resourcefulness
      intervention program on the learned resourcefulness, caregiver burden, quality of life for
      older family caregivers. Through the use of convenience sampling strategy, one teaching
      medical hospital with approximately 104 older family caregivers in southern Taiwan will be
      recruited and simple randomly assigned based on teaching medical hospital to a Learned
      resourcefulness intervention program experimental group or a wait-list control group.
      Participants in the experimental group will receive the learned resourcefulness intervention
      program led by researcher, one time per week, 50 minutes for one week, 10 minutes for these
      weeks; participants in the wait-list control group will continue to receive their home care
      service. One pre-test and two post-tests, all participants will assessed for learned
      resourcefulness, caregiver burden, quality of life at baseline, and at 5 and 9 weeks of the
      study.
    

Intervention name(s): learned resourcefulness intervention
Intervention type(s): Procedure
Intervention description(s): The LR program includes: 1) Solving problem strategy, 2) Organizing daily actions, 3) Using self-regulation, 4) Reframing positive situations, 5) Changing negative self-thinking, 6) Exploring new thinking and skills. It is conducted one time per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Condition: Anorexia Nervosa; Osteoporosis
MeSH terms: Osteoporosis; Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      Decreased bone strength is a common and serious medical problem present in many women with
      anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to
      suffer broken bones than women with normal bone strength.

      We are investigating whether a hormone that is naturally produced by the human body --
      parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.
    

Detailed description: 
      Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a
      number of significant medical conditions including bone loss. A majority of women with
      anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2
      standard deviations below normative means. Bone loss in anorexia nervosa is characterized by
      a decrease in bone formation, therefore therapy with an anabolic agent may be an effective
      treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study
      the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking
      at the effects of parathyroid hormone on bone mineral density (primary outcome).
    

Intervention name(s): Placebo; Teriparatide
Intervention type(s): Drug; Drug
Intervention description(s): sc daily for 6 months; 20 mcg sc daily for 6 months
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Disordered Eating; Osteoporosis; Parathyroid Hormone; Bone
Endotracheal Tube Cuff Pressure Measurement
Condition: Ventilator Associated Pneumonia; Morality; Trauma, Brain; Endotracheal Aspiration
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Brain Injuries, Traumatic
Study type: Observational [Patient Registry]

Summary: 
      The effect of endotracheal cuff pressure measurement technique for preventing ventilatory
      associated pneumonia.
    

Detailed description: 
      Aim of this study is to evaluate the effect of endotracheal cuff pressure measurement
      technique for preventing ventilatory associated pneumonia of severe traumatic brain injured
      patients in a tertiary level intensive care unit.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who followed up in a tertiary intensive care unit diagnosed with traumatic brain
        injury and under mechanical ventilation.
      
Keywords: pneumonia, cuff pressure, brain injury
Functional Magnetic Resonance Imaging (fMRI) Investigation of Nicotine Withdrawal Symptoms
Condition: Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      A single center, double blind, randomized, placebo controlled, two-treatments, two-period
      crossover study conducted in adult smokers.
    

Detailed description: 
      The main objective of this study is to use blood oxygen level-dependent (BOLD) functional
      Magnetic Resonance Imaging (fMRI) in abstinent smokers to directly evaluate the effect of the
      4 milligrams (mg) nicotine lozenge on brain activation associated with visual attention. The
      experimental task featured 3 conditions: 1. a highly demanding cognitive/attention task, 2. a
      simple cognitive/attention task, and 3. simply look at a '+' symbol. During the experiment
      these conditions are each presented a number of times in an alternating manner while
      acquiring images.
    

Intervention name(s): Nicotine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine lozenge containing 4 mg of nicotine; Placebo lozenge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nicotine; therapy; fMRI/EEG; replacement
Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study evaluate the effectiveness of adding neuromuscular exercises with tactile, visual
      and auditory feedback to a scapula-focused treatment, both emphasizing the periscapular
      muscles on improvement of disability in patients with subacromial pain syndrome compared to
      patients receiving only strengthening exercise protocol.
    

Detailed description: 
      Evidence of the effectiveness conservative treatments in shoulder impingement are in favor
      the application of specific exercises for scapulothoracic muscles and rotator cuff on pain
      reduction and improvement of upper limb function, supervised or performed at home, and these
      same exercises associated with other therapies promote a greater reduction in pain and
      improvement in disability.

      Currently, the evidence of better methodological quality present in the literature13 points
      out that the performance of motor control exercises focused on the scapula associated with
      mobilization and stretching generate pain improvement and clinically relevant improvement of
      the function. The few studies in this area have great methodological diversity with
      significant limitations. The hypothesis is that patients with subacromial pain syndrome who
      will receive traditional exercise protocol with the addition of neuromuscular training will
      show less functional disability, a greater reduction in pain intensity, increase muscle
      strength and range of motion when compared to the patient group that will receive only the
      protocol without neuromuscular training, immediately after the intervention, four and eight
      weeks and four months after randomization and that these benefits are clinically relevant.
    

Intervention name(s): Scapula-focused exercises; Motor control exercises
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Shoulder
Gabapentin to Reduce Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The intrathecal administration of morphine is gaining popularity. It is easy to do and can
      reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and
      vomiting more than other methods providing postoperative analgesia. Patients suffering from
      these side effects have to spend a longer period of time recovering in the hospital with high
      cost of medical treatment.
    

Detailed description: 
      Objective: to study the efficacy of oral administrating of gabapentin 600 mg before surgery
      to reduce the postoperative nausea and vomiting in patients receiving intrathecal morphine.

      Methods: Eighty patients undergoing orthopedic surgery and receiving intrathecal morphine
      will be randomized into 2 groups. The first group will receive oral gabapentin 600 mg and the
      second group will receive a placebo tablet. Both groups will receive a standard prophylactic
      medication for postoperative nausea and vomiting. The degrees of nausea and vomiting in both
      groups will be assessed over 24 hours postoperatively.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Other intervention name(s): Neurontin; Sugar pill
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
Condition: Fever; Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor
      access to health facilities, home management of malaria (HMM) can improve the timeliness of
      treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and
      impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up
      to 80% of malaria cases are treated outside the formal health sector and shops are frequently
      visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs
      in Africa thus also need to examine the role of shops in home management and to ensure that
      drugs sold are appropriate. The current practice of presumptive treatment of any febrile
      illness as malaria (both at health facilities and in the context of HMM) based solely on
      clinical symptoms without routine laboratory confirmation, results in significant over-use of
      antimalarial drugs. With ACT being a more costly regimen, it is important to be more
      restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of
      confirming malaria diagnosis in remote locations lacking electricity and qualified health
      staff.

      This study therefore proposes to evaluate the feasibility, acceptability, and
      cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by
      community-based drug distributors.The accuracy of RDTs, and the acceptability of this
      approach, will be evaluated in both low and high transmission areas.
    


Intervention name(s): Rapid diagnostic test; presumptive malaria treatment
Intervention type(s): Device; Other
Intervention description(s): Use of rapid daignostic tests for diagnosis of malaria; Treatment of malariabased on clinical diagnosis without use of diagnostic test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: History of fever; measured fever