bioihbjkbjnl/mcl2 huggingface dataset:
Brief Academic Future Thinking Intervention for College Student Drinkers
Condition: Heavy Drinking
Study type: Interventional

Summary: 
      The present study investigated the feasibility, acceptability, and initial utility of a brief
      academic goal-relevant episodic future thinking (A-EFT) task among heavy college drinkers.

      First, the study attempts to extend the temporal reach of EFT interventions which have
      demonstrated immediate reductions in discounting, and alcohol demand. The current study
      utilized a longitudinal design to evaluate whether EFT can change drinking behavior outside
      the lab in heavy drinking college students. The two-group experimental design included an
      active control group, weekly booster contact, and 1-month follow-up. Second, this study seeks
      to investigate whether the process of engaging in EFT is sufficient to produce effects when
      cues are not presented during the decision-making task. Lastly, this study adds an academic
      goal-related focus to the EFT task based on previous research indicating that forming
      meaningful academic goals is protective against drinking and associated problems.
    


Intervention name(s): Academic Episodic Future Thinking; Vivid Memory Task
Intervention type(s): Behavioral; Other
Intervention description(s): Brief Academic goal related EFT intervention involving desirable outcomes of current academic goals; Matched for time control task involving recall of vivid memories of distinct events/actions from a children's story
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT
Condition: Squamous Cell Carcinoma; DaRT Treated Patients
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Observational

Summary: 
      Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT
      seeds for management of their malignancy following initial response.
    

Detailed description: 
      Medical records of patients that previously underwent the Alpha DaRT treatment will be
      reviewed by an authorized staff member.

      Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for
      management of their malignancy following initial response. These outcomes include:

        -  Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the
           Alpha DaRT seeds

        -  Efficacy -

             -  assessment of local recurrence rates in patients who achieved initial complete
                response (CR) following the Alpha DaRT treatment

             -  assessment of duration of response in patients who achieved initial CR following
                the Alpha DaRT treatment

             -  assessment of survival status in patients treated with the Alpha DaRT seeds
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The medical records of patients previously treated with Alpha DaRT as part of the completed
        clinical trial "CTP-SCC-00" will be accessed to follow up with their status, if available.
      
Keywords: Squamous Cell Carcinoma; Alpha Radiation
Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
Condition: Knee Osteoarthritis
MeSH terms: Cumulative Trauma Disorders
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml)
      single intra-articular injection, in the management of pain caused by knee osteochondral
      lesions.
    

Detailed description: 
      There are no studies in literature up to now, that analyze the changes in knee pain and
      correlate this parameter with knee function and biomechanics, in regular casual sport player
      subject affected by knee overuse syndrome and underwent an intra-articular HA injection. The
      aim of this study is to evaluate efficacy and safety of Hymovis® ONE (32 mg/4 ml) single
      intra-articular injection, in the management of pain caused by knee osteochondral lesions.
    

Intervention name(s): Hymovis® ONE (32 mg/4 ml)
Intervention type(s): Device
Intervention description(s): Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic acid
BX-1 in Spasticity Due to Multiple Sclerosis
Condition: Spasticity Due to Multiple Sclerosis
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of orally administered BX-1 compared to placebo in
      patients with spasticity due to multiple sclerosis not sufficiently controlled by current
      anti-spasticity medication
    

Detailed description: 
      The aim of the present phase III clinical trial is to demonstrate superiority of BX-1, an
      oral solution containing dronabinol, over placebo in patients with spasticity due to MS not
      sufficiently controlled by their current anti-spasticity medication.

      The trial is designed to show that BX-1 is able to reduce spasticity in MS patients not
      showing sufficient response to their current anti-spasticity treatment.
    

Intervention name(s): BX-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.; Placebo of BX-1, oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabinoid; dronabinol
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy of three different long-term treatment strategies of reflux disease
      in primary care setting.
    


Intervention name(s): esomeprazole (Nexium®); Xolaam®
Intervention type(s): Drug; Drug
Intervention description(s): This randomized study was conducted on parallel groups and included two phases:
One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed; This randomized study was conducted on parallel groups and included two phases:
One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; Acid Reflux
Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of the study is to compare the short- and long-term effectiveness of an
      individualized, resource-oriented joint protection intervention with the standard,
      problem-oriented joint protection intervention for patients with rheumatoid arthritis.
    

Detailed description: 
      Joint Protection (JP)is an important intervention in the management of people with arthritis.
      Altering working methods (e.g. use of proximal joints, dynamic activities), energy
      conservation (balance between activity and rest) and using assistive devices should place
      less strain on joint structures weakened by the disease process. These strategies ought to
      decrease pain and stress on joints, improve function, and facilitate maintaining social
      roles.

      The effectiveness of JP has been evaluated in a number of studies, all in a group setting. JP
      has beneficial short-term effects on pain and function in patients with established RA and
      moderate functional problems. Using assistive devices reduces pain during task performance in
      comparison to normal methods and altering working methods significantly reduces difficulties
      in activities of daily living (ADL). However this generally does not result in significant
      behavioral changes and a long-term impact on reducing pain and maintaining function may only
      be reached if JP is taught using behavioral education methods. Additionally, adherence of RA
      patients to different interventions is generally modest, which may well determine the
      effectiveness of any given intervention, especially in the long-term.

      All previous studies were carried out in group settings, however, in Switzerland, standard JP
      education is provided on a one-to-one basis and an individualized education is assumed to be
      a promising approach.

      This clinical trial aims to test the hypothesis that an individualized, resource-oriented JP
      education in RA patients leads to a better therapy success in the short and long-term,
      compared to problem-oriented standard JP education in terms of joint protection behavior.
      Secondary outcome parameters are self-perception, general and specific self-efficacy and
      general and health-related quality of life.
    

Intervention name(s): psycho-educational Joint protection education
Intervention type(s): Behavioral
Intervention description(s): individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rheumatoid arthritis, occupational therapy, joint protection
Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
Condition: Myocardial Injury; Remote Ischemic Preconditioning
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and
      the lung.The heart and lung injury is a serious complication ,which increases both mortality
      and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper
      limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive
      strategy.Recent some trials suggested that RIPC could provide myocardial protection by
      reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed
      to show the protective effects of RIPC with respect to the troponin release and lung injury.

      Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase
      organ protective effects, whether the modified RIPC protocol induced repeatedly has the
      cardiopulmonary protective effect is still uncertain.
    

Detailed description: 
      modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective
      effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia,
      a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to
      200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
    

Intervention name(s): Modified Remote Ischemic Preconditioning; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg; Control group witnout remote ischemic preconditioning
Other intervention name(s): mRIPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Dextroamphetamine as an Adjunct in Cocaine Treatment - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an
      adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
    


Intervention name(s): Dextroamphetamine; D-Amphetamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg for first 8 weeks and 30 mg for 2nd 8 weeks; 30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total); Placebo
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Hand osteoarthritis (HOA) which affects the interphalangeal joints and the
      metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30
      % of the population over than 70. Some forms of HOA are refractory to usual treatments
      (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in
      vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is
      to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and
      function in patients with refractory hand OA.
    

Detailed description: 
      Patient is randomized to receive investigational product or placebo at week 0 and week 4
      (1:1)

        -  arm 1: 2 infusions four weeks apart of tocilizumab 8mg/kg

        -  arm 2: 2 infusions four weeks apart of saline solution

      Follow-up visits are organized at week 6, and then week 8 and week 12.

      Primary outcome is the pain as assessed with the VAS at week 6. Secondary outcomes include
      morning stiffness duration, patient and practitioner global assessments, functional indexes
      for hand OA, number of painful joints, number of swollen joints.

      110 patients is expected to be randomized in 36 months. Each patient sign an informed consent
      before the beginning of the study.
    

Intervention name(s): tocilizumab; saline solution
Intervention type(s): Drug; Drug
Intervention description(s): Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.; La saline solution is administered by intravenous infusion.
Other intervention name(s): ROACTEMRA®; NaCl 0,9 %
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand OA; Tocilizumab; Osteoarthritis; Interleukin-6
Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency; Muscular Atrophy; Atrophy
Study type: Interventional

Summary: 
      The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become
      the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance,
      this relates to 50,000 patients in France, life expectancy is very limited, and quality of
      life is poor.

      CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a
      profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance
      to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are
      not yet established. Recently, a chronic inflammatory condition has been quoted as a putative
      cause. This chronic inflammation would involve the molecular mechanisms leading to poor
      regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma
      and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of
      plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could
      explain a lack of protein synthesis.

      It is now well established that respiratory rehabilitation, including a program of exercise
      reconditioning, increases tolerance to exercise and improve the quality of life. Besides the
      classical type of endurance exercises stimulating the cardio-respiratory system, it is
      suggested to add resistance exercises. Several studies have reported the benefit of this
      strategy but the link with intracellular molecular pathways has not been described; moreover,
      it is unknown whether the existence of an initial muscular atrophy influences the gain in
      muscle strength/mass.
    

Detailed description: 
      We therefore propose to explore the effect of a rehabilitation program including endurance
      and resistance exercises on muscle biopsies.

      The present study should help to know the molecular pathways implicated in muscle atrophy in
      CRF patients and to assess their evolution with rehabilitation. This could lead to
      individualized recommendation for exercise program according to the muscle mass of the
      patients.
    

Intervention name(s): Respiratory rehabilitation
Intervention type(s): Procedure
Intervention description(s): The training begins 5 days after the initial assessment. It consists of 3 weekly sessions for 8 consecutive weeks, including the following activities interspersed with periods of rest, according to the needs of patients
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Respiratory Insufficiency; Muscular Atrophy; Respiratory rehabilitation
Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study will address the impact of genetical variation of a protein involved in the
      intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
    

Detailed description: 
      The study will address the impact of genetical variation of a protein involved in the
      intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
    

Intervention name(s): D->R->C+R; D->R->C+D; R->D->C+D; R->D->C+R
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg; one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg; RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg; RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: dabigatran; rivaroxaban; PKC; PKD; p-glycoprotein; polymorphism
Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK Biologicals is developing in partnership with the Program for Appropriate Technology in
      Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine
      immunization of infants and children living in malaria endemic areas. The vaccine would offer
      protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine
      would also provide protection against infection with hepatitis B virus (HBV).

      This trial is being carried out following the demonstration of efficacy of a previous version
      of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated
      approximately 30% efficacy against clinical episodes of malaria and approximately 58%
      efficacy against severe malaria disease.

      In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI)
      regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has
      been developed. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Detailed description: 
      All infants participating in this phase I/IIb study will receive TETRActHib (a licensed
      diphtheria-tetanus-pertussis Haemophilus influenzae vaccine manufactured by Aventis Pasteur)
      by IM injection in their right thigh at 8, 12, and 16 weeks; They will be randomized to
      receive either the candidate malaria vaccine, GSK 257049 vaccine (0.5 ml dose) or Engerix-B
      (a licensed hepatitis B vaccine manufactured by GSK Biologicals) by IM injection in their
      left thigh at 10, 14, 18 weeks. Infants will be followed-up daily for 7 days after each
      vaccine dose for evaluation of safety and reactogenicity. There will be a 14-day follow-up
      period after each dose of TETRActHib and after Dose 1 and Dose 2 of GSK 257049 vaccine or
      Engerix-B, and a one month follow-up period after Dose 3 of GSK 257049 vaccine or Engerix-B
      for reporting unsolicited symptoms. Serious adverse events will be recorded throughout the 14
      month study period. A small amount of blood (2 ml = 1/2 teaspoon) will be obtained at four
      different time points to measure the immune response elicited by the vaccines administered
      during this study period. Preliminary indication of vaccine efficacy in this age group will
      be established by actively monitoring for infection with Plasmodium falciparum.
    

Intervention name(s): RTS,S/AS02D; TETRActHib™; Engerix-B®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3-dose intramuscular injection in the thigh; 3-dose intramuscular injection in the thigh.; 3-dose intramuscular injection in the thigh.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention