bioihbjkbjnl/mcl2 huggingface dataset:
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets
      for the reduction of motor and phonic tics associated with TS in children and adolescents 6
      through 16 years of age.
    


Intervention name(s): TEV-50717; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6, 9, 12, 15, and 18 mg oral tablets; Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
Other intervention name(s): Deutetrabenazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette Syndrome; adolescents; children
Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers
Condition: Heathy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this pharmacokinetic study is to assess the bioequivalence of the generic
      Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test
      product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG,
      Switzerland (reference product). Both formulations contain iron as an active ingredient.
      Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia
      in adult patients.
    


Intervention name(s): Ferrinemia; Venofer
Intervention type(s): Drug; Drug
Intervention description(s): Test product Ferrinemia will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.; Reference product Venofer will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Narrative Visualization for Breast Cancer Survivors' Physical Activity
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study tests the feasibility and acceptability of a physical activity intervention that
      combines use of a wearable activity monitor with a scrapbook. Half of the participants will
      receive this enhanced intervention, while the other half will receive a wearable activity
      monitor with a standard step log.
    

Detailed description: 
      Women breast cancer survivors could benefit from increased physical activity but are in need
      of greater motivation to be active. Interventions that use wearable activity monitors and
      mobile apps have shown promise in the short-term, but use drops off over time. Reports have
      suggested that users find the step data provided to be unclear and not very personally
      meaningful. The ultimate purpose of this line of research is to test whether enhanced
      motivational feedback, using scrapbooks, can increase motivation for activity. The scrapbooks
      will target integrated regulation, which is a type of motivation related to personal identity
      and values. Participants who receive this intervention will draw their step graph, add
      photographs and stickers an explanations to the graph, and answer reflection questions daily.
      Before testing the effects of this intervention on physical activity, the investigators must
      first ensure that the materials and procedures are feasible and acceptable. This small pilot
      study will allow the research team to iteratively test scrapbook materials and improve upon
      them for use in future studies. The investigators will compare an intervention using the
      enhanced materials to an intervention using only the wearable device, app, and a standard
      step log without scrapbook or reflection components. In addition to the primary outcome of
      feasibility (use of the scrapbook), the investigators will also explore the effects of the
      intervention on steps, motivational and values-related outcomes, and various aspects of
      feasibility and acceptability.
    

Intervention name(s): Narrative visualization; Standard self-regulation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants use narrative visualization procedures to connect their step data to important events or feelings that occurred at the same time, then reflect on their behavior; Participants self-monitor steps using a wearable device, app, and a hand-written step log
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: wearable; mobile app; physical activity; survivorship; narrative; identity
Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery
Condition: Unequal Length of Limbs; Congenital; Lower Extremity Deformities, Congenital
MeSH terms: Lower Extremity Deformities, Congenital; Congenital Abnormalities
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this six site multi-center study is to determine if BTX-A can alleviate the
      post-operative pain and improve the functional and quality of life outcomes of children with
      limb length discrepancy or angular deformity undergoing limb lengthening or deformity
      correction.
    

Detailed description: 
      The specific aims are to determine if BTX-A will:

        -  1a. Reduce pain post operatively and during the distraction and consolidation process,

        -  1b. Reduce the amount, frequency and duration of narcotics taken in the postoperative
           period.

        -  2. Improve the quality of life during the distraction and consolidation process.

        -  3 Decrease muscular spasm and subsequent muscle contracture during the distraction and
           consolidation process and accelerate earlier return to pre-operative mobility function
           including earlier weight bearing.

        -  4. To develop clinical practice guidelines for the interdisciplinary care of children
           undergoing limb lengthening or deformity correction.

      Methodology: A randomization process for this one time injection will be used to determine
      who will receive the BTX-A or the placebo. 150 subjects will be recruited; 75 to the BTX-A
      group and 75 to the placebo group. There will be an equal number of subjects in each group at
      each site. The medication will be injected intraoperatively into specific major muscles in
      the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of
      10 U/kg with a maximum of 50 U per site, not to exceed a total maximum dose of 400 units.
      Pain scores, medication dosages, range of motion and an ambulation scale will be measured
      post-operatively and during the distraction and consolidation phases.

      In addition families will be asked to complete six different questionnaires related to pain,
      quality of life and psycho-social issues at various times during the process. The children
      will receive standard nursing care and physical therapy and will be followed for three months
      after the external fixator is removed, for a total time of approximately one year.
    

Intervention name(s): Botulinum toxin A injection; saline injection
Intervention type(s): Drug; Drug
Intervention description(s): 10 units per kilo to maximum of 400 units; 10 units per kilo to maximum of 400 units
Other intervention name(s): botox; salt water
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics
      of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized,
      placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and
      female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of
      10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits
      are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a
      randomized sequence on 5 separate study occasions.
    


Intervention name(s): GSK1034702; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral or liquid; To match GSK1034702
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: schizophrenia; M1 receptor agonist; safety; pharmacokinetics; GSK1034702
Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined
      With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double
      platinum-based chemotherapy
    


Intervention name(s): Sintilimab Combined With Docetaxel Monotherapy
Intervention type(s): Drug
Intervention description(s): Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will assess the safety, tolerability
      and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be
      randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10
      days.
    


Intervention name(s): Placebo; RO5024048
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose; single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Platelet-Inhibitor Drug Trial in Coronary Angioplasty
Condition: Angina Pectoris; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Angina Pectoris; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the
      dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty
      (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in
      reducing the incidence of coronary events and the severity and incidence of angina.
    

Detailed description: 
      BACKGROUND:

      By dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise
      tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of
      dilated stenoses within three to six months following PTCA making it necessary to restrict
      patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery
      bypass surgery.

      Balloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media
      of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation,
      and intimal proliferation by mechanisms that appear similar to those causing aortocoronary
      vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy
      suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened
      platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in
      patients both early and late after the operation. Thus, a trial of these drugs in patients
      undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the
      initially successful PTCA therapy, namely the high rate of restenosis.

      DESIGN NARRATIVE:

      Randomized, double-blind, fixed sample. Patients were randomized to treatment with
      dipyridamole plus aspirin or placebo.

      The study completion date listed in this record was obtained from the Query/View/Report (QVR)
      System.
    

Intervention name(s): aspirin; dipyridamole; angioplasty, transluminal, percutaneous coronary
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Aspirin; Dipyridamole
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy
Condition: Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      Lung surgery under thoracotomy is known to induce long-term pain which can be considered as
      neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct
      traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be
      administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as
      it is already commonly administered intra and postoperatively for improvement of analgesia
      [6].
    

Detailed description: 
      Lung surgery under thoracotomy is known to induce long-term pain which can be considered as
      neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct
      traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be
      administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as
      it is already commonly administered intra and postoperatively for improvement of analgesia
      [6]. This study compares two groups of patients undergoing thoracotomy for partial
      pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then
      during 48 hours, the other receiving inactive normal saline (placebo). The study is
      prospective, randomized, and double-blinded. The primary endpoint is to reduce chronic pain
      (on visual analogue scale) at the 4th month after surgery with ketamine. The objective is to
      obtain a mean value under 20/100 in the ketamine group, considering that the expected mean
      value for the control group is 38/100 (based on personal observations). The secondary
      endpoints are lower scores of neuropathic pain in the ketamine group, assessed by the NPSI
      questionnaire [7]. The impact of treatment on quality of life, assessed by a questionnaire
      (SF-36), is also studied. The data collected by clinical and psychophysical examination
      performed on all patients at the 4th month after surgery will be also considered for
      analysis, in order to understand better the features of post-thoracotomy neuropathic pain.
    

Intervention name(s): Hypothetica
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thoracotomy; Neuropathic pain; Nerve trauma; Ketamine; NMDA receptors
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)
Condition: Attention Deficit Hyperactivity Disorder; Reading Disorder
MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      To test the hypothesis that a 4 week treatment with atomoxetine is more effective than
      placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD),
      patients with only Reading Disorder, and patients with combined type ADHD and Reading
      Disorder.
    


Intervention name(s): Atomoxetine Hydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atomoxetine, 1.2 mg/kg/day, by mouth (PO); Placebo, every day (QD), by mouth (PO)
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
Condition: Contraception
Study type: Observational

Summary: 
      This is local prospective, non-interventional multi-center comparative study. Primary study
      objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after
      insertion ( patient assessment questionnaire) in daily practice. For each patient, the
      treating gynecologist documents demographics, medical data, safety parameters and treatment
      signs and symptoms at an initial visit and one or two follow-up visit(s).
    


Intervention name(s): Levonorgestrel (Mirena, BAY86-5028); Copper IUD
Intervention type(s): Drug; Device
Intervention description(s): intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel; Copper device, inserted intrauterine
Intervention MeSH terms: Copper; Levonorgestrel
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females who plan long-term contraception and meet criteria of inclusion and exclusion.
      
Keywords: non-interventional; Mirena; Contraception; Russian Federation
Registry of Mastectomy for Breast Cancer Risk Reduction
Condition: Quality of Life; Mastectomy; Breast Neoplasms; Genetic Predisposition to Disease; Adjustment Disorder
MeSH terms: Breast Neoplasms; Genetic Predisposition to Disease; Adjustment Disorders
Study type: Observational

Summary: 
      This is a registry for patients who have a risk-reduction mastectomy ("prophylactic
      mastectomy") due to being at high risk for developing breast cancer, followed by breast
      reconstruction. Eligible patients include those who have a breast cancer-related gene, a
      strong family history of breast cancer, or a personal history of high-risk conditions such as
      cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the
      registry before surgery, and are followed for up to ten years afterwards. In addition to
      studying medical outcomes, we will periodically survey patients for quality-of-life issues
      and psychological well-being. There is no compensation for being enrolled in this registry.
      This registry is conducted through the Department of Plastic Surgery at Georgetown University
      Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi
      Comprehensive Cancer Center at Georgetown University.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are enrolled from the plastic surgery, breast surgery, or oncology clinics at
        Georgetown University Hospital who are at elevated risk for breast cancer. Please note that
        the Registry can only enroll Georgetown University Hospital patients.
      
Biospecimen description: 
      Patient operative specimens, blood samples, and saliva samples.
    
Keywords: prospective study; registry; quality of life; mastectomy; reconstructive surgical procedures; BrCa1; BrCa2; breast cancer prevention
Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
Condition: Muscle Cramp
MeSH terms: Muscle Cramp; Spasm
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR
      168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity
      of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be
      evaluated.
    

Detailed description: 
      Chronic leg cramps are prevalent among the aging population affecting sleep patterns and
      quality of life. Magnesium deficiency may cause muscle weakness and cramps. Magnesium
      supplementation will be evaluated for the relief and/or improvement of symptoms. The primary
      objective is to evaluate the efficacy of magnesium supplementation, MagTabSR, 168mg's twice a
      day, for the relief and/or improvement in the frequency, duration, intensity of leg cramps.
      Secondary objectives are to evaluate the improvement in sleep disturbances and quality of
      life.
    

Intervention name(s): MagTabSR; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): MagTabSR/placebo 168 mgs BID for 6 six weeks; MagTabSR/placebo 168 mgs BID for 6 six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment