bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
Condition: Diabetic Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose
      of an investigational product in subjects with diabetic neuropathy
    


Intervention name(s): ABT-894; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg BID tablets, 8 weeks of treatment; BID tablets, 8 weeks of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase I/II Study of Total Body Irradiation, Cyclophosphamide, and Fludarabine Followed by Alternate Donor Hematopoietic Cell Transplantation in Patients With Fanconi's Anemia
Condition: Fanconi's Anemia
MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      OBJECTIVES: I. Determine the probability of engraftment with total body irradiation,
      cyclophosphamide, fludarabine, and anti-thymocyte globulin followed by HLA nongenotypically
      identical donor, T-cell depleted hematopoietic cell transplantation in patients with
      Fanconi's anemia.

      II. Determine the incidence of acute and chronic graft-versus-host disease in these patients
      after undergoing this treatment regimen.

      III. Determine the one-year survival rate in these patients after undergoing this treatment
      regimen.

      IV. Determine the toxicity of this treatment regimen in these patients. V. Determine the
      incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia
      after undergoing this treatment regimen.
    

Detailed description: 
      PROTOCOL OUTLINE: Donor bone marrow, peripheral blood, or umbilical cord blood is processed
      to harvest CD34+ cells.

      Patients receive preparative cytoreductive therapy comprising total body irradiation on day
      -6; cyclophosphamide IV over 2 hours on days -5 to -2; fludarabine IV over 30 minutes on days
      -5 to -2; methylprednisone IV on days -5 to 24; anti-thymocyte globulin IV over 4-6 hours on
      days -5 to -1; cyclosporine IV over 2 hours every 12 hours (every 8 hours for patients less
      than 40 kg in weight) on days -3 to 180, and then tapering in the absence of
      graft-versus-host disease; hematopoietic cell transplantation on day 0; and filgrastim
      (G-CSF) IV starting on day 1 and continuing until blood counts recover.

      Patients are followed at days 60, 90, and 180, and then annually for 3 years.
    

Intervention name(s): anti-thymocyte globulin; cyclophosphamide; cyclosporine; filgrastim; fludarabine; methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclosporine; Methylprednisolone; Cyclophosphamide; Fludarabine; Cyclosporins; Antilymphocyte Serum
Primary purpose: Treatment
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
Condition: Transient Hypothyroxinemia
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to determine whether iodide supplementation of neonates born
      under 31 weeks gestation improves neurodevelopment measured at two years of age.
    

Detailed description: 
      Iodine is essential for the synthesis of thyroxine, and thyroxine is essential for normal
      brain development in utero and for the first 2-3 years of life. The recommended iodine intake
      in parenteral nutrition regimens is 1 μg/kg/day and commercially available parenteral
      solutions for infants reflect these recommendations. In the absence of other iodine sources,
      infants are vulnerable to negative iodine balance and insufficiency. As many preterm infants
      are fed parenterally for prolonged periods with solutions which have been shown to be
      iodine-deficient, the I2S2 Trial was designed as a UK multicentre randomised controlled trial
      to establish whether iodine supplementation of preterm infants benefits neurodevelopment.
    

Intervention name(s): sodium iodide; Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation; Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypothyroxinemia; preterm infants; iodine; neurodevelopmental outcome; Iodine supplementation; Randomised controlled trial
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
Condition: Hepatitis B Infection
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of
      hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to
      determine its optional dose.
    

Detailed description: 
      GC1102 is a new recombinant hepatitis B immunoglobulin (HBIg) from Chinese Hamster Ovary
      (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B
      surface antigen and several advantages compared to HBIg derived from blood plasma of human
      donors. Forty volunteers will participate in the study, receive 24-week treatment with low
      dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.
    

Intervention name(s): GC1102 50,000 IU; GC1102 80,000 IU
Intervention type(s): Biological; Biological
Intervention description(s): a recombinant hepatitis B immunoglobulin; a recombinant hepatitis B immunoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBV-related liver transplantation; Hepatitis B Immuno Globulin
Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Condition: Autoimmune Diseases; Inflammatory Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the
      systemic exposure of rosuvastatin in healthy participants.
    


Intervention name(s): BMS-986165; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.; Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.
Intervention MeSH terms: Deucravacitinib; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Muscular Diseases
Study type: Interventional

Summary: 
      Comparing the efficiency between manual therapy protocol and effleurage in patients with
      temporomandibular disorders.
    

Detailed description: 
      The investigators want to get better insights into the outcome of a manual therapy protocol
      compare with effleurage. The treatment is meant for people who has masticatory muscle
      disorders. Besides, if the trial can reduce the pain's intensity and the trial can improve
      range of motion in the dysfunction of temporomandibular joint. The results will be register
      on the short and long term.
    

Intervention name(s): Manual Therapy protocol; Effleurage
Intervention type(s): Other; Other
Intervention description(s): This protocol consists of:
Six minutes of joint's mobilisation (two minutes of each technique).
Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points.
Three minutes of trigemino's nerve stretching.; The protocol consists of:
Five minutes in temporal muscle.
Ten minutes superficial massage in the neck and cheek of the most painful joint.
Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post
      market clinical study conducted in Europe. The purpose of the study is to evaluate
      asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial
      fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.
    

Detailed description: 
      10-12 centers in Europe will enroll up to 56 subjects who meet the inclusion/exclusion
      criteria and provide consent to participate in the study. Subjects will undergo an ablation
      for paroxysmal AF with the Medtronic PVAC GOLD (CE-Mark). To assess for ACE lesions, pre- and
      post-ablation procedure cerebral MRIs will be done along with a neurological exam (Mini
      Mental State Exam). Subjects will be followed for 1 month post-procedure when a repeat MRI
      and neurological exam will be conducted if the subject had a positive MRI at pre-hospital
      discharge.
    

Intervention name(s): Ablation / MRI
Intervention type(s): Other
Intervention description(s): All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter.
MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children
Condition: Adhd
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public
      concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very
      usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism
      spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter
      pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power
      to better help numerus of children. We propose to study the phenylalanine and the tyrosine
      pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood
      and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a
      specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic
      signature with the reference methodology for ADHD diagnosis, as now practiced in our
      reference center for learning troubles.
    


Intervention name(s): Metabolomic approach
Intervention type(s): Other
Intervention description(s): Biological samples (blood and urine) for a multimodal metabolomic approach
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Child or adolescent with symptoms of attention disorders and / or hyperactivity, aged from
        6 to 15 years old, and consulting in current care in our university hospital
      
Biospecimen description: 
      Blood samples Urinary samples
    
Keywords: adhd; metabolomics; child
A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department
Condition: Pregnancy
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The objective of this study is to develop and test an emergency department (ED)-based
      intervention which uses text messages to facilitate contraception initiation.
    

Detailed description: 
      Our hypothesis is that adolescent females at high pregnancy risk who receive text message
      reminders and motivational messages that promote contraception and referral to the Family
      Planning Clinic are more likely to start effective contraception than those who receive
      standard paper-based referral to the Family Planning Clinic alone.
    

Intervention name(s): Text Messaging Intervention; Standard Referral
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pregnancy; Pregnancy, unplanned; Reproductive behavior; Pregnancy in Adolescence; Text messaging
Behavioral Treatments for Acute Stress Disorder In Firefighters
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute
Study type: Interventional

Summary: 
      This study will develop a treatment for firefighters experiencing symptoms of acute stress
      disorder (ASD). Effective treatments may reduce immediate symptoms and prevent the
      development of more chronic conditions, such as post-traumatic stress disorder (PTSD).
    

Detailed description: 
      Exposure to traumatic events has reached unprecedented proportions in American society, and
      the rates of PTSD have risen significantly, particularly among populations with repetitive
      exposure to critical incidents. The continued threat of attacks against Americans warrants
      development of preventive interventions to reduce the occurrence of PTSD and its precursor,
      ASD. This study will determine the effectiveness of a preventive treatment in urban
      firefighters who have experienced a traumatic event.

      Firefighters will undergo an initial assessment that will include an interview and
      self-report questionnaires to measure depression, anxiety, coping skills, social support,
      physical health, and work functioning. Following the occurrence of a traumatic work-related
      event, firefighters will be reassessed. The post-incident assessment will consist of
      self-report questionnaires that assess ASD symptoms.

      Participants who display ASD symptoms will be randomly assigned to one of two groups: the
      first group will learn cognitive behavioral strategies for symptom reduction, and the second
      group will receive psychoeducation regarding common reactions to traumatic events.
      Participants' treatment will last for 12 weeks. Participants will have follow-up assessments
      1 and 3 months after the interventional part of the study. Assessments will include clinical
      scales and interviews.
    

Intervention name(s): Cognitive behavioral therapy; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will learn cognitive behavioral strategies for symptom reduction; Participants will receive psychoeducation regarding common reactions to traumatic events
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Occupational Health; Trauma; Job; CBT
S0000 Selenium and Vitamin E in Preventing Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be
      more effective in preventing prostate cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E,
      either alone or together, in preventing prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effect of selenium and vitamin E administered alone vs in combination on the
           clinical incidence of prostate cancer.

        -  Compare the effect of these prevention regimens on the incidence of lung cancer,
           colorectal cancer, and all cancers combined in participants on this study.

        -  Compare the effect of these prevention regimens on prostate cancer-free survival, lung
           cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall
           survival, and serious cardiovascular events in these participants.
    

Intervention name(s): Vitamin E; Selenium; Vitamin E placebo; selenium placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 400 IU daily by mouth for 7-12 years; 200 mcg daily for 7-12 years; daily for 7-12 years; daily for 7-12 years
Other intervention name(s): alpha tocopherol; L-selenomethionine; placebo; placebo
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prostate cancer
N-acetylcysteine (NAC) for Children With Tourette Syndrome
Condition: Tourettes Syndrome; Tic
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple
      motor and vocal tics that last for at least a year in duration. Currently, there exist
      several effective pharmacological treatments for childhood tics including alpha-2 agonist
      medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These
      medications, however, have significant side-effects and are only partially efficacy in
      treating tics.

      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate
      modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in
      this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with
      NAC is nausea and this side-effect is seldom seen in the doses used in this trial.

      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled
      trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to
      be closely related to tics because these conditions (1) have similar clinical characteristics
      -- both groups typically experience urges before engaging in pulling or tics, (2)
      neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3)
      the same pharmacological treatments (neuroleptics) may be effective for both conditions and
      (4) they tend to be inherited together in families. In other trials NAC has evidence of some
      efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia
      and cocaine dependence.

      The investigators are conducting this trial to determine if NAC is an effective treatment for
      tics.
    


Intervention name(s): N-Acetylcysteine (NAC); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.; 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tic disorders,; Tourette syndrome; Chronic Tic Disorders
Wasting in Chronic Kidney Disease
Condition: Chronic Kidney Hospitalized
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Wasting Syndrome; Cachexia
Study type: Observational

Summary: 
      Protein energy wasting is an independent factor associated with morbi-mortality in chronic
      kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney
      disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients
      diagnosed with chronic kidney disease according to the degree of evolution of the disease and
      the diagnostic method.

      Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney
      disease. Nutritional treatment differs depending on the stage of the kidney disease acute or
      chronic treated whether or not by dialysis. Nutritional monitoring should be regular,
      individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding
      techniques should allow all the nutritional needs. Their indications depend on the clinic,
      biochemical assessment and nutrient intake.
    


Intervention name(s): Nutritional care
Intervention type(s): Dietary Supplement
Intervention description(s): Diagnosis of protein energy wasting : anthropometry, calculation of the nutrient intakes, evaluation of appetite, evaluation of gastrointestinal syndromes, hand grip test and bioimpedancemetry
Treatment of protein energy wasting : estimation of nutritional requirements, prescription of oral nutritional supplement or artificial nutrition, physical rehabilitation
Multidisciplinary approach (nephrologists, dieticians, physiotherapists, nurses)
Evaluation of the nutritional treatment (plasma albumin and prealbumin, weight evolution, muscle strength and body composition)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic kidney disease
      
Keywords: Chronic kidney disease; Enteral nutrition; Oral nutritional supplements; Parenteral nutrition; Refeeding; Wasting