bioihbjkbjnl/mcl2 huggingface dataset:
Lithium for the Treatment of Pediatric Mania
Condition: Bipolar I Disorder Without Psychotic Symptoms
MeSH terms: Mania
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is being performed under the Best Pharmaceuticals for Children Act,
      signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The
      purpose of this study is to examine the efficacy and safety of lithium in the treatment of
      pediatric patients with bipolar I disorder.
    

Detailed description: 
      This is a multiphase, multicenter, trial that will comprehensively examine lithium in the
      treatment of pediatric patients with bipolar I disorder. In order to examine the treatment of
      bipolar disorder with lithium, this study will include four phases of treatment. The first
      phase, the Pharmacokinetic Phase, will include 8 weeks of Open Label treatment to determine
      empirically based dosing strategies for children and adolescents with bipolar disorder.
      Patients completing the Pharmacokinetic Phase, may be eligible to continue in the Long-Term
      Effectiveness Phase for a maximum of 16 weeks of lithium treatment. Subsequently, patients
      meeting response criteria during the Long-Term Effectiveness Phase will be eligible to
      continue in the Discontinuation Phase. During the Discontinuation Phase, patients will be
      randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those subjects
      who experience a mood relapse during the Discontinuation Phase will be enrolled in an Open
      Label Restabilization Phase and treated with lithium for up to 8 weeks.
    

Intervention name(s): Lithium Carbonate; Lithium Carbonate; Lithium Carbonate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The starting dose of lithium was 300 mg for patients weighing < 20 kg; The dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patient"s response and tolerability. The starting dose of lithium was 900 mg and the dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patient"s response and tolerability; The starting dose of lithium was 900 mg and the lithium dose was increased by 300 mg every 3 days, (no more than twice weekly) to maximum tolerated dose based upon the patient"s response and tolerability.; During the third phase, which is the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks.
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mania, Lithium, Bipolar, BPCA, pediatrics
Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover,
      single-dose study to evaluate the effects of a therapeutic (1000 milligram [mg]) and
      supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg)
      and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter
      electrocardiograms (ECGs) in approximately 55 healthy volunteers.

      All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg,
      moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be
      used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo and
      GSK2140944 or placebo will be administered.

      Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report
      to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects will
      remain confined until check out procedures have been completed on Day 3 (5 days confinement
      in Period 1 and 4 days in the following 3 periods). There will be a washout of at least 7
      days between doses. The follow-up visit will occur 7-10 days after the final dose. Total
      duration of the study (from screening to the follow-up visit) will be approximately 60 days.
    


Intervention name(s): GSK2140944; GSK2140944 placebo; Moxifloxacin; Moxifloxacin placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK2140944 is available in dose strength 1000 mg and 1800 mg for single IV dose over 2 hours administration as a pale yellow to greyish yellow cake for reconstitution; GSK2140944 placebo is 0.9% sodium chloride available for single IV dose over 2 hours administration.; Moxifloxacin is available as pinkish red tablet with dose strength 400 mg for single oral dose to be administered in the morning in the fasted state with approximately 240 mL of water.; Moxifloxacin placebo is available as white, film-coated tablet. containing nonactive material for single oral dose to be administered in the morning in the fasted state with approximately 240 mL of water.
Intervention MeSH terms: Moxifloxacin; Gepotidacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TQTc; Moxifloxacin; GSK2140944
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a global multicenter randomized factorial double-blind, placebo-controlled
      trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally
      twice daily for five days compared to a placebo in the treatment of acute uncomplicated
      influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus
      Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide
      monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days)
      in the treatment of acute uncomplicated influenza.
    


Intervention name(s): Nitazoxanide; Oseltamivir; Placebo Oral Tablet; Placebo Oral Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Alinia; NTZ (nitazoxanide); Tamiflu; OST (oseltamivir)
Intervention MeSH terms: Oseltamivir; Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Influenza
Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior
Condition: Actual Suicidal Behavior Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000
      suicide attempts every year. SB management is therefore a major public health issue.
      Recently, investigators have demonstrated the interest of acceptance and commitment therapy
      (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in
      depressed patients having a history of suicide attempt within previous year (i.e actual SB
      disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth
      edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal
      and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly,
      previous functional MRI (fMRI) studies have also reported the modulation of these regions by
      ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to
      identify biomarkers of SB and its improvement by ACT.

      The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB
      disorder. Patients having a history of SB within previous year were randomized in an ACT
      program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after
      the completion of the group, they performed 3 tasks during fMRI: implicit emotional
      visualization, Cyberball game, motivational task Investigators will compare cerebral
      activations between groups, between pre and post intervention as well as measure baseline
      cerebral activations associated with improvement of suicidal ideation during follow up.
    

Detailed description: 
      42 patients having a history of suicide attempt within the year preceding inclusion have been
      recruited.

      First visit or inclusion (within 2 weeks preceding the beginning of the program): clinical,
      biological assessment and fMRI acquisition Second visit (within 2 weeks +/- 1 week following
      completion of the program): clinical assessment and fMRI acquisition Third visit (within 3
      months +/- 2 weeks following completion of the program): clinical assessment
    

Intervention name(s): Relaxation; ACT therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.; 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. The ACT program aims at
decreasing the tendency to try to escape unpleasant mental experiences
increasing psychological flexibility
developing acceptance of psychological events and engagement in valued actions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Psychiatry; Suicide; Randomized controlled trial; ACT; fMRI
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
Condition: Obesity; Fatty Liver, Nonalcoholic
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for
      dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the
      lipid-lowering effects of statins are well-known, other metabolic effects, including effects
      on glucose tolerance and ectopic fat distribution, are less completely understood. Recent
      studies have shown that some statins may increase the risk of diabetes. Further, research has
      suggested that statins may have some benefit in nonalcoholic fatty liver disease (NAFLD), a
      condition associated with obesity that includes increased fat in the liver (steatosis) and,
      in some cases, inflammation and hepatocellular damage (steatohepatitis). Pitavastatin,
      approved by the United States Food and Drug Administration (FDA) in 2009, is the most recent
      statin to enter the market. Unlike most statins, pitavastatin is not primarily metabolized
      through cytochrome P450 (CYP450), and thus has reduced potential for interactions with other
      medications that are metabolized by CYP450. Previous studies have suggested that pitavastatin
      may be neutral to glucose homeostasis and may improve hepatic lipid. Neither of these effects
      has been proven definitively, however, and the current proposal aims to characterize in
      detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and
      steatohepatitis.
    


Intervention name(s): pitavastatin; PLACEBO
Intervention type(s): Drug; Other
Other intervention name(s): Livalo
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; insulin sensitivity; statin (HMG-CoA Reductase Inhibitor); fatty liver
Functional and Performance Effects of a 4-week Weightlifting Program in Highly Trained Adolescent Basketball Athletes
Condition: Athletic Injuries
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      Weightlifting is an increasingly used intervention in the sport field to improve both
      function and performance outcomes. However, the effects in a pediatric and adolescent
      population are not well described, and require further research to elucidate the benefits and
      potential adverse effects compared to other strength training methods, such as plyometric
      training.
    

Detailed description: 
      Highly trained male and female adolescent basketball athletes aged 12-16 years will be
      recruited for the study. Participants will be randomly assigned to a 4-week program (12
      sessions) of weightlifting or plyometric training. The training programs will be identical in
      sets and repetitions, progressively evolving each week towards fewer sets and fewer
      repetitions. The training intensity will be the same in both groups, calculated from the RM,
      starting at 70% in the first week and progressing by 5% each week until a final intensity of
      85% in the last week. Therefore, both interventions evolve towards sessions with fewer sets
      and repetitions and higher loads.

      The weightlifting intervention refers to the performance of highly technical and explosive
      multi-joint strength exercises. The program consists of six basic weightlifting maneuvers
      (hang power clean, overhead squat, hang power snatch, clean, split jerk, snatch), two of
      which are performed in each of the three weekly sessions. The order of execution of the
      exercises in the weekly sessions is always the same. To ensure the correct execution of the
      maneuvers, before starting the intervention, a brief familiarization program will be carried
      out. This consists of an explanation of the exercises by the research staff and practice by
      the participants with simultaneous correction.

      The plyometric program follows the same structure, consisting in a total of 6 exercises (Max
      countermovement jump, double leg side jump, maximum squat jump, dropjump (20cm), single leg
      hurdle jump, doble leg multi hop) performed in groups of 2 for each weekly training session.

      The design of the intervention program is based on previously published related
      articles.Training sessions will be supervised by a member of the research team with expertise
      in strength and conditioning in basketball athletes.
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): 4-week weightlifting strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two arms
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weighlifting; Strength; Functional outcomes; Adolescent; Basketball
What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?
Condition: Neonatal Seizure
MeSH terms: Seizures
Study type: Observational

Summary: 
      The investigators aimed to determine the factors for ceasing anti-seizure medication in
      infants who experienced seizures during the neonatal period. This retrospective,
      single-center, descriptive study was conducted in Balıkesir between December 2020 and
      February 2023, and 157 neonates were recruited.
    

Detailed description: 
      This retrospective, single-center, descriptive study was conducted at the Department of
      Paediatric Neurology between December 2020 and February 2023, and 157 neonates were recruited
      to determine the factors related to ceasing ASM treatment in infants at a follow-up 2 years.
      According to the International League Against Epilepsy (ILAE) classification of neonatal
      seizures and their etiology, patients who were diagnosed with such seizures and received
      anti-seizure medication within the first 28 days of life were followed until their ASM was
      ceased after they were discharged from the neonatal intensive care unit. Infants are defined
      as children aged younger than 12 months. During this stage of neuronal development, the
      central nervous system is more susceptible to the harmful effects of external factors.
      Consequently, the investigators have planned to evaluate the study's initial 12-month
      follow-up results for our group. Afterwards, the infants were divided into two groups: the
      first group consisted of infants who continued to receive ASM treatment after 12 months of
      age (referred to as "infants still on ASM after 12 months", n=69); the second group consisted
      of infants who had stopped ASM treatment before 12 months of age (referred to as "infants who
      had ceased ASM before 12 months", n=88).
    

Intervention name(s): retrospective data collection
Intervention type(s): Other
Intervention description(s): retrospective data collecting from medical records
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infants are defined as children aged younger than 12 months.According to the International
        League Against Epilepsy (ILAE) classification of neonatal seizures and their aetiology,
        patients who were diagnosed with such seizures and received anti-seizure medication within
        the first 28 days of life were followed until their ASM was ceased after they were
        discharged from the neonatal intensive care unit.
      
Keywords: Neonate; Seizure; Early onset epilepsy; anti-seizure medication; acute provoke seizure
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of
      CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)
    

Detailed description: 
      Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to
      receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease,
      intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is
      objective response rate (ORR), as assessed by independent radiological review committee
      (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.
    

Intervention name(s): CS1001
Intervention type(s): Biological
Intervention description(s): Monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Preemptive Analgesic Efficacy of Nefopam
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast
      cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be
      reduced.
    


Intervention name(s): Nefopam; Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers
Condition: Heavy Metal Toxicity
MeSH terms: Heavy Metal Poisoning
Study type: Interventional

Summary: 
      This interventional study investigates the efficacy of Wet cupping therapy on heavy metal
      levels.The levels of the selected heavy metals will be measured in the blood samples obtained
      from the participants before and after the interventions
    

Detailed description: 
      Wet cupping therapy (WCT) is a traditional therapy which was used for centuries especially
      for detoxifiying purposes.Current literature also points out its blood clarifiying capacity
      in order to illuminate the underlying mechanism of this ancient treatment.

      Steel industry workers, different from the general population are exposed to heavy metals
      more often.Conducting a study in this special group where we will evaluate the levels of
      selected heavy metals in blood before and after the three sessions of WCT might let us know
      its detoxifiying capacity based on measurable parameters.
    

Intervention name(s): Wet cupping therapy
Intervention type(s): Procedure
Intervention description(s): CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46). The cupping technique procedure was conducted in five phases:
Primary suction; cups are left attached to the skin for 5 minutes.
Area disinfection; areas are wiped with sterile gauze after disinfection with povidone iodine.
Scarification; Superficial incisions (20-30 gauge), 5 mm length and 1-2 mm depth, are made on the skin with a sterile, number 11 surgical blade.
Bloodletting and secondary suction; the cups which had been previously removed are placed again on the scarified areas Blood leaks from the capillary vessels of the skin and subcutaneous tissue and fills the cups, which are left in place for 15 minutes.
Removing and dressing; the cups full of blood are removed. The areas of application are wiped with sterile gauze and then a dressing is applied
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heavy metal; wet cupping therapy; steel industry worker
A Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine whether or not Cialis (tadalafil) administered to
      head and neck squamous cell cancer patients augments immune response.
    


Intervention name(s): Tadalafil; Placebo Pill
Intervention type(s): Drug; Other
Intervention description(s): 20 mg once daily for 10 - 14 days; Placebo
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study for Patients With Secondary Progressive Multiple Sclerosis
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether MBP8298 is effective and safe in the
      treatment secondary progressive multiple sclerosis.

      Dirucotide is generic name for MBP8298.
    


Intervention name(s): dirucotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500mg, intravenous, dosed once every six months for 18 months; intravenous, once every six months for 18 months
Other intervention name(s): MBP8298; LY2820671
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment