bioihbjkbjnl/mcl2 huggingface dataset:
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Condition: Parkinson's Disease; Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of a drug called
      atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine
      (ATM) is an approved drug currently on the market for the treatment of attention deficit. It
      works to increase the amount of norepinephrine (a chemical in the brain that helps keep us
      awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration
      (FDA) to be used in the treatment of PD.
    


Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease
Bone Marrow Transplantation in Treating Patients With Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
      cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be
      able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to
      kill cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating
      patients with recurrent or residual low-grade lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Examine the potential role of high dose etoposide, cyclophosphamide, total
      body irradiation and bone marrow transplantation for patients at high risk for disease
      progression. II. Determine the value of monitoring the quality of remission by PCR assessment
      of BCl-2. III. Evaluate the efficacy of alpha interferon for patients with evidence of
      residual or recurrent lymphoma. IV. Evaluate the efficacy of bone marrow purging by PCR
      assessment of BCl-2.

      OUTLINE: Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum
      disease state. Etoposide is administered intravenously on day -8. Cyclophosphamide is infused
      intravenously over 2 hours daily on day -7 and -6. Patients receive mesna beginning 1 hour
      after initiation of the cyclophosphamide treatment. Total body irradiation is received on
      days -4, -3, -2 , and -1. On day 0 allogeneic or autologous bone marrow is infused
      intravenously. Patients with residual or recurrent lymphoma receive interferon alpha daily.

      PROJECTED ACCRUAL: 35 allogeneic and 40 autologous patients are expected to be enrolled.
    

Intervention name(s): Recombinant Interferon Alfa; Cyclophosphamide; Etoposide; Mesna; Bone Marrow Transplantation; Radiation Therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention description(s): Daily; Infused intravenously over 2 hours daily on Day -7 and -6.; Administered intravenously on Day -8; Beginning 1 hour after initiation of the cyclophosphamide treatment.; Infusion on Day 0.; Total body irradiation is received on days -4, -3, -2 , and -1.
Other intervention name(s): Cytoxan; Neosar; VePesid; Mesnex; BMT; RT; Radiotherapy; TBI
Intervention MeSH terms: Interferons; Interferon-alpha; Cyclophosphamide; Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Waldenstrom macroglobulinemia; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma; mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical
      bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and
      eradication rate in the western clinical trials. Development of azithromycin intravenous
      formulation would bring the clinical benefit to patients with pelvic inflammatory disease
      (PID) in Japan.
    


Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.
Intervention MeSH terms: Azithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy
Condition: Diarrhea; Gastrointestinal Complications; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .

      PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young
      patients with severe autoimmune enteropathy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the rate of treatment-free remission in young patients with severe autoimmune
           enteropathy treated with high-dose cyclophosphamide.

      Secondary

        -  Determine the toxic effects of this drug in these patients.

      OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive
      filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3
      days or until blood counts recover.

      After completion of study treatment, patients are followed periodically for up to 1½ years.

      PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.
    

Intervention name(s): filgrastim; cyclophosphamide
Intervention type(s): Biological; Drug
Intervention description(s): Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover; Administered IV over 1 hour on days 1-4
Other intervention name(s): G-CSF
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: unspecified childhood solid tumor, protocol specific; gastrointestinal complications; diarrhea
Food Supplement Effect on Overweight or Moderate Obesity
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The aim of this study is to assess the effect of a food supplement containing extracts of
      carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.
    


Intervention name(s): High dose; Low dose; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Food supplements are consumed during 3 months by healthy volunteers.; Food supplements are consumed during 3 months by healthy volunteers.; Food supplements are consumed during 3 months by healthy volunteers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Bioequivalence Study of Gabapentin 400 mg Capsules Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg
      dose under fasting conditions
    

Detailed description: 
      This was an open-label, randomized, single-dose, 2-way crossover relative bioavailability
      study performed on 24 healthy adult volunteers and 2 alternates. A total of 26 subjects (22
      males and 4 females) completed the clinical phase of the study. In each period, subjects were
      housed from at least 10 hours before dosing until after the 36-hour blood draw. Both periods
      were separated by a wash out period of 7 days A total of 26 healthy adult volunteers (22
      males and 4 non-pregnant females) enrolled in and completed the clinical phase of the study
      enrolled in and completed the clinical phase of the study
    

Intervention name(s): Gabapentin 400mg capsules
Intervention type(s): Drug
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence gabapentin 400mg capsules fasting conditions
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy
      volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release,
      and clonazepam tablet.
    

Detailed description: 
      To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in
      Mexico, both drugs are still widely used as first or second choice in the treatment of
      anxiety disorders.
    

Intervention name(s): Alprazolam; Alprazolam XR; Clonazepam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions; Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions; Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
Other intervention name(s): Tafil, Xanax; Tafil AP, Xanax XR; Rivotril
Intervention MeSH terms: Clonazepam; Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Alprazolam; Alprazolam extended release; Clonazepam; Pharmacokinetics; Mexican population; Healthy
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective, randomised, open-label phase IIb clinical trial assessing the effect of
      pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing
      nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

      The primary objective of the trial is to investigate whether the add-on of pegylated
      interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the
      percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48
      weeks.

      170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an
      oral antiviral regimen and having a nondetectable viral load for at least 12 months are
      included.
    


Intervention name(s): Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Intervention type(s): Drug
Intervention description(s): Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)
Other intervention name(s): Pegasys®
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis B
Non-Invasive Brain Stimulation as an Innovative Treatment for Chronic Neglect Patients
Condition: Spatial Neglect
Study type: Interventional

Summary: 
      Background Stroke is a leading cause of neurological impairments in language, motor and
      cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation
      (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here,
      we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current
      Stimulation (tACS), to promote functional recovery of people with neglect symptoms following
      stroke.

      Objective To determine whether neglect training complemented with tACS treatment in chronic
      stroke patients suffering from neglect improves neglect-related symptoms compared to neglect
      training with sham stimulation.

      Study design Double-blind randomized placebo-controlled intervention study. After enrollment
      and completion of baseline measurements, participants are randomly assigned to either the
      active tACS group or sham (control) group.

      Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes
      of (active or sham) tACS at alpha frequency. The intervention is administered three times a
      week for a duration of six weeks.

      Outcomes of the study Performance on standard, conventional neuropsychological tests, as well
      as on ADL observation scales.
    


Intervention name(s): Transcranial Alternating Current Stimulation (tACS); Visual Scanning Training (VST)
Intervention type(s): Device; Behavioral
Intervention description(s): Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off.; The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, & Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events
Condition: Obstructive Sleep Apnea Hypopnea Syndrome
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep
      apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement.
      The automatic analysis of respiratory events has never been evaluated in a pediatric
      population. The primary objective of this study was to determine the feasibility of pediatric
      RP in an ENT department routine practice. The second objective was to evaluate the
      reliability of the automatic signal analysis in children.
    

Detailed description: 
      Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3
      years) who benefited from an overnight RP in an ENT hospitalization department between
      January and August 2016 for OSAS suspicion. Manual detection of respiratory events was
      performed by the same ENT specialist, and compared to the automatic analysis.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children with clinical obstructive sleep apnea hypopnea syndrome in University Health
        Center
      
Keywords: pediatric obstructive sleep apnea hypopnea syndrome; pediatric respiratory polygraphy; device acceptance; signal quality; automatic detection of respiratory events
Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an exploratory study, which allows analysis of multiple immune parameters derived
      from peripheral blood mononuclear cells (PBMCs) from patients with relapsing remitting
      multiple sclerosis before and during immune-modulatory treatment with dimethyl fumarate in
      comparison to PBMCs from healthy subjects.
    

Detailed description: 
      The purpose of the trial is to shed more light on the mechanisms of action of dimethyl
      fumarate in patients with relapsing remitting multiple sclerosis. More specifically the
      influence of dimethyl fumarate on peripheral immune cells will be addressed to evaluate
      changes in cytokine production by the distinct T cell subsets and the differentiation
      capacity of naïve T cells. Furthermore, the impact of dimethyl fumarate treatment on the
      migratory capacity of T cells as well as the evaluation of changes in the suppressive
      capacity of regulatory T cells will be evaluated. To put the obtained results into context,
      response data of dimethyl fumarate-treated patients will be compared with data from healthy
      subjects.
    

Intervention name(s): Dimethyl fumarate
Intervention type(s): Drug
Intervention description(s): Dimethyl fumarate (Tecfidera®) treatment is initiated by daily administration of 120 mg Tecfidera® p.o. in the morning in week 0. At week 1, the dose is increased to 120 mg Tecfidera® p.o. twice daily, split into a morning and an evening dose. At week 2, the daily dose is further increased to 240 mg Tecfidera® p.o. in the morning and 120 mg Tecfidera® p.o. in the evening. Finally at week 3, the dose will be increased to the final daily dose of 240 mg Tecfidera® p.o. in the morning and 240 mg Tecfidera® p.o. in the evening and maintained throughout the study.
Other intervention name(s): Tecfidera®
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dimethyl fumarate
Period Tracker Lay User Study
Condition: Menstrual Cycles
Study type: Observational

Summary: 
      This study will assess the ability of the lay user to obtain and record a result.
      Comprehension of the instructions for use of the product will also be assessed.
    


Intervention name(s): LH Urine Test
Intervention type(s): Device
Intervention description(s): Test for qualitative detection of LH in urine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 18 to 45 represent the intended user of the product
Dasotraline Pediatric ADHD Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with
      ADHD.
    

Detailed description: 
      This is a randomized, double blind, multicenter, placebo-controlled, parallel group,
      outpatient study evaluating the efficacy and safety of dasotraline in subjects 6 to 12 years
      of age with ADHD using 2 doses of dasotraline (2 mg/day and 4 mg/day) versus placebo over a 6
      week treatment period. The study will consist of screening, treatment, and end of study
      visits.
    

Intervention name(s): Dasotraline; Dasotraline; Placebo Comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dasotraline 2 mg once daily; Dasotraline 4 mg once daily; Placebo once daily
Other intervention name(s): SEP-225289; SEP-225289
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate
Condition: Primary Hyperoxaluria Type I
MeSH terms: Hyperoxaluria, Primary
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the investigators will prospectively analyze the reduction of urinary oxalate
      excretion under the treatment with PLP in dosages of 5mg/kg/day up to 20 mg/kg/day and serum
      level response relationship with PLP as an i.v. solution used orally in 12 patients with
      primary hyperoxaluria type I as an inherited autosomal-recessive-disorder leading to
      increased endogenous oxalate production, urolithiasis and end stage renal disease.
    


Intervention name(s): Vitamin B 6
Intervention type(s): Drug
Intervention description(s): Oral solution of pyridoxal phosphate start with 5mg per kg body weight per day in two dosages over 6 weeks, increase stepwise by 5mg/kg body weight every 6 weeks up to 20 mg/kg body weight/d.
Intervention MeSH terms: Vitamin B 6; Pyridoxal; Pyridoxine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary hyperoxaluria; Pyridoxal-phosphate
SAP Depleter Dose Escalation Study in Healthy Volunteers
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to provide safety information and to define the optimal
      induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in
      healthy volunteers prior to assessing in patients
    

Detailed description: 
      This single centre, open label, dose escalation study is designed to assess safety (including
      adverse events, vital signs, ECGs, and clinical laboratory tests), and pharmacokinetic
      /pharmacodynamic parameters in healthy volunteers. Subjects will attend for 3 sessions:
      session 1 is a single intravenous (IV) infusion over a short time period to confirm the
      safety of a single dose of GSK2315698 over a wide dose range, sessions 2 and 3 will
      investigate IV infusion regimens over 24 hours (induction phase followed by maintenance
      phase). The dosing regimen will be adjusted adaptively to optimise the induction and
      maintenance phases of the dosing regimen. amyloidosis.
    

Intervention name(s): GSK2315698; GSK2315698
Intervention type(s): Drug; Drug
Intervention description(s): 5mg-400mg IV (in the vein) single dose over 1-4 hours; IV (in the vein) single dose over 24 hours, in two sessions
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment