bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability, Safety, and Tolerability of BIS-001 ER
Condition: Epilepsy, Complex Partial
MeSH terms: Epilepsy, Complex Partial
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the safety, tolerability, and pharmacokinetics of BIS-001 ER in
      healthy volunteers. Subjects will be dosed twice daily, with a dose escalation occurring
      every 2-3 days until a maximum dose of 5mg per day is reached.
    


Intervention name(s): BIS-001 ER
Intervention type(s): Drug
Intervention description(s): BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
Other intervention name(s): Huperzine A
Intervention MeSH terms: Huperzine A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Rehabilitative Approach in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using
      breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi
      muscle according to the Mézières Method to improve balance and posture and relief pain in
      patients with Parkinson's disease.
    


Intervention name(s): Mézières Method; Home based exercise program
Intervention type(s): Other; Other
Intervention description(s): 10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.; 1 single training session lasting 1 hour for the explication of the rehabilitation program that the patient has to perform independently at home followed by 2 sessions of home based exercises per week for 5 weeks, each lasting 1 hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Posture; Pain; Muscle stretching; Mézières method; Camptocormia; Trunk control
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Condition: Allergies
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine
      Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.
    


Intervention name(s): Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA); Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cetirizine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
Condition: Kaposi Sarcoma; HIV
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Observational

Summary: 
      The purpose of this study is to identify important associations between complete and
      comprehensive clinical, laboratory, and genomic data derived from patients and tumor
      specimens, with prospectively recorded clinical outcomes. The investigators also hope to move
      beyond simple risk factor associations as previously described, to develop a composite score
      specifically for KS recurrence or progression, analogous to widely used risk scores that are
      used to direct up-front treatment of other cancers. In so doing, the investigators will draw
      on extremely granular data to prospectively identify patients who are most likely to benefit
      from new treatments.
    

Detailed description: 
      This is a prospective, nonrandomized, open-label, single arm, cohort study of pathologically
      confirmed HIV-associated KS patients initiating chemotherapy in Malawi. The primary objective
      of this study is to estimate the complete response rate (CR by ACTG criteria) at 48 weeks.
      This will be done both overall and by chemotherapy (BV or not BV) treatment group. Secondary
      objectives are to estimate PFS and OS for both overall and by chemotherapy treatment group.
      Exploratory objectives include the investigation of: select clinical variables and laboratory
      biomarkers among HIV-associated KS patients and their possible association with response,
      PFS, and OS; the histopathology of KSHV-associated lymphoproliferative diseases among
      HIV-associated KS patients; KSHV strains in tumor biopsies, PBMC and plasma, and KSHV gene
      expression characteristics between KS that develops on and off ART.

      The investigators plan to accrue 200 HIV-associated KS patients at a rate of approximately 50
      patients per year. Approximately half of the patients will receive BV chemotherapy treatment.
      An important factor for this study's size is that it will be comparable to or exceed the size
      of other important KS cohort studies, which have demonstrated significant differences in
      outcomes based on gender or baseline KSHV DNA levels.

      The investigators want to show that there are definable biologic and clinical subsets within
      the HIV-associated KS population, and that identifying these subsets will have direct
      relevance to more effective treatment strategies for these patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-infected adults ≥18 years of age with pathologically confirmed KS who are initiating
        chemotherapy at Lighthouse Trust or the KCH Cancer Clinic.
      
Keywords: initiating chemotherapy; prospective, open label, single arm, cohort; non randomized, non interventional
TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Laryngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of
      Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment
      With TPF Chemotherapy.
    

Detailed description: 
      This study is being sponsored by a cooperative medical group.
    

Intervention name(s): TPF, radiotherapy and cetuximab; H&N surgery
Intervention type(s): Drug; Procedure
Intervention description(s): 3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days; Rescue surgery
Other intervention name(s): TPF plus radiotherapy and cetuximab; Rescue surgery
Intervention MeSH terms: Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Head and Neck Cancer
Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)
Condition: Bullying; Weight, Body; Trauma, Psychological
MeSH terms: Body Weight; Bullying; Psychological Trauma
Study type: Interventional

Summary: 
      This study will perform a clinical trial with adolescent girls to pilot a new
      cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2)
      acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video
      telehealth.
    

Detailed description: 
      Youth with obesity are more likely to be bullied than healthy-weight peers and weight-related
      bullying is the most common form of bullying. Treating bullying during childhood could reduce
      immediate and long-term health consequences, but there are no established individual-level
      treatments for weight-related bullying despite recommendations that they could improve
      children's health. This study will develop and test a new treatment for adolescent girls
      (11-17 years old) who have experienced bullying due to weight. The treatment will address
      traumatic stress and potentially co-occurring or developing problems with unhealthy
      weight-control behaviors, disordered eating, and weight. The treatment will be conducted via
      audio/video telehealth to increase accessibility and is therefore available to anyone in the
      United States who meets eligibility criteria.
    

Intervention name(s): CBT for Weight Bullying
Intervention type(s): Behavioral
Intervention description(s): Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescent; child; cognitive behavioral therapy; eating disorder; obesity
Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM
Condition: Tuberous Sclerosis; Lymphangioleiomyomatosis
MeSH terms: Tuberous Sclerosis; Lymphangioleiomyomatosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in
      patients with tuberous sclerosis complex or lam.
    

Detailed description: 
      The study design was an open label, phase I/II trial of sirolimus for one year followed by
      one year off therapy.Patients were seen at baseline,at two weeks to four weeks, and at
      2,4,6,9,12,18 and 24 months. Angiomyolipomata imaging was performed at all but the two to
      four week visit. Complete pulmonary function tests and six-minute walk were obtained at
      baseline,6 or 9 month, 12 and 24 month visits, while simple spirometry only was performed at
      all other visits.
    

Intervention name(s): Rapamycin, sirolimus
Intervention type(s): Drug
Intervention MeSH terms: Sirolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TSC and LAM; Tuberous Sclerosis Complex and sporadic LAM
Melatonin for Prevention of Metabolic Side Effects of Olanzapine
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether melatonin can prevent metabolic side
      effects of olanzapine such as weight gain, elevated glucose concentrations and lipid
      abnormalities.
    

Detailed description: 
      Atypical antipsychotics including olanzapine are associated with significant metabolic side
      effects. Animal studies have suggested that melatonin might prevent some of the
      olanzapine-associated side effects. Melatonin is safe and is widely used as a sleep-promoting
      complement, and is not associated with side effects seen with other used drugs such as
      metformin.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet melatonin 3 mg/day at 9 pm as intervention group; Placebo (with the same shape and taste as melatonin) at 9 pm as control group
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Melatonin; Olanzapine; Metabolic side effects; Psychosis; Hyperlipidemia; Hyperglycemia; Weight gain; Diabetes
Activation of Apoptosis-related Receptors on Alveolar Macrophages
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim is to understand whether activation of receptors involved in clearance of apoptotic
      cells will improve efferocytosis in COPD patients in vitro and whether generation of
      pro-inflammatory cytokines can be decreased in COPD patients.
    

Detailed description: 
      In order to assess pathway activation in COPD macrophages, alveolar macrophages will be
      isolated from BAL of COPD patients and healthy controls. Alveolar macrophages will be
      co-cultured in vitro with apoptotic cells and treated with compounds. In addition, BAL fluid
      will be frozen for later testing of soluble mediators.
    

Intervention name(s): Bronchoscopy
Intervention type(s): Other
Intervention description(s): Bronchoalveolar lavage, mucosal biopsy and bronchial brushes during bronchoscopy
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Enrolment will healthy subjects first, followed by subjects with COPD
Masking: None (Open Label)
Primary purpose: Basic Science
Pain Sensitivity of Subjects With Fibromyalgia Before and After Repetitive Transcranial Magnetic Stimulation Treatment
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the
      clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in
      the evaluation of the experimental sensitivity to mechanical pain (pressure application on
      the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days),
      and to put the results in relation to the clinical improvement and the psychometric
      evaluations (depression,fibromyalgia impact questionnaire, catastrophism).
    


Intervention name(s): experimental pain induction
Intervention type(s): Other
Intervention description(s): application of a pre-fixed pressure (160 kPa) on the forearm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: rTMS; fibromyalgia; experimental pain
VENUS: Septic Gene Expression Using SeptiCyte
Condition: Sepsis; Systemic Inflammatory Response Syndrome (SIRS)
MeSH terms: Systemic Inflammatory Response Syndrome
Study type: Observational

Summary: 
      The investigators seek to evaluate a new test for determining presence of infection/sepsis as
      compared to non-infection/systemic inflammatory response syndrome among critically ill
      patients within the first 24 hours of their being hospitalized in an intensive care unit
      (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to
      validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2)
      existing clinical parameters. The investigators also hope to assess how well a related, new
      blood test, SeptID® identifies different types of infection, as compared to cultures and
      other lab tests.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Critically ill subjects, admitted to an Intensive Care Unit
      
Biospecimen description: 
      Blood samples will be collected
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on
      neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD
      within a double-blind cross-over design over six weeks. The assessment of ADHD followed
      formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A
      neuropsychological testbattery and four behavioral questionnaires were selected as efficacy
      variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory
      control, motor activity), Score (auditory attention), Stroop Test (processing speed,
      inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on
      each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed
      by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by
      the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed
      by a parent and a teacher Monday till Friday through every week), Test Performance
      Questionnaire (completed by the child immediately after each of the three test sessions).

      Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will
      provide better results than a trial including only Met. a)Met and Dex are efficient as
      treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to
      Met. b)At an individual level some of the participants will show positive response to one
      type of stimulants and no response, mixed response or adverse response to the other type of
      stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in
      agreement but also add unique information in the assessment of the effect of stimulants.
      d)Qb-test is sensitive and valid as a measure of the effect of stimulants.
    


Intervention name(s): Methylphenidate; Placebo; Dextroamphetamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methylphenidate:10mg x 3 for one week; Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.; Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week
Intervention MeSH terms: Methylphenidate; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Children; Methylphenidate; Dextroamphetamine; Placebo; Crossover; Double Blind; Neuropsychological tests; Behavioural Questionnaires
A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in
      healthy Japanese male subjects will be evaluated.
    


Intervention name(s): nalmefene hydrochloride 10 mg
Intervention type(s): Drug
Intervention MeSH terms: Nalmefene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients
Condition: Tongue Edema; Tongue Enlarged; Mechanical Ventilation Complication; Intubation Complication
MeSH terms: Tongue Diseases; Edema
Study type: Observational

Summary: 
      Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and
      protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the
      tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop
      due to long-term pressure application of the intubation tube to the tongue, in patients
      hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by
      submental ultrasonography (USG) method.
    

Detailed description: 
      Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and
      protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the
      tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop
      due to long-term pressure application of the intubation tube to the tongue, in patients
      hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by
      submental ultrasonography (USG) method.
    

Intervention name(s): Measuring tongue cross-sectional area by submental ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): The tongue cross-sectional areas of both groups were measured with submental ultrasonography to detect tongue edema.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who underwent endotracheal intubation in the Anesthesiology and Reanimation
        intensive care unit were followed up on a mechanical ventilator were included in the study
        after obtaining informed consent from their legal representatives.
      
Keywords: ultrasonography; endotracheal intubation tube; complication; drugs; tongue edema
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
Condition: Edematous; Synovitis; Foreign Body Reaction; Osteolysis
MeSH terms: Synovitis; Osteolysis; Foreign-Body Reaction; Foreign Bodies
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is being conducted to determine if taking oral (by mouth in pill form)
      Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and
      improve function of non-infected symptomatic postoperative total joint replacements.
    

Detailed description: 
      To perform a prospective, randomized, double-blind clinical trial to determine if oral
      Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the
      conservative care customarily used to reduce inflammatory synovitis and to increase the
      functional capacity of proven non-infected symptomatic postoperative total joint
      replacements.
    

Intervention name(s): Placebo; Apatone®B
Intervention type(s): Drug; Drug
Intervention description(s): Two capsules taken twice daily with meals; Two capsules taken twice daily with meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total joint arthroplasty; synovitis; ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion); osteolysis; periprosthetic metallosis