bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence of Imeglimin Tablet Formulations
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of
      imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy
      Caucasian volunteers.
    


Intervention name(s): Imeglimin Reference product; Imeglimin
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product (new formulation tablet)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Osteopathic Manipulative Treatment of Fascial Restrictions on Body Awareness, Mood, and Proprioception
Condition: Segmental and Somatic Dysfunction of Other Regions (M99.09)
Study type: Interventional

Summary: 
      The purpose of this research is to assess the effects osteopathic manipulative treatment
      (OMT) of fascial strain patterns on body awareness, proprioception, and mood.
    


Intervention name(s): OMT
Intervention type(s): Other
Intervention description(s): OMT: direct myofascial release for the triplanar diagnonosis to the OA, thoracic outlet, respiratory diaphragm and pelvic diaphragm concluding with a pedal pump for 120 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of BMS-914392 on Pharmacokinetics of Metoprolol
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effects of BMS-914392 administration on the
      pharmacokinetics of a single-dose of metoprolol in healthy subjects.
    

Detailed description: 
      Protocol designed to evaluate the potential for a drug-drug-interaction
    

Intervention name(s): metoprolol; BMS-914392
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 200 mg, once, 1 day; Tablets, Oral, 60 mg, once daily, 7 days
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Glucose Control in Pre-Diabetic Renal Transplant Patients
Condition: Impaired Glucose Tolerance; Kidney Transplantation
MeSH terms: Glucose Intolerance; Prediabetic State
Study type: Interventional
Phase: Phase 2

Summary: 
      Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious
      complication after kidney transplantation. Patients who develop NODAT are at increased risk
      for loss of the transplanted organ and for diseases of the cardiovascular system.

      It is believed that in many patients the development of overt NODAT is preceded by a phase of
      impaired glucose tolerance that is called pre-diabetes.

      This study aims at improving glucose metabolism in patients after kidney transplantation who
      are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT)
      after kidney transplantation are randomized to either receive vildagliptin (Galvus),
      pioglitazone(Actos) or placebo for three months.

      The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to
      improved glycemic control compared to placebo.
    


Intervention name(s): Vildagliptin; Pioglitazone; Life-Style Modification
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 50mg tablets once daily 20 min before breakfast for 3 months; 30mg tablets once daily 20 min before breakfast for 3 months; All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Other intervention name(s): Galvus; Actos
Intervention MeSH terms: Pioglitazone; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: after
Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Observational

Summary: 
      This study is being done to look at the electrical activity of the heart. This study will
      help decide whether taking recordings for a 24-hour period gives more useful information than
      recording it for a few seconds in a doctor's office. The study will compare 24 hour
      electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other
      patients taking different medications that took part in another study.
    

Detailed description: 
      The objective of the study is to assess the Tpe and QTc measures in 24 hr Holter
      echocardiograms in patients treated with atypical antipsychotic drgs (APDs). The primary
      comparisons of interest are olanzapine (no QTc prolongation) to ziprasidone (QTc
      prolongation) and thioridazine (QTc prolongation) as well as ziprasidone (possibly low TdP
      risk) to thioridazine (TdP risk). Secondary comparisons will be among all APDs available. In
      a previously approved study, conventional 24 hr Holter electrocardiograms were recorded from
      a total of 78 subjects during the course of treatment with psychotropic medications and
      without medication (in the case of normals and unmedicated patients). These recordings will
      be analyzed to yield Tpe, QTc and heart rate, and other measures. Data from additional
      patients is needed, therefore this study will include only patients currently treated with
      Mellaril (thioridazine), Risperdal (risperidone) and Seroquel (quetiapine).
    

Intervention name(s): 24 Holter Monitor Recording
Intervention type(s): Device
Intervention description(s): All subjects will be fitted with a device to obtain 24-hour Holter EKG continuous recordings of bipolar leads C5C5R. They will also receive a standard 12-lead EKG recording prior to the placement of the Holter device. The subjects will be asked to keep a diary during the course of the 24 hours to record information such as wake and sleep times and symptoms such as shortness of breath, heart palpitations, lightheadedness, etc.
From each recording, 12 sets of 10 consecutive QRS epochs, plus QRS samplings obtained during sleep will be analyzed by a cardiologist blind to the medication status of subjects.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults diagnosed wtih schizophrenia, bipolar or schizoaffective disorder
      
Keywords: schizophrenia; schizoaffective disorder; bipolar disorder; antipsychotic drug treatment; safety; arrythmias
Artemisinin Resistance in Cambodia II
Condition: Falciparum Malaria
MeSH terms: Malaria, Falciparum
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of varying doses of artesunate on
      treatment outcome and whether higher doses of artesunate can overcome the problem of
      compromised artemisinin sensitivity in the region.

      To determine the safety and tolerability of this previously untested experimental high dose
      (6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.
    

Detailed description: 
      A total of 150 volunteers with acute uncomplicated falciparum malaria will be randomly
      assigned one of 3 arms to be treated with artesunate monotherapy for 7 days at a ratio of
      2:1:2.

      Arm 2 serves as a control and will serve as a bridge to the ARC 1 study performed in
      2006/2007. Patients in Arm 1 will receive a relatively low "standard" dose, and patients in
      Arm 2 will receive the intermediate dose of 4 mg/kg that was used in the ARC1 study. Patients
      in Arm 3 will receive an experimental "high-dose" regimen. Currently available safety data
      extends to subjects who have received the 28 mg/Kg total dose over 7 days and to another
      study administering 8 mg/Kg/day for 3 days (total dose 24 mg/Kg). Subjects randomized into
      this study's 'high-dose' Arm 3 will, therefore, receive a total dose that is higher than has
      been previously studied in humans.

      The study design will be based on the WHO recommendations for the 'Assessment and Monitoring
      of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria' (WHO,
      2003).
    

Intervention name(s): Artesunate; Artesunate; Artesunate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg/kg/day x 7 days; 4 mg/kg/day x 7 days; 6 mg/kg/day x 7 days
Intervention MeSH terms: Artesunate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artesunate; Plasmodium Falciparum; Cambodia
RESIST: Understanding the Role of Depression in Heart Disease
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      This study will investigate the biological pathways involved in anti-depressant resistance
      that increase risk of cardiovascular disease in people with depression.
    

Detailed description: 
      Rationale: Depression is known to be associated with the development of cardiovascular
      disease and poorer prognosis after cardiac events, however the mechanisms that mediate these
      links are poorly understood. Inflammatory and neuroendocrine processes are thought to play an
      important role in this relationship. In addition, antidepressants have been shown to improve
      cardiac outcomes and have anti-inflammatory effects, whilst inflammation has been shown to be
      elevated in patients who do not respond to treatment. Several possible biomarkers for
      antidepressant resistance have also been demonstrated to be cardiovascular risk markers.
      These include acute phase inflammatory markers, such as interleukin-6 (IL-6), and
      hypothalamic-pituitary-adrenal axis (HPA) dysregulation.

      Design: This will be conducted alongside a larger pharmacological trial, PANDA, where
      participants will be recruited from primary care and randomized to sertraline (SSRI) or
      placebo. The RESIST study will compare inflammatory cardiovascular risk factors between
      depressed patients taking sertraline, depressed patients taking placebo and healthy controls.
      This will be achieved by investigating the pharmacological effect of antidepressants on gene
      expression, glucocorticoid and mineralocorticoid receptor function and regulatory T cell
      (Treg) profiles.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Depressed patients will be recruited from the PANDA trial. Healthy controls will be
        recruited from primary care.
      
Biospecimen description: 
      Saliva, peripheral blood mononuclear cells, blood serum, blood plasma, RNA
Autologous Immune Enhancement Therapy (AIET) for Cancer Patients
Condition: Patients With Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a retrospective study that included 60 cancer patients who underwent autologous NK
      cell and CD8 T cell therapy between January 2016 and December 2021
    

Detailed description: 
      The dysfunction and reduced proliferation of peripheral immune cells including CD8 T and NK
      cells have been observed in both aging and cancer patients, thereby challenging the immune
      cell therapy in these subjects. Therefore, we evaluated the growth of these lymphocytes in
      elderly patients with several types of cancer and the correlation of peripheral blood (PB)
      indexes to the expansions. This is a retrospective study that included 60 cancer patients who
      underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021.
      By optimizing the antiviral and tumor surveillance ability of both NK cells and CTLs through
      serial steps from isolation and expansion, followed by re-infusion of these activated cells
      back to the patient body, AIET has become a promising, cutting-edge method in detecting and
      eliminating cancer cells. The study aimed to evaluate the safety and effectiveness of 60
      cancer patientsreceiving AIET.
    

Intervention name(s): Autologous immune enhancement therapy (AIET) for cancer patients
Intervention type(s): Combination Product
Intervention description(s): Autologous NK cell and CD8 T cell therapy for cancer patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety and effectiveness of
      open-label clobazam in the treatment of drop seizures in subjects with LGS.
    

Detailed description: 
      This multi-center, open-label study is designed to evaluate the long-term safety and
      effectiveness of clobazam as adjunctive therapy in subjects with LGS. Subjects enrolled in
      Lundbeck LLC (formerly Ovation Pharmaceuticals, Inc.) sponsored studies
      13108A/OV1002/NCT00162981 and 13110A/OV1012/NCT00518713 who either completed the study or who
      prematurely discontinued were offered the opportunity to rollover into this open-label study.
      Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must
      maintain the dose level for 48 hours. After 48 hours, investigators will be able to increase,
      decrease or maintain the subject's dose, up to a maximum target daily dose of 2.0 mg/kg
      (maximum dose of 80 mg/day). During the treatment period, seizures will be recorded during
      the week preceding each study visit or 30 days immediately following each study visit
      (dependent on Amendment approval). The subject or subject's caregiver will record daily
      counts of seizures, including drop seizures in the subject's seizure diary.
    

Intervention name(s): Clobazam
Intervention type(s): Drug
Intervention description(s): Clobazam will be provided in 5 mg, 10 mg and 20 mg tablets and will be dispensed in bottles as needed at each visit. Bottles may be dispensed between visits if necessary. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After the first 48 hours of the treatment period, investigators will be able to increase, decrease or maintain the subject's dose, up to an approximate maximum daily dose of 2.0 mg/kg (maximum dose of 80 mg/day).
Other intervention name(s): Aedon, Antacastill, Castilium, Clarmyl, Frisium, Karidium, Mefrilan, Mystan, Noiafren, Onfi, Psiton, Psyton, Sentil, Seryl, Urbadan, Urbanil, Urbanol, Urbanyl.
Intervention MeSH terms: Clobazam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lennox-Gastaut Syndrome (LGS); Epilepsy; Drop Seizures; Clobazam
Rivastigmine BA Trial With Multiple Application of Transdermal Patches, Adaptation and Tapering Phase
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The present clinical trial will be conducted to compare the bioavailability of rivastigmine
      and assess bioequivalence at steady-state of the Test product RIV-TDS 13.3 mg/24 h and the
      marketed Reference product Exelon® 13.3 mg/24 hours transdermal patch after multiple patch
      application. Each of both treatments will last 5 days.
    

Detailed description: 
      This will be a single centre, open-label, randomised (order of treatments), balanced,
      2-period, 2-sequence, cross-over trial with multiple applications of rivastigmine transdermal
      patches. There will be no wash-out, i.e. the first investigational patch application of the
      second study period will take place the day of the last investigational patch removal of the
      first study period (direct switch-over).

      Prior to start of first treatment, there will be an adaptation phase with 4 consecutive
      applications of Exelon® 9.5 mg/24 hours transdermal patch over a period of 4 days (each patch
      will be applied for 24 hours). Following the removal of the last investigational patch in
      period II, there will be a post-treatment tapering phase with 2 consecutive applications of
      Exelon® 9.5 mg/24 hours transdermal patch over a period of 2 days (each patch will be applied
      for 24 hours).

      Furthermore, during the adaptation phase, both study periods and the tapering phase,
      scopolamine transdermal patches will be applied as co-medication to attenuate effects of
      rivastigmine and reduce Adverse Events.
    

Intervention name(s): RIV-TDS 13.3 mg/24 h; Exelon® 13.3 mg/24 hours transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): 5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours; 5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Mindfulness Based Stress Reduction in COPD
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to test the efficacy of a Mindfulness Based Stress Reduction
      program in COPD on quality of life, dyspnea, daily physical activity and mindfulness during
      daily life.
    


Intervention name(s): Mindfulness Based Stress Reduction Program (MBSR)
Intervention type(s): Behavioral
Intervention description(s): Traditional eight-week MBSR Program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; COPD
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study conducted in healthy volunteers to evaluate the
      pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam,
      s-warfarin, omeprazole, and repaglinide as probe drugs.
    


Intervention name(s): SHR0302 Tablets; Midazolam Maleate Tablets; Warfarin Sodium Tablets; Omeprazole Enteric Capsules; Vitamin K1 Tablets; Repaglinide Tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): SHR0302 Tablets once daily; Midazolam Maleate Tablets single dose; Warfarin Sodium Tablets single dose; Omeprazole Enteric Capsules single dose; Vitamin K1 Tablets once daily; Repaglinide Tablets single dose
Intervention MeSH terms: Vitamin K; Vitamin K 1; Repaglinide; Midazolam; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Intervention model description: Single-center, single arm, open-label, fixed sequence, self-control
Masking: None (Open Label)
Primary purpose: Basic Science
Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the
      single dose pharmacokinetics of crizotinib in healthy volunteers.
    


Intervention name(s): crizotinib; ketoconazole; crizotinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.; Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16.; Treatment B: A single 150-mg dose of crizotinib will be administered in the fasted state on Day 4 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.
Intervention MeSH terms: Ketoconazole; Crizotinib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: crizotinib; healthy volunteers; ketoconazole; pharmacokinetics; single dose
A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in
      participants with ulcerative colitis (UC).
    

Detailed description: 
      This was a single arm, open-label, multicenter study. The primary objectives were to study
      the effect of adalimumab on QOL (as measured by Short Inflammatory Bowel Disease
      Questionnaire (SIBDQ)), the utilization of health care resources, and the costs of care for
      subjects with UC who were treated with adalimumab in the usual clinical practice setting. The
      secondary objectives were to further assess the effect of adalimumab on disease activity and
      to collect additional safety data in subjects with UC.
    

Intervention name(s): Adalimumab
Intervention type(s): Biological
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): ABT-D2E7; Humira®
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of Life; Costs of Ulcerative Colitis; Health Care Utilization
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study
      to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients
      uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind
      treatment period followed by an open-label treatment period, making up a total of 52 weeks.
    

Detailed description: 
      All eligible subjects would enter the 24 weeks of double-blind treatment period and were
      randomized into the SAL067 group (12 mg once daily) or alogliptin group (25 mg once daily) or
      placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would
      enter the extended open-label treatment period. Subjects in the placebo group were to be
      switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 and alogliptin
      groups continued the same treatment until the end of the whole 52 weeks.
    

Intervention name(s): SAL067; Alogliptin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SAL067 6mg(2 tablet) and placebo 25mg (1 tablet); Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet); placebo 6mg (2 tablet) and placebo 25mg (1 tablet)
Other intervention name(s): SAL067 Group; Alogliptin Group; Placebo Group
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment