bioihbjkbjnl/mcl2 huggingface dataset:
Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, AIDS-Related
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. Peripheral stem cell transplantation may allow the doctor to
      give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral
      stem cell transplantation in treating patients who have recurrent or refractory AIDS-related
      lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and tolerability of intensive chemotherapy and autologous
           peripheral blood stem cell transplantation in patients with recurrent or refractory
           AIDS-related lymphoma.

        -  Determine the response and response duration in these patients treated with this
           regimen.

        -  Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these
           patients.

      OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2
      hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood
      counts recover. Patients then undergo leukopheresis to collect CD34+ cells.

      Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days
      -7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and
      -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or SC
      daily beginning on day 1 and continuing until blood counts recover.

      Patients are followed monthly for 1 year and then every 6 months for 2 years.

      PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
    

Intervention name(s): filgrastim; busulfan; cyclophosphamide; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Busulfan
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIDS-related peripheral/systemic lymphoma; AIDS-related diffuse large cell lymphoma; AIDS-related immunoblastic large cell lymphoma; AIDS-related small noncleaved cell lymphoma; HIV-associated Hodgkin lymphoma; AIDS-related diffuse mixed cell lymphoma; AIDS-related diffuse small cleaved cell lymphoma; AIDS-related lymphoblastic lymphoma
Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy,
      Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type
      Psoriasis.
    

Detailed description: 
      A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy,
      Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type
      Psoriasis.
    

Intervention name(s): CEP-701 20mg; CEP-701 40mg; CEP-701 60mg; CEP-701 80mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dosages of oral CEP-701 20mg will be given twice daily. Escalation to the next higher dosage, CEP-701 40mg, may occur once the first 8 patients at the current dosage have completed 8 weeks of treatment without adverse events or laboratory abnormalities. Patients who remain in Cohort 1 will continue on the 20mg dosage until study completion.; Dosages of oral CEP-701 40mg will be given twice daily.Escalation to the next higher dosage, CEP-701 60mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 2 will continue on the 40mg dosage until study completion.; Dosages of oral CEP-701 60mg will be given twice daily. Escalation to the next higher dosage, CEP-701 80mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 3 will continue on the 60mg dosage until study completion.; Dosages of oral CEP-701 80mg will be given twice daily. Patients who have moved to Cohort 4 will continue on the 80mg dosage until study completion.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
Condition: Acne Scars
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The purpose of this study is to assess treatment of facial acne scars using the 755nm
      Alexandrite Laser with lens arrays.
    


Intervention name(s): 755nm Alexandrite laser with lens array
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study to be conducted at single study center, (additional center(s) may be
      selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD
      formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole
      will also be assessed. Blood samples will be collected at prespecified times for PK, clinical
      laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be
      monitored throughout the study from the time the ICF is signed through study completion.
    


Intervention name(s): CC-11050
Intervention type(s): Drug
Intervention description(s): CC-11050
Intervention MeSH terms: CC-11050
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-11050; Safety; Healthy Subjects
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard
      therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for
      the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with
      anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in
      the treatment of patients with VL in India.
    


Intervention name(s): Paromomycin sulfate; Amphotericin B
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amphotericin B; Paromomycin; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Safety and Efficacy of the Probiotic Bifidobacterium Longum ES1 and the Post Biotic Heat-treated Bifidobacterium Longum ES1 (HT-ES1) on IBS Symptom Severity in Patients With Diarrhoea Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      Randomized controlled clinical study has been proposed to evaluate the safety and efficacy of
      ES1 probiotic strain and heat-treated ES1 postbiotic strain in individuals suffering from
      IBS-D.
    


Intervention name(s): ES 1; HT ES1; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Two capsules orally once daily after breakfast for 84 days; Two capsules orally once daily after breakfast for 84 days; Two capsules orally once daily after breakfast for 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised, double-blind, placebo-controlled, parallel-group multicentre study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
Condition: Peripheral Arterial Disease; Fistula
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon
      Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for
      the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.
    

Detailed description: 
      To evaluate the safety and efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon
      Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for
      the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.

      This is a prospective, multi-center, randomized controlled, open-label, superiority study. A
      total of 160 subjects will be enrolled from 10 sites in China. All subjects enrolled will be
      randomly assigned to the test group (APERTO group, n=80) and the control group (OHICHO II
      group, n=80) with randomized allocation ratio of 1:1. Subjects in the test group and the
      control group will be treated with APERTO OTW or OHICHO II respectively.
    

Intervention name(s): Paclitaxel Releasing Peripheral Balloon Dilatation Catheter; Balloon Dilatation Catheter
Intervention type(s): Device; Device
Intervention description(s): Treatment group; Control group
Other intervention name(s): APERTO OTW; OHICHO II
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug eluting balloon, Arteriovenous Fistulae
The Effect of Phone Application Supported Nutrition Education on Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Internet-based applications are potential supporters for individuals in weight loss programs
      due to their accessibility and wide access. These applications are aimed at changing the
      lifestyle of individuals.

      This study is a randomized controlled study aiming to evaluate the effect of phone
      application supported nutrition education on weight loss according to standard education. It
      has been assumed that the telephone application would increase the adaptation and motivation
      of the people on diet. Anthropometric measurements and nutritional features of individuals,
      Weight Efficacy Lifestyle (WEL test), Quality of Life SF-36, Rosenberg Self-Esteem, Obese
      Individuals Specific Quality of Life, Healthy Life Style Behaviour Scale-II and Healthy
      Eating Index score changes questioned as intermediate variables. Between March and September
      2018, 79 people aged between 18-64 years, whose BMI was 25 and more, who were admitted to the
      dietitian at Ege University Faculty of Medicine Hospital Endocrine and Metabolic Diseases
      Clinic and received routine nutrition education were included in the study. In the first
      interview, the data collection form of all individuals was filled out and anthropometric
      measurements of all individuals were made by the researcher. All individuals received a
      classic nutrition education by the clinical dietician and then written personal weight loss
      diets. Afterwards, only a control appointment for 3 months later was given to the control
      group. Phone application named Motive designed by the researcher uploaded to only case
      group's phone. With the telephone application text, visual and video notifications were sent
      to case group for 3 months.
    


Intervention name(s): This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.
Intervention type(s): Procedure
Intervention description(s): This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obesity; phone application; nutrition education
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function
Condition: Hepatic Function Abnormal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center
      study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and
      tolerability of tolebrutinib compared with normal hepatic function, in male and female
      participants aged 18 to 79 years.
    

Detailed description: 
      The total duration of the study per participant is up to 41 days including:

        -  A screening period of up to 4 weeks (Days -28 to -2)

        -  A 5-day, open-label treatment period

        -  Up to 7 days post-treatment follow-up period
    

Intervention name(s): tolebrutinib
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Film-coated tablet Route of administration: oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared
      to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive
      disorder (MDD) who have a partial response to ADT.
    


Intervention name(s): Rapastinel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects
Condition: Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Prednisolone
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of prednisolone after single dose administration of prednisone. This study
      will also assess the safety and tolerability of isavuconazole alone and in combination with
      prednisone.
    


Intervention name(s): Isavuconazole; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557
Intervention MeSH terms: Isavuconazole; Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; prednisone; prednisolone; BAL8557; healthy volunteers
Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular
      architecture on lesion surface.The histology of early colorectal lesions could be predicted
      under NBI view.However,its capability for estimating invasion depth remains to be
      verified.The study is based on the hypothesis:NBI can predict histology and invasion
      depth,combined with the verification of microvessel count and MMP-7 expression.
    

Detailed description: 
      The microvessel count (MVC) is a classical method of assessing histologic grade.To verify
      whether NBI could predict histology through microvascular architecture,we measured lesion
      microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of
      matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion
      depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of
      colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in
      early colorectal lesions,combined with the verification of microvessel count and MMP-7
      expression.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with early colorectal lesions
      
Biospecimen description: 
      Samples after biopsy or resection are to be retained.
    
Keywords: narrow band imaging,microvessels,matrix metalloproteinase-7
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
Condition: Progressive Supranuclear Palsy; Corticobasal Degeneration
MeSH terms: Supranuclear Palsy, Progressive; Corticobasal Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive
      supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
    


Intervention name(s): Flortaucipir F18; Brain PET scan
Intervention type(s): Drug; Procedure
Intervention description(s): IV injection, 370 megabecquerel (MBq) (10 mCi); positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Other intervention name(s): [F18]T807; 18F-AV-1451; LY3191748; Tauvid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers
Condition: Anaemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a two-part with an open-label, single oral dose, two-way crossover study
      design. Part A and Part B of the study are independent and may be conducted in parallel. The
      Part A of the study will assess the effect of an oral dose of GSK1278863 on the
      pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in
      order to determine the potential for clinically-significant drug interactions with CYP2C8 and
      OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor
      (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites.
      Part A will be conducted in approximately 30 healthy subjects, having a randomized study
      design. There will be approximate 7-day washout period between each dosing period. Part B
      will be conducted in approximately 20 healthy subjects, having single sequence study design.
      Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The
      total duration of a subject's involvement in the part A of the study will be approximately 8
      weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to
      Follow-up).
    


Intervention name(s): GSK1278863 25 mg Tablet; Pioglitazone 15 mg Tablet; Rosuvastatin 10 mg Tablet; Trimethoprim 100 mg Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A round, biconvex, white film coated tablet to be taken orally in the fasted state in the morning; White to off-white, round, convex, non scored tablet with "ACTOS" on one side, and "15" on the other, to be taken orally in the fasted state in the morning; Pink, round, biconvex, coated tablets. Debossed "CRESTOR" and "10" on one side, to be taken orally in the fasted state in the morning; White, round, scored, convex tablet, debossed "93" above the score and debossed "2159" below the score on one side and plain on the other, to be taken orally as two tablets once in the morning and once in the evening
Intervention MeSH terms: Pioglitazone; Trimethoprim; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prolyl hydroxylase inhibitor; GSK1278863; Anemia; Drug interaction
High Protein Diet and Physical Activity in COPD
Condition: COPD
Study type: Interventional

Summary: 
      COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition
      commencing rehabilitation (7-10-week physical activity program) were randomized to receive a
      high protein diet (≥ 25 energy percentage) or standard care.
    

Detailed description: 
      Peripheral muscle function was measured by 6MWD (6-meter-walk-distance) and handgrip
      strength; FFM was measured by bioimpedance, mid upper arm circumference, and mid-thigh
      circumference; quality of life was measured by CAT (????); and dyspnoea was measured by the
      Medical Research Council dyspnoea scale and Borg scores at baseline and after 12 weeks.
    

Intervention name(s): intervention
Intervention type(s): Dietary Supplement
Intervention description(s): a protein intake of ≥25 E%. An oral nutritional supplement (containing 1570 kJ/100 g and 92 g protein/100 g. Atpro 200) was used as supplement to the patients' habitual diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parellel, not blinded
Masking: None (Open Label)
Primary purpose: Treatment
Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients
Condition: Perioperative Care
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and
      analgesic properties. This study was designed to evaluate the inhibitory effects of
      preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal
      intubation in elderly patients being treated for hypertension.

      Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of
      Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and
      assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg
      dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood
      pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate
      (HR) were recorded preoperatively at ward, immediately after study drug administration, and
      at 1, 3, and 5 minutes after endotracheal intubation.
    


Intervention name(s): Dexmedetomidine; Normal Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: dexmedetomidine