bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy male volunteers to assess how a new test medicine is taken up and
      broken down by the body as well as its safety and tolerability.
    


Intervention name(s): GLPG3667 capsule; [14C]-GLPG3667 solution for infusion; [14C]-GLPG3667 capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On Day 1, participants will receive a single oral dose of GLPG3667; On Day 1, participants will receive a single microtracer microdose of [14C]-GLPG3667 as an intravenous infusion; On Day 1, participants will receive a single oral dose of [14C]-GLPG3667
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Aerobic Exercise Training in Obese Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      To determine the effect of aerobic exercise training on arterial stiffness and hemodynamics
      in obese adults. Proper evidence on the effect of aerobic exercise training on both arterial
      stiffness and hemodynamics are sparsely present in obese adults whereas separate studies were
      done in mainly hypertensive and cardiovascular disease populations.
    

Detailed description: 
      Obese adults always have been trying to improve their quality of life by managing the
      complications associated with obesity like arterial stiffness and disturbed hemodynamics.
    

Intervention name(s): Aerobic exercise training; Conventional therapy
Intervention type(s): Other; Other
Intervention description(s): Hospital-based aerobic exercise training for 15-30 minutes including pre and post-vitals assessment.
3x/week on alternate days for 8 weeks at 40-70% of HR Max; Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic exercise, arterial stiffness, hemodynamics, obesity
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
Condition: Cervical Neoplasm
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Longitudinal study in two referral centers in Morocco to evaluate the effectiveness, the
      acceptability and safety of thermal ablation in the treatment of cervical neoplasia.
    

Detailed description: 
      The study population consisted of women with a positive Visual Inspection with Acetic Acid
      (VIA) screening test referred for ablative treatment. A total of 119 women with lesions
      eligible to ablative treatment were counselled and treated by thermal ablation. Informed
      consent was signed by each participant. Just after treatment, the patients were inquired
      about the level of pain during the procedure, and their level of satisfaction with the
      treatment. The women were followed-up at 6 weeks for any complication and re-assessed by
      colposcopy and biopsy at 12 months for any persistent or recurrent lesion and for any adverse
      event.
    

Intervention name(s): Treatment of cervical neoplasia by thermal ablation
Intervention type(s): Procedure
Intervention description(s): Women screened for cervical cancer by VIA presenting lesions eligible for ablative treatment were treated by thermal ablation. The treatment consisted in applying the probe on the lesion for 45 seconds at 100 degrees Celsius, with one to up to five applications depending on the lesion size. Following treatment, women were inquired about the pain level during the procedure, their satisfaction level of the procedure and whether they would recommend this treatment to their relatives. Women had a follow-up visit at 6 weeks to assess any complication of the procedure. Women were rescreened at 12 months, to evaluate the cure rate and any long-term adverse events.
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study where women presenting with cervical lesions eligible to ablation were treated and followed-up for cure and adverse events.
Masking: None (Open Label)
Primary purpose: Treatment
Non-invasive Prediction of Thermal Strain in Healthy Male Adults
Condition: Heat Stress
MeSH terms: Heat Stress Disorders
Study type: Interventional

Summary: 
      This is primarily an experimental study investigating methods of temperature measurement /
      heat strain detection. In the calibration study, there are different skin temperature sensor
      types, and in the prediction study there are different methods for determining heat strain,
      including conventional methods (rectal, gastro-intestinal), the development of a prediction
      model, and an index based on heart rate variability.
    


Intervention name(s): Heat strain
Intervention type(s): Other
Intervention description(s): The experimental procedure comprised 15 min baseline seated rest (23.2 ± 0.3°C, 24.5 ± 1.6% relative humidity), followed by 15 min seated rest and cycling in a climatic chamber (35.4 ± 0.2◦C, 56.5 ± 3.9% relative humidity; to +1.5◦C or maximally 38.5°C rectal temperature, duration 20-60 min), with a final 30 min seated rest outside the chamber.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.
    


Intervention name(s): colchicine
Intervention type(s): Drug
Intervention description(s): colchicine 1T tid
Intervention MeSH terms: Colchicine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted in healthy infants and will provide new immunogenicity and safety
      data for the modified process hepatitis B vaccine. This study was conducted to address the
      following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the
      modified process hepatitis B vaccine compared with a 10 microgram dose of the modified
      process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and
      to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
    


Intervention name(s): Modified Process Hepatitis B Vaccine (Experimental); Hepatitis B Vaccine (Recombinant); Hepatitis B Vaccine (Recombinant)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).; RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.; ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
Other intervention name(s): RECOMBIVAX HB™; ENGERIX-B®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)
Condition: Carcinomatous Edema
MeSH terms: Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      OPC-41061 will be administered to patients with volume overload associated with cancer, first
      by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine
      volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and
      safety and to determine the effective initial and maintenance doses of OPC-41061.
    


Intervention name(s): OPC-41061
Intervention type(s): Drug
Intervention description(s): orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
Condition: Cholangiocarcinoma; Surgical Treatment; Hepatectomy
MeSH terms: Cholangiocarcinoma; Klatskin Tumor
Study type: Interventional

Summary: 
      The investigators conducted a prospective study to determine the safety and efficacy of minor
      and major hepatectomy selected by predetermined criteria in 138 patients with hilar
      cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.
    

Detailed description: 
      Objective: To determine the safety and efficacy of minor and major hepatectomy selected by
      predetermined criteria in patients with hilar cholangiocarcinoma (HC).

      Summary Background Data: For HC treated with hepatectomy, the extent of liver resection
      remains controversial despite extensive studies.

      Methods: From January 2000 to December 2007, we prospectively studied patients who received
      surgical treatment for HC. Of the 187 patients who were surgically treated, 138 (73.8%)
      underwent resection with a curative intent. Minor hepatectomy was carried out in 93 patients
      who had Bismuth-Corlette types I, II and III HC without hepatic artery/portal vein invasion;
      and major hepatectomy in 45 patients who had type III HC with hepatic artery/portal vein
      invasion, or type IV HC.
    

Intervention name(s): Minor or Major Liver Resection
Intervention type(s): Procedure
Keywords: Minor Liver Resection; Major Liver Resection; Hilar
Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
Condition: Hypercholesterolemia in Coronaory Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol
      (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in
      subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of
      HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary
      heart diseases
    


Intervention name(s): HS-25 and Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily; Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The overall goal of this project is to improve cognitive control abilities in adults with
      mild cognitive impairment (MCI) through a form of non-invasive brain stimulation,
      transcranial alternating current stimulation (tACS).
    

Detailed description: 
      30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial
      alternating current stimulation (tACS) with simultaneous cognitive control training (CCT).
      The intervention took place within the participant's home without direct researcher
      assistance. Half of the participants received prefrontal theta tACS during CCT and the other
      half received control tACS. Outcomes were assessed pre and post intervention.
    

Intervention name(s): Transcranial alternating current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain
Condition: Sacroiliac; Sprain (Strain)
MeSH terms: Arthralgia; Sprains and Strains
Study type: Interventional

Summary: 
      The SIJ has long been considered an important source of low back pain because of the
      empirical ﬁnding that treatment targeting the SIJ can relieve pain.This study was be a
      Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore. The study was be
      completed within the time duration of Six months. Purposive sampling technique was be used.
      Sample size is calculated by using the G power 3.1. The sample size of 64 patients was be
      taken in this study to find the comparison of regional manual therapy and standard
      physiotherapy intervention in females with sacroiliac joint pain. Patients was be divided
      into two groups.. Patients was be divided into two groups. Group A was be treated with
      regional manual therapy. In regional manual therapy patients was be given mobilization to
      lumber region and SIJ, pelvic floor exercises and core strengthening exercises and Group B
      was be treated with standard physiotherapy in which patients was be given SIJ mobilization
      and Straight leg raise. Both groups was receive transcutaneous electrical nerve stimulator
      and heating pad as a common treatment protocol. Numeric pain rating scale (NPRS) and oswestry
      low back disability questionnaire was be used as Data collecting tools. Two session of
      treatment per week for eight weeks was be given. Data was be analyzed on SPSS 21.
    


Intervention name(s): Regional treatment; Standard physiotherapy treatment
Intervention type(s): Other; Other
Intervention description(s): In reginal treatment patients were given physiotherapy exercises and manual therapies on hip joint as well as on surrounding areas of hip joint such as lumber area and sacroiliac joint.; In this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate
Condition: Untreated Philadelphia Positive Acute Lymphoblastic Leukemia; De Novo; Secondary; Low-dose Corticosteroids Pretreatment
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted in different centres and will study adult patients with
      Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study
      treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase
      (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the
      achievement of an early negative minimal residual disease (MRD) status. The MRD study
      supports a risk/MRD-oriented final consolidation phase.
    

Detailed description: 
      The aim of this clinical study in adult ALL is to improve , by risk category, the overall
      disease-free survival in relation to the achievement of an early MRD negative status and
      following induction/consolidation with Peg-ASP, lineage-targeted methotrexate infusions and
      other disease-specific therapeutic elements, with or without the application of allogeneic or
      autologous SCT depending on risk class and MRD study results. A survey of severe infections
      occurring along the entire chemotherapy and stem cell transplant program and until 2 years
      from the achievement of CR will be performed with the aim to increase the knowledge of these
      complications and to evaluate their impact on the antileukemic program and on the long term
      outcome of the underlying malignancy. The prospective survey of severe infections will be
      performed as an ancillary observational objective of the present study.
    

Intervention name(s): Prephase PDN + CY; Cycle 1 Induction; Cycle 2 Induction / Early consolidation; Cycle 3 Early consolidation; Cycle 4 Consolidation; Cycle 5 Consolidation; Cycle 6 Consolidation; Cycle 7 Consolidation; Cycle 8 Reinduction; Maintenance; Allogeneic SCT or Autologous SCT
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): If MRD negative MRD u/k SR; If MRD positive MRD u/k HR
Other intervention name(s): VCR + IDR + DXM + ASP + IT; IDR + CY + ARA-C + ASP + 6MP + DXM + IT; MTX + ARA-C; VCR + IDR + CY + ARA-C + 6-MP + DXM + IT; MTX + ASP + 6-MP; VCR + IDR + CY + ARA-C + ASP + 6MP + DXM + IT; MTX + ARA-C; VCR + IDR + DXM + PDN + CY + IT; CY or VP and 6MP/MTX + 12 cycles of 6MP/MTX; + Maintenance
Intervention MeSH terms: Cytarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Untreated philadelphia positive acute lymphoblastic leukemia; De novo; Secondary; Low-dose corticosteroids pretreatment; Pegylated asparaginase; Lineage-targeted risk and minimal residual disease
Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Condition: Avascular Necrosis of Hip; Osteoarthritis, Hip; Inflammatory Arthritis; Post-Traumatic Osteoarthritis of Hip
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Hip; Necrosis
Study type: Observational

Summary: 
      This is a multi-center, prospective, non-controlled post market surveillance study. The
      objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in
      combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
    

Detailed description: 
      The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell
      in combination with the BIOLOX® delta Taper Liner when used in primary total hip
      arthroplasty.

      This will be done by analysis of standard scoring systems, radiographs and adverse event
      records. Data will be used to monitor pain, mobility and survivorship, and to confirm the
      safety and performance of the Allofit IT Ceramic Bearing System.

      A total of 200 patients will be enrolled in this study that will last 12 years (2 year
      enrollment plus 10 years follow-up) with the following visits at 6 months, 1, 2, 3, 5, 7, and
      10 years post-operatively.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be comprised of 200 males and females who require primary total
        hip arthroplasty. Subjects will be enrolled at 4 investigative centers. Subjects must be
        geographically accessible throughout the study and be willing and able to attend required
        follow-up appointments. Candidates who express interest in study participation will be
        offered informed consent, and eligibility will be determined based upon the
        inclusion/exclusion criteria.
      
Keywords: Total hip arthroplasty; Medical Device; Safety; Hip prosthesis
Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the recommended dose of CMC544 administered in
      combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and
      oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of
      this combination will be evaluated preliminarily in patients with DLBCL in relapse or
      refractory, who are no candidates for autologous transplant.
    

Detailed description: 
      This study is a multicenter, phase Ib/II, open-label, single arm trial evaluating the
      efficacy and safety of R-CMC544 alternated with R-GEMOX in patients with CD20 and CD22
      positive DLBCL in relapse after/refractory to 1st or 2nd line treatment, who are no
      candidates for autologous transplant.

      The study consists of 2 phases. In part 1 (potential dose de-escalation phase) subjects will
      be enrolled at a fixed dose of CMC544. In case of occurrence of dose limiting toxicity (DLT),
      cohorts of 3 to 6 subjects will evaluate a de-escalating dose of CMC544 in combination with
      set doses of rituximab, gemcitabine and oxaliplatin in order to obtain the MTD or recommended
      dose of CMC544 in this regimen. In part 2 (dose expansion phase) further safety and
      preliminary efficacy data of the proposed combination will be analyzed.

      All patients will receive two 56 day induction cycles of alternating R-CMC544 (given on day
      1) and R-GEMOX (given on day 29 and 43). Patients who obtain CR or PR, will then go on a
      consolidation of another two 56 day cycles of alternating R-CMC544 (given on day 1) and
      R-GEMOX (given on day 29 and 43).
    

Intervention name(s): Rituximab, CMC544, Gemcitabine and Oxaliplatine
Intervention type(s): Drug
Intervention description(s): 2 cycles of induction of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.
2 cycles of consolidation of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.
Intervention MeSH terms: Rituximab; Inotuzumab Ozogamicin; Gemcitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole
      lauroxil in adults with schizophrenia or schizoaffective disorder.
    


Intervention name(s): Aripiprazole Lauroxil
Intervention type(s): Drug
Intervention description(s): Intramuscular (IM) injection, single dose
Other intervention name(s): ARISTADA TM
Intervention MeSH terms: Aripiprazole; Aripiprazole lauroxil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Aripiprazole Lauroxil; Aripiprazole; ALKS 9072; Alkermes