bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613® (Devimistat) Plus Hydroxychloroquine in Patients With Relapsed or Refractory Clear Cell Sarcoma of Soft Tissue
Condition: Sarcoma, Clear Cell
MeSH terms: Sarcoma; Sarcoma, Clear Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this trial in Phase I is to determine the maximally tolerated dose (MTD) of
      hydroxychloroquine in combination with devimistat in patients with relapsed or refractory
      Clear Cell Sarcomas of the Soft Tissue and to describe the full toxicity profile. In Phase
      II, the goal is to evaluate the response rate [Complete Rate (CR) + Partial Rate (PR)] of the
      combination of devimistat and hydroxychloroquine in patients with relapse or refractory Clear
      Cell Sarcoma of the Soft Tissue and to evaluate the PK and PK/PD profiles for efficacy and
      safety of the combination of devimistat and hydroxychloroquine.
    


Intervention name(s): CPI-613 + Hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): dosing regimen was 600mg hydroxychloroquine PO followed 2 hours later by 2,000 mg/m2 of CPI-613 by central IV infusion over 2 hours followed by 600 mg hydroxychloroquine PO 12 hours following the initial dose daily on days 1 through 5 of every 28 days.
Starting dose of 80% of the maximum tolerated (MTD) identified in patients ≥ 45 kg for patients < 45 kg
Intervention MeSH terms: Hydroxychloroquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single
      rising dose and after multiple rising doses
    


Intervention name(s): Hyoscine butylbromide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Buscopan®
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in
      treating patients who have recurrent malignant glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan when
           administered with temozolomide in patients with recurrent malignant glioma.

        -  Determine the safety profile of this regimen in this patient population.

        -  Determine the efficacy of this treatment regimen as measured by 6-month progression-free
           survival and objective tumor response in these patients.

        -  Characterize the pharmacokinetics of this treatment regimen in these patients.

        -  Determine the antitumor activity of this treatment regimen in these patients.

      OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients are stratified
      according to concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin,
      phenobarbital, carbamazepine, or primidone) (yes vs no).

      In phase I of the study, patients receive oral temozolomide on days 1-5 and irinotecan IV
      over 90 minutes on days 1 and 14. Treatment continues every 28 days for up to 1 year in the
      absence of disease progression or unacceptable toxicity.

      Patients concurrently on EIAEDs undergo dose escalation of irinotecan. Cohorts of 3 to 6
      patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is
      determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients
      experience dose-limiting toxicity.

      In phase II of the study, patients receive the same treatment as in phase I at the MTD.

      Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months
      for 1 year, every 6 months until progression, and then every 4 months for survival.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I within 10 months and 48
      patients will be accrued for phase II within 6-8 months.
    

Intervention name(s): irinotecan hydrochloride; temozolomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irinotecan; Temozolomide
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma
A Comparison of Continuous Moderate Training and Reduced High Intensity Interval Training in Obese Young Adults
Condition: Obesity; Exercise; Oxygen Consumption
Study type: Interventional

Summary: 
      Exercise is a key component of obesity management. Obese subjects cannot attend or sustain
      exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they
      feel more exertion when comparing with normal weight subjects. Reduced-exertion
      high-intensity interval training (REHIT) is a alternative method to continuous exercise
      programs. The investigators aimed comparing metabolic effects of REHIT and continuous
      exercise in young adults, in this study.
    


Intervention name(s): REHIT Exercise; Continuous Aerobic Exercise
Intervention type(s): Other; Other
Intervention description(s): -Start with warm-up period --> %50 of maximum work rate, 3 minutes
One Exercise Cycle consists of:
15 seconds exercise period: %100 of maximum work rate
15 seconds recovery period: %50 of maximum work rate
Total Duration: 10 minutes; At %50 of maximum heart rate, 30-60 minutes aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Novel Lung Functional Imaging for Personalized Radiotherapy
Condition: Lung Cancer
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the safety and feasibility of personalized
      radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation
      imaging, which selectively avoids irradiating highly-functional lung regions.
    

Detailed description: 
      In this clinical trial, the investigators will assess the safety and feasibility of 4D CT
      ventilation image-guided personalized radiotherapy. The investigators will deliver
      personalized radiotherapy treatments that selectively avoid irradiating highly-functional
      lung regions for lung cancer patients, and follow up patients to assess the safety and
      feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided
      personalized radiotherapy can be delivered safely for lung cancer.
    

Intervention name(s): Ventilation image-guided radiotherapy
Intervention type(s): Radiation
Intervention description(s): Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiotherapy; Pulmonary Functional Imaging; Computed Tomography (CT); Image Registration; Functional Image-guided Radiotherapy
Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)
Condition: Symptomatic Diabetic Peripheral Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with
      symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20
      days followed by oral treatment 600 mg × 3 daily for 140 days.
    


Intervention name(s): Deproteinised hemoderivative of calf blood (Actovegin)
Intervention type(s): Drug
Intervention description(s): Symptomatic diabetic peripheral polyneuropathy
Intervention MeSH terms: Actovegin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Targeted Literature Review and Subject Interviews in Wiskott-Aldrich Syndrome (WAS)
Condition: Wiskott-Aldrich Syndrome
MeSH terms: Wiskott-Aldrich Syndrome; Syndrome
Study type: Observational

Summary: 
      WAS is a rare primary immune deficiency disease caused by genetic mutation and is more common
      in males than females. The purpose of this study is to understand experiences of WAS subjects
      and caregivers to identify important concepts of interest that could be measured in future
      Phase IIIb trials. This is a qualitative cross-sectional study that will include a sample of
      approximately, 8 subjects with WAS and 13 caregivers of subjects with a diagnosis of WAS in
      the United States, United Kingdom and France. A 60 to 90 minute open-ended interview will be
      conducted over the telephone or video conference that will be audio-recorded for subsequent
      transcription. The aim of these interviews is to obtain subject and caregiver perspectives on
      the impact of WAS and its associated treatments on quality of life and experiences of living
      with WAS.
    


Intervention name(s): Patient Interview guide; Caregiver interview guide; Sociodemographic questionnaire; Pediatric quality of life (PedsQL) questionnaire; Clinical questionnaire
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): The interviewer will conduct the interview for subjects with WAS using a semi-structured patient interview guide.; The interviewer will conduct the interview for caregivers of subjects with WAS using a semi-structured caregiver interview guide.; At the end of interview, subjects will be required to complete subject or caregiver versions of country-specific sociodemographic questionnaire.; The PedsQL is a validated generic measure of health-related quality of life (HRQOL) in children, adolescents, and young adults with acute and chronic health conditions. At the end of interview, subjects will be required to complete subject or caregiver versions of PedsQL questionnaire.; At the end of interview, subjects will be required to complete subject or caregiver versions of clinical questionnaire.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of approximately, 21 subjects with WAS and primary caregivers of WAS
        subjects will be included in the study.
      
Keywords: United States; United Kingdom; Wiskott-Aldrich Syndrome; Caregiver; Interview; immune deficiency; France
A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a
      photoallergic reaction when exposed to UV and VIS light on skin of healthy volunteers.
    

Detailed description: 
      This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to
      evaluate the potential of tazarotene foam 0.1% to induce a photoallergic reaction in healthy
      adult volunteers. Approximately 62 healthy, male and female, volunteer subjects aged 18 to 65
      years will be enrolled.

      All subjects will be exposed to patches containing tazarotene foam, vehicle foam, and no foam
      (blank; negative control). Inflammatory skin responses (eg, erythema and local skin
      reactions) or superficial effects at patch sites will be visually assessed to corresponding
      grading scales. The study duration will be 6 weeks or 9 weeks and will consist of the
      following phases: Screening, 3 week Induction, 2 week Rest, and 1 week Challenge, and if
      indicated, a second 2 week Rest and 1 week Repeat Challenge.
    

Intervention name(s): Tazarotene (Patch application in Challenge Phase)
Intervention type(s): Drug
Intervention description(s): There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated & will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E.
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteer Subjects
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effect of different doses, strengths (concentrations), diluent
      additives, depths of injection, and methods of injection on the severity of bruising
      potentially induced by QWO (collagenase clostridium histolyticum-aaes [CCH-aaes]).
    

Detailed description: 
      The study will comprise a Screening Period (28 days), Treatment Period (90 days), and
      Follow-up Period (90 days). Participants will receive CCH-aaes in different doses,
      concentrations, diluent additives, depths of injection, and methods of injection in a split
      buttock arrangement, with the right buttock serving as the control, and the left buttock
      (investigational side) receiving a study intervention.
    

Intervention name(s): CCH-aaes; Antifibrinolytic Agent
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection.; Self-administered by participants enrolled in Cohort 7.
Other intervention name(s): Collagenase clostridium histolyticum-aaes; QWO®
Intervention MeSH terms: Antifibrinolytic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Collagenase Clostridium Histolyticum; collagenase clostridium histolyticum-aaes
A Study of RO5267683 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate
      the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in
      healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally
      daily for 28 days. Follow-up will be 10 weeks after the last dose.
    


Intervention name(s): RO5267683; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses; Multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China
Condition: Moderate-to-severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of CBP-201 in Chinese subjects with moderate
      to severe atopic dermatitis.
    

Detailed description: 
      This study is a randomized, double-blind, multi-center, controlled study designed to assess
      the efficacy, safety and PK characteristics of CBP-201 in eligible subjects with moderate to
      severe AD.

      The study includes a screening period, a treatment period and a follow-up period. The
      treatment period is divided into two stages.
    

Intervention name(s): CBP-201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CBP-201 subcutaneous(SC) injection.; subcutaneous(SC) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical
      study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous
      fistula creation.
    

Detailed description: 
      Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical
      study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous
      fistula creation. Subjects will be followed regularly with office visits at the
      investigational site at days 15, 29, 57 and weeks 12, 26 for vessel imaging, blood draws and
      other follow-up tests.
    

Intervention name(s): natural human collagen arteriovenous graft for hemodialysis access
Intervention type(s): Biological
Intervention description(s): The True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration.
Intervention model: Single Group Assignment
Intervention model description: Prospective, nonrandomized, single-arm, single-center, open-label
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of The Consumption Of Fermented Dairy Drink On Common Infections In Shift-Workers
Condition: Healthy
MeSH terms: Infections
Study type: Interventional

Summary: 
      This clinical study plans to investigate the effect of the consumption of a fermented dairy
      drink on the occurrence of common infections. This study will be performed in a healthy adult
      population of shift workers.
    


Intervention name(s): fermented dairy product; non fermented dairy product
Intervention type(s): Other; Other
Intervention description(s): fermented dairy product (2 bottles/day during 16 weeks); non fermented dairy product (2 bottles/day during 16 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Shiftworkers; volunteers
12-week Pilates Program on Community-dwelling Middle-aged Women
Condition: Functional Fitness; Health Promotion; Exercise; Frail Elderly Syndrome
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of a Pilates exercise intervention
      program on functional physical fitness in community-dwelling middle-aged women.
    

Detailed description: 
      Based on quasi-experimental design with a parallel control group, Subjects were allocated
      into to intervention group and control group with convenience sampling method. The primary
      outcome included body composition, basal metabolic rate, and functional physical
      fitness-comprising cardiovascular capacity (3-minute step test), flexibility (sit-and-reach
      test), muscular strength of upper limbs (grip-strength test), muscular strength of lower
      limbs (30 s chair stand test), core strength (bent-knee sit-up test), agility (8-foot timed
      up-and-go test), static balance (single-leg stance with eyes closed test), and dynamic
      balance (functional reach test), assessed in both groups before and after the 12-week
      intervention.
    

Intervention name(s): Programed Pilates
Intervention type(s): Other
Intervention description(s): The 60 min Pilates sessions were held twice a week for 12 weeks. Each session included three stages: 10 min of warm-up exercises, 40 min of floor-based Pilates training, and 10 min of cool-down exercises. Each stage was adjusted according to the participants' physical capacity. Only participants with an attendance rate of > 80% were included in the final sample. The content of the exercise program was determined according to their muscular strength, flexibility, and fitness levels. The training course was divided into three levels: elementary, intermediate, and advanced. Each motion was performed in conjunction with a specific breathing pattern for effective muscle activations of each exercise.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was quasi-experimental design with a parallel control group and the participants were recruited with convenience sampling method.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pilates; middle-aged women
Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery
Condition: Gynecologic Disease; Cosmesis; Patient Satisfaction; Quality of Life
MeSH terms: Genital Diseases, Female
Study type: Observational [Patient Registry]

Summary: 
      To compare robot assisted versus conventional laparoscopic surgery performed for bening
      gynecologic disorders regarding cosmesis, patient satisfaction and quality of life
    

Detailed description: 
      30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders
      and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic disorders
      will be included in the study. All surgeries will be performed in the same hospital by the
      same surgeon. 6 months after the surgery the patients will be called and will be informed
      about the trial. After confirming that the questionnaires can be sent to them by e-mail, 4
      questionnaires will be sent to the patients via e-mail. To evaluate cosmesis, patient
      satisfaction and quality of life VAS (visual analogue scale), SF-12 (short form-12) health
      survey, BIQ (body image questionnaire) and POSAS (the patient and observer scar assessment
      scale) will be sent to the patients 6 months after the surgery. Patients who have not
      completed the questionnaires will be called for reminders after 1 week. Patients will be
      expected to complete the questionnaire completely and accurately.
    

Intervention name(s): Laparoscopic surgery
Intervention type(s): Procedure
Intervention description(s): Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders
        and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic
        disorders will be included in our study.
      
Keywords: Cosmesis; Laparoscopic surgery; Patient satisfaction; Scar assessment; Quality of life