bioihbjkbjnl/mcl2 huggingface dataset:
Allogeneic Mesenchymal Stem Cells in Osteoarthritis
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is planed to study if allogeneic mesenchymal stem cells would be safe and
      beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of
      stem cells will be used in this study.
    


Intervention name(s): Ex- vivo cultured adult allogeneic MSCs; Plasmalyte-A
Intervention type(s): Biological; Biological
Intervention description(s): Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan; Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee; Stem cells; Mesenchymal Stem Cells
Reversing Type 1 Diabetes After it is Established
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to determine if giving the combination therapy
      consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1
      Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.
    

Detailed description: 
      This is a randomized, placebo controlled, phase I/II trial. Potential subjects will be
      screened via a 4 hour mixed meal tolerance test to assess residual beta cell (C-peptide)
      function. If the C-peptide level at any time is ≥ 0.1 pmol/ml, and the subject meets the
      additional inclusion and exclusion criteria, they will be eligible for randomization and
      enrollment. The study will be randomized 2:1 such that 17 subjects will receive active
      therapy and 8 will receive placebo. Subjects must receive Thymoglobulin®/ Neulasta® or
      placebo within 8 weeks of randomization. Thymoglobulin® (2.5mg/kg)/placebo will be given as
      0.5 mg/kg IV on day 1 and 2 mg/kg on day 2. Six doses of Neulasta® (6mg/dose)/placebo will be
      given as standard of care every 2 weeks, with the first dose given prior to discharge after
      the Thymoglobulin® infusion. Complete metabolic panel (CMP) and complete blood count (CBC)
      will be done at the screening visit, just prior to study drug initiation, daily during the
      Thymoglobulin® infusion admission, and at follow up visits. Following discharge, daily phone
      calls will be made to the subjects during the first 5 days of therapy and weekly thereafter.
      In addition, weekly phone calls for the month following completion of therapy will be used to
      document adverse reactions. Thereafter calls will be made every two weeks.
    

Intervention name(s): Anti-Thymocyte Globin (ATG); Placebo; Pegylated GCSF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anti-Thymocyte Globin (ATG) will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2.; Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes; 6 doses of pegylated GCSF (6mg/dose) will be given subcutaneously every 2 weeks beginning after the ATG infusion.
Other intervention name(s): Thymoglobulin; Saline infusion; Neulasta
Intervention MeSH terms: Thymoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Autoimmune, Diabetes Mellitus, Glucose Metabolism
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body), and
      pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a
      long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male
      subjects with type 2 diabetes (T2D).
    


Intervention name(s): semaglutide; semaglutide; semaglutide; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.; Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.; Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.; Placebo semaglutide. For oral administration.; Placebo semaglutide with carrier. For oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Breast Cancer and Kinesiophobia and Physical Activity
Condition: Breast Cancer; Kinesiophobia
MeSH terms: Breast Neoplasms; Kinesiophobia
Study type: Observational

Summary: 
      Breast cancer is the most common type of cancer in women worldwide. A significant number of
      breast cancer survivors develop many complications. Breast cancer and survivors may develop a
      fear of physical activity avoidance and movement, called kinesiophobia, due to upper
      extremity pain, numbness, restricted arm/shoulder range of motion, and risk of lymphedema.
      Therefore, in the present study, it is aimed to compare the effect of fear of movement on
      physical activity, quality of life and psychological states in women who have had breast
      cancer with healthy people.
    


Intervention name(s): None intervention
Intervention type(s): Other
Intervention description(s): None intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sixty patients with grade I-II-III breast cancer, whose primary treatment (surgery,
        radiotherapy and/or chemotherapy) was completed at least three months ago, who applied to
        the Acıbadem Maslak Hospital Breast Unit clinic, will be included in the study. Patients
        with problems in reading and writing in Turkish, poor cognitive functions and a serious
        chronic disease, musculoskeletal pain or disease, severe psychiatric illness, current
        cancer attack or metastasis will be excluded from the study [17]. Since it is a
        case-control study, 60 healthy individuals matched for age and gender will also be included
        in the study.
Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on
      airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given
      as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a
      screening period and a treatment period which includes doses on day 1 and day 8.
    


Intervention name(s): IMA-026; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Question Prompt Sheet for Depressive Outpatients
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      question prompt sheet for outpatients suffering from depression. effects on
      patient-doctor-communication during the consultation.
    


Intervention name(s): question prompt sheet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy of treating locally advanced pancreatic cancer using
      Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine
    

Detailed description: 
      In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard
      gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy
      may prolong the interval to distant progression and improve overall survival in these
      patients. In this study, we will treat pancreatic cancer patients with locally advanced
      disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine.
      30 patients will be accrued to this study at Stanford University Medical Center, the only
      site participating in this research study. Treatment on this protocol requires placement of
      3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the
      fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper
      abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This
      imaging set will be processed for radiosurgery, using a modified linac based radiation
      treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on
      tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed
      to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as
      defined by the contrast CT. Following SBRT, patients will be monitored clinically and
      radiographically.
    

Intervention name(s): Stereotactic Body Radiotherapy; Gemcitabine; 4D pancreatic protocol CT scan; FDG PET scan
Intervention type(s): Radiation; Drug; Other; Radiation
Intervention description(s): Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator; Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes; Patients will undergo this imaging procedure prior to treatment for planning purposes.; Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.
Other intervention name(s): single fraction 25 Gy dose Stereotactic Body Radiotherapy; Gemzar; computerized tomography scan; Fluorodeoxyglucose (FDG)-positron emission tomography
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stereotactic Body Radiotherapy (SBRT); pancreas cancer; locally advanced; local control; Gemcitabine
Building Habits Together Online Weight Loss Program
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention
      where participants will all receive online weight loss counseling delivered via a private
      Facebook group, but be randomized to the Habit app (developed by the investigators) or
      MyFitnessPal, a commercial calorie tracking app.
    

Detailed description: 
      The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults
      with overweight or obesity will receive online weight loss counseling delivered via a private
      Facebook group, but be randomized to the Habit app (developed by the investigators) or
      MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app
      will be asked to record their weight daily, monitor their dietary temptations, plan their
      exercise, and solve diet and exercise related problems. The temptation tracker helps users
      identify triggers and track when and why those triggers lead to dietary lapses. The exercise
      planner allows users to plan their exercise for the week and track whether they completed or
      missed the exercise and why they missed it. The Habit app provides insights to users about
      the patterns of their dietary lapses and exercise habits. The problem solver feature helps
      users identify their biggest problem with diet/exercise and then asks a series of questions
      to help the app provide tailored solutions to the participant to work on. Participants
      randomized to MyFitnessPal will track their calorie intake and exercise daily during the
      intervention.
    

Intervention name(s): Building Habits Together; Getting Healthy Together
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app.; Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: obesity; lifestyle intervention; mobile app
Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment
      for patients - unsuitable for another approved first line therapy - with advanced RCC in the
      Middle East Region.
    


Intervention name(s): Sorafenib
Intervention type(s): Drug
Intervention description(s): 400 mg twice daily
Intervention MeSH terms: Sorafenib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
Condition: High Oxidation Stress; Oxidized LDL Level
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of
      ENI Patented Whole Grape Extract on Antioxidant Status.
    

Detailed description: 
      This study will investigate the effect of ENI Patented Whole Grape Extract versus placebo on
      antioxidant status. The primary objective is to determine antioxidant status by measuring
      total antioxidant capacity and superoxide dismutase (SOD) in blood and 8-OHdG and
      8-isoprostane in first morning void urine samples prior to and after six weeks of
      supplementation with ENI Patented Whole Grape Extract.

      Secondary objectives will include the assessment of oxidized LDL (oxLDL) and safety
      evaluations:

        1. oxLDL

        2. Safety laboratory tests: CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT,
           GGT,bilirubin

        3. Vital signs: heart rate and blood pressure

        4. Adverse events
    

Intervention name(s): ENI Patented Whole Grape Extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): ENI Patented Whole Grape Extract; Placebo
Other intervention name(s): Whole Grape Extract; Other ingredients pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Total antioxidant capacity; SOD; 8-OHdG; 8-isoprostane; oxLDL
Analgesic Effect of Intravenous Patient-Controlled Analgesia (IV PCA) Versus Paravertebral Block After Video Assisted Thoracic Surgery (VATS)
Condition: Postoperative Pain After Video Assisted Thoracic Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to compare the analgesic effect of paravertebral block with that
      of intravenous patient-controlled analgesia after video assisted thoracic surgery.
    


Intervention name(s): paravertebral block; PCA
Intervention type(s): Procedure; Procedure
Intervention description(s): Postoperative pain is controlled with local analgesics via PVB.; Postoperative pain is controlled with intravenous PCA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      For patients with progressive or recurrent glioblastoma there is no standard therapy. One
      strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done
      by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity.
      In study arm A patients receive temozolomide for one week, followed by a week without
      temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a
      week without temozolomide. The regimen that is less toxic will be selected for further
      evaluations.
    


Intervention name(s): Temozolomide in both arms; Temozolomide in both arms
Intervention type(s): Drug; Drug
Intervention description(s): initial dose 120 mg/m2 in arm A; initial dose 80 mg/m2 in arm B
Other intervention name(s): Temodal; Temodal
Intervention MeSH terms: Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: progressive or recurrent glioblastoma; temozolomide; dose intensification; comparison of two dosing regimens
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
Condition: Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of experimental medication BMS-986036 given to healthy participants.
    


Intervention name(s): BMS-986036
Intervention type(s): Drug
Intervention description(s): Crossover administration to abdomen then upper arm
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Observational

Summary: 
      Patients who were admitted to the Physical Medicine and Rehabilitation (PMR) outpatient
      clinic of our hospital between January 2017 and December 2020 and were treated with Major
      ozone autohemotherapy with a diagnosis of Fibromyalgia syndrome will include to the study.
      Visual anolog scale (VAS), Fibromyalgia Impact Questionnare (FIQ) and Short Form Health
      Survey-36 (SF-36) scores of the patients before and after treatment were recorded.
      Statistical analysis of these outcome scores will be made.
    


Intervention name(s): major ozone autohemotherapy
Intervention type(s): Other
Intervention description(s): This treatment is based on treating 100 ml of the pa- tient's blood with 100 ml of O3 followed by reinfusion in the donor, in a fast procedure. Each patient received 10 sessions of autohemotherapy with O3 twice a week.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        -  18-60 years ranged, male and female patients

          -  diagnosed fibromyalgia syndrome witc ACR 1990,2010 criterias,

          -  volunteers that gave consent,

          -  treated with major ozone autohemotherapy (10 sessions)
Effect of VPro5 Therapy on Clear Aligner Therapy
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The investigators hypothesize that brief, daily application of HFA will increase the
      efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or
      discomfort. The investigators will divide subjects into 5 groups changing clear aligners at
      different time intervals with or without HFA application for 5 minutes/day to assess the
      effect on: time intervals between aligners, cytokine activity, and pain perception.
    


Intervention name(s): VPro5 device; Deviation from Standard Tray Wear Time (14 Days)
Intervention type(s): Device; Other
Intervention description(s): Use of the VPro5 device for 5 minutes a day; Patients reduced Tray Wear Time Interval (14 Days)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: HFV; HFA; High Frequency Vibration
Preventing Drug Abuse Among Hispanic Adolescents
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The planned research aims to delay the onset of drug use and reduce harmful use and abuse
      among Hispanic youths. The culturally-tailored prevention program will be delivered to youths
      by computer. Over 5 years, the program will be developed and tested in a randomized clinical
      trial. The intervention program will include 10 initial sessions, followed by annual booster
      sessions. Outcome measurements will involve baseline, post-intervention, and three annual
      follow-up data collections.

      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower
      among participants assigned to receive the intervention. If proven to be efficacious, the
      program will be revised and disseminated nationally.
    

Detailed description: 
      America's largest ethnic minority group, Hispanics are also a youthful population: one-third
      of Hispanic Americans are less than 18 years old. Unfortunately, young Hispanic Americans are
      an at-risk population more likely than their majority culture peers to drop out of school,
      become involved in the criminal justice system, fall prey to violence, and face lifelong
      economic problems. Hispanic youths are also at risk for early drug use and subsequent harmful
      use and abuse. As early as eighth grade and relative to their Black and White peers, Hispanic
      adolescents report higher rates of most harmful substances. Drug use continues to pose
      problems for Hispanic youths throughout adolescence and into adulthood.
    

Intervention name(s): Prevention Program
Intervention type(s): Behavioral
Intervention description(s): Youths in the intervention-arm will interact online with the initial intervention program between pretest and posttest measurement occasions and will interact with booster sessions subsequent to 1- and 2-year follow-up measurement occasions. Owing to the expense associated with developing a treatment-as-usual intervention for computer delivery in the control arm, youths assigned to the control arm will receive no intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Drug abuse