bioihbjkbjnl/mcl2 huggingface dataset:
Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study
Condition: Facioscapulohumeral Muscle Dystrophy
MeSH terms: Muscular Dystrophies
Study type: Interventional

Summary: 
      The hypotheses is that regular post exercise supplementation increase fitness and daily
      activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.

      All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen
      consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of
      falls and daily activity level.
    

Detailed description: 
      The purpose of this study is to investigate the response to protein-carbohydrate
      supplementation doing regular exercise in patients with FSHD. All patients are tested before
      and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and a functional 6
      min walk test(6MWT) is used as primarily effect goals. Secondary effect goals are risk of
      falls and daily activity level. We measure manuel muscle strength, a balance test, a
      5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity
      level questionnaire and SP36.

      We use a blinded randomized controlled trail. The interventions are 12 weeks regular exercise
      and consumption of a post-exercise drink. The exercise consists of 30 session of 30 minutes
      moderate exercise on a cycle-ergometer. After each exercise session patients consume a
      protein or a non-caloric placebo drink.
    

Intervention name(s): Regular exercise; Protein-carbohydrate supplementation
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.; Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: FSHD; Endurance exercise; Protein supplementation; Placebo RCT
A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat chronic cough. Before patients with medical
      conditions can join clinical trials, researchers do trials in healthy participants first to
      understand how the body acts on the new treatment and learn how safe it is.

      In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into
      the blood in a small number of participants. The trial will include about 39 healthy Chinese
      male who are aged 18 to 45.

      For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose
      1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of
      BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080
      twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of
      BAY1817080.

      All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the
      participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The
      participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up
      to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group
      3.

      During the trial, the doctors will take blood and urine samples and check the participants
      blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer
      questions about how they are feeling to check their general wellbeing.
    


Intervention name(s): BAY1817080; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral, tablet.; Oral, tablet.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pharmacokinetics (PK)
Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy
Condition: Cholecystitis; Chronic Calculous Cholecystitis; Acute Calculous Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      This was a double blinded, randomized, controlled trial involved patients underwent
      laparoscopic cholecystectomy
    

Detailed description: 
      A double blinded, randomized, controlled trial involved patients underwent laparoscopic
      cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020
      till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white
      light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence
      cholangiography and intraoperative ICG florescence arteriography.
    

Intervention name(s): Indocyanine Green Fluorescent Laparoscopic Cholangiography; White Light
Intervention type(s): Procedure; Procedure
Intervention description(s): Indocyanine Green Fluorescent Cholangiography; Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light
Other intervention name(s): Indocyanine Green Fluorescent LaparoscopicCholangiography; WL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arms, randomized, double blinded
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Laparoscopic Cholecystectomy; Indocyanine Green Fluorescent Cholangiography; Indocyanine Green Fluorescent Angiography
Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
Condition: Chronic Nonspecific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aim to investigate the effects of back care pillow, in adjective with standard
      physical therapy treatment for chronic non-specific low back pain.
    


Intervention name(s): Back care pillow; standard physical therapy treatment
Intervention type(s): Device; Procedure
Intervention description(s): back care pillow is specific size by age groups of standard deviation of the lumbar spinal curvature, in 20-29 years was 51.68 ± 6.94 degrees, in 30-39 years was 59.67 ± 7.02 degrees, in 40-49 years was 63.66 ± 7.62 degrees, in 50-59 years was 65.75 ± 10.85 degrees and in 60-69 years was 64.19 ± 9.69 degrees; standard physical therapy treatment are ultrasound therapy and hot pack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back care pillow; chronic non-specific low back pain; randomized controlled trial
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of
      repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
    


Intervention name(s): AKB-6548
Intervention type(s): Drug
Intervention description(s): Different dose levels
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics
Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The objective of this randomized control trial is to determine the effectiveness of
      myofascial release in patients with nonspecific low back pain to improve Pain, Disability,
      and Quality of life This study is being conducted at the Outpatient Physiotherapy department
      of Sindh Institute of Physical Medicine and Rehabilitation, Karachi (former institute of Dow
      University of Health Sciences) and Musculoskeletal outpatient department of Dr. Ruth K. M.
      Pfau, Civil Hospital Karachi among 72 patients with nonspecific back pain on the basis of
      non-probability purposive sample technique with screening for study criteria through a
      consultant physician (blinded). After taking informed consent, all participants will be
      randomly allocated into two groups through a second researcher who is not involved in
      screening, baseline assessment, and providing intervention. Group 1 will receive myofascial
      release with generalized low back stretching and thermotherapy and Group 2 will receive
      Posterior-anterior glide with generalized low back stretching and thermotherapy. A total of
      18 sessions will be provided. Outcomes will be assessed at baseline, at the last session, and
      after 12 weeks of follow-up.
    


Intervention name(s): Myofascial Release Experimental; Posterior-Anterior Glide
Intervention type(s): Other; Other
Intervention description(s): Myofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.; Posterior-anterior mobilization is a standard assessment and treatment technique for most clinicians. It is a mobilization technique that involves passive oscillatory movements applied to a vertebral segment in a posteroanterior direction (Back to front).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a randomized controlled trial. Total 80 patients will be recruited, 40 in each group that includes 4 patients as a dropout in both groups. There will be one interventional group and one control group. Treatment will be allocated using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pain; Disabled Persons; Myofascial Release; Low back pain; Back pain; Exercise Therapy; Quality of life
Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of
      rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects
    

Detailed description: 
      Primary Objective:

      This study will evaluate the safety and efficacy of two different PEG-interferon and
      Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients
      have an equal chance to assignment to one of two treatment arms:

      Treatment Arm A:

      PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day

      OR

      Treatment Arm B:

      PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day

      Arm A & Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48
      weeks for genotype 2 or 3 patients.
    

Intervention name(s): Ribavirin, PEG-Intron
Intervention type(s): Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; chronic hepatitis C; ribavirin; WIN-R
Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and Prostate Cancer Patients
Condition: Breast Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate the prediction of late toxicity by the
      radiation induced CD8 T-lymphocyte apoptosis
    

Detailed description: 
      The two cancer sites concerned by this trial are intermediate risk prostate cancer treated
      with conformational radiotherapy with or without intensity modulation, and breast cancer
      patients treated with adjuvant radiotherapy after breast conservative surgery for patients
      aged under 60 years of age. The identification of 5% of patients at risk of severe toxicity
      should allow to deliver high dose radiotherapy among 95% of patients with a lower risk of
      severe late complications.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients treated in a cancer center
      
Keywords: Radiotherapy; Late side effects; Predictive assay
Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations
Condition: Arthroplasty, Replacement
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      Ischemia reperfusion injury causes the release of free oxygen radicals. The selective
      alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses
      during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine on
      inflammatory responses during ischemia-reperfusion injury in skeletal muscle.
    


Intervention name(s): Dexmedetomidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The dexmedetomidine group received the dexmedetomidine infusion at a rate of 0.4mg/kg/h after a loading dose of 0.5mg/kg for 10 minutes.; The control group received the normal saline infusion
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
Condition: Leishmaniasis, Cutaneous
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with
      cutaneous leishmaniasis.
    

Detailed description: 
      Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal
      leishmaniasis, a more serious and possibly fatal form of leishmania infection. All available
      medical therapies require weeks of treatment and cause significant toxicity. In Brazil, a
      standard therapy is Glucantime treatment, administered in cycles of 10 consecutive, once
      daily, intramuscular injections (Glucantime 10 mg/kg, maximum of 850 mg), followed by 11
      consecutive days without Glucantime injections (rest days). At the completion of each cycle,
      a study physician examines the patient to determine if a further cycle of Glucantime
      treatment is indicated.

      It appears that Leishmania infections can be eliminated by T helper 1 immune responses. This
      finding argues that a vaccine that augments cutaneous leishmaniasis patients' T helper 1
      response will eliminate the infection and disease. This study is a phase 1, randomized,
      double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and
      immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE
      adjuvant given at 4 week intervals as an adjunct to the standard chemotherapy with Glucantime
      cycles, as described above in patients with cutaneous leishmaniasis.
    

Intervention name(s): Leish-111f + MPL-SE vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Leishmaniasis; Subunit vaccine; Therapeutic; T cell; Antimony
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Condition: Leukemia; Lymphoma, Non-Hodgkin; Hematologic Diseases; Acute GVHD
MeSH terms: Lymphoma, Non-Hodgkin; Hematologic Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched
      related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL
    

Detailed description: 
      To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus
      host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation
      (BMT). This study will report the toxicities associated with this drug combination and also
      explore possible correlations between specific blood cell types and antibody production
      during this therapy.
    

Intervention name(s): Sirolimus; MMF; BCNU; VP-16; CY; FTBI; BU
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Immunosuppressant beginning day -3 with 12 mg oral loading dose, 4 mg/day orally for adults; Immunosuppressant given through IV on day 0 at 15 mg/kg twice daily ≥ 2hr after the completion for the donor cell infusion; 15 mg/kg, IV; 60 mg/kg, IV; For subjects aged 18-60 with lymphoma 100 mg/kg, IV For subjects aged with AML, ALL or CML 18-50 60 mg/kg, IV For subjects aged 51-60 with MDS, AML or ALL or patients age 18-60 with MDS, secondary AML or non-CML myeloproliferative disease 45 mg/kg; 1320 cGy delivered in 11 120 cGy fractions over 4 day; BU 1 mg/kg every 6hr x 4 doses, IV
Other intervention name(s): rapamycin; Mycophenolate Mofetil; Carmustine; BiCNU; etoposide; cyclophosphamide; cytophosphane; Endoxan; total body irradiation; busulfan
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Cyclophosphamide; Busulfan; Carmustine; Etoposide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Positive and Negative Emotions on Brain Activity in Alcoholics and Nonalcoholics
Condition: Alcoholism; Healthy
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      This study was designed to learn more about the areas of the brain involved in the experience
      of positive and negative emotions.

      Patients who would like to participate in this study will first undergo a screening process
      to see if they will be eligible for the study. Patients eligible to participate in the study
      will go through two sessions.

      During session one, researchers will attempt to evoke positive and negative emotions by
      showing patients slides of different emotion-arousing stimuli (pictures of pleasant and
      unpleasant scenes). While patients are viewing these slides, researchers will be measuring
      patient's heart rate, sweating, and eye-blinking.

      During session two, patients will undergo an MRI of the brain while seeing similar
      emotion-arousing pictures as in session one. In addition, patients may be asked to play a
      simple computer game for a reward of money while researchers use the MRI to measure brain
      activity.

      Researchers hope to develop methods to evoke positive and negative emotions and
      simultaneously (at the same time) see brain activation in normal volunteers, alcoholics, and
      recovered alcoholics.<TAB>
    

Detailed description: 
      Objective: The purpose of this protocol is two-fold: 1) to determine how individual
      differences in evoked brain responses relate to generalized trait personality and behavior
      differences (as assessed by psychometric questionnaire instruments and behavioral measures),
      and 2) to determine whether individual differences in evoked brain responses relate
      specifically to genetic polymorphisms in genes governing neurotransmitter activity.

      Study population: Healthy non-alcoholic adult volunteers, healthy adolescents aged 12 to 17
      years (with or without a family history of alcohol use disorder), inpatient or outpatient
      alcoholics, and recovering alcoholics.

      Design: In this event-related functional magnetic resonance imaging (fMRI) study we will
      attempt to evoke positive and negative affect via several different standardized methods
      including: (1) pictures of emotion-arousing stimuli; (2) pictures of emotional facial
      expression; (3) cues signaling reward or punishment. This protocol is designed to cover many
      different functional magnetic imaging studies all using similar techniques to evoke and
      measure positive and negative affect in the brain. Most subjects will not participate in
      studies involving all the methods described in the protocol.

      Outcome measures: The outcome measure is differences in blood oxygenation dependent level
      (BOLD) signal measured using standard fMRI techniques and analyzed using AFNI software.
    

Keywords: Brain Imaging; Affect; Limbic System; Cerebral Blood Volume; Alcoholism; Emotion; Brain; Operant; Autonomic; Relapse; Normal Volunteer
Comparison of Buprenorphine and Methadone - 3
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare agonist and antagonist profile associated with
      buprenorphine vs. methadone during opiate withdrawal.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Condition: Migraine Disorders; Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the consistency of response for Treximet
      (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine
      attacks at the mild pain phase and within 1 hour of onset of head pain.
    


Intervention name(s): sumatriptan succinate/naproxen sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Combination Tablet of Treximet; placebo to match
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute migraine; consistency of response; satisfaction; migraine; early intervention