bioihbjkbjnl/mcl2 huggingface dataset:
Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction
Condition: Iliac Venous Compression
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate that IVUS identifies more instances of
      significant iliac and common femoral vein outflow obstruction than multiplanar venography.No
      hypothesis testing is planned.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics
      
Keywords: Venous outflow obstruction; Iliac Vein; Common Femoral Vein; Iliac Compression
A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy
Condition: Radical Perineal Prostatectomy
MeSH terms: Recurrence
Study type: Observational

Summary: 
      To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the
      potential risk factors of capsular incisions.
    

Detailed description: 
      The pathological classification of the prostate following radical prostatectomy provides
      important prognostic information; an accurate pathology report is the cornerstone to cancer
      treatment and follow-up. In addition to the preoperative serum PSA, Gleason score on
      pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical
      margin with extraprostatic extension (EPE) are significant predictors of clinical and
      biochemical recurrence. However, the prognostic implication of a capsular incision, a tumor
      extending to the inked margins without a histologically documented EPE, remains to be
      defined.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the prostate cancer patients treated with radical perineal prostatectomy at single tertiary
        institution
      
Biospecimen description: 
      prostate gland
    
Keywords: capsular incision; biochemical recurrence; radical perineal prostatectomy
Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache
Condition: Headache; Headache Disorders; Healthy
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in
      Europe. Despite this high prevalence, there are persons who have never, in their whole life,
      encountered a headache.

      The aim of the study is to identify factors that protect against headache by studying
      multiomics in people who never have had a headache (headache resistant) versus non-resistant
      controls.

      The investigators will measure multiomic changes (transcriptomics and metabolomics) after
      pain induction by Cold Pressor Test. 3 blood samples, two for RNA and one for metabolites are
      taken 5 minutes before a Cold Pressor Test and again 1 hour after the Cold Pressor Test.

      The investigators hope to contribute with novelty to the current understanding of headache
      pathophysiology and development of more efficient treatment of headache.
    


Intervention name(s): Blood samples
Intervention type(s): Other
Intervention description(s): 3 blood samples, two for RNA and one for metabolites are taken 5 minutes before a Cold Pressor Test and again 1 hour after the Cold Pressor Test.
Intervention model: Single Group Assignment
Intervention model description: Case-control study
Masking: None (Open Label)
Primary purpose: Other
Phase III Sequential Open-label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Pazopanib Versus Pazopanib Followed by Sorafenib in the Treatment of Advanced / Metastatic Renal Cell Carcinoma (SWITCH-II)
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Sorafenib and pazopanib are both effective and promising treatments for advanced Renal Cell
      Carcinoma (RCC). Both drugs are registered for this indication. No prospective comparative
      data in advanced RCC (or other indications) have been published. A search in the
      clinicaltrials.gov database did not reveal any planned or ongoing studies. As sequential
      therapy is now the standard of treatment for advanced RCC it is important to evaluate in
      clinical trials what the value of different sequential strategies is. This needs to be done
      every time new agents are introduced into the treatment armamentarium. As there are no data
      yet on the sequential use of sorafenib followed by pazopanib or vice versa, this sequence,
      however, will most certainly be used in daily practice, it is required to examine efficacy
      and safety of this sequential approach in a clinical trial in a randomized setting.

      Therefore, the investigators have designed an open randomized study in patients not
      previously treated for advanced RCC. Suitable patients will be randomized (1:1) in 2 groups.
    


Intervention name(s): Sorafenib+Pazopanib; Pazopanib+Sorafenib
Intervention type(s): Drug; Drug
Intervention description(s): Sorafenib (first-line) followed by Pazopanib (second-line); Pazopanib (first-line) followed by Sorafenib (second-line)
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety,
      tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at
      three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).

      In this study temelimab is administered subsequently to rituximab therapy, i.e. no
      co-administration of rituximab and temelimab is done in this study.
    


Intervention name(s): temelimab 18 mg/kg; temelimab 36 mg/kg; temelimab 54 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).; temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).; temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).; Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing Forms of Multiple Sclerosis; GNbAC1; Human Endogenous Retrovirus Type W; HERV-W; Temelimab
Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      It is already known from animal studies that the study drug can improve mucosal immunity as
      shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an
      oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In
      addition, this trial will aim to determine if this intake is able ot improve serum and
      salivary IgA synthesis.
    


Intervention name(s): 2006-RD-05; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 300 mg daily, once a day for 28 consecutive days; Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia; Lymphoplasmacytic Lymphoma
MeSH terms: Waldenstrom Macroglobulinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the percentage of people who can attain remission
      and the length of time such responses to therapy are sustained, as well as the side effects
      that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.
    

Detailed description: 
      -  Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two
           weeks of thalidomide, the patient is doing well the dose of thalidomide will increase
           (400mg) and they will remain on it for up to 50 additional weeks. The length of time a
           patient is on thalidomide will depend upon how they are responding to therapy.

        -  During the second week of the study patients will also begin receiving rituximab
           intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later
           depending upon the response.

        -  A determination of how the patient is responding will be made based on testing conducted
           at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it
           is determined that the disease is not progressing, patients will begin a second phase of
           treatment which includes 4 additional weekly infusions of rituximab and the continuation
           of oral thalidomide.

        -  If it is determined at the 12-week evaluation, or at any time thereafter, that the
           disease has progressed (by studying serum immunoglobulin M (IgM) levels, bone marrow
           involvement, tumor cells, and/or development of new signs and symptoms) then the patient
           will be removed from the study.

        -  Periodic examinations and tests will be done to determine how the patient is doing, what
           response and side effects (if any) the patient may be having from the study drugs. If
           patient is responding to therapy then they will remain on this study and followed for a
           period of two years.

        -  Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending
           for 2 years following the last treatment.
    

Intervention name(s): Thalidomide; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.; Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Other intervention name(s): Thalomid; Rituxan
Intervention MeSH terms: Thalidomide; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thalidomide; rituximab; Waldenstrom's
The ISEO Biofeedback Tool During the Rehabilitation of Patients Treated for Rotator Cuff Tear
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The present study addresses the issue about post-surgical recovery process, for patients
      arthroscopically treated for rotator-cuff tear. The aim of the research is to test the
      effectiveness of a new rehabilitation protocol that includes kinematic biofeedback with the
      motion analysis system ISEO.
    

Detailed description: 
      The research includes at least 62 patients arthroscopically treated for the rotator cuff
      tear. For this purpose, two groups of patients of equal size are identified. The attribution
      of each patient to one of the two groups is random. The standard rehabilitation protocol is
      applied to the Control group (Group A), whereas the standard rehabilitation protocol
      integrated by proprioception exercises (physical therapist assisted) performed with ISEO is
      applied to the Experimental group (Group B). The primary objective is to verify if the ISEO
      system, used as a biofeedback tool, improves shoulder functionality and activity of patients
      arthroscopically treated for rotator cuff tear, both in the short (90 days from surgery) and
      in the medium term (6-12 months from surgery). All patients are longitudinally evaluated from
      the pre-surgery to a 6/12 months follow-up. Each evaluation includes both a clinical and an
      instrumented assessment of shoulder kinematics. The primary outcome tested is the
      Scapula-Weighted Constant-Murley Score, which represents a reformulation of the
      Constant-Murley Score, which is modified based on the quality of the scapular movement
      measured with ISEO.
    

Intervention name(s): Kinematic biofeedback with ISEO motion analysis system
Intervention type(s): Device
Intervention description(s): Exercises are performed with the help of the ISEO motion analysis system, that provides a real-time biofeedback of shoulder kinematics. All exercises are administered by the Physical Therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study considers participants divided in two groups: the control group and the experimental group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder; Biofeedback; Kinematics
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression
Condition: Depression
MeSH terms: Overweight; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a combination of naltrexone SR and
      bupropion SR is safe and effective in the treatment of major depression in overweight or
      obese subjects.
    


Intervention name(s): naltrexone SR 32 mg/ bupropion SR 360 mg daily
Intervention type(s): Drug
Intervention description(s): All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.
During the study, subjects will receive ancillary therapy including advice on diet and exercise
Intervention MeSH terms: Naltrexone; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; depressed; overweight; obese
Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
Condition: Colon Cleansing
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets
      compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to
      colonoscopy.
    


Intervention name(s): oral sodium phosphate tablets; polyethylene glycol
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the combined therapy
      using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic
      cancer.
    

Detailed description: 
      By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of the combined
      therapy using irreversible electroporation（IRE）and nature killer（NK） cells for advanced
      pancreatic cancer.

      The efficacy will be evaluated according to relief degree,progress free survival(PFS) and
      overall survival(OS).

      The safety will be evaluated by statistics of adverse reaction
    

Intervention name(s): NK cells; irreversible electroporation (IRE )
Intervention type(s): Biological; Procedure
Intervention description(s): The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd; The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced pancreatic cancer; nature killer cell; irreversible electroporation
Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral
      therapy for subthreshold depression and presenteeism in workplace, in comparison with
      treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program
      (EAP)).
    


Intervention name(s): CBT; EAP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Telephone cognitive-behavioral therapy; Employees Assistance Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive disorder; Behavior therapy; Workplace; Subthreshold depression
The Pharmacokinetic Interaction Between Oral Casopitant and Oral Dolasetron, Granisetron or Rosiglitazone in Subjects
Condition: Nausea and Vomiting, Chemotherapy-Induced
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This A Three-Part Drug-Drug Interaction Study To Evaluate Effects of Casopitant On
      Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adults
    


Intervention name(s): casopitant; dolasetron; granisetron; rosiglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The doses of casopitant will be comprised of 150 mg (one 150 mg tablet) and 50 mg (one 50 mg tablet). Casopitant will be taken with 240 milliliters (mL) of water on an empty stomach following at least 2 hour fast.; The dose of oral dolasetron will be comprised of 100 mg (one 100 mg tablet or two 50 mg tablets). Dolasetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.; The dose of oral granisetron will be comprised of 2 mg (two 1 mg tablets). Granisetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.; The dose of oral rosiglitazone will be comprised of 4 mg (two 2 mg tablets or one 4 mg tablet). Rosiglitazone will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
Intervention MeSH terms: Rosiglitazone; Granisetron; Casopitant; Dolasetron
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug-drug interaction,; rosiglitazone,; safety; CYP2C8,; pharmacokinetics,; CYP3A4,; granisetron,; dolasetron,; CYP2D6,; casopitant,
Spicy Diet on Salty Taste and Salt Intake
Condition: Salty Taste; Spicy Diet
Study type: Observational

Summary: 
      Excess dietary salt intake is closely associated with the development of hypertension and
      cardiocerebral vascular diseases. Reduction in high salt intake significantly prevents
      hypertension and cardiocerebral events. Currently, few promising method is available to
      reduce salt intake in human. This study focus on examining the salty taste in
      population-level and exploring whether dietary factors can reduce salt intake through acting
      on salty taste.
    

Detailed description: 
      Hypertension and its related complications are common health problems that can lead to
      multiple organ damage and death. Excessive salt intake plays very important role in the
      development of hypertension. Reducing salt intake prevents high blood pressure as well as
      cardiocerebral vascular diseases.

      The experimental design is a multi-center, random-order, double-blind observational study to
      investigate the salty taste and salt intake in population-level.

      A total of 606 individuals from four cities in China are recruited in this study. This study
      aims to explore the salty taste characterization and salt intake in participants who like or
      dislike spicy diet through questionnaire, spicy preference, salty perception and
      super-threshold as well as the 24-hour urinary sodium excretion.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Residents from four cities(Shenyang, Jinan, Chengdu and Chongqing) in China
      
Biospecimen description: 
      Blood, Urine
    
Keywords: Salty taste; Urinary sodium excretion; Spicy hedonic; Blood pressure
Sirolimus Effect on Hypertrophic Syndromes Related Gene PIK3CA
Condition: Segmental Overgrowth Disorders Due to PIK3CA
Study type: Interventional
Phase: Phase 2

Summary: 
      It was found that people who have an excessive growth in one or more parts of their body and
      normal growth in other parts, may have a change in genes responsible for controlling cell
      growth. This genetic discovery identified a possible treatment for this overgrowth, called
      Sirolimus.

      This is a pilot study, which help the investigators prepare a larger international study,
      which will aim to determine whether a treatment based Sirolimus is able to stop the excessive
      growth of one or more parties of their body in people who carry a genetic change in the
      PIK3CA gene (phosphatidylinosilol-3-kinase encoded by the gene PIK3CA).
    

Detailed description: 
      The duration of participation is 15 months:

        -  Visit screening: blood test, pre-clinical evaluation, urine collection and chest X-ray.

        -  First 6 months: participants will have their overgrowth monitored. This step includes 2
           visits taking place at the University Hospital of Dijon: complete clinical evaluation,
           MRI of the body part by the overgrowth and Dual-energy X-ray absorptiometry (DXA).

        -  Next 6 months: participants will take Sirolimus. This step includes 2 visits (4 and 13
           weeks after the start of treatment at local hospital): blood test, urine collection and
           clinical evaluation.

      and 1 end of study visit after 6 months of treatment taking place at the University Hospital
      of Dijon: blood test, complete clinical evaluation, urine collection, MRI and DXA.

      Participants will have several blood and urine tests between visits (1 and 2 weeks after the
      start of treatment at a local laboratory).
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Low dose sirolimus will be given in daily dosing to achieve trough levels of 2-6 ng/ ml.
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Condition: Hypertension
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a
      nutraceutical preparation on early markers of cognitive impairment, in patients affected by
      arterial hypertension.
    


Intervention name(s): Nutraceutical compound; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment