bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
Condition: Non Cirrhotic Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Variceal bleeding is a major cause of morbidity and mortality in patients with
      Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation
      (EVL) have been used to prevent rebleeding in these patients, largely based on data from
      cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing
      rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the
      rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of
      approximately 25% at 2yr and 35% at 5 years.

      Beta blockers have been found to be quite effective in both primary as well as secondary
      prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast
      to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty.
      Animal data and human data suggests that beta blockers reduce portal pressure in patients
      with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of
      variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of
      propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till
      date.

      Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta
      blockers will lead to reduction in portal pressure and decrease in portosystemic shunting
      leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy
      and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with
      NCPH.
    


Intervention name(s): Propranolol; multi band ligator for esophageal varices
Intervention type(s): Drug; Device
Intervention description(s): upto 320mg/day maximum; to obliterate esophageal varices
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Non Cirrhotic Portal Hypertension, secondary prophylaxis
A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to determine if the novel combination of the SSRI, sertraline, and
      the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable
      safety profile of SSRIs.
    


Intervention name(s): sertraline/[S,S]-reboxetine; sertraline/[S,S]-reboxetine; sertraline; sertraline; sertraline/[S,S]-reboxetine; Placebo; sertraline/[S,S]-reboxetine; [S,S]-reboxetine monotherapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks.; Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks.; Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.; Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks; Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.; Tablets, orally once per day for 8 weeks; Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks; Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
Intervention MeSH terms: Sertraline; Reboxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and potential immune
      response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose
      administrations in healthy men and postmenopausal women with low bone mineral density.
    


Intervention name(s): Placebo; AMG 167
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin.; Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amgen; Phase 1b; Postmenopausal; Bone Mineral Density
A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
Condition: Type 2 Diabetes Mellitus, CKD and Albuminuria
MeSH terms: Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this clinical research study is to determine whether dapagliflozin alone or in
      combination with saxagliptin can decrease albuminuria and improve glycemic control in
      patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned
      to randomize a total of 450 patients (150 patients per treatment arm)
    


Intervention name(s): Dapagliflozin 10 mg; Saxagliptin 2.5 mg; Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets administered orally once daily for 24 weeks.; Tablets administered orally once daily for 24 weeks.; Tablets administered orally once daily for 24 weeks.
Other intervention name(s): Forxiga™; Onglyza™
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Test How Well Healthy Men and Women Tolerate Different Doses of BI 706321
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 706321 in healthy male and female subjects following oral
      administration of multiple rising doses for 14 days.
    


Intervention name(s): BI 703621; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 703621; Placebo; Midazolam
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Conservative Treatment for Hip Osteoarthritis
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of manual treatment and a patient
      education programme for patients without indication for hip surgery.
    

Detailed description: 
      Hip osteoarthritis (hip OA) is the second most common arthritis of the larger joints and may
      result in pain and disability and lead to reduced quality of life (QoL). The prevalence of
      hip OA, in the adult population, > 35 years, is estimated to 4-11% in the western society. In
      specific countries hip OA affects up to 25% in adults > 60 years. With a growing elder
      population, these prevalence rates will increase and the demand for cost-effective and safe
      interventions will increase as well.

      International guidelines, 2008, on the management of hip and knee OA recommend a combination
      of non-pharmacological and pharmacological treatment. For years the majority of
      interventional research for hip and knee OA has focused on surgery and drugs. Surgery is an
      option, when pain and disability have reached severe levels, and an increasing group of
      patients are today looking for other treatment options than drug treatment (pharmacological).
      In the last 4-6 years, new randomized controlled trials (RCT) have shown promising results
      with non-pharmacological treatment, such as exercise, patient education, manual therapy and
      acupuncture.

      The purpose of this RCT is to investigate the effect of combining manual treatment and a
      patient education programme and compare it to a minimal intervention in form of a home
      stretching programme. It will further investigate the specific effect of manual treatment.
    

Intervention name(s): Hip School; Hip School and Manual Treatment; Minimal control intervention
Intervention type(s): Other; Other; Other
Intervention description(s): The hip school consists of one initial personal interview, three group sessions, and one follow-up personal interview. The hip school is a patient education programme which involves anatomy/physiology, epidemiology, disease progression and pain, advice on self-help and exercises.; Hip school as above. Patients receive manual treatment twice a week for 6 weeks. Manual treatment consists of joint manipulation and muscle energy techniques to the articular and soft-tissue structures of the hip.; As control group, an information leaflet is used with instructions to live as usual during the 6 weeks intervention period. The exercise sheet of the hip school is given to the patients with no further instruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; manual therapy; manipulation; hip school; chiropractic; patient education
Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Condition: Obstructive Sleep Apnea; Fatty Acid Metabolism; Continuous Positive Airway Pressure
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80%
      of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the
      development of glucose intolerance and T2DM. The project is targeting the gap in providing
      effective treatment of metabolic impairments associated with OSA, particularly T2DM. In
      contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure)
      on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are
      disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP
      treatment, as investigators suggested recently. Clearly, the search for additional
      treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated
      levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM
      development. The aim of the study is to target adipose tissue and muscle dysfunction leading
      to elevated FFA and develop thus novel pharmacological treatments based on lipolysis
      inhibition and stimulation of FFA oxidation.
    


Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): Continuous Positive Airway Pressure in cases of moderate/severe OSA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Observational

Summary: 
      The pathological variants of IgA nephropathy identified by the Oxford classification may be
      related to the clinical data at presentation and follow-up, including proteinuria and renal
      function. This study is aimed to identify the potential relationship between pathological
      variants and clinical data in IgA nephropathy.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population from which the cohort will be selected is these who have received renal
        biopsy in Guangdong General Hospital
      
Keywords: IgA nephropathy
Treatment of Acute Ischemic STroke With Edaravone Dexborneol II (TASTE-2)
Condition: Acute Ischemic Stroke; Mechanical Thrombectomy; Edaravone Dexborneol; Phase III
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicentre, randomized, double-blind, placebo parallel controlled,
      investigator-sponsored study that aims to investigate the efficacy and safety of Edaravone
      Dexborneol treatment in patients with acute ischemic stroke who had received early
      reperfusion therapy.
    

Detailed description: 
      This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to
      investigate the efficacy and safety of Edaravone Dexborneol treatment in patients with acute
      ischemic stroke who had received early reperfusion therapy. Patients who were eligible to the
      inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into
      two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15 ml
      edaravone and dexborneol concentrated solution for injection (37.5 mg, containing edaravone
      30 mg and dexborneol 7.5 mg) twice a day for 10-14 days, and those in the other arm will be
      given an equivalent placebo drug. All patients will be followed up for 90 days. The primary
      outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the
      proportion of severe adverse events.
    

Intervention name(s): Edaravone Dexborneol Concentrated Solution for injection; Edaravone Dexborneol placebo
Intervention type(s): Drug; Drug
Intervention description(s): Edaravone and Dexborneol Concentrated Solution for Injection, 15 ml (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) in 3 ampoule bottles, twice a day for 10 to 14 days.; Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
Other intervention name(s): Xian Bi Xin, CFDA Approval Number H20200007; Xian Bi Xin placebo
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficiency of TISSEEL for Sleeve Gastrectomy Complications
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice
      in the surgical management of patients with morbid obesity. However, this restrictive
      procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage
      (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently
      reliable technique to prevent these complications.
    

Detailed description: 
      The hypothesis is the following : the use of fibrin glue (Tissucol ®) during Laparoscopic
      Sleeve Gastrectomy would reduce the incidence of complications (gastric fistula,
      intra-abdominal hemorrhage and intra-abdominal locoregional collection).

      The aim is to investigate whether the use of fibrin glue (Tissucol®) during Laparoscopic
      Sleeve Gastrectomy reduces the incidence of postoperative complications (gastric fistula,
      intra-abdominal hemorrhage and intra-abdominal locoregional collection)
    

Intervention name(s): tisseel; no tisseel
Intervention type(s): Drug; Other
Intervention description(s): The product will be given as a 2 mL bottle per patient, which will be spread along the staple line. If necessary, a second bottle of 2 mL is used. The precautions for use are described in the user manual.; the surgeon does not applied tissucol during the surgery
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; surgical management; sleeve gastrectomy
Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AML
Condition: AML
Study type: Interventional
Phase: Phase 2

Summary: 
      Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the
      expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory
      molecules and adhesion molecules. The leukemias cells treated by decitabine will become more
      sensitive to the following adoptive T cell therapy.We proposed a hypothesis that
      decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in
      eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.
    


Intervention name(s): Decitabine 20 mg/m²/day for 5 days
Intervention type(s): Drug
Other intervention name(s): Cytarabine; aclacinomycin
Intervention MeSH terms: Cytarabine; Decitabine; Aclacinomycins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: demethylating agent; lymphocyte infusion
Improving Quality of Life of Children With Cancer Through Psychosocial Screening
Condition: Cancer
Study type: Interventional

Summary: 
      In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of
      childhood cancer and its aggressive treatment can have devastating psychosocial effects on
      the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). It
      is not known whether health care providers who treat these children use and value
      psychosocial tools or how beneficial the use of these tools is for these families. This
      research team will test the benefits of using psychosocial screening on the quality of life
      of treated children, parents and siblings.
    

Detailed description: 
      In Canada approximately 1450 children are diagnosed with cancer annually. Childhood cancer
      diagnosis and treatment can have devastating psychosocial effects on the family. Tools to
      screen for psychosocial risks (PSR) in pediatric oncology are rare. Our preliminary work
      adapted the Psychosocial Assessment Tool (PAT) for the Canadian population, PATrevised
      (PATrev), and developed the Psychosocial Care Checklist (PCCL). The PATrev is completed by
      parents of children with cancer, and yields a summary of the psychosocial needs of the
      patient, parents, and siblings. The PCCL assesses HCPs knowledge of family's psychosocial
      needs and services. Importantly, psychosocial screening is associated with reduced parental
      anxiety and improved child's quality of life (QOL). Demonstration of the tool's ability to
      maximize patient and family psychosocial outcomes is needed. Participants will be parents of
      children newly diagnosed with cancer, (patients and siblings (> 8 years), if available).
      Design: RCT with concealed allocation to experimental group (EG) and control group (CG), with
      repeated measures (after diagnosis= T1, 6 months later=T2). The EG treating team will receive
      a summary of PATrev risk information based on parent report. No risk information will be
      provided in the CG. Parents in both groups will complete the PATrev, family environment
      questionnaire, self--report and proxy reported QoL, distress and mood measures for the
      patient and one sibling. Patients and siblings will self-report on QOL, distress and mood.
      Patient charts will be reviewed (T2) to determine treatment intensity and documented
      psychosocial services for each family.
    

Intervention name(s): Summary of psychosocial risk factors; Control
Intervention type(s): Other; Other
Intervention description(s): The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.; The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: psychosocial screening, quality of life
The Double Exposure Study: The Impact of Job Strain and Marital Cohesion on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have
      previously been associated with a sustained increase in blood pressure (BP).

      In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the
      researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS
      and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in
      subjects enrolled with normal or untreated high BP.
    

Detailed description: 
      Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have
      previously been associated with a sustained increase in blood pressure (BP).

      In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we
      evaluated whether JS and marital cohesion continued to be associated with ambulatory blood
      pressure (ABP) in subjects enrolled with normal or untreated high BP.
    

Intervention name(s): Observational
Intervention type(s): Behavioral
Observational model: Defined Population
Time perspective: Prospective
Keywords: Hypertension; Job Strain; Marital Strain; Blood Pressure