bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of IONIS-AGT-LRx compared to placebo on
      seated automated office systolic blood pressure (SBP) from baseline to Study Day 85 in
      uncontrolled hypertensive participants on ≥ 3 antihypertensive medications and to evaluate
      the effect of IONIS-AGT-LRx on ambulatory blood pressure, seated automated office SBP, seated
      automated office diastolic blood pressure (DBP), and plasma angiotensinogen (AGT) at each
      scheduled visit in uncontrolled hypertensive participants on ≥ 3 antihypertensive
      medications.
    

Detailed description: 
      This study will be a Phase 2, double-blind, randomized, placebo-controlled study in up to 150
      participants. Participants will be randomized in a 2:1 ratio and will receive a once-weekly
      subcutaneous (SC) treatment with either IONIS-AGT-LRx or matching placebo. The length of
      participation in the study will be approximately 31 weeks, which includes an up to 6-week
      screening period, a 12-week treatment period, and a 13-week post-treatment period.
    

Intervention name(s): IONIS-AGT-LRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses of IONIS-AGT-LRx will be administered by SC injection.; IONIS-AGT-LRx-matching placebo will be administered by SC injection.
Other intervention name(s): ISIS 757456
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Hypertensive; AGT; Angiotensinogen; Blood Pressure
Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We plan to conduct a phase I/II clinical trial using biweekly gemcitabine, oxaliplatin, and
      48-hour infusion of high dose 5-FU/leucovorin to treat patients with advanced pancreatic
      adenocarcinoma. In the phase I part, the maximum tolerable dose of oxaliplatin in combination
      with biweekly gemcitabine 800 mg/m2 and 48-hour infusion of 5-FU 3000 mg/m2 and leucovorin
      300 mg/m2 will be determined. In the phase II part, the efficacy and safety of the biweekly
      chemotherapy with GOFL will be evaluated.
    

Detailed description: 
      For each dose of GOFL chemotherapy, intravenous infusion of gemcitabine at a fixed rate of 10
      mg/m2/min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and
      then a 48-hour intravenous infusion of 5-FU and leucovorin.The starting dose of oxaliplatin
      in the phase I part is 65 mg/m2, with dose increment of 10 mg/m2. Since the recommended dose
      for biweekly single dose oxaliplatin is 85 mg/m2, there will be no further dose escalation of
      oxaliplatin beyond 85 mg/m2.Patients will be entered in cohorts of three.If one out of three
      patients develops DLT, three additional patients will be accrued to the same dose level.9.1.3
      The six patients treated at the MTD dose level will be included in the phase II part of this
      study if only they have measurable lesion(s) prior to chemotherapy.For the phase II part, If
      three or more responders are observed in the initial 21 evaluable patients, the trial will
      proceed to the second stage. Additional 24 patients will be accrued in the second stage of
      the phase II part.
    

Intervention name(s): oxaliplatin; gemcitabine; 5-FU/LV
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic adenocarcinoma; Oxaliplatin; Gemcitabine; 5-FU
Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare the effect of antiviral therapy with entecavir or tenofovir for
      hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included
      patients will randomly divide into two groups.
    

Detailed description: 
      Hepatocellular carcinoma (HCC) is associated with a poor prognosis, and its incidence has
      increased dramatically in many countries. Hepatectomy is a radical therapy for early-stage
      HCC. However, even after radical resection, the prognosis for HCC patients remains
      discouraging because of the high recurrence rate and frequent incidence of intrahepatic
      metastasis. Therefore, preventing HCC recurrence is very important.

      Hepatitis B virus (HBV) infection is the major risk factor for HCC development in China. Some
      retrospective studies have shown that tenofovir or entecavir treatment for HBV-related HCC
      patients can effectively reduce the HCC recurrence rate and increase the survival rate after
      hepatectomy. However, which drug has more efficacy has not been addressed.
    

Intervention name(s): Entecavir; Tenofovir
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be received entecavir (10 mg/d) before liver resection.; Patients will be received tenofovir before liver resection.
Other intervention name(s): ETV
Intervention MeSH terms: Tenofovir; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: adjuvant; entecavir; hepatocellular carcinoma; hepatic resection
A Clinical Study to Assess the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This exploratory, randomized, double-blind, placebo-controlled study aims to explore the
      effect of novel glycans on nitrogen metabolism in the gut in healthy subjects using a stable
      isotope.
    


Intervention name(s): KB195; Polydextrose; Pullulan; Maltodextrin
Intervention type(s): Other; Other; Other; Other
Intervention description(s): KB195 is a novel glycan; Polydextrose is an oligosaccharide; Pullulan is an oligosaccharide; Maltodextrin is a digestible carbohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: microbiome; nitrogen metabolism; Kaleido; Kaleido Biosciences; KB195; Oligosaccharide; Glycan; Microbiome metabolic therapy; MMT
Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery
Condition: Epiretinal Membrane; Cataract Senile
MeSH terms: Vision Disorders; Cataract; Epiretinal Membrane
Study type: Observational [Patient Registry]

Summary: 
      This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge
      vitrectomy and phacoemulsification with intraocular lens implant in patients with
      metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All
      30 patients recruited underwent complete ocular examination, visual acuity measurement with
      ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness
      evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.
    


Intervention name(s): Phacoemulsification, intraocular lens implant, vitrectomy.
Intervention type(s): Procedure
Intervention description(s): Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatient of all gender, with complain of visual impairment and distortion
      
Keywords: Metamorphopsia; Epiretinal membrane; Vitrectomy
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
Condition: Pain
Study type: Interventional

Summary: 
      In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized
      clinical trial to compare the clinical effectiveness of radicular pain relief by either
      acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative
      Sensory Testing (QST).
    


Intervention name(s): Acupuncture; Sham Acupuncture; Gabapentin; Sham Gabapentin
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): In true acupuncture the needles penetrate the skin.; In sham acupuncture the needles do not penetrate the skin.; Gabapentin is a commonly prescribed drug used to treat neuropathic pain.; Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
Other intervention name(s): Neurontin; Benadryl, diphenhydramine
Intervention MeSH terms: Diphenhydramine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Pain; Pain management
Laparoscopic Adrenalectomy for Large Adrenal Tumors.
Condition: Adrenal Tumor; Adrenal Adenoma
MeSH terms: Adenoma; Adrenal Gland Neoplasms; Adrenocortical Adenoma
Study type: Observational

Summary: 
      Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm.
      However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of
      this study was to assess whether the size of the adrenal tumor affects preoperative and
      postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as
      well as to evaluate the learning curve.
    

Detailed description: 
      From April 2010 to October 2018, preoperative and postoperative data of 107 patients who
      underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.

      The inclusion criteria were all hormonally active adrenal lesions, detection of increases in
      size in < 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence
      of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American
      Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified
      suspicion of malignancy on imaging such as local invasion, irregular tumor margins were
      evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery.
      Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the
      study.

      Totally 102 patients were included in the study. The patients were allocated according to
      adrenal tumor size as <6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as
      demographics, tumor size, and laterality, operation time, blood loss, per-operative and
      postoperative complications, length of hospital stay, final pathology result were compared
      between the two groups. In order to evaluate the learning curve, the patients were also
      classified into three consecutive groups including group A (1-25), group B (25-50), group C
      (51-75) and group D (76-102) according to the chronological order of their surgery. Variables
      including operation time, tumor size, blood loss, and hospital stay, and overall
      complications were used to investigate the learning curve.
    

Intervention name(s): Laparoscopic Adrenalectomy
Intervention type(s): Procedure
Intervention description(s): minimally invasive lateral transperitoneal adrenalectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From April 2010 to October 2018, preoperative and postoperative data of 107 patients who
        underwent laparoscopic adrenalectomy
      
Keywords: endocrine surgery; laparoscopic adrenalectomy;
The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery
Condition: Cardiac Disease; High Risk Sex
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational
      study suggested that the cumulative duration of a triple-low state [intraoperative low mean
      arterial pressure (MAP), low bispectral index (BIS), and low target effect-site
      concentration(Ce) ]was associated with poorer 30-day mortality.This randomized, prospective
      study based on individualized Oxygen dynamics is designed to confirm this association in
      high-risk patients cardiopulmonary bypass (CPB).
    


Intervention name(s): mean artery pressure; bispectral index; Brain oxygen saturation; Controlled
Intervention type(s): Procedure; Procedure; Procedure; Other
Intervention description(s): mean artery pressure declined with less than 20% of baseline; BIS 45-60 before and after CPB; and BIS 40-45 during CPB; Brain oxygen saturation declined with less than 20% of baseline; receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
Other intervention name(s): BIS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional group:MAP declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.
Control group：no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: oxygen dynamics; Prognosis
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 After Intravenous Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to measure the effect of OP-101 after being administered intravenously in
      healthy volunteers.
    


Intervention name(s): OP-101
Intervention type(s): Drug
Intervention description(s): Intravenous Injection of OP-101 in healthy volunteers.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adrenoleukodystrophy (ALD); Childhood Cerebral Adrenoleukodystrophy (ccALD); OP-101; Dendrimer; N-Acetyl-Cysteine (NAC)
The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD
Condition: COPD
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of planned inhaler medication training on self-care
      agency and self-efficacy level.
    

Detailed description: 
      Pulmonary diseases are a major source of mortality and morbidity globally. The major symptom
      of COPD is dyspnea. Since dyspnea leads to activity limitation and inadequate self-care
      skills among individuals, it is often associated with major psychological comorbidity, social
      isolation and poor perceived quality of life. COPD patients with high self-efficacy are high
      enough to level of treatment adherence. On the other hand, the most preferred treatment
      method for the management and mitigation of COPD symptoms is by the use of inhaler
      medication. However, incorrect use of the inhaler would lead to failure in the control of
      COPD patients. Also, it fails to provide COPD patients with self-care agency and
      self-efficacy levels. In COPD, planned inhaler medication training has been shown in many
      studies to reduce dyspnoea, increase self-care and self-efficacy levels. Therefore, planned
      inhaler medication training increases quality of life in COPD patients.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): Planned Inhaler Medication Trainning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: COPD; dyspnea; self-efficacy; self-care
Herbal Tonic Fertile Supplement(ZO2C5)
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the effect of mixed herbals drug (citrus,
      citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male
      infertility: oligospermia
    

Detailed description: 
      In the last few years, a marked decrease in the quality of semen has been reported.
      Infertility is one of the major health problems in 10 to 15% of couples' lives; from which
      approximately 50% of couple's infertility is due to Male factors. The aim of the present
      study was to evaluate an herbal mixed effects on spermatogenesis and the normal production of
      sperm. Researchers have reported that using antioxidants and vitamins A, B, C, E, flavonoids,
      Sulfur compounds, terpenoids and phenolic compounds in the daily diet can protect sperm. In
      this study the investigators aimed to assess synergistic effect of these herbal compounds in
      male Infertility. 700 mg tablet for 180 consequence days/daily will be advising, for 40
      patients semen samples in 1th and 180 day after treatment will take, in andrology lab
      according WHO method:samples put into 2 mL of medium (Hams F10) containing 0.5% bovine serum
      albumin. After 5 min incubation at 37oC (with 5% CO), the sperm samples were determined using
      the standard haemocytometric method, and sperm motility was analyzed by microscope (Olympus
      IX70) at 10 field and reported as the mean of motile sperm according to WHO methods . The
      sperm abnormality was evaluated according to the standard method of Narayana .Briefly, smears
      of the sperm suspension were made on clean glass slides and stained with periodic
      acid-Schiff's reaction haematoxylin. The stained smears were observed under a light
      microscopic with 40× magnification. The sperms were classified into normal and abnormal. The
      total sperm abnormality was expressed as percentage incidence. Other biochemical tests will
      be doing according the our research protocol and thesis for blood samples for measure LH,
      Testosterone, TAC, Glc and Cholesterol.
    

Intervention name(s): coated tablet
Intervention type(s): Dietary Supplement
Intervention description(s): this supplement contains 700 mg of 8 natural herbals: Citrus & ZINGIBER OFFICINALE & Onion & Ocimum basilicum & Cinnamomum zelanicum & Citrullus lanatus & Citrullus vulgaris & Daucus carota
Other intervention name(s): Dietry supplement
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: male infertility,oligo spermia
Rotational Stability of the AcrySof® Toric
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To assess the rotational stability and the residual refractive cylinder and patient reported
      outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.
    


Intervention name(s): AcrySof® Toric intraocular lens
Intervention type(s): Device
Intervention description(s): Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cataract
Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants
Condition: Metabolic Syndrome; Insulin Resistance; Hypertension
MeSH terms: Hypertension; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The present study examined the effect of Montmorency tart cherry juice on functional and
      blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants consumed
      Montmorency tart cherry juice or a placebo beverage continuously for 7 days in a randomised,
      crossover trial. Outcome variables were measured immediately prior to supplementation and
      post-supplementation. Furthermore, on the 7th day of supplementation outcome variables were
      measured pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry
      juice would improve cardio-metabolic markers, particularly fasting insulin and systolic blood
      pressure. Furthermore, the study aimed to identify the mechanism of action for any effects of
      Montmorency tart cherry juice on blood pressure.
    


Intervention name(s): Montmorency Tart Cherry Juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
Concentrate contains no sweeteners, preservatives, flavourings or added sugar.; Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Montmorency Tart Cherry; Anthocyanins; Polyphenols; Metabolic Syndrome; Insulin Resistance; Hypertension; Lipid Profile; Prediabetes