bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of the Social Factors and Rehabilitation Program to Address the Implications on Kidney Failure in Hail
Condition: Chronic Renal Disease
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The aims of our study to evaluate the effect of social factors and medical rehabilitation
      program on kidney function and quality of life among chronic kidney disease patients.
    

Detailed description: 
      1. This study aims to evaluate the effect of social factors and medical rehabilitation
           program on kidney function and quality of life among chronic kidney disease patients.

        2. Identify the health problems facing patients with kidney failure in Hail region.

        3. Detect the reality of the problems facing patients with kidney failure in Hail region
           and ways to reduce them.

        4. Identify the family, psychological, economic and social problems facing patients with
           kidney failure in Hail region.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): aerobic and resisted ex
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        participants with CKD stages (3 and 4) will be participated in this study, their ages
        ranged from 40 to 60 years. Both sexes will be included.

        Participants should be: Saudi persons living in Hail City, married, both genders,
      
Keywords: Renal failure patients -Saudi community - social program
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and
      pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and
      Moderately Decreased GFR
    


Intervention name(s): MT-3995 Low; MT-3995 High; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MT-3995 Low dose for 8 weeks; MT-3995 High dose for 8 weeks; Placebo for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic
      kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics
      of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel
      orodispersible tablet formulation for the treatment of children, in comparison to the adult
      tablet formulation.
    


Intervention name(s): Finerenone (BAY94-8862): 1 0mg tablet; Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets; Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg finerenone immediate-release tablet; single dose in the fasting condition; 5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition; 1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae
Condition: Enterobacteriaceae Infections
MeSH terms: Bacteremia; Enterobacteriaceae Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The continuous increase in the bacterial resistance rate and the slow arrival of new
      therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by
      stewardship programs to try to change this situation described worldwide is the use of
      antibiotics with the lowest possible antimicrobial spectrum.

      Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The
      empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases
      one or two antibiotics with antipseudomonal activity, being much less common than desirable a
      subsequent change to narrower spectrum antibiotics based on susceptibility data ("de
      escalation"). This is because the safety of de escalation is based only on expert advice and
      some observational studies, so their efficacy and safety is questioned by many clinicians and
      therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane
      Library concluded that randomized studies to support this practice are needed. Investigators
      propose a "real clinical practice-based" randomized trial to compare the efficacy and safety
      of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified
      rule, in patients with bacteraemia due to Enterobacteriaceae.
    


Intervention name(s): Antipseudomonal beta-lactam antibiotic; De-escalation(short-spectrum antibiotic)
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: solution for infusion; Pharmaceutical form: solution for infusion
Other intervention name(s): Ampicillin; Trimethoprim/sulfamethoxazole; Cefuroxime; Amoxicillin/clavulanate; Ciprofloxacin; Ertapenem; Piperacillin/tazobactam; Meropenem; Imipenem; Aztreonam; Ceftazidime; Cefepime
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Ciprofloxacin; Meropenem; Tazobactam; Piperacillin; Clavulanic Acid; Imipenem; Ceftazidime; Ampicillin; Cefepime; Ertapenem; Cefuroxime; Piperacillin, Tazobactam Drug Combination; Lactams; Aztreonam; Amoxicillin-Potassium Clavulanate Combination; beta-Lactams; Antibiotics, Antitubercular; Trimethoprim; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enterobacteriaceae; Bacteremia; Escalation; Bacterial resistance; Bloodstream infection; Recurrence
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System
Condition: Uterine Fibroids; Polyps
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this study is to develop a recommended local anesthetic protocol and
      post-treatment pain management regimen, in order to assure patient comfort during
      office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject
      self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time
      intervals between all treatment groups.
    

Detailed description: 
      Forty subjects will be enrolled in a randomized, controlled study conducted at four physician
      offices or day surgery settings. Subjects will be randomized 1:1 to a local anesthetic group
      (Group #1 or Group #2). Subjects will undergo a hysteroscopic tissue removal procedure to
      remove intrauterine polyps, type 0 fibroids, or type I fibroids. Subsequent to the procedure,
      subjects will be randomized 1:1 within the local anesthetic group to a post procedure pain
      management group (Group A or Group B). Subject self-reported pain scores (as rated on an 11
      point scale)will be compared at three time points: Immediately post procedure, prior to
      discharge from the treatment facility, and at 48 hours post procedure.
    

Intervention name(s): Hysteroscopic Morcellator
Intervention type(s): Device
Intervention description(s): The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.
Other intervention name(s): MyoSure Hysteroscopic Tissue Removal System; MyoSure Tissue Removal Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morcellator; hysteroscope; myomectomy; polypectomy; uterine fibroids; uterine polyps; local anesthetic; cervical block; pain management
The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study
Condition: Postpartum Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To determine whether early placental drainage plus cord traction reduces the incidences of
      manual removal and blood loss, and to determine the risk factors associated with blood loss
      after delivery.
    


Intervention name(s): Placental cord drainage
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vitamin E Versus Placebo for the Treatment of Non Diabetic Patients With Nonalcoholic Steatohepatitis
Condition: NASH (Non-Alcoholic Steatohepatitis)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to
      evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults
      with NASH compared to treatment with placebo in China.
    


Intervention name(s): Vitamin E softgel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).; All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
Height and weight, waist-to-hip ratio Review of diet and exercise
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin E, Non Diabetic
Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Reperfusion Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to
      have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during
      open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue.
      The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.
    

Detailed description: 
      Cardiopulmonary bypass(CPB) can cause lung function deterioration through various mechanisms.
      Lung parenchymal tissue ischemia resulted by pulmonary atelectasis and decreased bronchial
      circulation during CPB is one of the reasons. There were few studies reported that RIPC and
      RIPoCcan benefit lung function of children or infant after CPB, but studies about adults are
      still lacking.

      Purpose:

      The purpose of this study is to evaluate effect of RIPC and RIPoC on the lung function after
      CPB.

      Methods:

      Patients will randomly allocated either in study group or control group. Study group will
      receive RIPC and RIPoC maneuver before and after CPB. Control group will have same automated
      cuff around their arm but it will not activated. Care givers will be blinded whether the
      automated cuff is on or not.

      We will compare pulmonary parameters (PaO2/FiO2, dynamic and static compliances,
      Intrapulmonary shunts, etc.) between study group and control group, and check levels of
      plasma cytokines(IL-4, IL-8, IL-10, TNF-alpha) till 24hr after the operation.
    

Intervention name(s): remote ischemic preconditioning and postconditioning; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): RIPC is done before the use of CPB. It consists of 4 cycles of 5 minutes inflation of pneumatic cuff to 200 mmHg and deflation for 5 minutes. RIPoC is exactly same procedure done "after" CPB.; This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: RIPC; lung protection; ischemic reperfusion injury; cardiopulmonary bypass
Diet and Exercise Intervention in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a worksite-based intensive lifestyle
      therapy intervention (weight loss with exercise training) on blood sugar control in people
      with obesity and type 2 diabetics.
    

Detailed description: 
      The purpose of this study is to conduct a randomized, controlled trial in people with obesity
      and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy
      conducted at the worksite compared to standard care on: i) the major factors involved in the
      pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic
      response to glucose ingestion), ii) body composition; iii) physical function
      (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms
      that can affect insulin action in muscle and adipose tissue (fat).
    

Intervention name(s): Intensive Lifestyle Intervention; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be instructed to consume ~500 kcal/day less than their calculated estimated total daily energy requirements. The supervised exercise program will include both endurance and resistance exercise training sessions. The doses of diabetes medications will be adjusted by study physicians every 1-2 weeks, as needed to avoid hypoglycemia.; After receiving dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines participants will meet approximately every month for about 7 months with a study team member to record body weight, review diet and physical activity behaviors, and document medication use. Participants will continue their routine medical management, including regular clinic visits with their personal physician and/or diabetes educator during their participation in this study. Any changes medications will made by the participants' personal physician(s).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Exercise; Weight loss
Dexamethasone for Post Cesarean Delivery Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when
      used as part of a multimodal regimen to manage post cesarean delivery pain.

      We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal
      analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid
      consumption and pain
    

Detailed description: 
      After the subjects consent to participate in the study they will be transferred to the
      operating room for their scheduled cesarean delivery. They will have their routine spinal
      anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage
      hypotension. After delivery of the baby the subjects will be administered either the study
      drug or placebo depending on the randomization. The subjects will then be prescribed a
      standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and
      48 hours post cesarean delivery. During the interview the subjects will be asked to rate
      their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality
      of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be
      contacted 6 months after the study to rate their pain using a Short-Form McGill Pain
      Questionnaire
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Decadron; Normal saline
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cesarean delivery; Analgesia; Pain; Dexamethasone; intrathecal morphine; spinal anesthesia
A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety
      of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when
      co-administered with montelukast in patients with inadequately-controlled asthma. Patients
      will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.
    

Detailed description: 
      This is a multi-centre, randomised, placebo-controlled, double blind, parallel group 3-arm
      study (including montelukast as an active comparator) designed to compare the efficacy and
      safety of a once daily dose of ADC3680 with placebo in subjects with inadequately-controlled
      asthma despite receiving a low to moderate dose of an ICS controller therapy, over a 10 week
      treatment period. At the end of the 10 week treatment period open label montelukast (10 mg)
      will be added to ADC3680 and placebo arms for a two week extension period to assess whether
      efficacy of ADC3680 is enhanced by the addition of montelukast compared with montelukast
      alone. The montelukast arm will continue with 10 mg montelukast alone.
    

Intervention name(s): ADC3680; Placebo; montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period; Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period; montelukast for 12 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the tolerability of a combined regimen of a topical
      antibiotic and retinoid and a benzoyl peroxide wash.
    


Intervention name(s): CTGel/ BPO Wash; Soap Free Cleanser and CTGel
Intervention type(s): Drug; Drug
Intervention description(s): Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days
Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.; Soap Free Cleanser will be used once daily in the morning for 28 days
Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.
Other intervention name(s): Veltin; Veltin
Intervention MeSH terms: Clindamycin, tretinoin drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne Vulgaris
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
Condition: Hypertension; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the long-term safety and tolerability profile of
      valsartan and valsartan-based treatments in children with hypertension, with or without
      chronic kidney disease.
    


Intervention name(s): Valsartan; amlodipine; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily; added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose; added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
Other intervention name(s): VAL489; HCTZ
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, pediatric; Hypertension with or without chronic kidney disease
Biomarkers in Thoracic Aorta Surgery
Condition: Aortic Aneurysm; Thoracoabdominal Aneurysm; Aortic Dissection; Complication
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Dissection
Study type: Interventional

Summary: 
      Biomarkers can play a vital role in prognosing the perioperative complications in thoracic
      aorta surgery. The goal of a study is to determine the correlation between intraoperative
      level of certain biomarkers and total amount of peroperative complications.
    


Intervention name(s): blood sample tests for determination of biomarkers levels
Intervention type(s): Diagnostic Test
Intervention description(s): Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science