bioihbjkbjnl/mcl2 huggingface dataset:
Implications of Stress Management Program
Condition: Chronic Conditions, Multiple
MeSH terms: Disease; Chronic Disease; Multiple Chronic Conditions
Study type: Interventional

Summary: 
      Previous studies indicated that patients with diabetes mellitus and hypertension had higher
      level of perceived stress, used maladaptive coping strategies and poor health-related quality
      of life. Therefore, stress management program was applied to reduce their perceived stress,
      improve their coping strategies, improve their health-related quality of life and
      psychological health of the patients with type 2 diabetes mellitus and hypertension in
      current study. The main objectives of the current study were to observe the effects of stress
      management program on perceived stress, coping strategies and health-related quality of life
      using pre-experimental research design. Patients with diabetes mellitus type 2 and
      hypertension were selected through purposive sampling technique to apply the eclectic
      approach of the stress management program. Total 110 patients with type 2 diabetes and
      hypertension completed the program from 114 patients who gave inform consent for
      participation in the first session. Perceived stress scale, WHOQOL and Coping strategies
      questionnaire were administered at the pre and post-levels of the program. Further, base line
      of targeted domains variables was also filled from the participants at pre, mid and
      post-levels to access the efficacy of the program which was formulated according to previous
      research data by the researcher. The stress Management program consisted of 10 session which
      were delivered to eight groups (diabetic and Hypertensive) in five weeks. Each session had
      the duration 90 minutes and two sessions were conducted in one week.
    


Intervention name(s): Stress Management Program
Intervention type(s): Behavioral
Intervention description(s): Stress management program includes different techniques such as relaxation technique, psycho-education, laughing, emotional freedom technique, referenting, cognitive restructuring, rational emotive imagery, time management, anger management, assertiveness and social support
Intervention model: Single Group Assignment
Intervention model description: The patients with chronic conditions which included type 2 diabetes and hypertension were selected through purposive sampling technique
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Hypertension; Chronic Condition; Stress Management Program; Perceived Stress; Coping Strategies
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Condition: Muscular Dystrophies
MeSH terms: Muscular Dystrophies
Study type: Interventional

Summary: 
      This is a study to determine whether albuterol or oxandrolone, alone or in combination, are
      able to increase strength and muscle mass in patients with FSHD. It also will determine if
      albuterol given in "pulsed" fashion will have more effect than when given continuously.
    

Detailed description: 
      Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both
      pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable
      side effects occur. Patients will undergo testing of muscle function. All patients will
      return for follow-up assessments at Weeks 4, 12, 26, and 52.
    

Intervention name(s): Albuterol; Oxandrolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Albuterol; Oxandrolone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Muscle Weakness, Muscular Dystrophy
Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
Condition: Hemodynamic Instability
Study type: Interventional
Phase: Phase 2

Summary: 
      Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult
      in some situations and need to be confirmed with other investigations.

      Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness
      to fluid filling maneuver in patients with hemodynamic instability.
    

Detailed description: 
      Vascular filling represent the milestone of the treatment of hypovolemia. Its main objective
      is to restore vascular volume and correct perfusion issues preventing the deleterious
      consequences of prolonged shock.

      Hypovolemia diagnosis is easy to made in obvious clinical situations such as hemorrhagic
      shock, deshydratation..., but there still many diagnostic difficulties regarding latent
      hypovolemia especially if associated with left ventricular dysfunction.

      In this situations, diagnostic of hypovolemia is hard to made and other investigations are
      needed.

      Central venous pressure (CVP) and pulmonary occlusion artery pressure (PAPO) are the mainly
      used parameters for indicating vascular filling but actually many studies underline their low
      liability in this situation.

      After vascular filling, outcome measurment is needed to evaluate the efficacity of the
      treatment.

      Outcome measurment based on hemodynamic criteria is still insufficient. In fact, tissue
      hypoxia persists if the cardio - respiratory system did not adapt to the metabolic needs,
      that's why a pathway based on therapeutic objectives like venous oxymetry is needed.

      Theorically, a filling maneuver is beneficial if associated with a ScvO2 amelioration. It
      reflects the amelioration of cardiac output and predicts the positive responsivness to the
      filling test.
    

Intervention name(s): Sodium Chloride 0.9% Intravenous
Intervention type(s): Drug
Intervention description(s): vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN
Condition: Healing Wound
Study type: Interventional
Phase: Phase 3

Summary: 
      Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing
      salivary levels of bone markers, OPN and BMP-2.
    

Detailed description: 
      objectives of study: To study the effects of ziziphus honey on bone healing of extracted
      tooth socket in humans by comparing 1) Levels of BMP-2 and OPN in experimental and control
      groups at different intervals and 2) By radiographically measuring RBD of extraction sockets
      in experimental and control groups.

      Aim of study: Post extraction ridge resorption is a major concern for future tooth prosthesis
      or implant placement. Honey can possibly help to improve bone healing and minimize ridge
      resorption after extractions.

      Materials and Methods: Randomized controlled trial with simple random sampling of healthy
      individuals will be done. Total number of 30 participants will be equally divided into
      experimental group and control group. After tooth extractions in both groups, ziziphus honey
      will be injected into extracted sockets of experimental group while control group will be
      left as it is. Levels of BMP-2 and OPN will be tested in saliva through ELISA technique at
      day 0, 3 and 7 of tooth extraction and RBD will be measured on periapical radiographs at day
      3, 21 and 40 in both groups.

      Keywords: Bone morphogenetic protein-2 (BMP-2), Osteopontin (OPN), Relative bone density
      (RBD), Enzyme linked immunosorbent assay (ELISA).
    

Intervention name(s): ziziphus honey
Intervention type(s): Drug
Intervention description(s): ziziphus honey obtained form ziziphus spina-christi trees also called sidr tree
Other intervention name(s): sidr honey; honey
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial with simple random sampling technique
Masking: Single (Participant)
Primary purpose: Supportive Care
Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia
Condition: Postoperative Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between
      the epidural and continuous wound infusion techniques.
    

Detailed description: 
      The analgesic requirements and pain scores postoperatively differ between the epidural and
      continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.
    

Intervention name(s): Epidural analgesia; Continuous wound infusion
Intervention type(s): Other; Other
Intervention description(s): Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly; Continuous wound infusion via catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidural analgesia; continuous wound infusion; ropivacaine; total abdominal hysterectomy
Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of the present study is to explore the efficacy of small doses of oral
      glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and
      improving the prognosis of patients.
    

Detailed description: 
      In order to explore the efficacy and safety of oral glibenclamide on brain edema after acute
      primary ICH, a web-based 1:1 randomization process will be employed to assign 220 subjects to
      Glibenclamide group (giving standard management for ICH plus glibenclamide) or Control group
      (giving standard management for ICH). The investigators will make a neurofunctional
      assessment at baseline, and 3 days, 7 days, 90 days after enrollment. The investigators also
      assess the midline shift, and the change in the volume of ICH and perihematomal edema (PHE)
      from the initial to follow-up (3 days and 7days after enrollment). The serious adverse events
      of all-cause mortality, cardiac-related and blood glucose-related adverse events will be
      collected to assess the safety of glibenclamide.
    

Intervention name(s): Glibenclamide Tablets; Standard management for ICH
Intervention type(s): Drug; Other
Intervention description(s): Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.; Usual care and drug in hospital
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intracerebral hemorrhage; Perihematomal edema; Disability; Clinical trial
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
Condition: Liver Transplantation
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aimed to present our experience in treating recurrent HCV genotype 4 infection post
      living donor liver transplantation (LDLT) since introduction of the second generation direct
      acting antiviral drugs (DAAs) in Egypt.
    

Detailed description: 
      This was a cohort study conducted in patients who had undergone LDLT for HCV related disease
      from 2014 to 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .The hypothesis
      early initiation of DAAs( after 12 weeks of the operation ) is effective and safe strategy in
      transplant recipients following LDLT. Patients who take the sofosbuvir and ribavirin after 6
      months after transplantation were compared with those who take early treatment after 3 months
      of transplantation with sofosbuvir and daclatsvir+/- ribavirin..Patients were on regular
      follow up visits monthly to assess the clinical condition, any side effects, laboratory tests
      including complete blood picture, liver functions , renal functions and trough level of
      immunosuppressant drugs.
    

Intervention name(s): treatment of HCV with oral direct acting antiviral therapy
Intervention type(s): Drug
Intervention description(s): A total number of 89 patients transplanted for HCV genotype 4 related end stage liver disease Were included in this study 53 PATIENTS were treated after 6 months of transplantation with sofosbuvir 400mg and weight based ribavirin for 24 weeks. 7 patients were treated with sofosbuvir 400mg + simeprevir 150 mg + weight based ribavirin for 12 weeks after 6 months post transplant. In September 2015, we started to adopt early treatment strategy for all recipients after the first 3months post- transplant. 26 recipients were treated with sofosbuvir 400mg+Daclatasvir 60mg ± weight based ribavirin for 12 weeks or 24 weeks. 2 recipient are treated with sofosbuvir 400mg + ledipasvir 90mg for 24 weeks and one recipient is treated with fixed-dose combination of ombitasvir (12.5 mg), paritaprevir (75 mg) and ritonavir (50 mg) + weight based ribavirin due to having persistent renal impairment post transplantation.
Intervention MeSH terms: Antiviral Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Discrepancies Between Patients and Physicians in Their Perceptions of Rheumatoid Arthritis Disease Activity
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA)
      disease activity, as quantified by the patient's global assessment (PGA) and by the
      evaluator's global assessment (EGA).

      The objectives of this study were:

        1. to explore the extent and reasons for the discordance between patients and physicians in
           their perception of RA disease activity

        2. to determine if this discordance at baseline is associated with RA outcomes at 1 year
           (remission, function and structure) in early arthritis (EA) in daily clinical practice.

             -  Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2
                swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR
                criteria for RA at baseline

      Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed.
      Multivariate linear regression was used to determine the patient and EA features
      independently associated with discordance (calculated as PGA - EGA). Logistic regression was
      used to analyze discordance as│PGA - EGA│≥20.

      Multivariate logistic models were used to determine if discordance at baseline is associated
      with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25)
      and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        from the south of France (Nîmes, Montpellier, Toulouse, Bordeaux, Limoge), fulfilling the
        ACR-EULAR criteria for RA
Comparison Of Two Tablet Formulations Of SB-568859
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-568859 is a medication that is being developed for the treatment of atherosclerosis
      (hardening of the arteries). The purpose of this study is to see if there is a difference in
      how the human body takes up the study drug depending on how the study drug is made. This
      study will compare SB-568859 tablets that are made in 2 different ways. This is not a
      treatment study.
    


Intervention name(s): SB-568859
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: unmilled formulation,; micronised formulation; relative bioavailability,
Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of Amaryl when added to
      Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM)
      patients.
    


Intervention name(s): Glimepiride
Intervention type(s): Drug
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Condition: Obesity; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether treatment of children and adolescents with
      Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin
      sensitivity and glucose tolerance.
    

Detailed description: 
      Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence
      in obese children and adolescents with marked obesity. This condition tends to progress to
      Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of
      childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in
      this population set the stage for a series of studies aimed at understanding the metabolic
      phenotype and natural history of pre-diabetes in obese youth. The investigators found that
      obese children and adolescents with IGT are characterized by marked insulin resistance
      related to altered lipid partitioning, favoring lipid deposition in the visceral and
      intramyocellular compartment. Furthermore, the investigators found an impairment of the acute
      insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to
      frank diabetes. Based on these studies, there is a strong rationale for changing the balance
      between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in
      order to improve insulin sensitivity.

      The primary objective of this study is to determine, in a group of ethnically diverse
      children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements
      in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether
      rosiglitazone is safe and well tolerated.
    

Intervention name(s): Rosiglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2mg to begin then 4mg, twice daily for 4 months; Subject receives placebo.
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Childhood and Adolescent Obesity; Metabolic phenotype; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus; Insulin Sensitivity; Insulin Resistance; Abdominal fat partitioning; Impaired Glucose Tolerance (IGT); Type 2 Diabetes Mellitus (T2DM)
AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
Condition: Healthy; Postmenopausal; Surgically Sterile Women
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to investigate the pharmacokinetics of AZD1981 given in different
      formulations and to measure renal clearance
    


Intervention name(s): AZD1981; AZD1981; AZD1981; AZD1981
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg iv infusion, single dose, 4 hours infusion; 514 mg oral solution, single dose; 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose; 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Serum Lactate Trend in Liver Resection
Condition: Lactase Persistence
Study type: Observational

Summary: 
      The study aimed to evaluate the correlation between the serum lactate concentration ed
      cumulative Pringle time after liver resection. In addition, the correlation between lactate
      clearance and clamping time was investigated.
    

Detailed description: 
      During liver resection high serum lactate (sLac) concentration can be related to several
      clinical factors: impairment in lactate metabolism (i.e. extraction and utilization by the
      liver) or overproduction by splanchnic tissues; restrictive fluid regimen in order to limit
      the intraoperative back-flow bleeding; ischemia-reperfusion syndrome. However, the Pringle
      maneuver (temporary clamping of the hepatic hilum) seems having a sensible effect in inducing
      a significant increase in sLac levels during liver resection, particularly in the event of
      compromised liver function such as in cirrhosis.

      Although the peak of sLac concentration may correlate with outcome, the lactate clearance
      (cLac) seems to be a better predictor. To date, this relationship has been mainly
      demonstrated in severe sepsis and shock septic. However, the effective correlation between
      the cumulative clamping time and cLac has not been clearly investigated. The correlation
      between cumulative hepatic ischemic time and sLac trend in the perioperative period after
      liver resection with intermittent PM was investigated.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        133 consecutive patients scheduled for liver resection for primary and secondary tumors