bioihbjkbjnl/mcl2 huggingface dataset:
Cardiovascular Health of Older Adults and Resveratrol (CORE)
Condition: Aging
Study type: Observational

Summary: 
      This study will investigate how resveratrol (phenol present in red grapes, wine and peanuts)
      can improve heart muscle function and ability of arteries to dilate in response to an
      increase in blood flow in adults 65 years of age and older. Additionally, investigators will
      look at how resveratrol can improve functioning of cells (cellular house-keeping) which can
      be related to cardiovascular function.
    

Detailed description: 
      Age-related declines in left ventricular function and endothelium-dependent vasodilation
      increase the risk for cardiovascular (CV) disease and premature death in older adults.
      Structural changes to the arterial wall and cardiac muscle are indicated as a cause and
      appear to be induced by age-related oxidative stress and inflammation and reduced levels of
      autophagy, the cellular "house-keeping system". Pre-clinical studies indicate that
      resveratrol (RSV), a polyphenol present mostly in grapes and red wine, may improve left
      ventricular cardiac muscle and endothelial vasodilator function. Although, RSV has been shown
      to induce autophagy and improve CV function in animals, evidence for its effects on the CV
      system in humans is lacking, and there is a need for clinical trials to better understand the
      effects of RSV on CV function in humans. Because older adults are most likely to have
      impairments in the central and peripheral CV systems, they represent an ideal population to
      test the effects of RSV on CV function. Therefore, the central hypothesis is that RSV
      supplementation will improve age-related left ventricular cardiac muscle function and
      arterial vasodilation in older adults (> 65 years). The participants will undergo 90 days of
      RSV treatment (n=12) (1,000mg/day), or (n=12) (1,500mg/day) or placebo (n=12). Before and
      after the intervention, investigators will non-invasively investigate left ventricular and
      arterial vasodilator function. Additionally, investigators will examine cardiac muscle damage
      and inflammatory biomarkers in blood and autophagy and endothelial function protein levels
      and in skeletal muscle to better understand molecular mechanisms that may underlie the
      hypothesized beneficial effects of RSV on cardiovascular health in older adults.
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): In this trial, cardiovascular function will be measured without drug administration. The drug will be administered within the main trial.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Moderately functioning older adults.
The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility
Condition: Cyst Ovary
MeSH terms: Ovarian Cysts
Study type: Interventional

Summary: 
      Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly
      divided into 2 groups according to intervention technique-half will be allocated to the
      bipolar coagulation group and half to the SURGIFLO group.

      Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests
      including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2),
      Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian
      volume and antral follicle count.
    

Detailed description: 
      Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing
      an informed consent, and randomly divided into 2 groups according to intervention
      technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO
      group.

      Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests
      including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian
      volume and antral follicle count.

      Antral follicle count will be performed on the cyst post-surgery using light microscopy. The
      difference in hormone levels, especially AMH reflects the damage done during surgery to the
      ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle
      count also reflect the damage done during surgery to the ovarian reserve.
    

Intervention name(s): Bipolar coagulation forceps (ETHICON inc.); SURGIFLO hemostatic matrix (ETHICON inc.)
Intervention type(s): Device; Device
Intervention description(s): Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.; Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.
Intervention MeSH terms: Hemostatics; Surgiflo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of
      beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical
      onset of disease that persists until 48 months after administration.

      The investigators also hypothesize that in type 1 diabetic patients with recent clinical
      onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18
      and 48 months after administration, based on assessment of clinical and laboratory adverse
      events.
    


Intervention name(s): ChAgly CD3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 days treatment 8mg/d intravenous; 6 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, type 1; ChAgly CD3
Smooth Extubation With Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary
Condition: Smooth Extubation
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      the effect of ketofol, a combination of propofol and ketamine, on hemodynamics and airway
      response during induction of general anesthesia has been studied before. Its effect on the
      smoothness of extubation has not been studied before. In the present study; we aimed to
      assess the effect of ketofol on the smoothness of extubation as regards, airway response,
      sedation score during suction and extubation and hemodynamic changes comparing it with
      propofol for induction of general anesthesia.
    

Detailed description: 
      After securing intravenous access by a 20g catheter, intravenous premedication (midazolam 2
      mg and 4mg ondansetron) was administered to all patients. Standard ASA(american society of
      anesthesiologists) monitoring (5-lead ECG, noninvasive blood pressure (NIBP), and pulse
      oximetry) was applied to all the patients for the recording of heart rate (HR), NIBP and
      oxygen saturation by a multiparameter monitor. Induction of general anesthesia was achieved
      as follows: in Group K (Ketofol group), fifty three female patients received propofol
      (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia while in Group P
      (Propofol group), fifty three female patients received propofol (2mg/kg) only at the
      induction of general anesthesia.

      Patients in both groups received fentanyl 2 ug\kg and atracurium 0.5 mg\kg. After tracheal
      intubation, general anesthesia maintained by isoflurane 1.5 volume % in 2 L\min oxygen-air
      mixture 50:50 and atracurium 0.1 mg\kg every 30 minutes, if needed. At the end of the
      surgery, inhalational anesthesia was stopped and reversal of the patients was done by
      injection of neostigmine 0.05mg\ kg and atropine 0.01mg\kg.

      Hemodynamics (HR and mean arterial pressure ''MAP'') was assessed at 5 minutes interval from
      the time of reversal of muscle relaxant up to 30 minutes after extubation.

      The level of sedation during suction and extubation was assessed using observer assessment
      sedation score and the airway response under direct laryngoscopy to suction was noted by
      five-point scale. After 5 minute interval, the level of sedation and smoothness of extubation
      was noted by four-point scale.
    

Intervention name(s): Ketofol as induction agent; Propofol as induction agent
Intervention type(s): Drug; Drug
Intervention description(s): Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia; Patients who received propofol (2mg/kg) only at the induction of general anesthesia.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ketofol; Propofol; Laparoscopic Drilling of Polycystic Ovary
Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass
Condition: Coronary Artery Occlusive Disease
Study type: Observational

Summary: 
      Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool
      to accurately assess ascending aorta disease. To date, several studies have reported that EAS
      is superior to TEE and surgical palpation
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2001 to December 2011, 2292 patients who underwent isolated off-pump coronary
        artery bypass at Yonsei Cardiovascular Hospital in Seoul
Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement
Condition: Prevention of Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to investigate the effectiveness of iron in the treatment of iron
      deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the
      hemoglobin, hematocrit and iron in serum and assess the course of treatment.
    

Detailed description: 
      The purpose of the study is to investigate the effectiveness of iron in the treatment of iron
      deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the
      hemoglobin, hematocrit and iron in serum and assess the course of treatment
    

Intervention name(s): Iron
Intervention type(s): Drug
Intervention description(s): oral treatment
Other intervention name(s): oral iron
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcome After Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon
Condition: Patella Dislocation
MeSH terms: Joint Dislocations; Patellar Dislocation
Study type: Interventional

Summary: 
      Soft tissue realignment of the tibial insertion of the patella tendon is a simple operative
      technique for treating dislocation of the patella in childhood and adolescence. It is
      performed in children with either recurrent dislocation or complicated primary dislocation in
      cases with malalignment or maltracking of the patella and a lateralised tibial tuberosity. It
      can be performed in patients with open epiphyses. We investigate long-term outcome after this
      procedure.
    

Detailed description: 
      Method. Investigation of the outcome of a relatively new method for centralisation of the
      insertion of the patella tendon in patients with open epiphyses. Using a soft tissue
      technique the patella tendon is released from the tibial tuberosity with the tendon still
      fixed to the distal periosteum. The tibial periosteum is split on the lateral border of the
      tibia distally. Together with lateral release this procedure releases the patella tendon
      which finds a new insertion more medially. Because the tendon is still fixed at the distal
      periosteum no additional fixation is needed and therefore no complications occur at the
      tibial apophysis due to osteosynthetic material. Full weight bearing is possible after 4
      weeks and movement is not restricted.Results. From 1999 to 2004 a total of about 90
      operations in about 80 patients for soft tissue centralisation of the distal insertion of the
      patella tendon were carried out on children and adolescents aged between 10 and 18 years old.
      This study is a retrospective analysis of the outcome after 6 to 10 years. Relevant outcome
      criteria will be evaluated with the occurrence of recurring dislocation, the Lysholm score,
      the Tegner activity scale and subjective measurement with the VAS scale and an additional
      functional outcome score, that we created especially for children. Eventual occurrence of
      growth disturbance or osteoarthritis will be documented be clinical or radiological features.
    

Intervention name(s): Medialising insertion of patella tendon
Intervention type(s): Procedure
Intervention description(s): surgical treatment of medialising tibial tuberosity
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Centralisation; Patella dislocation; Open epiphyses; Malalignment syndrome; Relapse rate
Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series
Condition: Ankle Injuries; Ankle Fractures; Deltoid Ligament; Sprain (Strain) (Ankle); Ligament Rupture
MeSH terms: Fractures, Bone; Rupture; Ankle Fractures; Ankle Injuries; Sprains and Strains
Study type: Observational

Summary: 
      To demonstrate the functional results of patients with ankle fractures operated with
      arthroscopic deltoid repair.
    

Detailed description: 
      Introduction: The diagnosis and treatment of ankle medial ligament lesions in malleolar
      fractures have always been surrounded by controversies. Even in the certainty of deltoid
      involvement and its consequent instability, the direct repair of this structure is not a
      consensus. In recent years, the arthroscopic technique to approach this ligament has been
      described with the objective of potentiating clinical results and minimizing possible
      complications.

      Objective: To demonstrate the functional results of patients with ankle fractures operated
      with arthroscopic deltoid repair.

      Methods: This is a retrospective study in patients diagnosed with ankle fractures associated
      with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic
      repair between January 2018 and January 2020. All patients will fill an epidemiological
      questionnaire and will be evaluated for pain and function according to the Visual Analogue
      Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months
      (6-24 months) average of follow-up.

      Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique
      can improve the clinical outcomes of these patients. Additional studies, with a prospective
      and comparative methodology are required to sustain this proposal.
    

Intervention name(s): Arthroscopic Deltoid Repair
Intervention type(s): Procedure
Intervention description(s): . A 4.5 mm arthroscopic set was used to clean the joint and assess medial and associated injuries. After deltoid injury confirmation through the method already mentioned, the medial gutter was prepared. The ideal positioning for the bone anchor in the medial malleolus followed Vega's recommendations and was located in the inferolateral quadrant created by the intersection of two lines: (1) tibia-talar joint line and (2) tangent line to the medial malleolus joint surface.(14). Sutures were passed respecting the safe zone illustrated by Acevedo at al, at the area between the posterior tibial tendon and the saphenous vein (16-25mm) (15). Sutures were passed but not tightened.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Tertiary/Quaternary hospital patients
Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin,
      5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular
      carcinoma (HCC).
    

Detailed description: 
      In most current guidelines, unresectable HCC with major PVTT are considered not generally
      suitable for transarterial chemoembolization, and sorafenib is recommended as standard
      care.3-5 However, for patients with major PVTT, the median overall survival of those treated
      with sorafenib monotherapy was only 3.1 to 6.0 months.

      Whether combining sorafenib with hepatic arterial infusion (HAIC) of oxaliplatin,
      5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with
      no prospective clinical data currently available.The investigators therefore conducted a
      prospective single center, single-arm phase II trial to evaluate the safety and efficacy of
      sorafenib combined with HAIC in patients with unresectable advanced HCC.
    

Intervention name(s): Hepatic arterial infusion chemotherapy; Folfox Protocol
Intervention type(s): Procedure; Drug
Intervention description(s): administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries; Oxaliplatin , fluorouracil, and leucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic arterial infusion chemotherapy; Sorafenib
Lifestyles and Endothelial Dysfunction
Condition: Healthy
Study type: Observational

Summary: 
      Objectives: To analyze the relationship of physical activity, fitness, energy intake and
      dietary pattern with the circadian pattern of blood pressure, central and peripheral blood
      pressure pulse wave velocity and biological markers of endothelial dysfunction in active and
      sedentary people without atherosclerotic disease.
    

Detailed description: 
      Objectives: To analyze the relationship of physical activity, fitness, energy intake and
      dietary pattern with the circadian pattern od blood pressure, central and peripheral blood
      pressure pulse wave velocity and biological markers of endothelial dysfunction in active and
      sedentary people without atherosclerotic disease.

      Methods:

      Design: Cross- sectional study 1ª step of clinical trial later. Project multicentric with
      seis research groups.

      Subjects: From subjects of PEPAF project cohort, that remain in last control 3105 (1.163
      active and sedentary 1942) and 2346 were excluded for actives. By Random sampling included
      352 subjects who remained sedentary, 588 who have become active and 560 of which were
      excluded for being active in baseline assessment, a total of 1,200. Each of the six groups
      included 250 subjects.

      Measurements: We evaluated height, weight, abdominal perimeter, blood pressure clinic,
      ambulatory blood pressure with Radial pulse wave acquisition device (BPro), central blood
      pressure, (aortic) and Augmentation index with Pulse Wave Application Software (A-Pulse) and
      Sphigmo cor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with Sphigmo cor
      System Px (Pulse Wave velocity), nutritional pattern with a food consumption survey, physical
      activity 7 Par-day questionnaire and the accelerometer (MTI/CSA 7164) and physical fitness
      with cicloergometro (PWC170) and endothelial dysfunction biomarkers (endoglin and
      osteoprotegerin).
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy people 20-80 aged that visit their family doctor and accept be involved in study
        from six Spanish cities
      
Keywords: lifestyles; diet; exercise; central blood pressure; arterial stiffness; endothelial dysfunction; Healthy people
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to compare between efficacy of post-caesarean section infiltration with lidocaine and
      epinephrine versus lidocaine only to reduce post-incisional pain.
    

Detailed description: 
      assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean
      section wound in prolongation of its anaesthetic effect.
    

Intervention name(s): Lidocaine; lidocaine and Epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): •The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.; The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.
Other intervention name(s): local anaesthetic agent.; local anaesthetic agent.
Intervention MeSH terms: Lidocaine; Epinephrine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: incisional; infiltration; cs; lidocaine; epinephrine; Adverse Reaction to Topical or Infiltrative Lidocaine