bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Tolerance Evaluation of an Anti-age Food Supplement
Condition: Moderate-severe Skin Aging/Photoaging
Study type: Interventional

Summary: 
      Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled
      Clinical Study Versus Untreated Group
    

Detailed description: 
      Aim of the study was to evaluate the anti-age activity of "Pre-Hyaluron 465 Innēov" a food
      supplement, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA
      synthesis (manganese), taken for 4 consecutive months by female subjects aged 35-60 years
      (with preference for subjects over 45 years), with moderate-severe skin aging/photoaging
      according to a reference photographic scale.

      The study foresaw the evaluation of the study product activity versus a control group,
      untreated.
    

Intervention name(s): Pre-Hyaluron 465 Innēov
Intervention type(s): Dietary Supplement
Intervention description(s): Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Closing the Loop in Adolescents During Non-compliance Behaviours
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The ultimate goal of the investigators ongoing research is the development of a closed-loop
      system for insulin delivery, which can help people with type 1 diabetes (T1D) attain a tight
      glucose control avoiding the risk of hypoglycaemia. The main components of the system are a
      continuous glucose monitor (CGM), an insulin pump and a computer-based 'model-predictive
      algorithm', which computes the amount of insulin to be given by the insulin pump according to
      the CGM values. In the studies performed thus far the efficacy and safety of closed-loop
      glucose control was evaluated both overnight and over a prolonged period of time including
      the day-time in children and adolescents with T1D. The results showed that closed-loop
      improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the
      conventional insulin pump therapy.

      The objective of the current study is to test the performance of closed-loop further, by
      evaluating the system during common non-compliant behaviours in the administration of meal
      insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use of
      closed loop systems to control glucose levels in T1D under various "real-life mimicking"
      common circumstances. The present study adopts an open-label, randomised, 2 period cross-over
      design whereby closed-loop insulin therapy will be compared with the conventional insulin
      pump therapy in 12 adolescents with T1D.

      Participants aged 12 to 18 years will be randomised for two 24 hour studies in a clinical
      research facility, during which glucose levels will be controlled by either the
      computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump
      therapy (control arm). On both occasions, participants will under-estimate and omit the
      meal-related insulin dose for the evening-meal and lunch, respectively. The study will take
      place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants
      recruited from paediatric diabetes clinics in England.
    


Intervention name(s): Closed-loop; standard insulin pump
Intervention type(s): Device; Device
Intervention description(s): Subcutaneous insulin delivery will be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings; Subcutaneous insulin delivery will be administered according the standard insulin pump settings
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closed-loop insulin delivery; Non-compliant behaviours during adolescence
Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome
Condition: Healthy; Medial Patellofemoral Ligament Reconstruction
Study type: Observational

Summary: 
      The purpose of this retrospective study was to determine the accuracy of femoral tunnel
      placement utilizing Redfern et al's radiographic method for anatomic femoral attachment
      during MPFL reconstruction in addition to the resultant outcome.
    

Detailed description: 
      Reconstruction of the medial patellofemoral ligament (MPFL) has been shown to be an effective
      treatment for recurrent patellar instability, There has been some concern in the literature
      about the accuracy of femoral tunnel placement and the effect that it might have on patient
      outcomes.

      The investigators evaluated the accuracy of MPFL placement using an intraopetative
      fluoroscopy technique and to assess subsequent patient outcomes.

      All patients undergoing MPFL reconstruction using an intraoperative fluoroscopically guided
      technique between 2005 and 2010 were identified. A retrospective review of their charts and
      radiographs were performed and the subjects were brought back for a follow up exam,
      radiographic series, and Kujala questionaire.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A single surgeon experience beginning in 2005 with patient's undergoing MPFL reconstruction
        using intra-operative fluoroscopy for proper placement of the femoral tunnel.
The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
Condition: Remote Ischemic Conditioning
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of serial remote ischemic conditioning
      on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
    

Detailed description: 
      Remote ischemic conditioning(RIC) is the phenomenon whereby brief cycles of ischemia and
      reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic
      cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been
      proved to be critical for the occurrence,development and prognosis of ischemic neurovascular
      disease. In this study, we hypothesis that RIC provides neuro-protection by means of
      improving dCA.
    

Intervention name(s): BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China; Intravenous blood collection; dCA measurement
Intervention type(s): Device; Procedure; Device
Intervention description(s): The RIC consisted of 4 cycles of extremities ischemia (5-minute blood pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm. This intervention was undertaken twice a day for 7 days.; Nurses will collect intravenous blood 3ml four times (at baseline and the first, seventh and eighth day of the study).The blood samples will be stored for laboratory test.The blood samples only use for the trial.; Serial measurements of dCA were performed at 10 days, baseline, 1st, 2ed, 4th, 7th, 8th, 10th, 14th, 21th and 35th of the study.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Remote Ischemic Conditioning; Dynamic Cerebral Autoregulation
Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial
Condition: Healthy
Study type: Interventional

Summary: 
      Objectives

      Main objective: Assessing the effectiveness of the health workshops, in terms of quality of
      life.

      Secondary: To determine the effectiveness of the health workshops in relation to: Increase
      knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced
      diet. Incorporate and maintain regular physical activity; Keep variables related to risk
      factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To
      estimate costs.

      Methodology

      Design: randomized controlled trial comparing a group of patients who performed the health
      workshops with a control group with similar characteristics.

      Scope of the Study: The study was conducted in 54 health centers of Barcelona city.

      Subjects of study: general population between 18 and 65 years who consent to. 188 people with
      speech (have conducted workshops for health) and 188 people without (not made health
      workshops. Data Analysis: T- test to compare the differences between quantitative variables
      or equivalent non-parametric if the distribution of the variable does not meet criteria of
      normality (Kolmogorov-Smirnov).
    

Detailed description: 
      This is the evaluation of an educational activity to promote health in the general population
      in order to establish healthy habits and changes in quality of life.

      We have designed a proposal for a workshop aimed at general public health which includes
      biological, psychological, social, cultural and spiritual health related and welfare. It is
      structured in 12 sessions that will provide tools that facilitate the involvement of people
      in maintaining their health.

      Content of the sessions: Breathing and Snuff. Food. Disposal. Physical activity. Sleep and
      rest. Appropriate clothing. Hygiene. Avoid danger. Communicate feelings and emotions. Feel
      useful. Recreational activities. Each participant is given a folder and at the end of each
      session a summary sheet of the same with the aim that at the end of the course have a
      reference material.

      To validate this material is piloted with the participation of 13 persons. Participants
      completed the SF36 questionnaire at the beginning and end of the workshop.
    

Intervention name(s): health workshops
Intervention type(s): Behavioral
Intervention description(s): health workshops in relation to: Increase knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced diet. Incorporate and maintain regular physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: general population
International EXPAND Lung Pivotal Trial
Condition: Lung Transplant
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess
      donor lungs that may not meet current standard donor lung acceptance criteria for
      transplantation.
    

Detailed description: 
      The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet
      current standard donor lung acceptance criteria from one or more of the following
      characteristics:

        -  Donor PaO2/FiO2 ≤ 300 mmHg; or

        -  Expected ischemic time > 6 hours; or

        -  Donor after Cardiac Death (DCD donor); or

        -  Donor age ≥55 years old
    

Intervention name(s): OCS Lung Preservation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung transplantation; lung preservation; breathing lung transplant
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of topic ketorolac in
      treatment for center point thickness secondary to panphotocoagulation in proliferative
      diabetic retinopathy.
    

Detailed description: 
      Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3
      to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in
      the long term. Nonetheless, it induces macular thickness that delays the conclusion of the
      treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit
      additional photocoagulation.

      Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and
      produce early benefits in the patient.
    

Intervention name(s): Ketorolac tromethamine; Polivynilic alcohol
Intervention type(s): Drug; Drug
Intervention description(s): Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation; Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
Other intervention name(s): Godek; Acuafil
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: proliferative diabetic retinopathy; macular edema; panphotocoagulation; topic ketorolac; efficacy; treatment
Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine that six 2-mg tablets of perampanel are
      bioequivalent to one 12-mg tablet of perampanel.
    


Intervention name(s): Perampanel; Perampanel
Intervention type(s): Drug; Drug
Intervention description(s): 6 x 2 mg perampanel once per day; 12 mg perampanel once per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Central Nervous System
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a
      Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
    

Detailed description: 
      NOTE: Detailed description has not been entered.
    

Intervention name(s): Multivalent; 13vPnC
Intervention type(s): Biological; Biological
Intervention description(s): Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Other intervention name(s): Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic a Single Day of Dosing With GSK1614235.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A single blind, randomized, placebo-controlled, dose escalating study to evaluate the safety,
      tolerability, pharmacokinetic and pharmacodynamic parameters of repeat doses of GSK2330672 in
      healthy volunteers, given alone and with a single day of dosing with GSK1614235
    


Intervention name(s): GSK2330672; Placebo; GSK1614235
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BID, repeat doses; BID, repeat doses; BID, co-dosed BID with last dosing day of active/placebo repeat doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pharmacokinetic; intestinal bile acid transporter inhibitor; GSK2330672; pharmacodynamic; GSK1614235; dose escalation
Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy
Condition: Colonoscopy; Colon Adenoma; Colorectal Neoplasms; Inflammatory Bowel Diseases; Colon Disease
MeSH terms: Adenoma; Colorectal Neoplasms; Inflammatory Bowel Diseases; Colonic Diseases
Study type: Interventional

Summary: 
      Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy
      quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel
      preparation.

      The role of diet in preparing for colonoscopy is not fully established. Currently there is
      not enough evidence available to choice between 3 days of low residue diet versus 1 day.

      The research hypothesis is that the low residue diet offers a non-inferior bowel preparation
      and an improved tolerance.
    


Intervention name(s): 1 day low residue diet; 3 day low residue diet
Intervention type(s): Other; Other
Intervention description(s): Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.; Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.
Other intervention name(s): low fiber diet; low fiber diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: bowel preparation; low residue diet; colonoscopy
Acute Effects of Foam Rolling on Viscoelastic Tissue Properties and Fascial Sliding
Condition: Fascia; Self-Myofascial-Release; Passive Stiffness; Fascial Sliding; Flexibility
Study type: Interventional

Summary: 
      Treatment or training of fascial tissues has moved into the focus of medical research in the
      last decade. In this context, the use of foam rollers or roller massagers for
      self-myofascial-release (SMR) techniques has become increasingly popular in health and
      fitness professionals. The primary objective of these techniques is to mimic manual massage
      or myofascial-release therapy with a self-usable tool. Recent studies suggest that SMR
      improves, inter alia, range of motion (ROM) without a decrease in neuromuscular performance
      (Cheatham et al. 2015).

      Concurrent effects on the muscle and especially the surrounding connective tissue network
      have been proposed as underlying mechanisms for these observed changes in ROM after SMR.
      Several authors assume a positive effect of SMR on sliding properties of different
      independent fascial layers. Also, changes in passive tissue stiffness is suggested. Passive
      stiffness is thereby characterized by passive resistance in the tissues' (muscles')
      functional direction, the passive resistive torque (PRT).

      In conclusion, for many of the proclaimed effects of SMR, such as improvements of sliding of
      fascial layers or decreases of passive stiffness, there is a lack of evidence in the
      literature. Therefore, the aim of the study is to evaluate acute effects of SMR on the
      viscoelastic properties of the muscles on the anterior thigh and the corresponding fascia.

      In a cross over design, 16 subjects receive all of the following interventions after a
      familiarization session: a) 2x60 seconds of SMR at the anterior thigh, b) 2x60 seconds of
      static stretching at the anterior thigh, c) no intervention in a balanced permutated
      randomization sequence. Before and directly after each intervention, outcome parameters are
      collected.

      Passive Resistive Torque is evaluated using a computerized isokinetic dynamometer. In passive
      mode, the lower leg is moved from full knee extension (0°) to the point of maximal knee
      flexion with a velocity of 5°/s. Torque and angle are recorded at 100 Hertz (Hz). Sliding of
      fascial layers is quantified with a frame-by-frame cross correlation algorithm of
      high-resolution ultrasound images (Dilley et al. 2001).

      First stretch sensation is quantified using the passive mode in the isokinetic dynamometer.

      Maximal ROM is detected using a an ultrasonographic movement analysis system in a prone
      position.
    


Intervention name(s): Self-Myofascial-Release; Stretching
Intervention type(s): Other; Other
Intervention description(s): Self-Myofascial-Release performed at the anterior thigh; Static Stretching performed at the anterior thigh
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment