bioihbjkbjnl/mcl2 huggingface dataset:
A Physiological Profile of Recovery From Resistance, Endurance, and Mixed Exercise Types
Condition: Sports Nutritional Sciences
Study type: Interventional

Summary: 
      The aim of this study to increase understanding of physiological and functional perturbations
      following a continuum of exercise stressors.
    

Detailed description: 
      This study utilised a between groups design, with a within-groups control. This allowed the
      within-subject profiling of recovery during both a control and exercise week. This design
      also allowed each group to perform an ecologically valid exercise session as well as having
      markers of recovery tailored to the areas of interest specific to each cohort. By having each
      group perform a non-exercise control week, this gives valuable information on the reliability
      and smallest worthwhile change for a range of both novel and commonly used recovery markers.
    

Intervention name(s): Resistance exercise weight training session; High-Intensity stochastic cycling session; Simulated Team sport protocol
Intervention type(s): Other; Other; Other
Intervention description(s): A resistance exercise session was performed. Following a warm-up that consisted of five-minutes cycling at a self-selected intensity, as well as three progressive lifts at 50, 75, and 90% 6 rep max (RM), participants performed four sets of six repetitions at 100% of 6RM (as determined by the maximal weight lifted during the maximal strength assessment) of the following lifts; back squat, front squat, good mornings, and Bulgarian split-squat. Two minutes rest was afforded between sets and exercises.; A high-intensity stochastic cycling session was performed. The cycling protocol was performed using a magnetically-braked cycle ergometer (Velotron, RacerMate). Following a 10 minute standardised warm-up including 3 × 3s sprints, participants completed a simulated road-race, consisting of sprints of varied length, differing work to rest ratios and short time-trials.; A simulated team sport protocol was performed. Participants performed a standardised warm-up consisting of performing three laps of the circuit jogging, and three laps at 50, 75, and 90% of perceived maximal speed. Participants were then afforded five minutes to perform self-selected stretching prior to commencing the session. Participants performed two sets of 45 minutes of the simulated team sport protocol, separated by 15 minutes rest. Each 45 minute period consisted of a one minute circuit repeated 45 times that replicates typical movement patterns observed during team sports and includes walking, jogging, jumping, sprinting, agility, and decelerations. Each circuit was initiated on the minute, therefore enabling participants to rest following the completion of each circuit. Pilot testing showed participants completes each circuit in approximately 48-55 seconds (sec) therefore enabling 5-12sec rest after each circuit.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Paliperidone Palmitate in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within
      three different group of schizophrenia patients.
    

Detailed description: 
      In this study, the investigators are going to examine the effectiveness of paliperidone
      palmitate after changing from other antipsychotics. This study design is a Prospective
      Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within
      three different groups of schizophrenia. Investigators would also assess the safety during 24
      weeks follow up period.
    

Intervention name(s): paliperidone palmitate
Intervention type(s): Drug
Intervention description(s): paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)
Other intervention name(s): paliperidone palmitate(sustenna)
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Injection; Switch; Paliperidone; refractory, chronic akathisia, poor complianc
Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns
Condition: Hemodynamics
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      To investigate the effect of goal-directed hemodynamic management on perfusion and short-term
      prognosis of patients undergoing scab grafting in early stage of extensive burns.
    

Detailed description: 
      Objective: To investigate the effect of goal-directed hemodynamic management on perfusion and
      short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.

      Methods: Ninety-five patients with extensive burns undergoing early debridement grafting were
      randomly divided into a standard hemodynamic management group (control group) and a
      goal-directed hemodynamic therapy group (GDHT group), with the control group guided by
      conventional parameters and the GDHT group guided by SV based on Vigileo. The primary outcome
      were incidence of cardiac complications, pulmonary complications, neurological disease, acute
      kidney injury, and pain within 7 days postoperatively. Secondary outcome included
      microcirculatory perfusion metrics: Lactate (lac), The central venous-arterial carbon dioxide
      partial pressure difference (Pcv-aCO2).
    

Intervention name(s): Goal-directed hemodynamic therapy
Intervention type(s): Procedure
Intervention description(s): Compounded sodium lactate 3 ml/kg/h was given intravenously as a basal rehydration volume before induction, and 200 ml of electrolyte solution was given after induction. If SV increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but mean arterial pressure (MAP) <65 mmHg and/or cardiac index (CI) <2.5l/min/m2 give low-dose norepinephrine continuous pumping and/or dobutamine continuous pumping. If hypotension was accompanied by hypovolemia (defined as urine output <0.5 ml /kg/h and/or heart rate more than 20% above baseline), plasma was administered until urine output and/or HR returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors
Condition: Malignant Solid Tumour
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is the efficacy of autogenic and allogenic natural killer (NK)
      immunotherapy on recurrent solid tumors.
    

Detailed description: 
      By enrolling patients with multiple kinds of solid tumor adapted to enrolled criteria, this
      study will document for the first time the short/long term efficacy of auto/allogenic NK
      cells.The outcome will be evaluated according to local relief degree, progress free survival
      (PFS) and overall survival (OS).
    

Intervention name(s): NK immunotherapy
Intervention type(s): Biological
Intervention description(s): Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumor; NK immunotherapy
Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.
Condition: ACL - Anterior Cruciate Ligament Deficiency; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Observational

Summary: 
      Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate
      ligament (ACL) reconstruction surgery remains a major challenge.

      challenge. Among the objective criteria retained, the isokinetic muscle strength assessment
      is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4
      months (intermediate) and at 6-8 months (final) after surgery. However, the factors
      associated with muscle imbalance are uncertain and the threshold values of the intermediate
      isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the
      investigators aim to assess the predictive criteria for muscle imbalance after ACL
      reconstruction surgery.
    

Detailed description: 
      The investigators aim to retrospectively studied all sports patients who had a muscle
      evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (ACL) reconstruction
      surgery since January 2016. The objective criterion were based on the international
      guidelines for muscle imbalance after ACL surgery and return to sport, as a muscle deficit of
      less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the
      operated knee (vs. healthy).

      The investigators will study the predictive analysis of the intermediate muscle strength test
      to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment.
      The investigators will also study the individual, injury and surgical criteria associated
      with muscle imbalance.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All sports patients included in the sport medicine follow-up protocole with isokinetic
        muscular assessment at 3-4 months and 6-8 months after ACL reconstruction surgery since
        January 2016
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind,
      placebo-controlled, sequential group study in healthy male subjects to assess the safety,
      tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral
      doses of GLPG2737 administered for 14 days.
    


Intervention name(s): GLPG2737 single dose; Placebo single dose; GLPG2737 multiple dose; GLPG2737 multiple dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GLPG2737 oral suspension, single ascending doses; Placebo, oral suspension.; GLPG2737 oral suspension, multiple ascending doses, daily for 14 days.; Placebo, oral suspension, daily for 14 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
AuraGain Performance in Lateral Position
Condition: Airway Complication of Anesthesia
Study type: Observational

Summary: 
      To compare the clinical performance of AuraGain including insertion time and success rate at
      first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease
      of gastric tube insertion, and peri-operative adverse effects in young children in supine,
      moderate lateral and extreme lateral position.
    

Detailed description: 
      Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently.
      AuraGain has an inflatable cuff and a curved body. In addition, because the airway tube of
      AuraGain is wide, it can be used as a conduit for tracheal intubation. However, only a
      limited number of studies have been conducted on the performance of AuraGain in pediatric
      patients.

      Changes in the position of the head and neck alter the shape of the pharynx leading to
      changes in the oropharyngeal leak pressure and the quality of ventilation through the LMA in
      both the adult and pediatric population. Having a large occiput and a relatively cephalically
      placed glottis, the ventilation in children is more compromised due to poor alignment of the
      pharyngeal-laryngeal axes during flexion of the head and neck. The hanging epiglottis covers
      the laryngeal inlet during flexion and the cuff of the LMA compresses the narrow laryngeal
      inlet both decreasing the delivered tidal volume. Different changes occur during extension
      and lateral rotation

      Although the clinical performance of the AuraGain would be expected to be high, or at least
      non-inferior, to that of the widely used currently available SGAs, clinical trials are
      required to verify its performance in head and neck positions other than the neutral position
      (i.e flexion, extension and lateral rotation).
    

Intervention name(s): AuraGain
Intervention type(s): Device
Intervention description(s): Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        - children scheduled for elective outpatient surgery in which airway management with a®
        AuraGain would be appropriate.
Influence of Beta Amyloid Imaging on Care of Patients Cognitive Complaints.
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      When older patients develop cognitive problems - like memory loss - there may be any of
      several underlying causes, sometimes occurring in combination. Clinicians have a better
      chance of providing appropriate treatment if they understand what the cause of the problem
      is. A diagnostic tool can help the patient by helping the clinician to make a more accurate
      diagnosis. This study investigates whether a new diagnostic tool - beta amyloid imaging - may
      potentially improve medical practice. The tool can potentially improve practice only if it
      can influence clinical judgment. This study investigates whether the provision of beta
      amyloid imaging information influences clinical judgment. The investigators will conduct a
      survey that presents clinicians with descriptions of hypothetical older patients with
      cognitive complaints. Some of the respondents also receive beta amyloid imaging information.
      The investigators will test the investigators hypothesis that the information will affect
      diagnostic judgment and management recommendations by comparing the responses of clinicians
      who receive the beta amyloid information to the responses of clinicians who do not.
    


Intervention name(s): Beta amyloid imaging
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Neuroimaging; Diagnostic Tool
ROTEM in Patients With Placenta Previa
Condition: Placenta Previa; Placenta Accreta; Placenta Increta; Placenta Percreta
MeSH terms: Placenta Accreta; Placenta Previa
Study type: Observational

Summary: 
      The rotational thromboelastogram (ROTEM) test can be performed on patients with placenta
      previa/accreta/increta/percreta who have a high likelihood of massive bleeding, and the
      predictors can be identified by comparing the patients who actually show massive bleeding
      with those who do not.

      Applying these predictive factors to pregnant women undergoing cesarean section after
      diagnosis of placenta previa/accreta/increta/percreta, it will be advantageous for the
      perioperative management because it is possible to select pregnant women with a factor of
      massive bleeding.
    


Intervention name(s): ROTEM
Intervention type(s): Diagnostic Test
Intervention description(s): ROTEM including INTEM, EXTEM, APTEM, and FIBTEM
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women over 20 years old who are scheduled for cesarean section under spinal
        anesthesia after diagnosis of placenta previa/increta/percreta/accreta
Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled
      treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off
      and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a
      similar way. The purpose of the study is i) to investigate the safety and tolerability of
      oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the
      effects of oral selexipag on PAH severity and exercise ability before and after transition,
      and iii) to gain new information about the patients experience taking oral selexipag compared
      to inhaled treprostinil. Study participants may stay in the study until the FDA has granted
      marketing authorization.
    


Intervention name(s): Selexipag
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration containing 200 micrograms (mcg) of selexipag to be administered twice a day. The individual dose is to be established during the first 12 weeks of the study. Doses are in the range from 200 micrograms (1 tablet) to 1,600 micrograms (8 tablets).
Other intervention name(s): Uptravi; ACT-293987
Intervention MeSH terms: Selexipag
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
Condition: Bacterial Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the uptake of azithromycin in white cells relative to plasma concentrations in
      HIV-infected patients.
    

Detailed description: 
      Patients are randomized to receive azithromycin orally or intravenously, with crossover to
      the alternate treatment after a 21-day wash-out period.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; Azithromycin; Bacterial Infections
Bioequivalence of Telmisartan / Ramipril Fixed Dose Combination Compared With the Monocomponents Given Concomitantly to Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril fixed-dose
      combination (FDC) versus its monocomponents given concomitantly
    


Intervention name(s): Telmisartan/Ramipril; Telmisartan; Ramipril capsule; Ramipril tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): fixed dose combination tablet
Other intervention name(s): Micardis®; Altace®; Delix®
Intervention MeSH terms: Telmisartan; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
Condition: Neoplasms, Rectal
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this post-marketing surveillance (PMS) study is to collect safety information
      on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at
      least 600 Korean women and men) within 30 days after each vaccination dose, when administered
      according to the approved prescribing information (PI) in Korea in a real health care setting
      over a period of 4 years.
    


Intervention name(s): Safety data collection (following routine vaccination) by a continuous surveillance method.
Intervention type(s): Other
Intervention description(s): This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.
All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Korean male and female subjects aged 9-25 years, who are eligible for the series of
        Cervarix vaccination, according to the locally approved PI.
      
Keywords: Human Papillomavirus Vaccine; Adverse events after vaccination; Safety; Serious adverse events after vaccination