bioihbjkbjnl/mcl2 huggingface dataset:
Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine
Condition: Instantaneous Clearance
MeSH terms: Reinfection
Study type: Interventional
Phase: Phase 4

Summary: 
      Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia
      and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is
      not known whether the problem exist in Tanzania. This study assessed parasite clearance time
      and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among
      children with uncomplicated malaria.
    

Detailed description: 
      Artemether/Lumefantrine (AL) has been in wide scale use in Tanzania since 2007 as first line
      treatment for uncomplicated falciparum malaria. Nonetheless, reports of confirmed resistance
      against Artemisinin derivatives expressed phenotypically as prolonged parasite clearance have
      emerged from South-East Asia (SEA), signifying reduced parasites susceptibility to the
      otherwise rapidly acting artemisinins. Prolonged clearance is associated with an increase in
      day 28 treatment failure, gametocytes carriage and transmission of resistance. Nonetheless,
      no detailed study has been done in East Africa to assess parasite clearance time following
      treatment with Artemisinin based combination therapies (ACTs).

      In order to evaluate time to parasite clearance following treatment with AL, we conducted a
      detailed clinical trial with twenty blood sampling time points prior, during and after
      treatment. Detailed sampling allowed us to assess parasite clearance, and selection of
      Plasmodium falciparum multidrug resistance (Pfmdr) 1 N86Y and Plasmodium falciparum
      chloroquine resistance transporter (Pfcrt) K76T genes between different time points and its
      association with parasite clearance and recurrence. Furthermore, as a sensitive tool and an
      ideal early warning system, nested polymerase chain reaction (PCR) was used to assess
      parasite clearance and compare it with microscopic findings.
    

Intervention name(s): Artemether/lumefantrine
Intervention type(s): Drug
Intervention description(s): Medication was given at 0, 8, 24, 36, 48 and 60 hours. Food was given to all patients prior to medication to ensure proper absorption of the drug.
Other intervention name(s): Coartem
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clearance time; Recurrence time; Artemether/lumefantrine; P. falciparum; Uncomplicated malaria; Children
Trunk Strength Study
Condition: Ventral/Incisional Hernia Repairs
MeSH terms: Hernia; Incisional Hernia
Study type: Observational

Summary: 
      The purpose of this study is to measure abdominal wall strength both preoperatively and
      postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators
      hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the
      rectus musculature to the midline. Abdominal wall strength measurements would be obtained
      utilizing various abdominal strength testing.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who will undergo laparoscopic ventral hernia repair or open repair. People between
        the ages of 18 to 65 in relative good health.
PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia
Condition: Dysbiosis
MeSH terms: Dyspepsia; Dysbiosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective interventional study of the effect of PPI on the duodenal microbiome in healthy
      volunteers and functional dyspepsia patients
    

Detailed description: 
      PPIs are the first-line therapy in functional dyspepsia (FD) but frequently (over-)prescribed
      with potential adverse events, especially in the long term. As C. difficile and CAP are
      important causes of morbidity, mortality and healthcare costs, it is important to study the
      underlying mechanisms of PPI-induced dysbiosis.

      In this prospective interventional study, study procedures will be performed at inclusion
      (1), after a baseline period of 4 weeks (2) and after treatment with Pantoprazole (Pantomed®)
      40mg once daily during 4 weeks (3) in healthy volunteers and FD patients. In addition, study
      procedures will be performed at inclusion (1) and after PPI-withdrawal for 8 weeks in
      refractory FD patients.

      The investigators aim to assess alterations of the duodenal (mucosa-associated and luminal)
      microbiome with PPI therapy and to correlate changes in the duodenal microbiota with oral and
      fecal microbiota, bile acids, intestinal permeability and histology and biochemical
      variables.

      The results from this study will help to unravel the onset and extent of dysbiosis and
      provide additional arguments not to prescribe or continue PPI without clear clinical
      indications, especially in cases where alternative regimens may be available or the benefits
      of PPI are uncertain.
    

Intervention name(s): Pantoprazole 40mg; PPI withdrawal
Intervention type(s): Drug; Other
Intervention description(s): Peroral Pantoprazole 40mg once daily during 28 days; PPI withdrawal for 8 weeks
Other intervention name(s): Pantomed
Intervention MeSH terms: Pantoprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective interventional study with study procedures at inclusion, after a baseline period of 4 weeks and Pantoprazole therapy for 4 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: duodenum; microbiome; proton pump inhibitor
GABA (Gamma Amino Butyric Acid) Medication for Tobacco
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to examine the effects of a GABA (gamma amino butyric
      acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal
      and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day,
      will be more effective than placebo in decreasing smoking behavior and attenuating tobacco
      withdrawal and cigarette craving.
    

Detailed description: 
      A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300
      mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated
      by 3 to 15 days of washout period. Smokers will have twice daily outpatient visits during the
      first 3 days and a test session on day 4. In each treatment period, smokers will abstain from
      smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the
      test sessions, measures of smoking behavior and tobacco withdrawal will be obtained.

      Smoking is an important public health problem costing over 430,000 lives a year in this
      county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion,
      compared to placebo, approximately double the long-term success rate for smoking cessation.
      Given that there remains 46 million smokers in this country and over 70 percent of them
      interested in quitting smoking, development of new treatments for smoking cessation will have
      great public health implications.

      Currently this protocol is complete with 24 completers. This study has been published. (April
      2011)
    

Intervention name(s): pregabalin; cigarettes
Intervention type(s): Drug; Other
Intervention description(s): Help stop smoking; help stop smoking with study medication
Other intervention name(s): 300mg/day for pregabalin with smoking cigarettes
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: smoking sensations; no cravings; desire to smoke
Controlled Trial of WLS vs. CLI for Severely Obese Adolescents With NASH
Condition: Obesity; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The goal of this study is to determine effective treatment and identify diagnostic biomarkers
      for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study will be
      participating in either a weight loss surgery (WLS) group or a comprehensive lifestyle
      intervention (CLI) group. People in the WLS group will receive vertical sleeve gastrectomy
      (VSG). The CLI group will receive dietary, activity and behavioral interventions provided by
      trained study staff.
    

Detailed description: 
      The investigators have designed a rigorously controlled study designed to evaluate NASH
      outcomes in two parallel cohorts: 1) severely obese adolescents with NASH who have chosen to
      undergo WLS (specifically VSG) for clinical indications compared to 2) a control group of
      severely obese adolescents with NASH enrolled in a CLI offered as part of this study. The
      study will provide the best evidence to date of the effectiveness of WLS and CLI in treating
      NASH in adolescents with body mass index (BMI) ≥ 35 kg/m2. The investigators will also
      concurrently collect health-care utilization data to enable subsequent cost-effectiveness
      analyses (CEA) to evaluate the cost-effectiveness of WLS vs. CLI intervention in
      severely-obese adolescents with NASH. If the investigators' data support our hypothesis that
      WLS yields superior results, this will set the stage for randomized studies (if needed) and
      translational studies of weight loss-independent biological mechanism(s) unique to WLS, which
      may include specific changes in bile acid signaling and in the intestinal microbiome. The
      latter would facilitate developing novel pharmacotherapies accessible to younger or less
      obese children with NASH to whom WLS is not applicable. Cumulatively, this study has the
      potential to yield significant improvements in medical and quality of life (QOL) outcomes for
      a large proportion of pediatric patients with NASH and to reduce long term health care costs
      by identifying effective treatment options and decreasing progression to cirrhosis and
      end-stage liver disease.
    

Intervention name(s): Comprehensive Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): Dietary, behavioral and activity interventions designed to reduce weight.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63
      CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite
      protein. All volunteers recruited will be healthy adults. They will be primed with various
      doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a
      booster vaccination with MVA CS administered via intramuscular route. Safety data will be
      collected for each vaccination regimen. Secondary aim of this study will be to assess the
      immune responses generated by vaccination.
    


Intervention name(s): ChAd63 CS; ChAd63 CS, MVA CS; ChAd63 CS; ChAd63, MVA CS
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): ChAd63 CS 5x10^9 vp intra-muscularly Day 0; ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56; ChAd63 CS 5x10^10 vp intra-muscularly Day 0; ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone
Condition: Musculoskeletal Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The study design was a randomised, controlled, parallel, two-arm trial. The subjects were
      randomly assigned to one of the study groups: the intervention group or the control group.
      The passive mechanical properties, i.e. the stiffness and tone of the medial and lateral
      gastrocnemius muscle (dominant leg) were assessed. Measures were taken twice: in the
      intervention group before and after the 5-minute massage session, and in the control group at
      the beginning of the meeting and again after 5 minutes.
    

Detailed description: 
      The purpose of this study was to determine whether a 5-minute massage, applied to healthy
      individuals, may change the passive mechanical muscle properties, which supposedly may
      prevent MSDs. The study is carried out on the medial and lateral gastrocnemius muscles
      because of their accessibility and crucial role in locomotion. MyotonPRO and TMG S2 devices
      were used to assess the stiffness and radial muscle displacement of the gastrocnemius muscle
      respectively.
    

Intervention name(s): Massage session
Intervention type(s): Procedure
Intervention description(s): Participants in the intervention group are provided with the 5-minute massage session in the medial and lateral gastrocnemius muscle (dominant leg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Massage therapy; Muscle tone; Muscle stiffness
Interstitial Lung Diseases in Primary Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Lung Diseases; Lung Diseases, Interstitial; Syndrome
Study type: Observational

Summary: 
      Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of
      Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were
      retrospectively reviewed. Characteristics were analyzed.
    

Detailed description: 
      Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified.
      Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary
      function tests (PFTs) were collected. pSS-ILD patients were further categorized into
      subgroups according to HRCT patterns or PFTs.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eighty-five patients with pSS-ILD were identified, and 85 patients with pSS non-ILD were
        used for comparison. The average age at disease onset and median disease duration in
        patients with pSS-ILD were greater when compared with pSS non-ILD patients. There was no
        difference regarding presenting symptoms at disease onset between pSS-ILD and pSS non-ILD
        patients.
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, single center, single arm, open-label study to assess the PK, safety and
      tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy
      Chinese participants.
    


Intervention name(s): Aztreonam-Avibactam
Intervention type(s): Drug
Intervention description(s): 500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours
Intervention MeSH terms: Aztreonam; Avibactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: no clinically relevant abnormalities
Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy
Condition: Breast Surgery; Thoracic Paravertebral Block; Post-operative Pain Control; Erector Spinae Plane Block; Opioid Use
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block
      versus thoracic paravertebral (TPV) block in the post-operative pain control after radical
      mastectomy.
    

Detailed description: 
      Primary outcome of our study is to compare the effectiveness of two regional anesthesia
      techniques, ESP block and TPV block, in the post-operative pain-control after radical
      mastectomy.

      We will also evaluate both intra and post-operative opioid consumption, the incidence of
      PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and
      the incidence of chronic pain 6 months after surgery.
    

Intervention name(s): Thoracic paravertebral block; Erector spinae plane Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level; Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast surgery; Thoracic paravertebral block; Erector spinae plane block; Mastectomy; post-operative pain control
Effectiveness and Cost Management of Multicolumn Spinal Cord Stimulation in Neuropathic Pain Patients With Failed Back Surgery Syndrome
Condition: Failed Back Surgery Syndrome
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe
      handicap for patients and represents a considerable expense for healthcare system.
      Neurostimulation has currently not been validated in the treatment of back pain because of
      technological limitations in implantable spinal cord stimulation (SCS). The lack of a
      validated technique for back pain relief has prompted the development of newer devices,
      including leads with increased number of contacts (up to 16) and various geometric
      arrangements, the objective of which is to cover a larger area while attempting to extend,
      steer, or focus the electric field of the stimulation within the spinal cord regions. This
      led companies to design a new generation of multicolumn surgical leads that allow the
      activation of longitudinal and transverse electric fields (multicolumn spinal cord
      stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.

      The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal
      and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using
      axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of
      lumbar pain.

      A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and
      80 years old suffering from refractory neuropathic pain of radicular origin with associated
      back pain will be included. Patients will be divided into two groups. One group with MSCS
      during the 12 months after the new generation electrode implantation and one group with CSCS
      during 6 months and MSCS between 6 and 12 months after the new generation electrode
      implantation.

      The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS,
      back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale,
      Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing
      in relation to surgery and patient management.
    


Intervention name(s): comparison of spinal cord stimulation
Intervention type(s): Device
Other intervention name(s): Specify(TM) 5-6-5 lead (Medtronic)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Incidence of Perioperative Hypothermia in Adults
Condition: Hypothermia; Anesthesia; Hypothermia Following Anesthesia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      Perioperative hypothermia is associated with many complications, including surgical site
      infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit
      length of stay. Perioperative close monitoring of the body temperature is important, and this
      is recommended by many clinical practice guidelines. In this study the investigators aimed to
      detect the incidence of perioperative hypothermia in adult patients in the operating room,
      and to detect the possible associated risk factors.
    


Intervention name(s): Measurement of body temperature
Intervention type(s): Diagnostic Test
Intervention description(s): The patients' body temperature will be measured pre-, intra- and post-operatively via an infrared thermometer.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients scheduled for any elective operation (except for open heart surgery) will be
        recruited.
      
Keywords: hypothermia; perioperative; intraoperative; postoperative
Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The primary objective of this study is to develop normative hemodynamic data (means and
      standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and
      3D-echocardiographic analyses.
    


Intervention name(s): Conductance catheterization
Intervention type(s): Device
Intervention description(s): CD Leycom Conductance Catheter
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic