bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth
Condition: Ventricular Septal Defect; Appetite Loss; Growth Delay
MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular
Study type: Observational

Summary: 
      In this study; Changes in appetite, hormones and growth of ventricular septal defect patients
      treated with non-surgical method were evaluated.
    

Detailed description: 
      The study included 20 patients whose ventricular septal defect closed percutaneously and 26
      children as control group. The symptoms, anthropometric measurements and laboratory tests of
      patient group were recorded at initial, 1st month and 6th months after closure.

      Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index
      (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference
      (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were
      defined as malnutrition.

      Questions about the symptoms like appetite, weight gain, frequency of illness, rate of
      breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual
      analogue scale (for appetite) were repeated at 1st and 6th month visits.

      During the initial evaluation, approximately 6 ml of venous blood samples were taken between
      9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and
      leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and
      alanine aminotransferase (ALT), total protein, and albumin were measured.

      Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients who underwent transcatheter VSD closure in our institute and whose
        growth was followed for 6 months as patient group.

        Healthy children without appetite or growth retardation were included in the study as a
        control group.
      
Biospecimen description: 
      Venous blood samples, plasma, serum
    
Keywords: ventricular septal defect; appetite; growth; interventional therapy
Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease
Condition: Obstructive Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Study type: Observational

Summary: 
      Whole-body plethysmography (WBP) is the gold standard for measuring lung volume, but its
      clinical application is limited because it requires expensive equipment and is complicated to
      use. Studies have shown that the single-breath helium dilution (SBHD) method, which is
      commonly used in clinical practice, significantly underestimates lung volume in patients with
      obstructive lung disease (OLD). Therefore, by comparing the differences in lung volume
      measured by the SBHD method and WBP in patients with different severities of obstructive lung
      disease, we aim to establish a correction equation for the SBHD method to determine the total
      lung volume in obstructive lung disease patients.
    


Intervention name(s): the single-breath helium dilution method and Whole-body plethysmography
Intervention type(s): Diagnostic Test
Intervention description(s): The patients with obstructive lung disease simultaneously subjected to the single-breath helium dilution method and Whole-body plethysmography tests.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        628 patients with obstructive lung disease simultaneously subjected to the single-breath
        helium dilution method and Whole-body plethysmography tests in Second Affiliated Hospital
        of Zhejiang University School of Medicine were continuously enrolled from January 2018 to
        December 2020
      
Keywords: obstructive lung disease; total lung capacity; the single-breath helium dilution; Whole-body plethysmography; correction equation
The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
Condition: Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, placebo-controlled trail, the objective of this study is observation
      the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by
      hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the
      presence of post-delivery intra-operative nausea and vomiting in parturients. The patients
      demographic characteristics, blood pressure, sensory block level, and the medications will be
      collected.
    


Intervention name(s): Propofol; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump; first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 60 maternal aged 20-40 years will be collected
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: nausea and vomiting; hemabate; propofol
Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
Condition: Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to
      determine the effectiveness of regular intranasal steroid use in alleviating allergic
      rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine.
      Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An
      oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if
      patients fail to improve nasal symptoms.
    


Intervention name(s): Mometasone furoate; Mometasone furoate
Intervention type(s): Drug; Drug
Intervention description(s): Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days; Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician
Other intervention name(s): Nasonex; SCH 32088; Nasonex; SCH 32088
Intervention MeSH terms: Mometasone Furoate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting
Condition: End Stage Renal Disease; Kidney Disease; Protein Energy Wasting
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745
      or placebo in treating protein energy wasting (PEW) in patients receiving maintenance
      hemodialysis (MHD).
    

Detailed description: 
      This is a randomized (participants will be assigned by chance to study treatments),
      double-blind (participants and study personnel will not know the identity of the study
      treatments), placebo (an inactive substance that is compared with a drug to test whether the
      drug has a real effect in a clinical trial)-controlled study in patients who receive
      maintenance hemodialysis. Three participants will receive PINTA 745 for every participant
      that receives placebo. PINTA 745 or placebo will be taken intravenously once per week
      following dialysis.

      The study period will consist of screening, treatment for 12 weeks, and follow up for 8
      weeks. Evaluations will be performed to assess the safety, pharmacokinetics (study of what
      the body does to a drug), pharmacodynamics (study of what a drug does to the body) and
      effectiveness in treating protein energy wasting (such as increasing muscle size and muscle
      function) throughout the study.
    

Intervention name(s): PINTA 745; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PINTA 745 will be administered once weekly by IV infusion.
Cohort dose schedules:
3mg/kg weekly for 12 weeks
3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks; Placebo will be administered once weekly by IV infusion.
Cohort dose schedules:
3mg/kg weekly for 12 weeks
3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: End Stage Renal Disease; ESRD; Maintenance Hemodialysis; Hemodialysis; Dialysis; MHD; Protein Energy Wasting; PEW
Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove the safety, in normal conditions, of the odontological use formulation of the
      product Cepacol Canela Power.
    


Intervention name(s): Cetylpyridinium chloride
Intervention type(s): Drug
Intervention MeSH terms: Cetylpyridinium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: oral hygiene
A Study of PRA023 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is randomized, double-blind, placebo-controlled, single and multiple ascending dose
      study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023
      in healthy volunteers.
    


Intervention name(s): PRA023; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PRA023; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Mild Weight Loss on Circulating Metabolite Profiles
Condition: Visceral Fat; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma
      metabolites and metabolic traits from baseline.
    

Detailed description: 
      Over a 12-week clinical intervention period, a randomized, controlled study was carried out;
      overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a
      weight-maintenance diet (control, n=50) were included for analyzing plasma samples and
      metabolites using an ultra-performance liquid chromatography and mass spectrometry
      (UPLC-LTQ/Orbitrap MS).
    

Intervention name(s): Control group; LCD group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Recommend to consume usual diet during 12-week study period; Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: High visceral fat; Low calorie diet; Mild weight loss; Metabolomics; Metabolites; Acylcarnitines
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to determine the safety and effectiveness of risperidone compared with
      placebo in the treatment of bipolar disorder (manic or mixed type) in children and
      adolescents aged 10 to 17 years.
    

Detailed description: 
      Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering
      from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1
      of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral
      risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study
      medication will be increased to the target dosage during the first 7 days, then further
      increased within the target dosage range reached until maximum tolerated dose is reached by
      day 10. The maximum tolerated dose will be given for the last 12 days of the study.
      Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3,
      or 4 mg tablets (or matching placebo) each day for 3 weeks.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar; Mania; Manic; Depressive; Manic Depressive; Bipolar mania; risperidone; adolescents; children
24-hour IOP-lowering Effect of 0.01% Bimatoprost
Condition: Intraocular Pressure; Glaucoma; Ocular Hypertension
MeSH terms: Ocular Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in
      patients with glaucoma or ocular hypertension
    

Detailed description: 
      Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular
      pressure (IOP) and ocular perfusion pressure (OPP).

      Design Prospective, open-label experimental study.

      Setting Single tertiary ophthalmic clinic.

      Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular
      hypertension (ages, 49-77 years).

      Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep
      laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting
      and supine body positions during the 16 h diurnal/wake period and in the supine position
      during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were
      treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP
      data were collected under the same laboratory conditions.

      Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared
      with baseline.
    

Intervention name(s): 0.01% bimatoprost
Intervention type(s): Drug
Intervention description(s): 0.01% bimatoprost once in the evening for 4 weeks
Other intervention name(s): Lumigan 0.01%
Intervention MeSH terms: Bimatoprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Versus Delayed Cholecystectomy
Condition: Acute Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      This study examines complications, mortality rates, cost-effectiveness and safety of early
      laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L
      (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D
      (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks
      later) laparoscopic cholecystectomy.
    

Detailed description: 
      There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC)
      versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis
      considering the surgeon's work experience. This study examines complications, mortality
      rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical
      trial was performed between November 2015-2016 in our General Surgery Clinic. Patients
      suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two
      study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy
      immediately or Group D (n:88) patients first treated medically and than treated surgically
      with delayed (4-8 weeks later) laparoscopic cholecystectomy. All operations and medical
      treatments were done by surgeons having work experience <2 years.
    

Intervention name(s): laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure. Second 10-mm trocar was inserted from subxyphoid area. Two 5-mm trocars were inserted in the right upper quadrant area. After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle. In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula. Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients suffering acute pain because of acute cholecystitis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy, Delayed Cholecystectomy
Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training
Condition: Disease as Reason for ERCP
Study type: Interventional

Summary: 
      Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques
      in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform
      enough cases to grasp this technique. The methods of ERCP training include hands-on teaching,
      training on different kinds of simulators, training on ex-vivo or live anesthetized porcine
      stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.

      Selective cannulation is considered the most difficult and challenging part of learning ERCP.
      There is not an optimal time for trainees to attempt cannulation during hands-on ERCP
      training. The time used for attempting cannulation by trainees was 5min or 10min in several
      centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt
      cannulation for about one year. The incidence of post-ERCP pancreatitis, the major
      complication related to cannulation, was 4.0%, which was comparable with previous studies.

      The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation
      would increase success rate of selective cannulation and help to improve skills more quickly.
      At the meantime, with actively verbal or hands-on assistance from the instructor during
      performance of trainees, the risk of complications would not increased with a longer time to
      attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study
      was designed to evaluate the effects of different periods of time for trainees to attempt
      selective cannulation on success rate of cannulation, self-satisfaction of performance and
      post-ERCP pancreatitis.
    


Intervention name(s): Hands-on ERCP training.
Intervention type(s): Procedure
Intervention description(s): The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of common bile duct (CBD) or pancreatic duct (PD). During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within the designated length of time, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation. The whole procedure of cannulation was recorded by video. Rectal indomethacin and/or pancreatic stent was used in high-risky patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA
Condition: Hypertensive Intracerebral Hemorrhage; Intraventricular Hemorrhage; Brain Injuries
MeSH terms: Brain Injuries; Cerebral Hemorrhage; Intracranial Hemorrhage, Hypertensive; Hemorrhage
Study type: Observational

Summary: 
      This study compares the neuroinflammatory response in patients with hypertensive ICH
      associated with IVH treated with intraventriculary applied rtPA, and the control group. The
      inflammatory mediator concentration is analyzed in local cerebrospinal liquor.
    


Intervention name(s): intraventricual recombinant tissue plasminogen activator application
Intervention type(s): Drug
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All subjects from 18 to 80 years.
      
Keywords: secondary brain injury; neuroinflammation
Non-Response to Exercise
Condition: Non-Responder
Study type: Interventional

Summary: 
      The purpose of this prospective intervention study is to find biomarkers and underlying
      pathomechanisms for non-response of improvement in glucose metabolism to exercise.

      An additional goal is to identify non-responders at an early stage, where prevention
      strategies (pharmacologically or by specific training) will be successful.
    

Detailed description: 
      At baseline and end of study, an intensive metabolic phenotyping including cerebral insulin
      sensitivity as well as tissue biopsies are performed in overweight untrained healthy
      participants at high risk for type 2 diabetes. During the study, an individual exercise
      training at 80% VO2max is performed for 9 weeks. Before and after the training intervention,
      acute tissue biopsies after a standardized bout of exercise are obtained.
    

Intervention name(s): exercise training
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma
      which is also active during allergy seasons in pediatric patients with seasonal aeroallergen
      sensitivity.
    


Intervention name(s): montelukast sodium; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.; Placebo. Up to 3 weeks of treatment
Other intervention name(s): MK0476
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment