bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
Condition: Sperm Motility (Focus of Study)
Study type: Observational

Summary: 
      The aim of this study is to study the effect of peginterferon alpha and ribavirin on
      spermatozoa.
    

Detailed description: 
      During and six months after treatment with peginterferon alpha and ribavirin strict use of
      birth control is recommended (the producers advice two reliable forms) for both men and women
      because ribavirin has teratogenic and/or embryo-lethal effects in animal studies.

      In cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin
      elective termination of the pregnancy is usually recommended. However three cases of births
      after paternal exposure are reported with no birth defects. Cases of abnormalities after
      paternal exposure to ribavirin are lacking.

      Also studies on the influence of ribavirin on sperm in human are lacking.

      The aim of this study is to study the effect of peginterferon alpha and ribavirin on
      spermatozoa in men using these medication.
    

Intervention name(s): peginterferon alpha and ribavirin
Intervention type(s): Procedure
Intervention description(s): sperm collection
Intervention MeSH terms: Ribavirin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: sperm chromatin structure integrity; sperm concentration; sperm motility; sperm morphology; peginterferon; ribavirin; hepatitis C
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1
      Adult and Pediatric Subjects.
    

Detailed description: 
      The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system
      (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting. The main objective
      in conducting this research is to collect data from patients who use the AHCL system at home,
      at work, at school and everywhere else. Subjects will use 670G 4.0 system with Guardian
      Sensor 3 (GS3) during study period, and will be allowed to participate in continued access
      phase, and use 670G 4.0 system with GS3 and 780G system with Guardian 4 Sensor (G4S).
    

Intervention name(s): AHCL insulin pump system
Intervention type(s): Device
Intervention description(s): 670G 4.0 system with GS3; 780G system with G4S (continued access phase);
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glucose Control in the ICU Using Continuous Glucose Monitoring
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit
      (MICU) and is associated with increased morbidity and mortality. However, randomized
      controlled trials examining the effects of strict glycemic control demonstrated conflicting
      results. A common finding in these trials was the high risk of hypoglycaemia.

      This randomized controlled trial evaluates the impact of real-time continuous glucose
      monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU
      patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.
    


Intervention name(s): experimental: real-time continuous glucose monitoring; Active comparator: blinded continuous glucose monitoring
Intervention type(s): Device; Device
Other intervention name(s): RT-CGM using the GlucoDay device (A. Menarini, Italy)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: medical ICU patients; APACHE-II score ≥20
Non-compliance on Treatment Among Diabetic Students at Sohag University
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      A cross-sectional study on diabetic students in Sohag University will be conducted to collect
      data about factors affecting compliance and adherence to diabetes treatment and its impact on
      development of complications.
    

Detailed description: 
      Personal interviews with diabetic students through a questionnaire :

        1. To determine factors affecting non compliance on treatment among diabetic students.

        2. To detect relation between non compliance on treatment and development of complications.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        all the diabetic students in sohag university from different faculties
Otologic and Rhinologic Outcomes in Children With Clef Palate
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Observational

Summary: 
      OBJECTIVE:

      To compare otologic and rhinologic outcomes in patients with cleft palate according to
      surgical protocols and type of cleft.

      DESIGN:

      Monocentric retrospective and prospective analysis of medical reports.

      PATIENTS, PARTICIPANTS:

      All consecutively treated patients affected by a cleft palate, born between December 2006 and
      December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

      INTERVENTIONS:

      Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial
      tomodensitometry done at the age of 10 were evaluated.

      MAIN OUTCOME MEASURE(S):

      The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutively treated patients affected by a cleft lip and palate or a cleft palate,
        born between December 2006 and December 2009 and followed in the Montpellier University
        Hospital, at the age of 10 years.
      
Biospecimen description: 
      Middle ear effusion fluids
    
Keywords: cleft palate; Eustachian dysfunction; Obstructive ventilation
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with
      panic disorder.
    


Intervention name(s): sertraline; Paroxetine
Intervention type(s): Drug; Drug
Intervention description(s): dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks; dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks
Other intervention name(s): Zoloft, JZoloft; Paxil
Intervention MeSH terms: Sertraline; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Panic Disorder
Rib Raising for Post-operative Ileus
Condition: Intestinal Pseudo-Obstruction; Manipulation, Osteopathic; Postoperative Care; Postoperative Nausea and Vomiting; Postoperative Complications; Osteopathic Medicine
MeSH terms: Intestinal Pseudo-Obstruction; Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      We are conducting a randomized controlled trial the use of rib raising for post-operative
      ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all
      patients undergoing major abdominal surgery and once they have been enrolled, we will
      randomize them to receive daily rib raising or a control technique where we place hands on
      the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to
      reduce post-operative ileus and hospital length of stay by up to 50%.
    


Intervention name(s): Rib raising and lumbar release; Sham procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Rib raising per protocol described in arm description.; Sham procedure per protocol described in arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Low Glycemic Index Diet in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate if a low glycemic index diet in comparison with a
      medium/high glycemic index diet improves the metabolic control in patients with type 1
      diabetes.
    

Detailed description: 
      The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a
      concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A
      meta-analysis of randomised controlled trials of the effect of low GI diets in the management
      of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI
      foods. However, several critical points concerning the GI concept remain, for instance, how
      to apply it in practical every day life, how to calculate GI in mixed meals, how to find
      relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue,
      however, is the fact that studies on the long-term effects of a low GI diet in type 1
      diabetes are lacking. In this study, the critical issue of finding palatable low GI foods
      will be solved in close collaboration with the food industry. This may lead to the
      development of new commercial products with low GI, which is necessary if low GI diets are to
      be advocated for diabetics in the future.

      Comparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.
    

Intervention name(s): Low GI food
Intervention type(s): Other
Intervention description(s): Comparison of carbohydrates in diabetic patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Glycemic Index Diet; HbA1c; Lipids
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating
      single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678
      on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed
      condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts
      (Ascending single dose, multiple dose and food effect). Participants will receive either
      ZSP0678 or placebo .
    


Intervention name(s): ZSP0678-10mg; ZSP0678-30mg; ZSP0678-60mg; ZSP0678-120mg; ZSP0678-180mg; ZSP0678-240mg; ZSP0678-320mg; ZSP0678; ZSP0678-Dose 1; ZSP0678-Dose 2; ZSP0678-Dose 3; ZSP0678 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ZSP0678 tablet administered orally under fasted condition; ZSP0678 tablets administered orally under fasted condition; ZSP0678 tablets administered orally under fasted condition; ZSP0678 tablets administered orally under fasted condition; ZSP0678 tablets administered orally under fasted condition; ZSP0678 tablets administered orally under fasted condition; ZSP0678 tablets administered orally under fasted condition; ZSP0678 tablets administered orally under fasted or fed condition; ZSP0678 tablets administered orally once daily for 14 Days; ZSP0678 tablets administered orally once daily for 14 Days; ZSP0678 tablets administered orally once daily for 14 Days; Participants will receive placebo matching to ZSP0678 orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NASH
The Effect of BIIL 284 BS on Induced-sputum Variables in Patients With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in
      patients with asthma
    


Intervention name(s): BIIL 284 BS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery
Condition: Heart Valve Disease
MeSH terms: Heart Valve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass
      grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to
      describe the haemodynamic effects of levosimendan in comparison to placebo in patients
      undergoing elective aortic valve replacement (AVR) together with coronary artery bypass
      grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will
      be carried out in Heart Center.

      Twenty four patients will be randomized into two groups of 12. The treatment group will
      receive 24 hour infusion of levosimendan preoperatively where as the placebo group will
      receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be
      measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn,
      Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate,
      cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and
      extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be
      carried out as in standard care. Echo cardiography will be done pre- and postoperatively.
      Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24
      hours.
    


Intervention name(s): levosimendan; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min; nacl 0.9% coloured with thiamin in same volume and time than levosimendan
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: levosimendan; CABG; AVR
Epileptogenic Focus Localization for Children With Epilepsy Using 18F-FDG PET Molecular Imaging
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      This retrospective study aimed to develop a new approach for automatic localization of
      epilepsy foci in children with epilepsy.
    

Detailed description: 
      This retrospective study aimed to develop a new approach for automatic localization of
      epilepsy foci in children with intractable epilepsy.

      Pediatric patients with intractable epilepsy would be retrospectively included in this study.
      The inclusion criteria included (1) age between 6 and 18 y; (2) detailed seizure semiology
      evaluation, MRI, EEG and interictal 18F-FDG PET/CT examination; (3) clinical diagnosis as
      focal epilepsy. The exclusion criteria included (a) any history of central nervous system
      disease; (b) poor image quality due to head movement.
    

Intervention name(s): 18F-FDG
Intervention type(s): Radiation
Intervention description(s): All subjects received 18F-FDG PET examination.
Intervention MeSH terms: Fluorodeoxyglucose F18
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        130 pediatric patients with focal epilepsy, 67 age-matched controls, and 37 validation
        group children.
      
Keywords: Epilepsy; Peidatrics; Positron emission tomography (PET)
Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only
Condition: Plantar Fasciitis; Achilles Tendinitis; Patellofemoral Pain Syndrome
MeSH terms: Fasciitis; Fasciitis, Plantar; Patellofemoral Pain Syndrome; Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if dry needling both low back and extremity areas
      is more effective for reducing pain and improving strength, balance and functional
      performance among patients with chronic musculoskeletal conditions compared to dry needling
      of extremity areas only.
    

Detailed description: 
      This study will determine if spinal and peripheral dry needling sites results in decreased
      pain, increased muscle strength, increased proprioception and increased functional
      performance among individuals with chronic musculoskeletal conditions of the lower
      extremities, such as plantar fasciitis, Achilles tendinopathy, and patellofemoral pain
      syndrome. Specific aims are to determine if individuals with chronic musculoskeletal
      conditions of the lower extremities receiving dry needling to both spinal and peripheral
      sites exhibit differences in pain, muscle strength, proprioception, and unilateral hop test
      scores compared to individuals with chronic musculoskeletal conditions of the lower
      extremities receiving dry needling to peripheral sites only.
    

Intervention name(s): Spinal and Peripheral Dry Needling; Peripheral Dry Needling
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will be positioned lying flat and the relevant spinal level will be treated using a Seirin L- type 50 mm needle. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.; Participants will be positioned lying flat and the relevant peripheral points will be treated using a Seirin L- type 50 mm needle. The peripheral treatment site(s) will be determined by the physical therapist's palpation of active or latent trigger points or tender points. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthopedics
Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
Condition: Anesthesia
Study type: Observational

Summary: 
      Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate,
      deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch
      statistical analysis for underlying factors are done.
    

Detailed description: 
      In this observational study estimation of anesthetic depth by anesthesiologists is compared
      with the EEG based monitoring Narcotrend®. 10-20 voluntary anesthesiologists of the Kepler
      University Hospital, unfamiliar with EEG-monitoring during anesthesia, assess depth of
      anesthesia (moderate, deep or light level) during a steady-state period by clinical signs and
      measured or calculated concentrations of anesthetics. Concurrently Narcotrend® provides data
      of anesthetic depth (index, stadium) blinded for the anesthesiologist. Each anesthesiologist
      is included 30 times during study period. The aim of this study is to define conformity
      between subjective and objective assessment of narcotic depth. In the cases of divergence
      data of the patient (age, body mass index, comorbidity…), data of the anesthesiologist (age,
      years of practice…), data of anesthesia (balanced anesthesia, target controlled infusion,
      endtidal concentration of volatile anesthetic…) and data of the operation (eye surgery,
      cardiac surgery…) will be analyzed by statistics with regard to underlying or concomitant
      factors. These findings could help to develop recommendations in the use of EEG-processed
      monitoring to improve subjective assessment and facilitate an adequate depth of anesthesia to
      be provided for every patient.
    

Intervention name(s): EEG monitoring
Intervention type(s): Device
Intervention description(s): EEG will be performed. Data obtained will be analyzed using software. Anesthesiologists will enter their assumption in a blinded fashion and data obtained will be compared with EEG data
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients:

        Randomization of patients (m/w) after informed consent. For detailed inclusion criteria see
        corresponding section.

        Patients are randomly assigned to anesthesiologist. Anesthesiologists are blinded and must
        assume anesthesia level. Evaluation will be performed by study leader.
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Condition: Fibrosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy
      volunteers.
    


Intervention name(s): BMS-986263; Placebo; Diphenhydramine; Famotidine
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 3 weekly doses of 90 mg infused intravenous administration; Placebo; 50 mg intravenous administration; 20 mg intravenous administration
Intervention MeSH terms: Diphenhydramine; Promethazine; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to prove that intramuscular midazolam is more effective than buccal
      midazolam in cessation of seizure activity with comparable side effects.
    

Detailed description: 
      Both buccal and intramuscular midazolam have been used to control seizures with variable
      succuss rates and side effects.

      In this study the investigators are going to assign patient randomly to receive either buccal
      or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.
    

Intervention name(s): Buccal midazolam; Intramuscular midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Study subject will receive Buccal midazolam, Intramuscular placebo.; Study subject will receive Intramuscular midazolam,Buccal placebo
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment