bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults
Condition: Healthy
MeSH terms: Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1
      Vaccine in healthy adults.
    


Intervention name(s): HAI-05 Influenza Vaccine; Saline
Intervention type(s): Biological; Other
Intervention description(s): injection, vaccine, twice every 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention
tDCS and Robotic Therapy in Stroke
Condition: Stroke; Upper Extremity Impairments
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      After stroke a limited motor recovery in the paretic upper limb accounts for a large
      proportion of the disabling sequelae. Only about 15% of those with initial complete upper
      limb paralysis after stroke recover functional use of their impaired arm in daily life.

      The aim of this study is to test the effects of tDCS combined with upper extremity
      robot-assisted therapy on stroke survivors.
    


Intervention name(s): real-tDCS + UE robot-assisted therapy; sham-tDCS + UE robot-assisted therapy
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
Condition: Rotator Cuff Injury; Pain
MeSH terms: Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Arthroscopic shoulder rotator cuff repair and acromioplasty are associated with severe
      postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery,
      providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve
      block provides extremely effective analgesia for the first 6-8 hours, patients experience
      severe pain once its effect has regressed. This study will assess whether a single dose of
      oral hydromorphone controlled release, given to overlap the waning of the ISB, will improve
      postoperative pain control and reduce the incidence of rebound pain.

      Seventy patients undergoing rotator cuff repair will receive standardized ISB and general
      anesthesia for the surgery. Six hours (+/- 1 hour) after ISB, the patients will randomly
      receive either a single oral dose of 2 mg Hydromorphone (immediate release formulation) or
      placebo. The patient will be then discharged home with a prescription for multimodal
      analgesia, which is the standard of care. Patients will be given a diary to record their pain
      scores and track use of analgesic medications for 24 hours. Twenty-four hours after the ISB,
      the patients will receive a phone call from a nurse as per the standard of care. During this
      phone call, questions will be asked about their pain control.

      If a single dose of pre-emptive hydromorphone is demonstrated to be safe and effective, it
      will lead to change in practice of how we manage pain after rotator cuff repair. Furthermore,
      the finding of this study may apply to similar surgical procedures (such as elbow, knee and
      ankle repairs) that are associated with rebound pain when the nerve block wears off.
    


Intervention name(s): Hydromorphone Hcl 2Mg Tab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.; Patients may be randomized to placebo.
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rotator cuff repair; Interscalene block; Hydromorphone; Pain; Rebound pain; Acromioplasty
Effects of Respiratory Exercises in Patients With Hemiplegia
Condition: Hemiplegia; Respiratory Abnormality
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      This study evaluates the effects of respiratory exercises on respiratory function test
      parameters and ultrasonographic diaphragmatic measurements. Half of the hemiplegic patients
      will receive respiratory and neurophysiological exercises, while other half will receive only
      neurophysiological exercises.
    

Detailed description: 
      After stroke, diaphragm, the most important muscle of respiration, is wasted as well as the
      other muscles of the affected side.

      Ultrasonography is a non-invasive, practical, low cost utility that may measure the thickness
      of diaphragm in maximum expiration and inspiration thus examining the functionality of the
      muscle. Correlation between respiratory functional tests and diaphragm ultrasonography has
      been proven in recent literature. In this manner, the aim of this study is twofold. First is
      to determine whether ultrasonography can be used practically to evaluate the respiratory
      functions of the patients after stroke. Respiratory function tests will be used for the
      correlation analysis. Second is to evaluate the effectiveness of respiratory exercises via
      diaphragm ultrasonography and respiratory function tests.
    

Intervention name(s): Conventional rehabilitation; Respiratory rehabilitation
Intervention type(s): Procedure; Procedure
Intervention description(s): Static and dynamic control of position, balance skills, weight shift, and activities of daily living.; Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: hemiplegia; respiratory function tests; respiratory exercises; diaphragm ultrasonography
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, open-label study with an active standard-of-care
      comparator (penicillamine)
    

Detailed description: 
      This is a multicenter, randomized, open label study with an active standard-of-care
      comparator.

      Stable patients who are already considered to be stable on their standard-of-care
      penicillamine chelation therapy for at least 1 year will enroll in the study and enter a
      12-week Penicillamine Baseline Period comprising of 1 month (4 weeks) run-in period followed
      by a 2 month (8 weeks) evaluation period. During this time all patients will continue to take
      their current penicillamine under study conditions. At the end of the Penicillamine Baseline
      Period, patients who fulfill the protocol definition of being adequately controlled and
      tolerating penicillamine will be randomized in a 1:1 ratio to receive either TETA 4HCl or to
      continue to receive penicillamine. There is then a 24-week Post-randomization Phase
      comprising of a 1 month (4 weeks) run-in period for both treatment arms and a 5 month (20
      weeks) evaluation period.

      Patients who successfully complete the 24-week Post-randomization Phase of the study will
      have the opportunity to enter an Extension Phase. In the first version of the clinical trial
      protocol, the intention was to have an 18 month (72 weeks) Extension Phase. During the first
      24 weeks of the Extension Phase, subjects would continue receiving their allocated TETA 4HCl
      or penicillamine (i.e., up to Week 60 of the study). Thereafter all patients were receiving
      TETA 4HCl for a further 48 weeks (i.e., from Week 60 to Week 108). Study clinic visits occur
      were scheduled every 6 months in the Extension Phase.

      With the final version of the protocol, the Extension Phase stopped at Week 60. Patients who
      already passed the Week 60 visit were allowed to end the study at the next planned visit.

      As a consequece end of treatment varied Week 60 and Week 108
    

Intervention name(s): Penicillamine (D1-W12); TETA 4HCL (W12-60); Penicillamine (W12-W60); TETA 4HCL (60-<W108)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Penicillamine during baseline period (D1-W12); TETA 4HCL during post randomisation and 1st extension period (W12-W60); Penicillamine during rondomisation and 1st extension period period (W12-W60); TETA 4HCL during 2nd extension period (W60-<W108)
Other intervention name(s): D-penicillamine; trientine tetrahydrochloride; D-Penicillamine; trientine tetrahydrochloride
Intervention MeSH terms: Penicillamine; Trientine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Onset and Duration of Mometasone by Oscillometry and Spirometry
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects
      in chronic asthma. However, they also have largely unappreciated early effects when initiated
      as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such
      an early effect better than spirometry. The investigators sought to examine the onset of
      action and sustained effects over 4 weeks treatment of mometasone furoate as measured by
      Impulse Oscillometry System (IOS) versus spirometry.
    


Intervention name(s): Mometasone furoate 220; KoKo Spirometry; Mometasone furoate 440; Oscillometry
Intervention type(s): Drug; Device; Drug; Device
Intervention description(s): dry powder inhaler QD for 28-43 days; dry powder inhaler QD for 28-43 days
Other intervention name(s): by Nspire; by Jaeger, MS IOS Digital
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; FEV1 and IOS change after mometasone for asthma
A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to evaluate the effect of
      semaglutide on cardiac repolarisation in healthy subjects.
    


Intervention name(s): semaglutide; placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.; Solution for s.c. injection or tablets for oral administration; Tablets for oral administration
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Three Laparoscopic Access Techniques
Condition: Benign Gynecological Pathology
Study type: Interventional

Summary: 
      The study compares the Veress needle technique, the Direct trocar insertion and the Open
      technique with each other, in terms of minor complications, in elective laparoscopic
      procedures for benign pathologies.
    


Intervention name(s): laparoscopy; Laparoscopy; Laparoscopy; Laparoscopy
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Trocar access in laparoscopy; The angle of the Veress needle insertion is 45 for non-obese women. After insertion of the needle, tests to determinate its correct positioning are: the double click test, the aspiration test, the handing drop test, serial intrabdominal gas pressure measurements.
The volume of CO2 inserted with the Veress needle depends on the intra-abdominal pressure. Adequate pneumoperitoneum should is determined by a pressure of 20 to 30 mm Hg and not by predetermined CO2 volume.; Direct insertion of the trocar is performed without prior pneumoperitoneum. Infra-umbilical skin incision is wide enough to accomodate the diameter of a sharp trocar/cannual system. The abdominal wall is elevated by pulling on, by hands, two towel clips placed 3 cm on either side of the umbilicus, and the trocar is inserted at a 90°angle.
On removal of the sharp trocar, the laparoscope is inserted to confirm the presence of omentum or bowel in the visual field.; A small incision, 1 cm long, is made through the skin of the lower edge of the umbilical fossa. The skin and the subcutaneous adipose tissues are retracted with the Zimmerman dissectors. The anterior rectus fascia is incised with the scalpel. The dissection with the Zimmerman valves allows the exposure of the peritoneum. After the peritoneum is incised, the trocar is inserted under direct vision. The laparoscope is introduced and insufflation is started. At the end of the procedure the fascial defect is closed.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparoscopy; trocars; veress; open; direct
Misopristol Versus Pitocin for Second Trimester Abortion
Condition: Abortion, Missed
MeSH terms: Abortion, Missed
Study type: Interventional
Phase: Phase 4

Summary: 
      Second trimester abortion can be done surgically or medically. Medical abortion with
      mifepristone and misopristol is one of the common protocol, but misopristol have high rate
      side effect. The investigators recent study proved the efficacy of pitocin after mifepristone
      in second trimester abortion with minimal side effects.

      Working hypothesis and aims: To compare misopristol and pitocin after mifepristone
      preparation in second trimester in seccess rate, interval to abortion, side effects and
      patient satisfaction.
    


Intervention name(s): mifepristone and misopristol; mifepristone and oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses; 200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)
Intervention MeSH terms: Oxytocin; Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1)
Condition: Shock,Hemorrhagic
MeSH terms: Shock, Hemorrhagic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the first part of this study is to determine the safety and tolerability of
      ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion
      (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects.

      The second part of the study will also be to determine the safety and tolerability of single
      ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic
      shock.
    

Detailed description: 
      Part 1 of the study will be a single center study intended to assess the safety and
      tolerability of valproic acid dosages at 15 mg/kg, 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg,
      150 mg/kg 180 mg/kg, 210 mg/kg and 250 mg/kg. Up to 72 healthy subjects (9 dose groups of 8
      subjects) will receive single doses of valproic acid or placebo via a 60-min IV infusion in a
      ratio of 3:1 active drug: placebo.

      Part 2 of the study will be a multicenter, double blind, placebo-controlled study in trauma
      patients with hemorrhagic shock who are able to give consent or severe trauma patients with
      hemorrhagic shock in whom a legally authorized representative can give consent. Up to 12
      patients (2 dose groups of 6 patients) will receive single doses of valproic acid or placebo
      via a 60-min IV infusion in a ratio of 2:1 active drug : placebo. The dose levels in Part 2
      will be the two highest doses that are demonstrated to have acceptable safety profile based
      on the review of safety data from Part 1.
    

Intervention name(s): Valproic Acid; Isotonic saline solution
Intervention type(s): Drug; Drug
Intervention description(s): By infusion over 1 hour; By infusion over 1 hour
Other intervention name(s): Depacon
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      The purpose of the study is to evaluate variation of BNP in non invasive mechanical
      ventilated patients with severe acute respiratory failure.
    

Detailed description: 
      The aim of the study is to evaluate in patients with severe acute respiratory failure
      requiring non invasive mechanical ventilation BNP levels at admission and during the
      following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure
      Ventilation or Continuous positive airway pressure).

      Because in patients affected by acute respiratory failure it is often difficult to
      distinguish if the disease precipitating the respiratory failure is a cardiac disease or a
      lung disease, aim of the present study is to evaluate the discriminating role that BNP could
      have in this group of patients; evaluation will be completed, once obtained clinical
      stabilisation, with an echocardiography and respiratory functional test.
    

Intervention name(s): Non invasive mechanical ventilation
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of the city of Torino, admitted to the emergency department for acute respiratory
        failure.
      
Keywords: Natriuretic peptide brain; Continuous positive airway pressure; Intermittent positive pressure breathing; Respiratory insufficiency
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
      effective therapy to improve glycemic control in patients with type 1 diabetes.
    

Detailed description: 
      Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
    

Intervention name(s): Dapagliflozin; Placebo for dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes
Large Overuse of Post-polypectomy Surveillance Colonoscopy
Condition: Colonic Polyps; Surveillance; Colonoscopy
MeSH terms: Colonic Polyps
Study type: Observational

Summary: 
      In colorectal cancer screening era a huge burden of medical resources has been applied to
      surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a
      mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of
      surveillance are lacking.

      The aim of present study was to evaluate the percentage of subjects in which timing of
      surveillance colonoscopy in practice agrees with that recommended by guidelines and to
      identify factors associated to the appropriateness of surveillance.
    


Intervention name(s): colonoscopy
Intervention type(s): Other
Intervention description(s): evaluation of surveillance timing adequacy as compared to the guidelines
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients referred to one out of 29 endoscopy units in Italy to undergo colonoscopy
A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare how well adalimumab works versus methotrexate (MTX) in children with
      moderate to severe psoriasis in the short term. It will also study how safe and how well
      adalimumab works in the long term and how long disease response can be maintained after
      stopping therapy.
    

Detailed description: 
      The study had a 30-day screening period and a multi-period study design, as described below:

      Period A - Primary Treatment Phase: Participants were randomized to receive adalimumab 0.8
      mg/kg, adalimumab 0.4 mg/kg, or MTX in 1:1:1 ratio for 16 weeks.

      Period B - Treatment Withdrawal Phase: Responders were withdrawn from active treatment and
      monitored for loss of disease control for up to 36 weeks.

      Period C - Re-Treatment Phase: Participants who had experienced loss of disease control in
      Period B were re-treated with adalimumab for 16 weeks.

      Period D - Long-Term Follow-Up Phase: Participants received adalimumab or were observed
      off-treatment (if disease remained under control) for 52 weeks.
    

Intervention name(s): Adalimumab; Methotrexate; Placebo to Adalimumab; Placebo to Methotrexate
Intervention type(s): Biological; Drug; Biological; Drug
Intervention description(s): Adalimumab by subcutaneous injection every other week (eow); Methotrexate 0.1 mg/kg at Week 0 and up to 0.4 mg/kg per week (maximum dose of 25 mg/week) orally.; A single subcutaneous loading dose at Week 0 followed by eow dosing beginning at Week 1.; Orally once a week
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Double-blind; Chronic plaque psoriasis; Pediatric
ROSCAP: Reduction of Smoking in Cardiac Patients Study
Condition: Nicotine Dependence; Tobacco Dependence; Cardiac Disease
MeSH terms: Heart Diseases; Tobacco Use Disorder
Study type: Interventional

Summary: 
      Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to
      test the effect of a smoking reduction intervention on cigarettes per day (cpd) and
      biochemical and clinical indicators of tobacco exposure. .
    


Intervention name(s): smoking reduction intervention (including NRT)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: tobacco; nicotine; smoking reduction