bioihbjkbjnl/mcl2 huggingface dataset:
Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. It is not yet known whether gemcitabine and erlotinib are more effective when given
      alone or together in treating non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how
      well they work when given alone or together as first-line therapy in treating older patients
      with stage IIIB or stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the progression-free survival rate of older patients with stage IIIB or IV
           non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib
           hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line
           therapy.

      Secondary

        -  Determine the response rate in patients receiving these regimens.

        -  Determine the overall survival rate in patients receiving these regimens.

        -  Determine the toxicity profile of these regimens in these patients.

        -  Determine the quality of life of patients receiving these regimens.

      OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study.
      Patients are stratified by gender, smoking status (never or light vs current or former), and
      ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.

        -  Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with
           progressive disease may cross over to arm II.

        -  Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.

        -  Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib
           hydrochloride as in arm II.

      In all arms, treatment repeats every 21 days for 4 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study therapy, patients are followed every 2 months for 3 years.
    

Intervention name(s): erlotinib hydrochloride; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): given orally; given IV
Other intervention name(s): Tarceva; Gemzar
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Nutritional Supplements for Exercise Recovery
Condition: Post-exercise Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      This study will examine the effects of nutritional supplement on post-exercise muscle
      soreness as well as recovery of muscle strength and function.
    


Intervention name(s): Supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): dietary supplement contain protein from milk and fruit extract; color, taste, and calorie-matched placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Obesity is one of the greatest causes of preventable morbidity and mortality worldwide with
      the main treatments requiring significant changes to lifestyle, particularly dieting and
      physical exercise. Glucomannan is a dietary fibre that expands in the stomach, creating the
      feeling of fulness, while chromium can regulate insulin response.
    

Detailed description: 
      The aim of this pilot study was to investigate the effect of agglomerated glucomannan,
      oligofructose and chromium, as part of a calorie restricted diet plan, on weight loss,
      satiety, satiation, mood and gut microbiome composition in a human intervention study.
    

Intervention name(s): agglomerated glucomannan, oligofructose and chromium mixture
Intervention type(s): Dietary Supplement
Intervention description(s): Participants visited the University of Roehampton on three separate occasions: visit 1 (screening), visit 2 (baseline), and visit 3 (end of the trial) in total over a period of 4-weeks. During the 4-week study period, participants were instructed to replace breakfast and lunch with a shake (206 kcal/shake) each delivering 3g of the active ingredient (Mix: agglomerated glucomannan, oligofructose and chromium picolinate), and one snack bar each delivering 1.5g of the active ingredient (112 kcal/bar) in between breakfast and lunch, and lunch and dinner following by a selection of healthy dinner according to standard nutritional guidance not exceeding 1500 kcal/day. All subjects were instructed to prepare shakes by using a shaker or blender by mixing all ingredients with 200 ml of water. Participants were also instructed to consume all shakes and bars with an extra 200 ml glass of water throughout the study period.
Intervention MeSH terms: Chromium; (1-6)-alpha-glucomannan
Intervention model: Single Group Assignment
Intervention model description: Single group, prospective, open label pilot human intervention study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hormones; microbiota; mood; hunger; weight loss
Chest Physiotherapy in Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of
      age, during two consecutive seasonal outbreaks.
    

Detailed description: 
      A randomized controlled trial was conducted (following CONSORT Statement) in the Paediatric
      Emergency Department of Centro Hospitalar Universitário São João-Porto (CHUSJ), a tertiary
      care hospital, during the period from December to March in 2011 and 2012.

      Ethical approval was obtained from the Ethics Committee of Centro Hospitalar Universitário
      São João-Porto.

      Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on
      clinical findings, including wheezing or wheezing with crackles, respiratory distress and
      alteration of feeding condition, were signalized by the physician who met them at the
      emergency room.

      Then, the main investigator of the study interviewed the caregivers and informed about the
      aims and procedures of the study, after a formal written consent in accordance with the
      Declaration of Helsinki was sign by all the caregivers.

      Severity grade was established with the Kristjansson Respiratory Score which variate from
      light to severe, being the light to moderate selected to study.

      Randomization in intervention or control group was made by the method of permuted-blocks. All
      children were assessed in a calm environment, while awake and not crying, and were submitted
      to a standard assessment protocol consisting of a clinical demographic data collection by
      interview of parents and the application of the Kristjansson Respiratory Score. All children
      underwent the same medical treatment protocol at the pediatric emergency department (PED),
      consisting in nebulization with medication, during the emergency room episode, and counselled
      in the subsequent one or two weeks and were followed during two weeks after discharge from
      PED, being reassessed at the end of the two weeks.

      Children from Intervention Group (IG) underwent a standard intervention chest physiotherapy
      protocol performed by a physiotherapist, consisting on the techniques: prolonged slow
      expiration (PSE), rhinopharyngeal retrograde clearance (RRC) and provoked cough (PC).
    

Intervention name(s): Chest physiotherapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trial with two groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bronchiolitis; chest physiotherapy; children
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term
      20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
    

Detailed description: 
      Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical
      treatment in PDA is associated with higher rate of complication than pharmacologic treatment.
      Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in
      term neonates after the first days of birth are rare. The aim of current study is to evaluate
      the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to
      Bandarabbas children' hospital in 2011.
    

Intervention name(s): Oral Ibuprofen
Intervention type(s): Drug
Intervention description(s): 10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
Other intervention name(s): Advil
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patent Ductus Arteriosus; PDA; Term newborns; Ibuprofen
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation
      with controlled release flecainide on patient's quality of life.
    


Intervention name(s): Flecainide controlled release
Intervention type(s): Drug
Intervention MeSH terms: Flecainide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tambocor; Paroxysmal Atrial Fibrillation; Quality of Life
Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
Condition: Hemorrhagic Stroke; Intracerebral Hemorrhage (ICH)
MeSH terms: Stroke; Cerebral Hemorrhage; Hemorrhagic Stroke; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate
      efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage
      (ICH)
    

Detailed description: 
      This was the first trial of BAF312 in ICH patients to evaluate if BAF312 had the potential to
      limit brain inflammation after ICH, and thereby improve neurological outcome for stroke
      patients when administered in addition to standard of care.

      ICH patients meeting study criteria were randomized at 1:1 ratio into either active or
      placebo group. Patients received an intravenous infusion (i.v.) treatment within 24 hours of
      an ICH event and were up titrated for 7 days. Following the i.v. treatment, participants
      received 10 mg BAF312 or placebo in tablet form (taken daily orally) for an additional 7
      days. Participants were followed for an additional 76 days after treatment for neurological
      and safety conditions during three clinic visits.

      Recruitment for the trial was put on hold due to the COVID-19 pandemic. Thirty-two patients
      had been enrolled in the trial and completed the protocol as planned. After seven months of
      the trial being on hold, an Interim analysis was conducted and reviewed by the Data
      Monitoring Committee. Novartis terminated the trial due to lack of potential efficacy.
    

Intervention name(s): BAF312 solution; Matching Placebo for BAF312 solution; BAF312 tablet; Matching Placebo for BAF312 tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Solution for intravenous (IV) infusion - 4.5mg/4.5mL; Solution for intravenous (IV) infusion - 0mg/4.5mL matching placebo; 2 mg film-coated tablet; 0 mg film-coated tablet matching placebo
Other intervention name(s): Siponimod; Siponimod
Intervention MeSH terms: Pharmaceutical Solutions; Siponimod
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, patient- and investigator-blinded, placebo-controlled, parallel group study of BAF312 on top of standard-of-care for ICH, consisting of 3 epochs: Screening/Baseline, Treatment (Day 1-14), and Follow-Up (to Day 90)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; intracerebral hemorrhage; ICH; BAF312; siponimod; sphingosine-1-phosphate receptor; adult
Safety and Performance Study of the NeoChord Device
Condition: Mitral Valve Regurgitation
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000
      Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in
      patients with mitral regurgitation.
    


Intervention name(s): NeoChord DS1000 Artificial Chordae Delivery System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NeoChord; DS1000; Mitral Valve; Mitral Valve Regurgitation; MR; Mitral Valve Repair; Mitral Valve Prolapse; Artificial Chordae
Early Mobilization Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is
      done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease
      pain, and to increase range of motion (ROM) and strength. This is done arthroscopically;
      through a small incision in the patient's shoulder. After surgery, patients are usually
      placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this
      time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or
      active shoulder movement is usually not permitted to allow the repaired tendons to heal.
      Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can
      delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a
      slower return-to-work or daily activities, and may also impact the health care system,
      through increased use and cost of rehabilitation.

      This study's purpose is to determine if patients can safely stop wearing their sling as early
      as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will
      be randomly assigned to one of two study groups:

      Patients in Group A (accelerated rehab) will wear their sling for comfort only following
      surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may
      stop wearing their sling if pain and comfort allow, and start active movement for activities
      of daily living only.

      Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A,
      self-assisted ROM exercises are allowed at any time, but active movement will not be allowed
      until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM
      exercises after surgery.

      Patients who agree to participate in the study will see their surgeon and the study physical
      therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months
      post-surgery). Each visit will take about 30 minutes and will include a ROM assessment,
      strength assessment (as appropriate) and disease-specific quality of life questionnaires.
      Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at
      12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse
      events will be examined between the two groups. Differences will also be examined according
      to RC tear size and patient characteristics.
    


Intervention name(s): No Sling; Sling
Intervention type(s): Procedure; Procedure
Intervention description(s): Early range of motion; Patients will use the sling for 6 weeks, as per usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of 3 different dose
      levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults
      20 to 49 years of age.

      This study will also evaluate the safety and tolerability of 3 different dose levels of
      ASP3772 administered subcutaneously or intramuscularly, in comparison to the active
      comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly
      subjects 65 to 85 years of age.
    


Intervention name(s): ASP3772 (subcutaneous); ASP3772 (intramuscular); PPSV23 (subcutaneous); PPSV23 (intramuscular)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Subcutaneous injection; Intramuscular injection; Subcutaneous injection; Intramuscular injection
Other intervention name(s): Pneumovax NP; Pneumovax NP
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; ASP3772
Melatonin Treatment for Tardive Dyskinesia in Schizophrenia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional

Summary: 
      This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on
      therapy to antipsychotics will be performed to examine the effects of melatonin on tardive
      dyskinesia symptoms and cognitive deficits in 120 patients with established tardive
      dyskinesia (TD). This study addresses a free radical hypothesis of TD.
    

Detailed description: 
      1. Since it has been proposed that neuroleptic-induced increases in free-radical production
           may relate to the development of TD, the investigators hypothesize that melatonin, an
           effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms.

        2. Due to increased cognitive deficits in patients with TD and implication of oxidative
           stress in cognitive impairment, the investigators hypothesize that both cognitive
           impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological
           stimulus--oxidative stress. Hence, the investigators further hypothesize that both
           tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved
           by melatonin simultaneously.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg/day, 12-week treatment; 10mg/day, 12-week treatment for TD
Other intervention name(s): APRD00742
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tardive Dyskinesia; Schizophrenia; Melatonin; Oxidative Stress; Antioxidant
Evaluate Severe Hepatic Impairment on Dacomitinib PK
Condition: Severe Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a post approval requirement to study the effect of severe hepatic impairment on the
      pharmacokinetics of dacomitinib.
    

Detailed description: 
      This is a Phase 1, open label, parallel group study to investigate the effect of severe
      hepatic impairment on the plasma PK, safety and tolerability after a single oral 30 mg dose
      of dacomitinib under fasted conditions.

      Approximately 18 participants will be enrolled into the study to ensure at least 6 PK
      evaluable (having data for estimating primary PK parameters for dacomitinib) participants in
      each cohort.
    

Intervention name(s): Dacomitinib
Intervention type(s): Drug
Intervention description(s): anti-cancer agent
Other intervention name(s): PF-00299804; VIZIMPRO
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Dacomitinib; Hepatic Impairment
Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
Condition: Coronary Occlusion
MeSH terms: Coronary Occlusion
Study type: Interventional

Summary: 
      This study will include up to 60 eligible male and female subjects. The purpose of this trial
      is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to
      facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The
      procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel
      that requires revascularization after a previously failed attempt to cross or refractory to
      10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's
      Pivotal study.
    

Detailed description: 
      The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™
      micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in
      coronary arteries. The procedure will be conducted on consenting patients diagnosed with a
      CTO in a coronary vessel that requires revascularization after a previously failed attempt to
      cross or refractory to 10 minutes of conventional guidewire attempt.
    

Intervention name(s): NovaCross™ Chronic Total Occlusion micro-catheter
Intervention type(s): Device
Intervention description(s): The NovaCross™ micro catheter is a guidewire positioning and support micro catheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment. Investigators will use the NovaCross Micro catheter during a standard of care catheterization of patients diagnosed with coronary total occlusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment