bioihbjkbjnl/mcl2 huggingface dataset:
Effect of IDEA-070 on Pain and Inflammation Induced by PDT
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objectives: effect of IDEA-070 compared to placebo on pain and inflammation induced
      by PDT. The primary objective is to detect a statistically significant difference of pain and
      inflammation induced by PDT in test areas treated with IDEA-070 compared to placebo-treated
      areas.
    


Intervention name(s): IDEA-070
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
FDA: Lowering Orthopedic Opioid Dosing (FLOOD)
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This randomized trial evaluates an intervention to minimize use of opioids following total
      hip and total knee replacement. Half the participants will receive an intervention (mailed
      educational materials, followed by a pharmacist call), and half will receive usual care.
    

Detailed description: 
      Surgeons and anesthesiologists prescribe opioids and other analgesic medications for acute,
      post-surgical pain. Recent studies have reported that some patients persist in taking opioids
      for months beyond the surgery. While opioids are commonly used for pain management following
      surgery, patients and their providers often don't have a planned method to optimize opioid
      exposure. This can lead to patients entering a cycle of opioid use that is difficult to
      manage, because, as opioid exposure is continued, pain relief is reduced and side effects
      increase. The investigators' study is aimed at reducing opioid exposure following total hip
      and total knee replacement.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention consisted of a mailing 2 weeks prior to surgery, another 2 weeks post surgery, and a pharmacist intervention if a refill of opioid medication was requested within 90 days of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Condition: Attention-deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 -
      12 years of age, inclusive) with a confirmed diagnosis of ADHD.
    


Intervention name(s): Centanafadine
Intervention type(s): Drug
Intervention description(s): Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohorts (Cohorts 1 and 6), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Condition: HHT; Morbus Osler; Epistaxis
MeSH terms: Epistaxis; Telangiectasis; Telangiectasia, Hereditary Hemorrhagic
Study type: Interventional
Phase: Phase 2

Summary: 
      In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in
      patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser
      therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal
      bevacizumab compared to placebo in a randomized double blind trial setting.
    


Intervention name(s): Bevacizumab; NaCl
Intervention type(s): Drug; Drug
Intervention description(s): 100mg intranasal submucosal bevacizumab in 10ml; 10ml of 0.9% NaCl intranasal submucosal
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epistaxis; Osler; Weber; Rendu; HHT; Hereditary haemorrhagic telangiectasia
AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or
      upper intestinal damage following administration of high-dose aspirin in healthy volunteers
    


Intervention name(s): AGN 201904; esomeprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, parallel, multi-center, single-blind study is designed to compare the safety
      and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy
      for a routinely accepted indication.
    


Intervention name(s): HalfLytely and Bisacodyl Tablets - Formulation 1; HalfLytely and Bisacodyl Tablets - Formulation 2; NuLYTELY
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Bisacodyl; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: colonoscopy; bowel preparation; prep
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants in Australia
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the
      treatment of Epilepsy.
    

Detailed description: 
      The purpose of this study is to see how safe the study drug is and how well it is tolerated
      after dosing. The study will also test how the study drug is taken up and eliminated by the
      body. An additional part of the study is to look at how this could be changed by giving the
      study drug with food.And identify and characterize metabolite of investigational product(s).
    

Intervention name(s): CB03-154; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CB03-154 tablet once daily.; Placebo tablet once daily.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nutrition Protocol and Premature Infants' Growth
Condition: Premature Infants; Nutrition Deficiency Due to Insufficient Food; Growth Retardation
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the
      first weeks of life is responsible for postnatal growth restriction and adverse long-term
      outcomes.

      This study aimed at evaluating the impact of the introduction of an updated, standardized,
      nutrition protocol on very premature infants' growth and morbidity, and the care givers'
      compliance to the new protocol.
    


Intervention name(s): nutrition protocol introduction
Intervention type(s): Other
Intervention description(s): Growth comparison of 2 cohorts of infants evaluated in a before-after design
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All infants born between 26 to 32 weeks gestation and admitted to our level III NICU were
        eligible and included in the study
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized
      double blind-controlled trial
    


Intervention name(s): Zolpidem (Myslee®); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Myslee; FK199B
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Zolpidem; Adolescent
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is
      Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted
      State, and to Assess the Relative Bioavailability of Process Variants of Tablets
    

Detailed description: 
      An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406
      in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state
      and in Combination with Ranitidine in Fasted State, and to Assess the Relative
      Bioavailability of Process Variants of Tablets
    

Intervention name(s): Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference); Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed; Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A); Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B); Ranitidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference); 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed; 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A); 1 x 150mg mannitol based 38% drug loaded tablet(batch variant B); 150 mg ranitidine
Intervention MeSH terms: Mannitol; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: R406,; Fostamatinib,; Phase I,; Healthy Subjects,; Pharmacokinetics,; Fed/Fasted
The Optiflow Patency and Maturation Study
Condition: End-stage Kidney Disease; End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The objective of this study is to assess the performance and safety of the Optiflow
      Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous
      arteriovenous fistula (AVF) anastomoses.
    

Detailed description: 
      The investigation is designed as a multi-center, prospective, single-arm, clinical study of
      the Optiflow performance and safety in a maximum of 180 subjects which includes one (1)
      roll-in subjects per investigator (maximum of 36 roll-in subjects). Subjects will be followed
      at 14 days post-procedure, 42 days post-procedure, and 90 days post-procedures.

      Results will be compared to a pre-established performance goal.

      Up to fifteen (15) investigational sites will participate in the investigational study.

      The primary performance endpoint is the overall maturation percentage rate at 90 days.
      Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm
      and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound.

      The primary safety endpoint is a composite endpoint of serious adverse events known to be
      associated with arteriovenous fistula anastomosis surgical procedures through 90 days.
    

Intervention name(s): Optiflow
Intervention type(s): Device
Intervention description(s): The Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access.
Other intervention name(s): Optiflow Anastomotic Connector
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End-stage renal disease; ESRD; AVF; Fistulas
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Condition: Progesterone Levels; Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate levels of progesterone in the luteal phase after
      various stimulations in the follicular phase and treatment with GnRH antagonist protocol
      followed by GnRHagonist as induction of ovulation.
    

Detailed description: 
      The purpose of this study is to investigate levels of progesterone in the luteal phase after
      various stimulations in the follicular phase and treatment with GnRH antagonist protocol
      followed by GnRHagonist as induction of ovulation. Furthermore the aim is to explore whether
      the luteal phase can be supported with small daily boluses of hCG without the administration
      of exogenous P, while maintaining good reproductive outcome.
    

Intervention name(s): hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase; hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase; LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase; vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): when the follicles are over 12 mm FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) is replaced by hCG (r-hCG, Ovitrelle,Merck-Serono, Hellerup,Denmark).; hCG(r-hCG,Ovitrelle,Merck-Serono, Hellerup, Denmark) is given together with FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) from the beginning of the FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark)stimulation.; LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.; The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-
Intervention MeSH terms: Chorionic Gonadotropin; Estradiol; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Daily Dose Regimens of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for 4 Weeks on Top of Maintenance Therapy With Inhaled Corticosteroid Controller Medication
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks
      treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg
      tiotropium administered twice daily (morning and evening). In addition compare the 24 hours
      pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium
      administered twice daily in pharmacokinetic sub-investigation.
    


Intervention name(s): Tiotropium 5 mcg qd; Tiotropium 2.5 mcg bid
Intervention type(s): Drug; Drug
Intervention description(s): 2 puffs (2.5 mcg each) in the evening 5 mcg in total and 2 puffs of matching placebo in the morning; 2 puffs (1.25 mcg each) twice daily, in the evening and in the morning, 5 mcg in total
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Effect of Early Education on the Observance of CPAP Treatment
Condition: Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed.
      SA can increase the occurrence of cardiovascular, endocrine and metabolic events
      (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard treatment of
      SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is
      a significant problem where a significant rate of rejection and abundance after 6 months of
      treatment.
    

Detailed description: 
      Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years)
      and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male
      gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic
      events (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard
      treatment of SA and to prevent these events, with a major clinical benefit, long term
      adherence to CPAP is a significant problem where a significant rate of rejection and
      abundance after 6 months of treatment.

      The investigators hypothesize that an early education and information of SA (in the first 2
      weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to
      increase significantly the optimal observance of CPAP (> 5 h/night).

      Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the
      apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health
      consequences in an early education and information during five months against a control group
      receiving only usual care (standard).
    

Intervention name(s): Coaching group; Control group
Intervention type(s): Behavioral; Other
Intervention description(s): patients will have a medical consultation at 2 weeks post-diagnostic and one phone call/month for duration of 5 months. The consultations will use visual support, CPAP device and its accessories.; patients receive only usual care (standard), it's mean: diagnosis with explanation of the disease and benefit of CPAP, entrusts a medical device provider, then an appointment proposed by the doctor or taken by the patient (5 months).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleep Apnea; CPAP
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
Condition: Heart Arrhythmias
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The registry will obtain information to determine the safety of sports participation for
      patients with defibrillators (ICDs).
    

Detailed description: 
      Patients who are participating in sports who have defibrillators will be invited to
      participate in a prospective registry to determine the rate of adverse events occurring
      during sporting activities. Patients will be followed for four years and adverse events
      quantified. Yale is the coordinating center for this multicenter registry.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals between the ages of 10 and 60 years who have defibrillators who participate in
        competitive (organized sports at any level) or dangerous sports.
      
Keywords: ICD; Sports
Superset Strength Training for Time-efficiency
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Physical inactivity is a global challenge and there is an urgent need to find strategies to
      increases people's activity levels. Strength training is one of the activities that is
      recommended to engage in regularly by both the American College of Sports Medicine and the
      World Health Organization. Understanding how strength training can be done effectively
      without spending much time could potentially increase people's involvement in strength
      training, as lack of time often is reported as barrier to training. Superset strength
      training can potentially be a time-efficient way of strength training, as this training
      method has been found to take half the time of the traditional ways of training.

      The aim of the present study is therefore to compare the effects of superset strength
      training and traditional strength training on muscular strength, body composition and
      fatigue.
    


Intervention name(s): Superset strength training; Traditional strength training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three weeks of familiarization (two times per week) to the exercises leg-press, bench press, lateral pulldown and seated rows, followed by superset strength training two days per week for 12-weeks. Superset 1 are bench-press and seated rows, and superset 2 are leg-press and lateral pulldown. Each superset is performed three times.; Three weeks of familiarization (two times per week) to the exercises leg-press, bench press, lateral pulldown and seated rows, followed by strength training two days per week for 12-weeks. Each exercise is performed for three sets with rest intervals between each set.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Resistance training; Muscle strength
Olfaction Changes in Patients Undergoing Spine Surgery
Condition: Orthopedic Disorder of Spine; Smell Disorder
MeSH terms: Musculoskeletal Diseases; Spinal Diseases; Olfaction Disorders
Study type: Observational

Summary: 
      This observational prospective study evaluates perioperative olfaction alterations,
      comprising changes in threshold value, discrimination and identification, which occur in
      spine patients. The single group is subjected to a preoperative and a postoperative
      assessment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing spine surgery.
The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Observational

Summary: 
      The effect of portal hypertension on gastrointestinal motility, and how reversal or
      improvement in portal hypertension may alter gastrointestinal motility, remains unclear and
      further research is needed. Additionally, patients with cirrhosis have altered gut
      microflora, particularly rich in lactobacilli, including enterococci and bifidobacteria.
      Transjugular Intraheptic Portosystemic Shunting (TIPS) is a procedure performed by
      interventional radiologists, in which a connection is made between the portal and venous
      circulations, allowing high pressure portal blood to more easily enter the systemic
      circulation and bypass the liver; thus effectively decreased portal pressure.
    


Intervention name(s): SMART Pill Pre-TIPS; SMART Pill Post TIPS
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies; Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 patients recruited from NYU Langone Medical Center
      
Keywords: Gut Microflora; Transjugular Intraheptic Portosystemic Shunting