bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair
Condition: Umbilical Hernia; Epigastric Hernia
MeSH terms: Hernia, Umbilical; Hernia
Study type: Observational

Summary: 
      Umbilical and epigastric hernia repairs are common and performed by numerous surgical
      techniques. Considering that the hernia repairs in general are relatively small and simple
      procedures there are disproportionate poor results.

      The aim of present study is to determine surgical risk factors for readmission after
      umbilical and epigastric hernia repair and to report risk factors for later reoperation for
      recurrence.
    

Detailed description: 
      All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database
      are included in the study. The included patients will be followed in up to 4 years in order
      to identify correlation between technical aspects of the hernia repair and postoperative
      morbidity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All elective umbilical or epigastric hernia repairs registered in tha Danish National
        Hernia Database from January 1st 2007 to December 31st 2010
      
Keywords: readmission; recurrence; umbilical; epigastric; hernia; outcome; morbidity
Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The research study is designed to assess the technical feasibility and safety of a
      perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal
      popliteal, tibial or peroneal arteries immediately following successful angioplasty.
    


Intervention name(s): vonapanitase; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): PRT-201
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: peripheral artery disease; PAD; vonapanitase; critical limb ischemia; CLI; tibial artery; stenosis; distal popliteal artery; peroneal artery; below the knee; BTK; elastase; chymotrypsin-like elastase 1; CELA1; PRT-201
Aripiprazole Effects on Alcohol Drinking and Craving
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)
      is effective in reducing of alcohol craving and drinking compared to placebo depending on
      participant's baseline level of impulsivity.
    

Detailed description: 
      Non-treatment seeking individuals meeting criteria for alcohol dependence (N=120) will be
      recruited through advertisement and paid for their participation. Subjects will have blood
      drawn for DNA analysis of various brain dopamine system genes. Alcoholics, after baseline
      evaluation, will be assigned through urn randomization to one of two experimental groups,
      depending on their baseline level of impulsivity, in which they will receive either
      aripiprazole (up to 15 mg/day) or an identical placebo. Subjects will take the study drug or
      placebo for 8 days (day 1-6 being the natural observation period). After a minimum of 24
      hours of abstinence from alcohol (day 7-8) they will undergo an alcohol administration
      (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects
      will receive a brief counseling session at the end of the study to enhance their awareness of
      problem drinking and to motivate them to seek treatment. Referral for treatment will be
      offered.

      Each subject will undergo a functional MRI (functional magnetic resonance imaging) brain scan
      with cue stimulation on day 7, on the evening before the alcohol administration paradigm.
      fMRI (functional magnetic resonance) imaging brain imaging technology will be used to
      determine if alcoholics treated with aripiprazole differ in alcohol cue-induced activity in
      the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus accumbens
      activation to alcohol cues compared to placebo.

      Whether dopamine system genetic differences will be predict drinking, nucleus accumbens
      activity, and aripiprazole response will be explored.
    

Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole(up to 15 mg/day) for 8 days; Placebo to match active drug Aripiprazole for 8 days
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol; Aripiprazole; Impulsivity; Alcoholism; drinking; treatment; craving; brain imaging; genetics
Effects of the Ivabradine on Reduction of Inflammatory Markers in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether a pure heart rate-lowering agent
      (Ivabradine) reduces vascular inflammatory stress in patients with acute coronary syndromes
    

Detailed description: 
      The activation of inflammatory pathways plays an important contributory role in coronary
      plaque instability and subsequent rupture, which can lead to the development of acute
      coronary syndromes. Elevated levels of serum inflammatory markers such as high-sensitivity
      C-reactive protein (hs-CRP) represent independent risk factors for further cardiovascular
      events. Raised resting heart rate (HR) has been shown to be associated with cardiovascular
      events. Ivabradine is a new HR-reducing agent, which has demonstrated antianginal and
      anti-ischemic properties in patients with stable angina. In an atherosclerosis model,
      selective HR reduction with ivabradine has been shown to decrease markers of vascular
      oxidative stress, to improve endothelial function, and to reduce atherosclerotic plaque
      formation. We hypothesized that the addition of ivabradine to standard medical therapy has a
      beneficial effect on markers of inflammatory stress in acute coronary syndrome patients.
    

Intervention name(s): Ivabradine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).; Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ivabradine; Acute coronary syndrome.; Inflammation; C-reactive protein; Atherosclerosis
A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen.
Condition: Pregnancy Rate; Oocytes
Study type: Observational

Summary: 
      The aim of this non-interventional study is to extend the knowledge on effectiveness of
      Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a
      Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.
    


Intervention name(s): Ovaleap®
Intervention type(s): Drug
Intervention description(s): About 6-8 weeks of observation per patient from start of the stimulation therapy with Ovaleap® depending on the duration of the required stimulating therapy. Up to 10-11 months per patient for follow-up but only if in case of songraphically intact intrauterine pregnancy to determinate the "Baby-Take-Home-Rate" (live-births).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who get an ovarian stimulation therapy with Ovaleap® as preparation for a
        technique of an assisted reproduction (here: In-vitro-Fertilisation (IVF) or
        Intracytoplasmatic Sperm Injection (ICSI).
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics
Condition: Muscle Loss
Study type: Interventional

Summary: 
      The study investigates effects related to muscle protein metabolism at provision of
      Parenteral or enteral nutrition
    

Detailed description: 
      Randomized study investigation alterations in muscle protein metabolism at provision of
      parenteral or enteral (oral drink) nutrition. The study uses a
      genomic/transcriptomic/proteomic approach to evaluate factors related to activation of
      skeletal muscle protein synthesis and protein degradation. Patients scheduled for major
      gastrointestinal surgery are included. Muscle specimens are collected during surgery.
    

Intervention name(s): Parenteral nutrition (PN); Enteral nutrition; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.; Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.; Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN
Other intervention name(s): Total parenteral nutrition (TPN); nutrition drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Skeletal muscle
Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia
Condition: Sleep Apnea, Obstructive; Hypotonia; Child, Only
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Muscle Hypotonia
Study type: Interventional

Summary: 
      Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive
      sleep apnea, which if not treated has significant clinical consequence. Available treatment
      approaches, such as surgery and positive airway pressure, show limited efficacy and
      adherence. The multidisciplinary team has developed and now proposes to further test a
      non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has
      resolved even extremely severe obstructive sleep apnea, and improved patient and family
      quality of life.
    

Detailed description: 
      There is a critical need for safe and effective treatment options for persistent obstructive
      sleep apnea (OSA) in patients with Hypotonic Upper Airway Obstruction (HUAO). HUAO encompass
      conditions such as cerebral palsy, hypoxic encephalopathy, syndromic tone anomalies, and
      neuromuscular disorders, and typically share a similar pattern of multisite upper airway
      collapse. OSA is characterized by recurrent episodes of partial or complete upper airway
      obstruction during sleep with associated arousals and/ or oxygen desaturations. Of hypotonic
      patients with symptoms of sleep disordered breathing, one quarter have moderate OSA, and more
      than half have severe OSA. Thus, not only are patients more likely to have OSA, but it is
      likely to be much more severe. Currently available treatment options, ranging from palliative
      care to tracheostomy, often fail to fully meet the needs of these patients. The
      multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal
      airway stent that has demonstrated good tolerability in hypotonic patients. This initial
      phase will test an enhanced version of the device for acceptability and tolerability.
      Critically, insertion, adherence, and compliance protocols will be optimized for preparation
      of the full trial.

      This record originally included the Secondary Outcome Measure "Device Design". This Secondary
      Outcome Measure was removed during the results reporting process upon advisement of
      ClinicalTrials.gov reviewers, as it was not a directly health-related outcome.
    

Intervention name(s): ssNPA
Intervention type(s): Device
Intervention description(s): The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Hypotonia; Nasal airway; Tolerability
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of co-administration of itraconazole or
      diltiazem on the single-dose pharmacokinetics of danicamtiv in healthy participants.
    


Intervention name(s): Danicamtiv; Itraconazole; Diltiazem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Itraconazole; Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Danicamtiv; Itraconazole; Diltiazem; BMS-986434; CYP3A4
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius)
      syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a
      day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is
      called SCORAD. The doctor also rated how much relief the patient got from treatment and
      recorded any side effects.
    


Intervention name(s): desloratadine
Intervention type(s): Drug
Intervention description(s): desloratadine syrup; 5.0 mL once daily for 28 days
Other intervention name(s): Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
Intervention MeSH terms: Desloratadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Relationship Between Blood Clotting Disorders, Inflammation, and Obesity in Individuals With Venous Disorders and Post-Thrombotic Syndrome
Condition: Venous Thrombosis; Venous Insufficiency
MeSH terms: Thrombosis; Venous Thrombosis; Venous Insufficiency; Postthrombotic Syndrome; Postphlebitic Syndrome; Inflammation
Study type: Observational

Summary: 
      Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome
      (PTS) is a painful condition that can develop following a venous thrombosis in one of the
      deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein,
      other factors may be responsible for the development of this condition. This study will
      analyze genetic and biologic samples from participants of a previous study to examine other
      possible causes of venous diseases and PTS.
    

Detailed description: 
      The long-term effects of venous thrombosis, known collectively as PTS, include persistent
      swelling, pain, cramps, and numbness in the leg. These symptoms result from impaired return
      of blood through the veins of the lower leg to the heart. PTS is believed to occur as a
      result of direct damage to the valves and walls of the vein. There may be specific factors
      that make certain individuals more prone to PTS. Individuals who are obese, have a genetic
      predisposition to blood clotting disorders, or have high levels of inflammation biomarkers
      may have an increased risk of developing venous diseases. The purpose of this study is to
      investigate the possible link between these factors and the occurrence of chronic venous
      disease and PTS. The study's findings will be useful in developing new prevention and
      treatment strategies.

      This study will examine previously collected data from participants in the San Diego
      Population Study, a study that gathered information on the prevalence of chronic venous
      disease in a multi-ethnic group of individuals. There will be no study visits specifically
      for this study. Researchers will examine stored genetic and biologic samples of 370 control
      participants and 370 participants with chronic venous disease. Specifically, levels of
      inflammation biomarkers, levels of obesity-related biomarkers, and genetic predispositions
      for blood clotting disorders will be studied.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will examine previously collected data from participants in the San Diego
        Population Study.
      
Keywords: Deep Vein Thrombosis; Chronic Venous Insufficiency; Post Thrombotic Syndrome; Blood Coagulation; Inflammation
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This is a dietary intervention study designed to assess the impact of long chain (LC) n-3
      polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS).
      Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the
      adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary
      supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive
      age. Long-term, safe and efficacious treatments are needed for women with this condition, and
      dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to
      be potent biological regulators, involved in the amelioration of many of the adverse
      metabolic risk factors which are often present in women with PCOS. The aim of this study was
      to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well
      as on the hormonal profile of women with PCOS.
    

Intervention name(s): LC n-3 PUFA (fish oil) Supplement; Placebo (olive oil) supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks; 4 x 1g olive oil capsules were given daily for 6 weeks
Other intervention name(s): LC n-3 PUFA (fish oil); Placebo (PL); Wash-out (WO)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PCOS
A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of Part I of this study is to evaluate the relative bioavailability of a new
      formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given
      to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by
      the body. In Part II, the main aim is to assess the dose linearity of the new formulation.

      Participants will receive 2 doses in Part I and 4 doses in Part II.

      Participants need to visit their doctor approximately 14 days and 30 days after the last dose
      of study drug.
    

Detailed description: 
      This study will be conducted in two parts (Part I and Part II). Part I consists of two
      treatment periods with 2 sequences and part II consists of four treatment periods with 4
      sequences. In Part I, relative bioavailability of Formulation A (Test: 100 microgram [mcg]
      rhPTH[1-84]) will be compared with Formulation B (Reference: 100 mcg rhPTH[1-84]). In Part
      II, dose linearity of the new formulation, Formulation A, of rhPTH (1-84) will be assessed
      based on 4 different dose levels as dose c - f (dose c = 25 mcg, dose d = 50 mcg, dose e = 75
      mcg and f = 200 mcg). Both parts may be conducted concurrently.
    

Intervention name(s): rhPTH(1-84)
Intervention type(s): Drug
Intervention description(s): Participants in both part I and part II of the study will receive a single SC injection of rhPTH(1-84) depending upon the treatment sequence allocation on Day 1 of each treatment period.
Other intervention name(s): Recombinant Human Parathyroid Hormone
Intervention MeSH terms: Parathyroid Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      Post Marketing study, Interventional, Prospective, non randomised

      Describe how the MD is using the information of the ICM in addition of standard FU(clinical
      exam and holter 24h)post AF ablation(1 year FU).
    


Intervention name(s): ICM Implantation
Intervention type(s): Device
Intervention description(s): Sub cutaneous implantation of the ICM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care