bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
Condition: Gastroesophageal Reflux; Sleep Apnea
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Patients with a clinically indicated sleep study will be enrolled in this study. They will
      have a diagnostic and a therapeutic sleep study with continuous positive airway pressure
      ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic
      reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be
      compared to reflux episodes while on continuous positive airway pressure ventilation.
    


Intervention name(s): Continuous positive airway pressure ventilation
Intervention type(s): Procedure
Intervention description(s): CPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety Study of AADvac1, a Tau Peptide-KLH-Conjugate Active Vaccine to Treat Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-time-in-man study is mainly designed to assess the safety and tolerability of
      AADvac1 in the treatment of Alzheimer's disease.

      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is
      the main constituent of neurofibrillary tangles (NFTs), and is intended to be a
      disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.

      As this study is a Phase I study focused on tolerability and safety, efficacy will be
      assessed in an exploratory manner.
    

Detailed description: 
      AADvac1 is a candidate therapeutic vaccine for Alzheimer's disease that targets misfolded tau
      protein, a common denominator of neurofibrillary pathology. Based on preclinical results, the
      intervention is expected to reduce the number of neurofibrillary tangles, remove
      hyperphosphorylated tau protein and reduce the amount of oligomerized and insoluble
      pathological tau in the brain, to halt the spread of neurofibrillary pathology through the
      brain, and thus prevent associated cognitive decline.

      The vaccine's antigenic determinant is a synthetic peptide derived from a tau protein
      sequence, which is coupled to keyhole limpet hemocyanin (KLH) and uses aluminum hydroxide
      (Alhydrogel) as an adjuvant.

      At present AADvac1 is intended as an active immunotherapy for patients with diagnosed
      Alzheimer's disease (AD). Patients will receive 3 - 6 immunization doses; the raised titers
      of therapeutic antibodies and possible benefits of the treatment can extend beyond the
      duration of the study.

      Because of the central role of pathological misfolded tau protein in the etiology of AD, the
      vaccine is expected to be more effective than active or passive immunotherapies aiming to
      eliminate the amyloid β plaques that have been clinically investigated so far.
    

Intervention name(s): AADvac1; Placebo
Intervention type(s): Biological; Other
Intervention description(s): AADvac1 is intended as an active vaccination for disease-modifying treatment of Alzheimer's disease.; The placebo contains the same buffer and adjuvant as AADvac1, but lacks the API.
Other intervention name(s): (no commercial or INN name assigned yet); (no other names)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer disease; tau protein; neurofibrillary degeneration; disease-modifying
Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes
Condition: Trauma; Emergencies; Child, Only
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The aim of this study is to compare trauma related to others sport to trauma due to
      trampoline in pediatric emergencies of Rennes.
    

Detailed description: 
      Trampoline accidents are increasing since a few years. In Rennes hospital, pediatric
      emergencies are experiencing a subjective increase in admissions for trampoline trauma with
      increasingly early ages and severe trauma. The aim of this study is to compare trauma related
      to others sport to trauma due to trampoline in pediatric emergencies of Rennes.

      In parallel, retrospective data analysis will be performed on the same data during the year
      2008, to compare with a period before the explosion of trampoline sales.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 2 and 16 years old consulting in pediatric emergencies for a trauma
        related to trampoline Children between 2 and 16 years old consulting in pediatric
        emergencies for a trauma related to others sport
      
Keywords: trampoline
Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation
Condition: Healthy
Study type: Interventional

Summary: 
      The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated
      with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in
      an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early
      development of diaphragmatic atrophy in as early as 18 hours of complete diaphragm
      inactivity. These changes in muscle properties result in a decrease in the force generating
      capability of the muscle, ultimately resulting in difficulty to restore spontaneous breathing
      and a subsequent prolonged weaning process or failure. A prolonged weaning period is
      associated with longer duration of MV, which may result in a cascade of further diaphragm
      dysfunction, weakness, and injury.

      Stimulation of the phrenic nerves to produce diaphragm contraction and activity is a possible
      mechanism to reduce MV related diaphragm dysfunction. Two promising studies have shown the
      potential of repetitive phrenic nerve stimulation on inducing diaphragm activity in human
      subjects with trains of pulses via both cervical and bilateral phrenic nerve stimulation.
      However, neither study provided optimal stimulation settings. As such, the primary purpose of
      this study is to investigate the optimal settings for noninvasive phrenic nerve stimulation
      to induce diaphragm contraction.
    


Intervention name(s): Uni- and bilateral magnetic phrenic nerve stimulation
Intervention type(s): Other
Intervention description(s): Uni- and bilateral magnetic phrenic nerve stimulation using different coils, stimulation patterns (frequency, intensity, number of pulses) and locations (neck, chest).
Intervention model: Single Group Assignment
Intervention model description: Each participant enrolled in the study will be tested with different stimulation settings on three different days in a randomized order.
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of RZL-012 on Submental Fat Reduction
Condition: Submental Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 135 eligible male or female subjects will be randomized according to a
      predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection
      treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored
      for safety and efficacy over 84 days.
    

Detailed description: 
      Each subject will be randomized to either active treatment (high or low dose RZL-012) or
      placebo at a ratio of 1:1:1 per group and receive one of the following:

        -  low dose (concentration of injected solution 34 mg/mL RZL-012) of 5.1 mg/0.15
           mL/injection point that results in a dose/volume of 163.2±20.4 mg/4.8±0.6 mL RZL-012,

        -  high dose (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15
           mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL
           RZL-012,

        -  placebo of 0.15 mL/injection point that results in a total maximum volume of 4.8±0.6 mL.

      Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections.
      The maximal number of injections will be 36 with maximal doses of 183.6 mg and 270 mg for the
      low and high doses, respectively. Each injection point will be dosed with 5.1 mg RZL-012 for
      the low dose or 7.5 mg for the high dose in a volume of 0.15 mL/injection site. Placebo
      (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The
      maximal injection volume for all groups will be up to 5.4 mL.
    

Intervention name(s): RZL-012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): small synthetic molecule for submental fat reduction; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea
Condition: Rosacea
MeSH terms: Rosacea; Headache
Study type: Interventional

Summary: 
      The investigators aim is to investigate the incidence of headache and rosacea-like flushing
      after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment
      with sumatriptan in patients with rosacea
    

Detailed description: 
      Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in rosacea
      pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in migraine patients.
      PACAP38 also induces flushing which may imitate rosacea-like flushing. We are investigating
      whether the flushing after PACAP38 resembles rosacea-like flushing, and whether treatment
      with sumatriptan has an effect on the headache and flushing effects of PACAP38.

      The purpose of this study is to investigate PACAP38-induced headache and flushing in patients
      with rosacea who have been treated with either sumatriptan or placebo using purpose-developed
      standardized interview. The investigators will use a double-blind, placebo-controlled
      crossover study design to investigate this.
    

Intervention name(s): Imigran; Isotonic Saline
Intervention type(s): Drug; Other
Intervention description(s): All patients will undergo this intervention on one of two study days; All patients will undergo this intervention on one of two study days
Other intervention name(s): Sumatriptan
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Screening for Endometrial Abnormalities in Overweight and Obese Women
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to develop an endometrial biopsy screening program for
      endometrial cancer and its precursor lesions in overweight and obese women.

      There is a BMI threshold at and above which optimal screening parameters exist for
      identifying endometrial cancer and its precursor lesions in overweight and/or obese women.
      Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in
      overweight and/or obese women offers substantial health benefits.
    


Intervention name(s): Endometrial Biopsy
Intervention type(s): Procedure
Intervention description(s): Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. During the interview, the purpose of the study will be explained as well as the surgical technique used for obtaining an endometrial sample. If the patient consents to the procedure, then this will usually be a D&C performed in one setting at the time of her bariatric surgery under general anesthesia. In the case where a patient is diagnosed with complex atypical endometrial hyperplasia or early endometrial prior to her bariatric surgery, an IUD can be inserted at the time of her bariatric surgery.
For patients not undergoing bariatric surgery, an endometrial biopsy will be performed in the clinic or office setting using an endometrial suction catheter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of a Probiotic Composition as Adjunct in MAFL Management
Condition: Non Alcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Some studies have shown beneficial results with probiotics on hepatic function of subjects
      with fatty liver, but significant variability has been noted among probiotic formulations.
      This study aims at providing a comprehensive characterization of the effect of a particular
      probiotic formula in hepatic function of said subjects.
    

Detailed description: 
      Some studies have shown beneficial results with probiotics on hepatic function of subjects
      with Non-Alcoholic Fatty Liver (NAFL) also known as Metabolism-Associated Fatty Liver (MAFL).
      However, meta-analyses have found significant variability among probiotic formulations. In
      fact, many probiotic properties are thought to be strain-specific.

      This study aims at providing a comprehensive characterization of a particular probiotic
      formula containing Lactoplantibacillus plantarum (formerly Lactobacillus plantarum) and
      Levilactobacillus brevis (formerly Lactobacillus brevis) in hepatic function of individuals
      with NAFL. The study will assess hepatic stiffness via transient elastography (Fibroscan),
      hepatic function via liver enzymes in serum (ALT, AST, GGT) and liver-specific inflammation
      via cytokeratin18 in serum, as well as some general metabolic and inflammatory markers.
    

Intervention name(s): Probiotic composition; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Mixture of two Lactoplantibacillus plantarum strains (formerly Lactobacillus plantarum) and one Levilactobacillus brevis strain (formerly Lactobacillus brevis), in a maltodextrin carrier (E1400); Maltodextrin (E1400, qs)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFL; MAFL
Diabetes and Travel: Evaluation of a Diabetes Education Module - a Randomized Controlled Trial (PRIMO_Travel)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly
      developed treatment and education module will be tested compared to a waiting-list control
      group. The module covers the topic "diabetes and travel". Primary outcome variable is
      diabetes-specific empowerment regarding diabetes and travel. Secondary outcome variables are:
      diabetes-related distress, health-related quality of life, depressive symptoms, self-care
      behavior, and glycemic control.
    

Detailed description: 
      The module consists of one lesson (duration: 90 minutes). The module is derived from the
      empowerment approach and is based on the previously evaluated education and treatment program
      for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by
      a trained diabetes educator. Patients are randomized either to the immediate participation in
      the module or to the control group. Control group is a waiting-list control group. Patients
      in this waiting-list control group get the education after the completion of the 6-month
      follow-up.
    

Intervention name(s): Education - Diabetes and Travel
Intervention type(s): Behavioral
Intervention description(s): Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Travel" was created. The module covers specific and detailed aspects of the topic "travel" such as insulin adaption to intercontinental flights, dealing with exotic food, and treatment goals during vacation. With this module, a more comprehensive education of patients with specific interest is possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; education; randomized; prospective
A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the
      blood, and how it is affected if raltegravir is taken at the same time as another medicine
      for high blood pressure (amlodipine). Many patients with HIV will also have high blood
      pressure, so it is important to know which drugs for each of these conditions can be taken
      together without affecting how well they work individually.

      Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks,
      with the middle week being on both drugs. The investigators will look at and compare the
      levels of these two drugs in the blood after subjects have taken them separately and both
      together.

      This study is randomised into two groups with both study medications received by all
      participants in a three-period crossover pattern; randomisation determined which medication
      was taken first. Once randomised allocation was performed, medications were administered in
      an open-label fashion.
    

Detailed description: 
      HIV-negative male and female volunteers will be enrolled, after written confirmation of
      informed consent, in a phase I, open-label, cross-over, PK study (approved by Westminster
      Research Ethics Committee and UK Regulatory Authorities; Eudra number 2012-005400-18).

      Subjects are randomized to receive either raltegravir 400mg twice-daily (seven days),
      followed by raltegravir 400mg twice-daily plus amlodipine 5mg once-daily (seven days),
      followed by amlodipine 5mg once-daily alone (seven days), or the same treatments in the
      opposite order, in the fasted state (at least eight hours) with 240mL of water.

      Intensive PK sampling and safety laboratory analysis are performed at the end of each phase
      (Days 7, 14 and 21). Raltegravir and amlodipine plasma concentrations will be analysed by a
      validated liquid chromatography-mass spectrometry (LC-MS/MS) method.

      PK parameters are determined by non-compartmental methods [WinNonlin Phoenix (version 6.1;
      Pharsight Corp, Mountain View, CA, USA]. These are the concentrations measured 12 and 24
      hours post-dose (C12h, C24h) for raltegravir and amlodipine, respectively; the maximum
      concentration (Cmax); and the area under the curve over 12 and 24 hours (AUC12h, AUC24h) for
      raltegravir and amlodipine, respectively.
    

Intervention name(s): Raltegravir; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): Isentress 400mg tablet taken twice daily; generic amlodipine 5mg tablets (Accord healthcare Limited, UK)
Other intervention name(s): Isentress; Amlodipine 5mg tablets
Intervention MeSH terms: Raltegravir Potassium; Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
Condition: Arthropathy of Knee; Arthropathy of Hip
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The purpose of this single center randomized controlled trial (RCT) is to investigate whether
      outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day
      of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day
      discharge, without compromizing safety and outcome.
    

Detailed description: 
      Introduction of fast-track total hip arthroplasty (THA) and total knee arthroplasty (TKA) has
      led to a decrease in length of stay without compromising patient safety and clinical outcome
      . In recent years outpatient THA and TKA has gained popularity, especially as major focus is
      placed on reducing cost and increasing efficiency in all medical treatments . Studies have
      shown outpatient arthroplasty to be feasible both for THA and TKA patients , with up to 70%
      of unselected patients being potentially eligible for outpatient surgery. Various results are
      published on success rate of discharged patients on the day of surgery, ranging from 25% to
      99% , depending on patient selection and logistic setup. While the majority of published
      studies utilizes a modern fast-track setup with early mobilization and multimodal pain
      treatment, the optimal logistic setup remains unknown.

      The purpose of this single center randomized controlled trial (RCT) is to investigate whether
      outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day
      of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day
      discharge, without compromizing safety and outcome.
    

Intervention name(s): Mobilization at a dedicated daycare facility
Intervention type(s): Other
Intervention description(s): All THA's are performed using a standard posterolateral approach with simple posterior soft-tissue repair. No infiltration anesthesia (LIA) is used in THA's. All TKA's are performed with a standard medial parapatellar approach without the use of tourniquet. Physiotherapy is started as soon as possible after surgery in the dedicated day care facility. Time till first mobilization is recorded as is total time mobilized supervised by a physiotherapist before discharge.
Patients are discharged if fulfilling the discharge criteria before 8 pm. Number of hours spent in hospital in total is recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
Condition: Post-herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain
      experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three
      weeks of treatment compared to the baseline period.
    

Detailed description: 
      A 3 week randomised crossover study to investigate the effect of repeat oral dosing of
      CNV2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia
      (PHN. Each 3 week treatment period is seperated by a 2 week washout period. The primary
      outcome measure is the change from baseline in the PI-NRS after three weeks of treatment.
      Secondary outcome measures include pain responder rates, clinical and patient global
      impressions of pain, and the Neuropathic Pain Symptom Inventory.
    

Intervention name(s): CNV2197944; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment