bioihbjkbjnl/mcl2 huggingface dataset:
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine safety and efficacy of an oral contraceptive in
      treating acne papulopustulosa.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Valette; Diane; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles; 1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles; 2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne papulopustulosa
Arterial Stiffness in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Diurnal variations in the cardiovascular system apparent in healthy individuals, are
      different in chronic kidney disease patients. Therefore, diurnal variations in arterial
      stiffness may also differ in chronic kidney disease patients. This study aims to identify and
      evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and
      compare them to those in age matched healthy controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Potential patients will be identified from renal clinics at the Royal Infirmary and Western
        General Hospital. Suitable participants will initially be identified by a member of the
        direct healthcare team.

        Healthy volunteers will be indentified through the Clinical Research Centre community
        database and poster advertising at the University of Edinburgh.
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Condition: Growth Hormone Therapy; Infant, Very Low Birth Weight
MeSH terms: Birth Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and efficacy of Somatropin will be evaluated in short children born with a list weight
      below 1500 g and that did not catch up to normal height at the age of 4.
    


Intervention name(s): Somatropin; Control Arm
Intervention type(s): Drug; Other
Intervention description(s): Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.; Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of ranolazine in people with pulmonary
      arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies:
      ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or iloprost.
      The primary objective is:

        -  To estimate the effect of ranolazine administration on acute hemodynamics.

        -  To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after
           12 weeks of therapy

        -  To assess changes in right ventricular function after 12 weeks of therapy.
    

Detailed description: 
      Pulmonary arterial hypertension is a medical disorder in which pressure in the blood vessels
      going from the right side of the heart to the lungs is higher than normal. The increased
      blood pressure in the lungs places a strain on the heart. This strain causes the heart to
      pump less blood into the lungs, causing physical symptoms of shortness of breath and
      tiredness. The added strain to the heart can cause physical symptoms of swelling in the feet
      and abdomen. These symptoms can get worse over time due to the decreased pumping ability of
      the heart.

      This study will use a drug called ranolazine. This drug has been approved by the Food and
      Drug Administration (FDA) to treat chronic angina (chest pain). However, since it has not
      been approved for use in PAH its use in this study is considered experimental.
    

Intervention name(s): Ranolazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ranolazine sustained release at a dose of 500mg for one month followed by a dose of 1000mg.; placebo at a dose of 500mg for one month followed by a dose of 1000mg.
Other intervention name(s): GS-9668; sugar pill
Intervention MeSH terms: Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PAH; Ranolazine; right ventricle; Safety; cardiopulmonary exercise testing
Drug-drug Interaction Study With GLPG3970 and Sulfasalazine in Adult, Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on
      the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in
      healthy adult subjects.
    


Intervention name(s): Sulfasalazine; GLPG3970
Intervention type(s): Drug; Drug
Intervention description(s): On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.; On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.
Intervention MeSH terms: Sulfasalazine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The population for this current study will include stage 1 and stage 2 hypertensive patients
      who are newly diagnosed or didn't have treatment during the last 3 months and patients who
      are currently treated but uncontrolled on present monotherapy.

      The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a
      treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.
    


Intervention name(s): valsartan; amlodipine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Valsartan,; amlodipine,; hydrochlorothiazide
Pharmacokinetic Interaction Between Ibuprofen and Acetaminophen, Tablets Administered Individually or in Combination
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was carried out in the Clinical and Analytical Unit of the Pharmacology and
      Toxicology Department of the Faculty of Medicine of the Autonomous University of Nuevo León,
      with the aim of comparing the bioavailability (Cmax, AUC) of an oral formulation containing
      ibuprofen 400 mg/ Acetaminophen 1000 mg in combination with the two oral formulations
      ibuprofen 400 mg or Acetaminophen 1000 mg administered as a single dose, in healthy subjects
      under fasting conditions
    

Detailed description: 
      The study design was crossover, 3 x 6 x 3, open, prospective and longitudinal, at a single
      dose of the combination of Ibuprofen 200mg/ Acetaminophen 500mg (2 tablets), administered
      orally versus each component administered individually Ibuprofen 400mg (1 tablet) or
      Acetaminophen 500 mg (2 tablets), with three treatments, three periods, six sequences with an
      elimination period (washout) of 1 week and with a number of 42 healthy subjects, of both
      genders, under fasting conditions. In order to compare the pharmacokinetic profile (Cmax and
      AUC 0-t) of the combination Ibuporfen/Acetaminophen 200 mg / 500 mg, single dose versus each
      component administered individually, to establish the non-interaction of the drugs in
      combination. Like, Characterize the pharmacokinetic parameters, Cmax and AUC 0-t, AUC 0-,
      Tmax, Ke and T1/2, of Ibuprofen and Acetaminophen after oral administration in a single dose.
      The frequency and type of adverse events with the two formulations were established.
    

Intervention name(s): A1: Ibuprofen/Acetaminophen Fixed dose combination (Laboratorios Silanes S.A. de C.V.); A2: Ibuprofen (Motrin®, Pfizer S.A. de C.V.); A3: Acetaminophen (Tylenol caplets®, from Janssen-Cilag, S.A. de C.V.)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Formula : 200 mg/ 500 mg Pharmaceutical Form: Tablet Dosage: 400 mg / 1000 mg (2 tablets) Administration way: oral; A2: Pharmaceutical Form: tablet Dosage: 400 mg (1 tablet) Administration way: oral; A3:Pharmaceutical Form: tablet Formula: Acetaminophen 500 mg Dosage: 1000 mg (2 tablets) Administration way: oral
Other intervention name(s): IBU / ACETA; IBU; ACETA
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; No interaction; Fixed-dose combination (FDC); Ibuprofen; Acetaminophen; Pain
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2
      crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and
      Control lenses in a random order for 1-week each as a daily disposable modality with a
      wash-out period of 1 week between the wearing periods.
    


Intervention name(s): etafilcon A with novel molding process; etafilcon A with current molding process
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Depth of Anesthesia and Proteomics
Condition: Anesthesia Complication; Immune Suppression
Study type: Interventional

Summary: 
      The primary aim of the study is to compare cellular activity of T-cells, NK-cells and
      monocytes after anesthesia. Phagocytosis and cellular lysis activity of neutrophils and
      monocytes are analyzed by flow cytometry. Secondly, we analyze anesthesia induced protein
      expresssion pattern in the blood. The proteome of monocytes is identified by
      3D-gel-chromatography and mass spectrometry (MALDI-TOF).
    

Detailed description: 
      Patients undergoing shoulder surgery in the orthopedic center are screened and consented to
      the randomized controlled, blinded study. Patients, surgeons, and the study personell
      involved in data interpretation and management are blinded towards the randomly assigned
      computerized group allocation (SAS, Cary, NC). The study director informs the anesthesiology
      staff about the group allocation. Patients are randomized to deep vs. light general
      anesthesia guided using a bispectral index monitor (BIS Vista, Aspect) with BIS < 45 in group
      1 (deep anesthesia) or BIS ≥ 55 in group 2 (light anesthesia). Anesthesia depth is recorded
      via USB port every minute.
    

Intervention name(s): Deep anesthesia; Shallow anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Drug: High dose propofol, fentanyl and sevoflurane Deep Anesthesia
Other Names:
BIS lower than or equal to 45; Drug: Low dose propofol, fentanyl and sevoflurane Shallow Anesthesia
Other Names:
BIS above 45
Other intervention name(s): Profound anesthesia; Light anesthesia
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating
      factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of
      greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer
      days of apheresis than MM patients mobilized with G-CSF alone.

      Secondary Objectives:

        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM
           patients.

        -  To compare the 2 treatment arms with respect to the number of participants who achieved
           a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.

        -  To compare the 2 treatment arms with respect to the number of days of apheresis required
           to reach the target of greater than or equal to 6 x 10^6 CD34+ cells/kg.
    

Detailed description: 
      Total study duration for a participant can be approximately up to 68 days.
    

Intervention name(s): plerixafor GZ316455; Filgrastim
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:vial Route of administration: subcutaneous injection; Pharmaceutical form:vial Route of administration: subcutaneous injection
Other intervention name(s): Mozobil
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
Condition: Hemiparesis;Poststroke/CVA; Gait, Hemiplegic
MeSH terms: Paresis; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the
      ground during walking. This impairment, termed as "foot drop", is caused by an association of
      weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. As a
      consequence, walking performances are reduced and energy cost of walking is deteriorated.
      This may increase performance fatigability, as the locomotion will be realized at a higher
      percentage of the subjects' capacities. In order to overcome these issues, different
      treatments are proposed. One of the most conventional solutions are the use of ankle foot
      orthosis (AFO) and it is the most commonly prescribed device used to compensate for "foot
      drop". There is a very large choice of AFO on the market which can be proposed to patients
      with foot drop.

      The aim of this study is thus to assess the mechanical effects of using a manufactured carbon
      AFO in by comparison to a custom-made thermo-plastic AFO on walking capacity (distance and
      energy cost), fatigue and "foot drop" control throughout the gait phase in patients with
      hemiparetic stroke.
    


Intervention name(s): Ankle Foot orthosis (AFO)
Intervention type(s): Device
Intervention description(s): The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order).
Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4.
During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order :
5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured
6MWT where energy cost will be measured
5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed
Other intervention name(s): Sprystep (Thuasne)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, cross-over, open labelled, monocentric, controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Glycine Treatment of Prodromal Symptoms
Condition: Schizophrenia
MeSH terms: Prodromal Symptoms; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label trial of the NMDA agonist glycine used alone for symptoms that appear
      to be prodromal for schizophrenia in adolescents and young adults.
    


Intervention name(s): glycine
Intervention type(s): Drug
Intervention description(s): 0.8 g/kg/day
Intervention MeSH terms: Glycine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Load Carriage on Upper Limb Performance
Condition: Healthy
Study type: Interventional

Summary: 
      Purpose: Quantify the relationship between brachial plexus deformations caused by backpack
      carriage and upper extremity performance.

      Significance of expected results:

      The study will allow to quantify the effect of load carriage on both neural and vascular
      function parameters.

      Study plan The effect of nerve strain on neural function: based on the strains obtained for
      each load from computational simulation, and from animal studies published in the literature,
      the expected neural function, (e.g., motor and sensory) dysfunction will be estimated.

      Following signing an informed consent form, 12 young adult subjects (18-35 years) will don a
      military backpack loaded with 25-40 kg. Each volunteer will undergo the following test at
      baseline, following 45 min exposure, and following 15 min of recovery:

        1. Index finger microvascular flow will be measured by photoplethysmography (PPG).

        2. Sensory measurement at the finger; Light touch threshold will be measured by mechanical
           stimulation that will be applied using Von Frey Filaments of the Semmes-Weinstein
           Monofilament (SWM) type.

        3. Forearm thermal sensation threshold; As a measure of sensory function in the forearm,
           cold and warm sensation thresholds will be measured with a computerized quantitative
           thermal sensory device.

           Immediately following the 45 min loading exposure, the fine motor function of the index
           finger will be tested by the following procedures (in an unloaded condition):

        4. Index finger motor function; Force application profile during a trigger press will be
           measured using a force sensor located on a trigger of a dummy weapon simulator. Force
           application rate, peak force, and press-to-press peak force variability will be measured
           based on 10 trigger presses.

        5. Accuracy of force application; Will be evaluated by the simulated shot accuracy,
           horizontal displacement (X) and vertical displacement (Y).

        6. Subjective parameters; in all time points, the volunteers will be asked to rate their
           level of pain sensation intensity (VAS sensory) and degree of unpleasantness (VAS
           affective) in the shoulders and other load bearing sites, as well as ratings of
           perceived exertion (RPE). All subjective parameters will be assessed using visual
           analogue scales.
    


Intervention name(s): load carriage
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neurology; Sports Medicine
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to understand the mechanism of action of BI655130 in
      patients with UC

      Secondary objectives are to explore clinical effect, safety and tolerability (including
      immunogenicity) of BI 655130 treatment
    


Intervention name(s): Spesolimab
Intervention type(s): Drug
Intervention description(s): 12 weeks treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
Condition: Bladder Neck Obstruction; Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Urinary Bladder Neck Obstruction; Hyperplasia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and efficacy of MediTate Temporary
      Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction
      (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck
      and prostatic urethra under local anesthesia for few days and taken out some 5 days later in
      the doctors office.
    


Intervention name(s): Insertion of Temporary Implantable Nitinol Device (TIND)
Intervention type(s): Device
Intervention description(s): Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BPH; bladder neck obstruction; Bladder neck obstruction secondary to BPH