bioihbjkbjnl/mcl2 huggingface dataset:
Invasive Revascularization or Not in Intermittent Claudication
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent
      claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology
      Assessment Report identified only limited evidence for the effectiveness of invasive
      treatment for IC in patients already on exercise training. The prognosis for the extremity is
      usually benign and treatment therefore aims at improving quality of life. Invasive treatment
      can also cause serious complications. Coronary artery disease is common in IC patients
      increasing the risk with invasive treatment. In spite of these uncertain merits and potential
      risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD
      in Sweden are performed for IC. The aim of this study is to evaluate the additional effects
      of modern invasive treatment in patients with intermittent claudication receiving modern best
      medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in
      addition to BMT improves health related quality of life and walking performance compared to
      BMT only.
    


Intervention name(s): INVASIVE (INV) treatment; Best medical treatment (BMT)
Intervention type(s): Procedure; Other
Intervention description(s): Modern endovascular and/or open revascularisation according to the TASC II recommendations.; Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intermittent claudication; Health Related Quality of Life; Walking performance; Daily walking capacity
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a
      safe and effective add-on to psychostimulant therapy in children and adolescents with
      attention deficit hyperactivity disorder (ADHD).
    


Intervention name(s): CLONICEL (clonidine HCl sustained release); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flexible Dose (0.1 - 0.4 mg); Matching placebo tablets
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; ADD; Attention Deficit Hyperactivity Disorder; Attention Deficit; Clonidine; CLONICEL; Addrenex
Misoprostol+Oxytocin vs. Carbetocin in CS
Condition: Cesarean Section
MeSH terms: Postpartum Hemorrhage
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This prospective randomized double-blind clinical trial will be conducted at Ain-Shams
      University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment
      cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol
      following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100
      ug carbetocin intravenous after cord clamping.
    


Intervention name(s): Misoprostol; Oxytocin; Carbetocin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Mesotec; Mesotac; Syntocinon; Pabal
Intervention MeSH terms: Misoprostol; Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Misoprostol; Oxytocin; Carbetocin; Prevention; Post-partum hemorrhage
Pharmacokinetics Of Celecoxib Test Formulations
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected
      to provide more favorable bioavailability characteristics than the present commercial
      formulation.
    


Intervention name(s): Celebrex capsule; Test formulation D1; Test formulation D2; Test formulation D3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose 200 mg commercial Celebrex capsule; Single dose 150 mg celecoxib as formulation D1; Single dose 150 mg celecoxib as formulation D2; Single dose 150 mg celecoxib as formulation D3
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability, pharmacokinetics, celecoxib
A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.
Condition: Acute Gastritis; Chronic Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, active-controlled, randomized, double-blinded, paralleled group
      clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients
      with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three
      times a day for four weeks.
    


Intervention name(s): Stillen Tab.; Mucosta Tab.
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Pacing Mode and Diastolic Function on Cardiac Output
Condition: Diastolic Function; Cardiac Output; Pacemaker Stimulation Mode; Stroke Volume; AV Block
MeSH terms: Atrioventricular Block
Study type: Interventional

Summary: 
      Background It is known from previous research that in patients with complete AV
      (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are
      higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which
      patients profited from AV-synchronous stimulation varied substantially.

      Aim of the study Aim of this study is to systematically analyze the impact of diastolic
      function and other echo parameters on the difference of stroke volumes/cardiac output between
      AV-synchronous and AV-dyssynchronous pacing modes.

      Methods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any
      vendor eligible) in this monocentric, prospective, interventional study. Baseline data will
      be collected with a standardized questionnaire. During an echo examination, parameters of
      diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac
      output will be measured twice in each patient, once with AV-synchronous and once with
      AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will
      be randomized (coin tossing) which stimulation mode is first and which is second (sonographer
      and patient will be blinded). Descriptive statistics will be applied and regression models
      will be fitted to explore the data.
    


Intervention name(s): Pacemaker stimulation mode
Intervention type(s): Other
Intervention description(s): Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Diastolic function; Cardiac output; Pacemaker stimulation mode; Stroke volume
The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment
      drug HEC585 in Healthy Male and Female Subjects
    

Detailed description: 
      This will be a double-blind, placebo-controlled, single, and multiple oral dose study
      conducted in 2 parts.

      Part A will comprise a single-dose, sequential-group study incorporating a food effect
      evaluation. Up to 48 subjects will be studied in up to 6 groups (Groups A1 to A6), with each
      group consisting of 8 subjects. Each subject will participate in 1 treatment period only and
      reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144
      hours postdose), except for Group A3, which will participate in a second treatment period for
      a food effect evaluation. Each subject in Group A3 will participate in 2 treatment periods
      separated by a minimum of 7 days. Dosing of subjects in the fed state in Group A3 can
      commence after review of the safety data from Group A4.

      Part B will comprise a multiple-dose, sequential-group study. Up to 36 subjects will be
      studied in up to 3 groups (Groups B1 to B3), with each group consisting of 12 subjects. Part
      B of the study may start after completion of Group A5, at a dose equal or less than given in
      Groups A1 to A3.
    

Intervention name(s): HEC585
Intervention type(s): Drug
Intervention description(s): HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Duloxetine for Acute Post-mastectomy Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet
      (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.
    

Detailed description: 
      patients undergoing mastectomy with axillary evacuation will be divided to four groups,
      Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule
      Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg
      capsule the study medication is administered orall 2 h before surgery. Primary outcome
      variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain
      score measured every 4 h in the first 24 h postoperatively.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: duloxetine; mastectomy; postoperative pain
The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      In this study the Investigators are examining the effects of a 12-week exercise program
      (intervention) on measures of appetite and food intake regulation in overweight to mildly
      obese healthy adults. The Investigators hypothesize that individuals who lose a significant
      amount of weight in response to the intervention will show a reduction in the brain response
      to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to
      those who do not lose weight. These changes in neuronal activity will be associated to
      physiologic and behavioral measures.
    


Intervention name(s): Exercise; Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks.; A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by ~2000 kcal/week.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetic Drug-drug Interaction of CKD-330 and D086
Condition: Hypertension; Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is examining and comparing the pharmacokinetic drug interaction and
      safety of both single administration and combination administration of CKD-330 and D086 to
      healthy male subjects
    

Detailed description: 
      An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study

      Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330
      affects pharmacokinetics of D086.
    

Intervention name(s): CKD-330; D086; CKD-330 + D086
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or
      greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.

      Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia
      in patients on dialysis.
    


Intervention name(s): AMG 223; Renagel® (sevelamer hydrochloride)
Intervention type(s): Drug; Drug
Intervention description(s): 2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7; 2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Will Lactobacillus Increase Cure Rate After Treatment of Bacterial Vaginosis and Chronic Vulvovaginal Candida
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Observational [Patient Registry]

Summary: 
      From the earlier studies the investigators have treated women with bacterial vaginosis and
      cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10
      days for 2 month. The investigators will continue to follow them and investigate if treatment
      with lactobacilli every week for 6 month will increase cure rate.
    

Detailed description: 
      Clinical diagnosis of bacterial vaginosis using air dried smears combined with Hay/Ison
      classification. Test of cure every month or every menstrual cycle using self taken smears.
      The cure will be if the woman are in group 1 according to Hay/Ison classification. This will
      also allow us to use molecular diagnosis of BV to test cure and compare this with hay/Ison.

      Test of cure for candida patiens are no visibel candida on wet smear and free of symtoms of
      candida.
    

Intervention name(s): lactobacillus (EcoVag)
Intervention type(s): Other
Intervention description(s): Probiotic human lactobacillus (L. gasseri and L rahmnosus)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women with vaginal discharge with either bacterial vaginosis or candida infection
Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth
      Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced
      periodontal osseous defects at 6 months of healing.
    

Detailed description: 
      This triple blind, prospective and parallel arm trial was conducted in subjects requiring
      surgical treatment of a periodontal osseous defect.
    

Intervention name(s): B-TCP + 0.3 mg/ml rhPDGF-BB in buffer; B-TCP + 1.0 mg/ml rhPDGF-BB in buffer; B-TCP +buffer
Intervention type(s): Biological; Biological; Biological
Intervention description(s): B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.; B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.; B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
Intervention MeSH terms: Becaplermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury
      (mTBI). Early identification of patients at risk for UO is crucial for suitable management to
      be initiated, increasing their chances for a return to a normal life. The investigators
      previously developed a diagnostic tool enabling early identification (8 to 21 days after the
      injury) of patients likely to develop UO. In the present study, the investigators examined
      the value and beneficial effects of early multidimensional management (MM) on prognosis. The
      investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO
      (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of
      developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group
      that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific
      management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome
      was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and
      only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94%
      had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had
      persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for
      the main confounding factors, was statistically significant (p<0.001). These results show
      that the initiation of MM after early identification of at-risk mTBI patients can
      considerably improves their prognosis.
    


Intervention name(s): cognitive-behavioral rehabilitation
Intervention type(s): Procedure
Intervention description(s): Combination of clinical examination and neuropsychological and psychological tests
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mild TBI; quality of life; coping strategies; symptoms; neuropsychological tests; pain; memory reactive; Cognitive dimension
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338
      (insulin 338) in subjects with type 2 diabetes.
    


Intervention name(s): insulin 338 (GIPET I); placebo; insulin glargine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels.; S.c placebo administered in combination with insulin 338; Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels.; Oral placebo administered in combination with s.c. insulin glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Condition: Aneurysm
MeSH terms: Aneurysm
Study type: Observational

Summary: 
      The objective of the study is to assess the incidence of safety outcomes in patients treated
      with Pipeline™ Flex embolization device with Shield Technology™.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neuroradiologists and surgeons practice
Cognitive Ability Training in Seniors
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study investigates the beneficial effects of prefrontal brain stimulation (with
      transcranial direct current stimulation [tDCS]) during working memory training in seniors
      with subjective memory impairments.The placebo-controlled double blinded study includes 50
      elderly probants which were randomized into verum or sham tDCS.
    


Intervention name(s): Verum tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anadal, right cathodal; Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subjective Memory Impairment; tDCS; NIRS; Cognitive Training; Working Memory