bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
Condition: Fontan Procedure; Hypoplastic Left Heart Syndrome; Tricuspid Atresia
MeSH terms: Hypoplastic Left Heart Syndrome; Tricuspid Atresia
Study type: Interventional

Summary: 
      In this study, investigators will evaluate the effect of vitamin C on endothelial function,
      exercise tolerance and quality of life in patients with a single ventricle who have been
      palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved
      exercise tolerance and endothelial function in patients who have undergone the Fontan
      operation, compared to placebo.
    

Detailed description: 
      Recent evidence suggests that after Fontan operation, single ventricle patients have impaired
      function of the vascular endothelium due in part to abnormalities in nitric oxide signaling.
      Endothelial dysfunction may contribute to the development of congestive heart failure and
      exercise intolerance that have been well-documented in Fontan patients. Therapeutic
      interventions to improve endothelial function in adults with heart failure have mainly
      focused on increasing the synthesis or decreasing the degradation of nitric oxide. We propose
      a randomized, prospective, placebo-controlled trial of vitamin C, an antioxidant that
      protects NO deactivation, in subjects with single ventricular anatomy after Fontan
      palliation. The specific aims of this study are to compare NO signaling, endothelial function
      and exercise capacity in Fontan subjects to that of a control group that is frequency-matched
      to case subjects by age and sex, and to assess NO signaling, endothelial function and
      exercise capacity in Fontan subjects after 4 weeks of oral vitamin C (or placebo) therapy.
      These results have particular importance because improving the endothelial response in Fontan
      patients has the potential to reduce the risk of developing congestive heart failure and
      improve exercise capacity. Furthermore, assessing endothelial function and the effects of
      therapies aimed at improving vascular health may be generalizable to many other chronic
      pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes
      mellitus, and hypertension.
    

Intervention name(s): Vitamin C; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High-dose Vitamin C will be administered in 4 age-based dosing groups; Placebo will be administered twice daily for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diabetes Complications and Hearing Loss
Condition: Diabetes Mellitus; Diabetes Complications; Hearing Loss
MeSH terms: Hearing Loss; Deafness; Diabetes Mellitus; Diabetes Complications
Study type: Observational [Patient Registry]

Summary: 
      Observation study, shows the relation between diabetes, its neurological and optical
      complication and hearing loss, by asking participants questions about there age,BMI,job,the
      history of any cataract,diabetes retinopathy or heart attack,hypertension,swollen or tingling
      legs and take there consent to measure the hearing impairment.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We collected participants from the clinical of Damascus hospital
      
Keywords: Diabetes retinopathy; Cataract
Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A
      maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled
      patients will receive a single intra-articular (IA) injection of FX006.
    

Detailed description: 
      This is a multi-center, single-arm, open-label study in patients with hip OA to evaluate a
      procedure for intra-articular injection of FX006 in patients with hip OA. A maximum number of
      approximately 30 patients may be enrolled in this protocol.

      All enrolled patients will receive a single intra-articular (IA) injection on Day 1 and be
      followed for 8 weeks.
    

Intervention name(s): FX006 32 mg
Intervention type(s): Drug
Intervention description(s): Extended-release 32 mg FX006 IA injection
Intervention MeSH terms: FX006
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Osteoarthritis; Hip; Intra-articular; Injection
ToT and Estrogen in Postmenopausal Females
Condition: Stress Urinary Incontinence; Postmenopausal Disorder
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the subjective and objective outcomes of TVT-O procedure alone versus the same
      procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female
      with genuine stress incontinence.
    

Detailed description: 
      a randomized controlled trial comparing the effect of using local estrogen cream after tot in
      postmenopausal female
    

Intervention name(s): TVT-O
Intervention type(s): Procedure
Intervention description(s): transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A
Other intervention name(s): local vaginal estrogen cream
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post menopausal stress incontinence; local estrogen
Early Primary Prophylaxis of Esophageal Varices
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Esophageal and Gastric Varices; Fibrosis
Study type: Interventional

Summary: 
      Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal
      varices with or without red color signs and have not bled previously will be enrolled. After
      baseline evaluation, the participants will be randomized to receive either Placebo or
      Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary
      endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or
      Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change
      in CTP and MELD score& adverse events.
    


Intervention name(s): Carvedilol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol or with a maximum of 12.5 BD.; The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 4 BD.
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Circuitry-Guided Smoking Cessation in Schizophrenia
Condition: Smoking Cessation; Nicotine Addiction; Schizophrenia
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional

Summary: 
      In a double-blinded, randomized, parallel controlled design, patients with schizophrenia
      spectrum disorder will be exposed to active or sham repetitive transcranial magentic
      stimulation (TMS) which was guided by functional magnetic resonance image (MRI). Smoking
      reduction/cessation and brain functional connectivity changes will be assessed at baseline,
      different stages of rTMS and/or follow-ups.
    

Detailed description: 
      Neuroimaging studies suggest that high rate of smoking in patients with schizophrenia may be
      due to an overlap of nicotine addiction related circuitries and schizophrenia related
      circuitries, such that schizophrenia impact some of the same circuitries that increase risks
      for severe nicotine addiction in general. Those identified overlapping circuitries have been
      linked to several key features of nicotine addiction and can be represented by resting state
      functional connectivities. Transcranial magnetic stimulation (TMS) provides a non-invasive
      means for altering brain electrical neural activity. TMS has been approved by FDA for
      treatment of depression. Other applications have not been approved but it has been used in a
      wide range of clinical research especially in neurology and psychiatry. There are
      preliminarily significant improvements in treatments of smoking cessation in schizophrenia
      using TMS with small samples, but those treatments are not robust in larger samples. The high
      inter-subject variability limits the efficacy of TMS treatment in schizophrenia patients. We
      aim to develop a TMS method targeting special brain circuits that are both smoking cessation
      and schizophrenia related. If the corresponding brain circuits were successfully modulated,
      the treatment efficacy will be significantly improved and schizophrenia patients will benefit
      from the TMS treatment of smoking cessation.
    

Intervention name(s): Active TMS stimulation; Sham TMS stimulation
Intervention type(s): Device; Device
Intervention description(s): Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.; Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Transcranial magnetic stimulation; schizophrenia; MRI; smoking
Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01
      in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600
      mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or
      fasted state
    

Detailed description: 
      This is a Relative Bioavailability Study to compare single oral doses of 1600mg IX-01, either
      as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state. Each
      volunteer in the study will receive each of the formulations listed below. Each formulation
      will be separated by at least a 5-day drug-free (washout) period.

        -  Treatment A: A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fasted
           conditions

        -  Treatment B: A single 1600 mg (4 x 400 caplets) oral dose of IX-01 under fed conditions

        -  Treatment C: A single 1600 mg aqueous dispersion (20 mL) oral dose of IX-01 under fasted
           conditions.

      In the fasted treatment periods, dosing will follow an overnight fast of at least 10 hours.

      In the fed treatment period, following an overnight fast of at least 10 hours, a standard
      high-calorie, high-fat breakfast meal will be given 30 minutes prior to administration of the
      study drug.

      There will be a final follow-up visit 7-10 days after the final dose of study medication.
    

Intervention name(s): IX-01 caplets 1600 mg (4 x 400 mg), fasted; IX-01 caplets 1600 mg (4 x 400 mg), fed; IX-01 aqueous dispersion 1600 mg (20 mL), fasted
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral dose under fasted conditions; oral dose under fed conditions; oral dose under fasted conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
Condition: Acne Scars
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The purpose of this study to evaluate the SmartLipo Triplex laser system along with the
      SideLaze800 hand piece in the treatment of Acne Scars.
    


Intervention name(s): SmartLipo Triplex laser system along with the SideLaze800 hand piece
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      compared with placebo in pediatric outpatients (7-17 years of age) with major depressive
      disorder.
    


Intervention name(s): Vilazodone; Placebo; Fluoxetine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Viibryd; Prozac
Intervention MeSH terms: Fluoxetine; Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dry Needling of Scalene Muscle Trigger Points in Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      There is preliminary evidence suggesting that referred pain from active trigger points can
      play a relevant role in individuals with mechanical neck pain. Some studies have investigated
      the effectiveness of dry needling over the upper trapezius muscle in this population.
      However, other muscles, such as the scalene muscles, can be also relevant for neck pain
      symptoms. No study has investigated the effects of the application of dry needling over
      active trigger points in the scalenes muscles in a sample of patients with mechanical neck
      pain.
    


Intervention name(s): Dry needling; Manual Therapy
Intervention type(s): Other; Other
Intervention description(s): A solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles.; The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hyperhydrosis Treatment Using Botulinum Toxin
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to describe two safe and reproducible techniques for the
      treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different
      injection technique in each armpit and will be evaluated subjectively and objectively.
    

Detailed description: 
      The abobotulinumtoxinA (ABO) will be used in all patients. The ABO will be prepared by adding
      4 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection patient
      pictures will be taken showing the technique used for each armpit.

      Injection technique:

        1. Technique 1 The Quadrant technique: 5 vertical lines and 5 horizontal lines will be draw
           on the hair bearing area of the armpit amounting to 25 injection points being more
           concentrated on the center. Each injection consists of 5Units of abobotulinum

        2. Technique 2 the six injection technique: will consist on 6 injections in the hair
           bearing area equally spaced with each consisting of 8units

      Follow up will be done at 15 days for post injection pictures with iodine starch test A total
      of 15 male patients will be recruited. And the injection for each armpit in a given patient
      is randomized.
    

Intervention name(s): botulinum toxin A
Intervention type(s): Drug
Intervention description(s): injection in hair bearing area of armpits
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: botulinum toxim; abobotulinum; hyperhydrosis; injection
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1278863A in Healthy Subjects
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      A first-time in human study to investigate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of GSK1278863A in healthy subjects
    


Intervention name(s): GSK1278863A
Intervention type(s): Drug
Intervention description(s): GSK1278863A planned doses from 2mg to 450mg which may change based on safety or PK from previous cohorts.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tolerability; Safety; pharmacokinetics
Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open -label randomized phase II study of dose-dense
      Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2
      (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.
    

Detailed description: 
      Arm A: the FEC75 regimen will be given at the following doses:

      Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v
      infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be
      administered intravenously on Day 1 of each 14-day cycles.

      Arm B: the FEC90 regimen will be given at the following doses:

      Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion
      and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.

      All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

      Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms
      on Day 2 of each cycle.

      Six cycles of adjuvant chemotherapy will be administered in both arms (A + B)
    

Intervention name(s): the FEC75 and 95 regimen
Intervention type(s): Drug
Intervention description(s): Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Arm B: the FEC90 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
Six cycles of adjuvant chemotherapy will be administered in both arms (A + B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: early breast cancer,; Fluorouracil
Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen
      species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of
      nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after
      30, 60 and 120 minutes.
    

Detailed description: 
      Apocynin reduced hydrogen peroxide concentration in exhaled breath condensate 60 and 120
      minutes after apocynin nebulization comparing to placebo (0.43 μM vs. 0.59 μM and 0.41 μM vs.
      0.58 μM respectively, p<0.05). Interestingly, apocynin caused decrease of NO2- concentration
      30, 60 and 120 minutes after apocynin inhalation (3.9 μM vs. 4.5 μM, 3.8 μM vs. 4.5 μM and
      3.7 μM vs. 4,4 μM respectively, p<0.05) comparing to placebo, but did not cause any
      significant changes in concentration of NO3- in any timepoint (p>0.05). No influence of
      apocynin on safety parameters, and no adverse effects has been observed.
    

Intervention name(s): Apocynin and placebo nebulization
Intervention type(s): Drug
Intervention description(s): 6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) and 0,9% NaCl as placebo, has been nebulized for 15-20 min through the mouthpiece with using of a nose clip. A nebulizer Pulmo Aide AP-50 (DeVilbiss; Richmond, VA) was used (mass median aerosol diameter 3.1 mm, output 0.3 ml/min.)
Other intervention name(s): 4-hydroxy-3-methoxyacetophenone,; acetovanillone
Intervention MeSH terms: Acetovanillone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: apocynin; COPD