bioihbjkbjnl/mcl2 huggingface dataset:
Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery
Condition: Coronary Artery
Study type: Interventional

Summary: 
      Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties.
      In addition, previous reports showed that trimetazidine was effective in reducing
      intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the
      evaluation of these combination effects of statin and trimetazidine on patients with aspirin
      monotherapy who had previously received CABG and were free of the major adverse cardiac
      events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that
      atorvastatin 40mg/day would be more effective in the prevention of the further late adverse
      cardiac and cerebrovascular events than other statin. To test this hypothesis, the
      investigators will perform a multi-center, randomized, prospective trial aimed at
      demonstrating the superiority of combination of high dose atorvastatin therapy and
      trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG
      surgery in real world practice.
    


Intervention name(s): Pravastatin 20mg/day for 12 months after randomization; Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization
Intervention type(s): Drug; Drug
Intervention description(s): Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program:
Test group:
Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization
Control group:
Pravastatin 20mg daily for 12 months after randomization; Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program:
Test group:
Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization
Control group:
Pravastatin 20mg daily for 12 months after randomization
Intervention MeSH terms: Trimetazidine; Atorvastatin; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
Condition: Squamous Cell Carcinoma of the Hypopharynx Stage III; Squamous Cell Carcinoma of the Hypopharynx Stage IV; Squamous Cell Carcinoma of the Larynx Stage III; Squamous Cell Carcinoma of the Larynx Stage IV; Squamous Cell Carcinoma of the Oropharynx Stage III; Squamous Cell Carcinoma of the Oropharynx Stage IV; Squamous Cell Carcinoma of the Oral Cavity Stage III; Squamous Cell Carcinoma of the Oral Cavity Stage IV
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Laryngeal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel,
      cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.
    

Detailed description: 
      It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a
      taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head
      and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of
      cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a
      acceptable alternative to patients.
    

Intervention name(s): Docetaxel; Cisplatin; 5-fluorouracil; Cetuximab Induction; Cetuximab Radioimmunotherapy; Boost irradiation
Intervention type(s): Drug; Drug; Drug; Biological; Biological; Radiation
Intervention description(s): 75 mg/m² on day 1 of 21-days cycle; 75 mg/m² on day 1 of 21-days cycle; 750 mg/m² day 1 to 5 during 24 hours of 21-days cycle; weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days; weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks; First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks
Other intervention name(s): Erbitux; Erbitux; Concomitant boost-irradiation
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: local advanced squamous cell carcinoma; Larynx; Hypopharynx; Oropharynx; Cavum oris; docetaxel; cisplatin; 5-fluorouracil; Cetuximab
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after
      exercise compared to the full coverage observed prior to exercise.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions
Condition: Type 1 Diabetes in Adolescence
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Background: In type 1 diabetes, adolescence is often associated with deterioration in
      glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment
      compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to
      insulin. Therapeutic patient education (TPE) is the key to successful management of the
      disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the
      Mediterranean region in France, and the care teams implementing them wish to promote joint
      reflection with sick teenagers and families to identify needs and expectations of everyone on
      priority skills to develop, to promote better management of the disease and improved quality
      of life.

      Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be
      developed during the educational sessions, to promote self-management of their disease and
      their treatment.

      Method: Four audio-recorded focus groups will be organized in all 10 clinical settings
      (adolescents, parents and health professionals). Thematic analysis will be carried out from
      the transcript of the focus groups.

      Expected results: The results will allow a joint reflection involving the participation of
      young patients, families, health professionals and the research team to build and implement
      new educational sessions that meet the identified needs. This action resulting from the
      research is expected to pool resources in different health facilities providing therapeutic
      education programs and to harmonize practices.
    


Intervention name(s): education programs
Intervention type(s): Behavioral
Intervention description(s): Four audio-recorded discussion groups will be organized in each of the 10 clinical settings
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of App and Electronic Device in the Treatment of Premature Ejaculation
Condition: Premature Ejaculation; Masturbation; Medical Device
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional

Summary: 
      Randomized control trial to determine if we can produce increases in the IELT using a new
      masturbator electronic in subjects with premature ejaculation in combination with a exercise
      app, producing improvements in the quality and satisfaction of the sexuality of the patient.
    

Detailed description: 
      This project of research will use one experimental groups, It will manage the affairs the
      therapy "sphincter control training" (SCT) into app combined with the external device called
      Myhixel I .Experimental groups will receive therapy with the protocol of exercises SCT.

      The main measure will be the "fold increase" (FI) of the IELT, which was calculated using the
      geometric mean of post-treatment IELTs (period B) divided by the geometric mean of
      pre-treatment IELTs (period A): FI = (geometric mean of IELT_7wk)/(geometric mean of
      PRE_IELT)

      The efficiency on the EP will see (IELT) reflected in an increase in the times of latency of
      intravaginal ejaculation and in punctuations of subjective perception, of the therapy on the
      line base.

      The subjects that will be born in mind will be all the interested parties in informing that
      their answer to the campaign of national advertising that will be started.

      The duration of the treatment will be 8 weeks during which a series of exercises app will be
      practised usin the masturbation device Myhixel I.

      The material used in the research will be innocuous and his responsible use does not produce
      adverse reactions of interest.
    

Intervention name(s): Sphincter Control Training (SCT); Sphincter Control Training (SCT)
Intervention type(s): Device; Behavioral
Intervention description(s): The SCT + device consists of 8 different exercises and an educational session into a app using a masturbation electronic aid device; The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Premature ejaculation; IELT; Medical device
Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
Condition: Contact Lens Base Curve (BC) Fit and Comfort
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine if corneal diameter and keratometry readings
      correlate to subjective comfort and lens fitting characteristics.
    


Intervention name(s): Contact Lenses with 8.5 BC; Contact Lenses with 9.0 BC
Intervention type(s): Device; Device
Intervention description(s): Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.; Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Other intervention name(s): Marketed Daily Disposable Soft Contact Lenses; Marketed Daily Disposable Soft Contact Lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Growth Hormone Evaluation in the Elderly People
Condition: Aging
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone
      (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon
      stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some
      parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with
      secretion of GH.
    

Detailed description: 
      subjects over 65 years old were recruited from the geriatric ambulatory unit of our hospital
      to voluntarily participate in a research study concerning the GH and ACTH axis in the
      elderly, which included the realization of the glucagon stimulation test as the first phase
      of the study.

      The GST (Glucagen® Hypokit, Novo Nordisk A/S, Denmark) was the chosen test to assess both
      ACTH and GH release because of its few known contraindications and mild side effects. It is a
      provocative test to evaluate GH and ACTH axis, i.e, a diagnostic test, without therapeutic
      effects.
    

Intervention name(s): growth hormone secretion
Intervention type(s): Other
Intervention description(s): The glucagon stimulation test (GST) was performed by intramuscular injection of 1 mg of glucagon (Glucagen® Hypokit, Novo Nordisk A/S, Denmark). The blood samples were collected at baseline and after 90 minutes, 120 minutes, 150 minutes and 180 minutes of glucagon injection for GH and cortisol measurements. The subjects were recumbent during the test, and a cannula was maintained in a vein in the arm or forearm with a saline solution slowly infused to avoid multiple punctures.
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Immunogenicity Study of Three Candidate HIV-1 Vaccines, Administered in Combination to Healthy HIV-1 Uninfected Adults
Condition: HIV-1 Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety
      and immunogenicity of three novel HIV vaccines.
    


Intervention name(s): ChAdV63.HIVconsv low dose.; ChAdV63.HIVconsv high dose.; pSG2.HIVconsv; MVA.HIVconsv; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): Attenuated chimp adenovirus. 5x10^9 virus particles.; Attenuated chimp adenovirus at 5x10^10 virus particles.; DNA at 4mg per dose.; Attenuated poxvirus at 4x10^8 plaque forming units per dose.; Phosphate buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre,
      placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety,
      tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2
      will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion
      cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male
      subjects and female subjects of non child-bearing potential with IPF.
    

Detailed description: 
      Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive
      either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an
      ascending dose fashion.

      A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to
      receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to
      placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on
      pre-clinical efficacy and safety data.
    

Intervention name(s): Inhaled TD139; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DPI Galectin-3 inhibitor; DPI placebo
Other intervention name(s): TD139; inhaled placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a pilot randomized controlled trial, to determine
      whether providing financial incentives for meeting daily step goals (a) increases the daily
      step counts of participants, (b) increases compliance with the overall program (including
      diet recommendations), and (c) increases weight loss.
    


Intervention name(s): Daily step goal financial incentive; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.; Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)
Condition: COPD; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in
      COPD patients.
    

Detailed description: 
      Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation,
      which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and
      independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering
      drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have
      anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive
      protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that
      activates the acute phase CRP response.

      Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and
      ET-1 in COPD patients.
    

Intervention name(s): simvastatin
Intervention type(s): Drug
Intervention description(s): 40 mg po daily
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Inflammation; CRP levels; simvastatin
Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
Condition: Total Hip Replacement
Study type: Interventional

Summary: 
      Studies have shown that surgery causes some reactions in your body consistent with
      inflammation. When the inflammation is extensive, it may affect different parts of the body
      including the lungs. Corticosteroids are commonly used to treat inflammation and are
      different from performance enhancing steroids associated with athletics. The purpose of this
      study is to determine the influence of low dose steroids given 3 times in a 24 hour period on
      thrombotic markers (markers that are associated with increased risks of clotting, a possible
      complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response
      seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized
      placebo controlled trial patients undergoing total hip replacement.
    


Intervention name(s): Prednisone; Hydrocortisone; Placebo (for Prednisone)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Low dose steroids to be administered preoperatively and then repeated over a 24-hour period; 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital; 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by; 3. Another dose of 100 mg hydrocortisone IV 8 hours after; Low dose steroids to be administered preoperatively and then repeated over a 24-hour period; 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital; 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by; 3. Another dose of 100 mg hydrocortisone IV 8 hours after; Lactose filler to mimic 20 mg prednisone tablet
Intervention MeSH terms: Prednisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which
      is being studied for possible prevention and treatment of postmenopausal osteoporosis.

      PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms
      of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of
      postmenopausal osteoporosis.

      The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,
      breakdown and elimination in the body) of a single dose of PREMARIN® when administered
      together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.

      Information will also be obtained regarding the safety and tolerability of the study
      medications when given together to healthy postmenopausal women.
    


Intervention name(s): Bazedoxifene and conjugated estrogens
Intervention type(s): Drug
Intervention description(s): Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pregabalin Premedication for Conscious Sedation
Condition: Conscious Sedation
Study type: Interventional

Summary: 
      Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done
      without causing respiratory depression or loss of consciousness. The present study was
      designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and
      respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and
      midazolam.
    

Detailed description: 
      Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two
      equal groups, 35 patients each. All patients received premedication one hour before the
      procedure. PG group received 150 mg pregabalin and C group received placebo. All patients
      sedated to achieve optimum working conditions. Intra-operative respiratory rate and post
      procedure patients' and pulmonologists' satisfaction were compared in both groups.
    

Intervention name(s): Pregabalin (PG); Control placebo (C)
Intervention type(s): Drug; Drug
Intervention description(s): Pregabalin 150 mg one hour before the procedure as premedication.; Placebo tablets one hour before the procedure as premedication.
Other intervention name(s): Pregabalin for premedication; Placebo for premeditation
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other