bioihbjkbjnl/mcl2 huggingface dataset:
Pain in Competitive Athletes With Physical Disabilities: Techniques, Support and Perceived Difficulties
Condition: Pain; Athletes; Physical Disability
Study type: Observational

Summary: 
      Pain in physically disabled athletes affects the sporting career directly or indirectly
      through psychological consequences. Numerous studies address psychological skills in
      able-bodied athletes and in able-bodied athletes they are scarce.This information is part of
      a research project aimed at finding resources to help athletes in their pain management.
    

Detailed description: 
      The purpose of this study is to determine how competitive athletes perceive how pain can
      affect their sporting careers; what techniques and/or strategies athletes use for pain
      management and how useful these are; to determine the extent to which athletes with
      disabilities have received support for pain management and to what extent they have found it
      useful; and to determine the difficulties they often face in managing their pain.The aim of
      this questionnaire is to find out how pain, resulting from injury, can affect the sporting
      careers of competitive athletes with physical disabilities and what techniques they use to
      manage it.
    

Intervention name(s): Pain in competitive athletes with physical disabilities. Techniques for its management, support received and perceived difficulties.
Intervention type(s): Other
Intervention description(s): A total of 413 athletes with physical disabilities participated in the study, 157 Spanish athletes and 260 Latin American athletes. The athletes were contacted through different sports federations, Paralympic Committees and sports teams of people with disabilities.For the distribution of the questionnaire, the researcher made an initial telephone contact with the Spanish Paralympic Committee and the Spanish Sports Federation for People with Physical Disabilities, to explain the objectives of the study and ask for their collaboration in the dissemination. Subsequently, the information was officially sent to them by email.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        A total of 413 participants were interviewed on a voluntary basis. Spanish and Latin
        American nationality.
      
Keywords: Athlete; Physical disability; Chronic pain; Psychological models
Pilot Study to Evaluate the Safety and the Efficacy of the Matrix and Cells Obtained by the AmeaCell® Device and Intended for the Filling of Wrinkles on the Face.
Condition: Skin Aging
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by
      the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles
      on the face.
    

Detailed description: 
      The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by
      the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles
      on the face.

      This is a mono-center, pilot study in 24 subjects
    

Intervention name(s): AmeaCell
Intervention type(s): Device
Intervention description(s): Lipoaspirate obtained from liposuction is treated by the AmeaCell® device in order to obtain Matrix and Cells which contains cellular phase and matrix phase. The Matrix ancd Cells are injected in the same patient as facial wrinkles filler.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Age-related Changes in Sleep-wake Regulation
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      A sleep deprivation protocol combined with state-of-the-art, simultaneous positron emission
      tomography and magnetic resonance spectroscopy imaging will be employed to investigate the
      effects of sleep deprivation and aging on hypothesized molecular markers of sleep need.
    


Intervention name(s): Prolonged wakefulness
Intervention type(s): Behavioral
Intervention description(s): 40 hours of prolonged wakefulness
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Positron emission tomography; Magnetic resonance spectroscopy; Aging
Optimum Menstrual Cycle Time for Endometrioma Excision
Condition: Endometriosis; Endometrioma
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      This study evaluates the optimum day of menstrual period for the excision of endometriomas to
      minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as
      follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be
      evaluated with both pathologic examination and anti-mullerian hormone levels before and after
      the surgery.
    

Detailed description: 
      Endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age.
      The most common site of endometriosis is overt. Cystic formation of ovarian endometriosis is
      called endometrioma (chocolate cyst). Definitive treatment of endometriomas is excision by
      laparoscopy. The disadvantage of this surgery is the removal of some of the normal ovarian
      follicles within cystectomy material. This procedure can damage the ovarian reserves with the
      treatment of endometriomas, which are already the cause of infertility, and lead to the
      conditions such as infertility or early menopause. It has been understood that the ovarian
      reserves of the patients who underwent endometrioma cystectomy with the decrease of the
      Anti-Mullerian Hormone values, which is an over reserve parameter.
    

Intervention name(s): laparoscopic endometrioma cyst excision
Intervention type(s): Procedure
Intervention description(s): laparoscopic resection of ovarian endometrioma
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who admitted to out-patient clinic between the ages of 18-40 years,had 4-10cm ovarian
        unilateral endometrioma and had an indication of laparoscopic ovarian endometrioma
        excision.
      
Biospecimen description: 
      blood sample
    
Keywords: ovarian reserve; endometriosis; endometrioma
Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Explore pharmacodynamics

             -  glucose

             -  insulin

             -  C-peptide

             -  glucagon

             -  intact GLP-1

             -  DPP-4 activity

             -  CGMS (continuous glucose monitoring system)

        2. Assess Safety

             -  adverse events

             -  clinical laboratory test

             -  physical examination
    

Detailed description: 
      Pharmacodynamic assessment

        -  CGMS data is obtained from day 1 to day 3 (48 hours)

        -  PD is measured before (day 1) and after drug administration (day 2)

             1. AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity

             2. MAGE (mean amplitude of glycemic excursion) from CGMS data
    

Intervention name(s): Sitagliptin; Mitiglinide; Sitagliptin, Mitiglinide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral administration of sitagliptin 100 mg; Single oral administration of mitiglinide 10 mg; Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg
Intervention MeSH terms: Sitagliptin Phosphate; Mitiglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sitagliptin; mitiglinide; type 2 diabetes mellitus; Pharmacodynamics; Safety
Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of five
      different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1,
      Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule
      formulation of Dabigatran Etexilate.

      The secondary objective is to evaluate and compare several pharmacokinetic parameters between
      the treatments.
    


Intervention name(s): Dabigatran etexilate tablet E1; Dabigatran etexilate tablet D1; Dabigatran etexilate tablet C1; Dabigatran etexilate tablet B1; Dabigatran etexilate tablet A1; Dabigatran etexilate capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar
Condition: Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study intends to investigate the use as a booster of a dose of sanofi pasteur's
      Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth's Prevnar
      vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar®
      at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined
      vaccine (DTaP-IPV-HB-PRP~T)
    


Intervention name(s): Pneumo 23; Prevnar
Intervention type(s): Biological; Biological
Intervention description(s): Vaccine (Pneumo 23); Vaccine (Prevnar)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Streptococcus pneumoniae
The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then
      gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and
      impedance kinetics.
    

Detailed description: 
      The participants will be on one week medication after two-weeks observation period.
      Intragastric and intraesophageal multichannel intraluminal impedance-pH (pH-MII) monitoring
      will be performed before and after medication. The pre- and post-treatment data will be
      compared. The safety tests will be performed during study in terms of possible side effects.
    

Intervention name(s): Dexrabeprazole 10 mg Enteric-Coated Tablets
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease (GERD), GERD, impedence
Exploratory THS 2.1 Biomarkers of Exposure Study
Condition: Smoking
Study type: Interventional

Summary: 
      The goal of this exploratory study is to evaluate the effect of a candidate modified risk
      tobacco product (MRTP), THS 2.1, on selected biomarkers of exposure to harmful and
      potentially harmful smoke constituents (HPHCs), compared to conventional cigarettes (CC). The
      subjective effects (urge to smoke and withdrawal symptoms) which are related to the use of
      this product will be explored. Initial information on safety and on some biological effects
      when using THS 2.1 will be collected. Human Smoking Topography (HST) will be explored.
    

Detailed description: 
      This study intends to evaluate the levels of selected biomarkers of exposure to selected HPHC
      and of cytochrome P450 1A2 (CYP1A2) enzymatic activity, as compared to smokers continuing
      smoking CC ad libitum, after 5 days of ad libitum use.

      Additional parameters will be explored, such as: cytochrome P450 2A6 (CYP2A6) enzymatic
      activity, nicotine pharmacokinetics, product evaluation and safety, marker of platelet
      function, and HST.

      After screening, subjects will be admitted to the clinic for 9 days, including the Day of
      Admission, 2 days of baseline during which all subjects will continue to smoke their usual CC
      for a 5-day exposure after randomization. After leaving the clinic on the Day of Discharge,
      the subjects will be followed up for safety over a period of 7 days. All subjects will
      receive smoking cessation advice at screening, at Day of Admission and at Day of Discharge.

      This clinical study will be conducted in compliance with International Conference on
      Harmonisation of technical requirements for registration of pharmaceuticals for human use
      (ICH Good Clinical Practice), the Declaration of Helsinki as amended in 2008, and the
      applicable regulatory requirements.
    

Intervention name(s): Conventional cigarettes (CC); THS 2.1
Intervention type(s): Other; Other
Intervention description(s): Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1; Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: smoking; cigarette; exposure; biomarker; human smoking topography (HST); modified risk tobacco product (MRTP); THS 2.1
Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell
      mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin
      disease.
    


Intervention name(s): TG-0054 (2.24 mg/kg); TG-0054 (3.14 mg/kg)
Intervention type(s): Drug; Drug
Intervention description(s): TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions); TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
Condition: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of
      worsening heart failure or cardiovascular death in patients with chronic heart failure with
      reduced ejection fraction
    

Detailed description: 
      This is an international, multicentre, parallel group, event-driven, randomized,
      double-blind, placebo-controlled study in patients with chronic heart failure with reduced
      ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once
      daily in addition to background regional standard of care therapy, for the prevention of
      cardiovascular (CV) death or reduction of heart failure (HF) events.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg or 5 mg tablets given once daily, per oral use.; Placebo matching dapagliflozin 10 mg or 5 mg.
Other intervention name(s): Forxiga TM; Farxiga TM
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HFrEF; Heart Failure (HF); Cardiovascular Events (CV); Phase III outcome trial
Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
Condition: Female Contraception
MeSH terms: Amenorrhea
Study type: Observational

Summary: 
      MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is
      to describe the acceptability of Amenorrhea in contraception indication of Mirena users
      during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in
      the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be
      evaluated.
    


Intervention name(s): Levonorgestrel IUD (Mirena, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Women who have been prescribed Mirena in contraception; followed up for 12 months
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who have been prescribed Mirena for contraception.
      
Keywords: Mirena; Contraception; Amenorrhea
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis
Condition: Plantar Fasciitis, Chronic
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of
      Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue
      pain reduction began in August 2016 and was completed in April 2017. The clinical setting:
      University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal
      study for chronic plantar fasciitis.
    

Detailed description: 
      Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which
      sound waves are concentrated and focused into selected musculoskeletal tissue, to produce
      selective thermal coagulative changes over a small controlled area while leaving the
      surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue
      response cascade and promote collagen generation in the targeted anatomy resulting in pain
      reduction.
    

Intervention name(s): Intense Therapeutic Ultrasound Treatment
Intervention type(s): Device
Other intervention name(s): Guided Therapy Systems, Ardent Sound, GTS, ITU; Actisound
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Condition: Pulmonary Hypertension, Familial Persistent, of the Newborn
MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide
      treatment and reduce the failure rate of available treatments for persistent pulmonary
      hypertension of the newborn.
    


Intervention name(s): placebo; iv sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.; loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
Other intervention name(s): revatio
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: persistent pulmonary hypertension; newborn; neonates; iv sildenafil; hypoxic respiratory failure and at risk of persistent pulmonary hypertension of the newborn
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)
Condition: Nutritional Safety
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of an infant formula
      supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance,
      mimicking that of breast-fed infants.
    

Detailed description: 
      Oligosaccharides are one of the major breast milk components. They are not digested and reach
      the colon where they're used by selected groups of microflora positive bacteria, specifically
      bifidobacteria and lactobacilli.

      Therefore, oligosaccharides have prebiotic effects accountable for health benefits in
      infants.

      Over the last years the supplementation of infant formulae has been studied to mimic breast
      milk prebiotic functions enhancing gut microflora growth similar to that of breast fed
      infants.

      However further scientific data are necessary to support the efficacy of the supplementation
      of oligosaccharide in infant formulae.
    

Intervention name(s): Infant formula (with GOS)
Intervention type(s): Other
Intervention description(s): Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Formula; Feeding; Healthy; Full; Term; Infants
Postural and Clinical Outcomes of SNAGs Treatment in Cervicogenic Dizziness Patients: a Randomised Controlled Trial
Condition: Cervicogenic Dizziness; Rehabilitation
MeSH terms: Vertigo; Dizziness
Study type: Interventional

Summary: 
      Previous works demonstrated the relationship between postural disturbances and reduction in
      cervical range of motion (CROM) in patients suffering from cervicogenic dizziness (CGD).
      Since sustained natural apophyseal glides (SNAGs) have been proposed as an effective
      treatment, the aim of the present study was to evaluate how clinical measures could be
      affected in patients with cervicogenic dizziness undergoing SNAGs.
    


Intervention name(s): SNAGs Treatment; Sham Laser Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): a sustained passive accessory movement (glide), i.e. SNAGs, will be applied by the physiotherapist while the participant will be asked to move actively as allowed by his/her physiological range in the direction producing his symptoms.; A Laser YAG 3 Chronic (Winform Medical Engineering s.r.l., San Donà di Piave (VE), Italy), will be detuned and applied in the region of cervical spine in order to have a sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly allocated to SNAGs (n = 41) or placebo (n = 39) treatment, constituted by a detuned laser. Both groups received their interventions 6 times over 4 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cervicogenic dizziness; sustained natural apophyseal glides; posturography testing; fast Fourier transform; cervical range of motion