bioihbjkbjnl/mcl2 huggingface dataset:
Estrogen Treatment (Oral vs. Patches) in Turner Syndrome
Condition: Turner Syndrome; Hypogonadism; Premature Ovarian Failure
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Primary Ovarian Insufficiency; Menopause, Premature; Hypogonadism; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The study attempts to evaluate if the way of administering estrogen, the principal female
      hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome.
      These are girls who are very short and whose ovaries do not work. We will examine changes
      bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough
      the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH
      therapy.
    

Detailed description: 
      Girls with Turner Syndrome, between the ages of 10-16 years, were chosen as the study
      population. The study requires 3 overnight admissions to an in-patient Clinical Research
      Center(CRC). A baseline study is performed using stable isotope tracers of leucine, glycerol
      and glucose and serial blood sampling to measure protein and fat metabolism. Indirect
      calorimetry is used to measure substrate oxidation rates and total energy expenditure. DEXA
      scan is used to measure bone mineral density and body composition. Once the baseline study is
      complete subjects are randomly assigned to receive either estrogen orally or through a patch
      placed onto the skin in increasing doses changed every 2 weeks. After 6 weeks of estrogen
      treatment a second metabolic study, identical to the first, is performed, followed by a wash
      out period of 4 weeks. Subsequently, the subjects are switched to the alternate form of
      estrogen. At the end of 6 weeks a third and final metabolic study is repeated. All subjects
      continue to be on growth hormone throughout the study procedures.
    

Intervention name(s): 17 beta estradiol
Intervention type(s): Drug
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Turner syndrome; Hypogonadism; GH; Estrogen; Estrogen Patches; IGF-I; Body Composition; Protein Metabolism; Lipolysis
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, crossover pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fed
      condition in healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Capsules USP 300 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Etodolac Capsules USP 300mg of Taro Pharmaceutical Industries Ltd., USA,
      under fed condition in healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 300 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 10 days including washout period of 7
      days between administrations of study drug in each study period.
    

Intervention name(s): Etodolac Capsules USP 300 mg; Etodolac
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg capsule once a day; 500 mg tablet once a day
Other intervention name(s): Test Product; Reference Product
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fed
Drug-Drug Interaction Study: ASP2151 and Bupropion
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo the
      effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this
      trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe
      substrate bupropion.
    


Intervention name(s): Bupropion; ASP2151
Intervention type(s): Drug; Drug
Other intervention name(s): Zyban
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Herpes; volunteers; drug-drug interaction
Pathways for Patient-centered Diagnosis and Management of Endometriosis-associated Deep Dyspareunia
Condition: Endometriosis-related Pain; Dyspareunia Deep
MeSH terms: Endometriosis; Dyspareunia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the acceptability and effectiveness of two tools
      that may help address the management of deep dyspareunia: 1) A phallus length reducer (PLR,
      brand name: Ohnut), consisting of 4 interconnected silicone rings worn externally over the
      penetrating object to reduce pain with deep penetration by allowing adjustable limitation of
      penetration depth, and 2) A vaginal insert for at home self-assessment of the extent and
      severity of deep dyspareunia.
    

Detailed description: 
      Background: Endometriosis is a gynecological condition characterized by the abnormal growth
      of endometrial like tissue outside of the uterus. The condition affects approximately 10% of
      reproductive-age females and can cause various types of pain, including chronic pelvic pain
      and deep dyspareunia (pelvic pain with deep sexual intercourse). Research has shown that
      individuals with endometriosis and dyspareunia have significantly reduced sexual quality of
      life, lower self-esteem, and impaired sexual function. Qualitative research has also
      demonstrated that many individuals with dyspareunia feel guilty about their pain, and often
      continue to engage in intercourse even when the pain is severe.

      Aims and Hypotheses:

        1. To measure the reduction in deep dyspareunia observed among people using the PLR with
           their partner. The investigators hypothesize that the PLR will be associated with a
           reduction in self-reported deep dyspareunia scores among participants randomized to the
           PLR intervention, compared to participants randomized to the waitlist control group. The
           measured reduction in deep dyspareunia will be used to power a future definitive trial.

        2. To assess the acceptability of the phallus length reducer (PLR) for participants with
           endometriosis and their partners. The investigators hypothesize that both partners will
           indicate the PLR is acceptable on the self-reported questionnaire.

        3. To explore whether an at-home assessment of dyspareunia is an acceptable and valid
           alternative to clinical measures. The investigators hypothesize that the at-home
           assessments of dyspareunia will be acceptable to participants and will yield results
           that are highly correlated with questionnaire-based and clinical assessments of this
           pain.
    

Intervention name(s): Phallus Length Reducer; Self-assessment of dyspareunia
Intervention type(s): Device; Other
Intervention description(s): Phallus Length Reducer; Use of a vaginal insert to self assess dyspareunia
Other intervention name(s): OhNut
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: endometriosis; dyspareunia; sexual distress; buffer
A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel group, single and multiple
      ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of ICP-332 in Healthy Subjects
    


Intervention name(s): ICP-332; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ICP-332 will be administered as tablet; Matching placebo will be administered as tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Myocardial Contrast Echocardiography in Congenital Heart Disease
Condition: D-Transposition of Great Arteries; Tetralogy of Fallot
MeSH terms: Heart Diseases; Heart Defects, Congenital; Tetralogy of Fallot; Transposition of Great Vessels
Study type: Observational

Summary: 
      Patients with congenital heart disease in whom the right ventricle is exposed to pressure or
      volume overload show progressive systolic dysfunction of the right ventricle, the fact of
      which conveys substantial morbidity and mortality. The aim of this study is to investigate
      the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in
      order to determine whether disturbed blood flow plays a role in the development of right
      ventricular systolic dysfunction.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population is divided in three groups, which are all age- and gender-matched. The
        TGA group consists of 15 patients treated withMustard or Senning procedures for surgical
        repaired of D-TGA atrial switch operation. The TOF group consists of 15 patients with
        surgically corrected TOF. The control group C consists of 15 control subjects (AH) with
        normal Doppler Echocardiographic echocardiographic examinations.
A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride
      (HCl) (migalastat) in participants with Fabry disease.
    

Detailed description: 
      This was a Phase 2, open-label study in male participants with Fabry disease. The study
      consisted of a 4-week screening period, during which participants' galactosidase (GLA)
      genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat.
      Participants were required to have α-Gal A activity responsive to migalastat. The study
      consisted of a 24-week treatment period, followed by an optional 24-week extension period.
      Participants received migalastat once every other day (QOD) for 24 weeks during the treatment
      period and the optional 24-week extension for a total treatment duration of up to 48 weeks.
    

Intervention name(s): migalastat HCl
Intervention type(s): Drug
Other intervention name(s): AT1001; Galafold; migalastat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate
Pharmacokinetics of Ciprofloxacin in Pediatric Patients
Condition: Urinary Tract Infection; Pyelonephritis
MeSH terms: Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in
      children aged 3 months - 17 years who are treated for urinary tract infections.
    


Intervention name(s): ciprofloxacin
Intervention type(s): Drug
Intervention description(s): Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration
Intervention MeSH terms: Ciprofloxacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ciprofloxacin; pharmacokinetics; excretion; clearance; infant; children; adolescent
Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded,
      placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects
      receive investigational product (IP) and undergo safety monitoring, evaluations, and
      subsequent follow-up after IP administration.
    

Detailed description: 
      This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB1934
      within the following 2 study parts:

      Part 1 is an inpatient, placebo-controlled, multiple ascending dose (MAD) study in HV male
      and female subjects in up to 5 dose cohorts (6 treated: 2 placebo) for 5 days of dosing to
      identify the maximum tolerated dose (MTD). During the second cohort an additional 6 treated
      subjects will be enrolled; all treated subjects in Cohort 2 will complete a second treatment
      period with SYNB1618 in a cross-over design.

      Part 2 is an open-label, randomized sequence, crossover study of SYNB1934 that will be
      initiated after determination and selection of a well-tolerated dose in Part 1. Subjects will
      receive treatment with SYNB1934 with a proton pump inhibitor (PPI), will complete a treatment
      washout period, and receive SYNB1934 treatment without a PPI. Initially 16 HV male and female
      subjects will be enrolled with the option of expanding Part 2 up to 60 HV subjects.
    

Intervention name(s): SYNB1934; SYNB1618
Intervention type(s): Drug; Drug
Intervention description(s): SYNB1934 is formulated as a nonsterile solution intended for oral administration; SYNB1618 is formulated as a nonsterile solution intended for oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
An Assessment of Dual Site Left Ventricular Endocardial Pacing
Condition: Atrial Fibrillation; Ventricular Tachycardia; Heart Failure
MeSH terms: Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      We are investigating ways to help patients with heart failure, which is caused by damaged
      hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of
      energy and swelling.

      Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function
      of the main heart chamber in certain suitable people with heart failure. CRT requires a
      pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on
      the outside of the left heart chamber. These two wires act together to re-time the
      coordination of the heartbeat, which is known to improve heart function.

      The investigators are assessing whether they might be able to improve heart function even
      more by placing two wires on the inside of the left heart chamber, rather than one around the
      outside.

      The investigators wish to assess whether:

        1. Using two wires within the left side of the heart gives a greater increase in heart
           function than one.

        2. It is possible to choose the best spot inside of the heart by measuring the pattern of
           the heart beat.

        3. Is it possible to use a different type of heart monitor placed outside the body instead
           of a monitor wire inside the heart to assess improvement in heart function? They are
           investigating this in people with hearts that beat less effectively than normal.
    


Intervention name(s): Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol
Intervention type(s): Procedure
Intervention description(s): Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Endocardial pacing; Multi site pacing
The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain
Condition: Chronic Pain; Quality of Life; Alexithymia
MeSH terms: Chronic Pain; Affective Symptoms
Study type: Interventional

Summary: 
      It was aimed to investigate the effect of aerobic exercise on pain, alexithymia level and
      quality of life in young alexithymic individuals with chronic pain. There is no study in the
      literature comparing the effectiveness of aerobic exercise on alexithymia and chronic pain.
      Since our study will be the first study to investigate the subject, we foresee that it is
      scientifically important and will shed light on future studies. In addition, it is planned to
      make national or international papers and publications after the study is completed.
    

Detailed description: 
      In the study, after the necessary permissions are obtained, the Graded Chronic Pain Scale
      (ECAS) and Toronto Alexithymia Scale-20 (TAS-20) will be sent to the students who are
      studying at KTO Karatay University and whose age range is between 18-25 years. Among the
      students who fill out the form voluntarily, individuals who mark the 3rd or 4th option in the
      first question in the DKAS and who have a total score of 52 and above in the TAS-20 scale
      will be identified. Among these individuals, a total of 40 people will be included in the
      study randomly with a computer program. These participants will again be randomly divided
      into two groups as the control group (n=20) and the exercise group (n=20).
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Participants assigned to aerobic exercise training will walk on a treadmill (RodbyTM, RL 1600E, Enhorna, Sweden) for 40 minutes at an intensity of 60-75% of maximum heart rate (220-age formula) three times per week for 8 weeks. The heart rate of the participants will be measured with an electric heart rate monitor throughout the session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is a single center, early phase 1 clinical imaging study designed to assess the
      dosimetry of 68Ga-Galmydar for PET/CT imaging.
    

Detailed description: 
      The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics
      following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal
      volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group).

      Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous
      Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by
      whole-body PET/CT imaging.
    

Intervention name(s): Ga-68 Galmydar
Intervention type(s): Drug
Intervention description(s): Single intravenous injection of the PET radiotracer 68Ga-Galmydar.
Other intervention name(s): IND 157468
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: myocardial perfusion imaging; pharmacological stress; biodistribution; positron emission tomography; myocardial blood flow
Semiconductor Heat Extraction Cooling
Condition: Hyperthermia
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      Heat-related injuries and other physiological stresses continue to be a significant threat to
      the health and operational effectiveness of the US Armed Forces (Armed Forces Health
      Surveillance 2011). This is because military personnel are exposed to exertional and
      environmental heat-stress factors during both deployment and training at US installations in
      hot and humid climates. Cold water immersion (CWI) is considered the gold standard for the
      treatment of exertional heat stroke (EHS) and has been shown to increase survival rates to
      100% with the implementation of CWI best practices. However, in a field setting other cooling
      strategies have been developed to aid in the prevention of EHS and other heat-related
      illnesses. One such proposed strategy is a portable hand cooling device that does not require
      the use of ice or water. Therefore, the primary purpose of this investigation is to validate
      hand and back cooling devices using physiological, cognitive, performance, and perceptual
      responses that occur during and following rest, exercise, and cooling in the heat.
    


Intervention name(s): Hand Cooling at 12-15 degrees celsius; Hand Cooling at 16-20 degrees celsius; hand and back cooling at 12-15 or 16-20 degrees celsius; Passive cooling
Intervention type(s): Other; Other; Other; Other
Intervention description(s): hand cooling at 12-15 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature; hand cooling at 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature; hand and back cooling at 12-15 or 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature while also wearing the back wrap cooling device set to this temperature; participants will sit in a chair and "passively cool" (no active intervention)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive four cooling treatment on separate study visits 1)hand cooling at 12-15C 2)hand cooling at 16-20C 3)passive cooling 4)back and hand cooling (at 12-15C or 16-20C depending on results of trials 1-3)
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in
      healthy male and female adult subjects. Subjects will be randomly assigned to receive either
      nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization
      schedule. The following treatments will be administered:

        -  Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a
           period of 3 hours for 3 days.

        -  Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive
           placebo.
    


Intervention name(s): Nafithromycin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nafithromycin 200 mg as IV infusion; placebo administered as IV infusion
Intervention MeSH terms: Nafithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science