bioihbjkbjnl/mcl2 huggingface dataset:
Metformin in High Responder Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF Cycles
Condition: Infertility; Polycystic Ovary Syndrome (PCOS)
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of metformin pre-treatment and co-administration was recently proposed in infertile
      women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.

      Data from meta-analyses showed that metformin administration significantly reduced the
      stimulation length and the total dose of gonadotropins used in PCOS women undergoing
      gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in
      IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation
      syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.

      The metformin regulating effect on the ovarian response was also observed in a randomized
      controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving
      gonadotropins for mono-ovulation induction. In particular, metformin increased the
      mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used,
      while it reduced the number of dominant follicles and the estradiol (E2) levels.

      The aim of the present study was to evaluate the effect of metformin administration in high
      responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.
    

Detailed description: 
      Infertile young non-obese insulin-resistant patients with PCOS who had a background of the
      first IVF treatment cycle cancelled because of high risk for OHSS will be enrolled and
      randomized in two treatment arms.

      In their second IVF attempt, the experimental group will receive metformin (500 mg, 3 times
      daily) pre-treatment for two weeks and co-administration during gonadotropins ovarian
      stimulation; the control group will be treated with placebo (2 cps daily) pre-treatment and
      co-administration by using the same schedule of the experimental group. In all patients,
      ovarian stimulation will be carried out with a personalized step-down gonadotropin in
      association with a minidose flare-up GnRH agonist protocol.
    

Intervention name(s): Metformin; Placebo administration
Intervention type(s): Drug; Drug
Intervention description(s): Metformin pre-treatment and co-administration; Placebo pre-treatment and co-administration
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCOS; Polycystic ovary syndrome; Cancelled cycles; OHSS; Infertility
Hypoxia Impairs Endothelial Function in HAPEs
Condition: Healthy
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of the study is to investigate the function of the systemic vascular endothelium in
      individuals susceptible to high-altitude pulmonary oedema during normoxia and normobaric
      hypoxia.
    

Detailed description: 
      Rationale: High-altitude pulmonary edema (HAPE) is characterized by excessive pulmonary
      vasoconstriction and is associated with decreased concentrations of nitric oxide (NO) in the
      lung. Objectives: We hypothesized that individuals susceptible to HAPE (HAPE-S) would also
      have dysfunction of the vascular NO vasodilator pathway during hypoxia in the systemic
      vasculature. Methods: During normoxia (FI(O(2)) = 0.21) and 4 hours of normobaric hypoxia
      (FI(O(2)) = 0.12, corresponding to an altitude of 4,500 m above sea level)
      endothelium-dependent and endothelium-independent vasodilator responses to intraarterial
      infusion of acetylcholine (ACh) and sodium nitroprusside, respectively, were measured by
      forearm venous occlusion plethysmography in nine HAPE-S subjects and in nine HAPE-resistant
      control subjects. Main Results: Pulmonary artery systolic pressure increased from 22 +/- 3 to
      33 +/- 6 mm Hg (p < 0.001) during hypoxia in control subjects, and from 25 +/- 4 to 50 +/- 9
      mm Hg in HAPE-S subjects (p < 0.001). Despite similar responses during normoxia in both
      groups, ACh-induced changes in forearm blood flow markedly decreased during hypoxia in HAPE-S
      subjects (p = 0.01) but not in control subjects. The attenuated vascular response to ACh
      infusion during hypoxia inversely correlated with increased pulmonary artery systolic
      pressure (p = 0.04) and decreased plasma nitrite correlated with attenuated ACh-induced
      vasodilation in HAPE-S subjects (p = 0.02). Conclusions: Hypoxia markedly impairs vascular
      endothelial function in the systemic circulation in HAPE-S subjects due to a decreased
      bioavailability of NO. Impairment of the NO pathway could contribute to the enhanced hypoxic
      pulmonary vasoconstriction that is central to the pathogenesis of HAPE.
    

Intervention name(s): Hypoxia
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia (HoFH)
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety of Rosuvastatin in Children and
      Adolescents with Homozygous Familial Hypercholesterolemia.
    

Detailed description: 
      This is a long-term extension (LTE) to the randomized, double-blind, cross-over study of
      rosuvastatin 20 mg once daily (QD) versus placebo QD in children and adolescents (aged from 6
      to <18 years) with homozygous familial hypercholesterolemia (HoFH) (Study D3561C00004).

      The study is designed to assess the long-term safety and tolerability of rosuvastatin 20 mg
      in pediatric patients with HoFH.

      In this study all patients will receive rosuvastatin 20 mg QD. Investigators will also be
      permitted to titrate the dose of rosuvastatin from 20 to 40 mg per day if they feel it is
      warranted to more aggressively treat patients' elevated LDL-C levels. This up-titration will
      not be permitted in Asian patients. Pharmacokinetic data of the trough plasma exposure of
      rosuvastatin will also be assessed for the pediatric patients with HoFH taking a daily dose
      of rosuvastatin 40 mg.

      The primary outcome measures to be assessed include 1) Adverse events, including:

        -  The frequency and severity of adverse events,

        -  Rate of discontinuations due to adverse events,

        -  Abnormal serum and urine laboratory values, electrocardiograms (ECGs), physical
           examinations, and vital signs; and 2) Assessments of growth.
    

Intervention name(s): Rosuvastatin 20mg
Intervention type(s): Drug
Intervention description(s): Active drug 1 or 2 tablets will be taken taken orally, QD, either in the morning or in the evening
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDL-C; HoFH; Hyperlipidemia
Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Condition: Obesity; Spinal Cord Injuries; Diabetes
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of a low carbohydrate diet on
      increasing dietary adherence and improving cardiometabolic risk factors among adults with
      spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one
      of two groups: 1) a reduced carbohydrate diet or 2): a "standard" diet (STD). Participants
      will take part in a 6-month behavioral lifestyle intervention implemented through a novel
      eHealth platform specially designed for individuals with SCI.
    


Intervention name(s): eHealth Behavioral Lifestyle Intervention Device: Telecoach
Intervention type(s): Behavioral
Intervention description(s): Participants will receive weekly/biweekly coaching sessions with a telecoach and use eHealth platform to log food and exercise, review daily goals, and find strategies for reaching goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Web-Based Adolescent Motivational Enhancement Study
Condition: Alcohol Risk Behaviors; Health Care Services Quality of Care
Study type: Interventional

Summary: 
      The proposed study is a randomized controlled trial that compares the effectiveness of an
      electronic personalized health screening app incorporating motivational feedback (i.e. "Check
      Yourself") to usual care among moderate to high risk alcohol users. The purpose of this study
      is to determine whether Check Yourself is more effective than usual care in reducing alcohol
      consumption and binge drinking and improving quality of care among adolescents receiving
      school-based health clinic services.
    


Intervention name(s): Check Yourself App with Feedback
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the change of medication satisfaction measured by
      Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are
      switched into paliperidone palmitate, either immediately or in a delayed mode.
    

Detailed description: 
      This is a prospective (patients are first identified and then followed forward as time
      passes), multicenter (study conducted at multiple sites), randomized (the study medication is
      assigned by chance), comparative and open-labeled (all people know the identity of the
      intervention) study.

      The study mainly consists of 3 phases including, the screening phase (14 days before
      administration of study medication), treatment phase, and the follow-up phase (28 days after
      the last dose of the study medication). In the treatment phase, patients will be randomly
      assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown
      characteristics. Group 1 (immediate switch group): Patients will be administered with
      paliperidone palmitate immediately after randomization and will continue throughout the
      treatment phase. Group 2 (delayed switch group): Patients will remain on current oral
      antipsychotics until Week 8, and later on will be completely switched to paliperidone
      palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further
      deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.

      Safety evaluations will include evaluation of adverse events, clinical laboratory tests,
      electrocardiogram, vital signs, and physical examination and these will be monitored
      throughout the study.

      The total duration of the study will be approximately 148 days.
    

Intervention name(s): Paliperidone palmitate
Intervention type(s): Drug
Intervention description(s): Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.
Other intervention name(s): INVEGA SUSTENNA
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone Palmitate; Invega Sustenna; Antipsychotics; Atypical antipsychotics; Medication Satisfaction and Adherence
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
Condition: Otherwise Healthy Overweight or Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD)
      study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in
      otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort,
      subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary
      objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of
      orally-administered PHP-303.
    


Intervention name(s): PHP-303; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
Condition: Aortic Valve Disease; Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Aortic Valve Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this investigation is to compare the cardioprotective effects and safety of
      two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients
      undergoing aortic valve surgery. The study design is a prospective, double blind,
      multicenter, randomized, Phase III comparison study intended to demonstrate superiority in
      surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24
      hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement
      (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively
      (e.g., myocardial infarction).
    


Intervention name(s): Custodiol-N; Custodiol
Intervention type(s): Drug; Drug
Intervention description(s): comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery; comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: aortic valve disease; coronary bypass surgery; cardioplegic solutions
Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Objectives:

      A lot of children who injure their ankles come to the emergency department for an evaluation,
      and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In
      more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be
      treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency
      departments are time consuming, often uncomfortable for the patient, and expose children to
      radiation, the long-term effects of which are not yet fully understand by doctors or
      scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not
      produce radiation. It was been shown to determine the presence of bone fracture in childrens'
      wrists and forearms just as well as X-rays do. In our study, the investigators would like to
      determine if a bedside ultrasound can also be used to evaluate ankle fractures in children.

      Research Procedures:

      In our study, the investigators will ask the parents and children, who are scheduled to get
      an X-ray of their ankle in the emergency department, to examine their ankles with an
      ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming,
      does not require patients to remain still, and is readily available in the department, the
      procedure will be performed while kids are waiting to get an X-ray, getting registered, or
      awaiting further treatment. On the data collection form, the investigators will document the
      patients' names, birthdates, medical record numbers so that their X-ray results can be
      compared to the ultrasound results for the purpose of the study. The information will be
      stored in a secure cabinet in a locked office. The investigators will also document which
      side is injured, where the patient feels pain and what the ankle looks like to help perform
      the ultrasound. The results of both the ultrasound and X-ray will be documented for each
      patient.
    


Intervention name(s): Ultrasound
Intervention type(s): Other
Intervention description(s): Single interventional group - patients agree to an ultrasound of potential ankle fracture, to be compared to standard of care xray.
Other intervention name(s): ultrasound for fractures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.
      Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood
      vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is
      therefore being developed for the treatment of thromboembolic events in children and
      adolescents. As small children are often unable to swallow tablets, an oral suspension
      (mixture of a liquid containing finely distributed solids) has been developed which allows
      dosing according to body weight. The objective of this trial is to compare the
      bioavailability (proportion of a substance that remains available unchanged in the blood
      circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for
      treatment. In order to evaluate the potential influence of food, the oral suspension
      containing 20 mg rivaroxaban will be taken after consuming food. In addition, the
      pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood),
      safety and tolerability will be assessed.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939)
Intervention type(s): Drug
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Relative bioavailability; Rivaroxaban
Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Condition: Gastroschisis
MeSH terms: Gastroschisis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS)
      to treat infants with gastroschisis will result in improved outcomes, faster recovery times
      and fewer post-surgical complications than the standard selective use of the silo.
    

Detailed description: 
      Standard treatment of the infant with gastroschisis consists of , the bowel being reduced
      into the abdomen, when possible,and the abdominal wall defect being closed in the operating
      room. When complete reduction of the eviscerated contents is not possible, a silastic " silo"
      is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over
      several days. Once reduction is obtained, the silo is removed and the abdominal defect is
      closed.

      Current methods of treatment are associated with significant morbidity, prolonged
      hospitalization, and high costs. Gastroschisis closure continues to be accompanied by a
      number of complications ranging from ileus, sepsis, TPN-related liver damage, necrotizing
      enterocolitis, respiratory insufficiency, and death. The optimal timing and method of
      closure, including primary versus secondary closure, continues to be debated. No prospective
      randomized studies to date have examined the routine use of the spring-loaded silo.
    

Intervention name(s): Primary placement of a spring-loaded silo; Primary Closure
Intervention type(s): Procedure; Procedure
Intervention description(s): primary closure of abdomen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; gastroschisis; silastic spring-loaded silo
Renal Impairment in Type 2 Diabetic Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance
      in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type
      2 diabetic and healthy subjects with normal renal function
    


Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, once daily
Intervention MeSH terms: Dapagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk and Risk Perception of Knee Osteoarthritis in the US
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The investigators have created an interactive knee osteoarthritis (OA) risk calculator that
      estimates a user's risk of developing symptomatic knee OA as well as the user's risk for
      undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the
      calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk.
      Participants were randomized to either access general information about OA or use the risk
      calculator in addition to accessing general OA information. The investigators hypothesized
      that participants randomized to the risk calculator arm would have more accurate perception
      of their knee OA risk and would have increased willingness to change risky behavior compared
      to the general OA information group.
    


Intervention name(s): Internet-Based Osteoarthritis Risk Calculator; Generic osteoarthritis information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The investigators have developed a personalized risk calculator for knee osteoarthritis. This risk calculator uses the Osteoarthritis Policy Model to estimate an individual's risk of developing knee osteoarthritis within their lifetime based on demographic information and risk factors. It shows this information to the user with interactive graphs and compares their risk to the risk of an average American of the same age.; Subjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention