cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking

This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions.


Eligibility Criteria:
Inclusion Criteria:

* minimum 16 years of age, registered player in the highest Swedish professional ice hockey league for women, SDHL

Exclusion Criteria:

* age under 16 years.
Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT

To evaluate the natural history of visual function in subjects with IRD phenotypically diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or LRAT gene mutations.

This is a retrospective, uncontrolled, multicenter, case history study to determine the natural history of visual function in patients with IRD phenotypically diagnosed as LCA or RP caused by autosomal recessive mutation in RPE65 or LRAT.

Up to 60 subjects will be enrolled in this study at approximately 12 study centers in Canada, the US and Europe.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 8 or older with IRD (LCA or RP) caused by inherited autosomal recessive mutation in either RPE65 or LRAT.
* Subjects who have at least 2 documented kinetic visual field assessments of the same isopter(s) in at least one eye performed at least 2 years apart on the same type of equipment when the subject was between the ages of 6 and 65 years.
* If applicable, subjects who provide informed consent for the study (the requirement for informed consent may be applicable to all sites or may be waived by the IRB and/or local regulations). The parent or guardian must sign an approved informed consent form for the study for subjects younger than the age of majority.

Exclusion Criteria:

* Subjects, who in the Investigator's opinion, have any severe acute or chronic medical condition, psychiatric condition, physical examination finding or laboratory abnormality that may interfere with the interpretation of their visual function data.
* Subjects with concomitant bilateral ocular disorders that may affect visual acuity or visual fields (e.g., advanced glaucoma, optic neuritis, anterior ischemic optic neuropathy, advanced cataract, intraocular surgery).
A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants

This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks.

Duration per participant is up to 11 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, between 18 and 65 years of age, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Body weight between 70.0 and 90.0 kg, inclusive.
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
* Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -1.
* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
* History of light-headedness or syncope during blood collection or injection of medications.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
* If female, pregnancy (defined as positive β-human chorionic gonadotropin blood test) or breast-feeding.
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or 5 elimination half-lives of the respective investigational drug, whichever is longer, of the inclusion visit.
* Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of T2DM
* Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening
* Body mass index (BMI) 25 to 45 kg/m\^2, inclusive, at Screening
* HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose
* C-peptide ≥ 0.8 ng/mL at Screening
* Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period

Exclusion Criteria:

* Type 1 diabetes mellitus
* History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
* History of severe hypoglycemia
* Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening
* History of congestive heart failure
* Corrected QT interval (QTc) \> 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
* Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening
* Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \> 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) \> 3 x ULN and/or serum total bilirubin \> 2.0 mg/dL
* Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization
* Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days)
* Treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization
* Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization
* Treatment with simvastatin or lovastatin at a dose \> 20 mg or \> 40 mg daily, respectively, within 14 days prior to randomization
Effects of an Online Meditation Course on Quality of Life

Many interventions in the field of meditation are becoming increasingly popular and have gained worldwide acceptance over the past years, both in terms of health, but also psychological aspects. On the other hand, controversial and sometimes hypercritical positions are on the rise, questioning the positive effects of meditation on health due to the limited availability of high-quality scientific data. With regard to a large number of meditation interventions, the systematic exploration of procedures that have not yet been scientifically evaluated - also in online settings - is a meaningful contribution to meditation research.


Eligibility Criteria:
Inclusion criteria:

* Age: 18 years or older
* All persons registering for the online course
* Internet access
* Sufficient language skills, as well as cognitive and physical abilities, to participate in an online survey lasting approximately 30 minutes
* Active consent to the online consent form

Exclusion criteria

- Failure to provide informed consent to participate in the study
Transobturator Approach for Paravaginal Repair

A new technique for Applying sutures to the white line in paravaginal repair.

A new trial for transobturator repair of the paravaginal defect.

Eligibility Criteria:
Inclusion Criteria:

* paravaginal defect cystocele
* midline and paravaginal defect cystocele

Exclusion Criteria:

* uterine descent
* previous cystocele surgery
Lipid Infusions to Optimize Nutrition Trial

The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based lipid emulsion (SOLE) and to establish whether MOLE or SOLE is more effective in minimizing pulmonary outcomes, neonatal morbidities, long-term morbidity and mortality, and improving discharge growth and Bayley Scales of Infant Development Fourth Edition (BSID-IV) neurodevelopmental assessment at two years


Eligibility Criteria:
Inclusion Criteria:

* inborn \<28 weeks gestational age (GA) or ≤1000g birth weight (BW)
* survives until 12 hours after birth.

Exclusion Criteria:

* Infants who are unable to be enrolled by 96 hours postnatal age
* Major anomaly
* Overt non-bacterial infection
* Infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.
Human Mass Balance Study of HMS5552 in Healthy Subjects

This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of \[14C\]-HMS5552.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male 19-55 years of age
* Weight at least 50 kg, and BMI within the range of 18-30 kg/m2
* Written informed consent must be obtained before any assessment is performed

Exclusion Criteria:

* History or presence of clinically significant medical, surgical or psychiatric condition or disease in the opinion of the Investigator or designee which might significantly alter the absorption, distribution, metabolism and excretion of drugs.
* History or presence of alcoholism or drug abuse.
* Smoker.
* Abnormal bowel habits.
Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)

Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).

82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).

Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).

A monocentric retrospective observational study was realized at the Regional Hospital Center of Metz-Thionville, Mercy Hospital, Metz, France.

102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery). Surgery was considered successful when best spectacle corrected visual acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Over 18,
* had advanced FECD associated with visual symptoms and reduced visual acuity .

Exclusion Criteria:

* Prior intraocular surgery other than cataract
* Other indications for DMEK surgeries than FECD,
* Eyes with corneal (except FECD), retinal or optic nerve diseases
* Per-operative difficulties (tear's graft or complicated unfolding graft)
* Primary graft failure (cornea that failed to clear in the presence of an attached graft)
* Secondary graft failure (corneal decompensation after an initial period of a functional graft)
Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.

During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy.

The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 or type 2 diabetes
* both males and females
* age \>=18 anni
* insulin treatment from at least 6 months
* signed informed consent

Exclusion Criteria:

* pregnancy
* incapacity for filling in the questionnaires
* every illness or condition that, according to the investigator, could interfere with the study
Health Care Intervention Research- Improving Pre-natal and Maternal Care

Besides a dramatic lack of financial and human resources in developing countries, health care is additionally endangered by quality deficiencies caused by low staff motivation. This lack of motivation leads to an insufficient translation of knowledge into optimal utilization of resources. The "know-do" gap represents a challenge that must be addressed to strengthen health services performance towards achieving the Millennium Development Goals (MDGs). This is in particular true for some sensitive sectors like pre-natal and maternal health care. General objective of this research is to improve maternal health through better pre-natal and maternal care services offered by better motivated health workers. A computer-assisted clinical decision support system (CDSS) will be developed, implemented and tested aiming at (I) quality improvement of maternal and newborn care and (II) assessment of provider's performance. Based on this tool a commonly agreed incentive scheme to increase motivation will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and Tanzania.

The incentive scheme might contain both non-monetary and monetary incentives and will be designed according to the human resource policy in the three countries. The planned approach is an implementation study with control arms containing one hospital and 6 first line health facilities in each of the study districts and an equal number of facilities in the control arm. A set of indicators for measurement of changes in quality of delivered services will be identified in order to follow up the sustainability and effectiveness of the strategies after their implementation. The study findings will allow understanding the important factors of staff motivation and facilitate adequate management for improvement of maternal and neonatal health care. "Knowing is not enough, we must apply; Wanting to do, is not enough, we must do it1"

- J.W. v. Goethe


Eligibility Criteria:
Inclusion Criteria:

* the patient in the primary health care center

Exclusion Criteria:

* patients outside the research regions
18F-FSPG PET/CT for Cancer Patients on Therapy

The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.

OUTLINE:

Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG \[18F-(S)-4-(3-fluoropropyl)-L-glutamic acid\] or 18F-FDG (\[18F\]-fluorodeoxyglucose), before and after therapeutic treatment.

PRIMARY OBJECTIVE:

Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.

SECONDARY OBJECTIVES:

* Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
* Safety and tolerability of 18F-FSPG and 18F-FDG.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Able to complete a PET/CT scan without the use of sedation
* Females:

  * Of childbearing potential must:

    * Not be nursing
    * Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT
  * Not of childbearing potential must be:

    * Physiologically postmenopausal (cessation of menses for more than 1 year)
    * Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
* Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
* Scheduled to begin therapy
* The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
* Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)
* No clinically relevant deviations in renal function (serum creatinine \> grade 2 Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week

Exclusion Criteria:

* Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
* Known sensitivity to 18F FSPG or components of the preparation
* Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers

Assess mechanism of action of LCZ696 related to sodium excretion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure: documented NYHA class II-III heart failure
* Patients with hypertension: stable hypertensive medication for the preceding 2 months

Exclusion Criteria:

* Women of childbearing potential
* History of recent myocardial infarction
* History of dialysis or renal transplant
* Patients with type 1 diabetes mellitus
Ovarian Tumor Biopsies to Study Response to Treatments

This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.

Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.

The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Histological diagnosis of epithelial ovarian cancer
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Life expectancy of greater than 3 months
* Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
* Must be agreeable to paired biopsies
* Must have disease amenable to paired biopsy.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Any contraindication to biopsy
* Need for anticoagulation that cannot be interrupted