cyrilzakka/clinical-trials huggingface dataset:
Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.

For the double-blind portion of the study, dosing will be initiated in a subgroup of adults who are 18-65 years of age. Following independent Data Monitoring Board review of subgroup safety data, and review and confirmation to proceed by FDA, enrollment of subjects \<18 years of age will commence.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject and their legally authorized representative must be willing to provide informed consent
* Confirmed genetic diagnosis of PWS
* Body mass index (BMI) within the following range at Screening:

  1. Female and male subjects 18 to 65 years of age: 27 to 60 kg/m2; or
  2. Female and male subjects 13 to 17 years of age with BMI that is at least 85th percentile for age and sex;
* Female subjects must be of non-child-bearing potential
* Documented stable body weight
* Moderate hyperphagia at Screening and at Baseline
* Participants must have a reliable and stable caregiver who should be able to spend an adequate amount of time with the participants to be able to address behaviors, activities and symptoms
* Male subjects who are sexually active must be surgically sterile

Key Exclusion Criteria:

* Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
* Sitting BP that meets the following criteria after 5 minutes of rest at Screening:

  1. Adult subjects with systolic BP \>/=145 mmHg or \<100 mmHg; or
  2. Adult subjects with diastolic BP \>/=95 mmHg or \<70 mmHg; or
  3. Adolescent subjects with a systolic or diastolic BP that is 95th percentile or greater for age and sex
* Type 1 diabetes mellitus
* History of dementia (eg, Alzheimer's disease, Parkinson's disease)
* History of bulimia or anorexia nervosa
* History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder), or symptoms of delusions, hallucinations, or mania/hypomania within 90 days prior to Screening, as described by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
* Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
* Medical condition or recent systemic infection that, in the opinion of the Investigator, could impact the safety of the subject
* Use of prohibited medications, including current use of SSRIs/SNRIs
TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing

The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. The importance of the research is to allow patients who receive a total ankle replacement to bear weight 4 weeks earlier than the current protocol with no negative effect on the osseointegration and stability of the ankle replacement.

The study will be conducted using two groups. The first group will be a retrospective review of charts of 35 patients who received a total ankle replacement porous prosthesis by an orthopedic surgeon at the University of Oklahoma Health Sciences Center. This group was received a delayed 6 week post-operative weight-bearing protocol.

The second group will be prospective and include patients who will receive the same total ankle replacement porous prosthesis but will be assigned to early 2 weeks post-operative weight-bearing protocol.The retrospective and prospective groups will be age and gender matched. A Wright Medical Infinity Total Ankle Replacement System will be used for both groups.

Both groups will be assessed at 1 year and 2 years post-operative. This assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.

Eligibility Criteria:
Retrospective/Prospective Inclusion Criteria:

Patients who have had a total ankle replacement with the Principal Investigator from the initiation of his clinical practice from September 2015 to September 2020.

Had delayed weight-bearing. Patients whose age and gender match the retrospective delayed weight-bearing group.

Retrospective/Prospective Exclusion Criteria:

Patients who have had Total Ankle Replacement with subsequent development of suture wound infection.

Patients who have had Total Ankle Replacement with subsequent development of deep infection requiring revision.

Patient who have had Total Ankle Replacement with subsequent development of Peri-prosthetic fractures during surgery or post-op.
Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity

Soft contact lenses can affect the ocular surface and sometimes cause intolerance. The aim of this study is to measure corneal sensitivity using the Swiss Liquid Jet aesthesiometer at baseline, after one and after six weeks, in novice daily contact lens wearers.

Contact lens discomfort is described by many wearers. Wearing contact lenses can influence corneal sensitivity through three mechanisms: hypoxic, mechanical and inflammatory. A change in corneal sensitivity can be considered an indicator of a change in corneal physiology. Corneal sensitivity plays a major role in maintaining eye health. The interest of this study is to test the variability of the corneal sensitivity threshold during a new adaptation of silicone hydrogel contact lenses, and to verify whether there is a correlation with the wearer's comfort. For that, corneal sensitivity threshold measurements are taken at the baseline and then after one and six weeks of daily contact lens wear. The measurement is performed with the Swiss Liquid Jet aesthesiometer for corneal sensitivity (SLACS). After one week and six weeks of daily lens wear, participants complete a Contact Lens Dry Eye Questionnaire (CLDEQ-8) for comfort analysis.

Eligibility Criteria:
Inclusion Criteria:

* The Ocular Surface Disease Index questionnaire (OSDI) score for dry eye classification is ≤ 13
* Participants must be candidates for contact lens wear.
* Corneal radius between 7.4mm and 8.0mm
* If the corneal radius is \> 8.0mm, the corneal diameter must be greater than 12.0mm.
* If the corneal radius is \<7.4mm, the required corneal diameter is less than 12.0mm.
* Participants have a CL cylindrical ametropia ≤ -1.25 D.
* Participants will not have worn CL for 7 days prior to the start of the study.
* Participants do not wear CL regularly (no more than 1 days per week) prior to the start of the study.
* During the study, the participant wore the CL a minimum of 5 days per week for a minimum of 8 hours.
* The person being tested is in good health. This means that he or she does not suffer from any systemic diseases, such as diabetes or rheumatism, which could have an influence on eye health. He or she also has no eye disease and has not previously undergone corneal (refractive) surgery.

Exclusion Criteria:

* The participant is a minor.
* The participant has worn CL within the last 7 days.
* The radius of the cornea is not within the prescribed range. In addition, the corneal diameter is not within the prescribed range either.
* The participant's ametropia is not within the prescribed range.
* The participant has worn the lenses for less than 8 hours for less than five days.
* The participant has no diagnosis of dry eye.
* The OSDI questionnaire score for the Dry Eye classification is greater than 13.
* The participant suffers from a systemic disease (diabetes or rheumatism) that could influence ocular health, an ocular disease or has already undergone refractive surgery.
* Vulnerable participants
D-Stress Baltimore: School-based Mindfulness Instruction

Effective strategies to ameliorate the negative effects of stressful urban living are greatly needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of stress-reduction techniques, found to reduce mental health problems across many adult populations.

The investigators propose to conduct a randomized controlled trial of the 12-week school-based DSB program compared with a 12-week school-based health education control program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for mental health and behavioral problems among public middle-school students.

Urban youth in Baltimore City are under significant and inevitable stresses, including violent neighborhoods, failing schools, and interpersonal conflict. Effective strategies to ameliorate the negative effects of stressful urban living are greatly needed.

D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of stress-reduction techniques which has been found to be beneficial for adults in decreasing anxiety and depression, improving positive emotions, and reducing anger.

The investigators propose to conduct a randomized controlled trial of the 12-week school-based DSB program compared with a 12-week school-based health education control program at Elev8 schools among 5th-8th graders. The investigators hypothesize that the D-Stress Baltimore Program will reduce negative emotions, including hostility, and improve coping.

Eligibility Criteria:
Inclusion Criteria:

* 5th - 8th graders in select Baltimore City schools

Exclusion Criteria:

* N/A
Premedication Trial for Tracheal Intubation of the NEOnate

Multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome: pulse oxymetry value \< 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.


Eligibility Criteria:
Inclusion Criteria:

* Corrected age \< 45 weeks of gestational age
* Currently hospitalized in a neonatal intensive care unit
* Requiring semi-urgent or elective intubation
* Equipped with a reliable and permeable IV line
* Parental consent

Exclusion Criteria:

* Lack of parental consent
* Parental refusal
* Sedative or anesthetic treatment in the previous 24 hours
* Hemodynamic compromise defined as mean blood pressure\< corrected GA and/or refill time \> 3 seconds
* Upper airway malformation
* Life-threatening situation requiring immediate intubation
* Inclusion in another trial not permitting any other participation
* Impossibility to establish venous access
* Any contra-indication to any experimental drug
Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions

The REIN registry highlights significant disparities in the incidence of end-stage renal disease (ESRD) between regions, especially in the North East of France. According to the literature, the incidence of ESRD in an area could be related to contextual factors influencing the needs for dialysis or transplantation (age structure, prevalence of risk factors, socioeconomic and morbidity levels), as well as to primary and secondary care provision (general practitioners and nephrologists) and to practice patterns in nephrology.

The aims of this project are the following:

1. to compare the incidence of renal replacement therapy (dialysis or preemptive transplantation) for ESRD between the "départements" and the "cantons" belonging to the 5 regions of Eastern France (Alsace, Lorraine, Champagne-Ardenne, Bourgogne and Franche-Comté), while taking into account differences in population sizes and spatial patterns of the data,
2. to analyse the relations between incidence disparities and socioeconomic environment, geographic accessibility to primary and secondary care and medical practice patterns, after adjusting for morbidity and mortality rates (incidence of diabetes, cardiovascular mortality).

This project will enable a better understanding of the mechanisms involved in the spatial variations of ESRD incidence, while disentangling effects related to the need from effects related to service supply in different socio-economic contexts. It will be possible to identify a lack of equity in access to renal replacement therapy if, after adjusting for need indicators, there were variations of incidence of ESRD related to availability of service or to socioeconomic context. Highlighting such effects would lead to search for corrective measures in collaboration with the different stakeholders.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Resident of the 5 French administrative regions (Alsace, Bourgogne, Champagne-Ardenne, Franche-Comté, and Lorraine)
* First renal replacement therapy by renal dialysis or preemptive kidney transplant between January 1st, 2010 and December 31, 2014
* Found in the REIN registry

Exclusion Criteria:

* Transfer from another French administrative region
* Return to renal dialysis after graft rejection or a period without dialysis
FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France

FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

Breast cancer is the most common cancer among women. With the increase of the survival rates, a growing attention is paid to the side effects of the treatments, particularly chemotherapy-induced infertility.

The FEERIC study will give insights into spontaneous fertility outcomes following breast cancer in comparison with a control cohort and will provide data to help patients counselling towards spontaneous fertility rates following breast cancer. It will also provide data on contraceptive prevalence and unintended pregnancy rates in French breast cancer survivors. Reasons for unmet need for family planning will be deciphered, in order to point out pitfalls (lack of patient's information or orientation/ignorance of contraception methods available/topic insufficiently or not discussed with the physician/ lack of family planning offer etc...); and target the appropriate actions to lead (oncologist and oncology nurses education/ dedicated consultations in breast cancer centers/etc...).

Eligibility Criteria:
Inclusion Criteria:

* females aged from 18 to 43 at inclusion
* previous diagnosis of breast cancer and time from diagnosis comprised between one and five years or women free from breast cancer or other malignancy (healthy volunteers) .

Exclusion Criteria:

* hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
* healthy volonteer with history of malignant disease.
Altered PSA Test Due to Possible Suspected Heterophilic Antibodies

The purpose of this study is to investigate if clinically non explainable high or low Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the serum of participants. The investigators will examine if heterophilic antibodies are the reasons of altered PSA levels.


Eligibility Criteria:
Inclusion Criteria:

* Male, with a a clinically high or low unexplainable PSA measurement
* Age between 40 and 90 years
* Written informed consent

Exclusion Criteria:

* Female
* No PSA measurement available or planned
* Age over 90 or under 40 years
Detection of AD Biomarkers in Tear Fluid

Detection of AD biomarkers in tear fluid


Eligibility Criteria:
Inclusion Criteria:

* . Inclusion criteria were an MMSE score ≥ 20 and a CDR score from 0 to 1, thereby including patients across the whole clinical spectrum (i.e. from subjective cognitive disorder to (mild) dementia).

Exclusion Criteria:

* Exclusion criteria at baseline were neurological diseases (such as Normal Pressure Hydrocephalus, Morbus Huntington, brain tumor, epilepsy, encephalitis, recent Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA) (\< 2 years), or TIA/CVA with concurrent (within three months) cognitive decline) and a history of psychiatric disorders (such as schizophrenia, bipolar disorder or psychotic problems, current major depressive disorder (within 12 months), or alcohol abuse).
Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making

The study EPICS-6 consists of three study phases. Emergency Department patients are screened for nasal and pharyngeal colonisation with Methicillin sensitive and Methicillin resistant Staphylococcus aureus (MSSA/MRSA) using a point-of-care (POC)-PCR-testing method (cobas®LIAT®-System, Roche Molecular Systems Inc.) The first aim of this study is to describe the prevalence of MSSA/MRSA-colonisation in a routine cohort of Emergency Department patients. The second aim is to determine the impact of POC-guided decolonisation as compared to conventional laboratory testing on in-hospital infection rates with MSSA/MRSA in a pre-post-comparison study.

The study EPICS-6 consists of three study phases. In phase one the novel POC-PCR-testing method for MSSA/MRSA-proof (cobas®LIAT®-System, Roche Molecular Systems Inc.) is technically established and integrated in Emergency Department procedures. After evaluation of processes and sample handling the second phase of this study assesses the prevalence of positive MSSA/MRSA-POC-testing in the general ED-population and in different risk groups. Based on the results of the previous study phases, the final phase comprises an interventional pre-post-comparison study. The interventional study assesses the impact of POC-result guided early decolonisation of MSSA/MRSA-colonized patients on in-hospital infection rates with MSSA/MRSA.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Emergency Department (ED) visit in one of the participating EDs

Exclusion Criteria:

* none
Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.

OBJECTIVES:

* Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).

OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven unresectable or metastatic urothelial cancer

  * No transitional cell histologies
* Bidimensionally measurable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Hematopoietic:

* WBC at least 3,500/mm\^3
* Platelet count greater than 150,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL

Renal:

* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 55 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* No other concurrent malignancy except basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior systemic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* At least 3 weeks since prior radiotherapy

Surgery

* Not specified
Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis

This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.

Nonalcoholic steatohepatitis (NASH) is characterized by the liver damage in the form of fatty degeneration and hepatitis in people who do not abuse alcohol. The disease often develops in middle-aged women with excessive body weight, increased blood glucose and blood lipids, but can occur in all age groups and in both sexes. In most cases, the disease is asymptomatic. Laboratory data indicate an increase in the level of aminotransaminases. Ultrasound reveals hyperechoic tissue of the liver due to diffuse fatty infiltration. The degree of steatosis can also be estimated by a controlled attenuation parameter (CAP - Controlled Attenuation Parameter) in the fibroelastometry of liver tissue. It is also possible to verify the degree of fibrosis of liver tissue in its presence. Given that the mare's milk has therapeutic and dietary properties for various diseases of the internal organs, including liver diseases, the investigators decided to study its therapeutic effectiveness in NASH.

In this clinical study, the effectiveness of mare's milk in NASH will be studied in comparison with control groups taking monotherapy with ursodeoxycholic acid (UDCA) and combined therapy (mare's milk and UDCA). Patients will receive a sublimated form of mare's milk in the appropriate dosage within 2 months, and the results of clinical laboratory and instrumental studies will be compared among themselves using statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a verified diagnosis of non-alcoholic steatohepatitis;
* Aged 16 to 60 years;
* Absence of an allergic reaction to dairy products;
* Willingness to consent to participate in the study.
* Consent to adhere to treatment

Exclusion Criteria:

* Taking antibiotics, cytostatics and steroids during the last 3 months;
* Taking alcohol hepatotoxic doses (no more than 30 g alcohol per day for men and not more than 20 g for women);
* History of oncological diseases;
* Presence of diabetes mellitus, decompensated forms of diseases, intestinal dyspepsia, hypertension (blood pressure 140/90 mm Hg and more at the time of the initial visit to the doctor), tuberculosis;
* A positive result of screening for antibodies to viral hepatitis B, C and D, as well as HIV
* Presence of concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, oncological, mental health and decompensated endocrine diseases, tuberculosis, and HIV infection;
* Pregnancy and/or lactation;
* Patient involvement in other clinical trials within the last 3 months;
* Refusal to participate in the study.