cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of YVOIRE Y-Solution 540

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection


Eligibility Criteria:
Inclusion Criteria:

* 3 (moderate) or 4 (severe) on the 5-graded WSRS
* who sign the written informed consent form

Exclusion Criteria:

* who have received permanent facial implants
* who have received semi-permanent fillers
* who have undergone temporary dermal filler treatment within 12 months
* who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
* who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
Functional Inspiratory Muscle Training in Chronic Kidney Disease

Effects of functional inspiratory muscle training by telerehabilitation on respiratory and peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality of life, cognitive function, fatigue, physical activity, endothelial function and aortic stiffness in patients with chronic kidney disease will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease not receiving dialysis
* Access to the online program
* Volunteering to participate in the research

Exclusion Criteria:

* Having a musculoskeletal problem
* Having decompensated diabetes
* Having uncontrolled hypertension
Irritable Bowel Syndrome Regional Cohort

Setting up a regional (multicentre), longitudinal cohort of people suffering from irritable bowel syndrome followed up in consultation to study the natural history of the disease and its prognosis.

The strategy of this project is to develop a regional cohort of patients suffering from irritable bowel syndrome, in order to offer harmonised phenotyping, longitudinal follow-up and the study of clinical and biological factors associated with the development of the disease and its treatment.

To achieve this, the study plans to prospectively collect a complete phenotyping of patients suffering from IBS and followed up in consultation in the participating centres (questioning, questionnaires, physiological explorations and results of complementary examinations), with follow-up of the course of the disease and which will be supplemented by stool samples for analyses of the microbiota and metabolites.

The study aims to include all patients seen prospectively in the centres over a period of 2.5 years and to include as many stool samples as possible during follow-up visits. This should make it possible to include a total of 600 patients. This number will be sufficient to identify subgroups of patients with similar clinical or biological characteristics of reasonable size (at least 50 to 100 subjects each) and then compare their prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient
* Normal laboratory work-up as part of routine care (CBC, CRP)
* Over 18 years of age
* Patient affiliated to a social security scheme
* Person who has read and understood the information letter and does not object to taking part in the study

Exclusion Criteria:

* Patient suffering from an organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis when endoscopy has been performed because deemed necessary, digestive cancer, coeliac disease) or major digestive surgery (excluding appendectomy and cholecystectomy).
* Patient refusal
* Patient does not speak or understand French
* A pregnant woman or a woman in labour or breastfeeding
* Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal female patients;
* stage IV or locally advanced breast cancer;
* measurable disease;
* letrozole failure (Part 2);
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.

Exclusion Criteria:

* previous chemotherapy for metastatic breast cancer;
* concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
* history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
* concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

Reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. Commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. However, overloading patients with fluid also have several risks and known complications. Studies have also shown that a short period of decreased urinary output in the postoperative period do not have an increased incidence of acute renal failure. The aim of our study is to investigate the difference in renal function and postoperative complications associated with fluid overload on these patients that are randomized to either receiving a fluid bolus directly when urinary output decreases or to await for a maximum of four hours to see if urinary output increases spontaneously.

Patents after pancreatic surgery will be included in the study. Oliguric patients (urine output \<0.5 ml/kg/h) will be randomized to fluid bolus (5ml/kg Ringer's Acetate in 30 minutes) or no intervention. Primary outcome is difference in urine output two hours after the fluid bolus or no intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients going through pancreatic surgery.

Exclusion Criteria:

* If not oliguric (urinary output \<0,5 mls/kg/h) during their stay in the postoperative department
* Hemodynamic instability (the need for \>0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure).
* Patients that do not want to be a part of the study.
* \<18 years old
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education

Game on Philly is a multi-component out-of-school time intervention delivered by trained sport-based youth development coaches and health navigators using evidenced-based programming. The program evaluation assesses the impact of this minimal-risk intervention to reduce the prevalence of obesity-related health disparities in racial and ethnic minority middle school youth. The program is a virtual sport-based youth development program, supplemented with nutrition education. The program was modified due to Covid-19 and is entirely virtual. Using a quasi-experimental design, six schools are assigned to the intervention arm and six schools are assigned to the comparison arm. Participants in intervention schools receive access to daily, online after school programming, with live sessions with sports providers (via Zoom), weekly team meetings with a health coach (via Zoom), text-messages via the Remind app, and the monthly delivery of Activity Kits directly to their homes for six months. Comparison school participants receive access to the Game on Philly app with workout and sports content and receive one activity kit delivery at the start of the program. Parent-child dyads recruited from each school complete surveys at baseline and at the end of the 6-month program (follow-up). It is hypothesized that youth participating in the intervention will experience significantly greater increases in physical activity at the end of the 6-month intervention compared to youth participating in the comparison arm (primary outcome). Secondary outcomes will examine changes in dietary intake, self-efficacy for physical activity and positive youth development.


Eligibility Criteria:
Inclusion Criteria (Parents) :

* 18 years of age or older
* Parent or legal guardian of the enrolled child
* Can read, write and speak in English

Inclusion Criteria (Child):

* Interested in and able to participate in the program for 6-months
* Can read, write and speak in English
* Are in 6th, 7th or 8th grade at a participating school
Effects of Progressive Resistance Training on Physical State Energy and Fatigue During Pregnancy.

The purpose of this study is to compare the effects of progressive resistance training on physical state energy and fatigue during pregnancy. This study was a randomized controlled trial used to find the effects of progressive resistance training on physical state energy and fatigue during pregnancy. The data was collected from Sheikh Zaid Hospital via Visual analogue scale-fatigue, Numeric pain rating scale and Short form health survey-36. Sample size of 30 females was taken in 15 each group.

According to the findings of a study on physical activity during pregnancy in 2021, obese women, who exercise less than ladies of normal body weight may gain from gradually increasing their amount of exercise to reduce the amount of weight gain associated with pregnancy. Exercise during pregnancy was consistently associated positively with sob-R among the women in both categories, which denotes that it may have an impact on the control of lepton activity and pregnancy-induced insulin resistance. Overall, our research suggests that obese women, who are lepton-resistant and at pregnant women at high risk of gestational diabetes, fast weight gain, and increased fetal adiposity should receive advice and supportive services to raise their activity level, with an emphasis on the fact that even slight improvements in action can be good for both child and maternal health.

Eligibility Criteria:
Inclusion Criteria:

* Female with age of 20 to 40 years
* Between 20-25 weeks of gestation.
* Healthy individual
* Pregnant females who are easily fatigued during activities of daily living.

Exclusion Criteria:

* • Those who reported regular resistance training exercises

  * Complicated pregnancy
  * Low pre-pregnancy body weight
  * Anemia
  * Diabetes
  * Psychiatric disorder
  * Orthopedic and cardiovascular limitation
Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts

The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.

Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Collegiate athlete or athlete-cadet anticipated to be an active member of a varsity sport team.

Exclusion Criteria:

* Any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor
* History of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study.
* Participants currently undergoing active treatment for migraine, depression and/or anxiety or ADHD will not be excluded as these are high prevalence conditions in the adolescent and collegiate population (8-30%). However, exploratory stratified analyses will be conducted where possible.
* Participants with eye conditions or diseases that could impact the blood vessels in the eye.
* Determination that the participant is unsuitable for study entry or potentially unable to complete all aspects of the study based on the judgement of the Site Investigator or Study PI.
Use of a Hand-held Digital Cognitive Aid in the Early Management of Simulated War Wounds.

Combat casualty care has proven to increase survival rate in military conflict by treating without delay the quickest-to-kill wounds. The French militaries are trained to the MARCHE RYAN acronym, an algorithm designed to help every soldiers provide simple treatment in order to bring the patient to the surgeon alive.

Our first study (MAX, Lelaidier et al, BJA 2017) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia \& intensive care emergencies (malignant hyperthermia, anaphylactic shock, acute toxicity of local anaesthetics, severe and symptomatic hyperkalaemia).

The present study exclusively deals with the management of combat casualties with the same digital cognitive aid adapted for MARCHE RYAN algorithm.

In a first study (MAX, BJA 2017, Lelaidier et al) the investigators designed a digital cognitive aid (MAX for Medical Assistant eXpert) under the form of a smartphone application including 5 scenarios of anaesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anaesthetics, severe and symptomatic hyperkalaemia, ventricular fibrillation), designed to be used in the hand of the leader managing the situations. Technical and non-technical skills were improved in 4 out of 5 scenarios.

Combat casualties are dealt with a stereotyped management in the French army, and all soldiers learn the algorithm (acronym) designed for this purpose, the MARCHE RYAN. Situations requiring the use of the MARCHE RYAN are extremely stressful (on the battlefield, performed by non-medical personal, often on a comrade).

The present study exclusively deals with the management of combat casualties with the digital cognitive aid MAX adapted for MARCHE RYAN algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Soldiers
* already trained in Combat Care level 2, under training for external operations.

Exclusion Criteria:

* none
The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status

The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI) inquired by DS14 score in type D personality (distressed personality) to the relation of autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese patients within coronary heart disease group (CHD). As stress is the key psychological activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important risk factor for diminished immune competency and prevalence of chronic conditions such as obesity, investigators chose exercise as the stress release intervention, especially as chronic stress may have a role in obesity, related to initiation or exacerbation of the condition. Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally associated with chronic inflammatory conditions. Proinflammatory T-lymphocytes are present in visceral adipose tissue and may contribute to local inflammatory cell activation before the appearance of macrophages, suggesting that these cells could play an important role in the initiation and perpetuation of adipose tissue inflammation.

This study was performed at The Institute for Preventive Medicine in cooperation with The Institute of Microbiology and Immunology at the Medical Faculty of Ljubljana/University of Ljubljana in a clinical setting as an observational type. In the group of examinees the investigators chose only those obese without detectable complications of coronary heart disease while admitted. Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research. Since personality is the major determinant of chronic stress, according to the investigators hypothesis, further division on two global traits Negative affectivity (NA) and Social inhibition (SI) structured by Denollet has been positioned in the study. A total of 30 patients with CHD were divided in two groups. Participants who were obese with high DS14 score matched obese controls with normal DS14 score. In all subjects the investigators also observed white blood cell counts with a detailed lymphocyte analysis using flow cytometry and C-reactive protein (CRP) as the indicator of inflammation. Besides body mass (BM), body mass index (BMI) systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), and heart rate variability (HRV) were measured before and after three months period, while all subjects had been already exercising 4 times weakly (moderate walking of 5km/h) for an hour. Additionally STAIX-1, SWLS and QOLLTI-P questionnaires had been used.

Eligibility Criteria:
Inclusion Criteria:

* obese people without detectable complications of coronary heart disease

Exclusion Criteria:

* Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.
Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers

The study consists of evaluating the efficacy of an Educational Program for prevention of occupational musculoskeletal problems in workers. It is a randomized clinical trial with parallel groups and blinded evaluator, with a control group not submitted to the educational program, but that received a program for general orientation in health. The primary outcome was the change of the quality of life measured by means of Medical Outcomes Study 36-Term Short Health Survey (SF-36), that it is a generic instrument of evaluation of the quality of life, translated and validated in Portuguese of Brazil.


Eligibility Criteria:
Inclusion Criteria:

* All workers from a specific company, including administrative and production sections.

Exclusion Criteria:

* Workers absent from the workplace during all the study period.
Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload

The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.


Eligibility Criteria:
Inclusion criteria:

1. Transfusional iron overload three to six months after HCT with no evidence of active inflammation
2. History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
3. Patients of either gender and age ≥ 18 years.
4. Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraception , or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.

Exclusion criteria:

1. Non-transfusion related iron overload
2. Active malignancy
3. Known active viral hepatitis or known HIV positiveness
4. Mean levels of alanine aminotransferase (ALT) \> 5x ULN
5. Treatment with any iron chelator after transplantation
6. Uncontrolled systemic hypertension
7. Serum creatinine \> 1.5 ULN and/or serum creatinine clearance \< 60 ml/min
8. History of nephrotic syndrome.
9. Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
10. Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
11. Pregnant or breast feeding patients.

Other protocol-defined inclusion/exclusion criteria may apply
The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients

To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-infected patients.

Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.

Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.

Patients are randomized to receive either standardized point acupuncture or alternate point acupuncture treatment twice weekly for the first 6 weeks, then once weekly for the next 8 weeks, plus either oral amitriptyline or placebo daily for the entire 14 weeks. Acupuncture points are located on the lower leg. Patients are evaluated at weeks 6 and 14 and are asked to keep a daily pain diary.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral therapy.
* Nonsystemic treatment of Kaposi's sarcoma.
* Maintenance with an existing regimen of analgesic medication or herbal treatment.

Concurrent Treatment: Required:

* Acupuncture.

Patients must have:

* HIV infection.
* Lower extremity peripheral neuropathy secondary to HIV infection.
* Pain for at least 2 weeks prior to study entry.
* Life expectancy of at least 6 months.

NOTE:

* Co-enrollment in other experimental protocols is permitted as long as dual participation is allowed in those protocols.

Prior Medication:

Allowed:

* Antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known allergy to amitriptyline (not applicable for patients at sites using an acupuncture only study design).
* EKG indicating malignant arrhythmia or cardiac conduction disturbances (not applicable for patients at sites using an acupuncture only study design).
* Prison incarceration.

Concurrent Medication:

Excluded:

* Active treatment for an acute opportunistic infection or malignancy (nonsystemic treatment of Kaposi's sarcoma is permitted).
* Other tricyclic antidepressants.
* MAO inhibitors.

Patients with the following prior conditions are excluded (not applicable for patients at sites using an acupuncture only study design):

* History of cardiac disease.
* History of seizure disorder.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* MAO inhibitors.
* Tricyclic antidepressants.