cyrilzakka/clinical-trials huggingface dataset:
PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)

This is a prospective pilot study to evaluate the mean increase of bowel symptoms after pelvic radiotherapy (RT) in prostate cancer (PCa) patient using the validated \& newly translated EORTC-QLQ PRT20 module.

Questionnaires (QLQ-C30 and PRT20 modules) will be held to patients at the beginning and at the end of RT (4 weeks) to evaluate the mean increase of lower GI symptoms and decrease in overall QoL after pelvic RT.

For exploratory objectives, GLIM (Global Leadership Initiative on Malnutrition) criteria for malnutrition diagnosis, a 24h recall and DQI-I calculation will be assessed by the PI before the start of RT. CT sim \& dosimetry will be analyse by the PI before treatment to evaluation the body composition and the max and mean dose received by the bowel, the sigmoid and the rectum. A Polar watches will be loaned to the patient by the PI at the CT sim appointment to record patient's daily movement for two weeks (usual waiting time between CT and treatment) and recovered on the first day of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men with PCa which are candidate for pelvic radiotherapy (RT) with or without previous surgery, with or without concomitant hormonotherapy (HT), Performance status (PS) 0-2 (all patient able to undergo RT treatment), of all age, elderly included.

Exclusion Criteria:

* Previous RT to the pelvis
* Diagnosed Inflammatory Bowel Disease (IBD), celiac disease
* Severe GI symptoms before the beginning of RT (Grade \> 2 according to CTCAE grading system)
* Obvious cognitive impairment,
* Inability to understand French/English and no contact person able to accompany and translate.
Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter

Lesions of the anal sphincter complicate 0.8% of childbirth in France. The sexual health of patients following this type of lesion is little studied, there are only about twenty articles on the subject.

The objective of this search is to study of the obstetric lesions of the anal sphincter


Eligibility Criteria:
Inclusion criteria:

* Adult woman (≥18 years old)
* Patient who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019
* Single pregnancy
* 3rd degree or 4th degree perineal tear
* Intact perineum (control group)
* Good understanding of French orally
* Patient accepting to participate in the satisfaction telephone interview and not having expressed her opposition to the reuse of her data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Cesarean delivery
* Multiple pregnancy
* Premature delivery
* stillborn child
* impossibility of providing the subject with enlightened information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or guardianship
* Subject under guardianship, curatorship or safeguard of justice
Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy

The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose of ciprofloxacin 500 mg 1 hour before biopsy.

Transrectal ultrasound guided (TRUS) prostate biopsy is the procedure of choice for the diagnosis of prostate cancer. This technique is usually safe and well tolerated with a low incidence of serious complications. However, one of these complications, the bacterial infection can be complicated and cause urinary sepsis. The investigators have developed different regimens of antibiotic prophylaxis. Most of them include administering oral fluoroquinolones. In this area, approximately 40% of the strains of E. coli are resistant to ciprofloxacin (fluoroquinolone). Therefore, research is warranted alternative prophylactic approaches. Fosfomycin is an antibiotic ancient underused in recent decades that in recent years has been proposed as an alternative treatment for infections caused by multidrug-resistant microorganisms.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with prostate-specific antigen (PSA) values \>4 ng/ml or presenting either abnormality in rectal examination
* Patients who accept to participate in the study signing the consent informed form

Exclusion Criteria:

* Allergy to anyone of the study drug
* Intolerance to anyone of the study drug
* Urinary infection with positive uroculture
* Clinical finds suggesting infections
* Antimicrobial treatment during the las 4 weeks
* Patients with vesicle catheter
* Patients in dialysis
* Patients in hemodialysis
Effects of a Long-term Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism

Epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices.

Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

Epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices.

Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

Some scientific data obtained from animal studies or in vitro experiments suggested that flavanones could exert positive effects on several biomarkers of the cardiovascular or osteoporosis risks. However, until now, the clinical proof of the efficacy of these compounds is far to be obtained and more clinical trials are needed.

The main goals of this project are (1) to characterize the effect of a long-term grapefruit juice consumption on both vascular and bone protections and (2) to assess the specific role of naringin, in these potential protective effects.

To reach these goals, a randomized, cross-over clinical trial will be performed on 52 healthy post-menopausal women (50 to 65 years old, 3 to 10 years since menopause, waist \> 88 cm). Such a population shares an increased risk of CVD and osteoporosis.

They will consume for two periods of 6 months either 340 ml of grapefruit juice or a control isoenergetic beverage.

Major outcomes will be measured at baseline and at the end of each experimental period.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian healthy post-menopausal women
* 19≤ BMI ≤29 and waist measurement \> 88 cm

Exclusion Criteria:

* Metabolic diseases
* Hypertension
* Taking CYP3A4-metabolized drugs
* Taking blood lipids lowering drugs or antihypertensive drugs
* Hypercholesterolemia with HDL \< 1.30 mmol/L (i.e. \< 0.5 g/L)
* Osteoporosis (defined by T-score of -2.5 SD at hip and/or lumbar spine)
* Taking hormone replacement therapy (HRT)
* Smokers
* Taking dietary supplements
Gene Expression in Intervened Athletes

Background: Exercise represents an important challenge for the homeostasis of the entire body that occurs on a cellular and systemic level in which micronutrients play an important role in regulating the processes that sustain athletic performance. Objective: The investigators measured changes in gene expression of whole blood in a group of athletes and sedentary participants and compared gene modulation before and after nutritional intervention with micronutrients. Methods: Blood samples were taken from thirteen athletes and thirteen sedentary age- and gender-matched participants. The study design was carried out over a period of 4 months where three time points were established: (T0) baseline conditions in the sedentary and athlete groups; (T2) after two months of supplementation; (T4) after two months in the absence of nutritional supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.

Background: Exercise represents an important challenge for the homeostasis of the entire body that occurs on a cellular and systemic level in which micronutrients play an important role in regulating the processes that sustain athletic performance. Objective: The investigators measured changes in gene expression of whole blood in elite athletes and sedentary subjects and compared gene modulation before and after nutritional intervention with micronutrients. Methods: Thirteen elite athletes and thirteen sedentary controls were enrolled in the present study. Blood samples were taken from athletes and sedentary age- and gender-matched subjects. The study design was carried out over a period of 4 months where three time points were established: (T0) baseline conditions in the sedentary and handball groups; (T2) after two months of supplementation; (T4) after two months in the absence of nutritional supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.

Eligibility Criteria:
Inclusion Criteria:

* To pass a recruitment medical examination consisting of a clinical examination and recording the participant's medical history.
* Non-smoker and not being on a medication regimen.
* Written informed consent prior to participation.
* With regard to the sedentary controls, none of the subjects reported at least 150 min·wk-1 of moderate-intensity or 75 min·wk-1 of vigorous-intensity aerobic physical activity necessary for substantial health benefits.
* With regard to athletes, to be involved in a training regime including both indoor exercise and integrated conditioning exercises in addition to competing in matches on weekends.
Low Back Pain Prevalence

Brief Summery: Low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.

The aim of our current study is to assess the prevalence of low back pain among young adults, and we would like to examine the musculoskeletal and psychosocial factors associated with low back pain that can be justified as risk factors. Our further goal is to assess and compare lumbar sensorimotor control in young people without complaints and with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* in case of patients with low back pain: chronic pain
* in case of asymptomatic individuals: no symptomes

Exclusion Criteria:

* serious neurologycal symptomes
* serious scoliosis
* previous surgery which affected the local stabilizers
* serious pulmonar disease
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.

PURPOSE: This early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.

OBJECTIVES:

Primary

* To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV melanoma undergoing surgical resection.
* To determine whether treatment with riluzole alters expression of activated PLC and ERK in lysates from tumor tissue biopsies.

Secondary

* Determine if treatment with riluzole affects the overall metabolic activity of melanoma tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining for Ki-67.

OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the final dose of riluzole, patients undergo standard surgical resection.

Patients undergo tumor tissue sample collection at baseline and during surgery for laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection periodically for pharmacokinetics studies.

PET scans are obtained before and after treatment to evaluate the overall metabolic activity of the tumor and how this activity changes with inhibition of the Grm1 pathway.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed melanoma

  * Stage III or IV disease
* Must have at least two resectable tumors or a tumor large enough to undergo pre-treatment core needle biopsy
* Must be eligible for resection of disease with curative or palliative intent

PATIENT CHARACTERISTICS:

* ECOG performance status 0 or 1
* ANC ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³
* AST/ALT ≤ 3 times upper limit of normal (ULN)
* Total bilirubin normal
* Calculated creatinine clearance ≥ 50 mL/min
* INR ≤ 25% of ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 48 hours after completion of study treatment
* No history of allergic reaction to riluzole or similar compounds
* No known history of hepatitis B or C

PRIOR CONCURRENT THERAPY:

* Not specified
Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia

The rise in life expectancy implies an increased number of nonagenarian patients who need evaluation for critical lower limb ischaemia (CLI). The study goal is to evaluate whether revascularization techniques in these patients fulfill a set of security and efficacy criteria generated from surgical results in a validated historical cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Critical Limb Ischemia aged 90 year-old or above

Exclusion Criteria:

-
Expression of Optic Atrophy Type 1 (OPA1) Protein in Lung Adenocarcinoma

Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial bioenergetics and mitochondrial networks. The changes in mitochondrial shape and mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.


Eligibility Criteria:
Inclusion Criteria:

* We will collect paraffin blocked resected lung tissue samples from stage I\~IIIa non-small cell lung cancer patients (age, 40\~80 years old) who received lobectomy of the affected lung.

Exclusion Criteria:

* History of uremia, other malignant disease, and liver cirrhosis
* History of pneumonia and pulmonary tuberculosis
* History of long period of medications.
Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in general Chinese population. A total of more than 2000 diabetic participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. Every participants was complete DNA extracted and genotyped. Diabetic Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN. In addition, clinical risk model, simply screening model and nonlinear system model such as artificial neural network was created, respectively.

Little is known about the risk factors and risk models for diabetic cardiovascular autonomic neuropathy in Chinese population. A large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in general Chinese population. A total of more than 2000 diabetic participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. Every participants was complete DNA extracted and genotyped. Diabetic Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN. In addition, clinical risk model, simply screening model and nonlinear system model such as artificial neural network was created, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Survey Chinese participants with undiagnosed DCAN Aged 30-90 years, were included in this study.

Exclusion Criteria:

* Some diabetic patients were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:

  1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  2. pregnancy or lactation
  3. serious hepatic or renal dysfunctions (GFR \< 30 mL/min/1.73m2).
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.


Eligibility Criteria:
Inclusion Criteria:

All participants:

1. Physically healthy
2. willing and able to provide informed consent (if under 18 also parent or guardian consent)

MDD participants:

1. A definite diagnosis of DSM-5
2. a Children's Depression Rating Scale-Revised (CDRS-R) score \>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \>=4 rated over the last two weeks.

Suicide attempt group:

1. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale.

Non-psychiatric controls:

1. No history of any major mental illness (excluding specific phobia) or substance use disorder.

Exclusion Criteria:

* Exclusion criteria:

  1. Pregnancy or lactation
  2. post-partum state (being within 2 months of delivery or miscarriage);
  3. homicide risk as determined by clinical interview
  4. any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine/caffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.
  5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months
  6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO

This study aims to investigate prospectively throughout a period of 3- 6 months and not to exceed 12 months (according to local therapeutic plans) patients experiences of treatment with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII compared to their previous delivery system.


Eligibility Criteria:
Inclusion Criteria:

* Male adults (aged 18 to 65 years) with Haemophilia A (all severity levels) who currently use FVIII treatment either prophylactically or on-demand using traditional factor VIII delivery mechanisms.
* Patients advised for any reason by their physician to switch to a new factor VIII delivery device, namely FuseNGO, before receiving any details about this study or Patients who requested to be treated with a new factor VIII delivery device namely FuseNGO, before receiving any details about this study.

Exclusion Criteria:

* Patients not previously recommended by their physician to switch to this new factor VIII delivery system or Patients who did not previously ask their physician to be switched to this new factor VIII delivery system.
* Patients for which it is anticipated that 10 infusions will not occur in the 12 months following their inclusion in the study.
Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients

Postoperative cognitive dysfunction (POCD) is more common in older patients, and increased insulin resistance is an important factor for POCD. Fasting before surgery is performed to reduce the incidence of pulmonary aspiration after anesthesia. However, prolonged fasting increases insulin resistance. Recently, it is recommended to minimize fasting times and consume carbohydrate drinks before surgery. Therefore, the investigators investigate whether preoperative carbohydrate drinks can reduce insulin resistance in the elderly patients. Fifty patients (age\>65 years) scheduled for arthroplasty will be divided into carbohydrate (n=28) and control (n=28) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 h before surgery according to standard protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing arthroplasty
2. age\>65 years

Exclusion Criteria:

1. The subject is a foreigner or illiterate
2. Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
3. Patients with chronic renal disease or severe cardiovascular disease
4. HbA1c \>69 mmol/mol or BMI \>30 kg/m2
5. A duration of ≥5 h between consumption of CHO and initiation of surgery.