cyrilzakka/clinical-trials huggingface dataset:
Association of Body Fluid Distribution with Obstructive Sleep Apnea in Pregnant Women with Body Mass Index ≥ 40 Kg/m2

Obstructive Sleep apnea (OSA) is a common and underdiagnosed condition in obese pregnant women with serious and life-threatening complications to the mother and baby. The investiators propose that a non-invasive method may be used to detect patients at risk of OSA, giving these women access to the necessary treatment to treat this condition. The method is a estimation of body water, which has been shown to be linked to OSA in the non-pregnant population. Body water is estimated by applying surface electrodes to a participant who is lying down by measuring bioimpedance through body tissues by applying a tiny current between the electrodes. The electrical stimulation is not felt by the participant and has no negative effects on mother or baby.

It is already established that the increasingly prevalent condition of obesity is linked to OSA in pregnancy. Obesity is increasingly prevalent This study will evaluate a novel method of screening for OSA in the obese pregnant population, thereby treating this condition reducing the ill effects to mother and fetus.

This will be a prospective observational cohort study. Eligible participants will be approached for consent during their third-trimester antenatal all-day clinic visit. Body water will be measured by connecting electrodes to participants hands, feet and neck whilst lying supine for approximately 15 minutes.

Data on patient demographics, BMI, medical conditions, water body composition and indicators of OSA (breathing pattern and oxygen levels during sleep) will be collected, as well as data from patients' sleep tests as ordered by their physician.

Eligibility Criteria:
Inclusion Criteria:

* Participants who give written informed consent
* Pregnant women in the third trimester of pregnancy
* Grade III obesity
* Patients who have prior diagnosis of OSA within the last one year, and non-compliant to treatment such as continuous positive airway pressure (CPAP), or dental appliance
* Patients suspected to have OSA based on screening questionnaire (see page 2, OSA-Diagnostic tools for further details)

Exclusion Criteria:

* Fluid overload states including renal disease, liver disease and congestive heart failure
* Prior history of vascular surgery in the lower limbs such as varicose vein surgery, vascular by-pass surgery or evidence of venous efficiency.
* Patients with metal implants in lower limbs or spine, due to possible interference with the leg impedance signals. 58
* Participants with diagnosed OSA treated with Continuous Positive Airway Pressure (CPAP).
* Patients requiring urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guideline 59 e.g. unstable ischemic heart disease, recent cerebrovascular disease.
* Implantable cardiac devices
Outpatient Versus Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence: The IN/OUT Study

Detoxification, in an inpatient or outpatient program, is the primary and essential step for managing alcohol dependence. The superiority of one or other method of detoxification has never been proved in several previous randomized clinical trials (RCT). The aim of this multicenter RCT was to compare efficiency, on the abstinence rate as the primary outcome, at 1 and 3 months follow-up of two alcohol detoxification programs (a 5/7-days inpatient detox vs. an ambulatory detox).

Among patients consulting in 4 alcohol treatment centers in France seeking treatment for withdrawal, we included those who met criteria for current alcohol-dependence (DSM IV) and having drinking during the past three days before randomization. Exclusion criteria were: patients' refusal of one or other method, contraindication for outpatient detoxification method (history of DELIRIUM TREMENS or withdrawal seizures), homelessness, Major Depressive Episode assessed by MADRS \> 25, current Substance Abuse Disorder (except nicotine), indication for hospitalization (severe somatic disorder), judicial injunction, family crisis, patients seeking antabuse treatment.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependence according to DSM IV
* Detoxification program requested by patients

Exclusion Criteria:

* Refusal of the patient for the hospitalization or ambulant weaning alcoholic
* contraindication in ambulant weaning
* The state of the patient requires a hospitalization
* Ask of the patient for a treatment by the ESPERAL
Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on residual insomnia in major depressive patients.

This is a randomized single-blinded controlled trial. Patients will be randomly assigned to one of the three groups. One is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. Patients will be put into groups and then compared. The chance of getting into each group is 2:2:1.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder
* Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder
* Insomnia more than 3 nights per week for at least 3 months
* Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline visit
* Use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
* Hypnotic dosage has not been increased in the last 4 weeks

Exclusion Criteria:

* Have a Hamilton Depression Rating Scale scores above 18
* Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
* Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
* Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
* Have current alcohol or drug abuse and dependence
* Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
* Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
* Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
* Any acupuncture treatment during the previous 12 months prior to baseline and
* Unstable medical conditions.
Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial Carcinoma

Endometrial cancer, the most common gynecologic cancer worldwide, is steadily increasing in developed countries.The early-stage forms of endometrial cancer are usually highly curable by surgical treatment alone, whereas advanced stages require adjuvant interdictions such as radiotherapy and chemotherapy. Platinum and anthracycline drugs have long been used as standard adjuvant chemotherapy drugs for advanced and recurrent endometrial carcinomas. In one study, the standard combination adjuvant treatment with AP was found to be more effective as an adjuvant therapy than whole abdominal irradiation


Eligibility Criteria:
Inclusion Criteria:• Age group: Histologically diagnosed with primary endometrial carcinoma

* more than 20 years old.

  * Any histological type of endometrial carcinoma
  * Stage III, IV
  * Stage one I or II with one or more of the following factors:

    1. Histologic grade 3 endometroid carcinoma with myometrial invasion still within half of the myometrium
    2. histological grade 1,2 endometroid carcinomas with invasion of over half of myometrium
    3. cervical stromal invasion
    4. vascular invasion; or
    5. serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma
  * performance status 0-2
  * adequate function of all major organs

Exclusion Criteria:

* • Pt has received prior radiation or chemotherapy.

  * Pt with sarcomatous component
  * Metastatic endometrial carcinoma
  * Other malignancy
  * Unfit patient for chemotherapy
Role of Mitochondria in Non Severe Asthma

Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and remodelling. Bronchial remodelling is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. It can appear very early in the evolution of the disease and involves an increased mass of bronchial smooth muscle (BSM). The mechanism of such an increase has been related with an increase in smooth muscle cell proliferation. Recently, we have demonstrated that, BSM increased proliferation is induced by an enhanced mitochondrial biogenesis in severe asthma (T. Trian et al. J Exp Med 2007). The objective of this study is to investigate the role of smooth muscle cell mitochondria in non severe asthma

Bronchial remodelling mainly involves an increased mass of bronchial smooth muscle (BSM), which is related with an increase proliferation of BSM cells. Recently, using BSM cells obtained from severe asthmatics, we have demonstrated that such an increase proliferation was induced by an activation cascade involving an abnormal calcium entry, and the subsequent activation of Calmodulin-kinase IV, PGC-1alpha, NRF-1 and mt-TFA leading to an increase mitochondrial biogenesis (T. Trian et al, J Exp Med 2007). The objective of this study is to investigate the role of BSM cell mitochondria in non severe asthma.

For this purpose, 30 non severe asthmatic adult patients (\>18 yr) will be prospectively recruited from the "CHU de Bordeaux" according to the Global Initiative for Asthma (GINA) guidelines. Inclusion visit will include written informed consent, asthma control questionnaire, clinical examination, lung function testing (i.e. arterial gas, exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for total IgE levels. Bronchial specimens will be obtained from all subjects by fiberoptic bronchoscopy. BSM remodelling will be evaluated by morphological analysis. Patients will be divided into 2 groups according to the presence or the absence of BSM remodelling. Using BSM cell culture, the role of mitochondria will be analyzed by electronic microscopy, confocal microscopy, immunoblotting, RT-PCR and oxygraphy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged more than 18 years
* Diagnosis of intermittent asthma, mild persistent asthma or moderate persistent according to ATS criteria
* Forced expiratory volume in one second \> 60% predicted
* Written informed consent

Exclusion Criteria:

* Smoker or former smoker (tobacco or cannabis)
* Adults protected by law
* Subjects not affiliated with social security
* Subjects during exclusion relative to another protocol or for which the annual maximum allowance of 3800 euros has been reached
* Subject with any co-morbidity (except chronic rhinitis, chronic sinusitis nasal polyps or gastro-oesophageal reflux)
* Asthma exacerbation within 6 weeks before enrolment
* Infections of the upper airway within 3 months before enrolment
* Chronic viral infections (hepatitis, HIV)
* Pregnancy or breastfeeding
* Contraindications to bronchoscopy
Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment in the Elderly

The increasingly used oral anticancer treatments allow the patient to reduce treatment and social constraints to reduce hospitalization costs. The counterpart is a decrease in the monitoring of the correct intake of drugs and the detection of side effects. These two risks are major in the elderly, due to comorbidities, poly-medication and decreased attention. The project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes for 3 months, compared to a conventional management without a nursing visit. It is a prospective, randomized, controlled, multicenter study to include 224 patients over 18 months. The impact will be assessed by counting the tablets not taken and by filling an observation booklet with the nurse at home.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 70 and over
* Patient initiating an oral anticancer treatment (Chemotherapy, Targeted therapy, 2nd generation hormone therapy type Acetate abiraterone and Enzalutamide)
* Patient who received an onco-geriatric assessment
* Patient with informed consent signed

Exclusion Criteria:

* Patient in a medical institution
* Patient under exclusive hormone therapy
* Patient already eligible for nurse support
* Patient not speaking French
* Patient under tutelage and guardianship or under safeguard of justice
* Patient already included in a research protocol
* Patient sharing his or her home with a person receiving nursing care at home more than once a week and for a period longer than 1 month after the patient's inclusion.
Cannabinoid Receptor Function & Alcoholism

This study attempts to characterize the effects of tetrahydrocannabinol (THC). Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, "ganja", or "pot". This study will involve healthy volunteers who 1) have no history of alcoholism in their family or 2) have a family history of alcoholism. This study looks at individuals with or without a family history of alcoholism to determine if there is a difference between the two groups in the response to THC.


Eligibility Criteria:
Inclusion Criteria:

* Exposure to cannabis at least once

Exclusion Criteria:

* Pregnancy
A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy

The primary purpose of this study is to investigate the safety of Tasfygo.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.

Exclusion Criteria:

Not applicable.
Cardiac Allograft Vasculopathy Inhibition with Alirocumab

The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.


Eligibility Criteria:
Inclusion Criteria:

* Heart Transplant recipient

Exclusion Criteria:

* impaired liver function
Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).


Eligibility Criteria:
Inclusion Criteria: Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.

The exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age \<18 years, (4) inadequate ability to co-operate.
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2). Cysts begin to develop primarily in renal collecting tubules in utero and continue to form and expand throughout the patient's life. One of the goals of the study is to formulate a water prescription for use in clinical trials to determine the effect of sustained water diuresis on the progression of ADPKD.

The proposed study will devise a quantitative model to estimate the amount of water an individual would need to ingest in order to lower the 24 h mean urine osmolality to a level below plasma (\~285 mOsm/Kg). This osmolality goal is chosen because the 24h median urine osmolality of humans is ordinarily \~753 mOsm/Kg, much greater than 285 mosm/Kg (6, 7). In other words, normal humans are usually anti-diuretic during waking hours and while asleep. Median 24h urine volume is \~1225 ml (range 1051 - 2270). In temperate climates the insensible losses of water in sweat, respiration and stool are nearly balanced by the water ingested in solid and semi-solid foods and derived from metabolism. Thus, daily urine volume measured upon arising in the morning is a reasonably good indicator of the volume of fluids drunk over the preceding 24 h.

Eligibility Criteria:
Inclusion Criteria:

* ADPKD verified by ultrasound, CT or MRI, family history or physical exam
* Normal creatinine clearance, calculated by Cockroft-Gault formulat
* Good general health
* Controlled blood pressure, \< 140/90
* Absence of urinary tract symptoms such as dysuria, hesitancy, diminished flow

Exclusion Criteria:

* Azotemia
* Uncontrolled hypertension
* Urinary tract symptoms, dysuria, hesitancy, diminished flow, gross hematuria
* Diabetes mellitus, cancer, hematologic disorder
* Unable to follow directions
* Solitary kidney
* History of CHF, liver dysfunction or hyponatremia
* Currently taking diuretics
* Nephrotic range proteinuria (3.5 g/day)
COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy.

If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%.

Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.

Eligibility Criteria:
Inclusion Criteria:

* solitary rectal cancer observed at colonoscopy or on barium X-ray
* no evidence of distant metastases
* distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
* suitable for elective surgical resection
* informed consent

Exclusion Criteria:

* T1 tumors treated by locl excision
* T4 tumors
* patients under 18 years of age
* signs of acute intestinal obstruction
* more than one colorectal tumor
* Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
* active crohn's or active ulcerative colitis
* scheduled need for other synchronous colon surgery
* preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
* preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
* other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III)
* pregnancy
Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation.

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months.

The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Eligibility Criteria:
Inclusion criteria

1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum
2. WHO performance status of 0 or 1
3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
4. Written informed consent for participation in the trial.

Exclusion criteria

1. has prior other malignant cancer
2. has severe major organ dysfunction
3. has prior cancer therapy before surgery
Postoperative Analgesis in Total Knee Arthroplasty

Postoperative analgesic treatment methods are applied to patients who have undergone knee arthroplasty. These applications are a routine part of the procedure. It is medically and ethically necessary. Postoperative analgesia applications are started during the intraoperative period and continued during the postoperative period. The analgesia protocol to be used is shaped by the characteristics of the patient and the skill and experience of the anesthesiologist. The scientifically accepted method is multimodel analgesia protocols. These protocols cover a wide range from paracetamol to opioids to peripheral and central blocks (methods such as suprainguinal fascia iliac block (SFIP), adductor block (ACB) and infiltration analgesia (IPACK) applied between the posterior elements of the knee and the popliteal artery). Our aim in this study is to evaluate the effects of analgesia protocols applied to patients undergoing knee arthroplasty surgery on inflammatory biomarkers (such as neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), systemic immune inflammation score (SII), lactate) obtained from routine blood and blood gas examinations in the first 24 hours of the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* ASA I,II,III patients
* Patients who will undergo elective surgery

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients with bleeding diathesis
* Those who are allergic or sensitive to local anesthetics and opioid drugs,
* Those who use gabapentinoids
* Patients with neurocognitive disorders,
* Patients with chronic organ failure,
* Mothers with suspected pregnancy, pregnant or breastfeeding mothers
* Patients using opioids
* Those who use steroids
* Those with a history of substance use