cyrilzakka/clinical-trials huggingface dataset:
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements

Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not recommended during laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.


Eligibility Criteria:
Inclusion Criteria:

* all patients \>18 years scheduled for robot-assisted prostatectomy
* able to give informed consent

Exclusion Criteria:

* Patient with atrial fibrillation or other non-regular rhythm.
* Severe aorta/mitral stenosis
* Not able to give informed consent
Effect of Weekly GLP1 Agonist Treatment in "double Diabetes"

Between 16% and 22% of type 1 diabetic patients present a clinical and biological profile of insulin resistance favored by a family history of type 2 diabetes or metabolic syndrome. They constitute a group of patients with "double diabetes" since they have both true type 1 diabetes and inherited insulin resistance, typical of type 2 diabetes.

For several years, GLP1 agonists have been successfully used in the treatment of type 2 diabetes, leading to very significant improvements in glycemic control and weight loss.

Because of the insulin-sensitizing power of GLP1 agonists, the investigators hypothesize that they could reduce insulin resistance in patients with "double diabetes" and thus improve their glycemic control.

The investigators propose to use in this study semaglutide, the most recent and most potent GLP1 agonist (superiority demonstrated compared to exenatide LP and dulaglutide) and administered as a weekly subcutaneous injection (in contrast to liraglutide administered daily).


Eligibility Criteria:
Inclusion Criteria:

* Person who has given written consent
* Patient over 18 years of age
* Patient with type 1 diabetes confirmed by a C-peptide below laboratory standards
* Age at diagnosis \< 35 years
* Treated with optimized insulin therapy (multi-injections or pump) for at least 1 year, having received specific therapeutic education on insulin dose adaptation.
* BMI (weight/height2) ≥ 27 Kg/m².
* At least one of the following criteria:

  * Family history of type 2 diabetes (parents, grandparents, uncles, aunts, brothers and sisters)
  * Family history of obesity (BMI\>30 Kg/m2) (parents, grandparents, uncles, aunts, siblings)
  * Triglycerides \> 1.50g/l (1.7mmol/l)
  * HDL\< 0.5 g/l (1.29 mmol/l) in women, HDL\<0.4 g/l (1.03 mmol/l) in men
* HbA1c ≥ 7.5% and \< 12% in the 3 months preceding inclusion
* Having continuous glucose monitoring by a CGM (Holter Glucose Monitoring) system: Guardian, Dexcom or Free Style Libre
* For women of childbearing age: using an effective method of contraception until 2 months after the end of treatment. Effective contraception includes: hormonal contraception, intrauterine device, bilateral tubal occlusion, vasectomy and sexual abstinence

Exclusion Criteria:

* person not affiliated to national health insurance
* Pregnant, parturient or breastfeeding woman
* HbA1c ≥12% in the 3 months preceding inclusion.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by a fundus examination performed in the 6 months preceding the selection
* Person under a measure of legal protection (curatorship, guardianship)
* Renal insufficiency (GFR\<30 ml/mn)
* Hepatic insufficiency (INR\> 1.5)
* BMI \>40 kg/m².
* History of bariatric surgery
* History of pancreatitis
* Allergy to the active substance or to one of the excipients of OZEMPIC®.
* Patients treated with GLP1 agonists or oral antidiabetics in the month preceding month prior to inclusion
Game Plan for PrEP

This small pilot randomized controlled trial will test whether a brief, web-based intervention inspired by the principles of motivational interviewing helps high-risk men who take pre-exposure prophylaxis (PrEP) moderate their alcohol use, and improve key outcomes of PrEP care, including adherence, persistence, and STI rates. Men with a history of "lapses" in PrEP adherence will be randomly assigned to either (1) use the web-based intervention, called Game Plan for PrEP, or (2) watch video clips encouraging healthy lifestyles (e.g., sleep hygiene, balanced diet; attention-matched control). Participants will complete STI testing and submit dried blood spot (DBS) samples to facilitate analyses of alcohol use and PrEP adherence biomarkers at baseline, 3-months, and 6-months during the study period. Participants will also complete online surveys at baseline, 1-month, 3-months, and 6-months during the study period.

This small, pilot randomized controlled trial will explore preliminary evidence for the efficacy of Game Plan for PrEP, a brief, web-based intervention inspired by brief motivational interventions. The study will test whether Game Plan for PrEP is efficacious in reducing heavy drinking and sexually-transmitted infection (STI) incidence, and improving PrEP adherence/persistence, among heavy drinking men who have sex with men who are on PrEP, but who report a recent history of missing 3 or more consecutive doses in the past month. In this study, we will randomize 50 gay and bisexual men to receive either (1) Game Plan for PrEP (GP4PrEP) or (2) an attention-matched control at the same PrEP care/monitoring visit that they reported meeting eligibility criteria. We will use self-report measures of alcohol use collected at 1-, 3-, and 6-months and changes in a biomarker of alcohol use collected at baseline, 3-, and 6-months to explore whether Game Plan for PrEP reduces binge drinking compared with control. We will also use data from a biomarker of PrEP adherence to explore whether Game Plan for PrEP improves PrEP adherence versus control.

Eligibility Criteria:
Inclusion Criteria:

* Current male gender
* 18+ years old
* Fluent in English
* Heavy alcohol use in the past month (\>5 drinks on a single occasion or \>14 drinks in a week)
* Currently prescribed and actively taking PrEP
* Report missing \> 3 PrEP doses in a row at least once in the past 3 months.

Exclusion Criteria:

* Reporting a history or risk of complicated alcohol withdrawal
* Reporting currently receiving medications or counseling for an alcohol or drug use disorder
* Injection drug use in the past year
* Positive screen for drug-related disorders
Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection

Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. The consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. Pre-eclampsia associates maternal hypertension with dysfunction kidney. There is no cure for pre-eclampsia or IUGR vascular during pregnancy. These pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. Primary prevention and secondary education and screening for these pathologies are still insufficient. A better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* With or without vascular pathology

Exclusion Criteria:

* refusal to participate
* multiple pregnancy
* major fetal malformation diagnosed during pregnancy follow-up
B'More for a Peaceful Motherhood Hypertension Control Study

This study will assess whether an intervention including mindfulness, dietary education, and smoking cessation can help African-American women of childbearing age (age 18-44) with hypertension or high blood pressure to lower their blood pressure. The investigators propose to screen women of childbearing age for hypertension, and to invite women to participate in an intervention to reduce their blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.

Chronic and pregnancy-associated hypertension increase risk for poor birth outcomes, including higher rates of low birthweight and preterm birth. Mindfulness interventions, dietary education, and smoking cessation education have all been effectively employed to reduce hypertension, but have infrequently targeted women of childbearing age in community settings. This study will screen African-American women of childbearing age for hypertension, and invite women with hypertension to participate in a seven-session intervention to reduce blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Age 18-44
* African-American
* Female

Exclusion Criteria:

* Male
* Age \<18 or \>44
* Non-African American
* Not female
* Pregnant
A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain

This multi-center, phase 2, randomized, single-blind, three-arm, active-controlled study is comparing repeat doses, every 28 days, of standard of care (SOC) plus ST-01 against SOC plus 1% lidocaine HCL in men experiencing chronic scrotal content pain (CSCP). The main purpose of this study is to determine if repeat injections of ST-01 are safe and effective in reducing pain. After completing a screening phase participants will be randomized into one of three groups: 1) ST-01 70 mg/mL arm, 2) ST-01 140 mg/mL arm, 3) 1% Lidocaine HCL arm (Control). Participants may receive up to 4 study treatment injections given at a minimum of 28-day intervals. Participants randomized to the Control arm will be given the opportunity to cross over to an ST-01 treatment arm after 2 study treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 19 years) male
2. Unilateral or bilateral scrotal pain lasting \> 3 months
3. Have nociceptive scrotal pain
4. Average daily maximum scrotal pain score over 7 days ≥ 4 on the 0-10 NRS (Appendix 2). Participants with bilateral scrotal pain must be able to distinguish one side with pain score ≥ 4 and the opposite side must have a maximum scrotal pain score of ≤ 3.0 at baseline.
5. Positive response to test spermatic cord block with 1% lidocaine (Lidocaine Hydrochloride Injection, USP, 1%, 10 mg/mL), defined as a decrease in pain score of at least 2 within 1 hour of injection
6. Baseline blood levels without clinically significant abnormalities including liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\], and alkaline phosphatase \[ALP\]) no greater than 50% above the upper limit of normal
7. If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Exclusion Criteria:

1. Negative response to test spermatic cord block, defined as absence of a decrease in pain score of at least 2 within an hour of injection
2. Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation of scrotal pain
3. History of allergic reaction to lidocaine or any component of ST-01
4. Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type; hypokalemia, complete heart block, anticoagulants (aspirin permitted), antiarrhythmic medication.)
5. Active infection involving the urinary tract or scrotum
6. Inability to give consent
7. Inability to follow up according to the protocol
8. Negative response to previous spermatic cord block
9. Any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.
Flushes and Sertraline Trial

The primary outcome of FAST (a randomized double-blinded, placebo controlled, trial of the effect of sertraline vs. placebo in reducing the incidence and severity of hot flushes in healthy women) is to determine if 6 weeks of treatment with sertraline (50mg daily for 2 weeks, followed by 100mg per day for 4 weeks, if tolerated) results in a greater reduction in hot flush score (frequency \* severity) compared to placebo among women with moderate to severe hot flashes. The secondary aim is to determine the effect of treatment with sertraline on quality of life, sleep, sexual function, and mood.

The primary aim of FAST is to determine if 6 weeks of treatment with sertraline (50 mg daily for 2 weeks, followed by 100 mg per day for 4 weeks, if tolerated) results in greater reduction in hot flush score (frequency x severity), frequency and severity compared to placebo among women with moderate to severe hot flushes.

The Secondary Aims:To determine the effect of treatment with sertraline on quality of life, sleep, sexual function, mood, and cognitive function. To determine if a modified, short version of a sexual function instrument is valid.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 60 years old
* Report \> 14 hot flushes per week
* Willing to be randomized to sertraline or placebo
* Sign informed consent

Exclusion Criteria:

* History of bilateral oophorectomy
* Breast or ovarian cancer
* Liver disease
* Kidney disease requiring dialysis
* History of major depression (reported history of depression requiring therapy, hospitalization for depression, taking antidepressant drugs, history of suicide attempt)
* History of bipolar affective disorder (reported history of bipolar disorder requiring therapy, medications, hospitalized for bipolar disorder)
* Seizure disorder
* History of hypersensitivity to sertraline or to SSRIs
* Pregnancy or breast feeding
* Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial;
* No estrogens or progestins for 3 months prior to screening or during enrollment
* Selective estrogen receptor modulators (SERMS)
* The following medications: clonidine, gabapentin, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitors (SSRIs), megesterol , oral contraceptives, androgens; and medications that are listed on the Pfizer Pharmaceutical drug insert as "contraindicated"
Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.

When patients suffer from chronic pain after multiple back surgeries, this is denominated as the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord stimulation. This is an invasive treatment where no other treatment options (medication, minimal invasive treaments) can offer progress to the patients' health status. In spinal cord stimulation, an electrode will be placed at the spinal cord under local anaesthesia whereas via a battery a painless electrical stimulation will arise. Clinical research have demonstrated that a new way of spinal cord stimulation can improve back and leg pain significantly. This will lead to a better quality of life for the patients and a decreased use of medications. In Ziekenhuis Oost-Limburg, different manners of spinal cord stimulation will be compared to each other.

Three different groups of spinal cord stimulation will be compared

1. BASE - High Density Stimulation - Sham
2. BASE - Conventional stimulation- HDS
3. BASE - Sham - High Density Stimulation

BASE consists of the baseline where no intervention of stimulation will occur. Sequentially, two phases will follow which will last 7 days per phase. The conventional stimulation is the stimulation that is generally used. The high density stimulation is the new spinal cord stimulation offering lots of advantages improving quality of life.

The 3 different study designs will be compared against each other according to a questionnaire including pain, need for medication, sleep quality, quality of life, effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an implanted neurostimulation system met een FBSS met geïmplanteerd

Exclusion Criteria:

* no knowledge of the Dutch language
* Addicted to drugs
An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Male or female outpatients at least 18 years of age
* Constipated according to ROME I criteria
* If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
* Are otherwise in good health, as judged by a physical examination
* In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

* Patients with heme positive stool at screening. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion.
* Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results.
* Patients with known or suspected perforation or obstruction.
* History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
* Patients with a known history of organic cause for their constipation.
* Patients meeting the ROME definition of Irritable Bowel Syndrome
* Patients currently taking any of the following medications that are known to effect bowel habits:

  * Antidiarrheals
  * Antacids containing magnesium or aluminum salts
  * Anticholinergics
  * Antispasmodic agents
  * Erythromycin and other macrolides
  * Octreotide
  * Lotronex, Zofran, or other 5-HT3 antagonists
  * Zelnorm, or other 5-HT4 agonists
  * Opiods/narcotic analgesics
  * Prokinetics
  * Serotonin re-uptake inhibitors or tricyclic antidepressants
  * Calcium antagonists
* Patients who are breastfeeding, pregnant, or intend to become pregnant during the study.
* Female patients of childbearing potential who refuse a pregnancy test.
* Patients with a known allergy to polyethyleneglycol.
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Patients who, within the past 30 days have participated in an investigational clinical study
Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol

The purpose of the study is to compare the positivity rate associated with a novel simplified Tilt-Table (TT) test protocol versus the conventional TT protocol

All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) will be randomized to "conventional" HUTT protocol or "fast" HUTT protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; a provocation phase of further 10 min after 300 micrograms NTG sublingual spray. The novel simplified "fast" HUTT protocol has been designed to provide non inferior positivity rates as compared with the conventional protocol in the selected population.

Eligibility Criteria:
Inclusion Criteria:

* All patients with unexplained syncope at initial evaluation and indication to perform HUTT

Exclusion Criteria:

* No informed consent
* PM/ICD device recipients
Curcumin; Rose Bengal; Denture Stomatitis

Cigarette smoking in conjugation with bad oral hygiene is considered a typical predisposing factor for many oral diseases including denture stomatitis. This study investigated the effect of Rose Bengal (RB)-and Curcumin (CUR)-mediated photodynamic therapy (PDT) in comparison with nystatin therapy in the intervention of denture stomatitis in cigarette smokers. Overall, 45 habitual cigarette smokers aged \~58 years having denture stomatitis were categorized into three groups: Group-I - RB-mediated PDT, Group-II - CUR-mediated PDT, and Group-III - Nystatin therapy. The primary outcome of the interest was: counts of Candida colony from denture surface and palatal mucosa, calculated as CFU/mL, whereas the prevalence of Candida species determined in 3 research groups comprised the secondary outcome. Oral swab specimens were gathered from the denture surfaces and palatal mucosa. All clinical assessments were performed at baseline, 6 weeks, and 12 weeks. C. albicans was the most prevalent yeast identified on both denture surfaces and palatal mucosa, followed by C. tropicalis and C. glabrata. A considerable decrease in the CFU/mL scores were observed in Group-I and Group-II at the end of the interventions and on the 12-week follow-up (p\<0.05). Group-I, II, and III demonstrated clinical efficacy rates of 53%, 51%, and 49%, respectively. CUR-and RB-mediated PDT was found to be as effective as topical Nystatin therapy for the intervention of denture stomatitis among cigarette smokers.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria consisted of the following: (1) completely edentulous participants; (2) removable complete denture wearers diagnosed with denture stomatitis (loss of filiform papillae, erythema, and feeling of mucosal burning); and (3) habitual cigarette smokers (individuals smoking at least 1 cigarette per day since ≥3 years).

Exclusion Criteria:

The exclusion criteria consisted of the following: (1) individuals who received steroids, antifungals, or antibiotics over the past 90 days before the initiation of the study; (2) lactating or pregnant women; (3) individuals who had been using the same denture over the past ten years; individuals who underwent cancer treatment (chemotherapy or radiotherapy); (5) patients who are immunocompromised, anemics, or diabetics; (6) habitual alcohol drinkers; and (7) participants who refused to sign the informed consent document.