cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Pregabalin in Fibromyalgia

The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.


Eligibility Criteria:
Inclusion Criteria:

* At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
* At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Exclusion Criteria:

* Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
* Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
* Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
* Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.
Postprandial Fatty Acid Metabolism in the Natural History of Type 2 Diabetes (T2D)

Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to associated complications such as heart failure, kidney failure and microvascular diseases. Proper dietary fatty acid (DFA) storage in white adipose tissue (WAT) is now thought to prevent lean-tissue lipotoxicity. Using novel Positron-Emission Tomography (PET) and stable isotopic tracer methods which were developed in Sherbrooke, the investigator showed that WAT storage of DFA is impaired in people with pre-diabetes or T2D. The investigator also showed that this impairment is associated with greater cardiac DFA uptake, as well as subclinical left-ventricular systolic and diastolic dysfunction. Then, It has been found that modest weight loss in pre-diabetics, after a one-year lifestyle intervention, improved WAT DFA storage, curbed cardiac DFA uptake, and restored associated left-ventricular dysfunction. It has been also found that a 7-day low-saturated fat, low-calorie diet raised insulin sensitivity but did not restore WAT or cardiac DFA metabolism. Whether WAT DFA storage directly impacts cardiac DFA uptake is not known. Importantly, the investigator recently uncovered marked sex-specific differences in WAT DFA metabolism. These may explain, at least in part, sex-related differences in the cardiac DFA uptake, which occurs in pre-diabetes. Higher spillover of WAT DFA into circulating Non-Esterified Fatty Acid (NEFA) appears to be linked in women to greater cardiac DFA uptake, as opposed to direct cardiac chylomicron triglycerides (TG) uptake in men. Here, the investigator will isolate and compare organ-specific fatty acid uptake occurring postprandially from chylomicron-TG vs. NEFA pools, as well as the oxidative vs. non-oxidative intracellular metabolic pathways associated with increased cardiac DFA uptake in pre-diabetic men and women.


Eligibility Criteria:
Inclusion Criteria:

* For healthy subjects: fasting glucose \< 5.6, 2-hour post 75g Oral Glucose Tolerance Test (OGTT) glucose \< 7.8 mmol/l and HbA1c \< 5.8%
* For subject with glucose intolerance (IGT): 2-hour post 75g OGTT glucose at 7.8-11.1 mmol/l on two separate occasions and HbA1c of 6.0 to 6.4%

Exclusion Criteria:

* overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
* treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted)
* presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness
* smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day
* prior history or current fasting plasma cholesterol level \> 7 mmol/l or fasting TG \> 6 mmol/l
* any other contraindication to temporarily interrupt current meds for lipids or hypertension
* being pregnant
* not be barren
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

Chronic Obstructive Pulmonary Disease (COPD), , secondary to smoking, is a major public health issue with very high direct and indirect costs. The impact on the health system of undiagnosed patients, up to 70% of patients, is increasingly documented. However, systematic spirometry screening remains controversial among smokers in the absence of data to link the detection of new patients with improved management and clinical events and health goals. More generally, there is little data on the evolution of patients in real life once they have entered the care system.

The premise is that with systematic screening in general medicine, it is possible to identify the evolution of newly diagnosed COPD patients, to distinguish the different possible evolutions according to the initial phenotype and the management.

A description of the population from which the groups or cohorts will be selected Smokers who have a screening spirometry for COPD, either in general medicine, at a pulmonologist or in the CHIC or Henri Mondor hospital respiratory function tests department.

After screening, an equal number of men and women COPD will be included (150 men and 150 women). 1500 smokers will be included to reach 300 smokers with COPD.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria of smokers with spirometry (pre-inclusion)

* Age\> 35 years
* Smoking \> 20 PA
* Active smoking (cessation \< 1 month)
* Signature of consent to participate in Phase I of the study

Inclusion criteria for patients with incidental COPD

* FEV1 / FVC \<70% of the theoretical value and / or \<LLN (Lower limit of normal)
* Signature of consent to participate in Phase II of the study

Exclusion Criteria:

* Known COPD
* Cancer being treated
* No affiliation to the social security or other social protection scheme
* Pregnant or lactating woman
* Patient deprived of liberty or under legal protection (under tutorship or curatorship
Aneuploidy Rates of in Vitro Matured Oocytes

In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively).

The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Under controlled ovarian stimulation, patients with normal functional ovarian reserves produce a good number of oocytes at retrieval. However, in addition to quantity, oocyte maturity is an important variable for the success of reproductive technologies. In general, nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). Due to the limited expectations held for in vitro maturation in said stimulated cycles, the rescue of immature oocytes is not widely used in current clinical practice and these oocytes are usually discarded due to the possibility of abnormal embryonic development or an increased rate of abortion.

The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Eligibility Criteria:
Inclusion Criteria:

* 18-35-year-old women
* BMI: \>18 and \< 30 kg/m2
* Normal female karyotype
* Normal uterus and ovaries at transvaginal ultrasound

Exclusion Criteria:

* \> 35 years
* PCO syndrome carriers
* Null follicle aspiration
* History of chemotherapy or radiotherapy
Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure

The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants

Preterm infants admitted to NICUs are exposed to a range of painful procedures. The exposure to pain during this critical of brain development may have adverse consequences. Application of nasal CPAP is one of the painful procedures. A consensus statement on neonatal pain made recommendations for analgesia for neonatal procedures. Topical lidocaine is frequently used as a topical anesthetic during venipuncture, heel lancing, circumcision, endotracheal intubations, nasogastric tube insertion, endoscopy and bronchoscopy. However, the use of topical lidocaine for its analgesic effect on application of nasal CPAP has not been evaluated.

This study proposes a randomized controlled trial to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \< 37 weeks gestation
* Admitted to NICU, Mansoura University Children's Hospital
* Respiratory distress requiring use of nasal CPAP
* Informed consent obtained

Exclusion Criteria:

* Serious, life-threatening malformations
* Use of sedation, analgesia in the preceding 72 hours
* Those who undergo any surgical intervention
* Those who undergo any painful procedures as venipuncture, intubation, suctioning, blood sampling, heel-prick, catheterization 30 minutes before assessment
* Those with signs of nasal injuries at the time of application of nCPAP
* Necrotizing enterocolitis
Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women

Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:

1. Caloric intake will decrease following administration of oxytocin versus placebo
2. Appetite will decrease following administration of oxytocin versus placebo
3. Resting energy expenditure will increase following administration of oxytocin versus placebo


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* BMI 18.5-24.9, 25-40
* Regular breakfast eater (at least 4 times per week)
* Stable weight within the past three months

Exclusion Criteria:

* Psychiatric disease
* Use of psychotropic medications
* History of eating disorder
* History of excessive exercise within the last three months
* History of diabetes mellitus
* Active substance abuse
* Hematocrit below normal range
* Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
* History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
* Untreated thyroid disease
* Tobacco use
P-POSSUM Score and Length of Stay

P-POSSUM score had a predictive power of \>80% to predict the length of stay of kidney transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Subjects are medical record of recipients who underwent kidney transplant

Exclusion Criteria:

* Medical record was incomplete
* Patients who died during surgery or before the patient was discharged.
Suicide Ideation in Hereditary Angioedema

This study focuses on patients with Hereditary Angioedema (HAE) to better understand how mental health affects overall well-being. Through a questionnaire, the investigators will assess the presence of suicidal thoughts, anxiety, and depression, as well as cardiovascular risk markers. By analyzing these factors together, the investigators aim to identify possible links between mental health and heart health in people with HAE. This research will help improve care strategies and highlight the importance of mental well-being in managing HAE.

This observational study focuses on patients with Hereditary Angioedema (HAE) to explore the impact of mental health on overall well-being. Through a questionnaire, the investigators aim to assess not only the presence but also the severity of suicidal thoughts, as well as symptoms of anxiety and depression. Additionally, the investigators will evaluate how these mental health factors relate to disease variables such as HAE control, disease activity, and quality of life.

Beyond mental health, the investigators also seek to understand its connection to cardiovascular risk factors. By measuring triglycerides, glucose levels, and body mass index (BMI), the investigators aim to explore whether patients with higher suicide risk also face increased heart health risks. This research will help improve patient care by emphasizing the importance of both mental and physical health in managing HAE. After identifying patients with high risk of suicide ideation the investigators will conduct a folow-up study after patients have received mental health interventions and how evaluate how treatment can determine better HAE outcomes. With these resuts the investigators expect to attract the attention of the international scientific community to increase early detection and effective solutions to prevent suicide.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of hereditary angioedema
* Over the age of 18

Exclusion Criteria:

* Patients with intellectual disability
* Refusal to participate in the study
* Patients with acquired C1-INH deficiency
* Patients with other dermatological diseases.
Circulating Tumor Cells in Solid Tumors

The purpose of this study is to identify circulating tumor cells in patients with solid tumors. Quantify and characterize these cells, collect patient information in regards to the patient's cancer. Develop a database and a sample repository where future analysis could be done.

The primary purpose of this correlative study is to create a prospective database documenting the quantity and characterization of circulating tumor cells (CTCs) in solid tumor patients as identified by a various laboratory techniques and analyses. The investigators are developing this resource to provide data to achieve the following objectives: 1) correlate CTCs with known prognostic factors, 2) correlate CTCs with burden of disease, 3) evaluate the ability of CTCs to be used in the surveillance of disease recurrence, and 4) evaluate CTCs ability to be used as a biomarker for treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Biopsy proven solid tumor malignancy
* Seen at UNC Chapel Hill Hospital and Health Care System
* Consents to abstraction of their medical records
* Signed an institutional review board (IRB)-approved informed consent document for this protocol

Exclusion Criteria:

* \< 18 years of age
* Dementia, altered mental status, incarceration or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .

Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients at any stage of this disease

Exclusion Criteria:

* Patients of allergic history to Ivermectin or to doxycyline
Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes

This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery

Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of adverse consequences, such as elevated blood pressure, incision rupture, bleeding, cardio-cerebrovascular accidents and so on, leading to a great waste of resources.

Accumulating scientific evidence indicates that the incidence of EA is related to the use of perioperative sedative drugs. As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether perioperative sedation of Remimazolam besylate, propofol, and sevoflurane have different effects on the incidence of emergence agitation and hemodynamics in patients undergoing laparoscopic abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* 1 Aged 18-65 years, sex was not limited;
* 2 BMI 18-30kg/m2;
* 3 Patients were scheduled for elective laparoscopic abdominal surgery under general anesthesia, the operation time 2h\~4h;
* 4 ASA Ⅰ-III;

Exclusion Criteria:

* 1 Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications;
* 2 Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN;
* 3 People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment;
* 4 Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack;
* 5 Female pregnant patients;
* 6 Patients undergoing hepatobiliary surgery;
* 7 Allergy to the experimental drug;
* 8 Unable to cooperate to complete the test, the patient or family member rejected the participant;
Case-control Study of Sleep Disorders in Children With Cystic Fibrosis

Our primary purpose is to compare the prevalence of sleep disorders in children aged 6 to 17 with cystic fibrosis versus controls with a Sleep disorder screening score, the SDSC. Our hypothesis is that patients aged 6 to 17 with cystic fibrosis have a higher prevalence of sleep disturbances than the general population of the same age group.

Our secondary hypothesis is that these sleep disorders are mixed and that there are non-respiratory causes, sometimes modifiable by simple non-medical treatment and that's why our secondary purpose is to identify the responsible factors, in particular non-respiratory factors in the 2 groups and to compare them.


Eligibility Criteria:
Inclusion criteria for the case group :

* Cystic fibrosis followed at the pediatric (Centre de Ressources et de Compétences de la Mucoviscidose) in Strasbourg
* Aged from 6 to 17 years old
* Non hospitalized
* Able to read and understand French language
* Accompanied by at least one of his parents

Inclusion criteria for the control group :

* Emergency surgical consultation
* Aged from 6 to 17 years old
* Non hospitalized
* Able to read and understand French langage
* Accompanied by at least one of his parents

Exclusion criteria:

* Children under 6 years old
* Children over 17 years old
* Children and parents who don't understand or can't read French language
* Hospitalized children
* Children unaccompanied by their parents
Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Gut hypoperfusion - reperfusion injury is an unavoidable event at the end of laparoscopic surgery. It produces oxidative stress (reactive oxygen species). Malondialdehyde have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. On the basis of this knowledge, the investigators hypothesized that propofol has preventive effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical prostatectomy.

Increased intrabdominal pressure is associated with pneumoperitoneum for laparoscopic procedures and is one of the main factors in impairment of splanchnic perfusion by compressing vessels. An hypoperfusion - reperfusion human model is observed during and soon after laparoscopic surgery. After deflation of the abdomen, intrabdominal pressure and splanchnic blood flow normalize, representing reperfusion.

Reactive oxygen species is produced in metabolic and physiologic processes, and harmful oxidative reactions may occur in organisms that remove them via enzymatic and nonenzymatic antioxidative mechanisms.

Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. Propofol also attenuates ischemia - reperfusion induced lipid peroxidation in humans. On the basis of this knowledge, we hypothesized that propofol has preventive effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving robot-assisted laparoscopic radical prostatectomy in ASA II-III physical status

Exclusion Criteria:

* history of sepsis or shock, clinically relevant cardiopulmonary disease, persistent tobacco abuse, recent antioxidant or vasoconstrictor use