cyrilzakka/clinical-trials huggingface dataset:
The Predictive Value of Progesterone

To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. We assess whether the addition of SC P4 rescues cycles with serum P4 \<5 ng/ml and we study the impact of not supplementing cycles with serum P4 \>5 ng/ml by comparing them with serum P4 cycles above the conventionally proposed cut-off of 10 ng/ml.


Eligibility Criteria:
* Embryo transfer between March 1st 2021 and March 31st 2023
* Determination of progesterone on the day of embryo transfer
Synbiotic Treatment of Ulcerative Colitis Patients

Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is associated with high morbidity and incurs significant social, commercial and NHS costs. For a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. However, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. The aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with active disease. It is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. If the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for UC, making a significant contribution to relieving the clinical and financial burdens of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis
* Stable doses of medications for UC for the preceding three months
* Mayo score of 6 to 12
* Sigmoidoscopy subscore of 2
* Stable doses of medication

Exclusion Criteria:

* Pregnancy
* Lactation
* Antibiotic therapy in the last three months
* Probiotic or prebiotic therapy in the last month
* Crohn's Disease, indeterminate colitis
* Alterations to medications in the last three months
Mortality Surveillance of MRFIT Screenees

To ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in 1973-1975 for the Multiple Risk Factor Intervention Trial (MRFIT).

BACKGROUND:

The Multiple Risk Factor Intervention Trial was a randomized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease in 12,866 high-risk men aged 35 to 57. The primary screening for MRFIT began in November 1973 and continued through November 1, 1975. The primary screening was conducted at clinical center sites, central neighborhood locations, and places of employment. Information was collected on smoking history, blood pressure, serum cholesterol, birthdate, race, and social security number as well as previous hospitalization for a heart attack and use of medication for diabetes. Systolic and diastolic blood pressures were measured and blood drawn for serum cholesterol determinations. The results of the screening examination were transmitted to the Coordinating Center.

DESIGN NARRATIVE:

Using data supplied by the Social Security Administration, the vital status of the MRFIT screenees was determined. A screenee was identified as deceased if the social security number and first two letters of the last name, as recorded on the MRFIT screening form, matched a record on the Social Security Administration master death file. The state health department was contacted to obtain the death certificate which was then coded for the underlying cause of death according to the International Classification of Diseases, 9th Revision. Because the Social Security Adminstration master death file was not completely accurate, the National Death Index was also used. Studies were conducted on the relationships of isolated systolic hypertension to stroke and coronary heart disease mortality, and on seasonal and regional variations in cardiovascular mortality. Using data from the Census Bureau (education and income levels by zip code), the socio-economic status of participants was indirectly estimated and the coronary heart disease and cancer death rate differences between white and Black men were evaluated by social class. Studies were also conducted on the associations of cause- specific cancer mortality and serum cholesterol concentration, and on the association of serum cholesterol, diastolic blood pressure, and cigarettes smoked per day with mortality from coronary heart disease and cerebrovascular disease for Black and white men.

Eligibility Criteria:
No eligibility criteria
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy

Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy


Eligibility Criteria:
Inclusion Criteria:

* children between 6-18 years old.
* children with enlarged tonsils or adenoids.
* a sleep lab test before the procedure.

Exclusion Criteria:

* children under 6 years old and above 18 years old.
* patience that treated in ADHD / ADDOR with other neurocognitive disorder.
Stiripentol for the Treatment of Refractory Status Epilepticus

The investigators retrospectively analyzed all patients who were admitted to the Department of Neurology at Marburg University Hospital between 2013 and 2023 with a diagnosis of (super)-refractory status epilepticus and who received additional treatment of SE with STP. All patients who received STP during the SE were included, regardless of previous medication.

The investigators retrospectively analyzed all patients who were admitted to the Department of Neurology, University Hospital Marburg, Germany, between 2013 and 2023 with a diagnosis of status epilepticus, who received additional treatment of SE with STP. They were able to identify 25 patients who received STP as add on therapy. All these patients suffered from RSE or SRSE. Since there was no SOP or treatment algorithm available, they have listed the individual treatment regimens in Table 2. 5 of these patients were previously published in a case series (Strzelczyk et al. 2015).

Treatment success was defined as continuous interruption of the SE. Descriptive statistics are reported as absolute numbers and percentages, mean ± standard deviation (SD) or median ± median absolute deviation.

The study was approved by the local IRB.

Eligibility Criteria:
Inclusion Criteria:

* adult patients who suffered from RSE or SRSE and received STP as add on therapy.

Exclusion Criteria:

* children
A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.


Eligibility Criteria:
Inclusion Criteria:

* male/female subjects,
* aged 20-65 years old,
* triglycerides (TG) levels under 400 mg/dL,
* total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
* LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
* non diabetic and non hypertensive,
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
* effective contraceptive methods used for female subjects,
* having given written consent to take part in the study

Exclusion Criteria:

* subjects with sitosterolemia,
* subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
* taking any hypocholesterolemic treatment,
* presenting known allergy or hypersensitivity to plant sterols,
* dairy products and lactose, subject with heavy alcohol intake (\> 60g/day),
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* subjects receiving a transplant or under immunosuppressor treatment,
* receiving treatment for any serious pathology.
* for female subject:

  * pregnancy,
  * breast feeding or
  * intention to be pregnant during the study
GALLANT 6 Tesaglitazar vs. Pioglitazone

This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are ³18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion

To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for general anesthesia;
* No contraindication for propofol.

Exclusion Criteria:

* Data loss;
* Protocol violation.
LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety.

The objective of the LEGO®Bricks MRI project is to study a new play-based tool for use in children preparing to undergo MRI and evaluate its ability to reduce the need for anesthesia.

A randomized study design will be employed in the experimental "Child Life" (CL) group, in regard to which Child Life intervention patients will have. Age matched controls will be found retrospectively, and will be patients of the same age, undergoing their first non-contrast brain MRI with no Child Life intervention.

Patients in the CL group will be prepped by a Certified Child Life Specialist with the use of one of the following 2 tools, to be randomly selected:

1. LEGO Bricks model MRI (A model of the MRI machine and adjacent control room made out of LEGO bricks)
2. Mock MRI tube (A six foot long pop-out play tunnel for children, with a diameter of around 17 inches to simulate the MRI magnet bore)

Diagnostic imaging is frequently utilized in modern medical practice, and various imaging modalities are routinely utilized in the care of pediatric patients. Magnetic resonance imaging (MRI) is an advanced imaging modality that is utilized to evaluate many conditions in pediatric patients. MRI is frequently favored over other imaging modalities in pediatrics since it allows for high-quality cross sectional imaging without the use of potentially harmful ionizing radiation, to which children are more sensitive than adults. However, MRI quality is highly dependent on patients' ability to hold still and follow instructions, which is often challenging in pediatric patients. Young and uncooperative children often require anesthesia to successfully complete MRI. Anesthesia can often be avoided with the assistance of Certified Child Life Specialists, who use techniques to reduce patient anxiety and improve children's ability to follow instructions during MRI. For example, children may visit the MRI unit or a simulator prior to the examination to contextualize the procedure1-3. Preparation, in the form of play, has been proven to reduce anxiety in children prior to scans and invasive medical procedures. Children who are prepared for medical procedures experience less fear and anxiety and will have better long term adjustment to medical challenges (Koller, 2008).

Eligibility Criteria:
Inclusion Criteria:

* Between 4 and 10 years of age
* Undergoing first MRI
* MRI brain without contrast

Exclusion Criteria:

* Diagnosed serious illness/mental disability
* Have undergone prior MRI
Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery

The primary objective of this study is:

1. To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age undergoing cardiopulmonary bypass (CPB) for cardiac surgery

The secondary objectives of this study are:

1. To determine if the administration of AT concentrate prior to heparinization will decrease the amount of heparin required to achieve optimal anticoagulation (as defined by anti-Xa levels) during CPB
2. To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
3. To determine if there will be a reduction in postoperative bleeding and associated clinical complications


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients \< 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery
2. Planned cardiac surgery with cardiopulmonary bypass
3. Weight \> 2.5kg at the time of surgery
4. Enrolment in the CATCH main study (REB#1000020203)

Exclusion Criteria:

1. Preoperative antithrombin activity \> 85%
2. Prematurity \< 36 weeks gestational age at birth
3. Preoperative use of systemic anticoagulant (i.e. heparin or warfarin at a therapeutic dose) for \> 24 hours or at any time within the 48 hours prior to surgery
4. Any form of coagulopathy or thrombophilic disorder
5. Renal (blood creatinine - estimated GRF \< 60ml/min/1.73m2) or clinical liver failure
6. Antithrombin replacement therapy prior to surgery
7. Repeat surgery (including previous ECMO/VAD support as prior surgery)
8. Patients refusal to provide open consent for re-use of study data
Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp

Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients.


Eligibility Criteria:
Inclusion Criteria:

* writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders
* handwriting speed \< 140 letters per minute
* simple or complex writer's cramp
* scholarship in French language
* absence of treatment by botulinum neurotoxin, or last injection \> 3 months
* age \> 18 and \< 71 years
* informed consent
* medical insurance coverage

Exclusion Criteria:

* writer's cramp with no impact on writing
* writing tremor
* other neurological disease with effect on writing
* pain or traumatism of the limb used for writing, requiring medical or surgical treatment in the last preceding months
* participation in another research with a potential impact on evaluation criteria
* pregnant or breast feeding patient
* patient under judiciary protection
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery

The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.

Our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery

Eligibility Criteria:
Inclusion Criteria:

* requirement of surgical correction of two or more valves
Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

The aim of the study is to determine wether subcutaneus suction drain (type redon-drain) protect against surgical side infection by laparotomy in general surgery.

If subcutan drains inserted during wound closudsure after laparotomy avoid subcutaneous haematoma and seromas by suction, these drains shout protect against surgical site infections. This is the ratio why such drain are in use in many countries. To test whether this hypothesis is true or not we pland this study.

Eligibility Criteria:
Inclusion Criteria:

* indication for laparotomy
* age older 18 years
* informed consent

Exclusion Criteria:

* organ transplantation
* operation for abdominal hernia
* appendectomy by McBurney incision
* redo-operation
Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection

The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection

This is a randomized, placebo-controlled, double-blind phase IIa proof-of-concept study, designed to evaluate the effect of CR8020, CR6261, or placebo in hospitalized patients with influenza A infection that are receiving standard of care. Up to 262 participants will be randomized to receive 30 mg/kg of CR8020, 30 mg/kg of CR6261, or placebo. The study duration will be approximately 117 days for each participant. Prior to enrollment, participants will be screened to assess their eligibility. Eligible participants will be randomized to CR8020, CR6261, or placebo and study drug will be administered on Day 1. Participants will be followed up for 115 days in 9 visits on Days 2 to 8, Day 29, and Day 116 (end of study). After hospital discharge, the remaining follow-up visits will be performed as outpatient visits.

Eligibility Criteria:
Inclusion Criteria:

Participant requires hospitalization/ Each participant or his or her legally acceptable representative must sign an informed consent form/ Participant must be able to start the infusion within 36 hours from the time the screening specimen was collected/ A woman must either be not of childbearing potential or of childbearing potential and agrees to practice two forms of highly effective method of birth control/ A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta hCG\]) at screening/ A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control/

Exclusion Criteria:

Participant is a female who is pregnant or breastfeeding/ Participant undergoing peritoneal dialysis, hemodialysis or hemofiltration/ Participant has presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study/ Participant has prior treatment with an experimental mAb; or receipt of IgG within 3 months or on chronic mAb treatment prior to enrollment/ Participant has known or suspected hypersensitivity to any of the CR8020 or CR6261 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20)/ Participant received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment, is currently enrolled in an interventional investigational study, or is an employee of the investigational site/
Negative Pressure Wound Therapy in Post-Operative Incision Management

The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out after surgery.


Eligibility Criteria:
Inclusion Criteria:

Criteria for Eligibility Prior to Surgery:

* Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication
* or women who are morbidly obese (BMI\>40) undergoing laparotomy for any indication
* Age ≥ 18

Criteria for Eligibility During Surgery:

* Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication
* or women who are morbidly obese (BMI\>40) undergoing laparotomy for any indication
* Age ≥ 18

Exclusion Criteria:

Exclusion prior to Surgery:

* Women undergoing panniculectomy at the time of laparotomy
* Women with sensitivity to silver

Exclusion during Surgery:

* Women with laparotomy incisions left open due to case classification as "contaminated" or "dirty"
* Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage