cyrilzakka/clinical-trials huggingface dataset:
The (PIVOTAL) Study

The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.


Eligibility Criteria:
Inclusion Criteria:

* 40 to 90 years of age
* Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
* Maximum aneurysm diameter of 4-5cm
* If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
* Patient is willing and able to comply with the specified follow-up evaluation
* Life expectancy at least 3 years

Exclusion Criteria:

* Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
* Known co-existing condition with a life expectancy of less than 3 years
* Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
* Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
* Planned conduit procedure for introduction of endograft
Otago Exercise Program Applied By Telerehabilitation

The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging.

45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p\<0.05 level in the study.

Those using a randomized controlled clinical trial model that includes assessment methods over four different time periods. Detailed information about the procedure to be applied was given to each participant who would participate in the study. After the information, mini mental state test was applied to the participants who signed the consent form. Gender, age, weight, height, number of falls in the last 1 year, body mass indexes were calculated and recorded, including demographic information of the participants who met the inclusion criteria. Participants were randomly divided into 3 groups. The groups are; telerehabilitation otago exercise program (TOEG) (n=15, 8 males, 7 females), face-to-face otago exercise program (FOEG) (n=15, 8 males, 7 females), Control Group (CG) (n=15) , 8 men, 7 women).

Eligibility Criteria:
Inclusion Criteria:

* Presence of the ability to walk without assistance
* Living independently at home
* Having a history of at least one fall in the last 12 months

Exclusion Criteria:

* Having a score below 24 on the Mini Mental State Test
* Using a walking aid
* Having a history of uncontrolled epileptic seizures
* Having a history of surgery within the last six months
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery

This is a phase III, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. This study aim is to assess the efficacy of active gas extraction with a drain (arm A) in comparison to manual evacuation (arm B,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.

The primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain.

Secondary objectives of this study include :

* Comparing the evolution of specific pains after laparoscopic surgery, between study groups
* Description of postoperative antalgics consumption in each group
* Evaluating the safety of the evaluated procedure
* Evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans ;
* Woman who underwent laparoscopic or robotised laparoscopic surgery in peritoneal cavity (benign or malignant gynaecological affection) ;
* Planned ambulatory surgery
* Patient willing and able to be treated and followed according the protocol during the trial ;
* Patient covered by the French "Social Security" regime ;
* Effective contraception for reproductive age patients ;
* Signed written informed consent before surgery

Per-operatory eligibility criterion :

* No conversion from laparoscopic surgery to laparotomy surgery

Exclusion Criteria:

* Extra-peritoneal surgery scheduled ( example : aortic dissection) ;
* Upper-abdomen surgery (example : liver, gall bladder) ;
* History of shoulders pains prior to surgery (the assessment must be carried out within a period of 30 days before the surgery) ;
* Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
* Person under guardianship
* Pregnant or breastfeeding woman

Non eligibility criterion known during the operation :

* Conversion from laparoscopic surgery to laparotomy surgery
Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction

This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction".

Patients diagnosed with acute myocardial infarction will receive percutaneous coronary intervention to the culprit coronary artery according to standard procedures. For peripheral blood stem cell mobilization, Granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) will be injected for a total of 4 days, followed by collection of mobilized peripheral blood stem cell (mobPBSC) via apheresis. In ex-vivo setting, mobPBSC will be primed with angiopoietin 1 (Ang1) for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male and female aged ≥19 years and ≤ 80 years
* 2. A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization
* 3. Successful percutaneous coronary intervention to the target lesion (TIMI flow grade 3 and residual stenosis \<30% at the target lesion) with a drug-eluting stent and/or drug-eluting balloon
* 4. Agreement to give written informed consent.

Exclusion Criteria:

1. Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction \<20%)
2. Patients with uncontrolled chest pain due to ischemia
3. Patients with uncontrolled arrythmia
4. Active malignancy, or incompletely treated malignancy
5. Active infectious disease
6. Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis
7. Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization
8. Females with childbearing potential or breast-feeding
9. Refusal to give written informed consent
10. Other conditions that may result in protocol non-compliance by the committees
The Correlation Between Ovarian Function and Serum Biomarkers

The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.

Collect the serum of the observation group and control group volunteers, and measure the levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. in the serum.

Eligibility Criteria:
Inclusion Criteria:

1. The selection criteria for healthy individuals are follows.

   * women aged 18-45.

     * Basic FSH\<10IU/L, and AMH is within the normal range.

       * Regular menstruation.

         * Agree and sign an informed consent form.
2. The selection criteria for DOR patients are follows.

   * women aged 18-45.

     * For two consecutive menstrual cycles, 25 ≥ basal FSH ≥ 10IU/L or AMH\<1.1ng/ml.

       * Agree and sign an informed consent form.
3. Selection criteria for POI patients are follows.

   * 18 ≤ females aged \<40 years old.

     * Two consecutive menstrual cycles with basal FSH\>25IU/L or AMH\<1.1ng/ml.

       * Agree and sign an informed consent form.

Exclusion Criteria:

1. Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
2. Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
3. Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
4. Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
5. Patients during lactation or pregnancy.
6. Patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional Chinese medicine.

Those who meet any of the above 5 criteria for DOR and POI will be excluded and not included in this study. The exclusion criteria for healthy subjects are as (1), (3), (4), and (5).
Combination Versus Laser Treatment Only

Our objective is to determine the effects of (1) basic skin care regimen + "active" (Lytera 2.0) vs. (2) basic skin care regimen only, both groups combined with laser, on the appearance of skin tone and photo-aging on the face.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female patients 18 years and older
* Fitzpatrick skin types I-IV
* Has at least mild mottled skin tone of the face (score of 2 or more on a 5 point skin tone scale)
* Has at least 2 areas of the face with significant roughness, dyspigmentation, or fine lines or has all these characteristics in 1 or more areas
* Willing to refrain from using any other topical products on the face, systemic retinoids, or steroids, facial peels or other facial laser procedures throughout the duration of the study
* Willing to refrain from any cosmetic procedure including but not limited to facial surgery, dermal fillers, and neuromodulators for the duration of the study
* Willing to use only the facial skin care product regimen provided for the study
* Willing to avoid extended periods of sun exposure and the use of tanning beds during the study
* Willing to have photographs taken of the face to be used de-identified in evaluations, publications, and presentations
* For females: proof that they are not pregnant (urine pregnancy test)
* English-speaker

Exclusion Criteria:

* Has any uncontrolled systemic disease (such as autoimmune disorders and connective tissue disorders such as lupus erythematosus or Sjogren's syndrome
* Has any active infection in face
* Has history of any skin conditions that could interfere with treatment
* Has used self-tanner recently
* Is currently participating in another drug research study
* Is NOT willing to refrain from using any other topical products such as skin lightening, retinoids, alpha/beta-hydroxyl acids, salicylic acid, vitamins C or D, steroids, or antibiotics on the face or systemic retinoids, steroids, facial peels, neuromodulators, dermal fillers, facial surgery, or other facial laser procedures throughout the duration of the study
* For females: is pregnant
* Non English-speaker
Is the Perfusion Index an Accurate Predictor of Return of Spontaneus Circulation in Out-of-hospital Cardiac Arrest

The purpose of this pilot feasibility study is to evaluate the ability of the Perfusion Index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation.

The performance of the perfusion index will also be compared to the current gold standard, end-tidal CO2 (EtCO2).

The aim of this observational research is to measure the predictive performance the perfusion index to predict a return of a spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR).

The research focuses on patients in out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA) treated by the mobile intensive care unit of Saint Pierre University Hospital.

The study will be a pilot observational study during cardiac arrest. During the study period a non-invasive sensor will be connected to the patient's finger to measure continously and non-invasively the perfusion index. This non-invasive measurement is done by means of an infrared light which has no known risks for the health of the patient and which is usually used for the measurement of arterial oxygen saturation (SatO2). No intervention is planned as no decision will be taken on treatment based on the collected values of perfusion index during the arrest and post-arrest care of the participants.

The study will therefore be conducted during conventional advanced life support procedures without rescuers having access to the ongoing measurements.

The study will end when the participant returns to spontaneous circulation (RACS) or when patients is admitted to the emergency ward, whichever comes first in a time frame of maximum two hours.

The decision to stop resuscitation procedures will be made in accordance with the European Resuscitation Council (ERC) recommendations and the Resuscitation Termination Rules (TOR) for cardiac arrest.

Pulsatility index values will be sampled at a 0.5 Hertz frequency. These values will be tested for their ability to predict ROSC within 2 minutes. Similarly, EtCO2 values (as a gold standard) will be analyzed from the time of first measure. The sensitivity and specificity of the collected values of EtCO2 in the prediction of ROSC will be compared, at the end of the study to the diagnostic sensibility and specificity of different thresholds of the perfusion index.

The patient's consent will be requested at the moment when he/she recovers consciousness allowing the comprehension and signature of a consent after the cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest with an indication to initiate chest compressions
* In hospital cardiac arrest with an indication to initiate chest compressions

Exclusion Criteria:

* Pregnant patients
* Prisoners
Treatment of Hypertension in Primary Care in Spain

Non-interventional,observational and retrospective study assessing the therapeutic and diagnostic attitude followed in primary care for a hypertensive patient depending on his degree of blood pressure control.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary hypertension and/or treated for hypertension for one year or more
* Clinical data of blood pressure measures for the last 12+/- 2 months before inclusion.

Exclusion Criteria:

* Secondary Hypertension
* Physical or psychological impairment for the understanding of the information to be given to the patient
DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

The purpose of the study is to identify novel blood-based biomarkers for prediction and diagnosis of infected pancreatic necrosis (IPN) in patients with necrotizing pancreatitis (NP).

Acute pancreatitis (AP) is the leading cause of gastrointestinal hospital admissions, accounting for over 300,000 emergency department visits annually and imposing a significant socio-economic burden. It is an acute inflammatory condition of the pancreas characterized by damage to the acinar cells, which triggers an inflammatory response and causes widespread systemic damage. In about 20% of cases, the disease progresses to necrotizing pancreatitis (NP), a severe form characterized by tissue necrosis. NP poses serious health risks, especially when the necrotic tissue becomes infected, leading to infected (peri-)pancreatic necrosis (IPN), which is associated with secondary organ failure (OF), sepsis, and mortality rates as high as 40%. While patients with sterile (peri-)pancreatic necrosis (SPN) can often be managed conservatively, those with IPN typically require antibiotics and therapeutic interventions such as endoscopic drainage or surgery.

Timely recognition and treatment of IPN are crucial for improving patient outcomes, yet current diagnostic methods based on clinical symptoms and routine lab markers lack the specificity to reliably distinguish SPN from IPN in the early stages. Furthermore, while multifactorial scoring systems like Ranson, Imrie, and APACHE II predict necrosis and overall severity in AP, they are not accurate for identifying IPN or predicting mortality in NP. The diagnostic gap delays appropriate treatment, allowing the infection to advance and limiting available therapeutic options. The growing incidence and significant impact of AP and NP in the general population underscore the urgent need to better understand IPN pathophysiology and to develop specific diagnostic biomarkers that can improve prognosis, guide therapeutic decisions, and enhance patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>18 years.
* Diagnosis of NP based on CECT.

Exclusion Criteria:

* recurrent AP
* pancreatic cancer
* pregnancy, lactation
* solid organ transplant
* immunodeficiency disorders like AIDS.
A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management

This study will evaluate the efficacy of Colon Broom Premium on gut health, metabolism, weight management, and energy levels. The study will be conducted as a virtual single-group trial in which all 120 participants will use the test product. This study will last 12 weeks, and participants will take the product daily. Participants will complete study-specific questionnaires at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12. Participants will also provide body weight measurements and body circumference measurements at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12.

Before \& after photographs will be provided at Baseline and Week 12.

The Colon Broom Premium supplement contains psyllium seed husk powder, L-carnitine tartrate, CapsimaxⓇ cayenne fruit extract, chromium (as chromium picolinate), vitamin B6 (as pyridoxine HCl), vitamin B12 (as cyanocobalamin), and Iron.

The study Sponsor and product name will remain anonymous to participants throughout the trial. The Sponsor name or product name will not be included in any participant-facing documentation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between ages 30-50
* Have a BMI of 25 or more
* Have self-reported issues with gas, bloating, constipation, heartburn/acid reflux, abdominal pain, or digestion at least three times per week
* Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study
* Be generally healthy - do not live with any uncontrolled chronic disease

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Anyone who is currently undergoing, or planning to to undergo any gut or weight-related procedures in the next 12 week.
* Anyone with a history of severe allergic reactions including but not limited to psyllium seed husk powder and strawberries
* Anyone taking any prescription medications targeting the gut
* Anyone taking any supplements targeting the gut in the past month
* Use of antibiotics in the past 3 months
* Women who are pregnant, breastfeeding, or attempting to become pregnant
* Anyone unwilling to follow the study protocol
* Anyone following any particular dietary regime, such as a ketogenic diet or intermittent fasting.
* Anyone who has had bariatric surgery in the past 6 months
* Anyone who has chronic constipation
* Anyone who has Irritable Bowel Disease (IBD)
* Anyone diagnosed with severe digestive issues
Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy

To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.

The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.

Eligibility Criteria:
Inclusion Criteria:

1. age (6 months to 6 years)
2. ASA physical status I or II.
3. Operation: elective unilateral inguinal herniotomy.

Exclusion Criteria:

1. A history of developmental delay or mental retardation,
2. Known or suspected coagulopathy,
3. Known allergy to any local anaesthetic,
4. Known congenital anomaly of the spine or signs of spinal anomaly,
5. Infection at the sacral region.
Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of cystic fibrosis (sweat test or genotype)
* Of either gender
* Aged between 8 and 18 years
* Have a baseline FEV1 of \<70% of the predicted normal value
* Currently taking rhDNase for at least 4 weeks

Exclusion Criteria:

* Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA
* Listed for transplantation
* Known intolerance to mannitol, rhDNase or bronchodilators