cyrilzakka/clinical-trials huggingface dataset:
Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?

Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for aneuploidy risk assessment.

Obesity is a common public health problem which is increasing worldwide at an alarming rate. According to National nutrition survey statistics of 2007, the prevalence of obesity in the kingdom of Saudi Arabia was 23.6% in women and 14% in men. Also the prevalence of overweight in the Saudi community was determined to be 30.7% for men as compared to 28.4% for the women.

First trimester screening between 11-14 weeks gestation is known to be an effective and reliable screening test for Down syndrome and trisomy 18.First trimester screening allows earlier identification of the pregnancy at risk for fetal aneuploidy and anatomic defects, particularly, cardiac anomalies, therefore, providing an option of earlier diagnosis by chorionic villus sampling and analysis of amniocytes.

The well-known association of obesity during pregnancy with a variety of maternal and fetal complications increases the importance of early aneuploidy screening.

Fetal aneuploidy risk assessment is based on a combination of maternal age, prior affected pregnancy or family history, maternal serum biochemical tests and fetal ultrasound markers.

The impact of obesity on the quality of prenatal ultrasound examination is well established with a greater risk for suboptimal visualization, in particular, the fetal cardiac structures and the craniospinal structures only when body mass index above the 90th percentile.

The quality of prenatal screening for aneuploidy via nuchal translucency thickness measurement is significantly limited among obese pregnant women, thus, increased risk of fetal anomalies.

Gandhiet al, have noted that increased BMI is not associated with suboptimal visualization of nuchal translucency, but it is associated with a longer time to perform the first-trimester ultrasound examination for aneuploidy risk assessment, increased need for transvaginal ultrasound examination for optimum nuchal translucency visualization.

There is evidence suggesting that fetal anatomic evaluation in the low-risk gravida can be better accomplished in the first trimester using the transvaginal route, providing a valuable option for obese patients.

Eligibility Criteria:
Inclusion Criteria:

* women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.

Exclusion Criteria:

* multiple gestation.
* fetal size outside of nuchal translucency screening age (crown-rump length (CRL) outside of 46-71 mm).
* presence of a cystic hygroma.
* fetal demise.
Adults With Moderate to Severe Asthma

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 12 or over who have asthma
* Ability to properly use an electronic diary
* Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria:

* Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
* Planned hospitalisation during the study
* pregnant women or women planning to become pregnant
Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT

Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for bone marrow failure syndrome.

This is a prospective, randomized, non-blind study.

Conditioning therapy will start on day -5 in patients who are randomized to receive Cy+ATG. Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -5. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter. Mesna 12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2. Premedication for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.

Conditioning therapy will start on day -6 in patients who are randomized to receive Cy+fludarabine (FludaraÂ®, Berlex Laboratories, Richmond, CA)+ATG. Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 5 consecutive days (days -6 to -2). Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2. Premedication for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push. Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -3. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -3 to -2 by pump through a central venous catheter. Mesna 12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bone marrow failure syndrome.
* Written informed consent must be obtained from the patients and donors.
* Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor who is 60 years or less.
* Patients should be 15 years of age or older, but younger than 60 years.
* The performance status of the patients should be 70 or over by Karnofsky performance scale (see Appendix I).
* Patients should not have major illness or organ failure.
* Patients must have adequate hepatic function (bilirubin less than 2 mg/dl, AST and ALT less than three times the upper normal limit).
* Patients must have adequate renal function (creatinine less than 2.0 mg/dl).
* Patients must have adequate cardiac function (ejection fraction \> 45% on MUGA scan).
* Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlikely, and making informed consent impossible.
* Patients must not be in pregnancy.

Exclusion Criteria:

* Patients should have major illness or organ failure
Wearable Blood Pressure Monitoring

The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.

The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.

Eligibility Criteria:
Inclusion Criteria:

* written concent from the participant

Exclusion Criteria:

* pace maker, pregnancy
Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial

Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.

Mucosal erosions can occur on luminal surface of stomach in approximately 75-100% patients during the first 24 hours of intensive care unit admission. These erosions often cause bleeding with penetrating superficial capillaries. Clinically significant bleeding (Significant decrease in blood pressure or decrease in hemoglobin level of more than 2 g / dL) appears to be less than 5% in ICU patients.

Enteral nutrition (EN) has protective effects against stress ulcer bleeding by neutralizing the acidic pH in the stomach lumen, providing a structural and functional integrity of the mucosal surface and trophic effect on the GI mucosa. These effects have been shown in some studies. The above-mentioned studies are inadequate for clinicians to make suggestions for relation between enteral nutrition and stress ulcer hemorrhage.

The risk factors for stress ulcer hemorrhage are mechanical ventilation, coagulopathy and burns.

Proton pump inhibitors (PPI) and histamine receptor blockers (H2RB) are the main drugs used for stress ulcer bleeding prophylaxis.

Studies have shown that 90% of patients admitted to intensive care units receive prophylaxis for stress ulcer bleeding.

Drugs (H2RB, PPI) used for prophylaxis against stress ulcer bleeding have some undesirable harmful effects in critical illnesses. These drugs, which suppress gastric acid secretion, can cause hospital-associated pneumonia and Clostridium difficile enterocolitis.

The studies, for clinical proposals are generally performed in the 1980s and early 1990s. Oral intake was stopped in most of the critically ill patients and early enteral nutrition was not widely used at the time of these major studies performed. Patients who are receiving EN have been shown to develop less stress ulcer bleeding in some studies. In a limited number of animal studies, enteral feeding has been shown to protect stress-related mucosal damage in the gastric mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Admission to ICU
* Expected to stay in ICU \>24 hours
* No contraindications to EN within the first 24 hours after admission to the intensive care unit

Exclusion Criteria:

* Evidence of active GI bleeding during current hospitalization prior to study entry
* Coagulopathy (PLT\<50.000, INR\>1.5, aPTT\>2xcontrol)
* Patients receiving acid suppressing drugs prior to admission
* Pregnancy or lactation
* History/documented gastric ulcer
* Burn\>30% body surface area
* Head injury or increased intracranial pressure
* Partial or complete gastrectomy
* Shock
* Multi-system trauma
* Exposure to gastric irritant drugs
* Patients not giving informed consent
Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users

The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).


Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

1. One of the following:

   1. Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
   2. Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
   3. Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
2. Between 16 and 60 years of age.
3. Have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
4. Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
5. Refractive astigmatism between -0.75D and -3.00D in both eyes.
6. Have best corrected VA of 6/9 (20/30) or better in each eye.
7. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

   1. No amblyopia.
   2. No evidence of lid abnormality or infection.
   3. No conjunctival abnormality or infection.
   4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).
   5. No other active ocular disease.
8. Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only)

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

1. Requires concurrent ocular medication.
2. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
3. Corneal staining Grade 3 in more than two regions.
4. Extended wear in the last 3 months.
5. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
6. Abnormal lachrymal secretions.
7. Pre-existing ocular irritation that would preclude contact lens fitting.
8. Keratoconus or other corneal irregularity.
9. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
10. Has diabetes.
11. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
12. Pregnancy, lactating, or planning a pregnancy at the time of enrollment.
13. Participation in any concurrent clinical trial or in last 60 days.
Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of moderate to severe acne vulgaris

Exclusion Criteria:

* use of oral retinoid therapy in the past 12 months
* pregnancy, lactating, or planning to become pregnant
* excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne
Technical Evaluation Of JewelPUMP In Type 1 Diabetic Patients Treated With Extern Insulin Pump

The main objective of the study is to verify the reliability of the solutes volumes issued by the Debiotech JewelPUMPTM controlled by its remote.

Three clinical sites are participating in this study:

* CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume CHARPENTIER, Dr. Sylvia FRANC
* Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition, GRENOBLE (38): Pr Pierre-Yves BENHAMOU
* CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor Alfred PENFORNIS, Dr. Annie CLERGEOT

The study will be conducted in 20 patients with type 1 diabetes treated by external insulin pump. Patients will be informed of the study during a screening visit. After signing the informed consent, they will return to the center where they will wear a JewelPUMPTM containing saline water, they will use their pumps in parallel. The investigator or nurse education will form the operation of the JewelPUMPTM and they will be instructed to replicate the same settings between their usual and JewelPUMPTM pump. The patient will be asked to complete visual analog scales of satisfaction with their usual treatment and the various elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision balance to have a form of a base for comparison.

Patients will leave home for a period of about three days, but they will have to come back every days to the center. They will be asked to collect all events arising (programming problems to deliver a bolus, hardware failure ...) in a booklet.

At the end of study visit, patients will return to the center where the volumes will be assessed by the perfused weighed the various components and devices where they will complete the visual analog scales of satisfaction at endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetic patient treated by external insulin pump for at least 6 months
* Patient with a HbA1c \< 9%
* Patient age over 18 years of age
* Patient having signed the consent and informed form
* Patient affiliated with the social security

Exclusion Criteria:

* Patients with diabetes type 2
* Patient pregnant or likely to be
* All serious pathologies that can interfere with the study
* Incompatible psychiatric pathologies with the study
Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers

The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy.

There are no risks for the patients, as this is a retrospective data collection.

The use of neoadjuvant chemo-immunotherapy for the treatment of non-small cell lung cancer (NSCLC) is increasing. However, there is limited research comparing the feasibility and oncologic efficacy of robot-assisted thoracoscopic surgery (RATS), video-assisted thoracoscopic surgery (VATS), and open lung resection, in patients already treated with neoadjuvant chemo-immunotherapy. This study aims to evaluate the benefits of RATS compared to VATS and open surgery in terms of short-term outcomes for patients with NSCLC undergoing neoadjuvant chemo-immunotherapy.

All adult patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy will be included.

Patients are divided into three groups: robotic lung resection; video-assisted thoracoscopic (VATS) lung resection; open lung resection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024
* Received neoadjuvant chemo-immunotherapy or immunotherapy alone
* Age \>= 18 years old at the moment of surgery

Exclusion Criteria:

* Age \<18 years old at the moment of surgery
Personalized Dietary Advice 3 Months After Discharge From Hospitalization in Geriatrics: Effect on Nutritional Status According to Coronavirus Disease 2019 (COVID-19) Status (Positive or Negative) During Hospitalization

The principal aim of this interventional, multicentre study is to compare the impact of a follow-up by monthly telephone dietetic consultations, started 3 months after discharge from hospital, for a period of 3 months, on the energy intake in patients elderly people recently hospitalized for Coronavirus disease 2019 (Covid-19), Coronavirus disease Positive group "Covid (+)", or not, Coronavirus disease Negative group"Covid (-)".

The main outcome measure is to compare the total energy intake at 6 months, after 3 months of dietary consultations, between Coronavirus disease Positive group "Covid (+)" and Coronavirus disease negative group "Covid (-)".

This study consists of nutritional monitoring after hospitalization, carried out by dieticians. Consultations are done remotely, by phone only.

Eligible subjects are included, either upon discharge from hospital or within 3 months (at the latest) following their hospitalization.

135 subjects will be included, 50% will be included in Coronavirus disease Positive group "Covid (+)" and 50% in the Coronavirus desease negative group "Covid (-)" .

The following data will be collected

* At Inclusion (D0): Average length of hospital stay, medical diagnoses, severity of hospital stay, autonomy and dependency scores, albumin and body mass index (BMI).
* At M3, M4, M5 and M6: Dietary monitoring data, patient's vital status and dependency scores.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized or having been hospitalized in acute geriatrics
* Living at home 3 months after hospitalization in acute geriatrics
* Having a good understanding of the French language
* Being able to understand the study information and participate in telephone follow-up
* Having read the information notice and agreeing to participate in the study
* For the Covid (+) group: hospitalized for Covid-19 (diagnostic confirmation by positive RT-PCR)
* For the Covid group (-): hospitalized for any other reason (negative RT-PCR)

Exclusion Criteria:

* Patient refusing to participate in the study
* Subject to a legal protection measure (curatorship, guardianship or safeguard of justice)
* With cognitive impairment making it impossible to understand the study protocol and express consent.
Chiropractic Adjustment on Physiological Measurements

This research is designed to study the effects of chiropractic adjustment on the physiological responses (EEG, EMG, HRV, skin temperature, and respiration) of college student and faculty population.


Eligibility Criteria:
Inclusion Criteria:

Asymptomatic subjects (without somatosensory peripheral pain) will be recruited in the study.

Exclusion Criteria:

Subjects with heart failure and any nervous system diseases will be excluded from the study. Additional exclusions include osteoporosis, pregnancy, diabetes, vascular insufficiency, and history of joint replacement therapy. Subjects under medical treatment, surgery and trauma within six months will be excluded
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

The aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.

Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum.

Groups/Cohorts Assigned Interventions

1. Placebo group receiving conventional fish
2. intervention group receiving vitamin D fortified fish

Eligibility Criteria:
Inclusion Criteria:

* 18 years
* healthy

Exclusion Criteria:

* supplementation of vitamin d and calcium
* hypercalcemia
* hypercalciuria
* chronical illness (diabetes, kidney diseases, cardiovascular diseases)
* serum-creatinine above 115 mmol/l
* pregnancy or breastfeeding women
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza

The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic stress symptoms, depression, and levels of aggression compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* having experienced a political violence or war-related criterion A stressor
* meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale

Exclusion Criteria:

* former psychosocial or medical treatment for mental health conditions
* significant cognitive impairment