cyrilzakka/clinical-trials huggingface dataset:
Levonorgestrel-releasing Intrauterine System and Tubal Ligation

Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. The percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. The most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer.

Post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. The syndrome is caused by blood circulation problems in and around the Fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. Since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. In some cases, however, hysterectomy may be necessary.


Eligibility Criteria:
Inclusion Criteria:

* Women aged from 30-40 year
* Woman subjected to tubal ligation
* Women 12 month postpartum
* Non lactating women
* Nomedical disorders

Exclusion Criteria:

* contraindication for Levonorgestrel-releasing Intrauterine System
* Women with any uterine or ovarian pathology
* women refuse to participate
Assessment of Cardiopulmonary Fitness in Healthy Adults

This project was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.

Cardiorespiratory fitness is one of the 'health-related physical fitness' components of physical fitness and can be expressed as 'the ability of the heart, lung and vascular system to deliver oxygen and nutrients to working muscles'. Cardiopulmonary exercise testing (CPET) is a common procedure used to assess cardiopulmonary fitness, identify physiological factors limiting exercise, identify potential therapeutic targets for these factors, and evaluate the effects of an intervention. Therefore, in this project, it was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age,
* Volunteering to participate in the study,
* Co-operation,
* Being able to ambulate.

Exclusion Criteria:

* Having any known respiratory, cardiac, neurological or other internal disease or malignant disease,
* Having any problem or musculoskeletal system disorder that prevents walking,
* To have undergone any surgery within the last six months
Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and natural history remains unknown but progression of inflammation to dysplasia and then to adenocarcinoma is suspected.

As for surveillance recommendations for colorectal carcinoma in long standing inflammatory colonic disease, endoscopic screening of SB could be proposed in CD patients with risk factors of SBA. No study can be found in literature.

The investigators propose a multicenter exploratory open study on prospective cohort of CD patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population


Eligibility Criteria:
Inclusion Criteria:

* More than 18-years-old
* Crohn disease on jejunum and/or ileum since at least 10 years
* Radiography done during last year

Exclusion Criteria:

* Dysplasia previously detected
* Pregnancy
A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants

The purpose of this study is to evaluate the effects of stomach acid suppression by rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of healthy participants.


Eligibility Criteria:
Inclusion Criteria

* Healthy participant, as determined by medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index of 18.0 kilogram per meter square (kg/m\^2) to 32.0 kg/m\^2
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than (\>) 80 milliliter per minute per 1.732 meter square (mL/min/1.732 m\^2)

Exclusion Criteria:

* Any major surgery within 4 weeks of study drug administration
* Use of any prescription drugs or over-the-counter acid controllers
* Positive urine screen for drugs of abuse, alcohol, or cotinine
* History of allergy to BMS-986165, rabeprazole, or related compounds

Other protocol inclusion/exclusion criteria may apply.
Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial

The aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus midazolam on hospital mortality, intensive care unit outcomes and sedation management.

The hypothesis is that patients receiving midazolam have a 5% higher hospital mortality in comparison to patients receiving lormetazepam.

Sedation is an integral part of modern intensive care medicine and has seen a tremendous development throughout the last years. Current guideline recommendations are targeted at an awake critically ill patients (target Richmond Agitation-Sedation Scale 0/-1) as early deep sedation has been shown to negatively affect the outcome. Nevertheless, is an adequate and individualized anxiolysis still an important intervention that can be achieved via process optimization, modifications to the infrastructure of the ward and pharmacologic therapy. Bolus application of benzodiazepines is a recommended pharmacologic measure to achieve proper anxiolysis. Midazolam is currently the most commonly used benzodiazepine in European intensive care units. Midazolam accumulates after repetitive application due to its pharmacokinetic properties, which increases the likelihood for side effects and makes targeted sedation increasingly difficult. Lormetazepam is used with increasing frequency as it is eliminated independent of the patients age and has few relevant metabolites. It is therefore thought to be better suited for targeted sedation management, which in turn would be beneficial for the patients.

The aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus midazolam on hospital mortality, intensive care unit outcomes and sedation management.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care unit patients at the Charité - Universitätsmedizin Berlin
* Age ≥ 18 years
* Intensive care unit length of stay ≥ 48 hours
* Duration of mechanical ventilation \> 0 hours
* Midazolam or lormetazepam application during the ICU stay

Exclusion Criteria:

* Number of application \< 2
* Midazolam and lormetazepam application during the intensive care unit stay
* Neurosurgical intensive care unit patients
A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis

This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).


Eligibility Criteria:
Key Inclusion Criteria:

* Body weight ≥35 kg.
* Subjects must have an eligibleCFTR genotype.

  * Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF)
  * Part 2: Homozygous for F508del (F/F)
* FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* History of clinically significant cirrhosis with or without portal hypertension.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Lung infection with organisms associated with a more rapid decline in pulmonary status.
* History of solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

Recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. The last published study did not outline obvious improvements in the prognosis of all cardiac arrests but pointed out a possible increased survival rate when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare the efficacy of two successive injections of epinephrine (1 mg) with two successive injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital medical cardiac arrest in adult patients.

Exclusion Criteria:

* Traumatic cardiac arrest
* Pregnancy
* Patients younger than 18 years old or older than 85 years old
Pregnant Women Doing Resistance Exercise Training

Despite the increase in numbers of women who engage in heavy, free-weight resistance exercise training (e.g. powerlifting, weightlifting, cross fit), the knowledge on how such exercise may affect fertility, pregnancy and birth outcomes is poor. Based on observational and associational studies of pregnant women in labour, recommendations are not to lift more than 11 kg in external load after mid-term, or to lift more than a total of 100 kg during a day. Ignoring such recommendations is associated to increased risk of miscarriage and preeclampsia, and of low birthweight and premature birth, respectively. As such, fit women who continue to exercise during pregnancy, are met with scepticism and warnings, resulting in shame and insecurity. Such attitudes may also result in physical inactivity during pregnancy, being on the contrary of what is recommended for a healthy pregnancy and delivery. Elite athletes may additionally be deprived from an early return to sport if not being able to keep exercise intensity close to pre-pregnancy period. With poor knowledge on how fit, strong women respond to high external loads during pregnancy exercise, recommendations are to follow the general guidelines.

The aim of this observational study, is to explore how regular resistance exercise training may affect fertility, and how high external loads in resistance exercise training during pregnancy in resistance trained women affect; a)their pregnancy and birth outcome, and b)health of the women and their children up to 12 months post-delivery.

Pregnant women who are experienced in heavy, free-weight resistance exercise training, and who choose to continue their exercise regimes during pregnancy, are recruited in social media to regularly respond to an online questionnaire on personal health, foetus development, and the newborn child health.

A reference group of pregnant women being regularly physical active (still not lifting free weights of high loads) are concurrently recruited.

All will respond to questionnaire at mid-term, and week 23, 30 and 40 of pregnancy. During maternity leave the women will be asked to respond to questionnaires at 1 month, 3 months, 6 months and 12 months post-delivery.

Eligibility Criteria:
Inclusion Criteria:

* Being pregnant
* Group of interest: Being experienced with heavy, free-weight resistance exercise training, and aiming to continue exercise at comparable level during pregnancy
* Reference group: being regularly physical active before pregnancy (i.e. at least 2 work- outs per week), but not experienced in heavy, free-weight resistance exercise training

Exclusion Criteria:

* Any known metabolic condition or contraindication on doing physical activity during pregnancy (i.e. miscarriages, bleedings).
Radiological Study of PENG Block Depth

This study evaluates the depth of anatomical landmarks required in regional anaesthesia to perform either Femoral Nerve Block or PENG Block.

Measures will be performed on abdominal and pelvic computed tomography as part of daily routine patient care.

PENG Block is a new approach in regional anesthesia for hip surgery. The anatomical landmarks used to perform PENG Block are deeper than those for Femoral Nerve Block. Nevertheless, depth required for PENG Block is not yet evaluated since it may vary between patients.

Daily routine abdominal and pelvic computed tomography allow such anatomical description.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients who have had a CT scan including visualization of the pelvis and who have expressed no opposition

Exclusion Criteria:

* pregnancy
* Subject presenting a pathology likely to modify the anatomical landmarks studied: ie pelvic fracture, psoas haematoma, previous pelvic surgery or hip prosthesis or femoral bypass
Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)

The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and receive medical care, as agreed with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Norditropin® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* For non-naïve patients; patients who were previously enrolled in study: GHLIQUID-4020.
* For naïve patients; short stature due to Noonan syndrome diagnosed by the physician and a decision to initiate treatment with Norditropin® has been made by the patient/parent and the physician. At study sites, all patients will be registered consecutively from the first patient after approval date (consecutively registered system).
* Male or female, 3 years old or over, bone age: less than 17 years old for male / less than 15 years old for female.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Known or suspected allergy to study products or related products.
* In case of naïve patients, patients who have received growth hormone (GH) products for treatment of indication other than short stature due to Noonan syndrome before approval date of Noonan indication.
Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease

OBJECTIVES: I. Evaluate the effect of a new von Willebrand factor concentrate on bleeding time, in vivo recovery, and circulating half-life of the infused factor in patients with von Willebrand's disease.

II. Assess the safety of von Willebrand factor in these patients.

PROTOCOL OUTLINE: Patients receive 1 dose of von Willebrand factor concentrate. Timed blood studies are performed for the next 96 hours.

Patients are followed every 2 weeks for 16 weeks, and at 24, 36, and 52 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* von Willebrand's disease
Instillation of Gentamicin and Dexamethasone in Bronchiectasis Compared to Conventional Treatment

Safety and efficacy of local instillation of Gentamicin and dexamethasone in acute exacerbation of bronchiectasis in mechanically ventilated patients

bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea.

Clinically, the major manifestations of bronchiectasis are chronic cough with purulent sputum, dyspnea, and fatigue that may diminish the patients' quality of life. The frequency of exacerbation and the decline in lung function may lead to poor prognosis and decrease quality of life.

The purpose of bronchiectasis management is to reduce exacerbation, prevent complications, and improve the quality of life. Long-term instillation of gentamicin can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids which can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.

Eligibility Criteria:
Inclusion Criteria:

* patients with bronchiectasis confirmed by high resolution CT chest(HRCT)
* patients with acute exacerbation of bronchiectasis who need antibiotic treatment at hospital due to exacerbation
* mechanically ventillated patients at respiratory ICU
* Age more than or equal 18 years

Exclusion Criteria:

* patients with active pulmonary tuberculosis
* patients with allergic bronchopulmonary aspergillosis
* patients who underwent interventional bronchoscopy for hemoptysis
* age less than 18 years
Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study

This is a randomized sham controlled study that will include patients hospitalized in the internal medicine department and the orthopedics department at Bnei Zion Hospital presenting with pain from various sources with an NRS level equal to or above 4.

All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or BFA) one hour before and every 24 hours until discharge.

If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated assessments as above.

Eligibility Criteria:
Inclusion Criteria:

-1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment.

3.Eligible to participate in the study according to the assessment of the investigator

Exclusion Criteria:

1. Pain syndromes of non-muscular bony/rheumatological/orthopedic origin
2. Planned an MRI next week
3. An infectious process in the ear planned for acupuncture or a history of sensitivity to metal
4. have any participant condition that ' according to the Investigator ' could interfere with the conduct of the trial -
Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery

Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.


Eligibility Criteria:
Inclusion Criteria:

* Age Range between 18 to 80 years old
* Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

Exclusion Criteria:

* Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).
Telotristat Etiprate for Carcinoid Syndrome Therapy

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
* Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
* Documented history of carcinoid syndrome
* Patient is able and willing to provide written informed consent prior to participation

Exclusion Criteria:

* Presence of diarrhea attributed to any condition other than carcinoid syndrome.
* Presence of 12 or more watery bowel movements per day
* Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
* Karnofsky Performance Status ≤ 60%
* Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
* A history of short bowel syndrome
* History of constipation within 2 years of Screening
* Life expectancy \< 12 months from Screening