cyrilzakka/clinical-trials huggingface dataset:
Parental Project and Premature Ovarian Insufficiency

One of the main repercussions of POI is infertility. When the diagnosis of POI is announced, the question of fertility is addressed and the patient is often directed towards egg donation or adoption when she has a parental project. However, there are cases of spontaneous pregnancies after diagnosis.

This study was conducted to determine the proportion of patients with POI who were able to realize a parental project after diagnosis in the long term and by what means.

The investigators propose to study patients with POI who were hospitalized in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière Hospital for the etiological assessment of ovarian failure and its consequences between December 31, 1982 and January 12, 2021. The investigators will only include patients who were admitted to the day hospital because we have a complete etiological workup and a complete history for them, which allows investigators to describe the population properly. The patients must be over 18 years old at the time of the survey in order to be able to evaluate the presence of a parental project only in adult patients.

Patients for whom there is no valid contact information in the computer file (postal address or valid email address or cell phone number) or whose last consultation was more than 2 years ago will be excluded. Patients with Turner syndrome will be excluded because they may have comorbidities, particularly cardiac, that contraindicate pregnancy. Patients with POI secondary to oncological treatments (gonadotoxic chemotherapy or pelvic radiotherapy) will also be excluded because of the uncertain prognosis and the contraindications to pregnancy in case of hormone-dependent tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old at the time of the survey
* Patients with a diagnosis of PIO according to the current definition: cycle disturbances of more than 4 months and FSH \> 25 on 2 measurements one month apart
* Patients having been hospitalized in day hospital (HDJ) in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière hospital for the etiological assessment of ovarian insufficiency and its repercussions between December 31, 1982 and January 12, 2021
* Valid contact information available: address, cell phone, e-mail
* Patients who have been informed and do not object to participate in the study

Exclusion Criteria:

* Turner syndrome
* POI secondary to oncology treatments (chemotherapy, pelvic radiotherapy)
* Opposition to participating in the study
Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.

This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.

Patients fulfilling inclusion and exclusion criteria will be divided into two groups.

Group (A):

181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.

Group (B):

181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.

Data recording:

1. Duration of complete abortion.
2. Post abortion bleeding.
3. Incomplete delivery of the placenta necessitates evacuation under anesthesia.
4. Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
5. Recording maternal morbidities.
6. Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age between 12 weeks and 24 weeks.
* Hemoglobin \>10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Miscarriage .
* Living fetus with multiple congenital malformations incompatible with life.
* PPROMs with drained liquor and parents are consenting for termination of pregnancy.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age less than 12 weeks or more than 24 weeks.
* Hemoglobin \<10 g/dL.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
* Polyhydraminos.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25kg/m2 and more than 35kg/m2.
* Coagulopathy.
* History or evidence of adrenal pathology.
* Previous attempts for induction of abortion in the current pregnancy.
Berlin Atrial Fibrillation Registry

Investigator-initiated prospective multicentre hospital-based registry to uncover the proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and assessing the proportion of stroke, intracranial bleeding and all-cause death in the short (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic stroke or transient ischemic attack in an unselected urban population in Germany. In addition, annual follow-up is planned yearly up to 5 years after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke or transient ischemic attack (with clinical deficit on admission or corresponding brain MRI lesion)
* Age ≥ 18 years
* Known atrial fibrillation or ECG recording documenting atrial fibrillation during the in-hospital stay for acute ischemic stroke or transient ischemic attack
* Written or oral informed consent
* Willingness to take part in the planned follow up examinations

Exclusion Criteria:

* Life expectancy \< 1 year (before stroke)
* Assumed post-stroke life expectancy \< 1 month according to stroke severity
* Chronic anticoagulation for reasons other than atrial fibrillation
Tracheobronchial Secretion Removal

Patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. TBA Care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. In a prospective randomized trial in intubated and mechanically ventilated patients of a general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence of retained secretions compared to the standard indicators.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* presence of an endotracheal tube to provide mechanical ventilation
* expected duration of mechanical ventilation greater than 48 hours.

Exclusion Criteria:

* age \< 18 years, pregnancy
* presence of active bronchial bleeding
Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia

Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE).

Methods: LE is a musculoskeletal pain around the lateral epicondyle that may also present with decreased grip strength and/or neuromuscular disorders. An evidence-based treatment plan of dry needling, stretching and eccentric exercise in the patient with lateral epicondylalgia is established. It is carried out in two sessions, one session every 10 days and lasts about 45 minutes. There are three intervention arms: dry needling, atopic gel and NSAIDs, 30 patients in each group (n=90).

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with lateral epicondylalgia

Exclusion Criteria:

* diagnosed with compressive nerve syndromes with irradiation to the upper limb
Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria

1. Locally advanced or metastatic breast cancer
2. Bi-dimensionally measurable disease

Exclusion Criteria

1. Prior hormonal therapy
Effect of Physical Activity an Stress in Children

The objective of the study is to evaluate the impact of physical activity in obese and nonobese prepubertal children on:

1. biological stress responses during a psychosocial stress test
2. snacking and feeling of hunger in response to the same psychosocial stress test
3. the moderating factor of attachment on the biological stress responses and on snacking

Children will be investigated on one study day during 3.5 hours.

Hypotheses In this study, 3 primary hypotheses will be tested.

1. Moderate physical activity during 25 min in children decreases the cortisol levels in response to the Trier Social Stress Test TSST-C (for children).
2. Moderate physical activity during 25 min in children decreases the snacking (calorie consumption when corrected for expenditure and switch in quality of food intake) in response to the Trier Social Stress Test TSST-C (for children).
3. A secure attachment will be a moderating factor for the general increase in cortisol and the snacking in response to the psychosocial stress test (Trier Social Stress Test TSST-C).

Secondary objectives:

1. To test if the impact of physical activity on stress responses and snacking differs between obese and non-obese children
2. To test the impact of physical activity on the cardiovascular stress reactivity (blood pressure, heart rate) and the perceived stress (scale) in response to the Trier Social Stress Test TSST-C?
3. To test if the stress reactivity and its modulation by physical activity is different in anxious and in impulsives/labile children
4. To test if serious life events and parental worries and parental educational style influence the stress reactivity

Eligibility Criteria:
Inclusion Criteria:

* 7-10 year old children

Exclusion Criteria:

* Severe illness
* Medications interfering with study
Early Detection of Pancreatic Cystic Neoplasms

This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. The aim of this study is to use a combination of clinical, imaging, cyst fluid analysis, and molecular markers to try to help develop better tools to answer these questions.

Incidental pancreatic cysts are increasingly recognized due to the widespread use of cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with malignant potential, although the exact risk of malignant progression of these cysts is unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have features suspicious for malignancy.

However, current diagnostic tests cannot always reliably distinguish harmless from potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each cyst type has unique genetic features that could be used as diagnostic biomarkers. In this study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be collected after the cyst has been removed. In addition, a small amount of blood will be collected at the time of the EUS or surgical procedure.

AIMS: The general aim is to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients age 18 years and older with pancreatic cyst.

Exclusion Criteria:

* Individuals with ASA class 4 or greater.
* Inability to provide informed consent.
* Pregnancy or lactation.
Effectiveness Trial of the French Blues Indicated Depression Prevention Program

The purpose of this pilot study is to test the effectiveness of French adaptation of the Blues program, a school-based indicated depression prevention intervention. The program will be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to adolescents with sub-clinical depressive symptoms and compared to a no-intervention (Informational Brochure only) control condition, designed to represent the "usual intervention" in these schools.


Eligibility Criteria:
Inclusion Criteria:

* Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)

Exclusion Criteria:

* Current major depression diagnosis
* Current active suicidal behaviors
* Being in a special school curriculum for academic or behavioral problems
CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.

Crohn's disease (CD) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. Current therapy for active Crohn's disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management.

Tumor necrosis factor a (TNF-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD (van Deventer, 1997). Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD (Braegger et al, 1992). CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis. A monoclonal antibody to TNF, infliximab, is now approved for treatment of CD, but not all patients respond and many who do respond eventually become refractory to this treatment as well.

CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including TNF. Because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. In addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies.

The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohn's Disease in a placebo controlled setting.

Eligibility Criteria:
Inclusion Criteria

* Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive
* Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy
* Patients receiving medications for CD must be on stable doses entering the study
* Any CD medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening

Exclusion Criteria

* Patients with any ostomy or extensive bowel resection
* Current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery
* Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin
* Treatment with any other experimental therapeutics within the last 4 weeks before enrollment
High Flow Nasal Cannula Use in Infants With Bronchiolitis

Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation \<92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.

Eligibility Criteria:
Inclusion Criteria:

* Admission to pediatric ward due to a presumed viral bronchiolitis
* Need of oxygen therapy (oxygen saturation \< 92%)

Exclusion Criteria:

* Pertussis
* Needs intubation or CPAP on admission
* Severe congenital heart defect
* Down's syndrome
CCT-102 or Expectant Management in Delayed Pregnancy Loss

A Phase 3, multi-center clinical trial of a CCT-102 regimen or expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).

This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen for uterine evacuation in first trimester delayed pregnancy loss (DPL). Eligible study participants will have ultrasound documented DPL with estimated gestational age 10 weeks or less.

DPL is defined as arrest of embryonic or fetal development, in first trimester, where the cervix is closed and there is no or only slight bleeding. This includes: 1) anembryonic pregnancy, and 2) embryonic demise. Expectant management, which is an accepted treatment protocol recognized in 2018 ACOG Practice Bulletin on Early Pregnancy Loss (ACOG, 2018), consists of patient monitoring with no additional treatment.

Eligible participants will choose between the investigational product or expectant management on Day 1. They will be evaluated for the primary endpoint (resolution of DPL) on Study Day 7. All participants will be followed to Day 28.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 50
2. Ability to provide informed consent
3. Hemodynamically stable
4. Closed cervical os
5. If fetus exists, clinical observation indicates gestation is no more than 10 weeks
6. Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:

   1. Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
   2. Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.

Exclusion Criteria:

1. Unwillingness or inability to comply with the study protocol and visit schedule
2. Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.
3. Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
4. Hemoglobin \<10 g/dL
5. Coagulation disorder, inherited porphyrias, and/or current anticoagulants use
6. Chronic adrenal failure
7. Concurrent chronic corticosteroid therapy
8. History of trophoblastic disease
9. Current presence of an IUD
10. History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins
11. Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry
12. Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial