cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome

The article presents the results of a randomized, placebo-controlled study of the conservative treatment with Daflon (Detralex) in female patients with Pelvic congestion syndrome .


Eligibility Criteria:
Inclusion Criteria:

•The presence of pelvic varicose veins verified by transvaginal and transabdominal duplex ultrasound scanning

Exclusion Criteria:

* Severe disease of the gastrointestinal tract or hematopoietic system
* Terminal stage of cardiovascular, respiratory, renal or hepatic failure
* Grade IV malignancy
* Peripheral artery disease (PAD) of the lower extremities, any type of diabetes, or mental disease.
* Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

* Part A: Comparison between SB4 and EU sourced Enbrel
* Part B: Comparison between SB4 and US sourced Enbrel
* Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

* history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
* active or latent Tuberculosis or who have a history of TB.
* history of invasive systemic fungal infections or other opportunistic infections
* systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
* serious infection associated with hospitalisation and/or which required intravenous antibiotics
* history of and/or current cardiac disease
* have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
* Intake medication with a half-life \> 24 h within 1 month or 10 half-lives of the medication prior to the first administration of IP.
Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation

Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study.

The 6-min walk test (6MWT) is the most used field test for measuring functional impairment in cardiopulmonary patients. However, to be able to objectively interpret 6MWT of a patient with specific chronic condition, the distance walked in 6MWT should be compared to either a healthy control group or a cut-off value that was specifically determined for that population. Such cut-off values are present for 6MWT in several cardiopulmonary diseases including COPD (350 m), heart failure (200 m) and pulmonary hypertension (400 m) for identifying patients with high mortality, poor prognosis and/or poor health status, but there is no cut-off value determined for atrial fibrillation (AF). The European Heart Rhythm Association (EHRA) score is a practical measure for assessing symptom burden and functional impairment caused by AF-related symptoms. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment. Primary aim of this study is to determine a cut-off value in 6MWT for discriminating between the asymptomatic and symptomatic AF patients according to EHRA classification. In addition, a cut-off value for 30-second sit-to-stand test will be determined in these patients as well, since sit-to-stand tests have gained a lot of interest in the recent literature for practically evaluating functional status in various cardiopulmonary conditions.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of paroxysmal, persistant or permanent atrial fibrillation

Exclusion Criteria:

* Diagnosis of heart failure or any chronic respiratory disease
* Recent coronary bypass surgery
* Previous heart valve surgery
* Rheumatic valvular heart disease
* Recent acute myocardial infarction
* Having a pacemaker
Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer

Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.

Inhibition of uterine contractions in order to increase implantation rates have been studied on several agents in the last two decades. Beta-adrenergic agonists and non-steroidal anti-inflammatory drugs have been shown to have no benefit on implantation rates. Vasopressin V1a and oxytocin receptor antagonist atosiban was first studied on premature labor patients and found to be effective.

Endometrium-originated oxytocin can possibly stimulate myometrium and have a negative impact on embryo implantation. Inhibition of oxytocin receptors has been shown to reduce uterine contraction frequency in non-pregnant women. Atosiban has been studied on assisted reproductive technologies in the last decade and has been shown to be effective on increasing implantation and clinical pregnancy rates. However, previous studies have used a 37,5 mg total dose of atosiban which was used both before and during embryo transfer. We aim to use a single and low dose of 6,75mg atosiban only before embryo transfer, which is simpler and cheaper and the medication given to patient is significantly lower. If we can demostrate the positive effect of our protocol, it can be suggested to be used routinely in all in vitro fertilization cycles. Additionally, our study is an original study in terms of being the first randomized clinical trial studying the effect of atosiban on frozen-thawed embryo transfer cycles.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women applied to assisted reproduction clinic
* Follicle stimulating hormone \< 12
* Body mass index \< 25
* Patients whom antagonist protocol will be used
* Patients whom at least 2 good-quality embryos obtained
* Patients who are volunteer

Exclusion Criteria:

* Severe male factor (Sperm concentration \<5 M/ml, progressive sperm motility \<%10)
* Uterine anomaly
* Hydrosalphynx
* Difficult embryo transfer
* Patients who previously had a diagnosis of endometriosis and / or adenomyosis
* Endocrine problems (hypothyroidism, hyperthyroidism, hyperprolactinemia, premature ovarian insufficiency)
* Having more than 3 in vitro fertilization failure
* Refusing to participate
Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan

Parkinson's disease (PD) is a common disease. Dementia will affect 80% of these patients during their evolution. In addition, treatments of motor signs have a potential impact on these disorders and conversely.

The purpose of this study is to show focal abnormalities in brain metabolism in the precuneus and posterior cingulate region are predictive of the onset of dementia within 2 years.

Cognitive impairment and dementia have become major factors of disability induced by Parkinson's disease. The prediction of dementia in any given patient may be useful for prognosis but also for discussion of setting up heavy therapeutic techniques, especially surgical. Currently, known predictors are disease severity, age and existence of pre-cognitive disorders; other assumptions are discussed. Among these, morphological imaging techniques (MRI) and functional techniques (MRI, PET) are proposed.

Use increasingly early of heavy, expensive and potentially ineffective surgical treatment in dementia makes it necessary to find independent, early and reliable markers of the onset of dementia in Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria

* Male or female with Parkinson's Disease
* 45 \< Age ≥ 75 years
* Parkinson's disease with clinical diagnosis made for at least 5 years (60 months)
* Patient able to perform cognitive tests in French during 1 hour 30 minutes
* Patient having provided a signed consent to participate in this trial
* Be either affiliated to, or a beneficiary of, a social security category
* Existence of caregiver at least contactable by phone

Exclusion Criteria

* Parkinson's disease diagnosed before 40 years old
* Clinical evidence for dementia or dementia criteria according to level 1 MDS-Task Force (Dubois et al. 2007)
* Atypical form of parkinsonism
* Other disease affecting the central nervous system
* Poorly controlled diabetes with glucose \> 2.0 g/l or HbA1c\>7,5% based on results of less than 3 months
* Taking a cholinesterase inhibitor treatment, memantine or long-term benzodiazepines other than referred hypnotic, neuroleptic
* History of surgery for Parkinson's disease or planned surgery within 6 months. Surgery is possible beyond
* Cons-indication to 3T MRI
* Inability to lie down for 60 minutes
* Legal protection
* Patient living outside the Ile-de France region

Secondary exclusion criteria

* Pregnant, breastfeeding or non-menopausal woman not taking contraception in the first 2 months of the study
* Existence of a significant brain injury on MRI
* Neuropsychological assessment at baseline showing dementia
* Fasting glucose \> 1.6 g/l the day of FDG-PET
Zilver Flex Post-Market Study in Japan

Japanese post market clinical study of the Zilver Flex device.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Exclusion Criteria:

-
Italian Angelman Syndrome Registry Protocol

The Italian Angelman Registry is a national registry for patients with Angelman Syndrome. No experimental intervention is involved in participation. The data provided are stored in the registry according the EU General Data Protection Regulation (GDPR, enforced on 25 May 2018), unless participants wish to withdraw their child/ adult's information from the registry.

Parents/caregivers of a child or an adult with Angelman Syndrome living in Italy are eligible to insert data in this registry. The individuals must have a diagnosis of Angelman Syndrome confirmed by genetic testing results. The registry has been launched in February 2018 in coincidence with the International Angelman Day and the recruitment will be open until February 2021.

Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of Angelman syndrome

Exclusion Criteria:

* Does not meet diagnostic criteria for Angelman Syndrome Other medical or genetic disorders (except autism)
Cesarean Scar Pregnancy and Clinical Outcomes

This study is a prospective cohort study, led by Prof. Zhao Yangyu, from the Department of Gynecology \& Obstetrics, Peking University Third Hospital.

Cesarean section, myomectomy and other surgeries for uterus are likely to cause scars in different parts of the uterus. During the subsequent pregnancy, the incidence rate of cesarean scar pregnancy, placenta previa, placenta increta and the risk of termination of the first and mid-trimester pregnancy is likely to increase. Cesarean scar pregnancy is regarded as a risk factor of uterine rupture in the third trimester of pregnancy or delivery period, which severely affects the maternal and perinatal health and safety. This study is planning to prospectively include pregnant women aged 20-49 years from Peking University Third Hospital. All women with diagnosis on cesarean scar pregnancy was included prior to 14 wks of gestation. We divided the women into three different groups: type I, type II and type III according to characteristics in gestation sac,uterine scar, bladder, the latter with potentially worse outcomes in term of maternal morbidity and mortality. Data including demographics, medical history, reproductive history, prenatal health care, gestational complications, and pregnancy and birth outcomes will be collected via electronic data capture system.

Eligibility Criteria:
Inclusion Criteria:

* Female aged ≥ 20 years
* Female with cesarean scar pregnancy
* Less than 14 gestational weeks
* Planning to receive prenatal healthcare and delivery service at the study hospital

Exclusion Criteria:

* Inability to provide informed consent
* Women with mental disorders
Facilitated Referral for Children Screening Positive for Mental Illness

The purpose of this study is to find out how prevalent unidentified Mental Health issues are in the pediatric population that visits the Emergency Department in an urban city.

The purpose of this research study is to find out how many children in the Emergency Room have emotional issues and how many of them go unnoticed. In particular the study looks at how well a questionnaire for children and teenagers, the DISC Predictive Scales, Version IV (DPS-IV) works and what is the best way to ask the questions. In addition, for children aged 9-17 this study will look at families' readiness to seek care when a problem is indicated.

Eligibility Criteria:
Inclusion Criteria:

* Child Must be With Biological Mother
* Child Presenting to Emergency Department with an Urgent But Stable condition
* Child must be between the ages of 6 years and 18 years
* Child must have no prior history of Behavioral Health concerns or diagnoses

Exclusion Criteria:

* Child has prior Behavioral Health history, diagnosis, or concerns
* Child not between ages of 6 years and 18 years of ages
* Child presenting without Biological Mother present
* Child acuity level outside of Urgent But Stable for presenting complaints
Objective Sleep Behavior in Relation to a Nigth Competition in Athletes.

Sleep is a crucial factor for athletes' health and recovery. Many variables are able to negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high volume or high-intensity training period, and a nigth competition too. Therefore, the aim of this pilot study is to evalute how sleep quality changes in relation to a late nigth competition in athletes.


Eligibility Criteria:
Inclusion Criteria:

* both genders
* age between 18 and 45
* sport activity for \> or = to 8 hours/week.
* signed informed consent

Exclusion Criteria:

* smoking
* part-time or shift worker.
* Use of medications able to influence sleep
* any medical conditions (injury) contraindicating physical exercise as diagnosed by a sports medicine physician
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018
* Age of the participant at the time of migraine onset \< 50 years
* Confirmation of headache/migraine headache day frequency as follows:

  * History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
  * \>=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
  * \>=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
* Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion Criteria:

* Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* History of an inadequate response to \> 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
* Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.
Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis

The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate \< 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Eligibility Criteria:
Inclusion Criteria:

* patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (EUS)
* patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

* patient who participates in an other study
* patient mentally or legally incapacitated
* patient with contraindications to the achievement of upper gastrointestinal endoscopy
* patient with haemorrhagic disease, disorder of hemostasis and coagulation (TP\<60%, TCA\>40sec and platelets \<60000/mm3)
* patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure
* patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
* patient pregnant or lactating women
Correlation of the Paediatric Tracheal Tube Size

In the context of the study a retrospective data collection of all anaesthesia protocols of children under the age of 12 which underwent surgery in the Charité - University Medicine Berlin, Campus Virchow - Klinikum in the years 2011 and 2012 shall be executed. The correlation of the tracheal tube sizes with the weight, age and height shall be evaluated. This data collection should serve to reevaluate the already published formulas e.g. (Rettberg M. et al., 2011).


Eligibility Criteria:
Inclusion Criteria:

* Children under the age of 12 who underwent surgery in the Charité - University Medicine Berlin, Charité Campus Virchow - Klinikum in the years 2011/12

Exclusion Criteria:

* No endotracheal tube inserted
Antibiotic Prophylaxis for TEVAR

The infection rate of thoracic endovascular aortic repair (TEVAR) is unknown due to a lack of epidemiological data. The rate currently available comes from researches conducted decades ago, when open surgery was the standard of care. Because of the potentially fatal consequences of a stent graft infection in the thoracic aorta, the investigators tend to prescribe antibiotic prophylaxis for at least three days. In this study, the investigators are going to collect data on patients receiving TEVAR in the past five years and provide the following information: a. the infection rate (MAGIC classification), b. the rate of fever, c. the results of the lab tests, such as the WBC count and C-reaction protein. d. risk factors associated with infection and fever.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with thoracic aortic diseases
2. Received TEVAR

Exclusion Criteria:

1. Suspected infectious aortic disease, such as a mycotic aneurysm.
2. TEVAR combined with open surgery
3. Antibiotics have been used more than 24 hours before the operation
4. Combined with immune deficiency disease or using hormone or immunosuppressant；
5. The treatment is for the complications of TEVAR, such as endoleak
6. Endovascular aortic repair for abdominal aortic disease
7. History of open aortic surgery or heart surgery.
8. Revascularization of visceral arteries during the TEVAR
Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery

The purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability.

The current recommended method for monitoring glucose control is bedside point of care capillary blood glucose testing. A significant limitation for this method is the frequency by which blood glucose testing is typically performed, at most 4-6 times daily. Continuous glucose monitoring (CGM) provides an alternative approach to measure glucose values with the advantage of greater frequency of monitoring as it is measured every few minutes.

Whilst CGM use in the outpatient setting is rising and has demonstrated benefits on glycaemic control, the accuracy of these devices perioperatively is less investigated. In this study the sixth-generation factory-calibrated real-time Dexcom G6® system will be used as a CGM and its glucose values perioperatively will be compared to the capillary glucose values which will be measured simultaneously by the Accu-Check Inform II (Roche Diagnostics) point-of-care blood glucose meter.

The Investigators aim to assess the feasibility and accuracy of perioperative CGM.

Eligibility Criteria:
Inclusion criteria:

* Aged ≥18 years
* Pre-diabetic (HbA1c 5.7-6.5%) or diabetic (regardless of aetiology)
* Scheduled to have elective abdominal surgery at the University Hospital Bern
* Surgery duration \>2 hours

Exclusion criteria:

* Planned MRI procedure during hospitalization
* Inability to follow procedures
* Incapacity to give informed consent
* Presence of extensive skin abnormalities at the sensor insertion site (upper arm)
* Known allergic/irritative skin reactions to dressings/adhesives
* Haematocrit values outside the normal range
* Patients with immunosuppression defined as neutrophil count \<0.5x10\^9/L
* Patients on isolation precautions (contact, droplet, airborne)
* Pregnancy or breast-feeding