cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Thrombosis in Immune Thrombocytopenia

Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105 inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said "primary" when not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic infectious disease...). First-line treatment is based on corticosteroids. Intravenous immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP becomes persistent or chronic (lasting \>3 months and \>12 months, respectively). Second-line treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs), romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment.

Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the general population, due to the release of young hyperactive platelets from bone marrow. The incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100 patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy that is used in very few patients now. The role of other ITP treatments in thrombosis occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even in case of low or normal platelet count. However, this risk has not been measured in the real-life practice, adjusted for other risk factors for thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Incident primary ITP adults

Exclusion Criteria:

* Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the algorithm
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2

This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol)
* Patients willing and able to give signed consent on matching patient data with sick fund data
* Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control
* Patient is a member of the involved sick fund (AOK Plus)

Exclusion Criteria:

* Known or suspected contra-indication to the relevant study product according to current SPC
* Previous participation in this study
* History of type 1 diabetes mellitus
* Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
* Previous treatment with liraglutide
* History of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
* Progressive fatal disease
* Any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
* Patients without legal capacity
Breastfeeding Peer Counseling Intervention for Latine Families

The goal of this clinical trial is to learn how to improve exclusive breastfeeding rates in the Latine community. Breastfeeding initiation is high in this community, but many people ultimately do not breastfeed for as long as they would like to. The main questions it aims to answer are:

Do Latine mothers benefit from peer counseling support from peer counselors who can speak Spanish and share their cultural background? Are mothers more likely to continue exclusive breastfeeding if additional funds are given so that the WIC exclusive breastfeeding package has the same cash value as the WIC formula feeding package?

Researchers will compare participants in the intervention group (who receive peer counseling and additional funds) to a control group (who do not receive peer counseling or additional funds) to see if the intervention package improves breastfeeding rates.

All participants (intervention and control) will complete weekly surveys about their feeding experiences ($8 per week). Members of the research team will also take infant weight/length measurements at home (twice during the first month and then at 2, 4, and 6 months). Participants will be recruited during pregnancy and the study will last for the first 6 months after their babies are born.

Participants in the intervention condition will also be matched with Spanish-speaking Latine peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study) and receive $150 for every month they select the WIC exclusive breastfeeding package. Mothers can choose to receive an electric breast pump instead of one $150 payment.


Eligibility Criteria:
Inclusion Criteria Set 1 (determined at prenatal recruitment):

1. Confirmation of Latine origin
2. Receives or eligible for WIC
3. 18 years or older
4. Singleton pregnancy
5. intend to breastfeed.

Inclusion Criteria Set 2 (determined after infants are born):

1. Infant gestational age 37 weeks or more
2. Normal infant birth weight (i.e., \> 5 lbs 8 oz.)
3. Breastfeeding has been initiated
4. No congenital or other health issues (such as cleft palate) identified that require specific accommodations for feeding.

Exclusion Criteria:

1. Mothers below 18 years of age.
2. Mothers do not plan to breastfeed.
3. Mothers not eligible to participate in the WIC program due to high household income
4. Non-singleton pregnancy.
Reaction Time in Digital Game Players

With the increasing use of computers in recent years, the effects of games have started to be discussed. Young people who play computers are exposed to many stimuli during the game and they react to these stimuli with reactions at various rates. In our study, we wanted to find out whether there is a significant difference in reaction time between young people who play computers more than 14 hours a week and those who do not.

While doing our research, the reaction time test in the Human Benchmark application, where the reaction time to many different stimuli on the computer can be evaluated, the Aim Trainer test and the auditory reaction time tests at https://playback.fm/audio-reaction-time will be applied. The way the tests are applied; the first test will be separated as a trial and will not be included in the average. The next three tests will be averaged. Height, weight, smoking, use of antidepressants or stimulants, any ear or hearing problems, any eye disease, how many days a week and how much sports they do, the dominant side, whether they play digital and video games, for how long, what type of device (computer, tablet, phone), which games (League of legends, Player unknown's battlegrounds, World of Warcraft, Valorant, FIFA, PES, Call of duty, NBA, Counter strike:Global offensive CS:GO, other), how many hours a day and how many hours a week they play digital video games will be questioned whether they participate in the tournament with at least one of these games.

Eligibility Criteria:
Inclusion Criteria:

* male
* playing digital games for more than 2 years

Exclusion Criteria:

* female
* not having played any digital games for 2 years
PRIMA PFO Migraine Trial

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are age 18 to 65
* Subjects who have migraine headaches with aura diagnosed by a doctor
* Subjects who have not responded to or cannot take common migraine preventive medications

Exclusion Criteria:

* Subjects with a clinical history of stroke
* Subjects who cannot take aspirin and clopidogrel (Plavix)
* Subjects who are pregnant or desire to become pregnant within the next year
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a history of otitis media requiring bilateral tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
* Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
* Subject has a history of sensorineural hearing loss
Psychosocial Support to Facilitate the Return to Employment of Women With Breast Cancer

The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work

For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).

In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 with work at the time of diagnosis
* Presenting a unilateral breast cancer exclusively local extension
* Having received surgery
* Reporting of adjuvant chemotherapy (+ / - trastuzumab)
* Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
* In work at the time of diagnosis (employees, traders and professionals)
* Patient affiliated to a social security scheme
* Consent signed by the patient before the implementation of any specific procedure to study

Exclusion Criteria:

* Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
* Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
* Recognition previous ALD (due to another disease)
* Patient under guardianship
Brief Behavioral Treatment for Sleep Problems in IBS Study

Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-50
* Meet diagnostic criteria for IBS
* Stable medication for IBS for at least 1 month
* Stable medication for sleep for at least 1 month
* ISI cutoff score of 10 or higher
* Completes at least 5 out of 7 days of daily symptom and sleep diary during 1 week baseline

Exclusion Criteria:

* Medical history of significant head injury or other neurological disorder
* Pregnancy (self-reported)
* Post-menopause
* Major concomitant medical conditions
* Major psychiatric diagnosis with comorbid sleep problems
* Taking medications that might interfere with sleep
* Confirmed or suspected other untreated sleep disorder
* Active illicit drug use
Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon

This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.

This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.

Every method is long established and can be treated as clinical equal. So the surgical treatment is chosen randomly for each patient.

For this cause the microcirculation is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are nine measurements on this study: one before and one shortly after the surgery, followed by three measuring appointment every 6 hours (6,12,18,24 h post-op).Afterwards there are appointments planed after 12 days and 6 month. On the last appointment the patients are questioned according to established scores like AOFAS or VAS to register the functional outcome and level of pain.

Clinical parameters like time between rupture and surgical treatment, hospitalisation time, and form of anaesthesia are included to create comparable patient profiles. After 6 moths the last measurement appointment is stated, in which the clinical outcome is registered by Scores, e.g Mann-Whitney-Wilcoxon-Test.

This study is to detect any difference in wound heeling, re-rupture rate and functionality between these three methods.

Eligibility Criteria:
Inclusion Criteria:

* Acute rupture of the achilles tendon (on one or both sides)
* Older than 18 year of age
* Firmed letter of approval
* Patient speaks/understands German
* Planed surgical treatment
* No more than 48h after rupture

Exclusion Criteria:

* No-traumatic rupture of the achilles tendon
* More than 48h after rupture
* No planed surgical treatment
* History of surgery on the injured leg
* Condition of diabetes mellitus
* Condition of peripheral artery occlusive disease
Progesterone vs Placebo Therapy for Women With Epilepsy

The purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.

This is a 6-month study. The first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. The second 3 months will assess the effects of treatment on these parameters.

Eligibility Criteria:
INCLUSION:

1. Subject must be between the ages of 13 and 45.
2. Subject must have a history of seizures (documented by EEG).
3. Subject must have had at least 2 seizures or auras per month during the past 3 months.
4. Subject must be on stable antiepileptic drug therapy for at least 2 months.
5. Subject must have cycle intervals between 21 and 35 days during 6 months prior to entry.

EXCLUSION:

1. Subject that is pregnant or lactating.
2. Subject that is on major tranquilizers, antidepressant medications, or reproductive hormones.
3. Subject that is unable to document seizures.
4. Subject that has progressive neurological or systemic disorder or \> 2-fold elevation in liver enzyme levels
Effect of mgso4 on Oxygenation and Lung Mechanics in Morbidly Obese Patients During Bariatric Surgery

The purpose of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery

Background and objectives: morbidly obese patients are characterized by a high prevalence of restrictive lung disease. Respiratory mechanics are significantly altered in obesity. These changes are exacerbated with general anesthesia .Obesity also results in reduced lung and chest wall compliance ,increased lung resistance ,reduced oxygenation.MgSo4 is promising in managing several respiratory disorders.it cause smooth muscle relaxation and reduce airflow obstruction.

The objective of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery.

the following will be recorded :intraoperative oxygenation,lung mechanics,MAP,HR,EtCO2,plateau and peak airway pressure,sedation score,serum mgso4 level,change in P/F ratio and dynamic lung compliance,respiratory rate postoperative

Eligibility Criteria:
Inclusion Criteria:

* Patients age between 21-60 years.
* BMI more than 40kg/m2
* Patients with restrictive lung disease(FVC\>70%)
* American society of Anesthesiologists(ASA) physical status II
* No previous abdominal surgery
* Scheduled for laparoscopic bariatric surgery not exceeding 3 hours.

Exclusion Criteria:

* Patient refusal to participate in the study
* ASA physical status more than II
* patients with heart failure
* Kidney disease
* Patients on antiarrhythmic drugs
* Patients taking beta or calcium channel blockers
* Allergy to study drugs
* Patients with combined restrictive-obstructive lung disease
Validation of an Activities-of-daily-living Framework at Different Light Conditions

Primary objective of this study is the construction and validation of an experimental environment for the simulation of a variety of near- and intermediate-vision activities of daily living (ADLs) in different combinations of light temperature and light intensity.

Among the objectives of the study is to validate a framework of ADLs that require near and intermediate vision and better reflect visual capacity, in a special experimental environment of 9 different combinations of light temperature and light intensity.

The final list consists of the following ten basic ADL tasks:

1. Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).

The 9 light combinations are the following:

3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc

Eligibility Criteria:
Inclusion Criteria:

* normophakic participants with a clear natural lens
* age between 40 to 75 years old
* UNVA: logMAR 0.1, 0.4, or 0.7

Exclusion Criteria:

* astigmatism \>1.00 diopters
* glaucoma
* intraocular pressure lowering medications
* former incisional eye surgery
* corneal or fundus disease
* diabetes mellitus
* autoimmune diseases
* neurological, psychiatric or mental diseases
Pericarditis: Auto-Inflammation in Recurrent Disease

Pericarditis is swelling of the sac that surrounds the heart, the pericardium, causing chest pain. For most patients, the condition improves with simple anti-inflammatory medications like colchicine and ibuprofen. However, in 20-30% of patients the condition comes back. Diagnosis of recurrent pericarditis is frequently missed or delayed, and many patients require prolonged courses of corticosteroids to control their disease. Together these factors damage the quality of life of patients with recurrent pericarditis. Currently there is limited understanding of why pericarditis comes back in some patients, and how best to treat it when it does.

PAIReD (Pericarditis: Auto-Inflammation in Recurrent Disease) is an observational research study funded by the British Heart Foundation that will investigate the role inflammation plays in recurrent pericarditis. Patients with recurrent pericarditis and other auto-inflammatory diseases will be recruited from the specialist fever clinic at the Royal Free Hospital, where they will be asked to donate blood up to six times over a three year period. Healthy participants will be recruited at the Royal Free Hospital or Guy's Hospital. Relatives of participants with recurrent pericarditis will be recruited at the Royal Free Hospital. They latter two groups will attend one appointment where blood or saliva samples will be taken. A subset of participants will also provide fingerstick blood samples and questionnaires from home, for up to one year.

Clinical data will be collected prospectively and by retrospective case note review. Blood from participants will be analysed to look at how the immune cells of patients with recurrent pericarditis function during the course of their disease, and to look for genetic changes in patients with recurrent pericarditis that might contribute to their condition. Together this knowledge has to potential to help clinicians diagnose and monitor patients with recurrent pericarditis more accurately, and researchers to design more effective treatments.


Eligibility Criteria:
Inclusion Criteria:

Recurrent pericarditis (RP) cases:

1. Patients with RP, diagnosed by a clinician, meeting the European Society of Cardiology (ESC) diagnostic criteria.
2. Where the aetiology of the RP is defined as idiopathic (i.e. there is no other aetiology identified, such as infective, malignant, post cardiac injury, as part of an autoimmune condition, as part of another known auto-inflammatory disease).

Relatives of RP cases:

First degree relatives of participants meeting the criteria for, and included in the study as, RP cases.

Disease Controls:

Patients with a systemic auto-inflammatory disease, diagnosed by a trained specialist.

Healthy Controls:

Sex, ethnicity and aged matched healthy individuals who do not have a personal history of pericarditis or systemic auto-inflammatory disease.

Exclusion Criteria:

1. Individuals under 12 years of age
2. Adults who are unable to give written informed consent
3. Individuals who have received a blood transfusion within 4 weeks
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib

In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
* Patients must have signed an informed consent form
* Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

* Exclusion criteria must follow the approved local product information