cyrilzakka/clinical-trials huggingface dataset:
IVF Treatment in Women With Immature Oocytes in Previous Cycle

In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given between 12-24 hours before the hCG triggering dose.One protocol used at the investigators unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.

Lately, new researches showed that dual triggering of final oocyte maturation with a combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders undergoing the GnRH-antagonist COH protocol

Another treatment option is high dose hCG. Only few case reports have described the use of high dose hCG after aspiration of non mature oocytes at a previous cycle. At the investigators IVF unit, patients with previous history of high percentage of immature oocytes retrieved, are triggered at the following cycle, either with double trigger or with high dose of hCG decided by the physician consulting the patient. It is still not known with which way of triggering more mature oocytes is retrieved.

The aim of this study is to perform a prospective randomized controlled study in patients with low proportion of mature-MII oocytes oocytes (\<75%) per number oocytes retrieved, despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles triggered with high dose hCG to those triggered with hCG+GnRH agonist.

Patients will be prospectively randomized into two groups. The randomization will be organized through the computer. The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration, and the Double trigger Group- will receive gonadotropin-releasing hormone (GnRH) agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration. All patients will be supplemented with the same progesterone preparation( Crinone gel 8% once a day) for luteal support. Women that suffer from vaginal spotting or vaginal bleeding during the luteal phase will receive supplementation of Geston 50MG intramuscular once every 2 days.

At the day of oocyte aspiration, blood will be drawn for serum LH, FSH, estrogen (E2) and progesterone. Moreover, clear follicular fluid will be collected and tested for LH, FSH, E2 and progesterone levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients with low proportion of mature-MII oocytes oocytes (75%) per number oocytes retrieved at the prior IVF cycle
* Age between 18-42

Exclusion Criteria:

* Women with high ovarian response:anti-mullerian hormone ( AMH) \>5, antral follicle count ( AFC) \>15
* more than 20 oocytes retrieved at the prior cycle.
Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests was the transesophageal echocardiogram before each procedure. The cerebral MRI was performed in the 24 hours post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.

Objective: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become progressively safer and more effective with advances in single-shot devices. The aim of this study was to compare catheter ablation (CA) of second-generation pulmonary vein ablation catheter (PVAC) Gold technique versus clinical treatment in elderly patients (≥ 65 years old) with symptomatic paroxysmal AF (PAF) without structural heart diseases.

Methods: Prospective randomized study that selected consecutive patients with paroxysmal atrial fibrillation older than 65 years-old in two groups: (1) PVAC ablation group and (2) antiarrhythmic drugs therapy group. Primary outcomes were AF recurrences, progression to persistent AF forms. As secondary outcomes, changes in Mini-Mental State Examination and AF Quality of Life Score were accessed.This study doesn't include payment of participants. All patients signed the informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Indication for isolation of pulmonary veins
* Age \>= 65 years old
* Association with the following characteristics:

  1. Symptomatic Atrial Fibrillation;
  2. Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
  3. Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.

Exclusion Criteria:

* Prior Atrial Fibrillation ablation;
* Atrial Fibrillation permanent and/or persistent;
* Left atrial size \> 55 mm;
* Mechanical prothetic mitral valve replacement;
* Presence of atrial thrombus;
* Cardiac invasive procedure \< 90 days;
* Cerebral embolism \< 6 months;
* Hypertrophic cardiomyopathy;
* Contraindications to antiocoagulation and cerebral MRI.
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.

* Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
* Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
* Validate the system and procedure safety mechanisms.
* Collect required data for validation of safety algorithms and procedure workflow optimisation.
* Validate the HEARO system.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from profound sensorineural deafness requiring a Cochlear implant

Exclusion Criteria:

* Age under 18 years
* Pregnant women
* Anatomical anomalies of temporal bone
* Chronic otitis media with or without cholesteatoma
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Subjects of any race, aged 12 to 35 years inclusive
* Subjects with mild or moderate facial acne vulgaris
* Subjects with skin phototype I to IV

Exclusion Criteria:

* Subjects with more than 1 nodules or cysts on the face,
* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for long-term follow-up (LTFU) study participants only

* Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]

Inclusion criteria for directly enrolled (DE) study participants in Japan only

* Study participant is ≥ 4 years to \< 16 years of age
* Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
* Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
* Study participant had at least 1 POS during the 4-week Screening Period

Exclusion Criteria:

Exclusion criteria for all study participants

* Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
* Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).

Exclusion criteria for long-term follow-up (LTFU) study participants only

- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)

Exclusion criteria for directly enrolled (DE) study participants in Japan only

* Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
* Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
* Study participant has any clinically significant illness
* Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
* Study participant has a clinically significant ECG abnormality
* Study participant had major surgery within 6 months prior to the ScrV
Mind-Body Health in Uro-Oncology: Research Study

In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.

Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer
* Spouses/significant others will only be included if their partners with cancer diagnoses will be participating
* 18 years old or older
* Proficient in comprehending spoken English. Proficient in reading and writing English.

Exclusion Criteria:

* Is not able to receive email or text messages
* History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated.
* Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised.
* Diminished cognitive skills as to render consent meaningless
* Physical debilitation such that study participation would not be feasible or would create undue hardship.
* Participation in the intervention arm of the preceding study, "Reducing Stress During Active Surveillance" EH09-202.
Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome

The primary objective of this study was to evaluate and compare the prevalence of the following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical histories 10 years after their initial assessment/diagnosis.

* Mood disorders, including depressive episodes during the previous two weeks, recurrent depressive disorders at any point in life, dysthymia in the last two years, or any current or past manic episode;
* Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia with panic disorders, current social phobia, generalized anxiety in the last 6 months, or current posttraumatic stress syndrome;
* Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past or present (clinically validated),
* Current alcohol or drug problems (dependence or abuse).


Eligibility Criteria:
Inclusion Criteria:

* Three unexplained consecutive spontaneous abortions before the 10th week of gestation (the recurrent embryo loss subgroup) - OR -
* One unexplained death of a morphologically normal fetus (fetal loss) at or after the 10th week of gestation (fetal loss subgroup).

Exclusion Criteria:

* Any history of thrombotic events or any treatment given during previous pregnancies that might have modified the natural course of the condition
* Women whose pregnancy losses could be explained by infectious, metabolic, anatomic or hormonal facotrs, or associated with paternal or maternal chromosomal causes
* Seropositivity for HIV, hepatitis B or C
* Women with antithrombin, protein C, or protein S deficiency, and women with abnormal fibrinogen or with the JAK2 V617F mutation were further excluded.
Myofascial Induction in Breast Cancer Survivors

The purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

Background: To investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

Methods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant therapy except hormonal treatment. The study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical goniometry for range of motion, Profile of Mood States for psychological distress and Attitudes Toward Massage Scale.

Eligibility Criteria:
Inclusion Criteria:

* had a diagnosis of breast cancer (cancer stage I-IIIA)
* was between the ages of 25 and 65
* had completed adjuvant therapy except hormonal treatment

Exclusion Criteria:

* had cancer recurrence
Valerian to Improve Sleep in Patients With Parkinson's Disease

The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal herb, to improve sleep in patients with Parkinson's disease (PD).

Patients with PD have exceptionally poor sleep. Sleep in patients with PD is characterized by excessive activity in surface electromyographic (EMG) recordings from many different muscle groups. Despite sleep disturbances, approximately 50% of patients experience a transient (1 to 3 hour) reduction in waking motor symptoms upon arising in the morning. This effect has been termed Sleep Benefit. This study will evaluate the effects of valerian, a medicinal herb, on the sleep of patients with PD.

This is a 17 day study where participants will be evaluated by polysomnography on days one, two, three, sixteen and seventeen.. Polysomnographic measurements will include customary variables such as total sleep time, sleep efficiency, and sleep latency, as well as EMG measures of periodic and isolated muscle activity during sleep. Participants will be required to keep a detailed sleep log of their self reported sleep characteristics across the entire 17 study nights. Outcomes will include measures of both nocturnal sleep and waking motor function. Assessments of motor function will be made the morning immediately following Nights 3 and 17 in order to test for improvement related to improved sleep. On the morning following Night 17, participants are provided with a one-week supply of valerian in an Open Label extension. Participants are provided an additional Sleep Log for this week and asked to return the Sleep Log when they complete the Open Label phase.

Eligibility Criteria:
Inclusion Criteria

* Idiopathic Parkinson's disease
* Willing to undergo overnight, in-lab polysomnography
* Sufficient literacy to allow completion of sleep logs
* Stable doses and timing of all Parkinsonian medications during the course of the trial

Exclusion Criteria

* Dementia
* Parkinsonism secondary to toxic, infectious, or other medical conditions
* History of stroke, cerebellar disease, or progressive supranuclear palsy
* History of liver or renal disease
* History of duodenal or bladder obstruction
Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

The motivation results from the fact, that an intra-abdominal pressure is correlated with cerebral perfusion, in a mechanism of reducing venous outflow. Moreover, elevated intra-abdominal pressure leads to increase in intracranial pressure and decrease of cerebral perfusion pressure.

The main aim of the study was to investigate an influence of increase in intra-abdominal pressure on cerebral oxygenation measured with the use of non-invasive optical technique.

The investigators applied time resolved near infrared spectroscopy device in order to estimate changes in hemoglobin concentration in a brain during gynecological procedure that involves laparoscopy. The optodes were positioned on a forehead on left and right hemisphere.

The measurements were carried out during whole medical procedure, including anesthesia, start and stop of insufflation of abdominal cavity with carbon dioxide (CO2), surgical procedure, release of CO2 and waking up a patient. In those studies the special emphasis was put on a period of insufflation of abdominal cavity with CO2.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic procedure

Exclusion Criteria:

* no consent
4-PBA: Will it Increase the Level of Alpha 1-Antitrypsin(AAT) in Persons With AAT Deficiency?

The purpose of this study is to find out whether 4-PBA will increase the level of AAT in persons with AAT deficiency whether or not they have liver disease.

The purpose of this study is to determine whether 4-PBA will significantly increase serum Z AAT levels in AAT-deficient individuals with and without evidence of hepatocellular injury and to assess its effects on liver injury.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Serum A1-PI levels \<11uM an appropriate genetic phenotype/genotype
* 5 of 10 subjects must have documented laboratory evidence of liver disease
* Willingness to withhold Prolastin therapy for 6 weeks prior to screening and throughout the 4-PBA dosing period (up to 3 months)

Exclusion Criteria:

* Any cause of liver disease other than Alpha-1 Antitrypsin deficiency
* Evidence of advanced liver disease
* HIV positive
* Use of systemic steroids, ursodeoxycholic acid (Actigall, Urso), or herbs in the prior 6 months
Effect of a Low Glycemic Index on Metabolic Syndrome

Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. There has been an increased interest of researchers in the relationship between MetS and diet and, specifically, Mediterranean diet would be beneficial for people with high risk of developing MetS or individuals with established MetS.

Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin, associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. The National Cholesterol Education Program's Adult Treatment Panel III (NCEP-ATP III) defines MetS the presence of at least three of five diagnostic criteria consisting in the measure of waist circumference, fasting glucose, systolic pressure and/or diastolic blood pressure, serum triglycerides and HDL cholesterol. The level of physical activity, smoking habits, low social class membership as well as low level of education and even a mild degree of chronic inflammation have been associated with an increased risk of MetS. Recently, there has been an increased interest of researchers in the relationship between MetS and diet, and more specifically Mediterranean Diet (MD). A problem of the contemporary MD is the quality of carbohydrates as the foods rich in carbohydrates consumed actually, such as white bread and some type of pasta, are produced with refined flour, at high glycemic index (GI) and load (GL). There are numerous studies showing that taking large amounts of high GI and GL foods is a risk factor for coronary heart disease and type 2 diabetes. To our knowledge there is no diet trial that compared the health effects of Mediterranean diets with different quality of carbohydrates. Objective of this study was to compare, in a randomized clinical trial, the effects of a simple MD, a Low Glycemic Index diet (LGID), and a Low Glycemic Index MD (LGIMD) on MetS, MetS components and other metabolic variables. For this reason, after a baseline examination, participants were randomly divided into three groups, each receiving a specific dietary intervention, and all the parameters measured at the first visit were examined again at months third and sixth.

Eligibility Criteria:
Inclusion Criteria:

* MetS, Subject enrolled in the MICOL study in 2005-2006

Exclusion Criteria:

* Insulin treatment, Not enrolled in the MICOL study