cyrilzakka/clinical-trials huggingface dataset:
Oocyte Cryopreservation Study (Egg Banking)

Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be eligible to participate in a study investigating pregnancies that result from frozen eggs.

Participants follow standard fertility protocols to stimulate the growth of multiple egg follicles. When the egg follicles are mature, the eggs will be removed under sedation, examined by an embryologist under a microscope and the mature eggs will be immediately frozen and kept frozen in tanks at Penn Fertility Care using the same methods of labeling and quality assurance currently in place for frozen embryos.

Eggs will be thawed in the future when the participant wishes to attempt pregnancy and fertilized by standard methods used during In Vitro Fertilization (IVF). Resulting embryos will be placed into the uterus by a procedure that will require approximately 15-30 minutes. The number of embryos to be transferred will be dictated by standard clinical practice. After embryo transfer, subjects will return for serum pregnancy tests at 14 days after the embryo transfer. For those who are not pregnant, there will be no further participation in the study. For those who do achieve pregnancy, trans-vaginal ultrasound will be performed at approximately 6 weeks gestation and weekly thereafter until 8 weeks gestation at which time, they will be referred to their general obstetrician for prenatal care. Participants will be asked to provide the study team with information about birthweight, height, length, gestational age at delivery, complications at delivery, and infant number. This information is routinely collected from patients undergoing conventional IVF in order to maintain quality assurance as recommended by the American Society of Reproductive Medicine. Information will also be collected from the participant's medical records including physical characteristics, medical and fertility history, semen analysis of the partner if appropriate, egg stimulation characteristics including medications, days of stimulation, number of egg follicles, number of mature and immature eggs retrieved, number of eggs frozen, number of eggs thawed, number of embryos, disposition of embryos, pregnancy test results, number of pregnancies that survived the first 12 weeks and prenatal screening tests.

Eligibility Criteria:
Inclusion Criteria:

* age between 15 and 45
* desire oocyte cryopreservation or use of cryopreserved oocytes for the purposes of achieving pregnancy
* willingness to participate in study and provide informed consent

Exclusion Criteria:

* day 3 FSH over 20 mIU/ml, or Day 3 E2 over 100pg/ml
* ovarian cyst greater than 14mm at baseline ultrasound
* uncontrolled medical illness such as diabetes, hypertension, or cardiovascular disease
* current pregnancy
Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)

The study determines the EPA DHA uptake from different omega-3 supplements against a control.

The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women, ≥18 -65 years of age.
2. Willing to refrain from taking omega-3 supplements for 1 month prior to study start
3. Willing to take study supplement for 2 months

Exclusion Criteria:

1. Subjects with known allergy to fish products
2. Subjects known to be pregnant or breast feeding
The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series

An observational pilot study to determine the success rate of using LMA Proseal in conjuction with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.

The use of LMA has gained popularity secondary to benefits confirmed by many literatures. However, LMA is rarely used in thoracic surgery. To enable one-lung ventilation, the LMA need to be used with bronchial blocker. The use of this combination has been reported as a rescue technique in special clinical scenarios, i.e. patient with difficult airway. When used in patient with difficult airway, the LMA will be inserted until proper ventilation achieved, then endobronchial blocker will be subsequently placed through the LMA into the selected main bronchus. The success rate of the the bronchial blocker placement via properly placed LMA has never been studied. This pilot study was designed to evaluate the success rate, the quality of lung collapsed, the dislodgement or other associated problems including some minor complications i.e. postoperative dysphagia, sore throat hoarseness of voice.

Eligibility Criteria:
Inclusion Criteria:

* thoracic surgery that needed one-lung ventilation Exclusion Criteria:patient with
* Restrictive lung disease that needed positive pressure ventilation \> 30 cm.H2O
* Mass or hematoma in the mouth which obstruct LMA insertion
* Emergency surgery
* Pregnancy
* Severe infection or active pulmaonary tuberculosis
* Hemoptysis
* Pulmonary nodule \> 20 cm. or bronchilal pathology
* Pneumonectomy or sleeve resection
Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome

Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome (PCOS).

Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. Frequently, increased weight is a feature. Research suggests that they could have a higher risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure, angina, heart attack and stroke.

The fat from the diet is transported from the stomach into the blood and then taken up by the liver, muscles and fat tissues to store or use as an energy source. Delayed removal of fat from the circulation resulting rise of fat after a meal has been known to happen in PCOS. High fats after a meal are a strong risk factor for cardiovascular disease.

Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for many years. It has been proved to be effective in reducing risks of heart disease in patients with diabetes. However the effect of niacin on reducing cardiovascular risks and reducing fat level after a meal in PCOS has not been studied and this is why we plan to do this research.

Eligibility Criteria:
Inclusion Criteria:

* Females aged between 18 - 50 years
* Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement

Exclusion Criteria:

* Pregnancy/trying to conceive/breast feeding
* History of cardiovascular, renal, hepatic and active thyroid disease
* History of gout
* History of alcohol abuse
* History of diabetes
* History of allergy to nicotinic acid/laropiprant or food
* History of bleeding disorders/active peptic ulcers
* Patient on antihypertensive medications
* Patient on anticoagulants
* Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents
* History of smoking more than 15 pack year
* Unwilling for GP to be informed
Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury

Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation

It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program

Exclusion Criteria:

Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia
Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial

There is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. The current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. Due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2 (COVID-19).

After RECOVERY trial prepublication, low dose (6 mg QD for 10 days) dexamethasone was recommended as the usual care treatment for severe COVID-19. At this time only 3 patients had been included in the trial. Thus, we updated our recommendations for centers and decided to compare two different doses of this glucocorticoid for the treatment of ADRS due to COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* ARDS according to Berlin's definition
* PCR confirmed COVID-19
* Length of mechanical ventilation less or equal to 72 hours

Exclusion Criteria:

* Pregnancy or breast-feeding women
* Terminal illness with very poor prognosis according to the investigator judgement
* Therapeutic limitation
* Known immunocompromised condition
* Chronic use of systemic corticosteroids
* Participation in another randomized crinical trial
* More than 5 days of treatment of low dose dexamethasone for COVID-19
* Abscence of informed consent
* Active participation in other randomized clinical trial
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient is above 18 years old.
* Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
* Patient's fibroadenoma can be visualized with ultrasound.
* Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
* Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure.
* The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization.

Exclusion Criteria:

* Patients with history of breast cancer.
* Women with known pregnancy.
* Patients with superficial fibroadenoma very close to the skin.
* Patient has undergone major surgery within the previous 12 weeks.
* Patients with any terminal illness, or with a life expectancy \<2 year.
* Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
* Patient participating in other trials using drugs or devices.
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.

The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks.

AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Erythropoietin.

Concurrent Treatment:

Allowed:

* Transfusion.

Patients must have:

* Progressive HIV disease.
* At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active malignancy requiring chemotherapy.
* Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
* Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.

Concurrent Medication:

Excluded (unless exemption made by study chair):

* Oral anticoagulants (warfarin, dicumarol).
* Oral contraceptives.
* Digitalis glycosides.
* Phenytoin.
* Theophylline.

Patients with the following prior conditions are excluded:

* History of clinical pancreatitis.
* History of grade 2 or worse peripheral neuropathy.

Prior Treatment:

Excluded:

* Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.
I Change Adherence & Raise Expectations

The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement. Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention). The other half of the centers will receive CAP in year 2 of the study. Participants are patients age 11-20 years old who are diagnosed with CF and have been prescribed at least one of the following medications for at least 6 months prior to signing the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung function decline rates, exacerbation rates, and patient reported measures including health related quality of life and CF knowledge and skills, as secondary outcomes.

A central goal of this study is to test the effectiveness of the comprehensive adherence program (CAP), described above, versus standard care (SC) for adolescents and young adults seen in outpatient CF clinics.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age 11 - 20 years old
* Patients with a diagnosis of CF
* Patients attend the accredited care center for regularly scheduled clinic visits
* Patient must be prescribed at least one of the following medications for at least 6 months prior to signing the informed consent:

Azithromycin Hypertonic saline Pulmozyme® TOBI® Inhaled compounded tobramycin

-Patient has consented to provide data to the CF Foundation Registry prior to conversion to PORTCFv2

Exclusion Criteria:

* Patient is planning to change care teams within the next 2 years
* Patient is seen at a satellite clinic
* Patient is on the lung transplant list (Note: participation in this study will not delay or exclude patient from being placed on the transplant list in the future or receiving a transplant once enrolled in the study)
An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population

Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population

The main objective of the current Asian nutritional status study is to get more insight into the nutritional status of AD patients in an Asian population in Asia. Plasma levels of several micronutrients and the fatty acid profile will be compared between patients with mild and moderate AD and cognitively intact healthy controls in an Asian population

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years old
* Asian ethnicity
* Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating Scale for Geriatrics rating of ≤ 2 for all categories except for the category "psychiatric illness" which should have a rating of 0 and a CDR of 0 within 1 year prior to the visit.

OR

Group 2a: AD patients clinically diagnosed with mild AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1

OR

Group 2b: AD patients clinically diagnosed with moderate AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-2

- Written informed consent provided according to local regulations.

Exclusion Criteria:

* Group 1 only: Current diagnosis of AD or other dementias according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al.,1984 )
* Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g. donepezil, rivastigmine, galantamine or memantine)

Group 1 and 2:

* Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD), including vascular dementia according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria, cerebral tumour, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, seizures, major depression, schizophrenia and other entities
* Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3 months prior to the visit
* Use of vitamin B injections
* Alcohol or drug abuse as per investigator's judgement
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist

This study tries to evaluate the non-inferiority quality and safety of ultrasound examinations realise by electro-radiology assistant with a remote radiologist compared to those realize by electro-radiology assistant with a referent radiologist on site.

The number of requests for medical imaging examinations is clearly growing while there is an understaffing among the radiologists. The solution is the amelioration of information transmission technologies, for organize a territorial teleradiology in order to care duty. Currently, in the ultrasound field, the investigators can't realize image transfer because analyse and expertise are made during examination and only reading of fixed images can't be enough for the examination interpretation.

The most part of other developed countries recognize a paramedical job devoted to ultrasound. Tele-ultrasound is used in expert resort, for example during high-risk pregnancy.

A French society commercializes tele-ultrasound robots, arranged by a caregiver beside sick person and a tele-radiologist realize acquisition of information and images with remote commands from robot.

The CHR Metz-Thionville has a cooperation protocol between electro-radiology assistants and radiologists for the ultrasound practical, endorsed by Lorraine ARS and HAS (French health organizations) since 2012, and currently national impact.

This study purpose to evaluation the non-inferiority of agreement between two interpretations of the same ultrasound realize by an electro-radiology assistant on the one hand by two radiologists present in the radiology service and on the other hand, one radiologist in by the radiology service and one remote radiologist.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Who needs abdomino-pelvic ultrasound, except emergency cases
* With no substitutable examination

Exclusion Criteria:

* Pregnant and nursing women
* Patient in the incapacity to express his consent
* Unavailability of a remote radiologist or a second local radiologist during the examination realization
* Patient opposed to use data