cyrilzakka/clinical-trials huggingface dataset:
AneuFix - Prophylactic Sac Filling

This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.

The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.

ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:

  - Open IMA AND
  * 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \>17,5cm2 OR
  * 2 patent lumbars AND a CSAIMA \>15cm2 OR
  * 3 patent lumbars AND a CSAIMA \>12,5 cm2 OR
  * 4 patent lumbars AND a CSAIMA \>10 cm2 OR
  * 5 patent lumbars AND a CSAIMA \>7,5 cm2
* Infrarenal neck according to the IFU of the EVAR device
* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
* Patient having a life expectation of at least 2 years
* Being older than 18 years
* Willing and able to comply with the requirements of this clinical study

Exclusion Criteria:

* Patient not able or willing to give written Informed Consent
* Patient undergoing emergency procedures
* Patient undergoing EVAR for ruptured or symptomatic AAA,
* Patient with a suprarenal AAA
* Patient with an inflammatory AAA (more than minimal wall thickening)
* Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
* Patient in which a bilateral retroperitoneal incision is required for EVAR
* Patient in which a sacrifice of both hypogastric arteries is required
* Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
* Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent
* Patient with active infection present
* Patients scheduled for or having received an organ transplant
* Patient with limited life expectation due to other illness (\<1 year)
* Patient with non-iatrogenic bleeding diathesis
* Patient with connective tissue disease
* Women of child-bearing potential
* Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation
Regulation of Stem Spermatogonia in the Mature Testis

Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is to provide greater information on the mechanisms that effect stem spermatogonial maintenance renewal and proliferation in its relation to male infertility.

An essential requirement for sustaining male fertility is maintaining an adequate number of stem spermatogonia, the foundation of spermatogenesis. To achieve this, when the stem cells divide, some progeny must remain stem spermatogonia while other progeny differentiate. It is obvious that the correct balance between self-renewing replication and differentiation of stem spermatogonia is crucial to male fertility, and there is a indirect evidence that GDNF plays an important role in maintaining this balance in the normal mature testis. However, almost nothing is known about the in vivo regulation of this balance in the mature organ, of the specific function of GDNF in the adult testis, or if physiological changes in GDNF expression significantly affect the replication or differentiation of the stem cells. To address these critical issues, a unique mouse model that allows GDNF signaling to the stem spermatogonia to be specifically and reversibly inhibited in vivo by an ATP antagonist. With this model, the first direct evidence that GDNF is required for maintaining the stem spermatogonial pool in a normal mature testis. Additionally, the investigators have shown that when inhibition of GDNF signaling is reversed, the stem cells begin to rebuild the stem cell pool. Importantly, our data demonstrate that some stem spermatogonia are lost when GDNF signaling is inhibited for as little as 2 days, while other stem cells survive for up to 11 days. This suggests that factors intrinsic or extrinsic to the stem cells modulate the response to GDNF. Using this new mouse model the mechanisms responsible for the loss of stem spermatogonia proliferation and regeneration will be investigated along with GDNF signaling and inhibition. At the end of all of this these studies will be done on waste tissue obtained from normal men and men with infertility who otherwise have testicular surgery for therapeutic purposes.

Eligibility Criteria:
Inclusion Criteria:

* undergoing testicular biopsy at Weill Cornell Medicine/New York Presbyterian

Exclusion Criteria:

* females and any males outside of the age parameter of 18-75 years old
A Problem Solving Intervention for Hospice Caregivers

Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.


Eligibility Criteria:
Inclusion Criteria:

* enrolled as a family/informal caregiver of a hospice patient
* 18 years or older
* with access to a standard phone line or Internet and computer access at home
* without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
* speak and read English, with at least a 6th-grade education

Exclusion Criteria:

* hearing or visual impairment that prohibits from conducting phone conversations or video conference sessions
A Biomarker Exploration Study of Precision Treatment in Ovarian Cancer

This clinical trial aims to investigate the role of biomarkers in guiding precision treatment for ovarian cancer. The study will explore the effectiveness of personalized treatment strategies based on specific biomarkers identified in ovarian cancer patients. By analyzing the correlation between biomarker profiles and treatment outcomes, the trial seeks to optimize treatment decisions and improve overall survival rates in ovarian cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ovarian cancer.
* Willingness to undergo biomarker testing.
* Ability to provide informed consent for participation in the study.

Exclusion Criteria:

* Inability to comply with study requirements or follow-up visits.
* Previous participation in a conflicting clinical trial.
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Eligibility Criteria:
Inclusion Criteria:

* Main Selection Criteria for Healthy Volunteers:

  * Subject has provided written consent.
  * Subject is in general good health.
  * If female, subject is postmenopausal for at least 2 years or surgically sterile.
  * If female, subject is not pregnant and is not breast-feeding.
  * Male or female between 18 and 55 years old, inclusive.
  * If male, subject must be surgically sterile or practicing at least 1 method of birth control.
  * Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria:

* Use of medications including over the counter and vitamines.
* Abuse of alcohol, drugs, or nicotine.
* Current diseases or disorders.
* History of cardiac disease.
* If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.
Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.

This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* peripheral lung nodules \< 3cm in size
* Surgical candidate

Exclusion Criteria:

* Non surgical candidate
GDM Patients and Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist

Serum amyloid A and Interleukin-1 (IL-1) receptor antagonist (A-SAA and IL-1Ra) values;

* Comparison of pregnant women with and without GDM diagnosis
* Comparison of insulin therapy and diet-regulated GDM patients
* Comparison of pregnant women with and without LGA (large gestational age)
* Comparison of pregnant women with and without polyhydroamnios
* Investigation of its effect on pregnancy prognosis
* In the prediction of GDM diagnosis, it is aimed to study the sensitivity and specificity of both parameters and cut off values.

(In GDM patients, liver and kidney function parameters will also be evaluated with A-SAA and IL-1Ra levels).


Eligibility Criteria:
Inclusion Criteria:

* Patients with 50 gr OGTT + 100 gr OGTT + at 24-28 weeks of gestation
* Patients with 75 gr OGTT + at 24-28 weeks of gestation
* 18-42 years pregnant women

Exclusion Criteria:

* any infection
* Any known fetal chromosomal or structural anomaly
* Preterm membrane rupture
* Preterm delivery
* Preeclampsia or eclampsia
* Placenta previa
Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Extremely Complex perianal fistulae
* Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
* Previous failure in at least one closing fistula standard treatment

Exclusion Criteria:

* Presence of severe proctitis or dominant active luminal disease requiring immediate therapy
* Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
* Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
* Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
* Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
* Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
* Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
* Patients who have suffering major surgery or severe trauma in the prior 6 months
* Pregnant or breastfeeding women
* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug
DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used for the prevention of migraine attacks), can reduce the rate of migraine attacks.

Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and will have to report any migraine attacks they have during the study's 18-week follow up.

The multi-center trial has a double-blind, randomized, placebo-controlled, parallel-group design and will be carried out in Israel. Approximately 40 adult subjects with migraine will be randomly assigned (1:1) to either DP-VPA (maximum of 900mg/day) or placebo. Active and placebo will be administered orally and once-daily on an add-on basis, i.e. other permissible ongoing medications will be continued. Total study duration per subject will be 18 weeks. Subjects will report on their migraine attacks frequency and other attack characteristics using weekly diaries.

Eligibility Criteria:
Inclusion criteria (abridged)

* Male and female subjects with migraine with or without aura fulfilling the diagnostic criteria of the International Classification of Headache Disorders
* 3 to 6 migraine attacks per month
* Concomitant prophylactic migraine treatment with a beta-blocker or amitriptyline that has been stable in the proceeding 3 months. No changes in this concomitant treatment will be allowed until the end of study follow-up.

Exclusion criteria (abridged)Chronic migraine (\>15 days of migraine/ month).

* Migraine complicated by medication-overuse headache.
* Allergy or hypersensitivity to valproic acid, valproate sodium, or soy.
* Known contraindications to valproic acid.
* Pregnancy.
* Breastfeeding female subjects.
* Subjects with significant hepatic dysfunction indicated by SGOT or SGPT \>3 times the upper limit of normal at screening.
* Renal impairment indicated by serum creatinine \>1.5mg/dL at screening.
* Potentially fertile and sexually active women who do not practice reliable contraception.
* Men who do not practice reliable barrier contraception.
* Concomitant use of antipsychotic, antidepressant or antiepileptic therapy - with the exception of amitriptyline - within 1 month of screening, or a medical condition that is likely to require such treatment during the trial participation.
* An active central nervous system disease deemed to be unstable or progressive during the course of the study that may confound the interpretation of the study results.
* Any medical disorder that may makes the subject unlikely to fully complete the study- Blood coagulation disorder.
* Concomitant drugs known to interact with VPA.- Alcohol or other drugs abuse.
* Therapy with another investigational product within 30 days prior start of study.
* Concomitant participation in another trial or study
HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment

The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.

Single-center, prospective, open-ended, interventional study with minimal risks and constraints. Patients will be divided into 3 groups: patients not infected with COVID-19, patients infected with COVID-19 not hospitalized, patients infected with COVID-19 hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* Patient with possible or confirmed infection by COVID-19

Exclusion Criteria:

* Patient without liberty or guardianship
Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).

The post-operative complication of a sore throat after endotracheal intubation is unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of 35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore throat and/or vocal changes unless directly asked because surgical pain is more prominent and many patients may be unaware that intubation completed as part of the general anesthetic. (Harding 1987)

The Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino 2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of sore throat was not examined. (Kristensen 2003)

Our previous study (Jones 2007) demonstrated that modification of anesthetic techniques could reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the incidence of sore throat in patients undergoing oro-tracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient scheduled for elective surgery.
* ETT is indicated for the procedure in the opinion of the attending anesthesiologist.

Exclusion Criteria:

* Any patients with known or probable difficult airways.
* Any patient requiring rapid sequence induction.
The Effect of Su-jok Therapy Applied in the First Stage of Labor on Pain Level in Primiparas

The aim of this study is to examine the effect of sujok therapy applied in the first stage of labor on the pain level in primiparas.

Birth pain, known as acute pain, is felt in the human body as one of the oldest, complex, severe and most difficult to control types of pain. However, this pain differs from other types of pain due to the fact that it reunites the mother with her baby and covers a limited period of time. Pain is a subjective phenomenon that every individual experiences throughout their lives and to which people react differently.

Su Jok therapy, an alternative and complementary therapy technique, is seen as a method that balances the energy flow based on the philosophy of non-pharmacological and non-invasive acupuncture that can be used to control labor pain.

Su-jok application is the development of a massage therapy that will create a feeling of comfort in the body by using certain points. There are tiny swellings on the reflection points on the hands and feet (such as the area between the 3rd and 4th fingers reflecting the uterus area). These are also called micro acupuncture points. When pressure is applied to these swellings on the hands and feet for 1-2 minutes, pain and a feeling of pulling occur. Thus, the area to be massaged is determined. During the detection phase, a blunt-tipped diagnostic probe or a round-tipped stick can be used. At this stage, the same amount of pressure should be applied to the area to be applied. When a point is determined, the correct point for massage application should be massaged and energy flow should be provided. Since it does not have any side effects, it is a therapy that can be used in pregnant women and is a massage application that does not require any invasive intervention.

Eligibility Criteria:
Inclusion Criteria:

* Being primiparous
* The pregnant woman must be over 18 years of age
* To participate in the research voluntarily
* The beginning of labor (water breaking, presence of non-stress testa contractions, engagement)

Exclusion Criteria:

* Pregnancies outside 37-41 weeks
* Multiparas
* Those who are not pregnant
* Having visual, mental and auditory disabilities
* Being pregnant as an adolescent
* Not accepting participation in the research
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.


Eligibility Criteria:
Inclusion Criteria:

* male and female aged 18-75 years;
* BMI between 19 and 30 kg/m2 ,
* LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
* higher than 100 mg/dl in individuals with a 10-year risk \> 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
* with or without statin monotherapy,
* willing to respect the dietary advising delivered at the screening visit,
* agreeing to a written informed consent

Exclusion Criteria:

* subject with plasma triglycerides (TG) levels \> 400 mg/dL,
* with any cardiovascular event in the last 6 months,
* subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
* diabetic (type I and type II),
* presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
* pregnant or breast feeding women
Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

Evaluation of the optical effects of Systane Ultra


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or more.
2. Subjects must have Tear Break Up Time (TBUT) \< 5 seconds
3. Subjects must have a maximum blink interval (MBI) \< 10 seconds
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication