cyrilzakka/clinical-trials huggingface dataset:
Gamma-delta Tocotrienol as Potential Maintenance Treatment in Women With Metastatic Breast Cancer

Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.

Twelve healthy subjects will be admitted to a clinical study ward on the Day 0. Physical check up and the health status will be confirmed during check in. After fasting for a minimum of 10 hours overnight, each subject will be administered a single dose of TRF or Gamma-Delta after taking a standardized high-fat meal breakfast on Day 1. Thereafter, standard meals will be provided at 4 and 12 hours after dosing. Blood samples (5mL will be taken using an in-dwelling canula placed in the antecubital vein immediately before and at 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, and 24 hours after dosing. Subjects will be admitted for 24 hours and discharged after the last blood sampling. During the study, blood pressure and the heart rate will be monitored regularly for safety profile.

After a one week wash out period, subject will return to the ward and be given the other formulation (TRF or GDT) and the same procedures will be repeated. Any adverse events that arise during the treatment will be recorded and followed up till resolution.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 21-55 years old
* Good health
* No allergy to vitamin E/ palm oil
* No past (within 3 months) / current use of dietary supplements containing vitamin E

Exclusion Criteria:

* History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
* Candidate for surgery or had undergone surgery in the past 6 months
* Current or past use (last 3 months) of antithrombotic drugs such as antiplatelets (aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents (streptokinase), etc
* Current or past history of cancer
* Pregnant/ breastfeeding women
* Smokers
* Drug or alcohol abuse
* Hypercholesterolemia
* Chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, HIV infection, or other psychiatric illness/ social situations that might limit adherence to study protocol.
* Unable or unwilling to stop taking vitamins, herbal preparations or nonprescription medications
Predictors of de Novo Urge Urinary Incontinence After Photoselective Vaporization of the Prostate

The aim of this study was to investigate the incidence of de novo urge urinary incontinence after the photoselective vaporization of the prostate for benign prostatic hyperplasia using the validated overactive bladder symptom score, and to determine the predictors of de novo urge urinary incontinence following the photoselective vaporization of the prostate.


Eligibility Criteria:
Inclusion Criteria:

* men in whom 6-months follow-up data were available
* men who did not complain of urge urinary incontinence based on the OABSS (overactive symptom score): OABSS question 4 score of ≤ 1

Exclusion Criteria:

* previous prostate or bladder surgery
* a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease
IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena.

Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children

The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.


Eligibility Criteria:
Inclusion Criteria:

* Born weight upper or equal to the 10th percentile and absence of smoking declared by the mother
* Born weight lower than the 10th percentile and absence of smoking declared by the mother
* Born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day
* Born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day

Exclusion Criteria:

* Gestationnel age 37 LIMITED COMPANIES
* Low(Weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day)
* Pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)
Non-invasive Glioma Characterization Through Molecular Imaging

MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 year old)
* Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Patients unable to have MRI done
Seton or Glue for Trans-sphincteric Anal Fistulas

Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. Furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.In the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the American FDA approved the use and marketing of a human fibrin glue in 1998.

Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%.

Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.

Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature are lacking. We will run a prospective randomised trial comparing commercial fibrin glue treatment with classical seton treatment, taking into account the healing rate, hospital stay, healing time, faecal incontinence and postoperative pain.

Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up.

Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the two groups

Eligibility Criteria:
Inclusion Criteria:

* medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments

Exclusion Criteria:

* Crohn's disease
* anal abscesses
* complex fistulas (horse-shoe type or multiple secondary tracts)
* immunosuppression
* diabetes,
* anal fissures
* pregnancy
* anti-coagulant treatments,
* any allergic reaction to the bioglue components.
E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services

This randomized controlled trial evaluated the feasibility and potential efficacy of 1) e-cigarette switching (EC) or 2) e-cigarette switching + financial incentives for combustible cigarette cessation (EC+FI)

The current study examined the feasibility of e-cigarette switching and financial incentives contingent on combustible cigarette abstinence to promote combustible cigarette cessation among urban day shelter guests (N=60). A total of 60 adults who accessed the Homeless Alliance day shelter in Oklahoma City, OK were randomly assigned to 1 of 2 groups and followed weekly from 1 week prior to a scheduled EC switch date through 4 weeks post-switch date, with a final 8-week post-switch follow-up. The intervention groups were: 1) e-cigarette switching (EC) or 2) EC switching + small financial incentives for carbon monoxide (CO) verified combustible cigarette abstinence (FI + EC). The primary outcomes were self-reported combustible cigarette abstinence over the previous 7 days with carbon monoxide (CO)-verification at 4- and 8- weeks follow-up. Secondary outcomes included changes in CO from baseline, days of combustible cigarette smoking, and continued e-cigarette use. Other feasibility outcomes included study retention and perceptions of the intervention.

Eligibility Criteria:
1. ≥21 years of age
2. Expired CO level ≥8 ppm suggestive of current smoking
3. reported smoking ≥5 cigarettes per day
4. Willing and able to attend 8 study visits over a 10-week period
5. Interested in switching from CCs to ECs
6. Willing to abstain from smoking cannabis for the duration of the study
7. Able to speak and understand English
8. Demonstrated \>6th grade English literacy by earning a score ≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF),
9. Able to read a 3-sentence selection from the consent form
10. Not pregnant, breastfeeding, or planning to become pregnant.
The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy

The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.

Exclusion Criteria:

* Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are commonly used for autologous hematopoietic transplants. PBSCs are also now being used for some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors. However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and the effects of filgrastim on healthy individuals. The purpose of this study is to determine the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving unrelated donors and to determine the effects of this donation process on unrelated stem cell donors.

This study establishes and evaluates a system to supply peripheral blood stem cell (PBSC)products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The study also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for indefinite donor follow-up.

Eligibility Criteria:
Inclusion Criteria:

-Healthy adults

Exclusion Criteria:

* Pregnancy or uninterruptible breastfeeding.
* Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
* History of autoimmune disorders, including rheumatic disease and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
* History of deep vein thrombosis or pulmonary embolism.
* Thrombocytopenia \<150 x 10(9)/L (\<150,000/uL) at baseline evaluation.
* Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been full evaluated.
* Positive Hemoglobin-Solubility (e.g. SickleDex or equivalent) test.
* Donors receiving experimental therapy or investigational agents.
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial

The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing a repair of a proper digital nerve of the hand;
* 100% transection injury to the nerve under repair;
* Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
* Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
* Patient willing and able to provide a signed Patient Informed Consent Form;
* Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.

Exclusion Criteria:

* Patient has a known allergy to the constituent polymer of the investigational device;
* Patient has a documented diagnosis of peripheral neuropathy;
* Patient has a history of neuropathic pain;
* Patient has a history of injury to the nerve being studied;
* Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
* Patient is pregnant or nursing
* Any patient with a diagnosis of type 1 Diabetes Mellitus;
Effect of Electrical Stimulation at Acupoints on Blood Pressure

To determine if electrical stimulation on acupoints has any effect on hypertensive subjects.

All subjects will be assigned into control and experimental groups by a random table. The first 40 numbers in the first row will be used for the study. Subjects assigned with an odd number will be divided into the control group.

ROLE OF SUBJECTS Subjects in the experimental will receive Hans treatment for hypertension. No invasive procedures will be used for subjects in either the control and experimental groups.

This randomized controlled study will recruit hypertensive subjects into control and experimental groups using a random table. Only the subjects in the experimental group use Hans stimulation as a treatment for high blood pressure. The treatment regiment is discussed in the Treatment section in detail. The subjects in the control group will not

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild hypertension (160-140/100-90 mmHg), male and female subjects with any racial background will be invited to participate in the study.
* All adult age groups are included in the study.
* Subjects must sign an informed consent form.

Exclusion Criteria:

* Diagnosis of severe hypertension (200-161/120-101 mmHg), limited physical activity, heart failure, kidney diseases and mental diseases are excluded in the study. A questionnaire will be used in the initial patient screening.
Collecting and Storing Biological Samples From Patients With Ewing Sarcoma

This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone marrow, and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.

OBJECTIVES:

I. Collect biological specimens, including associated demographic and clinical data, from patients with Ewing sarcoma.

II. Provide a repository for long-term storage of Ewing sarcoma-related biological materials.

III. Make collected specimens available to qualified researchers to understand the biology of Ewing sarcoma and correlate these results with demographic and clinical data.

OUTLINE: This is a multicenter study.

Patients undergo collection of tumor specimens, bone marrow, and peripheral blood at diagnosis. Associated demographic and clinical data are collected and archived. Patients who are not enrolled on a therapeutic clinical trial are followed annually.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ewing sarcoma, including peripheral primitive neuroectodermal tumor and Askin tumor

  * Newly diagnosed or recurrent disease
Development of a Self-collection Device for Cervical Cancer Screening

Evaluation of a novel self-collection device for cervical cancer screening.

The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Inclusion Criteria - General Population Group

1. Subject is 25 to 65 years of age and willing to provide informed consent.
2. Subject with intact cervix.

Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group)

1. Subject is 25 to 65 years of age and willing to provide informed consent.
2. Subject with intact cervix.
3. Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy.

Exclusion Criteria:

1. Subject who reports current menstruation.
2. Subject is pregnant (based on self-reporting).
3. Subject has impaired decision-making capacity or unable to provide informed consent.
4. Subject is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
5. Subject has undergone partial or complete hysterectomy including removal of the cervix.
6. Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products.
7. Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.
The Relationship Between Psychological Factors and Bell's Palsy

The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine whether psychological factors are the potential risk factors for the occurrence of BP.

We conducted a case-control, multi-center clinical investigation. A total of 695 subjects were assigned to the case group (n=355) and the control group (n=340). All the BP patients were enrolled from 11 State Hospitals in China, and all the controls were selected from the same district to match for the patients. The study was coordinated by a tertiary referral centre, Tongji Hospital. The House-Brackmann grading system and Facial Disability Index (FDI) was adopted to assess the BP patients. Kessler 10-Item Psychological Distress Scale（K10）was usde to explore the psychological distress, and the Cattell 16 Personality Factor (16PF) scale was employed to evaluate the personality profiles of all subjects.

Eligibility Criteria:
Inclusion criteria:

1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
2. aged 18 to 65 years.

Exclusion criteria：

1. illiterate;
2. the facial paralysis is caused by herpes zoster;
3. recurrent facial paralysis;
4. noticeable asymmetry of the face before the illness which may affect the evaluation;
5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.
MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

The available therapeutic strategies for Multiple Sclerosis (MS)-related symptoms are usually faced with limited efficacy and numerous side effects. Patients with MS frequently suffer from fatigue, affective symptoms, and cognitive deficits.

For these reasons, non-invasive brain stimulation (NIBS) techniques, namely transcranial direct current stimulation (tDCS) might be of help in this context. tDCS is a new NIBS technique with a good safety profile, easy implementation, good patients' tolerance and little or no adverse effects. tDCS uses low levels of constant current delivered to specific brain area via sponge electrodes placed on the scalp. tDCS modifies the polarization of the exposed neuronal circuits. Indeed, it modulates the spontaneous neuronal excitability and activity by a tonic depolarization or hyperpolarization of resting membrane potential.

Therefore, applying a home-based intervention is of interest in a population suffering from high levels of physical disability prohibiting them from frequently coming to seek care at the hospital

Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis according to the 2017 McDonald criteria
* Fatigue since more than 6 months as assessed by fatigue severity scale (FSS\>5)
* Age between 18 and 75 years.
* Stable pharmacological and physical treatment since at least one month
* Affiliation to the social security regimen
* Signature of the informed consent
* Ability of the patient to understand the instructions for use of the pacemaker to ensure safe use

Exclusion Criteria:

* Relapses within the last two months
* Active medical device implanted
* Intracranial metal implants
* Craniotomy, cranial trepanation, aneurysm
* Uncontrolled epilepsy
* Non-weaned alcoholism, sleep debt
* Expanded disability status scale ≥ 6.5
* Severe depression based on Beck Depression inventory (BDI\>19)
* Daytime sleepiness based on Epworth Sleepiness Scale (ESS\> 11)
* Other neurologic and psychiatric diseases
* Known pregnancy by the investigator or breastfeeding
* Physical or mental incapacity to give informed consent
* Participation in another study (exclusion period following a previous study should be ≥ 6 months)
* Patients on AME
* Patients under legal protection
* Prisoners