cyrilzakka/clinical-trials huggingface dataset:
Polyphenols and Insulin Resistance

Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
* Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT \< 3 times the normal value and serum creatinine \<150 micromol/l).
* Age between 30 and 55 years.
* Fasting plasma glucose \<110 mg/dl and absence of any anti-diabetic treatment
* No regular physical activity (Voorips index \< 9)
* Absence of any drug treatment in progress and during the last 2 months
* Subjects with at least one 1st degree relative with T2D and with a body mass index between 25 and 35 kg/m² and a waist measurement \>94 cm for males, and \>80 cm for females.
* Normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l).
* Normal ferritin level (75 - 300 ng/ml)
* hs-CRP \<8 mg/l.
* Absence of arterial hypertension (systolic pressure \<140 mmHg and diastolic pressure \<90 mmHg).
* Non smoker or former smoker (quit smoking \>1 year).
* Alcohol consumption \<30 g/day.

Exclusion Criteria:

* Hyperthermia (T°\>38°c)
* Subject deprived of freedom by a court or administrative order
* Major protected by the law
* Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
* Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
* Subject who cannot be subjected to muscle biopsy.
* Allergy to the anaesthetic
* Woman in age to procreate and not taking any oral or intra-uterine contraception
Generation of Organoids of Neuroendocrine Neoplasms of the Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery

Observational, prospective, feasibility pilot study of the preparation of organoids starting from tumor tissue and surrounding healthy tissue, collected during surgery, performed according to standard clinical practice.

Given the need for the use of experimental models that mimic the tumor of origin

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age;
* diagnosis of GEP-NEN carried out via histological investigation or via positivity to the uptake PET-CT with 68Ga-peptides;
* availability of adequate material for the preparation of organoid cultures, derived from surgery;
* written informed consent.

Exclusion Criteria:

* previous chemotherapy treatments
Urodynamic Evaluation in Patients With Anorectal Malformation According to Spinal Cord Abnormalities

This study will examine the effects of spinal cord abnormalities on perioperative neurovesical dysfunction in patients with anorectal abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Anorectal malformation patients who underwent preoperative and postoperative urodynamic studies

Exclusion Criteria:

* Severe artifacts in urodynamic result graph when the postoperative urodynamic study was done after spinal surgery
Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

Systemic arterial hypertension is a disease with high prevalence in several countries, including Brazil. Many studies have correlated hypertension with accelerated loss of cognitive function, especially executive functions. There is some evidence that working memory (WM) is compromised in these populations. However, some computerized training has been developed to rehabilitate the WM, and among them the investigators highlight the Cogmed. Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance of WM and attention of hypertensive patients, as well as the impact of training in the structure and brain function.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both genders, of any ethnicity
* Signing the consent form
* Access to computer with internet at home
* Inexperienced to computerized cognitive training
* Hypertensive pre-diagnosed
* Basic schooling of four years
* Cognitive impairment

Exclusion Criteria:

* Marked functional limitation
* Cognitive limitation or serious communication
* Severe neurological and psychiatric diseases
* Stroke history, head trauma or substance abuse
Enhancing Brain Training With Virtual Reality

The purpose of this study is to evaluate the effectiveness of brain training in a Virtual Reality set up in neurotypical populations as well as in the traumatic brain injury population.

Brain training is a large and a growing field, both scientifically and commercially. Emerging evidence demonstrates that training can promote beneficial brain plasticity in both healthy individuals and clinical populations. Much of the recent interest in brain training can be traced back to the seminal work done at the University of Rochester, where Daphne Bavelier and colleagues showed that training with action video games (AVG) can lead to a wide range of cognitive and perceptual improvements. In our recent work, we developed a novel training paradigm that isolates and concentrates the key aspects of AVG-training while eliminating complex and often violent gameplay associated with AVGs. The results revealed similarly broad effects of training as with conventional AVGs. In this study, we aim to move this training paradigm to virtual reality (VR) and extend its application to cognitive aging and mild traumatic brain injury (TBI) populations.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is an adult over the age of 18.
* Has the capacity to give consent.
* Has normal or corrected to normal vision.
* Has adequate hearing.
* Is a non-action video game player.
* Is a non-VR game player. All subjects will be assigned to one of four groups: a Control Group training in VR, a Control Groups training on a 2D display, an Older Adult Group without dementia training in VR, and a College Athletes with mild TBI Group training in VR.

Specific Inclusion Criteria for both Control Groups. The subject must:

* Be between the ages of 18 and 35.
* Have no neurologic or vascular disorders/injuries.

Specific Inclusion Criteria for the College Athletes with TBI Group. The subject must:

* Be between the ages of 18 and 35.
* Be diagnosed with mild TBI (i.e., concussion) within the last two weeks.

Specific Inclusion Criteria for the Older Adult Group. The subject must:

* Be over the age of 65.
* Have no neurologic or vascular disorders/injuries.

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Is under the age of 18.
Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study

Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. MIH has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. Therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). The restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.


Eligibility Criteria:
Inclusion Criteria:

- At least one permanent first molar with occlusal surface with severe MIH grade (with post eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in the selected tooth.

Exclusion Criteria:

-
Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.

The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).

Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.

This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.
* Age ≥18 years.
* Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021.
* Availability of complete medical records in order to provide protocol required variables
* Signed written informed consent.

Exclusion Criteria:

* Patients not meeting the above-mentioned inclusion criteria.
* Refuse to sign a written informed consent.
Risk Factors for Recurrence After Pelvic Reconstruction

232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, including group A（accepted herniamesh polypropylene mesh， 117 patients)；group B （underwent biological graft of cook，115 patients)；follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

We prospectively study a total of 232 women who underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, the patients into two groups :group A was accepted herniamesh polypropylene mesh(117)；group B underwent biological graft of cook(115)；Each patient underwent an interview that included a POP-Q which was quantified according to the Pelvic Organ Prolapse Quantitation (POPQ) system;follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

Eligibility Criteria:
Inclusion Criteria:

242 postmenopausal patients with primary prolapse of the anterior vaginal wall or concomitant uterine prolapse,that was stage Ⅲ or higher (according to the Pelvic Organ Prolapse Quantification \[POP-Q\] system).

Exclusion Criteria:

pelvic floor repair surgery history and recurrent patients ; pelvic cancer and radiation to the pelvic area in the previous 6 months; simple uterine prolapse; combined with severe stress urinary incontinence or overactive bladder (OAB); local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position) ; vaginal bleeding; infection; coagulation disorders; uncontrolled hypertension and diabetes mellitus;
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Age 18-40 years

Exclusion Criteria:

* Any continuous medication
* Any significant disease
* Hypotension or hypertension
* Allergy to licorice or hydrochlorothiazide
* Pregnancy and breast feeding
* Fear of needles and previous difficult blood samplings
* Substance abuse
* Participation in another clinical drug trial within 1 month of enrollment
Drug Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying cell samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

PURPOSE: This research study is studying drug biomarkers in cell samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To determine, in vitro, the cytotoxic activity of novel CD33-targeting immunoconjugate agents in cell samples from patients with acute myeloid leukemia (AML).
* To define the characteristics of AML cells responding to or resisting these agents.

OUTLINE: Cell samples are thawed and used for in vitro studies to determine the cytotoxic activity of novel CD33-targeting immunoconjugate agents, including gemtuzumab ozogamicin, for genotyping characterization by flow cytometry-based assays and/or western blot, and colony-forming cell assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Cryopreserved samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
PocDoc Lipids Usability Study for Self-test Use

This study seeks to expand the approved indication of use for a UKCA approved IVD device. PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. This study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Subjects are legally competent and capable to understand character, meaning and consequences of the study
* Subjects own an approved mobile device (these will be available at the time of the study on the PocDoc website and a link will be contained in the PIS)

Exclusion Criteria:

* Being unable to give informed consent
* \< 18 years or \> 85 years
* Legally incompetent
* Language barriers potentially compromising an adequate compliance with study procedures
POWER Point of Care Effect on Satisfaction of Treatment

To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12 weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC) device, to similar women treated as per regular clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with postmenopausal osteoporosis using community practice standards
* Women previously non-treated for osteoporosis, OR treated for osteoporosis with biphosphonates (alendronate, etidronate), hormone replacement therapy estrogen, estrogen-related drugs, progesterone, subcutaneous estrogen implant), raloxifene, fluoride, or calcitonin within the past 2 years but discontinued prior to enrolment into the study either due to:lack of effect or intolerance

Exclusion Criteria:

* Subjects treated with Actonelr 5 mg daily,
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Known/Suspected hypersensitivity to any component of Actonelr 35 mg Once-a-Week
* Known/Suspected hypocalcaemia
* Known/Suspected severe renal impairment (creatinine clearance \< 30ml/min)
* Known/Suspected hyperparathyroidism
* Known/Suspected hyperthyroidism
* Known/Suspected active urinary tract infection
* Known high urine levels of calcium (3 4mg/ml)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Testicular Evaluation of Azoospermia Using Micro-Ultrasound

The investigation is a small feasibility study to determine whether there are imaging features related to the seminiferous tubules in the testes under microultrasound. The results from this study will provide guidance on the design and power analysis of future studies in this area.

Currently available ultrasound (US) technology is approximately 12 MHz and offers enough resolution to determine the presence of a tumor or varicocele, but has no real predictive value in terms of imaging robust seminiferous tubules. MicroUS offers significantly higher resolution - down to 70 microns. The average width of a normal seminiferous tubule is 200-250 microns. (Amer 1837). The average width of an atrophic SCO tubule is 75 microns. This echotexture difference cannot be visualized by a conventional ultrasound scan but should, in theory, be detected by a higher resolution (higher MHz) microUS scan.

This is a feasibility study to image 40 azoospermic or healthy controls in order to determine whether microultrasound (microUS) images can visualize differences within the testes of these subjects which may be useful in diagnosing the cause of azoospermia and regional differences within the testes where sperm retrieval may be more effective.

Specifically, in men with obstructive azoospermia we expect to visualize normal seminiferous tubules while in men with non-obstructive azoospermia we expect to visualize both normal and atrophic seminiferous tubules.

The normal tubules in cases of obstructive azoospermia will act as a control by providing an example of normal imaging within a closely related population. Localization of normal tubules within the NOA (non-obstructive azoospermia) population may simplify the microTESE procedure by reducing the amount of dissection required. Additionally, the ability to predict the success of the procedure (i.e. presence of normal tubules) would improve risk/benefit decision-making for men considering it.

Eligibility Criteria:
Inclusion criteria:

1. Men with azoospermia confirmed based on semen analysis
2. Post-vasectomy patients with verified azoospermia after the procedure
3. Men pre-vasectomy with proven natural fertility or with normal semen analysis
4. Males assigned at birth over the age of 18

Exclusion criteria:

1. History of prior microdissection of the testes
2. History of hypogonadotropic hypogonadism
Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia

The purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

Swallowing maneuvers are very effective if done correctly, but to evaluate the use of force and the extent of laryngeal elevation is very difficult.

The therapist often requests the patient to "swallow hard" or "maintain laryngeal elevation". However, it is difficult to provide appropriate feedback to the patient, because it's hard to see the throat muscle contraction and bone displacement,the real point of the force is not clear, only oral and tactile feedback is inadequate and when combined with sensory loss, fatigue or cognition impairment.

Biofeedback is defined as "the technique of using equipment (usually electronic) to reveal internal physiological events by visual and auditory signals, to teach patients to manipulate the intrinsic physiological activity (Basmajian, 1989).The rationale is thus that if a patient sees his muscle activity, rather than just feels his muscles contract, he will be able to contract his muscles more fiercely and therefore he will be able to train his muscles faster.

Past studies have shown that biofeedback can help nerve injury patients control their physiological activities such as swallowing training.

The purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

Eligibility Criteria:
Inclusion Criteria:

* stroke
* above 18 years-old
* pharyngeal stage dysphagia

Exclusion Criteria:

* on trachea
* cannot follow one command
Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.


Eligibility Criteria:
Exclusion Criteria:

* \< 18 years of age
* Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., \< 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
* Unwilling to unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study)