cyrilzakka/clinical-trials huggingface dataset:
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.

The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.

The benefits would be

1. greater sensitivity
2. a great speed because 8tests could be performed at the same time with a result in a few minutes
3. a very high specificity at least equivalent to PCR.

This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female or child without age limit
* Admitted to a Reference Health Establishment (RHS) in an emergency unit, hospitalization or intensive care unit for suspicion of SARS-CoV-2 infection regardless of clinical presentation and degree of severity.
* Patient to be diagnosed by PCR test on nasopharyngeal swab.
* Social insured

Exclusion Criteria:

* Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)
* Pregnant and breastfeeding women
* Protected Majors
3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females

The purpose of this research study is to measure the muscles that make up your anal sphincter (muscles that control bowel movements) by using ultrasound. The most common way for women to injure these muscles is through childbirth. Some physicians think about 30% of women delivering their first baby develop some anal sphincter damage, which may or may not lead to symptoms such as anal urgency or incontinence (involuntary loss of gas or stool). The purpose of the study is to measure muscles in normal women who have never given birth or had an injury to their anal sphincter.

Participants will be asked to complete a one page questionnaire. This questionnaire will address whether perineal trauma, sphincter lacerations, anal incontinence, and fecal urgency impact the subject on any level. Subjects will also be asked about their bowel habits and history of problems with bowel movements. Subjects will then be asked to undergo an ultrasound study of the anal sphincter at the time of enrollment. Completing the entire study will take no more than 15 minutes. This will be done at the doctor's office. Answering the questionnaire will take no more than 5 minutes.

The endoanal ultrasound is a probe with a diameter equivalent to the index finger. It is inserted in the rectum and measures the length and width of the sphincter muscles.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women over the age of 18.

Exclusion Criteria:

* any history of anal incontinence, chronic constipation, anorectal disease or trauma, neuromuscular or neuropsychiatric disease, diabetes, gastrointestinal disorders, or previous anorectal or pelvic surgeries.
Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.

Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.

The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.


Eligibility Criteria:
Inclusion Criteria:

* 1.History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urinary analyses, and urine cultures will be performed for all subjects;
* 2. Age 18 to 50 years.
* 3. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.

Exclusion Criteria:

* 1. Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
* 2. Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale.
* 3. Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis).
* 4. Residual urine volume≥100ML.
* 5. Qmax≤15ML/S.
* 6. Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha-blockers (terazosin HCI, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride), or any other prostatitis-specific medication (including herb and Chinese medicine).
Early Gestational Diabetes Mellitus

In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.

In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in early pregnancy is not justified by current evidence


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Singleton pregnancy
* Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia).
* First prenatal visit prior 20 weeks of gestation at the time of randomization.
* Signed informed consent

Exclusion Criteria:

Diabetic follow-up started at time of inclusion

* Pre-existing diabetes in pregnancy
* Renal impairment
* Hepatic insufficiency
* History of bariatric surgery
* Long time corticosteroids treatment
* Insufficient understanding
* Language difficulties
* Lack of social Insurance
* Person in emergency situation
* Person under the protection of justice (tutelage/ curatorship)
* Persons deprived of their liberty
Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock

QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFNγ) secretions after T-cell and natural killer lymphocyte stimulation.

This study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses.

A sepsis-induced immunosuppression phase has recently been characterized and has been associated with worse outcomes as well as increased healthcare costs. Furthermore, a marked suppression of the immune response has been partially described in patients hospitalized in the intensive care setting but its monitoring is not available in daily practice. QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFNγ) secretions after T-cell and natural killer lymphocyte stimulation. Several studies have shown the pertinence of this test, especially in patients with kidney failure requiring renal replacement therapy. Patients with lower IFNγ levels were also found to be at higher risk of infection.

This study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses. This should ultimately lead to determining thresholds for sepsis-related complications and identifying patients most at risk of sepsis-induced immuno-depression.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in intensive care and intensive care at Nice University Hospital and presenting with septic shock (defined by the presence of sepsis, the need for a vasopressor to maintain a MAP\> 65mmHg and hyperlactatemia\> 2mmol / l)
* Free and express informed consent signed by the patient or the confidential counselor in case of impossibility (deferred consent of the patient as soon as his condition allows it)
* Age\> 18 years old
* Affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman Patient under the age of 18
* Patient under guardianship or curatorship or placed in detention
* Patient with congenital or previously acquired immune deficiency
* Patient on prior immunosuppressive treatment
Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

Down Syndrome is a genetic condition in which a patient has an extra chromosome which is a copy of chromosome 21. It causes physical, cognitive, and behavioral symptoms. The person has difficulty with normal life activities. This study evaluates the effect of interactive sensory play on coordinated hand movements or manual dexterity in children with Down Syndrome. Down syndrome is one of the most common birth defects and causes impairments in the body. The children diagnosed with Down syndrome need great deal of therapies in early childhood so that can live a better life. The objective of this study is to assess the effects of interactive sensory play on manual dexterity in Down syndrome children.

The study design will be a Randomized Controlled Trial. The study setting will be Tehsil Headquater hospital Sadiqabad. The study duration will be 10 months after the approval of the synopsis. The Sample Size will be 22 which is calculated by epitools. The sampling technique will be a Non-probability convenient sampling technique. Children who are diagnosed with Down Syndrome will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory. Identification and recruitment of the participants with Down syndrome will be done. Participants will be selected through lottery for both groups. Group 1 will use Interactive Sensory play and Group 2 will use Free Play as intervention. The assessor will be blind. The data will be analyzed using SPSS 23.


Eligibility Criteria:
Inclusion Criteria:

* Children with moderate level of mental retardation who are able to follow commands

Exclusion Criteria:

* • Children with other musculoskeletal and neurological issues.

  * Children with down syndrome but also have complications such as epilepsy, congenital heart condition.
Wound Treatment With 3% Sodium Pentaborate Pentahydrate

Chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. This research is aim to observe the foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.

Chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. For these reason we prepared a hydrogel formulations.

Gel preparation:

Hydrogel formulations were prepared by dispersing 1%(w/v) carbopol polymer (Carbopol Ultrez-21, Lubrizol, USA) in distilled water. Neutralization buffer (1.6g of 1M sodium hydroxide solution for 1L polymer-water suspension) was used for the gelation of the polymer. Sodium pentaborate pentahydrate (3% w/v), F68 (2% w/v) and F127 (2% w/v) were mixed into the blank hydrogel and stored at 4 °C until it completely dissolved (approximately 24 h). pH of the hydrogel formulation was set to 6.5-7.0 using 1M sodium hydroxide. The hydrogel without any active ingredient was used as negative control (vehicle).

For the first group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate, and for the control group after wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.

Eligibility Criteria:
Inclusion Criteria:

Diabetic Foot wounds

Exclusion Criteria:

Child
Oral Steroid in Controlling Pain After TKA

To compare efficacy of oral steroid in controlling pain after TKA

To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis of the knee who undergoing unilateral TKA
* ASA class I-III
* Informed consent
* Good cognitive function

Exclusion Criteria:

* Uncontrolled DM (HbA1C \> 7)
* Uncontrolled HT
* Morbid obesity (BMI \> 40)
* History of bleeding in GI tract
* Corticosteroid used within 6 months
* Sever liver or renal impairments
* Studied drug allergy
Intelligent Segmentation Algorithm of Ultrasonic Image

This project aims to enhance the performance of ultrasonic image analysis by optimizing and refining neural network algorithms, while also collecting and constructing extensive datasets relevant to ultrasonic imagery. The algorithm will be trained and evaluated in a data-driven manner, with test results facilitating accurate segmentation of regional block images and identification of characteristic ultrasonic anatomy. This approach will significantly advance the study and development of ultrasonic technology.

1. Algorithm development: Develop high-performance intelligent ultrasonic image recognition and segmentation algorithms;
2. Data set: Establish ultrasound image data set, which is convenient for researchers to develop and verify algorithms;
3. Apply for patents, publish academic papers, promote and popularize technology.

Eligibility Criteria:
Inclusion Criteria:

* None.

Exclusion Criteria:

* None.
Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).

Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound.

Population selected:

- Patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma.

The purpose of our study is:

- To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry.

Planning:

* First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase.
* Second phase: 6 patients

Main outcome criteria:

Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.

Eligibility Criteria:
Inclusion Criteria:

* refractory primary open-angle glaucoma (POAG)
* IOP\> 21 mm Hg and \<32 mm Hg with an optimal treatment.
* Lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...)
* Lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of HIFU treatment.
* Male or female age (s) of at least 18 and able to give informed consent
* Patient who signed the informed consent form
* Patient affiliated to a social security scheme

Exclusion Criteria:

* History of glaucoma by placing a drainage implant (valves, pipes ...)
* previous refractive procedures preventing accurate measurement of intraocular pressure (PRK, LASIK)
* General treatment which may alter IOP began in the month before the HIFU procedure
* Patient monophthalmus
* thyroid orbitopathy
* History of ocular or retrobulbar tumor
* Cyclodialysis
* choroidal hematoma or uprising choroidal
* Anatomy of the eyeball inadequate treatment or medical device (eye too small or too large)
* Pregnancy, breastfeeding, lack of contraceptive use among women at risk of having a child
* Participation in another clinical investigation of a medical or surgical treatment can affect the intraocular pressure in the three months preceding the HIFU
* Patient minor or major protected by law
Drum-Assisted Therapy for Native Americans

Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is an R-21 NIH/NCCAM-funded study aimed to complete the development and pilot a new substance abuse treatment protocol utilizing drumming for American Indians/Alaska Natives with substance use disorders. The study includes activities to complete the protocol, followed by a randomized-controlled clinical trial.

During year 1, this study consists of a series of focus groups conducted among American Indians/Alaska Natives with substance use disorders, providers serving AI/ANs with substance use disorders, and a Community Advisory Board. These focus groups are conducted in order to obtain feedback with regard to the initial DARTNA treatment protocol. These focus groups are then followed by a pretest of DARTNA among 10 AI/ANs with substance use disorders followed by a series of focus groups to finalize the development of DARTNA. During year 2, a randomized controlled will be conducted among 30 AI/ANs receiving the DARTNA treatment protocol vs. 30 AI/ANs receiving treatment-as-usual at United American Indian Involvement, Inc. in Los Angeles.

Eligibility Criteria:
Inclusion Criteria:

* meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR; American Psychiatric Association, 2000) criteria of current alcohol or drug abuse or dependence
* self-identifying as at least ¼ American Indian/Alaska Native heritage
* seeking treatment for alcohol or drug abuse
* being at least 18 years old. Clients will be assessed for suitability for outpatient treatment.

Exclusion Criteria:

* have a psychiatric conditions that is not suitable for outpatient treatment (e.g., if they require inpatient rehabilitation treatment, have significant psychiatric disorders, require medical detoxification, or have significant medical problems)
* have a current suicidal ideation/plan as assessed by the ASI or BSI
* are mandated by the court to obtain treatment for substance abuse where such mandate requires the results of urine toxicology tests to be reported to the court
* expectation that the participant will fail to complete the study protocol due to probable incarceration or relocation from the clinic area.
Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. The purpose is to establish a model of how to measure mental and physical load in laparoscopy.

The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Most studies have been conducted in laboratory set-ups: Black Box.

This study will establish a model of how to measure the biomechanical loads at muscular, joint and postural level, as well as measuring stress-hormone and cardiac rhythm. The study is a precursor of ergonomic studies performed inside the operating room. Advanced operating rooms designed specially for laparoscopy have been introduced in many departments. We do not know if they are more ergonomically correct. We will simulate laparoscopic tasks in an operating room. The hypothesis is that a traditional laparoscopic set-up is more demanding than a set-up mimicking an advanced operating room.

Eligibility Criteria:
Inclusion Criteria:

* Healthy doctors

Exclusion Criteria:

* Pregnancy
* Left handed
* Endocrine disease
* Cardiac rhythm disturbances
* History of recent injury in shoulder/arms
Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months.

The study is randomized in the two following arms:

Control arm (standard care pathway) Psychosexual intervention arm

The aim of the study is to evaluate the effectiveness of a psychosexual intervention on sexual functioning, mood (levels of depression and anxiety), sleep, and quality of life, compared to standard care pathway. Considering the high incidence of sexual dysfunction in breast cancer patients, this study will focus on this population of patients.

The psychosexual intervention aims to improve female sexual functionality and satisfaction by facilitating the understanding of disorders, enabling adequate assessment of possible interventions, and adopting specific treatment exercises.

Patients will be randomized in one of the following two arms:

Control arm (standard care pathway) Psychosexual intervention arm

Eligibility Criteria:
Inclusion Criteria:

* Women with age \>=18 years;
* Breast cancer patients undergoing hormonal therapy for at least 6 months in accordance with clinical practice and scientific evidence;
* Pre-menopausal patients (regular menstrual cycles in the last year) before the start of oncological treatments;
* Presence of one or more criteria of sexual dysfunction as per DSM-5;
* Acceptance and signature of the Informed Consent.

Exclusion Criteria:

* Patients in postmenopausal status;
* Presence of psychiatric or neurological conditions that impair the ability to perform the exercises proposed by the research project;
* Already undergoing psycho-sexual counseling;
* Refusal to sign the informed consent