cyrilzakka/clinical-trials huggingface dataset:
Suicide Prevention for Justice Involved Managed Care Subscribers

The goal of this clinical trial is to test the effects of two suicide prevention interventions for individuals released from jail. The main questions it aims to answer are: Does the use of Caring Contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? and Will providing training and resources to behavioral health providers improve re-engagement with healthcare services for patients recently released from jail? Participants will include (1) subscribers of a managed care organization (MCO) and (2) behavioral health providers within the MCO system. Interventions include sending subscribers Caring Contacts letters for 6-months following jail release and providing resources and training to behavioral health providers to target healthcare re-engagement and suicide prevention.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Behavioral health (BH) providers/staff employed at a CareSource BH agency

Exclusion Criteria:

* None
Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

New porous tip catheters appear more effective in atrial fibrillation ablation than conventional irrigated catheter, with the same safety. We could hypothesize porous tip irrigated catheters are more effective than conventional irrigated catheter, reducing procedure time and RF ablation time.We realize a randomized comparison study.

For that, 70 patients with an indication for isthmus-dependent atrial flutter ablation will be randomized to conventional irrigated catheter ablation or porous tip irrigated catheter ablation. A ECG-Holter examination will be done at 1 month follow up after catheter ablation, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergone to cti-dependent atrial flutter ablation.

Exclusion Criteria:

* Left atrial flutter or atrial fibrillation
* Femoral venous access not available.
* Anticoagulation not therapeutic in patients at high thrombo-embolic risk
* Other contraindications to radiofrequency ablations: pregnancy, malignancy
Pilot Study of an Innovative Physiotherapy in Patients With Infantile Spinal Muscular Atrophy (SMA)

This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3 Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific exercise should promote motor skills of trained patients, as we have observed in different mouse models. Patient's motor skills will be assessed using different scales including MFM and Hammersmith.

This clinical trial attempts to develop a new non-invasive motor scale with sophisticated instruments.

This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of currently available scales.

In addition, the study attempts to validate a questionnaire on post-exercise physical well-being.

This multicenter study is based on a longitudinal assessment of the natural disease progression and on the effects of exercise protocol in a swimming pool. This study will compare patients to themselves after determining motor skills and the disease natural course for 12 months.

The study will compare different scales (MFM, Hammersmith) to our new innovative scale based on non-invasive analysis of motor skills.

30 patients will be enrolled and tested with MFM, Hammersmith and our non-invasive scale every 6 months for a total of 18 to 36 months due to the slow natural progression of the disease.

Among these 30 patients, 10 patients will be selected to perform a 6 months training in a swimming pool, from 12 to 18 months or 18 to 24 months or 24 to 30 months after enrollment, in defined and reproducible conditions.

These trained patients will finally be reassessed at 18 and 24 months or 24 and 30 months or 30 and 36 months to test the therapeutic effect of the training compared to the slope of the natural disease progression, and other parameters.

Only patients who have undergone training in the swimming pool will be reevaluated at 24 or 30 or 36 months (6 months post-training) to assess long term exercise effects.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with type II SMA who can sustain a sitting position without orthopedic corset or type III SMA, with genetic confirmation of the disease.
2. Age from 5 to 10 years old.
3. Patient able to understand and execute training instructions, and perform predetermined movements.
4. Patient able to achieve physical exercises in a swimming pool.
5. MFM score \> 35.
6. Patient having any contraindication to physical rehabilitation in a swimming pool.
7. Consent signed by the holders of parental responsibility for children participating in the study.
8. Patient with social security insurance.

Exclusion Criteria:

1. Pneumonia: the inclusion is to be delayed for at least 3 months after recovery of infection.
2. Heart, renal or hepatic failure.
3. Patient undergoing a major surgery during the study: spinal fusion.
4. Patient under the care of a guardian.
5. Inability to cooperate.
6. Medication potentially interfering with the SMA (i.e., riluzole, salbutamol, phenylbutyrate, sodium valproate) started less than 6 months before inclusion.
Sex-specific Effect of Restricted Sleep on Brain Health

The goal of this clinical trial is to compare the impact of restricted sleep on brain blood health in healthy men and women. The main question\[s\] it aims to answer are:

* Whether morning cerebral blood flow velocity is greater following a night of normal sleep compared to restricted sleep
* Whether the effect of sleep restriction on cerebral blood flow will be greater in males compared to females Participants will complete one 1-hour screening visit and two 2.5-hour study visits. Study visits will be conducted on two separate days.

Transcranial Doppler (TCD) is a non-invasive diagnostic tool used to estimate cerebral blood flow velocity (CBFV), cerebral autoregulation, cerebrovascular reactivity (CVR), intracranial pressure, cerebral perfusion pressure as well as other indicators of cerebral hemodynamics and autoregulation. Whereas TCD has been widely used in research, clinical, and outpatient settings, studies specifically designed to examine the effect of limited sleep on brain health and potential impact of sex are sparse. Thus, the present study will investigate sex-specific differences in cerebral blood flow under conditions of normal and restricted sleep. Investigators will conduct measures of CBFV and CVR on two separate days under tightly controlled experimental conditions. This study hypothesizes greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep. This study further hypothesize the effect of sleep restriction on CBFV and CVR will be greater in males compared to females. Results from the present study will provide important data necessary to develop future, well-controlled studies examining the impact of long-term modifications in exercise and/or sleep on cerebral hemodynamics and, by extension, risk for cerebrovascular events (i.e. stroke).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women, 18-45 years of age, BMI 18-30 kg/m2, non-pregnant, non-breastfeeding, and non-nicotine users

Exclusion Criteria:

* any medications known to affect sleep, autonomic, metabolic, or cardiovascular health, have a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological disease, stroke or neurovascular disease, bleeding/clotting disorders, sleep apnea or other sleep disorders, diabetes, history of alcoholism or substance abuse, major cardiovascular event or surgical procedure within the past three months, or hypertension
Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response

Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.

Serum AMH has shown to have a high predictive capability of the ovarian response to stimulation for IVF. On the other hand, patients who are carriers of polymorphisms in the FSH and LH receptors, have shown to need higher doses of gonadotrophins for ovarian stimulation. The proportion of carriers has been described to be around 20% of the population. Nevertheless, the determination of these polymorphisms is not performed in routine practice. It is unknown if their presence affects to the relationship between serum AMH levels and ovarian response.

This is a prospective, single center, non-interventional, cohorts study.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age presenting to IVF clinic
* BMI of 18-35 kg/m2
* Having been tested for serum AMH with the Elecsys assay
* Being planned to undergo ovarian stimulation cycle for IVF with the GnRH antagonist protocol
* Signed written informed consent or waiver

Exclusion Criteria:

* Current or past disease affecting ovaries, gonadotropin or sex steroid
* Current hormone therapy
Assessment of Knowledge, Attitude, and Practice of Minimal Intervention Dentistry in a Group of Dental Interns

Minimal intervention dentistry (MID) is a modern medical approach that aims to maximize preservation of healthy dental tissues. When operative intervention is required it is as minimally invasive as possible. This study will assess the knowledge of a group of dental interns regarding minimal intervention dentistry in Egypt and whether this knowledge is translated into positive attitude and practice among them.

Healthy oral tissues enable the child to eat, speak and socialize which contributes to general wellbeing. Dental caries during childhood is a major public health problem and throughout the 20th century, the dominant practice patterns of managing dental caries relied on the purely surgical approach of G.V Black such as the concept of "extension for prevention". One of the drawbacks of this approach is an unnecessary removal of healthy oral tissues.

Comprehensive knowledge of dental cariology, advances in dental restorative materials and modern diagnostic devices are changing pediatric restorative dentistry.

minimal intervention dentistry (MID) is a modern medical approach that aims to maximize preservation of healthy dental tissues based on individualized patient care of early detection of disease, risk assessment diagnosis, and prevention. When operative intervention is required it is as minimally invasive as possible.

There is insufficient information about knowledge and practice of modern dental approaches including minimal intervention dentistry among dental interns in Egypt. Available studies concerned with this subject were not done in Egypt.

Due to this shortage of information, the application of MID in the Egyptian society cannot be fully assessed, and problems associated with its practice cannot be identified and solved. This shortage of information may also deprive children of getting benefits of MID.

Thus; this study will assess the knowledge of a group of dental interns regarding minimal intervention dentistry in Egypt, and whether this knowledge is translated into positive attitude and practice among them.

Knowledge, attitude, and practice (KAP) surveys can be used to identify knowledge gaps and culturally related misconceptions of new health approaches or interventions. They can determine factors influencing behaviors that are not known, and how and why people practice certain health behaviors.

KAP surveys can be also used to identify needs, problems and barriers, as well as solutions for improving quality and accessibility of health services by studying factors and possible determinants influencing treatment decisions.

This study aims to identify deficiencies (if present) in knowledge, attitude, and practice of MID among a group of dental interns in Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Dental interns attending pediatric dentistry in the faculty of dentistry, Cairo University.

Exclusion Criteria:

* Interns refusing to participate in the study.
Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy

This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

Eligibility Criteria:
Inclusion Criteria:

* patients who picked-up Co-meds in the study period

Exclusion Criteria:

* NONE
Study Looking at the Effect of Silverlon on Post Operative Wound Infections

This clinical study is a prospective, randomized, controlled trial of patients undergoing elective colorectal surgical procedures that receive an abdominal skin incision of at least 6 cm. Treatment with Silverlon® will be compared to standard postoperative dressings of 4x4 Gauze and paper tape. Patients will be randomized with a 1:1 treatment allocation ratio to receive either 1) Silverlon® or 2) standard postsurgical dressing. Neither the Investigators nor the participants will be blinded to the treatment modality after randomization.

Silver has long been known to have antimicrobial properties. It interacts with structural proteins and DNA, inhibiting bacterial replication and causing fatal structural changes within the cell wall. It has broad antimicrobial activities and unlike antibiotics, it is rarely associated with microbial resistance. Silverlon® is a silver-nylon dressing specifically designed for surgical wounds to prevent the development of surgical site infections. It is an easy to use product with no known microbial resistance or adverse effects. The efficacy of Silverlon® in preventing surgical site infections has been shown in several retrospective studies but as of yet has not been tested in a prospective fashion. The objective of this study is to perform a prospective, randomized, clinical trial directly comparing the incidence of surgical site infections in patients treated with Silverlon® to standard postoperative dressing following elective colorectal surgery


Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing elective colorectal surgery by a trained colorectal surgeon with an abdominal skin incision of at least 3 cm
2. Patients that are willing and able to comply with the requirements of the protocol including follow-up requirements
3. Patients willing and able to sign a study specific informed consent

Exclusion Criteria:

1. Patients that fail to meet the skin incision size criteria
2. Patients with a known allergy to silver
3. Patients less than 18 years of age
4. Any contraindication to undergoing a surgical procedure under general anesthesia
5. Patients with preoperative evidence of a current abdominal wall infection/surgical site infection from a previous laparotomy/laparoscopy
6. Patients that have received antibiotic therapy within the week prior to surgery
7. Patients with preoperative evaluation suggestive of an intra-abdominal process that would preclude full closure of the skin
8. Patients with a previously placed anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure
9. Women who are pregnant or breast feeding or are considering becoming pregnant during the follow-up period
10. Mental incompetence as determined by the Investigator which would affect participation in the study
11. Concurrently participating in any other investigational study
The Effect of Chimeric Antigen Receptor (CAR)-T Cell Therapy on the Reconstitution of HIV-specific Immune Function

To study the safety and effectiveness of CAR-T Cell therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, which is expected to enhance the res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.

Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to curing human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which HIV-1 reservoirs could be eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells.the VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving successful cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. In this clinical trial, we intend to study the safety and effectiveness of CAR-T Cell Therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, by observing the adverse events, HIV-1 reservoir and the immune index.

Eligibility Criteria:
Inclusion Criteria:

1. HIV infection confirmed.
2. Receiving cART more than 12 months.
3. HIV viral-load \< 50 copies/ml and CD4 cell count more than 350 cells/ul.
4. Without serious liver, heart, liver and kidney diseases.
5. The subjects know about the study and volunteer to attend the research and sign the informed consent.

Exclusion Criteria:

1. With active HBV or HCV infection, or serious opportunistic infections.
2. With serious chronic disease such like diabetes, the mental illness,et al
3. History of suffering from pancreatitis during cART.
4. Pregnant or breast-fed.
5. With poor adherence.
6. Unable to complete follow up.
Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.

Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.

The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.

Study design is descriptive, prospective, multicentric, and the investigators have a single database centralized in Nantes University Hospital. Patient's data will be conserved and trapped anonymously and patients all give oral consent. Information letter is given to each patient.

Typical study calendar :

Baseline :

* Patient information (letter and oral consent)
* Clinical data and comorbidities collection
* Neurological examination
* Spine X-ray
* MRI or CT-scan imaging to confirm diagnosis

During Hospitalization

* Date collection : spine immobilization modalities (type, duration, changes...), duration of bed rest
* Other treatments (antibiotic therapy : molecules and duration)
* Daily neurological examination

  3 months follow-up visit : (if usually done by physician)
* Clinical and neurological examination
* Spine immobilization assessment
* Spine X-ray
* Oswestry questionary

  6 months follow-up visit : finale visit (if usually done by physician)
* Clinical and neurological examination
* Spine immobilization assessment
* Spine X-ray
* Oswestry questionary

Eligibility Criteria:
Inclusion Criteria:

* Adults patients, male and female
* Hospitalized of a vertebral osteomyelitis in one of the Centers
* Meeting the criteria for the definition of vertebral Osteomyelitis (typical imaging findings)
* Microbiological proof of infection (blood culture or discovertebral biopsy) or high suspicion of infection (Compatible histology, good response to antibiotics and no differential diagnosis).

Exclusion Criteria:- Spine device infection

* Recent spinal surgery less than 1month
* Children under 18 years old
* Under guardianship
* Pregnant woman
Satiety Effects of the Combination of Egg and Whole Grains

The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber.

Subjects will consume 3 different breakfast meals. Satiety will be measured by visual analogue scales; food intake will be recorded at subsequent meal as well as 24 hour food log; blood glucose response will be assessed following test meals. Subjects will consume an ad libitum lunch meal 3.5 hours after breakfast meal and food intake will be measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy,
* non-smoking,
* BMI of 18-27,
* non-dieting,
* typically consumes breakfast/lunch

Exclusion Criteria:

* distaste for eggs,
* vegetarian,
* current smoker,
* restrained eating habits,
* recent weight change,
* history of significant disease of past medical history,
* pregnant,
* lactating irregular menstrual cycle
Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?

To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.

Eligibility Criteria:
Inclusion Criteria:

history of alleged organophosphorus intake age \> 14 years \< 60 years clinical signs and symptoms of organophosphorus poisoning.

Exclusion Criteria:

\< 14 years or \> 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses

≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.