cyrilzakka/clinical-trials huggingface dataset:
Rebound Hernia Repair Device Mesh Trial

This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.

The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* Unilateral or bilateral inguinal hernia (moderate in size), primary in nature

Exclusion Criteria:

* Unable to provide informed consent
* Assessed as ASA 3 or 4
* Renal failure;creatinine greater than 2.0mg percent
* Ascites as determined by clinical suspicion/ultrasound confirmation
* Known pregnancy
* Femoral hernias
* Diabetes requiring injectable insulin
* Prior lower abdominal surgery through lower midline or Pfannenstiel incision
* TAPP approach
* Requiring anticoagulants during surgery
* Participation in another study involving another device or drug
* Emergent procedures for hernia incarceration and strangulation
* Recurrent inguinal hernias
Coronary Artery Disease in Patients Suffering From Schizophrenia

Schizophrenia is a severe mental illness associated with excess mortality and affecting nearly 1% of the population. The average life expectancy for patients diagnosed with schizophrenia has been 55-60 years through the last generations in Denmark, while the general population has over the same period of time experienced an increase in life expectancy. As a result, the standardized mortality rate for patients with schizophrenia has increased markedly over the last three decades and is currently a major public health concern. Causes of death are mainly cardiovascular disease and patients diagnosed with schizophrenia has a relative risk of cardiovascular disease that is about 2-fold higher than the general population.

Little is known about severe progression of premature coronary arteriosclerosis in patients suffering from schizophrenia. Coronary artery calcium score is a well-defined measure to predict cardiovascular disease events, however there has not yet been any attempt to investigate whether there is an association between coronary artery calcium score and premature morbidity and mortality in patients diagnosed with schizophrenia.

The objective of this study is to investigate the progression of arteriosclerosis in patients with schizophrenia at different stages of the disease, and to offer and implement adequate treatment for these patients according to their somatic condition. This study will identify risk factors of somatic diseases in these patients, with specific focus on early diagnoses, prevention, intervention and treatment of arteriosclerosis in schizophrenic patients.

The investigation is about the possibility of detecting any differences between developing arteriosclerosis in schizophrenia patients versus the general population, and how common risk factors are contributing to this process. The results of this study should provide important modifications in the clinical guidelines for treatment of patients diagnosed with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of F20 schizophrenia.
* Informed statement of consent
* Age \> 18

Exclusion Criteria:

* Incompetency to create stabile relation or make agreements
* Pregnancy and also breastfeeding women
* Participants with severe claustrophobia
* Participants with lack of ability to cooperate with the planned study program.
Improving Motorcycle Taxi Driver Visibility in Tanzania

The purpose of this study is to determine whether providing motorcycle taxi drivers with a free reflective fluorescent vest will result in increased use of reflective or fluorescent clothing compared to education about wearing reflective or fluorescent clothing alone.

Road traffic injuries are the 4th leading cause of death among individuals in the economically productive age group (age 15 to 59) in low and middle income countries. The Africa region currently has some of the world's highest traffic injury rates, with vulnerable road users, including motorcycle riders, bearing a disproportionate share of the injury burden.

Motorcycles are a rapidly growing form of transport in Africa, both for personal and commercial transportation. Conspicuity measures-factors that increase a motorcycle rider's visibility-for the prevention of motorcycle crash have been previously studied and found to be associated with a decreased risk of crash.

Motorcycle taxi drivers are a particularly high risk population for motorcycle crash as they operate a motorcycle for several hours a day. Reflective, fluorescent safety vests are a common article worn by motorcycle drivers in some locations; however, penetration of such clothing in Moshi is currently low. This study aims to increase use of reflective vests among commercial motorcycle drivers. We will test whether provision of a free reflective, fluorescent vest increases use of reflective, fluorescent clothing compared to education about wearing reflective, fluorescent clothing alone.

Eligibility Criteria:
Inclusion Criteria:

* motorcycle riders who identify themselves as motorcycle taxi drivers
* individuals must work at least 2 days a week as a motorcycle taxi driver
* have a telephone number for ride solicitation
* have a license plate that is able to be recorded
* are at least 18 years old
* are willing to have us contact them in the future for repeat surveys

Exclusion Criteria:

* motorcycle riders who do not meet the above criteria
* motorcycle riders who do not consent to participate
Subcutaneous Rehydration Compared to Intravenous Rehydration

Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.

This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.

Eligibility Criteria:
Inclusion Criteria:

* Children of either gender from one month to ≤10 years of age.
* Patients with mild or moderate dehydration
* Healthy child except for the underlying etiology for dehydration
* Pre-dehydration body weight ≥ 5th percentile for age
* Parents or legal guardian(s) available to provide informed consent.

Exclusion Criteria:

* Severe dehydration
* Shock or life-threatening situation (life expectancy \< 10 days).
* Requirement for IV access for any indication other than for treatment of dehydration.
* Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
* Any condition precluding SC infusion or infusion site evaluation
* Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
* Known hypersensitivity to hyaluronidase or hylenex.
* Known hyponatremia (\< 130 milliequivalents per liter \[mEq/L\]) or hypernatremia (\> 155 mEq/L).
* Known hypokalemia (\< 3.0 mEq/L).
* Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
* Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
Insulin Bolus Required for High Fat Foods in Type 1 Diabetes

The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.

Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (U/kg).

Subjects for this study will be adults with type 1 diabetes who use an insulin pump for diabetes self-management.

Subjects will be admitted to the clinical research center in the morning in the fasting state. Subjects will have several admissions. During the initial two admissions, subjects will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5 admissions during which they will receive the pizza-high fat meal with progressively increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target range 80-180 mg/dL.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18-75 years) with type 1 diabetes \> 3 years, on insulin pump therapy.

Exclusion Criteria:

* History or symptoms suggestive of gastroparesis or gastric dysmotility; History of celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion; Eating disorder; Diet allergies; Special diet restrictions, such as vegan; Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan); High-titre insulin autoantibodies with delayed insulin kinetics; Women who are breast feeding, pregnant, or wanting to become pregnant.
Improving Safety of Lead Extraction Procedures by Traction Force Sensing

Death and vascular tears occur in up to 1% of the patients undergoing lead extraction procedures. These complications are due to abnormal force vectors during the procedure. The investigators postulate that use of bidirectional traction (superior and inferior directions) and feedback from a digital force gauge is associated with minimal lead displacement compared to conventional lead extraction. Lead displacement is an indirect risk factor for potentially fatal lead extraction complications

Use of force no greater than 8 pounds of tension will improve lead extraction and minimize lead displacement compared to current standard of care methods which do not limit the force applied. Among subjects undergoing lead extraction procedures for CIED infection, bidirectional rail (superior and inferior) and traction force objective feedback using Force gauge is associated with minimal displacement (\<1cm) of the leads (surrogate marker) on fluoroscopy compared to conventional lead extraction. • The research nature of the protocol is explicitly explained to the patient and an informed consent is explained obtained from the patient prior to the procedure. Only patients with CIED infections requiring lead extraction are enrolled in the study. Patients are risk stratified based on our current risk stratifications scheme. Multiple superior and inferior venous accesses are obtained during the procedure. The leads are prepared using locking stylets. Baseline fluoroscopic image of the position of the leads is stored. A deflectable sheath and traction forceps are deployed from the groin to provide downward rail in the force feedback arm. Locking stylet from the lead is in turn attached to a Force gauge (McMaster-Carr Santa Fe Springs, CA). The procedure is performed using continuous fluoroscopic image save tool during the procedure for post procedural viewing and analysis. The patients are randomized to the active arm (to keep force around 8 lb) or the control arm (tactile force discretion based on the operator. The investigator is blinded to the force gauge reading for half of the patients enrolled in the study. For the other half of the patients, the operator optimizes the force to prevent overexertion (\<8-9 pounds). Three point along the lead course evaluated during the study. Position of downward turn of the lead in the SVC, heel of the lead (only in case of RV lead) and the lead tip positions are evaluated. The investigators postulate that there will be at least 5 cine-fluoroscopic views per every lead. The investigators hypothesize that use of bidirectional rail and force feedback is associated with minimal displacement of the lead on fluoroscopy.

Eligibility Criteria:
Inclusion criteria:

• Patients with CIED infection requiring extraction

Exclusion criteria:

* Age \<18 years
* Noninfectious reasons for extraction
* Patients with cognitive impairment, who are unable to consent.
Return to Work After a Workplace-oriented Intervention for Patients on Sick Leave Due to Burnout

The study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. The intervention intends to reduce job-person mismatch through patient-supervisor communication.The hypothesis is that the intervention group will show a more favourable outcome than a control group with respect to return to work.

Participants are consecutively recruited in co-operation with regional social insurance offices (RSIOs) in the two southern counties of Sweden. Persons accepting participation are clinically examined and interviewed of the course of events leading up to the burnout and the patient's expectations of changes necessary to facilitate return to work are recorded. The patient´s supervisor is then interviewed at the workplace, responding to the same questions on perceived main causes of the subordinate's sick leave and changes necessary to facilitate return to work. Finally, the core intervention takes place, namely a dialogue being initiated between the patient and the supervisor to find solutions to facilitate return to work. Out of those who do not want to participate, without giving any specific reason for that, a control group is matched by length and degree of sick leave at the time of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* employment
* sick leave at lest half time 2-6 months due to work related burnout
* previously healthy

Exclusion Criteria:

* other somatic or psychiatric disease explaining the symptoms
Discovering Clinical Study Experiences of Patients With Pulmonary Hypertension

Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of pulmonary hypertension patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Able to comprehend the investigational nature of the protocol and provide informed consent
* Diagnosis of pulmonary hypertension

Exclusion Criteria:

* No diagnosis of pulmonary hypertension confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Evolution of the SURvival of Patients With SEzary Syndrome (SS) Over the 1998-2020 Period and Its Association With the Early Use of Therapeutic Monoclonal Antibodies

Sezary syndrome (SS) is a rare, aggressive and advanced form of cutaneous T lymphoma with a poor prognosis (5-year survival rate varying between 24% and 52%). The treatments are only suspensive with short-term remissions. For the past fifteen years, therapeutic approaches have been based on depleting monoclonal antibodies (anti-CD52, anti-CCR4, anti-KIR3DL2, anti-CD70), or antibody-drug conjugates (anti-CD30). But while the efficacy of mogamulizumab on progression-free survival was reported in the phase III study, no study on a large cohort has compared the current overall survival of patients with Sezary syndrome to that before the era of monoclonal antibodies. In this context, we propose to report a large series of patients with Sézary syndrome in order to compare the current survival of patients with that of the pre-monoclonal antibodies era (1998-2003).

The objective of this study is to assess the evolution of the overall survival of patients with Sezary syndrome since the early use of therapeutic monoclonal antibodies. The underlying hypothesis of this study is that the use of therapeutic monoclonal antibodies has improved the prognosis of these patients. Patients included in this retrospective study are patients with a Sezary syndrome diagnosed between 1998 and 2020.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18 years of age
2. Patient with Sezary Syndrome diagnosed between 1998 and 2020

Exclusion Criteria:

1. Patient opposition to research
2. Patient under guardianship or curatorship, unable to express opposition
Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction

The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on penile and systemic microvascular function as well as in blood pressure.

A control group of normotensive age-matched healthy subjects will serve as a comparator group for normal penile and systemic microvascular function.

Vasculogenic erectile dysfunction (ED) is a highly prevalent health problem that is directly related with increased cardiovascular risk. In this context, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are indicated in the treatment of ED because these drugs increase bioavailability of the endothelial-dependent potent vasodilator nitric oxide. Thus, these drugs could also induce a reduction in arterial pressure and improve microvascular endothelial function in hypertensive patients.

The primary aim of the study is to investigate the acute and chronic effects of sildenafil citrate (®Viagra) on penile and systemic microvascular function of hypertensive patients presenting with ED. The secondary aim is to evaluate the effects of the treatment on arterial pressure.

The study design is a prospective 2 x 2 cross-over, randomized, double blind clinical trial that will include 75 sexually active hypertensive men (age between 50-70 years) under anti-hypertensive treatment (arterial pressure \< 160/100 mmHg) presenting with ED. Erectile function will be evaluated using the International Index of Erectile Function (IIEF-5) questionnaire. Patients with non-vasculogenic ED or diabetes will be excluded from the study. Forty-five age-matched healthy subjects will be included as a comparator group.

The evaluation of systemic microvascular function will be performed in the skin of the forearm and penile microvascular function in the skin of the base of the penis using the non-invasive methodology of laser speckle flowmetry coupled to cutaneous iontophoresis of a vasodilator (acetylcholine).

In the acute protocol, microvascular evaluation will be carried out before and one hour after the oral administration of 100 mg of sildenafil citrate. In the chronic protocol, only hypertensive men will be randomized to receive either or placebo sildenafil 50 mg twice daily for 30 days. After a 30-day washout period the patients will receive the complementary treatment.

The evaluation of penile and systemic microvascular function, as well as ambulatory blood pressure monitoring, will be performed before randomization and in the end of each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* arterial hypertension stage I or II
* erectile dysfunction (vasculogenic)

Exclusion Criteria:

* diabetes
* kidney, liver, neurologic and psychiatric diseases
Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).

Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
* Patients who underwent debridement for pilonidal disease

Exclusion Criteria:

* Patients with acute abscess (Tezel Class II)
* Antibiotic use within 4 weeks before surgery
* Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months