cyrilzakka/clinical-trials huggingface dataset:
Prevention of Parastomal Hernia by Mesh Placement

Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.

Subject to inclusion and exclusion criteria, patients will be randomized 1:1 to the control and intervention groups:

Randomization groups:

* Group 1 (control): Ileal Conduit
* Group 2 (intervention): Ileal conduit with concurrent mesh placement.

Ethicon PHYSIOMESH composite mesh will be utilized for this study. This is a composite mesh with a reduced polypropylene content. It is a widely used, commercially available hernia mesh, and its use and placement are simple and well described. The mesh will be placed at the time of radical cystectomy and ileal conduit. A small circle of mesh, the diameter of the ileal conduit, will be excised to allow for fitment around the ileal conduit. The mesh will be placed so that it encompasses the ileal conduit in a non-constricting manner, and will be sutured to the anterior abdominal wall. Product will be stored in a secure, sterile manner at the UMH operating room sterile supply room, and in accordance with institutional policies.

Patients from both groups will be followed up in a standard fashion. Follow up visits and clinical assessment will be at 6 weeks after surgery, 3 monthly during the first year, then every 6 months for at least 5 years. During each visit, patients will be clinically evaluated for the presence or absence of parastomal hernia, and any routine surveillance radiology imaging will be reviewed.

Parastomal hernia is clinically defined as an incisional hernia at the site of the ileal conduit stoma. This may be clinically apparent by examining the patient during performance of abdominal straining or Valsalva maneuver, or may be evident on radiology imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Patients eligible to undergo urinary diversion with ileal conduit.
2. Patients with the ability to understand and willingness to sign a written informed consent document.
3. Men and Women aged 18 to 80 years.

Exclusion Criteria:

1. Patients unable or unwilling to consent to the proposed surgery
2. Pregnant women
3. Patients with prior ileal conduit surgery undergoing revision.
VF Test for Prediction of Extremely PTB After Cerclage

The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening.

Prior to participants undergoing a scheduled amniocentesis two swabs to collect vaginal secretions for the VF tests will be done. During the amniocentesis your doctor will remove amniotic fluid as part of the routine clinical care. From that fluid sample, the study will use less than a quarter teaspoon for the amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.

The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervical shortening.

Prior to participants undergoing a scheduled amniocentesis, an ultrasound will be done to confirm cervical length and dilation. During a separate sterile speculum exam, the physician will use two swabs to collect vaginal secretions for the VF test. During the amniocentesis the doctor will remove approximately 2 teaspoon of amniotic fluid as part of your standard clinical care. From that fluid sample, the study will use less than a quarter teaspoon for a amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.

The vaginal fluid (VF) sample collection will take approximately 15 minutes to do. The total time in the study is about seven and a half months (from the time the patient consents until 4 weeks after delivery). The only study procedure the patient will experience during her study participation is the collection of the vaginal fluid specimens.

Eligibility Criteria:
Inclusion Criteria:

* Participant age 18 years or older
* Gestational age between 16w0d to 25w6d
* Singleton fetus with no apparent major anomalies on ultrasound exam
* Sonographically absent cervical length and/or sterile digital exam of 2cm or greater dilation
* Exam-indicated cervical cerclage has been recommended by clinician and patient agrees to proceed with cervical cerclage placement
* Decision has been made by provider to perform pre-cerclage amniocentesis to rule-out infection, with the understanding that cerclage is contraindicated if findings indicate probable or definitive infection, and patient agrees.

Exclusion Criteria:

* Planned termination of pregnancy
* Clinical features consistent with placental abruption or chorioamnionitis
* Need for immediate delivery based on maternal or fetal issues
* Fetus with ultrasound-determined major congenital anomalies
* Multiple gestation
* Rupture of membranes
* Patient does not give consent to participate in this study
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis


Eligibility Criteria:
Inclusion Criteria:

* not currently at risk of a sexually transmitted infection and willing to use other methods, such as condoms, for STI prevention;
* if diagnosed with an STI in the past two years and/or a partner was diagnosed with an STI in the past year, is willing to use condoms for STI prevention;
* willing to provide hair, blood, and urine samples;
* not currently enrolled in other STI prevention studies;
* able to speak English
* transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use
* transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use
* able to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
* willing to NOT shave hair or have a very short haircut or apply bleach for the duration of the study
* has suitable venous access for consecutive blood draws

Exclusion Criteria:

* any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions;
* pregnancy or plans to become pregnant;
* liver cirrhosis or fulminant liver disease;
* known hypersensitivity reaction to doxycycline.
* detectable doxycycline in hair at enrollment.
* unable to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
* does not have suitable venous access for consecutive blood draws
Long Term Cognitive Impact of Pediatric Acute Renal Injury

The research study will investigate the longitudinal cognitive outcomes in subjects admitted as children diagnosed with sepsis who may have had acute kidney injury. Each subject will be contacted 2-15 years after their incident admission in order to solicit responses to a functional and cognitive quality of life survey. Children admitted during the same time frame that did not have kidney injury will also be surveyed.

250 subjects with a prior admission for pediatric sepsis will be contacted 2-15 years following the incident admission in order to complete a survey to assess their overall quality of life. Children will be administered the Pediatric Quality of Life (PedsQL) survey with a parental section to allow for parental response. Adult subjects will take the adult version of the PedsQL.

Eligibility Criteria:
Inclusion Criteria:

* Subjects may be adults or children who were admitted to the hospital with a severe infection between January 1998 to December 2014.
* Consent from adult or parent/guardian of child to participate in study.
* Assent from subjects between 7 and 17 years of age.

Exclusion Criteria:

* Failure or inability to complete the survey
* Participant is unable to understand written or spoken English
* Subjects between 7 and 17 years of age unwilling to assent.
10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant

A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.

This study is a continuation of two previous conducted trials:

1. Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant:

   1. CAG5173: 6-month(1) and 3-year(2) data.
   2. CBAS5562: 5-year data(3).
2. 3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data.

In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation.

Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* To be included in the original trials, patients had to be at least 18 years old.

Exclusion Criteria:

* Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.
Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet

In this work, the investigators report the effects of consume of 15g walnuts and 15g almonds for 8 week on weight, waist and hip circumferences, body mass index, fat mass, serum LDL-cholesterol adiponectin, lipocalin-2 concentration and fatty acids profile.

The study consists of a diet-intervention in a single group under-free-living conditions. The diet was enriched with 15g of almonds and 15g of walnuts per day for eight weeks, supplied directly to the patient by the researcher. This amounts of walnuts and almonds contain polyunsaturated fatty acids of approximately 2.02g of omega 3 (alpha-linolenic acid) and 11.1g of omega 6 (linoleic acid) mostly. In a period of 14 months, the investigators recruited forty-eight sedentary subjects of 30 to 50 years old, and body mass index between 30 and 34.9 kg/m2, without evidence of chronic degenerative, infectious or neoplastic diseases, neither medication nor actually dietary treatment, and a physical level of exercise \< 2 hours/week. All participants gave their written informed consent to participate in the study. The study was approved by the Institutional Ethics Committee of the Universidad de Guanajuato.

Collected data included the clinical-nutritional history, 24-hour recalls, and the International Physical Activity Questionnaire was applied to evaluate if subjects were sedentary. The dietary intake evaluation was estimated in kilocalories/day, the amount and type of macronutrients according to the database of United States Department of Agriculture and the National Institute of Public Health (Mexico). In order to evaluate adherence to the diet, volunteers were visited every two weeks to carry out three 24-hour recalls (two on weekdays and one on weekends). Positive Adherence to the diet plan was considered when the food consumption, walnuts and almonds were not modified more than ± 20% of the amount indicated by the researcher.

The investigators recorded the anthropometric measures, body composition, and measured serum glucose, lipid profile, insulin, lipocalin 2, high sensitivity C-reactive protein, adiponectin, and fatty acids profile, which were analyzed at the baseline and after dietary intervention.

Eligibility Criteria:
Inclusion Criteria:

- obesity grade I

Exclusion Criteria:

* Subjects did not have evidence of chronic degenerative, infectious or neoplastic disease.
* Lack of adherence to the diet and consumption of walnuts and almonds
A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome

The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
* A person who is of East or Southeast Asian descent
* A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study
* If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control

Exclusion Criteria:

* A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure
* A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
* A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)
* A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
* A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
* A person who has a severe liver disease, such as cirrhosis
* A person who has a condition such as alcoholism, mental illness, or drug dependence
Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes

Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an association with T helper cells. In this study investigators aimed to investigate the difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.

The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG).

Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were compared with those in T2DPs and controls.


Eligibility Criteria:
Inclusion Criteria:

* Being \>18 years old
* Giving consent to participate

Exclusion Criteria:

* Acute and chronic inflammatory diseases
* significant concomitant disease likely to interfere with glucose metabolism,
* malignancies,
* hemoglobinopathies,
* In addition, glucose intolerance (fasting glucose level and that after glucose load) and HbA1C ≥ 5.7 % were also used exclusion criteria in the control group, group as American Diabetes Association (ADA) defined prediabetes as HbA1C between 5.7-6.4% (Standards of medical care in diabetes -2012. Diabetes care. 2012:35.)
Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. Age equal to or greater than 18.
2. Type 1 or 2 diabetes mellitus.
3. Wagner Grade 2 wound for at least 4 weeks. A diagnosis of a Wagner Grade 2 wound necessitates a persistent wound of 4 weeks (5).
4. DoD Beneficiary.

Exclusion Criteria:

1. Impending/urgent amputation due to ongoing or exacerbated infection.
2. Severe depression.
3. Claustrophobia.
4. Seizure disorder.
5. Uncontrolled asthma/severe COPD with pCO2 \> 45 mmHg on arterial blood gas.
6. Grade 4 congestive heart failure.
7. Unstable angina.
8. Chronic/acute otitis media/sinusitis.
9. Major tympanic membrane trauma.
10. Prior chemotherapy with Bleomycin and evidence of deterioration in diffusing capacity after a single hyperbaric oxygen exposure.
11. Candidates for vascular surgery/angioplasty/stenting or patients with major large vessel disease. These patients could have peripheral vascular disease of such severity that hyperbaric treatment would not improve their condition.
12. Vascular surgery/angioplasty within the last 3 months. This exclusion controls for improvements to a patients vasculature and perfusion that occur within 1-2 months after vascular surgery/angioplasty. This will ensure that any perfusion changes to the patient's diabetic wound ulcer area recorded during the study are a result of hyperbaric therapy instead of recent vascular procedures.
13. Women who are breast feeding or of childbearing potential.
14. Dementia or mental disability rendering the potential subject incapable of following instructions or consenting to treatment.
Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services

The project aims to investigate the effect of internet-based dietetic treatment (IDT) on patients, dietitians, and society.

The project will show:

* If IDT is equivalent to traditional dietetic treatment with physical meetings
* Patients' attitudes to, and experiences of, meeting a dietician through video calls
* How the dietician's work environment and working methods are affected by IDT
* If there are subgroups of patients where IDT is more or less appropriate
* Health economic and environmental consequences of IDT The major shortage of dietitians leaves patients with non-communicable diseases (NCD) without qualified dietary treatment. In a pilot study, the investigators have shown that IDT has great potential to streamline healthcare and increase accessibility. In the project Dietitian online, the investigators will conduct an RCT with 400 NCD-patients allocated to either IDT or standard dietetic treatment to see if IDT affect treatment outcome and whether IDT is appropriate for everyone. Even though internet-based treatment (IT) increases rapidly in society, there is little knowledge about the patients' experiences and how healthcare personnel incorporates IT in their daily work. The investigators will conduct qualitative studies to meet this knowledge gap. General assumptions are that IT is beneficial for society, both economically and environmentally, but very few studies have been done. The project will incorporate a full health-economic evaluation, including environmental impact.


Eligibility Criteria:
Inclusion Criteria:

* seeking/being referred to a dietitian for the treatment of obesity (BMI≥25) or obesity in combination with:

  * type 2 diabetes (HbA1c\>48mmol/mol) and/or
  * elevated blood lipids (total cholesterol \>4,5 mmol/l and/or LDL \>2,5 mmol/l and/or triglycerides \>2,0 mmol/l) and/or
  * high blood pressure (\>140/90 hg)

Exclusion Criteria:

* other diagnoses requiring/might require nutritional treatment (eg cancer, COPD)
* dementia
* severe impairment of sight, hearing, or other disability where internet-based dietetic treatment is deemed difficult
* pregnancy
* need for interpreter
Vessel Angles and Diameters in Stroke Disease

Retrospective analysis of internal carotid artery morphology on CT angiography images of patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Our study included 66 healthy individuals for control group. The control group consisted of individuals without any pathology or ischemia, selected from patients who underwent brain CTA for headache but showed no structural lesions. Additionally, none of the control group had a history of stroke or evidence of prior ischemic stroke on MRI.

Exclusion Criteria:

* After excluding patients with plaques in the carotid arteries (CCA and ICA), systemic vascular disease, risk factors for cardiogenic stroke, cardioembolism, ischemic stroke due to vasculitis or drug use, and other uncommon causes of stroke, 62 ischemic stroke patients were included in the study.
Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip

The purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board / Jamar's test)

Patients with burned hands will realise prehension test to explore dexterity of hand when they wear compressive's treatments and with free hands.

Each patient will realise each test with all conditions (free hands/ made to measure gloves/ compressive bandaging).

Running order of test and condition is randomly defined. Each patient realized this tests under the care and devices used at usual care. Realisation of this tests are not influenced by the study. Patient realised this tests during reeducation.

Eligibility Criteria:
Inclusion Criteria :

* Patient admitted from Leon Bérard Hospital
* Burn hand with 2nd or 3nd degree depp
* Dominant hand if bilateral's burning
* Patients requiring compression of the hand
* Patient receiving final compression gloves since seven days ± two days weekend
* Patient affiliated to a social security

Exclusion Criteria :

* No burning of the hand
* contraindication for the use of compression
* Incompatible articular balance with achievement tests
* Patients already included in a second study
* Minor patient or pregnant woman
* Presence of cognitive disorder, preventing the achievement of tests
* Guardianship or individual under the protection of a conservator
* Patients not receiving social security