cyrilzakka/clinical-trials huggingface dataset:
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers

Single centre, randomised, open-label, two-way crossover study to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of gliclazide.


Eligibility Criteria:
Inclusion Criteria:

Subjects were eligible for the study if they fulfilled all of the following inclusion criteria:

* Male or female subjects aged between 18 and 45 years, inclusive.
* Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
* Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
* Able and willing to give written informed consent.
* (If female) Not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
* (If female) Negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

Subjects were not eligible for the study if they fulfilled any of the following exclusion criteria:

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* Clinically relevant surgical history.
* History of relevant atopy or drug hypersensitivity.
* History of alcoholism or drug abuse.
* Consumed more than 14 units of alcohol a week.
* Significant infection or known inflammatory process at screening or admission to each treatment period.
* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
* Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
* Used any investigational drug or participated in any clinical trial within 6 months prior to screening.
* Participated in more than 2 clinical trials within the 12 months prior to screening.
* Donated or received any blood or blood products within the 3 months prior to screening.
* Vegetarians, vegans or with medical dietary restrictions.
* Could not communicate reliably with the investigator.
* Unlikely to co-operate with the requirements of the study.
* Unwilling or unable to give written informed consent.
* (If female) Pregnant or breast-feeding.
* (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
Open Versus Laparoscopic Radical Cystectomy

To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
2. Patients with an indication to ureterocutaneostomy or ileal conduit
3. ECOG Performance Status ≤ 2
4. WBC count ≥4,000/μL; platelet count ≥150,000/μL

4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC

Exclusion Criteria:

1. Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)
2. Patients who have previously received any pelvic irradiation
3. Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
4. Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
5. Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
Safety and Efficacy of P-ESWL and ERCP

To determine the types, incidence and risk factors of adverse events after pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP), define the grading criteria of adverse events after P-ESWL and ERCP, and analyze the efficacy of P-ESWL and ERCP, which will provide evidence-based medical evidence to guide physicians' clinical practice.

Currently, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) has become the preferred treatment for pancreatic duct stones. Although some studies had confirmed the safety and efficacy of P-ESWL and ERCP, the sample size were small and the follow-up period were short. Therefore, investigators designed this study with a large sample and a long follow-up period to clarify the efficacy and safety of P-ESWL and ERCP, so as to guide clinical work, standardize the diagnosis and treatment process of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in Changhai Hospital from 2011.03.01 to 2018.06.30.
* Painful patients with chronic pancreatitis.
* Patients who completed pancreatic extracorporeal shock wave lithotripsy.

Exclusion Criteria:

* Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.
* Patients who refused to participate in the study.
Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery

Exclusion Criteria:

* ASA 4 patients
* Maternal population
* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
* Patients with neuromuscular diseases
* Patients who refuse to participate in the study.
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.


Eligibility Criteria:
Inclusion Criteria:

1. Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
2. Cases with at least 2 year follow-up
3. Cases with regular follow-up visits completed

Exclusion Criteria:

1. Cemented sleeves
2. Patients with less than two year follow-up completed
3. Cases lost to follow-up
A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)

This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as defined by this screening protocol will have potential access to the separate vemurafenib protocol MO28072.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
* Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Uncontrolled concurrent malignancy
* Active or untreated CNS metastases
* History of known carcinomatous meningitis
* Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)
* Uncontrolled, severe medical illness or condition as defined in protocol MO28072
Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in young adults as a result of acute administration of a fruit-derived flavonoid-rich or flavonoid-poor drink.

There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to ameliorate age-related cognitive decline. Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-oxidant, anti-inflammatory and neuroprotective effects for example by increasing cerebral blood flow, protecting vulnerable neurons, enhancing existing neuronal function or by stimulating neuronal function. The research will initially involve a randomised cross-over human dietary intervention trial using two flavonoid-rich drinks (flavanone-rich and flavanone-poor) to investigate changes in cerebral blood flow in young adults (n=6; age range 18-30 years). Changes in cognitive performance and measures of serum BDNF levels will then be investigated in a second randomised cross-over trial using the intervention drink showing the greatest effect on cerebral blood flow in young adults (n=24; age range 18-30 years) and using a range of sensitive tests of executive function. The study is designed to measure acute effects of types of flavonoid supplementation and, as well as the primary cognitive outcome, will assess flavonoid/metabolite and BDNF (brain-derived neurotrophic factor) levels in blood and changes in vascular reactivity.

Eligibility Criteria:
Inclusion Criteria:

* MMSE between 26 and 30
* 18-30 years of age
* Native or good English speaker
* Normal BMI/body fat composition
* No significant vision, hearing or language problems
* Able to consume the beverages

Exclusion Criteria:

* Any form of disease/major mental illness/chronic fatigue syndrome
* On medication for hypertension/elevated lipids/diabetes
* On medication known to impact endothelial function
* Gall bladder/gastrointestinal abnormalities
* Sensitivity to orange or apple
* High consumer of fruit, vegetables, fruit beverages
* High consumer of caffeine or alcohol
* Consumer of illegal substances
* Vegetarian/vegan/other dieter/vigorous exerciser
* Use of antibiotics in the previous 8 weeks
* Consumer of dietary supplements
Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo

The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.

The secondary objectives of the study are to compare the two devices in terms of:

A. contact surface. B. heel pressure. C. On the occurrence of pressure ulcers anywhere on the body at month 1. D. patient comfort after 1 month (visual analog scale ranging from 1 to 10).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient spends more than 12 hours in bed with a possible verticalization and a predictable length of stay of at least 1 month.
* The patient has a stable medical condition (no complications in the last 10 days) without pressure ulcers
* The patient is at risk of pressure ulcers assessed a score ≤ 14 on the Norton scale
* The patient's weight is less than 120 Kg

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Contra-indication for strict decubitus dorsal position
* The patient has a rotation of the pelvis, asymmetric deformations of the hips in the frontal plane.
* The patient has bedsores, a recent scar in a pressure area.
* The patient has a knee flexion deformity\> 10 °
* The patient is agitated or uncooperative
* The patient's weight is greater than 120 Kg
Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.

Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Able to read, speak and understand English.

Exclusion Criteria:

* Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;
* Experience of recurrent fainting spells;
* Report of a chronic pain condition;
* Use of alcohol and/or pain medication in the last 24-hours;
* Currently receiving psychiatric care;
* Problems with allergic skin reactions or excessive bruising;
* Previous participation in a cold pressor experiment.
* All participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions.

These exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks.
Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

Rupture of the external anal sphincter occurs in about 4% percent of deliveries. It is not clear from other studies whether the results concerning anal function, e.g. fecal continence, are better with the overlap repair or end-to-end repair of the injured muscle. The researchers randomize women at birth to either overlap or end-to-end when the injury is recognized, and examine them one year later with special anal physiologic examinations and a validated questionnaire. The hypothesis is that the overlap technique is superior.

Rupture of the external anal sphincter occurs in about 4% percent of deliveries in our department. It is not clear from other studies whether the results concerning anal function are better with the overlap repair or end-to-end repair of the injured muscle. Our routine has been to perform an end-to-end repair, though anal surgeons, in the setting of a secondary repair, prefer the overlap method. Former studies, when the repair was performed by highly skilled operators, have indicated that the overlap method is better.

We wanted to compare the two methods through a RCT with the end-points examination results after one year addressing endoanal sonography findings, anal manometric results and continence score evaluated by a Weksner score questionnaire. Our study is performed in the routine clinical setting. The patients are recruited to the study during delivery when the injury is recognized. When she has given her informed consent she is randomized to one of the two operation methods. The operation is performed by the consultant obstetrician on call or the resident supervised by the consultant. The proctologist who performs the anal manometry and sonography after one year is blinded to the surgical method.

We plan to include approximately 160 patients at one center. In our center we have about 4500 deliveries per year.

Eligibility Criteria:
Inclusion Criteria:

* Delivery
* Anal sphincter rupture

Exclusion Criteria:

* Lack of ability to understand the informed consent form
* Lack of ability to cooperate
CAPTURE 2 Post-Marketing Registry

The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.

CAPTURE 2 is an amendment to the CAPTURE study and will provide a mechanism for collection of data from the RX ACCULINK and RX ACCUNET Systems, when used by a broad group of physicians under commercial use conditions. The original CAPTURE study had built-in features that limited the ability to collect on-going real world data because it restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (40 patients per site). CAPTURE 2 will not have these restrictions. CAPTURE 2 is a descriptive post-approval registry that will be conducted at approximately 400 clinical sites in the United States with open-ended enrollment. The purposes of this registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System (EPS) can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program. As with the previous CAPTURE study, data will continue to be collected on any rare or unanticipated events that may occur. Patients in CAPTURE 2 will be followed after the index procedure to 30 days. During the 30 day follow-up period, any occurrence of death, stroke, myocardial infarction (MI), new neurologic events, and device-related adverse events will be reported to Abbott Vascular.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent for data collection.
2. Intent to use the RX ACCULINK and RX ACCUNET to treat carotid artery disease.

Exclusion Criteria:

none.
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy.

The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH.

The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.

All enrolled patients will have a follow-up period of 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be an incident patient, i.e.newly diagnosed with PH
* Age at time of diagnosis is at least 3 months and less than 18 years
* Patients must present with PH belonging to one of the following categories

  * Group 1 according to updated Nice clinical classification
  * Group 3 according to updated Nice clinical classification
  * Group 4 according to updated Nice clinical classification
  * Group 5 according to updated Nice clinical classification
* PH confirmed by heart catheterisation (HC)
* At HC, the patient must present with mean pulmonary arterial pressure (PAP) of at least 25 mmHg at rest, a pulmonary vascular resistance index (PVRi) equal to or below 3 Wood units\*m\^2 and mean pulmonary arterial wedge pressure (PAWP) below or equal to 15 mmHg
* In case of congenital heart disease (CHD) patients who had undergone palliative procedure or repair to close systemic to pulmonary shunt, the diagnosis of PH must have been confirmed by HC at least 6 months after surgery/palliative procedure took place
* For patients with PAH-CHD open shunt, only those considered not operable due to advanced pulmonary vascular disease are eligible
* Patients to be included into the registry, and/or their legal guardians, must give informed consent. Where applicable patients will be asked for their written assent
* Participating sites must agree to adhere to the recommendations of the WSPH 2015 Nice, Pediatric Taskforce.

Exclusion Criteria:

* Patients belonging to Group 2 according to updated Nice clinical classification