cyrilzakka/clinical-trials huggingface dataset:
Aneurysmorrhaphy of Vascular Access for Haemodialysis

In patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative treatment, but precise recommendations when and how to intervene in available guidelines are missing.

Several surgical (remodeling, resection and substitution, ligation) and endovascular techniques have been described in the AAVF treatment, but there is currently no prospective randomized study comparing these techniques.

In 2008, our team published the first experience with a new surgical method of AAVF treatment - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was validated in several studies and has shown a good long-term patency and a minimal incidence of complications.

AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress, turbulent flow, endothelial damage, and thrombus formation, which should improve vascular patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized study comparing the effect of external porous prosthesis on AVF patency and the incidence of postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

1. Signature of informed consent.
2. A male or female subject aged 18 or older.
3. A subject with a naive vascular access aneurysm indicated for surgical treatment.

Exclusion Criteria:

1. Patients with pseudoaneurysm of prosthetic vascular access
2. Patients with a vascular access infection
Aprotinin US Special Access Protocol

This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older
* Patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. These patients may include the following:

  * Patients receiving preoperative antithrombotic drugs (e.g., clopidogrel, aspirin),
  * Patients undergoing repeat CABG or complex CABG procedures,
  * Patients undergoing urgent or emergent CABG procedures,
  * Patients who refuse to receive allogeneic blood products for religious or other reasons,
  * Patients undergoing primary CABG with advanced age or multiple comorbidities such as preoperative anemia, coagulopathies, diabetes mellitus, and peripheral vascular disease
* The physician has determined that no acceptable alternative comparable therapy is available for the patient and that there is a clearly favorable benefit-risk for the drug in that individual patient
* Documented, signed, dated informed consent obtained prior to entry into the study

Exclusion Criteria:

* Patients with a known or suspected previous aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products, and the use of these products should be considered when evaluating previous aprotinin exposure
* Patients with a known or suspected allergy to aprotinin.
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
2. Participants who have received the following previous therapy:

   1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
   2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:

      * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
      * those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either:

        * platinum doublet chemotherapy
        * Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Participants who is assessed as having at least one resectable lesion.
5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
6. Participants who have adequate organ function.
7. Cardiac function test required.
8. Pulmonary function test may be required.
9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.
10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

1. Participants who have melanoma of uveal/ocular origin.
2. Participants who have symptomatic untreated brain metastases.
3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
5. Participants who have any form of primary immunodeficiency.
6. Participants who have another primary malignancy within the previous 3 years.
7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.
DDI HV (ATV - Merck)

The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
* Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
* Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
* Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration
FAMILY Sleep Program

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.


Eligibility Criteria:
Inclusion Criteria:

* The eligibility criteria for patients are

  * newly diagnosed with stage I to IV of a solid tumor
  * diagnosis in the past three years at the time of enrollment
  * having a consistent sleep partner.
* The eligibility criterion for caregivers is

  * a sleep partner of the patient.
* Additional eligibility criteria for both patients and caregivers are

  * Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  * willing to change sub-optimal sleep habits,
  * 18 years or older,
  * able to speak/listen English at the 8th grade level for intervention sessions,
  * able to read English or Spanish at the 8th grade for self-reported questionnaires, reside in Brevard County, Florida (FL),
  * only for participants of Aim 2, \> 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria:

* Exclusion criteria for both patients and caregivers are:

  * having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
  * active suicidality, or substance or alcohol dependency in the past year;
  * currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
  * both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and
  * plan trans-meridian travel during the period of data collection blocks; and
  * having hearing or visual impairment, dementia, or cognitive dysfunction.
* Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.
Tai Chi for Patients With Rheumatoid Arthritis

The purpose of this study was to study the impact of Tai Chi group exercise on physical function, health and disease activity of patients with RA, and to examine the patients' experience and perception of Tai Chi.

Rheumatoid arthritis (RA) is a chronic, inflammatory and systemic disease that mainly affects the musculoskeletal system. The disease is often progressive and may result in reduced physical function, pain, fatigue, and joint destruction. Exercise programs are reported to improve physical functioning in patients with RA.

Tai Chi is a traditional Chinese martial art that was developed in the 13th century, and combines slow and gentle movements with mental focus.

The aim of this study was to examine the impact of a 12 weeks standardized Tai Chi group exercise program on disease activity, physical function and health status in patients with RA attending. Further, the patients experiences of possible effects of Tai Chi were to be obtained in a focus group interview.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA according to the American College of Rheumatology (ACR) 1987
* Stable medical treatment
* No earlier experience with Tai Chi

Exclusion Criteria:

* Lack of ability to bear weight on the lower extremities
* Recent or ongoing disease flare
* Unstable heart condition
* Participation in other physical exercise interventions more than twice a week included in other intervention studies.
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study

LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

Article Focus

* The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined as the highest efficient dose under toxicity restrictions for treating neonatal seizures.
* LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose levels of levetiracetam.

Strenghts and limitation of study

* For the first time, levetiracetam will be used as the first-line treatment of neonatal seizures and not as an add-on therapy.
* Statistical model is designed for a rare clinical situation with a sequential adaptive method updating in real time the dose allocation for next patient by using all available data from previous participants.
* The targeted population, i.e. the newborn less than 3 days of life, is particularly sensitive and the written consent of both parents is required before the levetiracetam administration.

Eligibility Criteria:
Eligibility Criteria:

1. Male or female term baby with gestational age of 36-43 weeks and postnatal age \< or= 72 hours
2. One or more of the following :

   * APGAR score \< 5 at 5 mins
   * Umbilical cord or arterial blood sample (within one hour after birth): pH \<7.0 or base deficit \> or = 16 mmol/L or lactates \> or equal to 11 mmol/L
   * Abnormal neurological examination before 6 hours of life
3. Suspected clinical or EEG seizures

Inclusion criteria:

* A seizure lasting more than 3 minutes or more than 2 seizures lasting more than 20 seconds on a 1 hour-period on standard EEG recording 4 hours before the levetiracetam loading dose
* Availability of 8 electrode EEG recording
* Written informed consent of both parents or the authorized guardians
* Subscription to social security health insurance are required

Exclusion Criteria:

* Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome or major congenital malformation
* Congenital (in utero) infection (TORCH)
* Babies who have received phenobarbital or any other anticonvulsive medication other than a bolus of midazolam for intubation
* Anuria/renal failure defined as serum creatinine \> 150 micromol/L
* Seizures secondary to treatable metabolic etiology as hypoglycemia and hypocalcemia
* Corrected QT interval (QTc) greater than 450 milliseconds on the electrocardiogram (ECG) prior to inclusion in the presence or absence of a condition that promotes QT prolongation (hypokalemia, maternal treatment during childbirth or treatment of the child with drugs known to prolong QT),
* Participation to an interventional research study
The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism

Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.


Eligibility Criteria:
Inclusion Criteria: Serum testosterone concentration \< 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

Exclusion Criteria: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies

-
Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard.

The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

Several commercial nucleic acid amplification tests (NAAT) are available to identify causative organisms. One of these commercial tests has undergone validation published in a scientific journal, only in an STD clinic population. The primary outcome of this study is to compare NAAT diagnostic methods to traditional gold-standard tests for BV, VVC and TV in symptomatic and asymptomatic women in the general gynecology office as well as in a vulvovaginitis referral office. Addressing incorrect evaluation and diagnosis will lead to correct treatment for women suffering from vaginitis.

Eligibility Criteria:
Inclusion Criteria:

1. Female participants aged 18 and older
2. Based on symptoms:

   * Symptomatic patients: with symptoms of vaginitis that include abnormal discharge, malodor, itching, irritation and / or discomfort
   * Asymptomatic controls: no vulvovaginal symptoms
3. Willing to provide written informed consent for participation in this study

Exclusion Criteria:

1. Use of oral antibiotics in the past 14 days
2. Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour
Improving Bowel Preparation With an Educational Video

The investigators goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. The video will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized fashion, patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a link to watch the instructional video. The investigators hypothesize that an educational tool that provides visual examples of a good and poor preparation, examples of the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and fewer recommendations for repeat colonoscopy based solely on inadequate bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* all outpatients
* age \>18
* referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

* inpatients
* prisoners
* patients allergic to PEG-ELS based laxatives
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery

The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery.

The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Undergoing colorectal surgery (predictable duration \> 90 min)

Exclusion Criteria:

* Patients with known history of hypersensitivity to cefoxitin or others beta-lactams
* Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)
* Patients with severe renal insufficiency (clearance creatinine \< 30ml/min)
* Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis
Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement

This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark

Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients.

Design: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.

The project consist of three substudies:

* Determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest.
* Evaluate the effect of implant design on postoperative mechanical muscle recovery
* Evaluate the effect of implant design on postoperative gait

Eligibility Criteria:
Inclusion Criteria:

* Primary arthrosis

Exclusion Criteria:

* Osteoporosis, (T-score \< 2.5 SD) of proximal femur
* BMI \> 35
* Severe acetabulum dysplasia (AP centre edge \< 15-20°)
* Femur anteversion \> 25°
* Severe caput deformity
* Leg length discrepancy \> 1 cm
* Off-set problems
* Earlier fracture of the ipsilateral proximal femur
* Rheumatoid arthritis
* Neuromuscular or vascular disease
Postoperative Pain Management on Patients Undergoing Lung Tumor Resection

Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.

This prospective, observational study is planned to investigate the efficacy of different MMA regimens conducting in our hospital. Patients undergoing video-assisted thoracoscopic (VATS) lung tumor resection will be invited to participate in the study and grouped based on the MMA regimens. Anxiety, quality of recovery, pain intensity will be evaluated pre- and post-operatively. Demographic data, surgery record, medicine record and postoperative complications will be gained from medical history system and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. aged above 18.
2. diagnosed as lung cancer.
3. planning to undergo primary, video-assisted thoracoscopic lung tumor resection.
4. American Society of Anesthesiology Physical Class 1\~3.

Exclusion Criteria:

1. unable to take assessments of the endpoints.
2. having this surgery in an emergency.
3. surgery involving other orangs, such as esophagus and stomach.
4. severe abnormality of cardiac, hepatic, or renal function.
5. allergic to opioids.
6. allergic to NSAIDs.
7. diagnosed as chronic pain or chronic use of analgesics.
8. unsuitable for participation judged by investigator.
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.


Eligibility Criteria:
Inclusion Criteria:

* Primary hyperparathyroidism who will be undergoing parathyroid surgery
* Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria:

* Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)
* Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
* Patients with secondary or tertiary hyperparathyroidism