cyrilzakka/clinical-trials huggingface dataset:
Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging

Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.


Eligibility Criteria:
Inclusion Criteria:

* women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

Exclusion Criteria:

* concomitant colo-rectal procedure
* allergy to pork
* any contraindication to laparoscopic sacrocolpopexy
Role of Echocardiography in the Assessment of Right Ventricular Function in the Pediatric Population With Valvular Pulmonary Stenosis.

Correct assessment of right ventricular function by transthoracic echocardiographic examination in pediatric patients with congenital valvular pulmonary stenosis after Percutaneous Balloon Pulmonary Valvuloplasty

The right ventricle plays an important role in the morbidity and mortality of patients presenting with signs and symptoms of cardiopulmonary disease. However, the systematic assessment of right heart function is not uniformly carried out. This is due partly to the enormous attention given to the evaluation of the left heart, a lack of familiarity with ultrasound techniques that can be used in imaging the right heart, and a paucity of ultrasound studies providing normal reference values of right heart size and function. In patients with CHD, the right ventricle (RV) may function as either the sub-pulmonary or the systemic ventricle as in transposition of great arteries (TGA). CHD more commonly affecting the right heart includes atrial septal defects (ASD), Tetralogy of Fallot (TOF), pulmonary stenosis (PS), Ebstein anomaly, arrhythmogenic right ventricular cardiomyopathy (ARVC), and pulmonary valve atresia. In many of these patients, prevention of "irreversible" right heart failure (RHF) will require timely corrective surgery or when not possible, surgical palliation . Congenital pulmonary valve stenosis is a common congenital heart disease. Isolated pulmonary valve stenosis comprises 8-10% of all congenital heart disease . While surgical pulmonary valvotomy has been available as a treatment since 1956, it requires a median sternotomy, use of cardiopulmonary bypass, and post-surgical ICU admission with multi-day hospitalization. Recognizing the potential advantages of a less invasive approach, the first attempts at percutaneous catheter-based dilation of stenotic pulmonary valves were performed in the 1950s. As the technique was refined and catheter and balloon technology have advanced, the results of balloon pulmonary valvuloplasty have improved and the approach has become the standard of care for treating pulmonary valve stenosis

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients with congenital valvular pulmonary stenosis attending echocardiographic outpatient clinic of Assuit University children hospital aged from one month to18 years old

Exclusion Criteria:

Age less than one month and older than 18 years. Patients with infundibular and supravalvular pulmonary stenosis
Manually Controlled Infusion Vs Target Controlled Infusion for StrokeThrombectomy

The goal of this randomized controlled trial is to compare manual general anesthesia induction to general anesthesia induction guided by target controlled infusion system in cerebral ischemic stroke

The main questions it aims to answer are:

* Does target controlled infusion has a more favorauble hemodynamic profile than manual general anesthesia induction?
* Do patients receiving general anesthesia with target controlled infusion system have a more favourable outcome? Participants will receive general anesthesia induction with a target controlled infusion system and will be compared to patients receiving manual general anesthesia induction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Anterior Cerebral Circulation Stroke
* Patient eligible for mechanical trombectomy
* mRS ≤ 2;
* Fasting patients (\>6 h solid, \>2 hours liquids)
* Glashow Coma Scale more than seven.

Exclusion criteria

* Patient in general anesthesia at hospital arrival
* Associated hemorrhagic stroke
This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

The purpose of this study was to evaluate the major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR of pembrolizumab as a single agent and the dynamic of the tumor microenvironment changes on treatment.

This was a randomized, phase II, open-label study evaluating canakinumab, an anti-IL-1β monoclonal antibody, or pembrolizumab, a monoclonal antibody designed to block the PD-1 receptor, as monotherapy or in combination as neoadjuvant therapy. The study population included adult subjects with resectable non-small cell lung cancer (NSCLC) planned for surgery in approximately 4-6 weeks. Subjects were treated for a maximum duration of 6 weeks (2 cycles) until surgery, progression, unacceptable toxicity or discontinuation from the study treatment for any other reason.

Subjects were randomized in a 2:2:1 ratio to one of the 3 treatment arms (canakinumab alone or canakinumab in combination with pembrolizumab or pembrolizumab alone). Surgery was performed between 4 to 6 weeks after the first dose of study treatment.

All randomized subjects were followed for safety for up to 130 days following the last dose of study treatment (safety follow-up period).

Eligibility Criteria:
Key inclusion criteria:

* Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors.
* Subject must have been eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).
* A mandatory newly obtained tissue biopsy from primary site was required for study enrollment. An archival biopsy was also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.
* Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

Key exclusion criteria:

* Subjects with unresectable or metastatic disease.
* History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
* Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening
* Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy was permitted
* Subject with suspected or proven immunocompromised state or infections
Reflectance Confocal Imaging in Cervical Cancer Patients

The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.

Primary Objectives:

1. To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
2. To obtain real time reflected light images in vivo of sites in the human cervix.
3. To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.

Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample. Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)

Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.

Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.

This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
* Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

* Pregnant individuals will be ineligible for this study.
Laparoscopy for Endometriosis in Obese Patients

Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.

Obesity may influence surgical variables such as operative time, laparotomic conversion rate and intraoperative and postoperative complication rate. Moreover, it might influence the hospital length of stay. For that reason, the study aims to compare a group of obese patients with a non-obese group of patients about these topics.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients undergoing endometriosis laparoscopic treatment
* Obteined Informed Consensus
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 2 between the ages of 18 and 64, inclusive
* Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
* Scheduled for surgery in supine position
* Given written informed consent

Exclusion Criteria:

* Subjects in whom a difficult intubation because of anatomical malformations was expected
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction
* Subjects known or suspected to have a (family) history of malignant hyperthermia
* Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
* Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
* Subjects who had already participated in CT 19.4.205
* Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
* Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
* Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (\>6 months), IUD, abstinence
* Subjects giving breast-feeding
Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

Eligibility Criteria:
Inclusion Criteria:

1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

   * Following Radical Prostatectomy: PSA \>0.2 ng/mL
   * Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.

Exclusion Criteria:

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
2. Patients currently receiving Androgen Deprivation Therapy (ADT).
Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

The main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.

The study is a low-intervention, randomised controlled clinical trial. Patient recruitment will be done by including in the sample those patients who have diagnostic confirmation of onychomycosis in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid. Participants in the trial will be assigned with equal probability to each treatment arm, according to their consecutive inclusion in the study. Subsequently, treatment assignment will be determined by a random code. The treatment used will be evident to both the participant and the podiatrist responsible for the intervention.

Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.

Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients who have received topical or systemic antifungal treatment in the previous month.
* Pregnancy or lactation.
* Patients with peripheral vascular disease.
* Patients with an immune system disorder or undergoing treatment with immunosuppressants.
* Patients with peripheral or central neuropathy.
* Patients with a coagulation disorder.
* Patients with Raynaud's disease or with any alteration in the perception of cold or heat.
Lentiviral Gene Therapy for MLD

This is a Phase I/II clinical trial of gene transfer for treating Metachromatic leukodystrophy (MLD) using a safety and efficiency improved self-inactivating lentiviral vector TYF-ARSA to functionally correct the genetic defect. The primary objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.

Metachromatic leukodystrophy (MLD) is a rare lysosomal storage disease. This disease is an inherited single gene autosomal recessive defect. MLD is caused by a mutation in the ARSA gene encoding arylsulfatase A which leads to a deficiency in sulfatide degradation, resulting in its accumulation in oligodendrocytes, Schwann cells and some neurons. A critical level of sulfatide storage can trigger demyelination, the hallmark of MLD, which results in multiple neurological symptoms. MLD has different onset ages including late infancy (1-2 years), adolescence (4 years-before sexual maturity) and adulthood (after sexual maturity). MLD patients are normally rescued by hematopoietic stem cell transplantation (HSCT) from a matched healthy donor. However, HSCT must be performed at a very early stage of the disease thus restricting its therapeutic opportunies in MLD patients. This trial aims to treat MLD using a safety and efficiency improved self-inactivating lentiviral vector carrying a functional MLD gene to correct the genetic defect by intracerebral injection to delivery the lentiviral vector carrying a normal ARSA gene to correct the pathogenic defect. The primary objectives are to evaluate the safety of the improved self-inactivating lentiviral vector TYF-ARSA, the in vivo gene transfer clinical protocol and the efficacy of degradative metabolite in patients at the time of treatment, assessment of vector integration sites, and finally the long-term correction of the related pathological symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. MLD patient age \>= 0 year
2. ARSA gene sequence analysis to confirm MLD mutations
3. Scoring system for brain MR Imaging confirmed MLD
4. Parent / guardian / patient signing informed consent
5. Patients and their families have a strong willingness to participate in clinical trials, and are willing to bear all the consequences caused by the failure of the trial, and sign an informed consent form

Exclusion Criteria:

1. HIV positive patients
2. Patients who are experiencing uncontrolled viral, bacterial or fungal infections, malignant tumors, heart abnormalities, liver dysfunction, or renal insufficiency
3. Cannot perform an MRI
4. Infection or dermatosis at pre-injection site
5. Any condition that may increase the subjects' risk or interfere with the results of the trial. In addition to MLD, there are other neurological disorders.
The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population

This study is being implemented for 3 aims. The first has been to conduct a systematic literatures review on CKD intervention models and their effectiveness. Findings have been adopted in our intervention program. The second purpose is to establish a practical management model or an intervention model for CKD patients and high risk population with the 18-month of follow-up.In the third year, we will use social perspective point to evaluate the costs and the benefits of intervention.

The object of the study is by screening for adults (20 years) with chronic kidney disease (CKD stage 1-3a) and high-risk groups. They were randomly assigned into experimental groups (self management and peer-assisted management) and control group (general management). All participants received a general education with the knowledge on care for early chronic kidney disease recently establishes by the National Health Insurance system. We then used the cross-theoretical model to assess the intervention among the three groups.

We collected information on baseline and follow-up data on biochemical and physiological check-ups, health promotion behavior, dietary intake status, self-efficacy and cost etc. Information on behavior changes, including smoking, chewing betel nut, medication, exercise and diet, was also collected and assessed. Participants in the self-management group are expected to emphasize on self-managed interventions, including self-monitoring and records keeping, self-education with digital video disc (DVD) courses. We negotiated their behavior change set goals for them etc. The peer-assisted management group received similar program for 3 months, the peer oriented group activities followed, including group discussions to share experience and sports map etc. The effectiveness assessments have been set for the baseline, 3rd, 6th, 12th and 18th months. With one year of intervention period, the 3 groups will be assessed at the 18th months of follow-up next year.

In the third year, we will use social perspective point to evaluate the costs and benefits of intervention. We suppose that a 100,000 people to screen out cases of chronic kidney disease (CKD stage 1-3a) and high-risk groups, and we will compare the cost-effectiveness analysis between the experimental group with accept the intervention for 12 months to the control groups without receiving extra intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 with chronic kidney disease (CKD) stage 1-3a patients and high-risk groups.

Exclusion Criteria:

* Inability to communicate in Chinese.
* Lack of capacity to write in Chinese.
* Ongoing treatment in dialysis.
* Suffering from major diseases.
* Treatment in cancer or suffering from cancer less than two years.
* Have received organ transplants or bone marrow transplantation.
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.

This study is to validate an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection


Eligibility Criteria:
Inclusion Criteria:

* Whole blood specimen collected in EDTA anticoagulant tubes
* Subject is considered to have severe or critical illness per below:

Severe Illness

1. SpO2 \< 94% on room air at sea level;
2. Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \< 300 mmHg;
3. Respiratory frequency \> 30 breaths/min;
4. Or lung infiltrates \>50% Critical Illness

a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criteria of severe illness

* Subject confirmed to be COVID-19 positive by an EUA RT-PCR test
* Subject is 18+ years of age
* Minimum volume of 100µL for Symphony IL-6 testing
* Specimen is available for testing within 12 hours from collection

Exclusion Criteria:

* Subject is receiving an anti-IL-6 treatment
* Subject is receiving corticosteroids
* Hemolyzed specimens