cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
* A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).

Exclusion Criteria:

* A document history of generalized status epileptics in the past 6 months.
* Seizures having a metabolic, neoplastic, or active infectious origin.

Other protocol-defined inclusion/exclusion criteria may apply
Impella RP Flex with Smart Assist

To capture observational data of the Abiomed Impella RP Flex in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.

Exclusion Criteria:

* None
Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.

Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index procedure

Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair with MIROMESH.

Primary Objective: Characterize the procedural and early post-operative safety profile of MIROMESH when used as reinforcement in hiatal hernia repair.

Secondary Objectives

A retrospective chart review will identify the appropriate cohort with a prospective follow-up survey to acquire safety and outcome information.

A retrospective chart review of appropriate subjects.

Data to be acquired will be:

Preoperative - Chart Review

* Gender
* Date of birth
* Weight
* Body Mass Index
* Specific diagnosis
* DeMeester Score
* 24 hour pH test (% acid exposure in 24 hours)
* Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review
* Date of surgery
* Number of stitches used to close wound
* Paraesophageal hernia type
* Mesh shape
* Mesh size used
* Attachment technique
* Length of stay
* Complications

Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review

* Complications (Mesh related)
* Complications (procedure related)
* Prolonged dysphagia (Y/N)
* Stenosis (Y/N)
* Dilations (Y/N)
* Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence
* GERD-HRQL Score

Prospective institutional review board approved Follow-Up Telephone Interview

* Have you had a revision surgery?
* GERD-HRQL Score
* How satisfied are you with the procedure?
* Have you used proton pump inhibitors in the last 3 months
* How likely are you to recommend this procedure to a loved one?

Eligibility Criteria:
Inclusion Criteria:

* Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study

Exclusion Criteria:

* N/A
Retrospective Review on Uterovaginal Anomalies

Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis.

Uterovaginal anomalies are congenital malformations of the female reproductive tract, including hymenal, vaginal, cervical and uterine anomalies. The incidence could be as high as 7% in females1. These anomalies can occur alone or in association with other anomalies such as renal anomalies.

There could be variable consequences from these malformations, some are asymptomatic while some may have various symptoms.

It is important to be aware that obstructive uterovaginal anomalies, examples including imperforated hymen and obstructive hemivagina and ipsilateral renal anomaly (also known as OHVIRA), may present after puberty, with symptoms including amenorrhoea, dysmenorrhea, pelvic pain etc. These are conditions that should be managed. Patient may require interventions. Surgery is the principal management for obstructive anomalies, dependent on the types of obstruction. Types of surgeries ranges from simple surgical procedures to complex surgeries that require multidisciplinary input.

Post-operatively patients should be offered follow up for monitoring in view of the risk of stenosis that may require ongoing dilation or additional surgical management.

There are limited studies on the post-operative outcomes for uterovaginal anomalies, so this study aims at reviewing and comparing the different outcomes after initial surgery.

This is a retrospective observational study. Electronic and paper clinical records of all patients who attended the Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital with the diagnosis of uterovaginal anomaly will be reviewed, data collected will be input and analyzed using different statistical analysis tools. Data between 1.1.2000 and 31.12.2023 will be reviewed retrospectively. No human subject will be recruited.

The aim of the study is to reviewing and comparing the different outcomes after surgery for patients who had uterovaginal anomalies

Eligibility Criteria:
Inclusion Criteria:

* All patients who attended the Prince of Wales Hospital with the diagnosis of uterovaginal anomaly since 2000

Exclusion Criteria:

* Nil
Nepafenac Once Daily for Macular Edema - Study 2

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
* History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
* Best-corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
* Understand and sign an informed consent document;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pre-existing macular edema in the study eye;
* History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
* Planned cataract surgery in the fellow eye prior to the Day 90 postoperative study visit or through study exit;
* Planned multiple procedures for the study eye during the cataract/intraocular lens;
* Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
* Participation in any other clinical study within 30 days of the screening visit;
* Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
* Other protocol-defined exclusion criteria may apply.
Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia

The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult men and women;
* 18-45 years of age;
* BMI 18-30 kg/m2;
* non-pregnant/non-breastfeeding;
* non-nicotine users;

Exclusion Criteria:

* Pregnancy, breastfeeding, hormonal contraceptives
* Diagnosed sleep apnea
* Current smoking/Nicotine use/drug use
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications
* Recent COVID-19 diagnosis with symptoms
Fractional FLOw Reserve In Cardiovascular DiseAses

The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world cohort.

The objective of the FLORIDA study was to investigate mortality outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world patient cohort, including patients with different stages of coronary artery disease as well as patients with acute coronary syndrome (ACS). All patients were followed for a period of 3 years after the index date. The analysis period extended from the individual index date to the date of death or the end of the 3-year follow-up period. Patients were matched for sex, presence of acute coronary syndrome, age ± 5 years, and propensity scores estimated with logistic regression based on 72 variables , with each FFR patient matched to the closest angiography-only patient

Eligibility Criteria:
Inclusion Criteria:

* At least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015.

Exclusion Criteria:

* Loss to follow-up of other reasons than death (i.e. change of insurance)
Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer

The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.

The purpose of this research is to determine the safety of serial intradermal vaccinations of a DNA vaccine encoding human PAP, with GM-CSF as a vaccine adjuvant, in subjects with stage D0 prostate cancer. In addition, to determine whether PAP-specific IFNУ-secreting CD8+ T cells can be augmented in subjects with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.

This is a phase I design where patients will receive the vaccine pTVG-HP with rhGM-CSF administered i.d. biweekly for 6 total doses. There will be three escalating dose cohorts. The dosing cohort considered to be the maximum tolerated dose level will be expanded up to a total of 16 patients.

Eligibility Criteria:
Inclusion Criteria:

* Must have histologic diagnosis of adenocarcinoma of the prostate
* Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
* Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be \> 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA \> 2ng/ml.
* Prior history of a second malignancy is allowed if treated with curative intent disease free for \> 5 years.
* Karnofsky performance score of \> 70

Exclusion Criteria:

* No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to \>30% of the bone marrow, within 6 months of the first vaccination.
* Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
* Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
* Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.

Study Design

This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection.

Treatments

In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.

In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).

In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged more than 60 years and recipients of compatible renal transplant

Exclusion Criteria:

1. Receptors of multiple organs;
2. non-heart beating donors;
3. donors aged under 5 or over 65 years;
4. Patients with body mass index greater than 35
Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.


Eligibility Criteria:
Inclusion Criteria:

The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Exclusion Criteria:

* CRN combined with local or regional relapse, or with distant metastasis. ② CRN combined with other cerebrovascular disease. ③CRN combined with the second primary malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes. ⑥CRN patients that were supposed to live less than 6 months.
Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix

The purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.

Carcinoma cervix is the 2nd most common malignancy among females and about 86% of this burden occurs in developing countries. India accounts for 27% of world cervical cancer burden; and most of them are of locally advanced stage ie stage IIA to IVA.

Significant development in radiation techniques and addition of cisplatin based chemotherapy to radiation schedule has led to improved survival but still it is far from satisfactory with 20 to 25% patients failing locally while 10 to 20% patients fail at distant sites. Novel techniques are required to improve this dismal rate.

Thus investigators intended to use combination chemotherapy with paclitaxel and cisplatin, considering that paclitaxel is a taxane which has shown good efficacy in other solid tumors such as ovary, lung and breast; it has also shown radiosensitizing effect in cervical cancer cell lines and it has also been shown to be effective in phase III trials with cisplatin in metastatic and recurrent carcinoma cervix.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven carcinoma cervix
* age 18 years to 65 years
* stage IIA, IIB, IIIA \& IIIB according to FIGO 2009

Exclusion Criteria:

* age \> 65 years and \< 18 years
* stage IA, IB, IVA \& IVB
* Histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma
* history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy.
* deranged renal function test and liver function test
* KPS \>= 60
* distant metastasis
Positron Emission Tomography Using Carbon-11 Acetate and Fludeoxyglucose F 18 in Detecting Hepatocellular Carcinoma (Liver Cancer) in Patients With Known or Suspected Liver Cancer

RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET) and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma (liver cancer) and allow doctors to plan the most effective treatment.

PURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F 18 PET work in detecting cancer in patients with liver cancer.


Eligibility Criteria:
INCLUSION:

* Biopsy-proved HCC (stage I and II by conventional staging) or one or more of the following in a patient with clinically documented cirrhosis:
* AFP \> 200 mg/dL;
* A contrast-enhancing tumor mass (\>1 cm) by CT or MRI; or
* A tumor mass confirmed by arteriography.
* Patient must provide written informed consent and have completed conventional imaging and staging before initiation of PET imaging.

EXCLUSION:

* Pediatric patients under the age of 18 will be excluded from consideration from this study.
* Patients with a known prior malignancy (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years will be excluded from entry into the study. However, patients with a prior HCC thought to have a new primary or recurrent HCC are eligible.
* Pregnant and breastfeeding patients.
* Patients with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL)
Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation

To check the influence of injected platelet-rich plasma (PRP) on the healing of medial retinaculum and the redaction in recurrent dislocation of the patella.

Autologous platelet-rich matrices may aid in the healing of ligaments \& tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Eligibility Criteria:
Inclusion Criteria:

* age 18-40 years old
* first time patella dislocation

Exclusion Criteria:

* pregnancy
* mental or physical disabilities
Treatment Decision-making in Patients With Recurrent High-grade Glioma

This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care..

High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care.

In this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs.

Little is known about how the patients and their close relatives experience the recurrence and the decision-making process.

The objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence.

Data will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis.

The study is part of a larger PhD-study.

Eligibility Criteria:
Inclusion Criteria:

* The patient is offered surgical treatment (after an assesment done by the multidisciplinary team)
* Able to speak and understand danish
* Able to participate in an interview
* Able to give informed concent for participation

Exclusion Criteria:

* Patients with severe cognitive impairment which prohibits them from either giving informed concent or participating in interview.
* Relatives are excluded if the patient do not give concent for the participation of relatives
Verily Clinical Study Watch Analytical Validation Study

This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' movement and pulse rate when the wearer is at rest.


Eligibility Criteria:
Inclusion Criteria:

* Participant is ≥ 22 and ≤ 80 years old
* Participant understands the study requirements and is able and willing to provide written informed consent
* Participant is without significant limitation in ability to participate in the study, in the opinion of the investigator
* Participant owns a smartphone with a data plan and be the primary user of the smartphone; smartphone must be compatible with the applications used in the study
* Participant is a US Resident

Exclusion Criteria:

* Participant has tremor or significant life-threatening arrhythmia
* Participant is allergic to nickel or metal jewelry
* Participant has a known severe allergy to polyester, nylon, or spandex
* Participant has a known allergic reaction to adhesives or hydrogels
* Participant has a tattoo covering the area where the watch face would rest on either wrist
* Participant has planned international travel during the study
Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.

The study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at MSK
* Current or prior history of primary neoplasms involving osseous structures, including all subtypes
* Confirmation of diagnosis that has been performed by the MSK's Department of Pathology via direct review of tissue/slides
* Patients must read and understand English
* Age \>/=4
* Patients must read and understand English

Exclusion Criteria:

* Patients that weight \<17 kilograms