cyrilzakka/clinical-trials huggingface dataset:
Influence of CPB Temperature on CABG Morbidity

To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to define differences in neurologic function in coronary artery bypass graft (CABG) patients.

BACKGROUND:

A pilot study of warm versus cold perfusion and preservation was completed in 32 patients prior to the ongoing study. The findings of the pilot study showed 53 percent of patients had evidence of new neurologic disturbance at postoperative day four. Only the neurologic dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75 percent cold, P less than 0.05). The changes in neurologic function had abated or clearly improved by one month of follow-up, and the distinction in neurologic dysfunction grading was no longer apparent between the two groups.

DESIGN NARRATIVE:

Patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with normothermic, tepid, and hypothermic cardiopulmonary bypass. All patients received a standard anesthetic protocol combining narcotic and inhalational anesthesia. Each patient entering the study had extensive clinical data collected prospectively incorporating most aspects of measurable determinants related to myocardial preservation. Additionally, neurologic tests were performed by a blinded neurologist and rated by an objective scoring system, the Mathew scale. The studies were performed preoperatively, on the third or fourth postoperative day, and at one month following surgery. Hematologic data were measured for fibrinolytic potential.

Eligibility Criteria:
Patients, referred for elective or urgent coronary revascularization, not having ongoing angina instability, requiring three or more bypass grafts, and under 70 years of age.
The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

To evaluate the scotopic and photopic ERG responses before and after one month of intravitreal avastin injection in patients with choroidal neovascularization.

A positive finding that will reveal a toxic effect of intravitreal avastin injection on any component of the retina will have a significant important clinical impact regarding the decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.

The study will include 20 patients who are diagnosed with CNV and were submitted for intravitreal injection of avastin. Patients with uncontrolled glaucoma, any ocular operation two months prior to the injection, ocular inflammatory disease, systemic hypertension treated with more than one medication, myocardial infarct, congestive heart disease will not be included in the study. After the patient will approve to participate in the study and will fall in with the inclusion and exclusion criteria, the patient will sign a written consent statement (enclosed).

Medical history and ophthalmic examination will be written in the study file. The patients will undergo the full-field ERG test using the ISCEV Protocol. Since the ERG is a non invasive test the patient will be admitted on the same day for intravitreal avastin in the designated eye. After one month the patient will undergo identical ERG protocol in addition to the standard follow-up examinations protocol for intravitreal avastin injection (1 day, 1 week, 1 month). The other eye will serve as control group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed with CNV caused by ARMD
2. ERG can be performed in both eyes

Exclusion Criteria:

1. Treatment within 7 days with VERTOPROFIN
2. Treatment within one month with laser photocoagulation
3. Ocular surgery for AMD (besides laser).
4. Participation in other medical study
5. Sub-fovea RPE atrophy in the study eye.
6. CNV with ocular histoplasmosis, trauma, pathological myopia.
7. Uveitis or history of uveitis.
8. Retinal pigment epithelium tear in the fovea of the injected eye.
9. Vitreous hemorrhage
10. Conjunctivitis, keratitis, scleritis, endophthalmitis.
11. Intraocular surgery (including cataract) within two months
12. Uncontrolled glaucoma (IOP≥30 mmHg under glaucoma medications)
13. Hypertension treated with two or more medication
14. History of myocardial infarct
15. History of myocardial insufficiency -
Exposure, Relaxation, & Rescripting Therapy-Child

Untreated trauma-related nightmares and sleep-related disorders are associated with chronic health problems, burdening both the suffering individual and the health-care system. The study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed children. It is the first randomized clinical trial with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a mechanism in development and maintenance of secondary post-trauma psychopathology, medical problems and family dysfunction. Therefore, this treatment may prevent long-term secondary health and behavioral problems. It provides a viable healthcare option to Oklahomans, lessening long-term financial medical and behavioral health expenses. Scientific models currently view PTSD treatment as primary, often leaving nightmares untreated. That approach does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy can advance the field's understanding of the development of trauma sequelae.


Eligibility Criteria:
Inclusion Criteria:

* children age 5-17 with traumatic or potentially traumatic/adverse experiences and nightmares occurring at least once per week over a minimum of one month
* have a parent or legal guardian who is able to participate in treatment assignments at home and be able to read and speak English

Exclusion Criteria:

* adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English
* in order to ensure the verbal comprehension of the child, the PPVT will be used to help evaluate if a child is suitable for treatment, as an index to ensure they can verbally comprehend the cognitive component of treatment
Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer

The purpose of this study is to determine the safety and effectiveness of the combination of docetaxel and ZD1839 on destroying prostate cancer before removal of the prostate.

It is recognized that there is a subset of patients who are at high risk for progression despite aggressive treatment of localized disease at the time of detection. The critical issue is in addressing micrometastatic disease that has already developed prior to diagnosis. This study utilizes daily doses of ZD1839 and weekly docetaxel for two cycles prior to radical prostatectomy.

ZD1839 has demonstrated antiproliferative activity against human tumor xenografts and in coadministration with cytotoxic agents against prostate cell lines (PC-3 and TSU-PRI). The combination of ZD1839 and docetaxel has been reported to be feasible with an acceptable toxicity profile.

This phase II, single center trial is specifically targeting those patients with high-risk adenosarcoma of the prostate.

Eligibility Criteria:
Inclusion Criteria:

* prostate carcinoma: clinical stage T2b-3 or serum PSA\>20 ng/ml or Gleason sum score 8-10.
* clinical T2 patients are eligible if endorectal coil MRI shows T3 disease, or Gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required)
* ECOG performance status of 0, 1 or 2
* adequate hematological, liver and renal function
* existing peripheral neuropathy \< grade 1
* ability to tolerate oral medications.

Exclusion Criteria:

* Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer
* any major surgery within four weeks
* prior hormonal therapy (except finasteride for obstructive voiding symptoms- -evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent
A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial

This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.

The assessed parameters will be:

* Efficacy of caries removal.
* Pain reaction and mean time required for the treatment.
* Total bacterial count before and after treatment.

Subjects:

A total of 30 children 7-9 years old with no history of systematic disease will be recruited from the out-patient pediatric dental clinic, Faculty of Dentistry, Mansoura University.

Each child with the following criteria will be eligible for the present study (22).

Inclusion criteria:

1. Cooperative child
2. Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
3. The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
4. The selected molars should have normal structure and morphology.

Exclusion criteria:

1. Un-cooperative child
2. Molars with clinical and radiographic signs of pulp involvement.
3. Children with special health care needs.
4. Molars which have already been restored or have developmental anomaly.

Eligibility Criteria:
Inclusion Criteria:

1. Cooperative child
2. Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
3. The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
4. The selected molars should have normal structure and morphology.

Exclusion Criteria:

* 1- Un-cooperative child 2- Molars with clinical and radiographic signs of pulp involvement. 3- Children with special health care needs. 4- Molars which have already been restored or have developmental anomaly.
Predictive Properties of the Hyperventilation Provocation Test for the Diagnosis of the Hyperventilation Syndrome

The Hyperventilation Provocation Test (HPTest) associated with end-tidal CO2 pressure (PETCO2) measurement is a diagnostic tool for idiopathic hyperventilation syndrome (HVS). However, interpretation of HPTest remains unclear regarding the relevant PETCO2 values to consider and the occurrence of subjective symptoms.

This case-control study aims to identify accurate HPTest measurements for the diagnosis of HVS, regardless of symptoms occurrence.

In a first stage, the investigators will analyze in a prospective way a training cohort of HPTest datas from 74 subjects, involving 37 subjects with complaints and a Nijmegen questionnaire score of ≥23/64 (HVS+) matched on gender, age, height, weight and BMI category with 37 healthy controls without complaints and a Nijmegen questionnaire score of \<23/64 (HVS-)(16).

All data will have to be collected by the same equipment and by the same operators in the pulmonology department of the CHU-St Pierre-Brussels between June 2018 and October 2021.

To rule out confounding respiratory pathology, each participant will have completed spirometry and methacholine testing, that will have a result within expected normal values.

For both cohorts, kinetics of the PETCO2 recorded during each of the 3 phases of the HPTest (adaptation, hyperventilation and recovery) will be mathematically modeled by an curvilinear model with the parameters (A, A', a and a') noted from the kinetic equation (TAU) : TAU \[PETCO2(t)〖=A+a(1-exp〗\^((b-t)/c))\]. For any observed differences in parameters between groups, the Area Under Curves will be estimated at the cut-off that offers the best Sensitivity and Specificity. False negative and false positive rates will be estimated.

The probability of a type I error is set at 5%.

In a second stage, in order to confirm/infirm the results, a retrospective validation cohort from another care setting, including subjects without confounding pathology, who completed a Nijmegen questionnaire and a HVTest between 2018 and 2021, will be analysed in the same way than the training cohort.

Eligibility Criteria:
Inclusion Criteria:

* Anyone over 18 years of age who has completed an HPTest and a Nijmegen questionnaire between 2015 and 2020

Exclusion Criteria:

-
Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System l

Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and HR using the absorption of light by the blood to define these signals In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal.

Although these systems have been technically valid, they have not been clinically evaluated in a health setting. This clinical trial is to assess parameters measurements by rPPG compared standard acquisition system in real conditions


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a Pulmonary function testing.

Exclusion Criteria:

* Patients with stable clinical status.
* Pregnant woman or Woman of childbearing potential without effective contraception
A Multicenter Multinational Observational Study of Children With Hypochondroplasia

This study will assess growth over time and the clinical course of HCH in children by collecting growth measurements and other variables of interest.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be ≤ 15 years old at the time of signing the informed consent
* Participants must have genetic confirmation of Hypochondroplasia diagnosis

Exclusion Criteria:

* Have a diagnosis of another genetic short stature condition other than Hypochondroplasia or a genetic variant known to cause another genetic syndrome associated with short stature
* Received an investigational product or medical device within 6 months before the Screening visit
Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years older
* Patients must be receiving his/her first dose of bevacizumab
* Patients must sign an informed consent

Exclusion Criteria:

* Patients receiving \> 10 mg/kg doses of bevacizumab
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery

The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.

This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.

The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.

This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Non-metastasized breast carcinoma
* Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
* Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions
* Age ≥ 18 years
* Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* \< 18 years old
* Mastectomy
* Need for LNI
* Bilateral breast irradiation
* Partial breast irradiation
* Unable to be treated in prone position
* Less than 15 treatment fractions planned
* Situs inversus
* Pregnant or breastfeeding
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. We will study recovery during the first week after surgery and also 3-12 weeks after surgery. We will give all patients spinal anesthesia. Some patients will also receive a continuous femoral nerve block for 2 days, or by a single injection. We predict that patients who received the nerve block will have significantly improved pain results, compared to patients who did not receive the nerve block.

In this project, we will measure outcomes of anesthesia and pain management for common orthopedic procedures. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the patient's potential to return to societal productivity during the first week after surgery. Therefore, we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery. Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function.

We will give consenting patients (n=270) undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection, a continuous infusion for 2 days, or saline placebo. We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired. We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery \[from anesthesia, QoR-40\] Score).

We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain. We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 14-65
* Undergoing ACL reconstruction at the University of Pittsburgh
* Agrees to spinal anesthesia and consents to one of the three nerve block interventions.
* Agrees to visit the University of Pittsburgh Center for Rehabilitation Services for postoperative physical therapy and rehabilitation (for standardized rehabilitation protocols)

Exclusion Criteria:

* Morbid obesity
* Chronic pain syndromes
* Opioid dependence
* Corticosteroid prescriptions
* Tricyclic antidepressant prescriptions
* Tramadol prescriptions
* Preexisting neuropathies
* Poorly controlled diabetes mellitus
* Poorly controlled anxiety disorders
Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury

The purpose of this study is to investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.

This is an open-label dose-escalating clinical trial. 20 patients will be randomly divided into 5 groups, 4 patient per group. The first three groups of four patients will receive transplants of increasing dose of HLA-matched umbilical cord blood mononuclear cells, starting from 4 spinal cord injection of 4µL of cell suspensions in Group A to 8µL in Group B and 16µL in Group C. If more than one subjects show neurological loss attributable to the cell injections, the trial will fall back to the previous dose. In the Group D, the highest volume of cells that do not cause neurological deficits (e.g. 16µL x4) along with a single bolus of 30 mg/kg methylprednisolone sodium succinate (MPSS) will be provided. Subjects in the Group E receive the same treatment as Group D plus a 6-week course of oral lithium carbonate. All subjects will enroll for three months intensive rehabilitation after the cell transplant.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic spinal cord injury (\>12 months post-initial spinal cord injury surgery) with stable neurologic findings for at least 6 months
* Subjects with current neurological status of ASIA A
* The neurological level of the subjects is between C5 and T11
* The injured site of the spinal cord is within three vertebral levels
* Subjects must be able to read, understand, and complete the VAS
* Subjects who have voluntarily signed and dated an informed consent form prior to any study procedures.

Exclusion Criteria:

* Significant renal, cardiovascular, hepatic and psychiatric diseases
* Significant medical diseases or infection
* Pregnant or lactating woman
* Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
* The length of spinal cord lesion exceeds three segments
* Unavailability of HLA matched umbilical cord blood cells
* any contraindication of laminectomy operation, methylprednisolone and/or lithium carbonate
* Subject who is currently participating in another investigational study or has been taking any investigation drug within the last 4 weeks prior to screening of the study
* In opinion of the investigator, who suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate the study