cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins

A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.

\* Study type: Interventional. Randomized comparative clinical trial..

* Outcome measures:

  * Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
  * Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (\> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
* Outcome measures time frame:

Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.

\* Focus of the study: Varicose great saphenous veins (GSV)

* Intervention information:

  * Intervention name: endovenous laser ablation (EVLA)
  * Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
  * Arm information: both interventions are active comparators.
* Locations:

Rotterdam, Zuid-Holland, The Netherlands

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 sec, and diameter of vein \> 0.5 cm
* Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
* No prior treatment of the insufficient GSV
* Informed consent

Exclusion Criteria:

* Acute deep or superficial vein thrombosis
* Agenesis of deep vein system
* Vascular malformation or syndrome
* Post-thrombotic syndrome, occlusive type
* Pregnancy
* Immobility
* Allergy to lidocaine
* Arterial insufficiency
* Diameter of GSV ≤ 0.5 mm at puncture site
An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.


Eligibility Criteria:
Inclusion Criteria Patients who have completed S308.3.002 trial Exclusion Criteria Patients with medically relevant abnormal findings (ECG, physical examination, Aes) at end of the maintenance phase (visit M6, week 24) of study S308.3.002
Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer

Study Objectives:

Primary objective

* The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.

Secondary Objectives

* Overall survival
* Progression free survival
* Response rates (RECIST)
* Duration of response
* To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP

not relevant

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG);
* Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR)
* Male
* Age greater than or equal to 18 years;
* Performance status 0,1,2 or 3
* WBC \> 3000 mill/l, ANC \> 1500 mill/l, platelet count \> 100.000 mill/l; serum bilirubin \< 1.5 x the upper limit of normal;
* Adequate renal function (Glomerular Filtration Rate (GFR) \>60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance)
* signed informed consent;

Exclusion Criteria:

* Uncontrolled active severe clinical infection (CTC grade 3 or 4).
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders.
* Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0.
* Second malignancy other than basal or squamous cell skin cancer.
tDCS for Increasing Exercise Adherence in Depressed Individuals

The purpose of this study is to examine the efficacy of tDCS (transcranial direct current stimulation) for increasing exercise adherence among low active individuals with elevated depressive symptoms. The investigators expect that this project will contribute much needed knowledge about the role that tDCS can play in changing the affective experience of exercise.

Exercise adherence is a significant public health problem. Affective experiences during exercise predict long-term physical activity (PA) levels. Therefore, approaches to improving the affective experience of exercise are both important and likely to have high impact. This may be particularly true among individuals with elevated depressive symptoms due to their tendency toward more negative and less positive affect. tDCS is a noninvasive brain stimulation approach with a growing body of literature supporting its effects on cognitive and emotional processing in varied populations, including some support for those with depression. In addition, there is recent increased interest in utilizing tDCS in the context of exercise (see above) and in obesity prevention. While the effects of tDCS on behavioral and cognitive functioning are still developing, promising findings have emerged for tDCS used in repeated combination with a behavioral or cognitive intervention. Given that tDCS is relatively safe, inexpensive, and portable, individuals who struggle with enjoying exercise could be afforded a practical option for increasing and maintaining physical activity levels.

We propose to conduct a pilot randomized controlled trial of tDCS versus sham delivered 3x/week for 8 weeks in the context of a supervised aerobic exercise (AE) program among 72 low-active individuals with elevated depressive symptoms. Follow-up assessments will be conducted at end of treatment, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* be between 18 and 65 years of age
* be low active
* have elevated levels of depressive symptoms
* interested in starting an exercise program in the next month

Exclusion Criteria:

* history of mania or hypomania
* current psychotic disorder
* current DSM-5 diagnosis of an eating disorder
* DSM-5 moderate and severe substance use disorder
* current suicidality or homicidality
* current DSM-5 diagnosis of major depressive disorder that is not currently being treated with pharmacotherapy or psychotherapy
* physical disabilities or medical problems that would prevent participation in moderate intensity exercise or may be contraindicated for tDCS
* current pregnancy or intent to become pregnant during the next 8 weeks
* pacemaker or metal implanted in the cranial cavity
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.

Eligibility Criteria:
Inclusion Criteria:

* Has signed a written informed consent prior to the first study intervention
* Is at least 18 and \<85 years of age
* Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm\^2 post-debridement; Present for at least 6 weeks
* Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
* Has a maximum fasting blood glucose level of 13.8 mmol/L
* An ankle-brachial systolic pressure index between 0.7 and 1.3
* If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study
* Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion Criteria:

* Known or suspected disease of the immune system
* Active or untreated malignancy or active, uncontrolled connective tissue disease
* Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
* Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
* Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb \< 4 weeks prior to enrollment
* Active febrile illness
* AST, ALT, ALP \>3x the normal upper limit
* Serum Creatinine \>2x the normal upper limit
* Osteomyelitis
* Active Charcot
* Use of any topical treatments other than SOC (standard of care)at the time of enrollment
* Enrollment in any investigational clinical trial within 30 days of the screening visit
* Known or suspected hypersensitivity to any study product components
* Recent or current history of alcohol or drug abuse
* Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
* All site personnel directly affiliated with this study and their immediate families
Feeding Tolerance Evaluation

Crossover study of 2 infant formulas

Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full-term (\> 37 weeks gestation)
* 0-2 months (birth-56 days) of age on enrollment
* Infant exclusively formula-fed for at least 2 days prior to enrollment
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Congenital illness or malformation
* Significant prenatal and/or postnatal disease
* Currently participating in another clinical study
Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury

Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period. Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound. In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.


Eligibility Criteria:
Inclusion Criteria:

1. Every child entering the PCICU, age \< 7 years
2. The child will enter arm 1 or 2 if he underwent the event described in section 3.
3. Hypoxic ischemic event that would render hypothermia treatment is defined as

   * During the hospitalization in the PCICU before or after the surgery:

   Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl OR Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood pH level of less than 7.1
   * During the surgery Near infra red spectroscopy lower than 40 for more than 5 minutes AND Serum lactate levels of more than 90 mg/dl during the event OR The patient is re-connected to cardio-pulmonary bypass machine as a result of the event
4. Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3.

Exclusion criteria

* Suspected hypoxic ischemic event as described in the Inclusion Criteria in the 2 weeks prior to the PCICU admission
* Prolonged low cerebral perfusion before the PCICU admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and pH lower than 7.1
* Rejection criteria
* A second resuscitation after the hypoxic ischemic event and before a brain MRI is done
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Phase I Primary Objective:

* Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Primary Objective:

* Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Secondary Objective:

* Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Eligibility Criteria:
Inclusion Criteria

* Pancreatic cancer (AJCC Stage II-IV);
* Unresectable cancer;
* Measurable disease (RECIST criteria);
* No prior therapy;
* ECOG Score 0-2
* Life expectancy greater then or equal to three months;
* Adequate hematopoietic, liver and renal function;
* Women of child-bearing potential must have negative urine/serum pregnancy test;
* Signed written informed consent;
* Subjects must be willing to be followed during the course of the treatment/observation and follow-up.

Exclusion Criteria:

* Prior therapy for pancreatic cancer;
* Previously diagnosed brain metastases if symptomatic and requiring active therapy;
* Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
* Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study
* Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication;
* Women must not be pregnant or breast-feeding;
* Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.
Brain Tissue Collection for Neuropathological Studies

The purpose of this study is to collect and study the brain tissue of deceased individuals to learn more about the nervous system and mental disorders. Information gained from donated tissue may lead to better treatments and potential cures for nervous system and mental disorders.

This study will ask relatives of deceased individuals to donate the brains of their deceased relatives to allow further study of neurological and psychiatric disorders. We do not accept prospective donations.

The knowledge of how affected tissue deviates from normal control tissue is an integral part of fully understanding a neurological or psychiatric disorder. The purpose of this protocol is to establish a coordinating program with the Office of the Chief Medical Examiner in Washington, DC, the Virginia Office of the Chief Medical Examiner, Central District, and Virginia the Office of the Chief Medical Examiner, Northern District for the donation of brain tissue.

Dissected brain tissue from selected brain regions, including but not limited to the dorsolateral prefrontal cortex and hippocampal formation, will be assembled from large cohorts of normal controls and schizophrenic subjects. The expression of mRNA and protein for selected molecules, chosen on the basis of their genetic association with schizophrenia, will be measured with a variety of assays including but not limited to qPCR and Western blots.

Outcome measures are the statistical comparison within normal controls of mRNA and/or protein levels in groups segmented by genotype. Similar comparisons will be made between schizophrenic cohorts and normal controls, in a diagnosis by genotype analysis with an ANOVA, or when appropriate an ANCOVA (controlling for variables such as age, race, gender, and postmortem interval).

Eligibility Criteria:
* INCLUSION CRITERIA:

Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, especially schizophrenia, but also anxiety disorders, suicide, bipolar disorder, depression, Tourette's Syndrome, drug addictions (PCP, cocaine, alcohol, heroin or the like) and any form of dementia. In addition, brains from normal individuals without a history of neuropsychiatric disease will be needed for controls.

EXCLUSION CRITERIA:

No living subjects are enrolled in this protocol. Tissue is obtained after death, with the permission of next of kin, or from existing institutions with appropriate samples via an MTA or other applicable agreement.

Brain tissue is excluded from collection if there is a previously known history of strokes, lesions, or other major neuropathological abnormalities prior to the consenting process.
Xenon Combined With Intraoperative Thoracic Epidural Analgesia

This is a monocentric study in 2 steps: A safety part to assess the feasibility of using Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be enrolled and followed over 45 days.

The first step is divided into 3 parts. 9 patients will be sequentially enrolled (3 patients in each part). The patients will be followed during 45 days and the following rules will be used to assess the safety:

First part: if no toxicity: initiation of the randomised part. If 1/3 toxicity: start of the second part. If 2 or 3/3 toxicity: end of the study.

Second part: same rules and possible start of the third part. Third part: if no toxicity: initiation of the randomised part. If 1 or more toxicity: end of the study.

The safety will be assessed after each part by an independent data safety monitoring board.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Planned surgery for oncologic colic and/or rectal surgery
* ASA score I or II
* Indication of complementary thoracic epidural analgesia
* Agree to use an effective form of contraception
* Patients who can understand, read and write French language
* Covered by a medical insurance
* Patients who have dated/signed an inform consent

Exclusion Criteria:

* Unstable angina within the 30 last days
* Myocardial infarction within 28 days prior to surgery
* Uncontrolled arterial high blood pressure
* Severe cardiac insufficiency
* Severe chronic obstructive pneumopathy
* Patient who requires FiO2 \> 40%
* Patient already enrolled in a clinical study which may interfere with the present study
* Known hypersensitivity to one of the study drugs
* History or familial history of malignant hyperthermia
* Documented high intracranial pressure
* Eclampsia or pre-eclampsia
* Pregnant or breastfeeding woman
* Liver injury (icterus) and/or unexplained fever and/or eosinophilia after halogen exposure
* Failure in epidural anesthesia installation
* Patient refusal
* Patient who can't be compliant to the present protocol
Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management

Individuals with diabetes often report that difficult thoughts and feelings about diabetes interfere with making healthy choices with regards to diabetes management. The purpose of this study is to evaluate a diabetes self-management group based on Acceptance and Commitment Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating psychological and behavioral difficulties. We are interested in whether individuals with diabetes will like an ACT-based diabetes management group and whether they find the group helpful.

The goal of the current study is to assess the acceptability and feasibility of an acceptance-based group to improve diabetes self-management among individuals with Type 1 Diabetes. Interested individuals will participate in a weekly acceptance-based therapy group focusing on improving diabetes management (e.g., adherence to dietary recommendations, appropriate insulin dosing) for a total of 8 weeks. Participants will also be asked to complete questionnaires both pre and post treatment. Questionnaires will assess diabetes management and acceptability of the group (post treatment only). Regular medical monitoring is required for participation in the current study. Participants will be asked to provide consent to contact their current medical provider in order to confirm that the participant's is receiving regular medical monitoring for diabetes care and that providers are aware of their patient's participation in group.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Diagnosed with type 1 diabetes
* Currently monitored by a physician for their diabetes

Exclusion Criteria:

* Current or history of psychosis or mania
* Current substance abuse
* Non-English Speaking
* Deficits in intellectual functioning that preclude informed consent