cyrilzakka/clinical-trials huggingface dataset:
Neopterin Dosage in the Eye

The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.

The study will be explained to subjects who are about to undergo ophthalmologic surgery. They will sign an informed consent and be included in the study. Urine sample will be collected specifically for the study. Eye's anterior chamber fluid will also be collected during the surgery as it is the usual practice (the sample is used for the neopterin dosage instead of being thrown away).

These samples will be centrifuged, frozen in a -80° C freezer. At the end of the study, all the samples will be sent to the central Lab for the neopterin dosage analysis. Results will be communicated to the principal investigator afterward.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old
* Non inflammatory or non infectious ophthalmic pathology requiring puncture of eye's anterior chamber fluid.
* Minimum of 200 microliter sample
* Immunocompetent subjects
* Signed and dated informed consent
* Samples management in accordance with the pre-analytical conditions specified in the protocol

Non-inclusion criteria:

* Age \< 18 years-old
* Subjects treated with intraocular corticoids, antibiotics or anti-inflammatory, locally or in systemic injection, prior to inclusion.

Exclusion Criteria:

* Subjects who exercised his right of withdrawal
* Study suspended on principal investigator, sponsor or health authorities' demand.
* Deceased subjects
Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
* No previous therapy for advanced/metastatic NSCLC is allowed
* Age \> 18 years
* Bidimensionally measurable disease
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
* Life expectancy of more than 3 months
* Patient able to take oral medication
* At least 4 weeks since prior radiotherapy
* Written informed consent

Exclusion Criteria:

* Active infection
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Malnutrition (loss of ≥ 20% of the original body weight)
* Performance status: 3-4
* Sensor or motor neuropathy \> grade I
* Second primary malignancy, except for non-melanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
* Known, symptomatic central nervous system metastases
Determinants of Diabetes Remission After Gastric Bypass Surgery

Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the role of endogenous glucagon-like peptide-1 (GLP-1).

The increased prevalence of obesity and type 2 diabetes (T2DM) has resulted in a surge in the number of patients seeking surgical weight loss. Gastric bypass surgery (GBP) results in 30-40% body weight loss with resolution of T2DM in 40-80% of cases. The mechanisms by which T2DM improves after GBP are unclear. Glycemic control occurs long before significant weight loss, suggesting that the nature of the procedure, rather than the weight loss, is responsible for the T2DM improvement. Recent data have singled out the role of the gut hormones known as incretins in diabetes improvement after GBP. The current proposal will study 1) whether the short and long term change in the gut hormone incretins after GBP results in improved insulin secretion in response to the administration of oral and IV glucose, in patients with diabetes undergoing GBP surgery; 2) the factors responsible for diabetes remission - or lack of - after GBP. The investigators wish to apply our finding to define better surgical outcome on diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a wide range of T2DM (duration, treatment modalities and control, in or not in remission) and scheduled for GBP surgery
* Blood pressure is under at least moderate control \<160/100 mmHg
* Patients can be on dyslipidemia medications but need fasting triglyceride \< 600 mg/dl
* Patients without recent (last 6 months) history of cardiovascular disease (CVD)
* BMI \> 35 and \< 55 kg/m2 prior to GBP surgery

Exclusion Criteria:

* Active cancer
* Unstable angina
* Recent stroke
* Current therapy that may affect glucose metabolism such as glucocorticoids, HIV medications, etc
* Active infection
* Kidney failure
* Severe liver dysfunction
* Severe respiratory or cardiac failure
* History of allergic reaction to exendin 9-39
* History of pancreatitis, history of cholelithiasis, history of alcoholism
* Presence of high triglyceride levels (\>600 ng/dl)
* Pregnancy (a pregnancy test will be done prior to enrollment and prior to each procedure in all premenopausal women)
Study: Effects of Strawberries on Blood Pressure

The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).

Primarily, we would like to find out whether freeze dried strawberry powder lowers blood pressure. In addition we would like to know if the strawberry alters the subject's blood cholesterol and the ability of the subject's blood vessels to relax.

Eligibility Criteria:
Inclusion Criteria:

* Pre-hypertensive men and women (JNC 7 \[The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure\] criteria) between the ages of 25 and 65 years who have no clinical evidence/history of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease.

Exclusion Criteria:

* Subjects who:

  1. are taking over the counter anti-oxidant supplements,
  2. are taking prescription medications that may interfere with study procedures or endpoints,
  3. have unusual dietary habits (eg., pica),
  4. are actively losing weight or trying to lose weight,
  5. are addicted to drugs or alcohol,
  6. present with significant psychiatric or neurological disturbances,
  7. have known allergies to strawberry, will be excluded from participating in this study.
  8. Patients known to have glaucoma
  9. Pregnant and/or lactating females
Myocardial Damage In Patients With Cerebral Infarction

Introduction

For several years "ischemic" electrocardiographic (ECG) changes in the acute phase of ischemic stroke have been reported. Whether these ECG changes reflect true myocardial ischemia remains controversial. So far no study has assessed different markers of myocardial ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic stroke.

Purpose

The main purpose of this study is to determine the potential burden of reversible and irreversible myocardial ischemia in patients with an acute ischemic stroke.

Patients and methods

Serial blood samples for measuring troponin T, CK-MB and NT-proBNP are collected in 250 patients with evidence of an acute ischemic stroke admitted to the Department of Neurology at Odense University Hospital. In addition resting 12-lead ECG recordings will be obtained on a daily basis, and a 24-hour ST-segment ambulatory monitoring will be performed once within the first week of hospitalisation. Finally, myocardial perfusion patterns during rest will be evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated troponin T level.

Six months later control measurements of troponin T, CK-MB and NT-proBNP and a 12-lead ECG will be obtained.

Expectations

The study will contribute with original observations in patients with acute ischemic stroke considering the following issues:

1. The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
2. The prevalence of transient ST-segment changes on ambulatory monitoring.
3. The prevalence and degree of myocardial necrosis as judged from biochemical markers.
4. The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
5. The prevalence, size and patterns of NT-proBNP.
6. Whether there is a change in ECG and biochemical markers over a 6-month follow-up period.

The results may have clinical implications regarding early and late treatment as well as clinical follow-up of patients recovering from an episode of acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke.
2. Age ≥ 18 years old.
3. Written, informed consent.

Exclusion Criteria:

1. Onset of stroke symptoms 8 to 21 days before admission.
2. Transient ischemic attack.
3. Intracerebral or subarachnoid haemorrhage.
4. Previous myocardial infarction.
5. Any pathological Q waves on the baseline ECG.
6. Current atrial fibrillation.
7. Unstable angina pectoris ≤ 3 weeks before admission.
8. Systolic blood pressure ≤ 90 mmHg and symptoms.
9. Resuscitation after cardiac arrest.
10. Unwillingness to participate.
Brain and Mindfulness

The main aim of this project is to explore the neuro-anatomical and -physiological correlates of meditation on attention and emotion-regulation. By investigating this, our scientific goal is to more generally identify the mechanisms and biomarkers of health and mental well-being. Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG), ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI; including Diffusion tensor - DTI). These brain measures will then be linked to behavioral measurements. Experimental methods (i.e., simple computer tasks) will be used to measure attention, conscious perception and regulation of pain and emotion.


Eligibility Criteria:
Inclusion Criteria:

* Age : 25-70
* Being affiliated to a social security system.
* Motivated to participate in this study.

Exclusion Criteria:

* Medication acting on the central nervous system
* Opioids, Antidepressive Agents.
* Actual or previous neurological or psychiatric illnesses
* Chronic pain or any other medical condition which is related to pain or an increased sensitivity to pain.
* Not having a personal or family history of epilepsy
* Alcohol or drugs consumption 2 days before or during the study.
Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment

Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line treatment with doxycycline has cured such patients. The investgators aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.

Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial in patients aged \> 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature \> 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (1:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investgators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature \< 37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the national ethic committees of the Senegalese Ministry of Health in May 2017 (0026/MSAS/DPRS/CNERS, March, 7, 2016).

Eligibility Criteria:
Inclusion Criteria:

* Participants over 8 years with no malaria fever

Exclusion Criteria:

Under 8 years Pregnanants women

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Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

Patients will be randomized either to receive standard daily dressing or hydrocolloid dressing using a randomization generator. After closing the wound with the sutures,the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days(Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly and bandaging during this time period, which has to be re-applied daily. Patients and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.


Eligibility Criteria:
Inclusion Criteria:

1. Adult \> 18 years of age
2. Linear scars
3. Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention

Exclusion Criteria:

1. Scar localization on acral or hair bearing sites
2. Patients unable to converse in English
3. Patients requiring flap or graft for closure of wound
4. History of allergy to adhesives
5. Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery
6. Use of hydrocolloid dressings for post-operative wound care in the past
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma

The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis with asthma attending regular follow up at respiratory clinic

Exclusion Criteria:

* Allergic to gel
* Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance
* Suffered from upper respiratory tract infection prior to the study
Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy

Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV \& V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.


Eligibility Criteria:
Inclusion Criteria:

* patients with cerebral palsy GMFCS (gross motor functional classification scale) IV-V
* age of patients 3-18 years

Exclusion Criteria:

* patients with neuro muscular disease
* patient age \< 3 years old and \> 18 years old
* patient with constitutionnal bone disease
* patient with growth hormone treatment
* patient with surgery \< 6 months
* patient with fracture \<3 months
* Refusal of the legal representative
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.

The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.

The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.

Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab.

Eligibility Criteria:
Inclusion Criteria:

* to have uncontrolled glaucoma
* to have accepted to undergo a primary trabeculectomy with mitomycin C
* to have one of the following types of glaucoma:

  * Normal tension Glaucoma
  * Chronic Open-Angle Glaucoma
  * Chronic Angle-Closure Glaucoma
  * Mixed mechanism glaucoma
  * Steroid-induced Glaucoma
  * Neovascular Glaucoma

Exclusion Criteria:

* to be less than 18 years old
* to be unable to observe the study protocol
* to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases
* a history of thromboembolic events and cerebrovascular accidents
* congenital glaucoma
* uveitic glaucoma
* to be pregnant
* to be breastfeeding
* surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages
* to have undergone a previous conjunctival surgery
* to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging
* to present an active or suspected intraocular or periocular inflammation
* to have a kidney failure
* to have a liver failure
Education Program for Patients Receiving Oral Anticoagulation

The aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better Health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment.

Patients who are going to use oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period. After the discharge 2 phone calls will be done (after: a week and four weeks) focusing on the strategies to improve patient's self-efficacy to manage the oral anticoagulation. There will be a personal contact among researcher and participants when the patients return at the oral anticoagulant ambulatory, two months after the treatment start. At this time the following variables of interest will be evaluated: Health-related quality of life; adherence to treatment and patients' self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in two public hospitals, in São Paulo state interior and who are going to start the use of oral anticoagulant during this hospitalization
* Patients admitted in two public hospitals, in São Paulo state interior and who are going to adjust therapeutically oral anticoagulant dosage or to start over treatment.

Exclusion Criteria:

* Individuals who do not at all have any ability to understand the data collection instrument questions, measured by the instrument Mental State Mini-exam.
* Individuals who do not have a telephone to be contacted after hospital discharge;
* Individuals who are going to metallic valve prosthesis implant surgery in the last six months.
Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
* No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Disease that is suitable for local therapy administered with curative intent
* Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine whether AL-37807 is safe and effective in treating patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded

Exclusion Criteria:

* Under 18