cyrilzakka/clinical-trials huggingface dataset:
Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) Inhibitor

The mainstay of therapy for GISTs is surgical resection, however, recurrence is almost inevitable in high-risk tumors and secondary surgery or other salvage therapy has yielded poor outcome. The median survival for patients with unresectable or metastatic GIST is approximately 20 months, and for patients with local recurrence it is 9 to 12 months. Responses to chemotherapy have been at best 5%. The introduction of imatinib has dramatically changed the prognosis of these patients yielding response rates between 41% and 71% and an overall clinical benefit (tumor responses plus stable disease) ranging between 73% and 90%.

However, resistance to imatinib may develop and represents a further clinical challenge. Sunitinib has recently been approved by the FDA for patients whose disease has progressed or who are intolerant to imatinib therapy. Patients with tumor progressing on sunitinib or another 2nd line agent have limited therapeutic alternatives. Reinstitution of imatinib, if possible, is considered an acceptable option for these patients because it may slow the rate of disease progression even in the setting of prior imatinib failure; however a more optimal 3rd line treatment is needed. AMN107 is a novel aminopyrimidine, available as an oral formulation that is ATP -competitive inhibitor of BCR-ABL,more potent than Imatinib. It inhibits proliferation and autophosphorylation of 32 out of 33 BCR-ABL point mutations. In addition AMN107 also inhibits PDGFRα,PDGFRβ, and KIT. Preliminary data from an ongoing Phase I study in imatinib-resistant GIST patients (CAMN107A2103) indicate that AMN107 alone (400 mg BID) and in combination with imatinib (imatinib 400 mg BID plus AMN107 200 mg QD and 400 mg QD) is well tolerated in this pre-treated patients.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years at Visit 1
* Radiological confirmation of disease progression (CT scan PET-CT, or MRI) during imatinib therapy, on 600- 800 mg per day for at least 6 weeks.
* Radiological confirmation of disease progression (CT scan or MRI and PET-CT) during 2nd line TK inhibitor therapy.
* Patients who were intolerant to Imatinib or second line TK inhibitor (like :sunitinib). Intolerance (at any dose and/or duration), is defined as patients who did not progress on imatinib or sunitinib and have discontinued imatinib and or sunitinib therapy due to any ≥ Grade 3 adverse events that persist in spite of optimal supportive care. Patients with Grade 2 adverse events related to imatinib or sunitinib therapy, in spite of optimal supportive care measures, that persist for ≥ one month or that recurs for more than 3 times whether the dose is reduced or discontinued will also qualify patients as intolerant

Exclusion criteria:

* Prior treatment with nilotinib
* Treatment with any investigational drug ≤ 4 weeks prior to Visit 1 with the exception of imatinib and sunitinib therapy .

Other protocol-defined inclusion/exclusion criteria may apply
Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries

Tissue hypoperfusion during cardiopulmonary bypass (CPB) affects cardiac surgical outcomes. Lactate, an end product of anaerobic glycolysis from oxygen deficit, is an obtainable marker of tissue hypoxia. The investigators aimed to determine the value of blood lactate level during CPB in adult cardiac surgeries in predicting outcomes.

The investigators retrospectively reviewed the patients underwent cardiac surgeries with CPB from January 2015 to December 2015. The patient's characteristics, pre-operative status, surgical type, and intra-operative lactate levels were collected. The outcomes were in-hospital mortality and complications. Receiver operating characteristics (ROC) curves were used to assess the ability of peak lactate level during CPB to predict in-hospital mortality.

The baseline characteristics, including age, gender, body mass index (BMI), comorbidities, left ventricular ejection fraction (LVEF, %), European system for cardiac operative risk evaluation II (EuroSCORE II), pre-operative hematocrit, and serum creatinine levels were recorded. The surgical type was classified as coronary artery bypass grafting (CABG), valve surgery, combined surgery including CABG and valve surgery, great vessel surgery including aortic dissection, and other surgeries. The priority of surgery was classified as elective, urgent, and emergent. The intra-operative variables included CPB time, aortic cross-clamp time, initial lactate level at the beginning of the operation, and the peak lactate level during CPB.

Eligibility Criteria:
Inclusion Criteria:

* adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015

Exclusion Criteria:

* patients with missing data from records
Rivastigmine Capsules in Patients With Probable Vascular Dementia

The goal of this research study is to evaluate, in the open-label extension phase, the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate.

Exclusion Criteria:

* Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks
Effect of the Subconscious on Mohs Micrographic Surgery

The goal of this study is to determine if relaxation therapy improves patient satisfaction with Mohs micrographic surgery.

Patients are instructed in relaxation techniques. The goal of this study is to determine how relaxation techniques affect the patient's Mohs micrographic surgery experience.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 and older
* Subjects are undergoing micrographic Mohs surgery for facial basal and squamous cell carcinoma.
* The subjects are in good health.
* The subjects have willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Subjects who have wound healing problems.
* Subjects who have had prior Mohs surgery.
* Subjects who are smokers.
* Subjects who are currently using anticoagulation therapy
* Subjects who have a history of bleeding disorders.
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders.
* Subjects who are taking medications that may affect healing such as prednisone, or any immunosuppressants.
* Subjects who are immunocompromised.
* Subjects who have Diabetes Mellitus or any other condition determined by the PI to affect healing.
Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia

The chronic coronary artery disease could be detected by a drop in the expression of A2A receptors to adenosine, while high values of the KD / EC50 ratio are a sign of coronary ischemia. Knowing the number of A2A receptors in circulating lymphocytes could allow detection of coronary artery disease and evaluating the functionality of A2A receptors in circulating lymphocytes could allow quantification of myocardial ischemia.

Thus, a simple and unique blood sample would quickly detect patients with life-threatening coronary ischemia. This would avoid prolonged hospitalizations and costly non-invasive tests (stress echocardiography, myocardial scintigraphy) in patients without coronary artery disease.

The main objective of this study is to evaluate the discriminating capacities of A2A adenosine receptors expression on the surface of circulating lymphocytes for the detection of coronary artery disease in patients hospitalized for surgery of the aorta and / or arteries of the lower limbs.

The secondary objectives are:

Assessment of the discriminating capacities of the functionality (KD / EC50) of A2A adenosine receptors on the surface of circulating lymphocytes, for the diagnosis of myocardial ischemia in patients hospitalized for surgery of the aorta and / or arteries of legs.

Determinate the best threshold for discriminating patients with coronary artery disease and estimate the discriminating performance associated with this threshold.

Determinate the best threshold for discriminating patients with myocardial ischemia and estimate the discriminating performance associated with this threshold.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for preoperative assessment of vascular surgery of the aorta and / or arteries of the lower limbs.
* Adult person (age\> 18).
* Affiliated with a social security scheme.
* Signature of informed consent.

Exclusion Criteria:

* Patients with a history of coronary artery disease awaiting revascularization.
* Hyperthyroidism, anemia (Hb \<13 g / dL).
* Contraindication to the practice of coronary angiography, stress echocardiography or myocardial scintigraphy.
* Unstable hemodynamic state or cardiogenic shock.
* Adults protected under guardianship, curatorship or legal protection.
* Pregnant or lactating women
Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum

Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum

"This study named effects of ayres sensory integration therapy versus conservative treatment in autism spectrum is a randomized clinical trail study.There is no evidence-based intervention protocol to treat sensory integration dysfunction in autism spectrum. This study may help finding best therapeutic treatment approach for sensory integration dysfunction results in repetitive behavior and impairments in functionality in autism spectrum.This study helps

* To evaluate best intervention plan for sensory integration dysfunction, Ayres sensory integration therapy versus conservative treatment in autism spectrum.
* To determine how many patients will be having what type of sensory integration dysfunction that come with autism spectrum leading to certain level of functional restrictions in Activity of Daily Livings (ADLs).
* Which type of sensory integration dysfunction having greater functional impairment and need to be focused more for intervention?
* To make better individualized rehabilitation treatment plan being an Occupational Therapist."

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of autism age range from 2 year to 8 years.
* All patients will be assed using sensory profile by Winnie Dunn.
* All the patients fulfilling the above-mentioned inclusion criteria will be assessed and evaluated by occupational therapist for sensory integration dysfunction.

Exclusion Criteria:

* All other patients not having diagnosed as autism spectrum criteria are excluded.
* All patients with sensory processing disorder assessed by using sensory profile.
Acute Effects of Autoregulated and Non-autoregulated Blood Flow Restrictive Exercise on Indices of Arterial Stiffness

To investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) BFR exercise on indices of arterial stiffness. AR BFR training devices adjust pressure in the cuff ensuring similar pressure throughout the range of motion when the muscles are contracted (dilatated) and relaxed. NAR BFR training devices do not adjust pressure in the cuff throughout the range of motion when the muscles are contracted and relaxed which cause greater pressures at different points in the range of motion. METHODS: Following a randomized AR or NAR familiarization training session, 20 adults (23±5 years; 7 female) participated in 3 randomized treatment-order sessions with AR-BFR, NAR-BFR, and no- BFR separated by 1-week washout periods. Participants performed 4 sets of dumbbell wall squats to failure using 20% of 1 repetition maximum (1-RM) at 2-second concentric/eccentric cadence. Training limb occlusion pressure (LOP) was set at 60% of supine LOP for both the AT and NAR sessions. Testing before and immediately following the training session included ultrasonography of the carotid artery, applanation tonometry, and blood pressure acquisition. Two-way ANOVAs were used to examine the effects of treatment and the treatment-order interaction on pulse wave velocity (PWV), beta-stiffness index (β-stiff), and arterial compliance (AC). RESULTS: There were no baseline differences in CF- (carotid-femoral) PWV, CR- (carotid-radial) PWV, β-stiff, and AC (all p \> 0.05). CF-PWV increased in the NAR-BFR (mean difference = 0.57±1.12 m/s, p = 0.02) and no-BFR (mean difference = 0.63±1.42 m/s, p = 0.03) groups following the exercise session. CR-PWV increased in the no-BFR (mean difference = 0.82±1.5 m/s, p = 0.03) group. And there was an interaction effect in CFPWV between AR-BFR and NAR-BFR (mean difference = 0.70±1.6 m/s, p = 0.03). CONCLUSION: These findings show acute AR-BFR training does not influence indices of arterial stiffness while acute NAR-BRF training increases central stiffness.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-40 years old
2. Physically active (\> 6 months of consistent exercise training)
3. Weight stable for previous 6 months (+/-2.5 kg)
4. Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion Criteria:

1. BP\>140/90 mmHg
2. BMI\>40 kg/m2
3. Diabetes
4. Familial hypercholesterolemia
5. Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
6. Women must not be pregnant, plan to become pregnant during the study, or be nursing
7. Active renal or liver disease
8. All medications and supplements that influence dependent variables
9. Recent surgery \< 2 months
10. Alcohol abuse
11. Sleep apnea
12. Claustrophobia
Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old \< Age \< 50 years old
* Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)

  1. History of opiates abuse no less than 3 years
  2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
  3. completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
* Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)

Exclusion Criteria:

* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
* Abuse of other type of drugs
* severe cognitive impairments
* Enrollment in other clinical trials
* Stereotactic respectively neurosurgical intervention in the past
* Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and instable organic diseases (e.g. instable coronal heart disease)
* tested positively for HIV
* pregnancy and/or lactation
* Severe disorders for coagulation and liver function
* Epilepsy or other severe brain trauma or neurological impairments
An Injury Prevention Program for Professional Ballet

The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.


Eligibility Criteria:
Inclusion Criteria:

* Professional Ballet Dancer
* Willing to participate and undergo informed consent process

Exclusion Criteria:

* Pregnant Women, non-English speaking subjects, or those who decline participation in the study.
Choroideremia Gene Therapy Clinical Trial

Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients will be required to attend a total of 11 study visits over a 24 month period with an additional 3 year follow-up.

This is a Phase II, open label study involving patients with a clinical phenotype of choroideremia and a confirmed CHM genotype. Following consent, patients will be required to attend an initial screening visit (Visit 1). Within 2 weeks of the screening visit patients will undergo a surgical procedure (Visit 2) under general anesthesia which will include a standard vitrectomy, retinal detachment and administration of a subretinal injection of AAV2-REP1 (1x1011 genome particles). Patients will be required to attend a further 9 study visits (Visits 3-11) over a 24 month period for functional, and anatomical assessments as well as monitoring of adverse events. The primary endpoint is the change from baseline in visual acuity in the study eye, compared to control eye. Secondary study endpoints are, change from baseline in autofluorescence evaluation, microperimetry readings and other anatomic and functional outcomes (all in the study eye compared to control eye). Secondary endpoints also include safety assessments to be conducted throughout the study. The fellow eyes of these patients will be utilized as controls in this study and will receive no study treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Male
* Able to give informed consent
* Genetically confirmed diagnosis of choroideremia
* Active disease visible clinically within the macula region
* Best-corrected visual acuity equal to or worse than 20/32 but better than or equal to 20/200 in the study eye.

Exclusion Criteria:

* Female
* Under the age of 18
* History of amblyopia in the study eye
* Men unwilling to use barrier contraception methods
* Relevant grossly asymmetrical disease or other ocular morbidity which might confound use of the fellow eye as a long-term control
* Any other significant ocular and non-ocular disease/disorder or retinal surgery
* Contraindication to use of medications or contrast agents
* Participated in research study involving an investigational product in the past 12 weeks
* Having had gene or cellular therapy at any time prior to this study.
Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)

Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven inoperable stage IIIb-IV NSCLC
* ECOG PS 0-1
* Life expectancy \> 3 months
* Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL
* Adequate liver function: total bilirubin \<1.5 times the upper limit of normal (ULN); AST and ALT \<2.5 times ULN in patients without liver metastases, \<5 times ULN in patients with liver metastases
* Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine clearance ≥ 50 mL / min and urinary protein \<2+. In patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
* International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN within 7 days before enrollment
* Written informed consent

Exclusion Criteria:

* Evidence of bleeding diathesis or coagulopathy
* History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
* Previously received chemotherapy and radiotherapy and biological targeted therapy
* Uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mm Hg)
* Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (New York Heart Association class ≥Grade II) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
* Unhealed wounds, active peptic ulcer or fracture
* Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
* Women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (IUD, spermicide barrier birth control device or sterilization) during the study. Male who are unwilling to take effective contraceptive measures during the study
* Participated in other clinical trials within 28 days before the initiation of treatment.
* Allergic to any of the study drugs
Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.

Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 28 kg/m²
* Good general health
* Regular eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria:

* Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation or chronic diarrhea)
* Surgery of the gastrointestinal tract (except for an appendectomy)
* Use of antibiotics during the month preceding the study
* Use of medication or dietary supplements influencing gut transit or intestinal microbiota during the month preceding the study. Examples of such medication/dietary supplements are antispasmodics (e.g. buscopan), antidiarrheal medication (e.g. imodium), probiotic medication (e.g. lacteol, enterol)
* Intake of pre- or probiotics during the study or during the month preceding the study
* Being on a weight-loss diet during the study or during the month preceding the study
* Extreme dietary habits (e.g. vegan, Atkins diet, Montignac diet)
* Females who are pregnant, lactating or planning to become pregnant during the study period