cyrilzakka/clinical-trials huggingface dataset:
Brain Circuits in Schizophrenia and Smoking

The principle aim of the project is to identify the key brain circuits associated with smoking and especially smoking in high risk population. The investigators hope that the study will provide concrete biomarkers for new therapeutic development and ultimately reducing the smoking related health burden.

There are several studies and hypotheses to be tested. This project includes (1) a cross-sectional study design that measures brain imaging, smoking, clinical diagnosis and symptoms, cognitive functional assessments, distress tolerance, and genetic information, which is also the baseline for the longitudinal study; and (2) a longitudinal study design for smoking cessation option for 1 year in some smokers and a longitudinal follow-up for all available subjects.

During the baseline portion of the study, subjects are expected to complete clinical symptom assessments, a computer challenge task to measure distress tolerance, MRI scan, role-play test to measure cognitive and functional abilities, and blood draw. Subjects who are eligible will participate in the longitudinal follow-up study where the research team will call subjects regularly regarding smoking related information (smoking risk and treatment options).

Eligibility Criteria:
Inclusion Criteria:

* Male and Female between ages 12-above (clinical assessments and blood draw only above 62)
* Ability to give written assent (age below 18)
* Ability to give written informed consent (age 18 or above)
* Individuals fulfilled other criteria but over age 62, with major medical illnesses, significant alcohol or other drug use, or unable to undergo MRI may participate in clinical assessments and blood draw if his/her participation forms a family unit (i.e., if at least one of the family member has participated).
* Subjects above age 62 will not participate in MRI measurements although they may still participate in clinical assessments and blood draw.

Exclusion Criteria:

* Inability to sign informed consent/assent
* For patient participants, Evaluation to Sign Consent (ESC) below 10.
* Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions.
* Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
* Woman who are pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test before MRI)
* Can not refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
* For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner
Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

In the 20th century, tobacco caused the death of 100 million people worldwide and it is estimated that it will be responsible for 1 billion deaths in the 21st century. Currently 8 million people die each year from smoking, 7 million are associated with active smoking, thus being the main risk factor for loss of disability-adjusted life years for men and the ninth most important risk factor for women. In previous studies it has been reported that approximately 21% (14%-30%) of subjects who have required hospitalization are active smokers, being higher in men than in women (28% vs 14%). The initiation of treatment for smoking cessation in this group of subjects has shown an effectiveness rate of up to 65% to maintain abstinence 6 to 12 months after discharge. The effectiveness has been analyzed in scenarios with only brief advice, in some others with the use of medications such as varenicline, bupropion and nicotine replacement therapy, however, the interventions have not been standardized for adequate analysis, which could contribute to the different results.

The objective is to know the effectiveness of combined treatment to maintain abstinence in participants with active smoking who are hospitalized in a reference center.

Bupropion and nicotine replacement therapy are the drugs used in this clinical trial.

Participants will be randomly assigned to two groups: nicotine replacement therapy or nicotine replacement therapy plus bupropion. All participants will have counseling, conductive behavioral therapy, follow-up at 3, 6 and 12 months with a pulmonologist. Pulmonary function tests will be performed every 3, 6, and 12 months. Abstinence will be corroborated with a cotinine (urine) test and an exhaled carbon monoxide test.

Eligibility Criteria:
Inclusion Criteria:

\>18 years Active smokers (consumption of more than 100 cigarettes in their entire life, and who have consumed cigarettes in the last 30 days) Hospitalized subjects Informed consent

Exclusion Criteria:

* Subjects who have had pharmacological treatment to stop smoking in the last month
* Subjects with contraindications for medications.

Sample size calculation, 80% power, unilateral, due to difference in proportions, estimated loss of 25%.
Endoscopic Therapy Or Surgery for Early Colon Cancer

The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
* Size ≤20 mm in diameter as deemed by the colonoscopist
* No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
* Patient eligible for surgical removal as deemed by the local MDT at the participating center
* Endoscopic images or video of the tumor
* No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
* No contraindication for any of the two treatment arms
* Written informed consent
* No prior or synchronous CRC
* No other malignancy which is not cured
* No more than 10 adenomas or serrated polyps
* No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
* No inflammatory bowel disease
Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy

The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.

Vibration devices have been used by some patients with cerebral palsy during therapy sessions. Researchers believe they have the potential to be even more useful for everyday use, and are doing this study to learn more about what they can do.

Participate in this study will be asked to complete assessments that test arm motion, muscle tone, motor control, and sensory function. They will then be asked to wear a wristband on each wrist and on their shoulder. These wristbands contain vibrators that can vibrate at different levels. The vibrations are caused by a low-level of sound waves that people may barely be able to hear. While wearing the vibration devices on the wrist and shoulder, participants will be asked to perform two tasks. The first task is called the box and blocks test, which consists of transferring wooden blocks from one box to another. The second test is called the Shriners upper extremity evaluation (SHUEE). In this test participants will perform a series of fine motor tasks with their hands. The SHUEE test will be video recorded for scoring by a study therapist at a later time on how much and how well participants use their impaired arm to perform the tasks. Participants will be asked to complete the box and blocks test and the SHUEE test 3 times. Participation in this study will be one single visit and last approximately an hour to an hour and a half.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy
* 3 years to 18 years of age
* Able to reliably express pain, discomfort or fear as reported by the parent/guardian
* Manual ability classification scale (MACS) levels I, II or III

Exclusion Criteria:

* Any unstable medical condition. An unstable medical condition is a state of imminent threat to life such as shock, acute asthma, respiratory distress, severe infection and sepsis. Any patient in a clinic or therapy center presenting with signs and symptoms of an unstable medical condition will be directed to emergency medical services
* Any medical condition preventing active rehabilitation reported by the parent/guardian such as:

  o Thromboembolic disease, acute progressive neurological disorder, cardiovascular or pulmonary contraindications, aggressive behavior, severe cognitive deficits, joint instabilities and compromised bone health, recent or non-consolidated fractures, osteoporosis
* Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices
* Skin lesions affecting the areas where the device straps will be attached to the body
Understanding the Relationship Between Inflammation and Insulin Resistance in the Adipose Tissue

This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .

This study is being done to determine whether eosinophils (a type of white blood cell) play an important role in human fat metabolism and inflammation.

This study is being done to determine if fish oil supplement could play a role in reducing inflammation and improving insulin sensitivity in your fat tissue.

Eligibility Criteria:
Lean, healthy person with a body mass index (BMI) of 25 or less, or you are obese, BMI between 30 and 50, and non-diabetic.

Lean healthy controls will not be on any medication and will be undergoing elective abdominal surgery excluding those involving acute inflammation (i.e. acute cholecystitis, bowel perforation, or diverticulitis).

Obese, non-diabetic subjects will have a BMI between 30 and 50 and be taking no medications affecting glucose metabolism or lipid metabolism. These subjects will be identified from a pool of patients undergoing an elective abdominal surgical procedure such as inguinal hernia repair, laparoscopic Nissen fundoplication, planned cholecystectomy, but also bariatric surgery.

Volunteers will not be taking corticosteroid therapy or have a history of asthma, COPD or atopic syndrome. All subjects will undergo a medical history intake and a physical examination followed by an OGTT to confirm normal glucose.
Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects

The goal of this study is the multimodal exploration via eyetracking, MRI and EEG data of ocular movements and the corresponding brain activation during ecologic visual stimulation in the healthy population.

Cerebral activation following visual stimulation is explored using two neuroimaging techniques EEG and MRI while eye movements are recorded. Three experiments are performed: in MR scanner 1) functional localisation of specific areas: LOC, FFA, MT/V5, V1 and V2 and 2) a saccadic choice experiment; with EEG, replication of the experiments performed in the MR scanner and 3) an additional experiment of movement detection during the ocular saccades.

Thirty young volunteers (18-40 y old) are involved.

Eligibility Criteria:
Inclusion Criteria:

* Normal vision or corrected to normal
* Social security affiliation
* Signed consent to participate
* No pregnancy fo women

Exclusion Criteria:

* Audition and motor troubles
* Incapable to decide (Persons mentioned in L1121-5,6 et 8 of public health code)
* Neurological disorders
* Pathology affecting oculomotor control
* MRI incompatibility
Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg

This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ≤20%.
* Positive somatostatin receptors type 2
* Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks

Exclusion Criteria:

* Grade 3 or rapidly progressive (within 12 weeks) NET
* Any NET other than pancreatic and midgut
* Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.
* Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group

To study the clinical and biochemical characteristics women with polycystic ovary syndrome (PCOS) in different aged groups.

Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder of reproductive age women, affecting an estimated 9-18% of all women in this age group. To diagnose of PCOS in early life is especially important because it is now thought to increase metabolic and cardiovascular risks. Investigating PCOS is crucial as it is now considered to increase metabolic and cardiovascular risk, thereby impacting the health of women to a much greater extent than previously thought. We are plan using retrospective analysis to evaluate the clinical and biochemical presentation of PCOS in different aged groups.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age women with sufficient data

Exclusion Criteria:

* Disorders of uterus (e.g. Asherman's Syndrome, Mullerian agenesis) and chromosomal anomalies (e.g. Turner syndrome)
* women who had had menarche at less than 3 years of age, Day 3 FSH \> 15, or who were older than 46
* women with inadequate clinical/biochemical records
* and women who had had ovarian cysts or ovarian tumors in ultrasonography examination
* pregnancy women
Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal triamcinolone plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.

Patients with symmetric proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and triamcinolone injections in one eye. For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Type II Diabetes
* symmetric proliferative diabetic retinopathy without high risk characteristics
* Informed consent signed

Exclusion Criteria:

* previous treatment for diabetic retinopathy
* media opacities that may interfere with clinical, photographically or OCT examinations
* inability to understands the implications of the protocol
* Glaucoma or ocular hypertension
* Any other pathology that could cause retinal alterations
* Patients with any other situation that may interfere in study completion based in Investigator´s opinion
Prospective Clinical Evaluation of Beta-D-Glucan Assay in Blood and BAL

In patients with invasive fungal infection (IFI) rapid diagnosis is essential for early initiation of appropriate antifungal therapy and thereby survival. Conventional culture is still the Gold-Standard for diagnosis of IFI. Sensitivity of conventional culture, however, is low (50%) and time to results minimum 24 hours.

Therefore usage of serological tests detecting fungal antigens has increased dramatically over recent years. Main advantages of this new methods are rapid results and higher sensitivity when compared to conventional culture. One of the most promising serological marker currently used is beta-D-Glucan, which is a component of the fungal cell wall. ß-D-Glucan has been detected in IFI caused by Aspergillus, Candida and Fusarium spp. The Fungitell Assay (Associates of Cape Code, Inc.) was developed and validated for detection of ß-D-Glucan in peripheral blood.

Up to date information about clinical performance of the Fungitell Assays in bronchoalveolar lavage fluid (BAL) is limited. This study will therefore evaluate clinical and diagnostic performance of the Fungitell Assay in BAL from patients with solid organ transplant or hematologic malignancy.

In addition Mn/A-Mn, the lateral flow device test for aspergillosis, and Galactomannan, as well as PCR will be determined and used as comparators for BDG performance.


Eligibility Criteria:
Inclusion Criteria:

* above 18 years of age
* Bronchoscopy performed in clinical routine due to suspicion of IFI
* Hematological malignancy or receipt of solid organ transplant/ICU

Exclusion Criteria:

* below 18 years of age
* No bronchoscopy performed
* No Hematological malignancy nor receipt of solid organ transplant/ICU
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
* Detectable metastases
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* Significant cancer related pain
* Prior gene therapy, chemotherapy, or immunotherapy
A Clinical Investigation With BARRIER® EasyWarm®

This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures. The investigation will enroll approximately 20 healthy volunteers in one investigation site and each subject will be evaluated for up to 10 hours in one visit.

This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures.

The investigation will enroll approximately 20 healthy volunteers in one investigation site. Each subject will be evaluated for up to 10 hours in one visit on site. Body core- and skin reference temperatures will be established before applying the blanket. After reference temperature assessments, the BARRIER EasyWarm is positioned on the subject with the neckline at the collarbone. Skin temperatures will be assessed with an IR camera and body core temperatures will be assessed with an ear thermometer at 30 min, 1 hour, 2, 3, 4, 5, 6, 7, 8, 9, and 10 hours post blanket application. Subject perception of heat from the blanket will be assessed at 30 minutes, 5 hours and 10 hours post blanket application by means of a five graded question.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Adult males and females ≥ 18 years old
3. Able to maintain a supine position up to 10 hours.

Exclusion Criteria:

1. Diseases/medical treatments that affect normal body temperature control:

   I. Persons who have/have had thyroid disease or who are treated with medications affecting the thyroid hormones

   II. Persons being treated with medication affecting normal body temperature control, based on investigator judgement.
2. Impaired circulation/vascular disease
3. Impaired sensitivity/neuropathy
4. Active skin disease
5. Female with temperature variations due to menopause
6. Pregnancy or lactation at time of study participation.
7. Person not suitable for the investigation according to the clinician's judgement.
Aspirin and Antiretroviral Therapy in HIV Infected Patients

The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.

Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected (by positive HIV Ab or detectable HIV RNA level)
2. No ART for at least previous 3 months
3. Ready to start or re-start ART (regimen pre-chosen by patient and provider)

Exclusion Criteria:

1. Age \< 18 years, or \>60 years
2. Pregnancy
3. Current aspirin use
4. Presence of known atherosclerotic CVD determined by:

   1. Previous myocardial infarction
   2. Significant coronary atherosclerosis by angiography
   3. Coronary revascularization procedure (coronary stent or surgical bypass)
   4. Previous cerebral vascular accident (stroke)
   5. Ischemic cardiomyopathy
   6. Carotid stenosis (\>25% narrowing by carotid ultrasound)
   7. Aortic aneurysm
   8. Symptomatic peripheral vascular disease (claudication)
   9. Surgical revascularization procedure of peripheral vessels
5. Hospitalization (within prior 2 weeks of study entry)
6. Concurrent self-limited bacterial infections (does not include chronic viral infections)
7. Clinical or pathologic diagnosis of systemic vasculitis
8. Active drug or alcohol use