cyrilzakka/clinical-trials huggingface dataset:
Transcranial Alternating Current Stimulation (tACS) in Stuttering

The purpose of this study is to investigate how mild, noninvasive electrical brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people that stutter. The long-term goal of this study is to test the therapeutic potential of transcranial alternating current stimulation (tACS) for the treatment of stuttering.

The study team hypothesizes that if stuttering involves impaired initiation of motor programs, delta-tuned tACS will strengthen communication between brain regions and decrease stuttering. Therefore, the study team delta-tuned sensorimotor tACS will be paired with fluency-induced speech (choral reading), which is hypothesized to decrease stuttering via improved auditory motor integration. However, if the primary impairment lies in planning of motor programs, the study team hypothesizes that theta-tuned tACS will strengthen communication between prefrontal and temporal brain regions and decrease stuttering.

Participants will have screening and baseline visits that include a variety of tests and procedures (i.e. standardized tests of speech, language, hearing test, music training questionnaire, working memory tests, and speech sample to characterize stuttering, magnetic resonance imaging (MRI) and electroencephalography (EEG)). Following these, participants will have 5 sessions (active and sham conditions) and then a one month follow-up phone call.

Of note, there will be an embedded pilot study to refine the experimental protocol in terms of practicality and feasibility and these participants will not be included in this registration. The only purpose of this embedded study is to refine the protocol and it does not have any health or behavioral outcomes.

Eligibility Criteria:
Inclusion Criteria for stutterers:

* Have normal language, hearing, and cognition
* Speak English as the primary language
* Currently stutter
* Score (per protocol) a certain value on the Stuttering Severity Instrument (SSI-4).
* Have not received any treatment for stuttering within the past year

Exclusion Criteria for stutterers:

* History of seizures
* Major medical or neurological illness (e.g., stroke, serious head trauma, brain infection, Parkinson's disease, etc.)
* History of closed head injury with loss of consciousness (e.g., concussion)
* Metal or electronic implants such as cochlear implants and pacemakers anywhere in the body
* Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
* Currently pregnant
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score \[\>0.45\] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.


Eligibility Criteria:
Inclusion Criteria:

- Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.

Exclusion Criteria:

* Presence of active infections
* Acute GI bleed
* Hepatorenal syndrome
* Patient unwilling
* DF\>120
* Autoimmune hepatitis
* Hepatitis B, Hepatitis C, HIV cases
* Pregnancy
Multimodal Therapy Impact on Pancreatic Cancer Survival

The goal of this retrospective cohort study is to analyze change of treatment strategies affect the survival outcomes in patients of pancreatic cancer who received curative-intent treatment. The main question it aims to answer is:

Hypothesis: Change of treatment strategies involving increased utility of neoadjuvant chemotherapy and aggressive surgical approaches of extended pancreatectomy improved the overall and progression free survival in the patients with pancreatic cancer.

Participants received curative treatment for pancreatic cancer.

This study is to analyze the change of treatment strategies and shift of the paradigm over time in a single center. Researchers plan to see the impact of the evolvement to the survival outcomes in pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic adenocarcinoma
* Received curative surgery

Exclusion Criteria:

* Other subtypes of pancreatic cancer including acinar cell carcinoma, mucinous carcinoma, undifferentiated carcinoma and intraductal papillary mucinous neoplasm with associated adenocarcinoma
* Cases with palliative or R2 resection were also excluded from the analysis.
Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block

assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.

ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.

Control group C(n =23 ): patients received spinal anesthesia without any block.

Eligibility Criteria:
Inclusion Criteria:

Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.

Exclusion Criteria:

Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.
A Combined Mindfulness-diving Protocol on Emotional Eating in Obese Patients: a Prospective Randomized Study

The goal of this clinical trial is to learn if a combined minfulness-diving program has an impact on emotional eating in adults with obesity. The main questions it aims to answer are:

Does the BathysMed protocol have an impact on emotional eating after the 2 months diving protocol? Researchers will compare the diving program to a control group of adult patients with obesity.

Participants will be asked to participate in the combined mindfulness-diving protocol for 2 months, and complete the questionnaires at baseline, 2, 5, and 8 months follow up.

This unblinded randomized controlled trial is performed in the community setting, Montpellier, France. Adults with a BMI \> 30kg/m2 were randomly assigned (1:1) to a Bathysmed® 2-month program (intervention group) therapeutic scuba-diving protocol with mindfulness exercises plus standard care, or stand-alone standard care including dietary and psychological support (control group). The primary outcome was the mean change in the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 2-months as intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* patients with obesity (Body Mass Index BMI \> 30kg/m2),
* adults over the age of 18 able to provide written consent
* affiliated to public medical insurance.

Exclusion Criteria:

* BMI \> 45 kg/m2,
* older than 60 years,
* unable to walk,
* known psychiatric pathology apart from anxiety and depression,
* intellectual deficit,
* routinely practising meditation,
* a known contra-indication to scuba-diving
* known past medical history of cardiac problems.
Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.

All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or an active control training program on iPad that includes commercial games and control emotional attention bias training.

Eligibility Criteria:
Inclusion Criteria:

* Between (or equal to) 15-25 years of age
* Ability to read/speak fluent English
* Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).

Exclusion Criteria:

* Diagnosis of mental health disorder
* Significant neurological or medical disorders that may produce cognitive impairment
* Current epilepsy or previous history of seizures
* Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
* Recent history of substance abuse or dependence (within past 3 months)
* MRI contraindication (e.g. metallic head implant, history of seizure, pacemaker, pregnancy, etc.)
* Current IQ \< 70 as measured by the Wechsler Abbreviated Scale of Intelligence Scale (WASI)
A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria).

The following criteria were employed to delineate complex or very complex angioplasties:

* Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI)
* Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI)
* Angioplasty of Chronic Coronary Occlusion (CCO-PCI)
* Angioplasty of a Bifurcation Lesion (CBL-PCI)

The following definitions pertain to the classification of angioplasty procedures:

* Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity.
* Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity.
* Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.

Eligibility Criteria:
Inclusion Criteria:

* The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.

Exclusion Criteria:

-
A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c \>= 7% and \<=10%.
* Patient either has not been previously treated with antihyperglycemic medication or has been treated for \<30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
* C-peptide \> 1.0 ng/ml
* Body Mass Index \<= 40 kg/m2
* Serum creatinine \< 1.5 mg/dL for men or \< 1.4 mg/dL for women.
* No overt proteinuria (microalbumin/creatinine ratio must be \<300 mg/g

Exclusion Criteria:

* Unstable renal disease
* Patients with significant liver disease including chronic active hepatitis
* Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
* Subjects with clinically significant anemia
The NORwegian Atrial Fibrillation Self-SCREENing

Atrial fibrillation (AF) is common, increases the risk of mortality, stroke and heart failure, and portending significant burden to patients, societal health and health economy. One of three AF cases are undiagnosed. Several methods for detection of AF exist, but most of them have major limitations and are associated with resource-demanding diagnostic workup in the speciality health care services.

This randomized clinical trial will evaluate whether self-screening for AF with the ECG247 patch monitor will reduce AF-related morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years and minimum one other risk factor for stroke according to the CHA2DS2-VASc risk score: Age ≥75 years, Diabetes, Heart failure, Hypertension, Previous stroke/TIA and/or Vascular disease
* Informed consent for participation

Exclusion Criteria:

* History of AF (self-reported)
* Use of anticoagulation therapy
* Pacemaker/CRT device
* No smart phone
Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer

Immunotherapy is now considered to be one of promising approaches for treating cancer. Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal cancer. Radiation-induced mutation genes were identified as new sources of tumor associated antigens using exon sequencing and peptide microarray technologies. Epitope peptides for these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL therapy in combination with radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus.
2. measurable disease by CT scan
3. ECOG performance status of 0 to 2
4. Expected survival of at least 3months
5. Laboratory values as follow:

   * Absolute neutrophil count (ANC) ≥ 1.5×109
   * White blood cell count ≥ 3×109/L
   * Platelets ≥ 100×109/L
   * Haemoglobin (Hb) ≥ 10g/dL (patients'Hb should be corrected to \>10g/dL before treatment)
   * Adequate liver function (within 1 week prior to randomization)
   * Serum bilirubin ≤ 1.5× ULN
   * Alanine aminotransferase/aspartate transaminase (ALT / AST) ≤ 2.5× ULN
   * Alkaline phosphatase (ALP) ≤ 3× ULN
6. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Active or uncontrolled infection
4. Prior chemotherapy, radiation therapy or immunotherapy
5. Concurrent treatment with steroid or immunosuppressing agent
6. Patient with peptic ulcer disease
7. Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
8. Disease to the central nervous system
9. Decision of unsuitableness by principal investigator or physician-in-charge
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy.

Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). Recently, these patients have been treated effectively with the implantation of a carotid stent (a metallic mesh tube). When implanting the carotid stent, physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain. The TriActiv® ProGuard™ System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted. Then, the TriActiv® ProGuard™ System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored. This study will evaluate the safety and efficacy of the TriActiv® ProGuard™ System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 year of age
* Patient gives informed consent
* Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic
* At least one medical or anatomic condition which makes the patient a high surgical risk.

Exclusion Criteria:

* Stroke within 14 days
* Major stroke with significant residual effects
* Myocardial infarction within 72 hours
* Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery
* Severe carotid artery tortuosity
* Total occlusion
* Presence of thrombus or heavy calcification in the carotid artery
* Pre-existing carotid artery dissection
* Any planned interventional or surgical procedures within 30 days
* Atrial fibrillation
* Creatinine \> 2 mg/dL
* Current participation in another investigational drug or device study
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients

After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's.

After 10 weeks of treatment patients will be requested to wear an ECG patch continuously for an additional period of 14 days.

Overall patients will participate in the study for 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-85 years with history of documented paroxysmal (\<7 days) atrial fibrillation
* AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours)
* Ability and willingness to sign an informed consent form
* Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone
* Known symptomatic AF event over the recent 3 months
* Willing not to change the antiarrhythmic treatment

Exclusion Criteria:

* Hemodynamic instability (systolic blood pressure \<100mmHg or heart rate\>170 bpm at Baseline) during recruitment visit
* Known history or current diagnosis of atrial flutter
* An active myocardial infarction evident from ECG
* Recent stroke or myocardial infarction (\<6 months)
* History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR\>300ms) 1st degree AV block
* Unilateral or bilateral vagotomy
* History of persistent AF with documented AF episodes of \>7 days
* Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases or valvular AF)
* History of Impaired systolic function with EF\<40 % or NY Class III or IV heart failure classification
* Dilatated left atria with a diameter \> 50mm as evident by an echocardiogram
* Currently enrolled in another study
* Recurrent vaso-vagal syncopal episodes
* Pregnancy or breast feeding
* Pacemaker or CRTD or any implanted electrical stimulating device
* History of epilepsy or seizures
* Peripheral neuropathy or dermatological condition affecting the tested upper extremity area
* Unsuitable for participating in the study according to attending physician
Strabismus Surgery and Driving Ability

The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of patients with strabismus may be reduced. The goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; Patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Strabismus
* Age \> 18 yrs old
* Driving license

Exclusion Criteria:

* Inability to driving under French law
Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC
* Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
* Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
* Measurable disease

Exclusion Criteria:

* Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment
* Patients who lack of tolerance of erlotinib therapy
* Patients with known brain Metastases
* Patients with demonstrated history of or presence of interstitial lung disease.