cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).

To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode (Phase I).

Secondary:

To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects.

To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) (Phase III).

To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) (Phase II).

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
* Duration of current episode of depression ≥4 weeks and ≤3 years
* Clinical Global Impression - Severity of Illness ≥ 4
* Resistance to antidepressant treatment in a discrete illness episode
* HAMD24 Item 1 ≥ 2 and total score ≥ 20
* Subjects able to commit to protocol visit schedule
* At the end of the baseline visit, subject must have a HAMD24 score of ≥ 18 and change in score may not be ≥ 25% decrease from that seen at the screening visit

Exclusion Criteria:

* Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)
* Contraindication to TMS
* Cardiac pacemakers, implanted medication pumps, intracardiac lines
* History of neurological disorder
* Unstable medical conditions
* Any psychiatric disorder, which in the judgement of the Investigator may hinder the subject in completing the procedures required by the study protocol.
* Significant acute suicide risk
* Inability to locate and quantify a motor threshold
* If sexually active female, not on an accepted method of birth control.
* Diagnoses of the following conditions (current unless otherwise stated):

  * Depression secondary to a general medical condition, or substance induced:
  * Seasonal pattern of depression as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  * Any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder,
  * Intellectually disabled,
  * Substance dependence or abuse within the past year (except nicotine or caffeine),
  * Bipolar disorder,
  * Obsessive compulsive disorder (lifetime),
  * Post-traumatic stress disorder (lifetime),
  * Eating disorder (lifetime).
Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

This prospective, observational, multi-center, patient registry will follow patients who are newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once enrolled, the patients' dose and titration will be followed for the first 6 months of treatment with Tyvaso.

A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 to review their dose and titration schedule. In addition to patient-reported dosing data, some patient demographic information, will be collected by the investigative site at Baseline.


Eligibility Criteria:
Inclusion Criteria:

* Are newly prescribed Tyvaso for the treatment of PAH and plan to initiate therapy
* Are willing and able to be contacted by the patient call center.

Exclusion Criteria:

* Have previously received Tyvaso.
* Are currently enrolled in an interventional (non-FDA approved) PH clinical trial.
New Technique in Congenital/Pediatric Cataract Surgery

In pediatric/congenital cataract surgery; multiple surgical interventions are performed, which needs multiple general anesthesias. Here, we describe a new technique, to end the operation in one session.

Generally, in congenital/pediatric cataract surgery, it might be possible to different multiple procedures with multiple general anesthesias. Here, the investigators found a new procedure to perform the cataract removal, intraocular implantation, and the anterior vitrectomy all in one session through a sclero-corneal tunnel. The corneoscleral tunnels are covered by the conjunctiva to abolish the need for both suturing and repeated general anesthesia to remove corneal sutures.

Eligibility Criteria:
Inclusion Criteria:

* Congenital/pediatric cataract

Exclusion Criteria:

* Aphakic and pseudophakic
DYNA EMBOLIZATION - Pilot Study of IV Dyna CT and CBV Imaging Techniques

This is a prospective pilot study evaluating the efficacy of DynaCT in direct comparison to conventional catheter angiography in demonstrating the anatomic details of the vessels supplying brain lesions. Forty patients will be recruited for this pilot study.

There are common intracranial lesions that have increased vascularity that makes surgical resection difficult. Embolization can improve the surgical procedure by easing the resection, decreasing blood loss during surgical resection, and improving visibility of the surgical bed during resection. Conventional intra-arterial (IA) angiography is the gold standard to evaluating pathologies for embolization candidates, however the invasiveness of the procedure (with associated risks), time requirements, and resource utilization of evaluating and possibly embolization of these patients are precluding its widespread use.

Devising a test methodology that is quick, with less risk, and can accurately detect arteries that are of value in embolizing these pathologies will improve the utilization as a screening tool and will result in improved resource utilization that focuses only on those patients that require embolization. Lastly, by correlating the Dyna CBV to surgical resection quality (ease of resection, blood loss from surgical site), a non-invasive, controlled method to evaluating embolization quality can be established to aid surgeons in pre-operative planning as well as serve as a method of evaluating embolization materials designed for the blood vessels associated with brain lesions.

The DynaCT technique is a fully FDA-approved application of the Siemens imaging system and software. DynaCT is often performed during our angiographic and interventional procedures. Neurointerventionists have begun to apply this technology within their practices, and the investigators have selectively applied DynaCT for various clinical applications. However, at this point the investigators have not incorporated the technology into clinical care for patients with intracranial lesions.

Although DynaCT is an approved technology, there have been recent improvements in the software performing the 3D reconstruction. These new features will be used in this study and thus the investigators consider them to be "research scans."

Study patients will provide informed consent for the scan and the patients will not be billed for the DynaCT portion of the procedure (only the standard of care conventional angiography). The investigators have specifically chosen to image patients already undergoing conventional angiography for surgical resection in order to have a direct comparison.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to have an intracranial lesion evaluated for possible surgical resection.

Exclusion Criteria:

1. Patients with severe contrast allergies
2. Women who are pregnant or lactating.
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria:

* Treatable conditions that may cause urinary incontinence
* Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.

PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.

This study will help to evaluate the specificity and sensitivity of the French translation of a self-questionnaire looking for a history of pre-eclampsia in women who gave birth at Brest University Hospital before year 2015.

First, women with pre-eclampsia (cases) and women with no hypertensive disorders (controls) during pregnancy were identified with the Medical Registry Database (MRD) of Brest University maternity ward.

All pre-eclampsia diagnoses were reviewed by 2 experts in order to confirm the accuracy of the diagnosis.

250 cases and 250 controls were finally selected after consultation of their medical file and were pre-included in the study.

Then, the 500 women will be contacted by phone or e-mail in order to inform them about the study and to offer them the possibility to participate in the study.

The women who will agree to participate in the study will fill in an online self-questionnaire on pre-eclampsia.

Their responses will then be compared to the diagnosis retained after consultation of their medical file.

Sensitivity and specificity of the questionnaire will then be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Women who gave birth after a pregnancy of more than 6 months at Brest University Hospital between January 2002 and December 2014
* For the cases: with a pre-eclampsia diagnosis during pregnancy
* For the controls: with no history of hypertensive disorder during pregnancy

Exclusion Criteria:

* Women Under legal protection
* Women unable to read French
* Medical interruption of pregnancy
* Pregnancy with a delivery before 6 months
* Women who refused to participate in the study
Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )

Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that can cause distant embolism. Closure of the left atrial appendage avoids long term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate:

* The efficiency and safety of implanting devices in France
* The type and duration of antithrombotic treatment prescribed after left atrial appendage closure


Eligibility Criteria:
Inclusion Criteria:

Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not).ot).

Exclusion Criteria:

* Refusal of the patient to participate in this study and therefore the use of his data
* Minor patient
Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung cancer;
2. stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC);
3. inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;
4. After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
5. performance status 0-1;
6. measurable or evaluable lesions;
7. Survival expectancy is not less than 6 months;
8. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function

Exclusion Criteria:

1. tumor progress after induction with immunothearoy and chemotherapy
2. EGFR, ALK, or ROS1 mutation;
3. Previous thoracic radiotherapy;
4. grade 2 or more immune-related adverse events after induction immunotherapy
5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
6. Pregnant or lactating women
7. undergoing other clinical trials;
8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
9. Patients with HIV positive and undergoing antiviral therapy;
10. Active tuberculosis
A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control Device (ABC) in Patients With Pancreatic Cancer

This is a study to assess the motion of pancreatic tumors during radiation therapy using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* A working diagnosis (with or without histologic confirmation) of pancreatic cancer
* A plan to treat with radiotherapy (or chemoradiotherapy)
* Patients must have fiducial marker(s) endoscopically placed within the pancreas for clinical treatment.

Exclusion Criteria:

* Previous abdominal radiotherapy.
* Patients with a history of major abdominal surgery.
* Patients who are pregnant.
Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment

The relationship between exposure to air pollution and spondyloarthritis (SpA) has been poorly studied. Based on data from the literature on other inflammatory pathologies such as rheumatoid arthritis, we hypothesize that there is a relationship between exposure to air pollution and the risk of presenting a flare-up in SpA patients following and living in Franche-Comté (France).

Primary objective:The potential relationship between exposure to air pollution (nitrogen dioxide, fine particles with a diameter of less than 10 or 2.5 microns and Ozone) and the onset of a spondyloarthritis flare-up will be explored in patients with this pathology.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Axial Spondyloarthritis (radiographic or non-radiographic) according to Assessment of SpondyloArthritis international Society (ASAS) criteria
* Patient having received a consultation / hospitalization during the period 2019-2022
* Patient enrolled in the MISTIC cohort
* Having lived in Franche-Comté during the 2019-2022 period.

Exclusion Criteria:

* Other chronic inflammatory rheumatism (rheumatoid arthritis according to ACR 2010 criteria or psoriatic arthritis according to ClASsification criteria for Psoriatic ARthritis criteria)
* No inflammatory rheumatic disease
Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients

The purpose of this study is to determine the safety and tolerance of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.

This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel. This study will enroll 30 PDAC patients over 12-15 months.

Eligibility Criteria:
Inclusion Criteria:

1.≥ 18 years old at the time of informed consent 2.Ability to provide written informed consent and HIPAA authorization 3.Untreated locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion) 4.Histologically or cytologically confirmed PDAC 5.Confirmed PDAC that is measurable or evaluable per RECIST 1.1 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7.Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less 8.Adequate organ function as defined by:

1. Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN)
2. Total bilirubin level ≤ 2 x ULN
3. Creatinine level \< 1.7mg/dL For patients with a Body Mass Index (BMI) \> 30 kg/m2, lean body weight should be used to calculate the glomerular filtration rate (GFR).
4. Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Acceptable coagulation studies as demonstrated by prothrombin time (PT) within normal limits (+/-15%) unless they are on anticoagulation therapy
5. Life expectancy estimated at ≥ 3 months

Exclusion Criteria:

1. With any cancer other than PDAC in recent 5 years;
2. With myocardial infarction;
3. Uncontrolled hypertension (systolic pressure\>150mmHg or diastolic pressure\>100mmHg after treatment)
4. LVEF\<50%
5. History of hemorrhage or thromboembolism in the last 6 months
6. Psychiatric history
7. Pregnant or breastfeeding
8. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
9. Autoimmune disease
10. Uncontrolled active infection
11. Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)
A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
* Asymptomatic from prostate cancer
* Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
* PSA ≥ 2 ng/mL at screening

Exclusion Criteria:

Has previously or is currently receiving:

* Hormonal therapy with intent to treat prostate cancer
* Systemic glucocorticoids
* Chemotherapy with the intent to treat prostate cancer
* Opiate analgesics for pain from prostate cancer
* Radiation therapy for treatment of the primary tumor or metastases
* Has history of known or suspected brain or skull metastases or leptomeningeal disease
* Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
* Clinically significant cardiovascular disease
Food, Activity and Behavior Study

The purpose of this research is to test the effects of the Dietary and Physical Activity Guidelines for Americans on health and on eating and exercise behaviors.

The Dietary Guidelines for Americans (DGA), which include the Physical Activity Guidelines for Americans (PAGA), is the primary United States (U.S) government resource for weight control. The researchers propose that chronic, low grade inflammation (CLGI) limits weight control by acting upon physiological and behavioral factors that moderate weight control. Diet and exercise reduce CLGI and provide weight control, but no one has investigated the efficacy of the DGA and PAGA to reduce CLGI, whether reduced CLGI promotes greater weight control, and the moderating roles of physiological and behavioral factors on the association of reduced CLGI with weight control. To accomplish this, the researchers will conduct a 6-month trial in 224 obese adults; a 3-month controlled feeding trial with four dietary arms; 1) DGA with weight loss, 2) Western diet with weight loss,3) DGA diet weight maintenance, 4) Western diet weight maintenance. Each dietary arm will have PAGA-recommended exercise and non-exercise arms. Post-trial is a 3-month weight maintenance period. The primary outcome is change in C-reactive protein (CRP), a marker of CLGI. The results will inform the DGA and PAGA; thereby helping clinicians, public health workers, and policymakers to improve the health of Americans.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI 30.0 kg/m2 - 350 lbs \[maximum weight for dual energy x-ray absorptiometry (DXA) machine\])
* No contraindications to participate in exercise
* hs-CRP level ≥3.0 and ≤10.0 mg/L or two consecutive measures of \>10.0 mg/L measured two weeks apart
* Access to high-speed internet

Exclusion Criteria:

* Taking chronic anti-inflammatory medications
* Being pregnant, lactating, or planning to become pregnant
* Diagnosed eating disorder
* Taking weight loss medication
* Smoking
* Overt hypothyroidism
* Cancer
* Physical conditions that prevent safe exercise
* Liking of \<3 out of 10 for all available physical activity modes
* Currently exercising for more than 30 minutes per day \>3 days per week
* Unwilling to continue with current exercise routine
* Not willing to comply with all study requirements
* Blood pressure greater than 140/90
Colonic Duplication; Two Cases Report and Review of Literature

Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed cases, excision of the duplicated part is indispensable, due to risk of malignancy.

Alimentary tract duplication represents(ATD) 0.2% of all pediatric congenital malformations Which affect all gastrointestinal tracts (GIT) from the mouth to the anus.

ATD more common in with no familial or racial predilection. The ileum is the most common site (30%-35%) and the colon is the least common site (7%-20%).

The transverse colon is the most common site for colonic duplication. The duplicated part of GIT maybe in the mesenteric or anti-mesenteric side. It may has same vascular supply and mesentry or not(reported only in small bowel)..

Communication between the anomalous and actual enteric lumens may or may not be present.

Here in, two cases of colonic and anal duplication add to the knowledge with review of literature of duplicated colon in children.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients till age of 18 years old
2. All patients diagnosed with duplicated colon with or without symptoms
3. Patients with duplicated colon and other associated colorectal anomalies

Exclusion Criteria:

1. Patients \> 18 years with duplicated colon
2. All patients with duplication cyst