cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).

1. To assess the clinical and technical success rates of EUS-Guided interventions
2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.

Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.

Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.

TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.

Evaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

Exclusion Criteria:

* Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
The Clinical Application of Adipose-Derived Stem Cells on Facial Rejuvenation

The purpose of this study is to determine whether the adipose-derived stem cells therapy is effective in the treatment of facial rejuvenation.

This study will be a prospective study of patients who undergo adipose-derived stem cells therapy for facial rejuvenation at the hospital of Xuzhou medical university. The therapy involves injection of patient's own adipose-derived stem cells, which are separated from vacuumed fat obtained through liposuction of abdomen, hip, thigh and so on. It was confirmed the adipose-derived stem cells can be induced differentiation into fat cells, osteoblasts, chondrocytes, muscle cells, endothelial cells and so on under the corresponding condition in the current literature. The therapy has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques，such as fat cells injection, sodium hyaluronate injection. Through the use of pre and post treatment photos, three-dimensional skin CT, in addition to the therapeutic evaluation, patient satisfaction questionnaire and a clinician assessment, it is our hope that the investigators will confirm the rejuvenating capabilities of adipose-derived stem cells therapy.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Ages18-60
* Patients of all racial and ethnic origins
* Patients of all undergoing facial rejuvenation

Exclusion Criteria:

* Ages under 18, and above 60
* Female patients in pregnancy or menstrual period
* Patients undergoing facial rejuvenation using other methods including botox injections, chemical peels, face lifts and others
* Patients using blood thinners, aspirin and hormone, that cannot be stopped
* Patients suffering with severe organic disease, such as coronary heart disease, hypertension, diabetes, lung dysfunction and so on
* Patients suffering with mental disease, and acute or chronic infectious diseases
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Have screening laboratory test results within the protocol specified parameters
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

* Current diagnosis of ulcerative colitis or indeterminate colitis
* Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
* Unstable doses of concomitant Crohn's disease therapy
* Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
* Any medical contraindications preventing study participation
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

The main objective of this exploratory 8 week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between 6 and 17 years of age.
* Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview.
* Participants with a score of ≥60 on the Anxiety/Depression subscale of Child Behavior Checklist (CBCL) and CGI-Anxiety severity of ≥4.
* Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose.
* Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria:

* Mental retardation (I.Q. \<70)
* DSM-IV-TR PDD diagnosis of Rett's disorder, and childhood disintegrative disorder.
* History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month).
* Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including: pregnant or nursing females, organic brain disorders, uncorrected hypothyroidism or hyperthyroidism, clinically significant abnormalities on ECG (e.g. QT prolongation, arrhythmia), history of renal or hepatic impairment.
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
* History of substance abuse (except nicotine of caffeine) within past 3 months or urine drug screen positive for substances of abuse.
* Any other concomitant medication with primary central nervous system activity other than stable regimens for \>2 weeks.
* A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician.
Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study

The peri-procedural management of direct oral anticoagulants (DOACs) in persons with cancer (PWC) undergoing tunneled or port central venous catheter (CVC) insertion is a common but understudied clinical problem, with conflicting management advice from guidelines and resultant uncertainty for best practices. Data from prospective studies assessing peri-procedural DOAC management exist; however, these data pertain to procedures in the general population. These management strategies may not be applicable to PWC because (1) although CVC insertion is a low risk, image-guided specialized procedure, (2) PWC are at considerably higher risk of peri-procedural bleeding and thrombosis than non-PWC. It is not surprising, therefore, that guideline recommendations and current practices vary widely. To resolve management uncertainty and establish a standard-of-care, the VENOCAT pilot randomized controlled trial (RCT) is a first step that will assess the feasibility of a definitive trial comparing continued vs. interrupted DOAC management in PWC undergoing tunneled or port CVC insertion. Evidence is needed to standardize clinical practice and reduce the risk of bleeding and thrombotic complications.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with VTE or non-valvular AF on prophylactic or therapeutic dose DOAC
2. Active cancer, defined as diagnosed within the past 6 months; or recurrent, regionally advanced, or metastatic cancer; or for which treatment had been administered within 6 months of port or tunneled CVC insertion; or hematologic cancer not in complete remission
3. Pending elective radiologically guided insertion of tunneled or port CVC
4. Able and willing to adhere to peri-procedural DOAC management plan and follow-up

Exclusion Criteria:

1. Creatinine clearance (Cockcroft-Gault equation) \<30 mL/min for Dabigatran, Rivaroxaban, or Edoxaban, and \<25mL/min for Apixaban
2. Diagnosis of VTE within 21 days
3. Platelet count \< 50 x 10\^9/L at time of study entry
4. Concomitant strong inhibitors or inducers to P-glycoprotein and/or CYP-3A4
Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome

The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled to undergo carpal tunnel release surgery.
* Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
* Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
* Patient is a male or non-pregnant, non-lactating female.
* Patient is 18-75 years of age, inclusive.
* Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
* Patient must voluntarily provide written, informed consent.

Exclusion Criteria:

* Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand.
* Patient has a medical condition that precludes the use of anesthetic required for surgery.
* Patient has an ipsilateral injury or other conditions affecting hand function.
* Patient has acute CTS resulting from an injury (e.g., fracture).
* Patient has had previous CTR surgery on the affected hand.
* Patient has psychiatric history, head injury or any other condition which, in the Investigator's opinion, would prevent patient from complying with post-operative hand therapy or follow-up visits.
Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3--way crossover. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:

* Treatment A: 500 mg nicotinic acid (Niacor(R))
* Treatment B: Niacor(R) Placebo

Each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.


Eligibility Criteria:
Inclusion Criteria:

* Good state of health physically and mentally

Exclusion Criteria:

* Treatment with any other investigational product in the last 60 days before the day of randomization into the study
* Regular use of medication in the last 60 days before the day of randomization into the study except of oral contraceptives in female participants
* Treatment in the 60 days before the day of randomization into the study with any drug known to have a well-defined potential for toxicity to a major organ, or any substance which is known to induce or inhibit hepatic drug metabolism (including general anesthetics)
* Any drug intake (including over-the-counter remedies) in the 2 weeks before the day of randomization into the study, unless the investigator considers a drug intake to be clinically irrelevant for the purpose of this study
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Presence, history or sequelae of gastrointestinal (e.g. peptic ulcer), liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
* History of hypersensitivity to the investigational product
* History or presence of abnormalities of the vascular bed
* History or presence of a dermatologic disease or skin lesions, particular in the area chosen for flush measurement
* History of allergy or hypersensitivity to other drugs or to food constituents
* History of other allergic diseases or hypersensitivity, unless the investigator considers it to be clinically irrelevant for the purpose of this study
* Blood donation of \> 400 ml in the 60 days before the day of randomization into the study
* Smoking
* Positive result in urine screen for drugs of abuse or in alcohol breath test
* Known or suspected to be drug-dependent, including consumption of \> 30 g alcohol per day
* Pregnancy or lactation
* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Intraocular Pressure (IOP) Changes Associated With Muslim Prayer Postural Changes

Elevated intraocular pressure is widely accepted as a risk factor for glaucoma and controlling the pressure remains the cornerstone of effective treatment. There is evidence that posture can have a significant effect on intraocular pressure fluctuations. Salat (or Salah) refers to the five daily prayers performed by Muslims. The time spent praying in a kneeling or prostrate position may be associated with wide fluctuations in intraocular pressure, potentially sight-threatening for Muslim patients with glaucoma. The researchers seek to investigate the link between traditional daily Muslim prayer postural changes and intraocular pressure changes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open angle glaucoma
* Must be age 18 and up
* Provide written informed consent to participate
* Able to cooperate with ocular examination for 60-90 minutes
* Able to assume the standing, bowing, and prostrate positions

Exclusion Criteria:

* Special patient populations (children, pregnant women, prisoners etc.)
* Patients who have had glaucoma surgery that could effect the change in intraocular pressure (ie trabeculectomy, tube-shunts, etc.)
* Patients who are unable to assume bowing or kneeling positions
Plasma Level of Various Omega-3 Lipids

The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers

This is a single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 products (one test period per product). The three different test periods will be separated by a washout period of at least 6 days (up to 21 days).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years old
* BMI in the normal and overweight range (18.5 to 29.9 kg/m2)
* Able to understand and to sign written informed consent prior to trial entry
* Informed consent signed

Exclusion Criteria:

* Food allergy
* Documented clinically relevant disease impacting the endpoints of the study or the safety of the subject, as determined by the medical (screening) visit:

  i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc. ii. Known hypertriglyceridemia (on anamnesis) iii. Known Type2 Diabetes Mellitus
* Under medication that may impact:

  1. Dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates (to the opinion of the investigator)
  2. Coagulation (blood thinning medications, anticoagulants). Indeed, OM3 have been shown to possibly exert some bleeding by themselves that may increase the bleeding effects of aspirin and anticoagulants
* Having taken omega-3, EPA/DHA, fish oil supplementation for more than two consecutive weeks during the last 2 months
* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
* Subjects not willing and/or not able to comply with scheduled visits and with the requirements of the study protocol, including trial products consumption and food restriction
* Pregnancy (on anamnesis)
* Any direct collaborator of the study leader (Dr. Maurice Beaumont)
* Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
First-day High Dose Vitamin C, E in Severe Birth Asphyxia

To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.

Design: A prospective, randomized controlled trial over 5 months. Patients: Newborns admitted within 6 hours after birth with gestation \>32 weeks, Apgar score of \<6 at 5 minutes, features suggestive of neonatal encephalopathy.

Intervention: After randomization, Group A newborns received oral vitamin C 250 mg once a day within a 24-hour interval along with a single dose of vitamin E 200 IU. Group B newborns received no intervention.

Outcome measures: Severity and progression of birth asphyxia, duration of hospitalization and mechanical ventilation, mortality, and neurodevelopmental outcome.

Eligibility Criteria:
Inclusion Criteria

1. Apgar score of \<6 at 5 minutes
2. Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)

Exclusion Criteria

1. Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth
2. Gestational age \<32 weeks.
3. Lethal congenital anomaly
Vagus Nerve Stimulation and Labor

The vagus nerve innervates both the uterus and the cervix. It is thought that a successful and positive birth experience can be achieved by stimulating the vagus nerve at the desired level. Making instinctive sounds such as singing, humming, and various exercises are methods that stimulate the vagus nerve. In this project, an application protocol based on polyvagal theory and including breathing, relaxation and voice exercises was prepared. Video-supported application material will be developed in line with the prepared protocol. The video-assisted vagus nerve stimulation intervention is called Vagal Active Tone (VAT). VAT is a new method in the literature and for which we have limited information about labor. This project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth. This study was planned as a randomized controlled experimental study. The number of samples was calculated using the G\*power 3.1.9.6 program. After the power analysis, it is aimed to reach a total of 50 people, 25 in the intervention group and 25 in the control group. Data will be collected with Personal Information Form, Labor Monitoring Form, Hormone Levels Monitoring Form, Visual Analogue Scale, State Anxiety Scale, Facial Anxiety Scale and Mother's Birth Perception Scale.

It is aimed to produce new and original evidence-based information with the use of VAT intervention based on polyvagal theory. It is thought that this intervention, which can be easily accessed and applied by pregnant women whenever they want, will contribute positively to labor pain, anxiety, oxytocin and cortisol levels, and the duration and perception of birth.

Keywords: Labor, oxytocin, cortisol, vagus nerve stimulation, midwife


Eligibility Criteria:
Inclusion Criteria :

Women who volunteer to participate in the study, are primiparous and in the 28-32nd week of pregnancy, Normal vaginal birth, Single fetus and cephalic presentation, 19 years of age or older, Communicate in Turkish will be included in the study.

Exclusion Criteria:

Women with obstetric complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios, polyhydramnios, presentation disorder, intrauterine growth retardation, İntrauterine dead fetus, macrosomic baby, fetal distress, etc.), Have a psychiatric diagnosis, Have a systemic disease, Have a heart and brain pacemaker, Have epilepsy, Have vision and hearing problems, Attend a childbirth preparation class, Undergo medical procedures for any reason at birth will be excluded from the study.