cyrilzakka/clinical-trials huggingface dataset:
AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

The study is a prospective multi-center, single -arm study with treatment of up to 67 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Gastric outlet obstruction from unresectable malignant neoplasm
2. Eligible for endoscopic intervention
3. GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
4. 18 years of age or older
5. Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
6. The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

Exclusion Criteria:

1. Patients with baseline ECOG \> 2 and/or Karnofsky Performance score \< 30
2. Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
3. Abnormal coagulation INR \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
4. Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
5. Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography
6. Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
7. Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
8. Ascites Grade ≥ 2 confirmed by cross-sectional imaging
9. Vessels located within a two-centimeter radius of the device insertion location
10. History of multiple abdominal surgeries and/or evidence of small bowel adhesions
11. Allergic to any of the device materials
12. Contraindications to use of electrical devices
13. Pregnancy
14. Prisoners and other vulnerable populations
Routine Outcome Monitoring in Mental Health Outpatient

Scientific Background: Inherent gaps exist between the worlds of research and clinical therapy, especially in mental-health systems. Developed as an important strategy aimed to bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a method devised for systematic ongoing quantitative measurements used in diverse clinical practices, from psychotherapies to psychiatric management. The efficacy of this approach has been repeatedly demonstrated in various measures, such as satisfaction with treatment by patients and therapists, lower drop-out rates, symptomatic benefits, and more.

Objectives: The aim of the current study is to test the feasibility and the clinical benefits of implementation of a Routine Outcome Monitoring System in a public clinical center, as a pioneering project in Israel, at the "Shalvata" Mental Health Center.

Working Hypotheses: Incorporation of a ROM system in routine clinical practice is hypothesized to improve patients' and therapists' overall satisfaction, allow for early detection and intervention in therapeutic raptures, decrease drop-out rates, and improve various clinical outcome measures.

Methods: The suggested study is a two-stage (implementation and intervention) open trial. 900 new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention (ROM) and control groups. Assessment questionnaires will be filled periodically using 'CORE-NET', a computerized system enabling repeated measurements and feedback in a user-friendly and efficient manner.

Data Analysis: The evaluation of the differential influence of monitoring processes on overall efficiency as compared to control group will be tested using Multiple Analysis of Variance (MANOVA). The predictive value of possible variables on process and outcome of therapy will be assessed using stratified regression analyses. The possible causal effects between specific lagged variables will be assessed using Hierarchical Linear Modeling and Time Series Analysis.

Contribution: This pioneering study is the first in Israel to offer a routine systematic evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently, a large and meaningful data-set will emerge, enabling significant enrichment of our evidence-based understanding of therapeutic processes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing intake to the clinic and beginning therapy

Exclusion Criteria:

* Mental retardation or dementia
* Hebrew Illiteracy
* Adults who are not under their own legal custody
* Not being able to fulfill the questionnaires with minor help
RADIANCE Continued Access Protocol

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.


Eligibility Criteria:
Inclusion Criteria:

* Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
* Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Exclusion Criteria:

* Renal artery anatomy ineligible for treatment
* Secondary hypertension not including sleep apnea
* Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
* eGFR \<40
* Brachial circumference ≥42 cm
* Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
* Documented repeat (\>1) hospitalization for hypertensive crisis within 3 months prior to consent
* Documented confirmed episode(s) of unstable angina within 3 months prior to consent
* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
* Primary pulmonary hypertension
* Night shift workers
* Pregnant, nursing or planning to become pregnant
Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation

Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.

The participant will undergo baseline MRI to measure blood flow in the brain for comparison later on. After baseline MRI, the participant will observe stimulation using the REVIVIEW system for 20 minutes. The content the participants will see is a nature documentary, after which the participant will undergo additional MRI imaging to assess the change in blood flow in the brain.

Eligibility Criteria:
Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

* History of brain diseases
* Glasses
* Diagnosed with Diabetes
* Diagnosed with Degenerative brain diseases
* Inability to undergo MRI
The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults

The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.

30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30 patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. Quality of life, anxiety and patient history data is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator test, exhaled nitric oxide test and a methacholine challenge before and a year after oral immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency medication such as antihistamine tablets, prednisolon tablets (40mg for three days in adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.

Eligibility Criteria:
Inclusion Criteria:

* severe milk, peanut or egg allergy verified with positive symptom history, skin prick tests and serum IgE tests and a challenge test

Exclusion Criteria:

* instable cerebrovascular or heart disease, active autoimmune disease or cancer, or current use of betablockers.
* poorly controlled asthma or FEV1 \< 70% (FEV1\< -2SD)
Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin

To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.


Eligibility Criteria:
Inclusion Criteria:

All resident physicians and nurse practitioners involved in inpatient care.

Exclusion Criteria:

None-
Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients

Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system. Patients are suffering from balance and gait impairments at the early stage of the disease.

85 % of the MS patients report gait disorders, which impact their autonomy and their quality of life and increase the risk of fall.

The three-dimensional analysis of the walking by a motion capture system associated with force platforms allows the quantification of the complex walking disorders, to look for the cause, as well as side effects such as compensation strategies.

According to the 2006 report of the French National Authority for Health, the 3D analysis of walking is essential in chronic pathologies to evaluate and quantify gait disorders. This analysis allows the functional follow-up of the patients throughout their rehabilitation. Some studies, on a small and heterogeneous population of MS patients, showed changes during the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation of lower limbs at early stages of the disease. Only two studies evaluate the joint power during walking in MS patients. However, these studies have some limits.

The 3D analysis of the walking proposed in this study would allow the biomechanical characterization of the gait impairments of MS patients through tasks such as walking, gait initiation and orthostatic posture. This methodology would contribute to adapt treatments and the rehabilitation care, at an early stage of the disease.

From a functional point of view, the gait initiation is an interesting dynamic task to be evaluated. Indeed, it represents the transition between the upright posture and the stabilized walking. Throughout this complex task, a stereotypical motor program is set up during a first phase of anticipatory postural adjustments, which allows the creation of dynamic conditions essential for the execution of the first step. The gait initiation is little documented for MS patients despite the risk of fall clinically highlighted. The articular power during the gait initiation was never estimated in MS patients. On the other hand, there is no study establishing correlations between the Expanded Disability Status Scale functional features and the impairments of the gait initiation.


Eligibility Criteria:
Inclusion Criteria for MS patients :

* EDSS \< 4.5
* Stable disease for at least 6 weeks
* No injection of botulinum toxin in the past 4 months

no specific inclusion criteria for healthy volunteers

Exclusion Criteria for MS patients :

* Neurological disease other than MS
* Disabling pathologies of the locomotor apparatus
* Non-stabilized Respiratory, Cardiovascular disease
* Pregnant or breastfeeding women
* Patient with cognitive impairment
* Recent modification of MS treatment (\<3 months)

Exclusion Criteria for Healthy Volunteers :

* Neurological disease
* Rheumatological disease
* Sprain of the lower limbs in the last 3 months
* Fracture of the lower limbs in the last year
* Pregnant or breastfeeding women
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).


Eligibility Criteria:
Inclusion Criteria:

* Participant is a healthy infant approximately 2 months of age

Exclusion Criteria:

* Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
* Participant's birth mother did not receive any prenatal care
* Participant has previous history of hepatitis B infection
* Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
* Participant has had a fever within 72 hours of study start
* Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant
Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

To compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large U.S. health systems.

We will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. The 3,200 participants to be enrolled will be current smokers who are Black, Hispanic, and/or have low socioeconomic status (defined as household income \<200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (LDCT) screening at 4 large health systems. All adult patients with LDCT orders will be further screened for eligibility. Eligible patients will enroll with opt-out consent and complete the study using the NIH-funded Way to Health online research portal. The primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. Relapse rates will be tracked at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker (≥ 1 cigarettes per day, not including e-cigarettes)
* Has a low-dose computed tomography (LDCT) scan ordered by their physician
* Underserved, defined as one or more of the following: (a) Black, (b) Hispanic, (c) rural residence, or (d) low socioeconomic status (Defined as one or both of: high-school education or less, or household income \<200% of the federal poverty line)
* Able to receive study invitation and screening, by virtue of showing up to a radiology location affiliated with a participating health system for the LDCT, or having a valid email address or telephone number on file with the health system
* Access to a cell phone with text messaging or the internet
* Aged 18 years or older

Exclusion Criteria:

* No cell phone
Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth

This project will evaluate an after-school substance abuse prevention intervention, compared to a standard substance abuse education program, targeting 6th grade AI youth in three AI communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.

A community-based participatory research approach will be used to culturally and technologically adapt the intervention. A two-condition controlled study will evaluate the efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI youth substance use involvement. An adult training program second level intervention study will also be implemented to train tribal personnel from the three regional tribes on how to implement the intervention as a tribal program beyond the study period.

Effectiveness will be determined by a small partial cross-over randomized trial comparing the intervention to a wait-list control condition. Process evaluations will focus on the future adoption and implementation of the intervention, and recommendations for sustainable adaptations.

The proposed study will consist of a 5-year plan: Year 1 has been completed and consisted of strengthening and extending community partnerships in each community and collecting data that will inform the cultural adaptation and tailoring of the intervention; Years 2, 3, and 4 will entail implementation by using a two-condition controlled study in which the culturally competent intervention is compared to standard care; and Year 5 will consist of final data collection, analysis of results, dissemination of results to local communities, and finalization of a sustainability plan for each Tribe.

Participants in the proposed study will consist of 540 male and female American Indian 6th grade students who represent at least three different Tribes - Choctaw, Ojibwe/ Chippewa, and Lumbee, in three different regions of the U.S. Participants will also include 70 tribal personnel (adults 18 and over) who be trained to implement the intervention in Years 3 \& 4 of the project. Finally, 15-20 stakeholders and community partnership members will be interviewed at various stages of this project.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for youth participants include:
* AIl students enrolled in the 6th grade at each of the 3 regions
* Active parental consent
* Student willingness to participate and signed assent. Inclusion criteria for adult participants include: adults over 18 years of age currently employed as personnel, educators, and counselors at tribal schools among the three regions.

Exclusion Criteria:

* Exclusion criteria include students who are not identified as American Indian, no active parental consent, and no signed assent.
The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living

Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.

The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.

Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.

The aim of the study; The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.

Thirty patients with chronic stroke will be randomized 1:1 to study (n:15) and control (n=12). Thumb localization test, finger swipe test, stereognosis test, and two-point discrimination test will be used to evaluate the sensory functions of individuals. Demographic information of individuals will be recorded with a sociodemographic information form. Before the treatment, the sensory levels of all patients will be determined by thumb localization, finger scrolling and stereognosy tests. Jebsen Taylor Hand Function Test (JTHFT), Modified Frenchay Scale (MFS), Canadian Occupational Performance Measure (COPM), Goal Attainment Scale (GAS) and Stroke-Specific Quality of Life Scale (SSQOL) will be administered before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stroke duration more than 6 months,
* To be able to communicate
* 10 degrees of wrist dorsiflexion starting from full palmar flexion of the wrist
* To initiate finger extension

Exclusion Criteria:

* Joint contracture in the upper and lower extremities that will affect functionality other than stroke,
* Having a significant uncontrolled health problem and a history of epileptic seizures,
* Having 3 or more spasticity according to the Modified Ashworth Scale (MAS),
* Unable to communicate and cooperate,
* With marked ataxia and dystonia,
* Lack of movement and function in the wrist and fingers
* Having a diagnosis of bilateral stroke
Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced and/or metastatic breast cancer.
* Measurable disease
* Previously treated with anthracycline

Exclusion Criteria:

* Patients with inflammatory breast disease