cyrilzakka/clinical-trials huggingface dataset:
Peer Support For Young Adult Women With High Breast Cancer Risk

This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. Study aims are to 1) Assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested YARs, 2) Identify YARs most likely to engage with and benefit from the intervention, 3) Understand intervention mechanisms. Participants will complete interviews at baseline, 1, 6, and 12 months.

Germline (e.g., BRCA) mutation carriers have highly elevated odds of developing hereditary breast-ovarian cancer (HBOC), as could their relatives. Referral to genetic counseling is the standard of care for young, at-risk adult relatives (i.e., ages 18-39; herein "YARs"). However, many female YARs struggle to make decisions about familial HBOC risk management, including whether and when to pursue genetic counseling, how to cope with stress and uncertainty about HBOC, and how to navigate lifecycle events entwined with HBOC threats (e.g., childbearing). Prior work points to YARs' strong desires to seek HBOC risk information and emotional support beyond traditional genetic counseling-especially support from knowledgeable peers who can relate to their experiences and offer neutral grounding and objective guidance about coping strategies. Peer support is a promising psychosocial cancer care approach that could fill this void. However, few evidence-based standards inform its practice as an adjunct to cancer genetic counseling. As genetic testing for HBOC risk expands population-wide, new ways must be tested to reach, educate, and support YARs to further reduce the cancer burden in communities of at-risk women. The 2-arm PeACE trial includes streamlined telephone counseling delivered by well-trained community peer coaches, with session content incorporating coping training for HBOC stress reduction, and decision making and problem solving training about genetic counseling and HBOC risk. Trial participants are female YARs (aged 21-30) randomized to an intervention or equated control condition, and followed for up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* There are two targets for recruitment with different eligibility criteria.

Index carriers:

* Men or women aged 18 or older with BRCA mutations with or without 2nd-tier multiplex panel genetic testing. Index carriers will have received testing.

YARs:

* Female 1st-, 2nd- or 3rd-degree biological relatives of index carriers aged 21-30.

Exclusion Criteria:

* Must be able to speak English or Spanish and provide informed consent
Pharmacological Study on Absorption of WE 941 OD Tablets in Japanese Healthy Male Volunteers

Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE 941 OD tablets are administered in Japanese healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* age 20 - 35 years
* body weight 50 - 80 kg
* Body Mass Index (BMI) +/- 20%
The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers

The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patient suffering from residual Crohn's disease related perianal fistulas already treated with TNF alpha blockers

This study is a prospective open-label study that consists three periods: screening, treatment and follow-up. After signing an informed consent, subjects will be assessed by a gastroenterologist, a surgeon (for the diagnosing the perianal disease and assessing the need for surgery) and a HBOT specialist for assessing the capability of the subject to undergo HBOT treatment.After the screening period, eligible subjects will enter an 8 weeks HBOT treatment period, combined with TNFalpha blocker treatment. This period will be followed by a 4 months follow-up period in which treatment with TNFalpha blocker will continue.

All patients will have an MRI and TRUS examinations to assess the fistulas and also blood tests for CBC, chemistry, inflammatory markers and cytokine analysis. Same evaluation will be repeated at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

patients aged 18 and above that suffer from Crohn's disease one or more perianal draining fistulas for at least 3 months currently receiving a TNFalpha blocker for at least 3 months (without improvement of the perianal disease)

Exclusion Criteria:

Pregnancy or plans to conceive during the next year Inability (such as previous adverse effects, tuberculosis, concurrent infection etc.)or unwillingness to start or continue with TNF alpha blockers treatment.

Any past or current malignancy Treatment with HBOT in the last year Claustrophobia Middle ear problems Inability to equalize pressure in the middle ear Medical status that precludes treatment with HBOT such as chest X-ray abnormality, epilepsy, severe congestive heart failure, uncontrolled diabetes or uncontrolled hypertension Any perianal surgery in the last 6 months Any change in Crohn's disease medications in the last 3 months
TURKish Acute Myocardial Infarction Registry

There is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (MI) in Turkey. TURKMI registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute MI in Turkey.

Background: There is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (MI) in Turkey. TURKMI registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute MI in Turkey.

Methods: TURKMI study, as a nation-wide registry, will be conducted in 50 percutaneous coronary intervention -capable centres selected from each EuroStat NUTS region in Turkey according to their population sampling weight, prioritizing the volume of hospital in each region. All consecutive patients with acute MI admitted to the coronary care units within the 48 hours of symptom onset will be prospectively enrolled during a predefined 2-week period.

The first step of the study has cross-sectional design in which baseline information such as symptoms, risk factors, time periods at each step from symptom onset to revascularization, way of arrival to hospital, biochemical analysis and in-hospital management and outcome will be assessed. The second step has a cohort characteristics in which enrolled patients will be followed-up up to 2 years. Follow-up visits will be conducted at 1st, 6th, 12th and 24th months, and predictors and risk of cardiovascular events, and implementation of guidelines will be assessed as secondary outcomes.

Conclusion: The national TURKMI registry is expected to provide important information to improve the national policy of the diagnosis, management and outcomes of MI in Turkey

Eligibility Criteria:
Inclusion Criteria:

1. having hospitalized within 48 hours of onset of symptoms of the index event
2. had a final (discharge) diagnosis of acute MI either \[ST elevation MI (STEMI) or non ST elevation (NSTEMI)\] with positive troponin levels, and
3. having signed an Informed Consent. To facilitate consecutive enrolment, all patients hospitalized at each participating site with acute MI will be recruited consecutively during the same 2 consecutive weeks (15 days).

Exclusion Criteria:

1. Patients unwilling or unable to consent will be excluded.
Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.

This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).

Eligibility Criteria:
Inclusion Criteria:

* Active carious white spot lesions.
* Patient compliance.
* Controlled oral hygiene condition.

Exclusion Criteria:

* Participant in another trial.
* Non carious lesions.
* Systemic diseases or concomitant medication affecting salivary flow.
* Cavitation of carious lesions.
* Parafunctional habits.
* Pregnancy.
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

To determine efficacy in the delivery of chronomodulated chemotherapy.

The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study.

It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.

Eligibility Criteria:
Inclusion Criteria:

* Histological proof of adenocarcinoma in primary colon or rectum tumor.
* Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
* Ages 18 to 86 years.
* Presence of at least one bi-dimensionally measurable disease with at least one diameter \> or = 2 cm.
* WHO/ECOG performance status \< 3 (0, 1, or 2)
* Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
* Signed informed consent

Exclusion Criteria:

* Peripheral sensory neuropathy \> or = grade 3.
* Serum bilirubin (total) \> 3 X ULN.
* Symptomatic or uncontrolled brain metastasis.
* Metastases limited to bone, pleural effusion, or ascites.
* Uncontrolled overt cardiac disease.
* Uncontrolled hypercalcemia.
* Uncontrolled infections.
* Uncontrolled hypertension (\>180/110)
* History of GI perforation.
* History of arterial thromboembolic events.
* History of congestive heart failure.
* Patients taking warfarin (Coumadin).
* Patients who are pregnant.
Treatment Use of Domperidone for Gastroparesis

Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.

This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.

The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 and older
* Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

  * increased prolactin levels
  * extrapyramidal side effects
  * breast changes
  * cardiac arrhythmias including QT prolongation and death
  * There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.

Exclusion Criteria:

* History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
* Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
* Clinically significant electrolyte disorders.
* Gastrointestinal hemorrhage or obstruction
* Presence of a prolactinoma (prolactin-releasing pituitary tumor).
* Pregnant or breast feeding female
* Known allergy to domperidone
Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures

This study explores the use of virtual reality (VR) to reduce pain and anxiety during thyroid biopsies and PICC line insertions under local anesthesia. One group experienced the procedure with VR, while the other group did not. Participants completed questionnaires before and after the surgery to measure pain and anxiety levels. The main goal is to observe if VR can significantly decrease pain and anxiety during these procedures.

This prospective, randomized, controlled study investigates the efficacy of virtual reality (VR) as a means to alleviate pain and anxiety in individuals receiving thyroid biopsies and PICC placements with local anesthesia. This study was conducted at Temple University Hospital between June 2021 and August 2022. A total of 107 patients were randomized into treatment and control groups. The VR experience involved wearing a headset with an immersive 3D visual display and accompanying music, simulating a calming environment. Patients completed Visual Analog Scales for pain and anxiety both before and after the intervention, reflecting their pain and anxiety levels prior to and during the procedure. The primary endpoints were to observe the effect of VR on pain and anxiety in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Scheduled to receive Fine-Needle Aspiration (FNA) Thyroid Biopsy
* Scheduled to receive Peripherally Inserted Central Catheters (PICC)

Exclusion Criteria:

* Declining to participate
* Inability to provide consent
* Emergency procedures
* Administration of general anesthesia/moderate sedation
* Visual or hearing deficits
* Pregnancy
* Current prisoner status
* Nerve or sensory deficits over area of procedure
* COVID-19 positive status
Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<70 years old
* Patients candidated for elective gynecological surgery for benign pathology
* Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
* Signed consent form

Exclusion Criteria:

* Contraindication to loco-regional anaesthesia
* Patients with ileus or subocclusive condition prior surgery
* Coagulation disorders
* Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
* Uncontrolled hypertension (\>180/95)
* Alcohol or drug abuser (current or previous)
* Psychiatric condition or language barriers
* Planned Intensive Care Recovery
Early Versus Delayed Treatment of Unilateral Neglect After Stroke

'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. A specific disorder that can appear in neglect patients is 'contraversive pushing': a postural deviation to the neglected side because the patient pushes himself away from the ipsi- to the contralesional side.

One of the most promising neglect interventions is prism adaptation (PA): inducing an optical shift of the visual field by means of prism glasses. This results in a modulation of brain areas involved in neglect and in an improvement of the neglect symptoms and postural deviation.

Research questions:

1. Which period is best suited to maximize therapeutic effects? In this respect the effects of early and delayed PA will be compared, regarding neglect-, postural and cerebral measures.
2. Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
3. Will the impact of PA be larger if postural factors are taken into account in the prism therapy?


Eligibility Criteria:
Inclusion Criteria:

* male or female
* \> 17 years of age
* stroke patients with clinical neglect, demonstrated by neglect tests

Exclusion Criteria:

* severe ocular abnormalities
* not being able to perform prism adaptation or neglect tests
Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).


Eligibility Criteria:
Participants:

* Inclusion Criteria AD:

  * Male or female \>=50 years of age
  * Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24
* Inclusion Criteria MCI:

  * Male or female \>=50 years of age
  * Have a Clinical Dementia Rating (CDR) of 0.5
  * MMSE \>24
* Exclusion Criteria:

  * Have a history or current diagnosis of other neurologic disease
  * Have had or currently have a diagnosis of other neurodegenerative disease
  * Have participated in experimental therapy targeted to amyloid plaque

Readers:

•Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans
Correlation Between Sacral Angle and Lumbar Range of Motion in Women With Genu Valgum

Many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere with lumbar range of motion. Investigators of this study try to answer the following question: is there a relationship between sacral angle and lumbar range of motion in women with bilateral genu valgum. the results of this study will help professionals to plan a proper treatment program for patients with genu valgum.

Sixty four female participants were under the following procedures:

* Screening for genu valgum via postural assessment from frontal view, then measuring the Q angle bilaterally.
* Patients with Q-angle \>20 degress were under the following procedures:

A. Full-Length AP standing X-ray,then the investigators measured the hip-knee angle (the angle between the mechanical axis of the femur and the tibia). It will be obtained by connecting the center of the femoral head to the midpoint of the tibial eminential spine in a line tangential to the femoral condyles, and another line from here to the centre of the trochlea tali.

B-Lumbo-sacral X-ray lateral view was done at the time and the sacral angle was the measured by Ferguson´s technique in degrees using a protractor and this was the sacral angle.

C- During the same session, trunk range of motion was measured by Modified schober test D- Collected data were taken for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Female with bilateral genu valgum (Q angle\> 20 degrees.
2. Age ranges from 18-25 years old.
3. BMI ≥ 30 (kg/m2)

Exclusion Criteria:

1. Previous lumbar surgery
2. lumbar spine fracture
3. Spondylolisthesis
4. Foraminal or extra foraminal lumbar disc herniation
5. spinal tumors, and bone metabolic diseases 6 - Knee surgeries