cyrilzakka/clinical-trials huggingface dataset:
DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections

The aim of this study is divided in 4 different steps:

* the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
* the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,
* the third step is to validate the use of:

  1. the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
  2. the Light-CT scanner use for tissue structural observation.
* the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.


Eligibility Criteria:
Inclusion Criteria:

* Male patient over 18 years old.
* Patient scheduled for trans-urethral resection of prostate with:

  1. prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age \> 80 years old
  2. a suspected prostate cancer after a digital rectal examination (DRE) and a PSA blood level \> 50 ng/ml or an existing prostate cancer
* Patient affiliated to social security or beneficiary of such a regime.

Exclusion Criteria:

* Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health
Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions

This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.

This pilot study will collect rich data from twenty participants on the feasibility and effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the young child and the parent participants. The investigators will collect video recorded child meals in the home during a baseline period (under normal circumstances), during parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn). This in depth examination of child meals will provide valuable information to guide the optimization of this intervention approach for future trials.

Eligibility Criteria:
Inclusion Criteria:

* Child must meet all criteria of the diagnosis of Sensory Food Aversions

  1. The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.
  2. Onset of food refusal occurs during the introduction of a novel type of food (e.g., the child may drink one type of milk but refuse another, may eat carrots but refuse green beans, may drink milk but refuse baby food).
  3. The child eats without difficulty when offered preferred foods.
  4. The food refusal causes specific nutritional deficiencies or delay of oral motor development.
* Parent is able to read, write, speak and understand English.

Exclusion Criteria: None
GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer

The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of youth with cancer. Human subjects must be used because they are the object of the intervention.

PRIMARY OBJECTIVE(S)- To examine the feasibility and accessibility of a brief intervention for caregivers of youth with newly-diagnosed cancer as a preliminary, data-generating step toward applying for a larger NCI R34 grant evaluating the efficacy of the program in a randomized controlled trial.

SECONDARY OBJECTIVE(S)- We hope to learn whether a psycho-educational, psychotherapeutic intervention offered in a virtual setting to caregivers of children diagnosed with cancer is feasible, is acceptable, and can prevent, minimize, or improve symptoms of psychological distress (including symptoms of anxiety, depression, and post-traumatic stress disorder). We also hope to further our understanding of family stress and expand the idea for a need of mental health services in pediatric oncology. We aim to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers. This is important because these symptoms can affect the quality of life of caregivers and affect their ability to adhere to their children's treatments.

Eligibility Criteria:
Inclusion and Exclusion Criteria: Parents

Inclusion

* Child (0-17yrs) with recent (\<12 mo) cancer diagnosis
* Fluent in English
* Consent to research

Exclusion:

* Lack of proficiency in written and spoken English
* Parent is under age 18
* Active Suicidal Ideation
* Child with cancer does not provide assent

Inclusion and Exclusion Criteria: Children

Inclusion:

* Recent (\<12 mo) cancer diagnosis in child
* 8-17 Years old
* Provides assent to participate in the study

Exclusion:

* Cannot read English
* Parent is not enrolled in the study

Anyone who is not a caregiver of children who have been diagnosed with cancer within the past 12 months will be excluded.
Therapeutic Adherence in Uncontrolled Arterial Hypertension

In hypertension, highly prevalent, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite being treated with ≥3 drugs, which is known as resistant hypertension. Resistant arterial hypertension, together with difficult-to-control hypertension, has a worse cardiovascular prognosis than controlled hypertension. In addition, data on therapeutic adherence in arterial hypertension show that 1 in 2 hypertensive patients do not fully or partially comply with the indicated therapeutic prescription. The determination of antihypertensive drugs or their metabolites in urine seems to be a good indicator of therapeutic adherence. On the other hand, the implementation of a specific program to improve knowledge of the disease and its risks and promote therapeutic adherence could improve the control of hypertension and reduce the associated morbidity and mortality.

Objective: To assess whether the implementation of a specific action plan to improve adherence for 3 months results in reduced peripheral 24h-systolic blood pressure (SBP) in patients with resistant hypertension (RH) or uncontrolled hypertension with 2 antihypertensive drugs.

Method: interventional, prospective, randomized, controlled, parallel groups, open study of a cohort of 150 consecutively recruited patients with RH (office SBP ≥140mmHg and/or diastolic blood pressure ≥90mmHg despite treatment with ≥3 drugs at appropriate doses, one diuretic) or patients with uncontrolled hypertension with 2 antihypertensive drugs, with ambulatory 24h-BP ≥130 and / or 80mmHg. The partially or completely non-adherent patients (confirmed by determination of antihypertensive drugs in urine) will be randomized (1: 1) to receive a specific program to improve adherence (intervention group) or routine follow-up (control group), with office BP measurement and determination of antihypertensive drugs in urine at pre-randomization, 3, 6 and 12 months; peripheral and central 24h-ambulatory BP monitoring will be performed at pre-randomization, at 3 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥18 years
* diagnosis of resistant hypertension with treatment superior to 3 drugs at maximum dose, one of them being a diuretic
* uncontrolled hypertension treated with 2 drugs at the maximum effective doses tolerated
* the prescribed treatment must be stable for the last 2 months
* given informed consent

Exclusion Criteria:

* secondary arterial hypertension
* pregnant women
* Impossibility to perform a 24-hour blood pressure monitoring, or poor quality results.
* Recent history of major vascular episode
* patients receiving treatment with Barnidipino / Felodipine / Lercanidipine / Manidipine / Nifedipine / Verapamil / Eplerenone
CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB

The goal of this case series is to explore whether a talking therapy, specifically Cognitive Behavioural Therapy (CBT) is acceptable and feasible in the management of mood-driven impulsive behaviours in people with bipolar disorder (BD).

The main questions it aims to answer are:

* Whether CBT Is a feasible intervention for participants with BD who report mood-driven, problematic impulsive behaviours.
* Whether CBT for mood-driven, problematic impulsive behaviours (CBT-PIB) is acceptable to service users with BD and therapists.
* Whether clinical outcomes are consistent with the potential for this novel intervention to offer clinical benefit to participants with BD.

The study also hopes to:

* conduct a preliminary examination of the safety of CBT-PIB and the research procedures.
* gather information on the potential mechanisms of action of CBT-PIB and,
* gather information on the types of mood-driven impulsive behaviours individuals with BD may seek support for.

Participants will:

* be offered up to 12 individual sessions of CBT focusing on mood-driven impulsive behaviours.
* be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment.
* be asked to track mood and impulsive behaviours by completing a brief set of measures (3) weekly during the two-week baseline phase, the intervention phase and the 2-week post-intervention phase.
* be asked to complete a survey on the acceptability of the intervention and
* be invited to an optional semi-structured interview on their research experience.


Eligibility Criteria:
Inclusion Criteria:

* meeting diagnostic criteria for Bipolar I or II Disorder (SCID-5- Structured clinical interview for depression )
* able to identify at least one impulsive, problematic behaviour to target during the intervention;
* participants will require working knowledge of written and spoken English, sufficient to be able to make use of therapy and to be able complete research assessments without the need of a translator.

Exclusion Criteria:

* major depressive episode (identified through SCID-DSM-5);
* current experience of mania;
* current/past learning disability (IQ of less than 70 with impairment of social and adaptive functioning)
* organic brain change or substance dependence (drugs and alcohol) that would compromise ability to use therapy;
* current marked risk to self (i.e. self-harm or suicide) that we deem could not be appropriately managed in by the therapy site;
* currently lacking capacity to give informed consent;
* currently receiving other psychosocial therapy for impulsivity or bipolar disorder;
* current engagement in another psychological intervention addressing bipolar disorder or impulsivity;
* presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis).
Mobilization With Movement in Distal Radial Fractures

Distal radius fractures (DRF) are the most common upper extremity disorders encountered in clinical practice. With an understanding of the mechanics of distal radius fractures, surgical intervention, and bone healing, the therapist can modify the therapy program according to the patient's individual needs. The therapeutic process is begun in the crucial stage of bone healing during fracture immobilization. By addressing edema reduction and early range of motion of the uninvolved joints, most problems can be avoided before cast or fixator removal. Rehabilitation following the immobilization period should focus on regaining wrist movements provided that earlier problems have been addressed properly. During the rehabilitative process, the therapist can incorporate scar management, modalities, joint mobilization, active and passive range of motion, splinting, and strengthening to maximize the patient's functional result.

Massage and mobilization techniques are used in the treatment of DRF due to their analgesic effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan) is a manual therapy method applies to correct the limitation of movement in the joint and to relieve pain and functional disorders. Many studies have shown that MWM technique provides faster and momentary painless joint movement compared to other physical therapy modalities. The patient group with DRF has a large place in the general population and long treatment processes cause both labour loss and economic loss. Therefore, this study aimed to examine the effectiveness of MWM technique in cases with distal radius fractures.

In this study, 42 DRF patients with age range 18-65 who applied to Kırşehir Ahi Evran University Training and Research Hospital were examined. The individuals included in the study were divided into two groups according to the paired randomization method. These groups were control and intervention groups. Traditional physiotherapy methods were applied to the control group, traditional physiotherapy and MWM techniques were applied to the intervention group. Traditional physiotherapy methods were included; Transcutaneous Electrical Nerve Stimulation (TENS), stretching and strengthening exercises.

For the evaluation of patients; Visual Analogue Scale (VAS), wrist goniometric measurements, grip strength measurement, pinch strength measurement, edema measurement and Munich Wrist Questionnaire (MWQ) were used.

Eligibility Criteria:
Inclusion Criteria:

* Patients with distal radius fracture

Exclusion Criteria:

* Patients with polytrauma,
* open fracture,
* ulnar head fracture (excluding ulnar styloid fracture),
* history of complex regional pain syndrome,
* limited cognitive capacity were excluded
Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients

The objective of this study is to investigate the effectiveness of in-hospital initiation of alirocumab combined with statin ± ezetimibe on major cardiovascular events (MACE) in Chinese ACS patients. The main question it aims to answer is:

whether early initiation PCKS9i in hospital could reduce recent cardiovascular event risk in Chinese ACS patients in real-world setting.

Data from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Acute Coronary Syndrome (ACS) upon hospital admission.
* Patients aged 18 years or older.
* Patients who received Alirocumab 75 mg in combination with statin therapy ± Ezetimibe as the intervention group, and those treated exclusively with statin therapy ± Ezetimibe as the control group, either during hospitalization or at discharge.
* Patients with at least one follow-up record.

Exclusion Criteria:

* Patients who received Evolocumab treatment at any time.
* Patients who received Inclisiran treatment at any time.
Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty

The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.

Primary objective

The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.

Secondary Objectives

Safety will be evaluated by monitoring the frequency and incidence of adverse events over time to 10 years postoperative.

Clinical, functional, radiographic, and quality of life outcomes will be assessed over time to 7 years postoperative. Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form. Radiographs will be reviewed to assess alignment, radiolucencies and other radiographic parameters. Health status and functional ability will be measured using the EQ-5D-3L and the UCLA Activity score.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible for this trial if they satisfy all of the following criteria:

  * Patient is 18 to 65 years of age, inclusive
  * Patient is skeletally mature
  * Patient qualifies for primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
  * Osteoarthritis
  * Avascular necrosis
  * Rheumatoid arthritis
  * Correction of functional deformity
  * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
  * Patient has no history of previous total hip arthroplasty or arthrodesis of the affected hip joint(s)
  * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent
  * Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB- approved informed consent

Exclusion Criteria:

* Subjects will be excluded from this trial if they satisfy any of the following criteria as determined by the research staff or in the judgment of the treating physician:

  * Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc.) in the affected hip joint(s)
  * Patient is septic or has an active infection
  * Patient is uncooperative patient or is incapable of following directions
  * Patient is diagnosed with osteoporosis
  * Patient is diagnosed with a metabolic disorder which may impair bone formation
  * Patient is diagnosed with osteomalacia
  * Patient has distant foci of infections which may spread to the implant site
Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps.

PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.

OBJECTIVES:

Primary

* To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vitamin D3) or placebo.
* To determine the compliance rates in patients treated with these regimens.

Secondary

* To compare changes in pre- and post-treatment vitamin D levels in patients treated with these regimens.
* To correlate vitamin D levels with vitamin D modifiers, such as levels of skin pigmentation, dietary vitamin D intake, and sun exposure in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires about demographics, dietary vitamin D intake, personal history (e.g., ancestry, alcohol and tobacco intake, occupation, height, and weight), medical history (e.g., personal and family history of colorectal cancer and polyps), and ultraviolet radiation exposure.

Blood samples are collected at baseline and at 6 months for correlative laboratory studies. Blood samples are analyzed for vitamin D levels by enzyme immunoassay. Patients also undergo assessment of skin pigmentation in sunprotected and sunexposed areas of skin by reflectance spectrometry at baseline.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenomatous polyp

  * At least 1 adenoma
* Self-identified as an African American AND undergoing screening or diagnostic colonoscopy at the University of Chicago
* No history of colon or rectal cancer or hereditary or familial colon cancer (e.g., hereditary non-polyposis colon cancer or familial adenomatous polyposis)

PATIENT CHARACTERISTICS:

* Total bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal
* Albumin ≥ 3.0 mg/dL
* Baseline serum calcium level normal
* Not pregnant
* No history of thyroid disease
* No history of renal stones

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No other concurrent vitamin D intake
Yoga for Rheumatoid Arthritis

The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis.

Yoga is a set of ancient Indian theories and practices, focusing on unifying mind, body, and spirit, and promoting strength, balance, and flexibility. The physical aspect of yoga includes poses, breathing techniques, and relaxation. Inflammatory arthritis, a chronic disease characterized by inflammation of the lining of the joints, can cause long-term joint damage, resulting in chronic pain, loss of function, and disability.

The primary objective of this study is to learn how people with inflammatory arthritis and knee osteoarthritis respond to an exercise program of yoga. To accomplish this, 30 persons with inflammatory arthritis or knee osteoarthritis will be randomly assigned to one of two groups. Group one will begin an immediate 8-week program of yoga classes consisting of 60-minute sessions, twice a week. Group two, or the "waitlist" control group, will receive 8 weeks of arthritis education followed by the same 8-week yoga program as group one. Participants also will have blood drawn, and complete various tests. The yoga classes will be taught by an experienced, certified yoga instructor, and are designed especially for the needs of people with inflammatory arthritis and knee osteoarthritis.

This study will provide important data on integrating mind-body activities into the treatment of inflammatory arthritis and knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ (RA only upper age limit 70)
* Confirmed or probable OA (using pre-specified criteria) OR Rheumatoid arthritis (participation approved by rheumatologist)
* Currently sedentary (physically active for 20 min \< 3times/week)

Exclusion Criteria:

* Inability to ambulate without use of assistive device
* Uncontrolled high blood pressure or existing heart condition
* Co-morbid inflammatory condition with overlapping symptoms (i.e., fibromyalgia)
* Surgery within 6 months