cyrilzakka/clinical-trials huggingface dataset:
Transperineal Laser Ablation Treatment (TPLA) for Prostate Cancer (PCa) Registry

Rationale: Transperineal laser ablation (TPLA) treatment for prostate cancer (PCa) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. In pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. However, (long-term) treatment outcomes of TPLA for PCa remain largely unknown. The aim of this international retrospective registry is to collect and combine data on patients treated TPLA for PCa in order to provide data on safety, feasibility, functional and oncological outcomes.

Objective: To assess safety and feasibility of TPLA for PCa, to assess functional and oncological outcomes of TPLA for PCa and to determine baseline patient characteristics in a multicentre cohort.

Study design: This is an international, retrospective observational registry in which data is recorded of patients who have been treated with TPLA for PCa.

Study population: Male patients treated with TPLA for PCa. Main study parameters/endpoints: The primary endpoint of this registry is oncological outcomes of TPLA for PCa. Secondary endpoints are safety, feasibility and functional outcomes of TPLA for PCa.


Eligibility Criteria:
Inclusion Criteria:

* Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed

Exclusion Criteria:

* Age \< 18 years
Action Observation and Motor Imagery Therapy in Parkinson's Disease

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in Parkinson's disease (PD). Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind.

The aim of this clinical trial is to test whether the application of AO and MI treatment in PD in addition to conventional rehabilitation programs has an additional effect on Balance, Functional Status and Quality of Life.

Parkinson's disease (PD) is a neurodegenerative disease with a chronic and progressive course. Freezing phenomena, gait disorders, and balance problems are common in PD. Gait and balance disorders and motor freezing attacks that occur as a result of PD increase the risk of falling, leading to a decrease in functional independence and quality of life. The main goal of Parkinson's rehabilitation is to ensure the maximum functional status and independence in daily living activities and to increase their quality of life.

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in PD. Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind.

The aim of this clinical trial is to test whether the application of AO and MI treatment in PD in addition to conventional rehabilitation programs has an additional effect on Balance, Functional Status and Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Parkinson's Disease
* Hoehn and Yahr Stage 1-3

Exclusion Criteria:

* Patients with cognitive dysfunction (those who cannot follow simple verbal instructions)
* Patients with severe hearing problems
* Patients with severe vision problems
* Patients with additional musculoskeletal system pathology that will affect physical performance (such as amputation, severe joint mobility limitation, peripheral nerve damage)
* Patients with uncontrolled hypertension and diabetes mellitus
* Patients with a history of symptomatic lung disease (such as asthma, chronic obstructive pulmonary disease, emphysema)
* Patients with a history of symptomatic cardiac disease (such as coronary artery disease, arrhythmia, heart failure)
Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome

This study aims to evaluate the role of Contrast-Enhanced Mammography (CEM) in identifying the primary tumor site in patients presenting with Cancer of Unknown Primary (CUP) syndrome. By integrating functional and anatomical imaging, the study explores CEM's diagnostic value compared to standard imaging modalities in a single-center setting.

The study of CUP syndrome was conducted with MRI, but we propose the study with CEM

Eligibility Criteria:
Inclusion Criteria:

* Age: Patients aged 18 years or older.
* Diagnosis of CUP: Patients with a clinical diagnosis of Cancer of Unknown Primary (CUP) syndrome.
* Suspected Breast Malignancy: Patients with clinical or imaging suspicion of a primary breast malignancy.
* Informed Consent: Patients who are able to provide informed consent to participate in the study.
* Presence of Breast Tissue: Female or transgender patients with breast tissue eligible for Contrast-Enhanced Mammography (CEM).

Exclusion Criteria:

* Confirmed Primary Tumor: Patients with a confirmed primary tumor identified in an organ other than the breast.
* Contraindications to Contrast Agents: Patients with contraindications to the use of iodinated contrast agents (e.g., severe allergic reactions to contrast).
* Severe Renal Impairment: Patients with severe renal impairment (eGFR \< 30 mL/min/1.73 m²) who cannot safely receive contrast agents.
* Pregnancy or Breastfeeding: Pregnant or breastfeeding women, as contrast administration may be harmful to the fetus or neonate.
* Severe Medical Conditions: Patients with severe medical conditions that may compromise their participation or safety in the study.
Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK

In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. The relationship between surgery type and nilotinib pharmakokinetic properties will be investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic or unresectable gastrointestinal stromal tumor
* Patients receiving nilotinib after failure to imatinib and sunitinib
The Role of Endometrial Blood Flow in Endometrial Cancer

The incidence of endometrial cancer is gradually increasing nowaday. Sonography can be used to evaluate the endometrial volume, the vascularity and the blood flow. This study will analyze the role of preoperative endometrial blood flow in the outcome of endometrial cancer patients.


Eligibility Criteria:
Inclusion Criteria:

- \>20 years old female had Endometrial cancer

Exclusion Criteria:

- \<20 years old female
Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate (HR)

This is a prospective randomized controlled trial comparing heart rate measurement by Doppler ultrasound or auscultation with a stethoscope in newborn infants who require stabilization or resuscitation immediately after birth. Enrolled subjects will be randomly assigned to have their heart rate (HR) obtained by stethoscope (ST) or by Doppler ultrasound (DO). Neonates will be resuscitated in accordance with the Neonatal Resuscitation Program (NRP) guidelines.

Obtaining a baby's heart rate (HR) is an important part of neonatal resuscitation in the delivery room and helps the medical team decide how to treat the baby. When babies do not breathe well on their own, the medical team places electrocardiogram (ECG) leads on the baby's chest to obtain an accurate HR rapidly that can be seen by the entire team. Before the ECG leads are placed on the baby's chest, the Neonatal Resuscitation Program (NRP) guidelines suggest that medical team members listen to the baby's HR using a stethoscope for 6 seconds. However, it can take longer than 6 seconds for medical team members to obtain a HR which can delay a baby's care. The purpose of this study is to determine if Doppler ultrasound is a useful, alternative tool, aside from a stethoscope, that can be used to quickly obtain a baby's HR, particularly in high-risk babies. The primary objective will be the time that it takes to obtain a baby's HR by Doppler ultrasound as compared to listening to a baby's HR with a stethoscope. With this study, the investigators will be able to understand if Doppler ultrasound is a useful tool in the resuscitation of babies who are high risk.

Eligibility Criteria:
Inclusion Criteria:

* All neonates admitted to the transitional nursery for resuscitation after delivery

Exclusion Criteria:

* Neonates with congenital heart disease, congenital diaphragmatic hernia
* Neonates whose mothers present and will have imminent delivery
The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD

This study aims to demonstrate the effects of triple therapy (ICS/LABA/LAMA) and dual bronchodilators (LAMA/LABA) on air trapping in the lungs' COPD patients and inflammatory mediators


Eligibility Criteria:
Inclusion Criteria:

* Patients who have met the criteria for COPD GOLD B defined by an exacerbation not more than 1 time in the last year prior to the study enrollment. These patients will be recruited in sequential sequence.
* Patients with COPD GOLD B are previously treated with either LAMA or LAMA/LABA or short-acting bronchodilators
* Patients who are able to provide informed consent.

Exclusion Criteria:

* - Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung, other malignancy, active heart diseases.
* Receiving long-term treatment with immunosuppressive drugs and systemic corticosteroids
* Being treated with triple therapy (ICS/LABA/LAMA)
* Being in terminally ill conditions
Effect of High-Dose Guarana And Cancer-Related Fatigue

This research will examine the effectiveness of a guaraná nutrition energy bar supplement on cancer-related fatigue based on scores from fatigue questionnaires. Participants will be randomized to one of three study arms: 1) two guaraná energy bars/day, 2) one guaraná energy bar/day 3) usual-care only/ no guaraná energy bars during study in cancer patients who have completed cancer treatment. We would also like to find out if this energy bar supplement improves physical performance, mood and reduces plasma glutamine and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of a malignant solid tumor between 4 and 36 months post-treatment (pathology report or MD documentation).
* Completed all forms of standard treatment (surgery, chemotherapy, radiation therapy, and/or immunotherapy) between 4 and 36 months prior to enrollment in the study.
* Be 18 years of age or older.
* Have cancer-related fatigue, as indicated by a response of a 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0": = 'no fatigue' and "10" = 'as bad as you can imagine' as taken from a single item question on the Symptom Inventory Questionnaire.
* Be able to read English (since the assessment materials are in printed format).

Exclusion Criteria:

* Participants must not: Have used guaraná supplements within the previous two months.
* Self-report that they are very sensitive to caffeine.
* Uncontrolled hypertension
* Have an allergy to walnuts, seaweed, soybeans and/or chocolate.
* Use medications for which caffeine intake is contraindicated including: β-adrenergic agonists, and/or medications that contain pseudoephedrine.
An Intervention to Improve Management of Dyslipidemia in Primary Care

To assess the effectiveness of a clinical audit and physician based intervention in improving the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica


Eligibility Criteria:
Inclusion Criteria:

* Attended the clinic for at least 18 months
* Is diagnosed with any of hypertension, diabetes, dyslipidemia, stroke, coronary heart disease (including angina, myocardial infarction), congestive cardiac failure or peripheral arterial disease, were eligible to be included in the audit

Exclusion Criteria:

* acutely ill or was diagnosed with established kidney disease
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
* Medium-high risk of delayed bleeding (DB risk score ≥ 4)
* Informed consent.

Exclusion Criteria:

* Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
* Lesions resected by endoscopic submucosal resection.
* Incomplete resections.
* Resections with suspected deep submucosal invasion.
* Mucosal defects treated with clips for known or suspected damage to the muscle layer.
* Lesions with low risk of delayed bleeding (DB risk score ≤3).
* Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).


Eligibility Criteria:
Inclusion Criteria:

* Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study)
* Had an overall study intervention compliance ≥80% while participating in their parent study

Exclusion Criteria:

* Has discontinued study intervention in their parent study
* Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
* Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
* Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
TransCare - Genital Surgery for Trans Women in Centralized vs. Decentralized Health Care Delivery Settings

Trans (i.e., transgender, transsexual) individuals experience a gender that does not match their sex assigned at birth (Gender Incongruence), which can lead to distress called gender dysphoria (formerly known as transsexualism). Trans health care (THC) is primarily focusing on transition-related medical interventions (e.g. genital surgery) to reduce gender dysphoria and improve the quality of life. To date, trans individuals access THC services in both decentralized (e.g., various transition-related interventions are spread over several locations) and centralized structures (e.g., gender affirmative medical treatments are provided by a single source). The TransCare study examines genital surgery for trans women (e.g. penile inversion vaginoplasty), focusing on the effect of different health care delivery settings (e.g., if patients received all treatments from a single source or spread over several locations) on psychosocial outcomes and the quality of healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or older;
* Gender different from their assigned male sex at birth
* Current or new surgical care patient at Department of Urology at the University Medical Center Hamburg-Eppendorf
* Able to read, speak, and understand German
* Written informed consent after written and oral information

Exclusion Criteria:

* Under 16 years of age
* Missing informed consent
* Unable to speak German
A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer

This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.

This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.

The study is planned to enroll 10 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).

Eligibility Criteria:
Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
* Males and females≥18 years of age, inclusive, at the Screening Visit.
* Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology.
* No prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer.
* Have at least one measurable lesion according to RECIST v1.1 criteria.
* An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
* Expected survival time of≥3 months.
* No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

Exclusion Criteria:

* Have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ.
* Previous treatment with other oncolytic viruses.
* Immunocompromised patients.
* Known alcohol or drug dependency.
* Women who are pregnant or breastfeeding.
PCA Loading Time Before Knee Prosthetic Joint Infection Revision

Proof of principle pilot study of the effect of dietary nutritional loading of protocatechunic acid (PCA) on the health and welfare of individuals with prosthetic joint infection (PJI), as measured by standard biomarkers

Our purpose in the pre-surgery serial aspiration study is to determine the optimal PCA loading time duration for those with knee PJI with planned single or two stage revision.Our hypothesis, related to changes in structure and function as a result of PCA administration is that dietary nutritional loading of this nutraceutical PCA via the oral route will benefit the health and welfare of such a subject and alter the function and or structure of the human body having a PJI, as measured by improvemen in a pain biomarker, and one or more laboratory-based biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* More than 3 weeks after total knee arthroplasty
* One or more symptoms of injection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
* WBC count of aspiration \>50,0000 cells per μL

Exclusion Criteria:

- Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks
Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion

The aim of this study was to evaluate and compare the effect of myofunctional trainer T4K versus twin block functional appliance on the dentoalveolar changes in children with class II division I malocclusion

This study was a parallel arm randomized comparative clinical trial including 20 healthy children age ranged from 9-12 years showing Angle's class II division I malocclusion due to mandibular retrusion. Preoperative photographs, radiographs and study casts were taken, children were randomly assigned into two groups according to the appliance used; Group 1: T4k, and Group II: twin block. Follow up was done every 4 weeks for 9 months. Postoperative cephalometric X ray, study casts and photographs were retaken for measurements and comparison.

Eligibility Criteria:
Inclusion Criteria:

* Angle's class II division I malocclusion due to mandibular retrusion depending on clinical judgement and confirmed with the lateral cephalometric X-ray.
* Parental written consent was secured.

Exclusion Criteria:

* Patients with mandibular shifts.
* Patients with severe crowding.
* Patients with anterior open bite.
* Patients with posterior crossbite.
* Patients with any peri-oral habits.
* Patients who had received any previous orthodontic or orthopaedic treatments.
Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

The purpose of this project will be to determine whether consumption of beet juice concentrate prior to exercise may acutely improve exercise tolerance in patients with heart failure.

Participants will complete up to four study visits. The first visit will involve completion of the informed consent process followed by a screening for study eligibility. The screening will consist of questionnaires pertaining to detailed medical history, diet, physical activity, and health-related quality of life (KCCQ). Anthropometric measures and a general health screening (including heart rate, resting blood pressure, and small blood (\<15 mL) and urine samples will be collected). Volunteers meeting eligibility requirements will be scheduled for a screening maximal cardiopulmonary exercise test. Immediately prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing. Qualified subjects will then undergo a maximal cardiopulmonary exercise (CPX) test.

Following successful completion of the screening CPX test, volunteers meeting eligibility requirements will be scheduled for two testing visits, at least one week apart. At one visit, participants will consume a small cup of beet juice concentrate, and at the other, they will consume placebo. Treatment will be double-blinded and administered in random order.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) class II-III heart failure
* receiving optimal medical therapy
* sedentary

Exclusion Criteria:

* smoking
* changes in medication or major cardiovascular (CV) event or procedure within the previous 6 wk
* fixed rate pacemaker
* unstable angina
* other co-morbidities or limitations that preclude safe participation in the exercise testing
* plans for hospitalization or cardiac transplantation within the next 2 months
* type 1 diabetes
* refusal or inability to provide informed consent