cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

The goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are:

* What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet?
* Are the effects of two different tourniquet pressures on neuromonitoring significantly different?
* Can the ideal time of the reperfusion interval be evaluated by neuromonitoring?
* Are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? Participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. It will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period.

The investigators will compare two different tourniquet pressure ( Limb occlusion pressure +50 mmHg / + 100 mmHg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative MEP decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.

As a result of the power analysis for this study, the number of samples was determined as 24. The study was started after the approval of the ethics committee.

Participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. It was planned to evaluate quadriceps tendon thickness by USG and MRI, thigh circumference, VAS scores, CBC, and CK in blood samples in the preoperative period of all patients. It was planned to obtain parameters related to MEP by using intraoperative neuromonitorization during the surgery. In the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. Finally, EMG evaluation was planned for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Operation planning in the foot and ankle area

Exclusion Criteria:

* Having a history of previous foot and ankle surgery,
* Having a history of previous knee surgery or spinal surgery,
* Diagnosis of diabetes mellitus,
* Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.),
* Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency),
* Having a disease that affects the ideal tourniquet application (Chronic Lymphedema, BMI\>35, Stage 3 and above chronic renal failure, uncontrollable hypertension),
* Having been diagnosed with a known coagulation disorder,
* History of pulmonary embolism or deep vein thrombosis.
* ASA score above 3
* Surgery time to be less than 80 minutes
Study of Breath-holding as a Means to Reduce Tumor Motion From Breathing

The purpose of this research study is to evaluate typical tumor motion caused by breathing using MRI and can help determine whether simple passive breathing and/or breath-holding could be used for the future treatment of similar lung and liver tumors using radiation therapy radiosurgery techniques.


Eligibility Criteria:
Inclusion Criteria:

* The patient is enrolled on U8700 RSRB # A Phase II Study For Using Radiosurgery On Limited Metastases Of Breast Cancer or U9700 A Pilot Study For Using Radiosurgery On Limited Metastases.
* ≥ 18 years of age
* has given Informed consent

Exclusion Criteria:

-Contraindications for any MRI procedure
Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs)

Primary objective To evaluate the therapeutic efficacy (clinical success) of dEBL at 3 months

2b. Secondary objective

To evaluate adverse events, technical success and recurrence on follow-up

50 patients over 1-year duration based on our previous study of Prospective data (2023-2024)

We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.

By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.

We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.

You are requested to come for follow up for 3 months for endoscopy prodecure.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \>18 years
* Size of lesion less than 15mm
* Site of lesion- duodenum (d1-d4)
* No of lesions- ≤6

Exclusion Criteria:

* Age less than 18 years
* Non-duodenal lesion
* Local or distant metastasis
* Lumen occluding lesions
* Uncorrectable coagulopathy
* Not willing for consent
Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

An effective therapy of persistent atrial fibrillation beyond pulmonary vein isolation remains unsatisfactory. Targeting endocardial low-voltage areas represents an approach of substrate modification.

This prospective, randomized study investigated the efficacy of ablation of low-voltage areas versus PVI and additional linear ablations in patients with persistent atrial fibrillation in terms of single-procedure arrhythmia-free outcome and safety.

Pulmonary vein isolation has become the cornerstone of the interventional treatment of paroxysmal atrial fibrillation. For the treatment of persistent atrial fibrillation the data remains unclear. All different approaches remain unsatisfactory for the treatment of persistent atrial fibrillation, including single pulmonary vein isolation, targeting endocardial areas of low-voltage, identifying areas with complex fractionated atrial electrograms (CFAE), ablating linear lines such as an anterior line, a roof-line or mitral isthmus line. Recurrence rates are still higher as compared to paroxysmal atrial fibrillation ablation. Several studies showed a good correlation between the volume of low-voltage areas (LVA) and the burden of atrial fibrillation. Earlier studies that investigated ablation therapy using a substrate-guided ablation as compared to circumferential pulmonary vein isolation (CPVI) alone, mostly showed no significant difference in recurrence rates between both approaches. In contrast, some other studies showed better outcomes when targeting low-voltage areas. However, there was significant heterogeneity in patient selection, mapping and ablation strategies and therefore, comparisons are hard to make.

The patients are randomized into three different treatment arms (Group 1: PVI alone if no low voltage areas are detected, Group 2: PVI alone if low voltage areas are detected, Group 3: PVI plus ablation of low voltage areas.

Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation according to the current guidelines
* Age \> 18 years
* Patient information

Exclusion Criteria:

* Minors
Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies

The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.

Objectives

The primary objective is to determine the incidence of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. Incidence will be determined via patient-reported incidence following G-CSF administration.

Secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).

Eligibility Criteria:
Inclusion Criteria:

* Receiving a G-CSF after the institution practice change
* Receiving a G-CSF for one of the following indications:
* Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma
* Mobilization of hematopoietic progenitor cells
* Neutropenia prevention following autologous hematopoietic cell transplant
* Took loratadine per protocol with G-CSF administration
* Completed a survey

Exclusion Criteria:

* Taking daily antihistamines for allergies, asthma, or other indications, not including bone pain
* Taking daily NSAIDs, with the exception of aspirin, for chronic conditions
* Treatment for solid tumor cancers
* Receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System

Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation


Eligibility Criteria:
Inclusion Criteria:

1. Aged 60 or older, regardless of gender;
2. Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
3. The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. \[No. of experts in cardiovascular surgery \>=2\]) considers the subjects to be at high risk for surgical operation (STS score \> 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair;
4. Patient with normal left ventricular function (LVEF≥40%);
5. The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.

Exclusion Criteria:

1. Patients with pulmonary artery systolic pressure ≥55 mmHg;
2. Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
3. Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
4. Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
5. Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
6. Received PCI less than 1 month ago;
7. MI happened or UAP was found less than 1 month ago;
8. CVA occurred less than 3 months ago;
9. Patients with comorbid active endocarditis or active RHD;
10. Patients with coagulation disorder, hypercoagulable state or anemia (HGB \< 90 g/L);
11. Patients with acute infection or other severe infections;
12. Patients with active peptic ulcer or active gastrointestinal bleeding;
13. Patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year;
14. Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
15. People who are addicted to alcohol, drugs or narcotics;
16. Patients with cognitive impairment who cannot cooperate with the study or follow-up;
17. Those with a history of epilepsy or mental illness;
18. Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
19. Other situations that the investigator considers inappropriate for participation in this clinical trial.
Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT

The results of the study suggest that an early change in CgA levels might serve as a prognostic factor in NET patients treated with PRRT.


Eligibility Criteria:
Inclusion Criteria:

* confirmed NET
* peptide receptor radionuclide therapy (PRRT)

Exclusion Criteria:

* lack of patient consent to a clinical trial
ForeseeHome NRich Registry

This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD) while monitored at home with the ForeseeHome Monitoring System (FSH) and during routine care with Spectral Domain Optical Coherence Tomography (SD-OCT) and to validate the predictive value of a non-NV-AMD FSH alerts.

The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye. The process of establishing a baseline is completed several weeks after setup of the device at home and initiation of testing. The aim of the registry is to collect data up to 20,000 patients on the ForeseeHome program for at least one year. The data will be collected for approximately a period of 5 years.

The registry will include clinics that provide direct care to the patients on the ForeseeHome device, and Notal Vision Monitoring Center. The registry aims to collect data from about 200 referring physicians.

The registry will include structural and functional data for the patients active on the ForeseeHome device. The details of data points to be collected are mentioned below.

Data from participating sites will be collected in a de-identified manner and collected in the registry. Patients will be assigned a patient ID and will be collected in a sequential manner from each site. No data shall be acquired outside standard of care. Not all data points for each patient are expected to be present. The following data points shall be shared in the registry:

From Notal Vision Monitoring Center

1. Patient ID, Date of Birth (DOB), gender, and testing eye From prescribing physician
2. Visual Acuity: Visual acuity as measured during regular examination, in a period when the patient is active on the ForeseeHome program, shall be shared in the registry. Maximum 2 visual acuity measurements shall be shared during one calendar year.
3. Structural OCT Images: OCT images (volume scans) acquired following a ForeseeHome alert shall be shared in the registry.
4. OCT Angiography (OCT-A) Images: OCT-A images acquired following a ForeseeHome alert shall be shared in the registry
5. Fluorescein Angiography (FA): FA images acquired following a ForeseeHome Alert visit shall be shared in the registry
6. Diagnosis of wet-AMD in case of ForeseeHome alert: The diagnosis related to status of patient's macular degeneration in both eyes shall be shared in the registry in case of an alert.
7. Status of the eye after exiting the ForeseeHome program regarding conversion to wet-AMD and its timing

Eligibility Criteria:
Inclusion Criteria:

* The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye.

Exclusion Criteria:

* Patients that are unable to establish a baseline
CryptoART Study: Decreasing Mortality Associated With Initiation of Antiretroviral Therapy in Sub-Saharan Africa

The study will determine if the initiation of a 'screen and treat' program for cryptococcal disease among HIV positive individuals decreases morbidity and mortality among individuals with CD4 count \< 100 cells/mm3. The study will screen individuals who are asymptomatic for CM and are either ART naïve or ART experienced with CD4 count \< 100 cells/mm3.

The introduction of an cheap, easy to use point of care diagnostic test the lateral flow assay will facilitate rapid diagnosis of cryptococcal disease in resource limited settings. The investigators will determine the efficacy of the lateral flow assay in identifying latent and asymptomatic cryptococcal disease. The investigators will determine the efficacy of the test in detecting disease in readily available body fluids such as urine and whole blood obtained via finger-stick method. The investigators will also determine the cost effectiveness of a screen and treat approach for cryptococcal disease in Zimbabwe.

The investigators also wish to understand why some individuals with low CD4 counts reactivate cryptococcal disease and screen positive for cryptococcal antigen (CrAg) while others with similar levels of immunocompromised do not.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV positive test by standard national algorithm
* CD4 count ≤100 cells/mm3
* Age \> 18 years
* Residence within 50 km of Harare
* Able to provide written informed consent

Exclusion Criteria:

* Presence of clinical symptoms suggestive of meningitis.
* Recent history of CM within 2 weeks of enrollment, i.e., participants within the induction phase of therapy.
* Individuals with severe hepatic injury, jaundice, alanine transferase (ALT) \>5x upper limit of normal
* Individuals with renal failure, defined by an estimated Glomerular filtration rate (eGFR) ≤30 mL/min (using MDRD (Modification of Diet in Renal Disease) equation)
* Currently known to be pregnant
* A negative urine pregnancy test is required for study entry for women with childbearing potential.
* The use of contraception will be recommended to women with childbearing potential while on high dose fluconazole therapy. Referral to family planning services will be given as necessary.
* Previous allergy or other reaction to amphotericin B and/or fluconazole
* Currently enrolled in another clinical trial/study
Exercise-induced Irisin in Individuals with Knee Osteoarthritis.

The goal of this prospective randomised controled study is to investigate the effect of 8-weeks brisk walking exercise on irisin levels, physical and psychosocial parameters in individuals with knee osteoarthritis, and the relationship between irisin levels and physical and psychosocial parameters. The main question it aims to answer is: does 8-weeks brisk walking exercise increase irisin levels and imoroves physical and psychosocial parameters and is the irisin level in relation with the physical and psychosocial parameters.

Irisin is a myokine secreted by skeletal muscle after physical activity. It improves subchondral bone density and quality by increasing osteoblast differentiation and proliferation and improves the mechanical support of cartilage. In addition, irisin promotes chondrocyte proliferation, inhibits chondrocyte apoptosis, and reduces the secretion of inflammatory factors and matrix metalloproteinases. As a result of all these, improvements in joint function may be achieved.

Besides, irisin can improve depressive mood in patients with depression, and irisin level is found to be positively correlated with sleep quality and negatively correlated with disease duration and disease activity in patients with rheumatoid arthritis.

This study aims to investigate the effect of an 8-week moderate-intensity brisk walking exercise program on irisin serum levels and physical and psychosocial parameters in individuals with knee osteoarthritis and the relationship between irisin levels and physical and psychosocial parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic knee OA
* Stage 1-3 knee OA according to the Kellgren-Lawrence classification
* Patients aged 40-65
* Patients agreeing to participate in the study
* Patients having physical and cognitive ability to participate in the exercise program

Exclusion Criteria:

* History of depression and/or anxiety etc. psychiatric disease
* Uncontrolled hypertension, uncontrolled heart rhythm disorders, history of hospitalization for cardiovascular reasons in the last 6 months
* History of symptomatic pulmonary disease
* Use of medication due to dyslipidemia and/or diabetes
* Presence of acute inflammation or effusion in the knee joint
* Presence of central or peripheral neurological disease that will cause loss of lower extremity muscle strength, sensation, and balance
* Presence of a prosthetic joint in the knee and previous lower extremity surgery
* Having received a physical therapy program in the last 6 months
* Patients with severe visual or hearing impairment
* Patients with severe peripheral vascular disorders
* Presence of severe knee joint instability, ligament and meniscal damage
* Being illiterate
Effectiveness of a Foster Parent Intervention: Results of a Trial

The hypothesis of the study is that the intervention leads to a reduction in foster children's externalizing problems and foster parents' parenting stress and that this in turn leads to a reduction in the number of breakdowns of foster placements.


Eligibility Criteria:
Inclusion Criteria:

* foster child has a borderline or clinical score on one of the small-band externalizing scales or the broad-band externalizing scale of the Child Behavior Checklist (CBCL)

Exclusion Criteria:

foster child:

* has a mental retardation,
* autism,
* uses psychotropic medication in an inconsistent way,
* behavioral problems are the result of medical problems or medication, foster parents:
* have insufficient knowledge of Dutch,
* have low cognitive abilities,
* are already receiving professional support for the foster child's externalizing problems,
* are divorcing.

Moreover, foster placements were excluded if at least two of the following criteria were present:

* foster parents considered terminating the foster placement during the past two months
* were experiencing psychological distress (measured with the General Health Questionnaire (GHQ; Koeter \& Ormel, 1991) and defined as a score ≥ 2),
* their foster child had a sum score above 3 (for children \< 6 years) or 5 (for children ≥ 6 years) on the critical CBCL-items.
Exercise Training Effect in Patients With HF and PEF

The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging).
* Diagnosis of HFPEF stable NYHA Stage II- III with an EF of ≥ 45%
* Stabilized on cardiac medications and post hospitalization \> 4 weeks
* Ability to participate in exercise testing and training.
* Referral from Cardiologist or primary care physician.

Exclusion Criteria:

* Unstable Angina
* Uncontrolled diabetes
* Moderate to severe aortic stenosis
* Uncontrolled hypertension Systolic BP\>150 mm Hg or Diastolic BP \>100 mm Hg
* Valvular heart disease
* Untreated coronary artery stenosis \>50%
* Arrhythmias
* Pulmonary disease/COPD
* Dementia or cognitive impairment
* VAD or Transplant planned in next 6 months.
* Current or recent participation in a Cardiac Rehab program within the last six months.