cyrilzakka/clinical-trials huggingface dataset:
Synapse Alterations in MSA Patients

Synaptic loss has been implicated in various neurodegenerative conditions, yet its understanding in multiple system atrophy (MSA) remains limited.

The aim of this study was to examine spatial synaptic density alterations in MSA patients and evaluate the potential of \[18F\]SynVesT-1 PET as an imaging biomarker for MSA in both diagnosis and monitoring disease severity.

60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent \[18F\]SynVesT-1 PET/CT for synaptic density assessment. Visual, voxel, and volumetric region-of-interest (VOI) analyses were employed to elucidate synaptic density patterns in the MSA brain and establish visual diagnostic criteria. VOI-based computer-assisted analyses were utilized to develop diagnostic models for MSA.

Eligibility Criteria:
Inclusion Criteria:

The MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.

Exclusion Criteria:

encompassed MRI contraindications, a history of epilepsy, stroke, or brain surgery, intracranial organic lesions unrelated to MSA, usage of levetiracetam or brivaracetam, and a history of alcohol or drug abuse
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age, inclusive
* primary diagnosis of chronic HCV infection
* non-responders to previous pegylated interferon-based therapy

Exclusion Criteria:

* patients naive to interferon-based therapy for chronic HCV infection
Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty

The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
2. Patients ≥18 years of age
3. Patients have been medically cleared and scheduled for surgery
4. Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.

Exclusion Criteria:

1. Patients already taking Losartan will not be included in the prospective study
2. Patients already taking an ARB (angiotensin receptor blockers) or other ACE (Angiotensin-converting-enzyme) inhibitor
3. Low blood pressure
4. Currently taking hypertensive medication
5. Revision surgery
6. Surgery for fracture, infection, or malignancy
7. Patients with a diagnosis of post-traumatic arthritis
8. Bilateral, simultaneous surgery
Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure

The primary objective of this study is to assess whether the urinary sodium/creatinine or chloride/creatinine ratio might predict successful downtitration of loop diuretics in patients with stable heart failure without clinical signs of volume overload. In addition, this study will provide information on loop diuretic efficiency and urinary electrolyte composition after intake of diuretics in stable outpatients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a left ventricular ejection fraction \<40% or has been previously hospitalized with a primary diagnosis of heart failure
* Patient receives a daily maintenance dose of loop diuretics

Exclusion Criteria:

* Patient was hospitalized for heart failure \<3 months before study inclusion
* The maintenance dose of loop diuretics was changed \<3 months before study inclusion
* The maintenance dose of renin-angiotensin-aldosterone system blockers or beta-blocker medication was changed \<3 months before study inclusion
* Cardiac resynchronization therapy (CRT) was initiated \<3 months before study inclusion
* At the moment of inclusion, the patient has either one of the following signs of volume overload: lower leg edema +2/4, ascites, lung congestion
* Patient is not able to measure his/her weight safely and correct at home
Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy

To propose a feasibility study of introducing a smoking cessation program in head and neck cancer patients with planned radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation.

Smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute and late complications but also poor clinical tumor response, poor local control, and poor overall survival. However, smoking cessation has not been included into the standard intervention in treating head and neck cancer patients in Taiwan. We propose a prospective study of introducing a smoking cessation program in head and neck cancer patients receiving radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation. The primary outcome is to test the feasibility of the smoking cessation intervention, and the secondary outcome is to test the efficacy of the intervention during radiotherapy on acute and late RT toxicities, tumor response, patterns of relapse, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Head and Neck Malignancy Stage I-IVB without distant metastasis
* Receiving five weeks or more of external beam radiotherapy
* Report smoking one or more cigarettes in the past 30 days or self-identify as a smoker
* KPS 70-100

Exclusion Criteria:

* Serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorders, as assessed by the study-site physician
* A current diagnosis of major depressive episode or a history of psychosis, bipolar disorder, or seizure disorder
* Pregnancy or lactation
Immediate Effect of Two Selected Mulligan Techniques in Nonspecific Low Back Pain

To compare between immediate effect of SNAG and mulligan lion position in range of motion (ROM) , pain, functional ability and kinesiophobia on patients with nonspecific low back pain.

Low back pain (LBP) is a global health problem.Orthopedic Manual therapy (OMT) is most commonly recommended form of treatment of LBP and it is also frequently used in clinical practice in various countries. Mulligan introduced a new technique in manual therapy. Mulligan has a great role in the treatment of LBP.General techniques of mulligan are MWM, SNAGs and natural apophyseal glides (NAGs).

Lumber SNAG have immediate and short term on pain and function in treatment of patients with NSLBP.Mulligan has special techniques, one of them is modified lumbar SNAG (lion position) .It has short term effect in reducing pain and activity limitation. Up to investigated knowledge, No previous studies comparing immediate effect of two techniques in range of motion (ROM), pain, functional ability and kinesiophobia

Eligibility Criteria:
Inclusion Criteria:

1. 3 to 7 on VAS.
2. Back Pain duration of 6 week or more .
3. 20-40 years old .
4. Patients of both sexes will be concluded .
5. body mass index (18.5-29.9 KG/M2).

Exclusion Criteria:

1. fracture, osteoporosis, myelopathy, multiple adjacent radiculopathies, cauda equina syndrome, vertebral bone disease and bony joint instability .
2. Infective conditions of spine, autoimmune disorders, Pacemakers, malignancy .
3. History of surgery or injection at lumbar spine 1 year ago .
Seroquel XR in Schizophrenia Relapse Prevention

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month

Exclusion Criteria:

* Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity
Evaluating the Effective and Safe Use of Stream™ Platform

The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use.

Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years - male or female.
* Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
* Subject underwent colorectal surgery with anastomosis.
* Subjects must be willing to comply with trial requirements.
* Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.

Exclusion Criteria:

* Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
* 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
* The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
* Plans that the subject will be discharged in less than 3 days post-surgery.
* Subject has reported that they are pregnant.
* Subject has a permanent end stoma.
* Subject is delirious.
* Subject has severe dementia.
* Subject was involved in the planning and conduct of the clinical investigation.
* Origin™ is not compatible with the drain used on the subject.
* Subject and/or caregiver is/are not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC/HCP/other research staff).
* The subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC/investigator/other research staff).
Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis

This study aims to evaluate the correlation of rectal wall thickness and vascularity measurements using trans-abdominal ultrasound (TAS), trans-perineal ultrasound (TPUS), and endoscopic ultrasound (EUS) in adult patients with ulcerative colitis (UC). The primary objective is to correlate rectal total wall thickness measured by TPUS with EUS, while secondary objectives include correlating rectal wall thickness and vascularity as measured by TAS, TPUS, and EUS, with endoscopic and histologic activity. Additionally, the study will assess changes in patient management following EUS/sigmoidoscopy compared to TAS/TPUS alone. Consecutive UC patients attending an IBD clinic will undergo clinical assessment using the Simple Clinical Colitis Activity Index (SCCAI) followed by TAS and TPUS as point-of-care tests. If clinically indicated, patients will also undergo sigmoidoscopy and EUS during the same visit, with measurements compared and correlated to histologic inflammation and fecal calprotectin (FCP) levels when available. This cross-sectional study will include a follow-up period until biopsy results are obtained, with a recruitment duration of 6-12 months and a target sample size of 170 patients (60 patients with mid-end ultrasound machine, rest with high-end ultrasound machine for transabdominal and transperineal ultrasound).

This study is designed to assess the correlation of rectal wall thickness and vascularity measurements obtained through trans-abdominal ultrasound (TAS), trans-perineal ultrasound (TPUS), and endoscopic ultrasound (EUS) in adult patients with ulcerative colitis (UC). The primary goal is to determine how well rectal total wall thickness measured via TPUS correlates with EUS findings. Secondary objectives include comparing rectal wall thickness and vascularity measured by TAS, TPUS, and EUS with endoscopic activity, histologic activity, and fecal calprotectin (FCP) levels. Additionally, the study aims to evaluate changes in patient management resulting from additional investigations, such as sigmoidoscopy and EUS, over the standard TAS and TPUS procedures. UC patients attending an inflammatory bowel disease (IBD) clinic will undergo a clinical assessment using the Simple Clinical Colitis Activity Index (SCCAI), followed by baseline TAS and TPUS, both performed as point-of-care tests. If deemed clinically necessary, patients will also undergo sigmoidoscopy and EUS during the same visit, with rectal wall thickness and vascularity measured across different rectal sections and correlated with histologic inflammation assessed via biopsy and measured by the Nancy histologic index. The study will also explore correlations with FCP levels where data are available. This cross-sectional study includes a follow-up period until biopsy results are obtained, with an estimated recruitment duration of 6-12 months and a target sample size of 50 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-75 years) with Ulcerative colitis

Exclusion Criteria:

* Pregnant
* Lactating mother
* Endoscopy not required
* No consent
Comparison of Architectural and Performance Adaptations of Hip Extension Exercise Under Gravitational or Inertial Loading Conditions

The main objective of this study is to investigate training-induced adaptations in Biceps femoris long head (BFlh) architecture and performance measures such as muscle strength, jumping, and power variables after following 6 weeks of resistance training program with gravitational or inertial hip extension (HE) exercise and a subsequent detraining period, comparing those adaptations with a control group. In addition, this study aims to determine the time course of BFlh architectural adaptations throughout a 6-week training intervention.


Eligibility Criteria:
Inclusion Criteria:

* at least two years of resistance training experience
* not have any injury, disease or pain that could reduce their maximal effort

Exclusion Criteria:

* history of injury to the lower limbs (including the hamstrings), wrist, or back in the past 18 months
Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition

The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed and dated informed consent form approved by Independent Ethics Committee and provided applicable privacy authorization prior to any participation in the study.
* Subject is considered malnourished or at risk for malnutrition
* Subject has normal GI function
* Subject requires oral nutritional supplementation ands is willing to comply with the study protocol

Exclusion Criteria:

* Subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Subject has a history of diabetes
* Subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment
* Subject has undergone major GI surgery less than 3 months prior to enrollment
* Subject has active malignant disease or was treated within the last 6 months for cancer
* Subject has immunodeficiency disorder
* Subject has had a myocardial infarction within the last 3 months prior to enrollment
* Subject is known to be allergic to intolerant to an ingredient found in the study product
* Subject has an aversion to the flavor of product being tested
* Subject has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastro-intestinal disease-causing symptoms including but not limited to uncontrollable severe diarrhea, nausea, or vomiting
* Subject is taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility.
* Participation in another study that has not yet been approved as a concomitant study by the Sponsor.
* Subject has a clinical condition that is contraindicated with this product.
* Subject is pregnant.
Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder

This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.

The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months

* Cognitive Therapy
* Structured session
* Conceptualization of the case with the patient
* Cognitive methods
* Guided discovery of the schemas
* Work on life-scenarios
* From scenarios to schemas
* Empathic confrontation to the schemas
* Building new schemas (Core belief work-sheet)
* Affective methods: role playing
* Interpersonal methods: counter transference issues
* Behavioral experiment
* Problem solving
* Consolidation methods
* Patients and therapists had manuals
* Supportive Therapy
* Therapist: active listening (face to face)
* Empathy
* Unconditional positive regard
* Reformulation and clarification
* Reflection of the patient's feelings
* Reassurance
* Therapist emphasizes the importance to ventilate problems
* Therapist answers some factual questions
* Therapist politely ignore or refuse requests for advice and directive attitudes
* Therapist demonstrates warmth and genuineness
* Patients and therapists had manuals

Eligibility Criteria:
Inclusion Criteria:

* DSM-4 DIBR \>=8 (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Diagnostic inventory for borderline-revised)
Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease

This study aims to examine performance on a neurological screening test, the Dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It will compare the results of these studies to neonates without CHD.

Neonates with congenital heart disease are at increased risk of adverse long term neurodevelopmental outcomes, including lower mean intelligent quotients (IQs). However, it is difficult to predict with neonates are most likely to be affected and a cost effective method is needed. AEEG has been used in neonates with hypoxic-ischemic encephalopathy and abnormal sleep wake cycles have been proposed to predict poorer long term outcomes. We thus hypothesize that abnormal sleep wake cycles in neonates with congenital heart disease will correlate with poorer outcomes. In our study, we will examine the relationship between performance on a neurodevelopmental screening tool, the Dubowitz neonatal neurological screening tool, and the sleep wake cycles on AEEG both before and after cardiac repair to try and predict which neonates are at increased risk of adverse long term outcomes. We will also compare the findings of the AEEG and performance on the neurodevelopmental tool to the data gathered from neonates without cardiac disease.

Eligibility Criteria:
Inclusion Criteria:

* Newborn with cardiac anomaly requiring surgical intervention or a newborn that is in NICU for at least 24 hours for monitoring
* If newborn has congenital cardiac anomaly, cardiac repair must be performed at Mount Sinai Hospital
* If newborn has congenital cardiac anomaly, he/she must be managed pre-operatively for at least 24 hours at Mount Sinai Hospital
* If newborn has congenital cardiac anomaly, he/she must be managed post-operatively at Mount Sinai Hospital for at least 72 hours

Exclusion Criteria:

* Newborns with previously known anomalies other than cardiac
* Chromosomal abnormalities other than 22Q, that might have long-term neurodevelopmental implications
* Diagnosis of hypoxic-ischemic encephalopathy
* Metabolic disorder
* Other genetic disorders
Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)

The 8-12 fold higher risk for sisters and brothers of patients with Abdominal Aortic Aneurysms (AAA) to develop AAA compared to persons in the population is well known in the scientific community. Recently the value of the screening program for siblings has been analyzed and is shown to be highly cost-efficient, similar to the population based screening of 65-year old men for AAA. Most importantly detection of siblings also adresses and includes women at risk. The adult offsprings to AAA patient would hypothetically bear the same risk of AAA as siblings. This has never been evaluated scientifically due to the practical difficulties in tracking the offspring and inviting them to screening at an age when they are at risk of AAA-disease. In Sweden, the unique multigeneration registry exists which could support such detection, with the possibility to track adult offspring to patients, and investigate the true contemporary prevalence in them.

The DAAAD project aims at investigating the prevalence in adult offspring parallel to developing a model for such a selective screening program

This project will evaluate four questions

1. Feasibility of study design; can we evaluate the prevalence of AAA by inviting and detecting risk groups in national registries ?
2. Point prevalence of AAA in a riskgroup of adult offspring to AAA patients as compared to a matched control group
3. Quality of Life in risk groups: measuring HADS, EQ-5D and questionnaire on heredity, including their awareness on their risk for AAA
4. Cost-effectiveness of such a national program based on prevalence and EQ-5D

This program will evaluate the risk for AAA in adult offspring and also evaluate a highly probable effective registry-based detection route. This could be more cost-efficient than any other AAA screening program, since the prevalence presumably is very high, and the registry-based route could be cheaper than nurse-based detection or incidental screening. The ultimate benefit of this program will be a crude reduction of sudden deaths from AAA for adult offspring to AAA patients, and this will be specifically impressive for the female relatives that are never subjected to any AAA-screening in our country.

Eligibility Criteria:
Inclusion Criteria:

Adult offspring to registered AAA parent (adult offspring) adult offspring not having a AAA parent (Controls)

-

Exclusion Criteria:

Not living in Stockholm below 45 or above 80
Real-Time Feedback (RTFB) to Improve Colonoscopy

To test whether real-time feedback will improve quality of endoscopic examination.


Eligibility Criteria:
Inclusion Criteria:

- Any endoscopist willing to parcipate and performing routine colonscopy

Exclusion Criteria:

- No exclusion criteria