cyrilzakka/clinical-trials huggingface dataset:
Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children

Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. The acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. The chronic phase usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. Progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic Chagas heart disease.

Objective: To evaluate cardiac involvement in children after pharmacological treatment for Chagas disease.

Methods: Open exploratory study, blind for cardiological evaluation. Population: children treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were included as a control group for final cardiological evaluation.

Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter.

Electrocardiogram (ECG) was performed at diagnosis and every year after treatment.

In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.


Eligibility Criteria:
Inclusion Criteria:

* Chagas diseases children treated with benznidazole / or nifurtimox
* Patients with at least 6 years of after-treatment follow-up.
* Diagnosis of Chagas disease: in infants younger than 8 months by direct observation of T.cruzi using parasitological concentration method (microhematocrit test); in infants older than 9 months 2 reactive serological test (ELISA, Indirect Hemagglutination ).

Exclusion Criteria:

* Patients with chronic diseases (renal, hepatic, neurological) that at the discretion of the researcher could affect the interpretation of the results.
* Subjects with congenital heart disease.
Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention

This study aims to verify the effectiveness of the connected network for EMS comprehensive technical-support using artificial intelligence (CONNECT-AI) system through demonstration in the local community. The study was designed as a prospective non-random cross-intervention study design in two preselected communities. The subjects of the study are patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community. If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED, it is excluded from the study. In this study, the developed CONNECT-AI system was installed in all emergency vehicles and EDs in two regional cohorts, and the effectiveness was measured by operating an intersection for the same period. The primary outcome is the transfer time spent in the pre-hospital stage, and the secondary outcome is whether the optimal transfer hospital is selected.


Eligibility Criteria:
Inclusion Criteria:

* patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community.

Exclusion Criteria:

* If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
* Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
* Child-Pugh Class A
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Prior liver transplant
* Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply
Effect of Norwegian Food Based Dietary Guidelines on Chronic Diseases in CRC Survivors

The current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. Since previous research on the role of diet for colorectal cancer survivors is limited, the study may be of great importance for this cancer population.

Men and women aged 50-80 years diagnosed with primary invasive colorectal cancer (Stage I-III) are invited to this randomized controlled, parallel two-arm trial 2-9 months after curative surgery. The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. Patients are followed-up at 6 months and 1, 3, 5, 7, 10 and 15 years after baseline. The study center is located at the Department of Nutrition, University of Oslo, and patients are recruited from two hospitals within the South-Eastern Norway Regional Health Authority. Primary outcomes are disease-free survival and overall survival. Secondary outcomes are time to recurrence, cardiovascular disease-free survival, compliance to the dietary recommendations and the effects of the intervention on new comorbidities, intermediate biomarkers, nutrition status, physical activity, physical function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer (ICD10 C18-20) TNM Stage I-III

Exclusion Criteria:

* TNM stage 0 or IV
Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
* Knee pain \> 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
* Moderately active
* Varus knee alignment equal or superior to 2°

Exclusion Criteria:

* Severe knee OA (K-L grade IV)
* Rheumatoid arthritis or other inflammatory arthritis
* Avascular necrosis
* History of periarticular fracture or septic arthritis
* Bone metabolic disease
* Pigmented villonodular synovitis
* Cartilaginous disease
* Neuropathic arthropathy
* Synovial osteochondromatosis
* Total or partial knee arthroplasty
* Flexion contracture of ipsi- or contra-lateral knee greater than 15°
* Hip or ankle joint damage with mobility limitation
* Obesity (BMI ≥ 40)
* Intra-articular corticosteroids injection in the affected knee during the two previous months
* Reduced mobility (Charnley class C)
Terlipressin Administration in Patients Undergoing Major Liver Resection

This study investigates if the administration of terlipressin reduces complications after major liver surgery.

Background

Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration.

Objective

Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection.

Methods

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing resection of 3 or more liver segments
* Minimum age of 18
* Any gender
* Written informed consent

Exclusion Criteria

* Preoperative renal failure (GFR \< 50ml/min)
* Severe liver dysfunction (Child-Turcotte-Pugh grade C)
* Hyponatremia (\<132mmol/l)
* Severe aortic regurgitation, severe mitral regurgitation, heart failure
* Symptomatic coronary heart disease
* Bradycardic arrhythmia (heart rate \< 60/min)
* Peripheral artery occlusive disease (clinical stadium II-IV)
* Dilatative arteriopathy, history of subarachnoidal bleeding
* Decompensated arterial hypertension (Blood pressure \>160/100mmHg despite intensive treatment)
* Present or suspected acute mesenteric ischemia
* Septic shock
* Pregnancy
IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe.

Preserving ejaculation is a significant factor that impacts patient's decisions regarding what proceeding with treatment of BPH symptoms. The UroLiftTM system provides a safe procedure that has proven preservation of ejaculatory function. However, it is contraindicated in patients with prominent median lobes. The combination with laser median lobe enucleation may provide the same improvement in symptoms and widen patient inclusion criteria to those desire preserved ejaculation that also have a prominent median lobe.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 45 years of age or older
2. Patients must be diagnosed with benign prostatic hyperplasia
3. Patients must opt for surgical management of their BPH with desire for preservation of ejaculatory function
4. Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy

Exclusion Criteria:

1. Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline IIEF-5 score \< 15
2. Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
3. Patients with prostate glands greater or equal to 100 grams
4. Patients with less than a grade I intravesical protrusion of median lobe on pre-operative cystoscopy
5. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy

This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy.

The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. The study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years.

This study will be conducted in 2 hospitals: UZ Leuven and AZ ST. Jan Brugge on the consultation Ear, Nose and Throat Diseases (ENT) and the department of Internal Medicine / Allergology


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and ≤60 years
* Persistent or intermittent allergic rhinitis complaints, confirmed by SPT and/of immunocap for the specific IgEs.

OR suspected local allergic rhinitis

* Patients who start with AIT treatment
* The patient must be motivated and willing to come to all visits
* The patient must be able to understand and sign the informed consent

Exclusion Criteria:

* Uncontrolled asthma
* Conditions affecting the functioning of the immune system (eg: immune deficiencies, malignancies, autoimmune diseases)
* Use of β-blockers, immunosuppressants or ACE inhibitors
* Hypersensitivity to aluminum hydroxide and/or hypersensitivity to any of the excipients in AIT
* Anaphylaxis after allergen challenge in the past
* Acute rhinosinusitis in the last 12 weeks
* Recent surgery on the nose and/or paranasal sinuses in the last 12 weeks
* Pregnancy
Negative Predictive Value of Drug Provocation Tests to Beta-lactams

Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam
* The patient or the patient's legal representatives are not their opposition to participate in this study
* The patient must be affiliated or beneficiary in a health insurance system

Exclusion Criteria:

* The patient is exclusion period determined by a previous study
* The patient is under judicial protection, guardianship or curatorship
* The patient or the patient's legal representatives do not read fluently the French language
RSHF in Colorectal Cancer

The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Social Insurance
* Performance Index \<2
* Life expectancy\> 6 months
* adenocarcinoma colorectal (histologically proven)
* Metastases (inoperable or recurrent after surgery),
* hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if the two bodies are metastatic). The largest diameter of the metastasis will \< ou = 6cm for the liver, \< or = 6 cm for the lung. If multiple metastases, the sum of their maximum diameter is 6cm \< ou = the liver, \< ou = 6 cm for the lung.
* Lesion (s) measurable (s) and evaluable (s)
* CT less than 3 weeks
* Patients must have received at least one prior chemotherapy regimen containing 5FU

  • Patients may have received one or more lines of chemotherapy including irinotecan.
* bilirubin \<1.5 x ULN
* AST and ALT \<5x ULN
* neutrophils\> 1.5x109 / L, platelets\> 100x109 / L, hemoglobin\> 9 g / dL
* TP, TCA Normal (only for patients treated with a permanent implant)
* Informed consent signed.

Exclusion Criteria:

* contraindication to the administration of irinotecan.
* History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation.
* History of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted)
* Metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)).
* Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left.
* Pregnancy or breastfeeding.

  - Lack of means or refusal to use effective contraception for men or women of childbearing age.
* Any other concomitant experimental treatment.
* Any other concurrent anticancer therapy, immunotherapy or hormonal therapy.
* Monitoring impossible because of psychological, sociological or because of geographical distance.
Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access

This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.

This study is a multicenter, randomized controlled, prospective, non-inferiority, open-label clinical trial designed to compare the efficacy and safety of using 7F thin-walled sheaths versus 6F thin-walled sheaths for coronary intervention (PCI) via distal radial artery access (dTRA). The study will enroll adult patients with coronary artery disease who are scheduled to undergo PCI.

Participants will be randomized into two groups: the experimental group, which will receive PCI using a 7F sheath, and the control group, which will receive PCI using a 6F sheath. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure, assessed by ultrasound. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events during follow-up, cannulation success rate, PCI success rate, and the rate of radial artery occlusion at 30 days post-procedure, among others.

The study aims to determine whether the 7F sheath is non-inferior to the 6F sheath in terms of safety and efficacy for PCI through dTRA. The study will be conducted at multiple centers in China, with a planned enrollment of 574 participants, and it will span from Sep 2024 to January 2026. All procedures will adhere to the highest standards of clinical practice, and patient data will be managed with strict confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤80 years;
* Height ≤180 cm;
* Distal radial artery diameter ≥1.7 mm;
* Completed distal radial artery angiography and requires coronary intervention;
* Tolerates dual antiplatelet therapy and intraoperative anticoagulant therapy, with no history of related drug allergies;
* Patient consents to participate in the study.

Exclusion Criteria:

* Acute myocardial infarction requiring emergency PCI;
* Ultrasound-confirmed occlusion of the radial artery on the procedure side;
* Radial artery and distal radial artery anomalies (e.g., small caliber, tortuous, looped vessels) that make the dTRA approach unsuitable;
* Previous bilateral radial artery intervention or surgery;
* No coronary intervention performed after coronary angiography;
* Inability to undergo coronary angiography and intervention due to subjective or objective reasons;
* Coronary lesions requiring the use of a 7F guiding catheter;
* Coronary arteries not suitable for 7F guiding catheter;
* Severe liver or renal insufficiency, unresolved bleeding disorders, or other serious conditions with an expected survival of less than 1 year;
* Currently breastfeeding or known pregnancy.
Reducing Mental Health Disparities Among Latinxs With a Telenovela Intervention

The primary aim of our study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Telenovela video interventions are a low-resource, low-cost methodology developed to diminish the treatment-provider gap (Heilemann et al., 2017). Research shows that telenovela interventions represent an acceptable (Heilemann et al., 2018) and potent (Heilemann et al., 2017) intervention option for disseminating information to the Latinx population. Prior research utilizing transmedia telenovela interventions that include a telenovela component have demonstrated some effectiveness at reducing symptoms of anxiety and depression among Latinxs (Heilemann et al., 2017; Kajiyama et al., 2018) as have fotonovelas (Sanchez et al., 2019). To date researchers have not investigated how the telenovela approach combined with a transdiagnostic treatment paradigm might help reduce behavioral health disparities among Spanish-speaking Latinxs given that such an intervention would be easily disseminable and target the two most common disorders observed among this population. The primary aim of this study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Identify as Latinx
3. Prefer behavioral health services in Spanish
4. Meet the DSM criteria for any mild to moderate anxiety disorder
5. Ownership of a smartphone

Exclusion Criteria:

1. Suicidality
2. Psychosis
3. Bipolar disorder
4. Severe anxiety disorders
5. Severe depressive disorders
6. Homicidality
Trodat 1 SPECT and Dopamine Polymorphism

The study population will include 100 parkinsonian patients in early stage of disease, with total duration not exeeding 5 years.

The patients will undergo neurologic examination and evaluation of disease severity using the unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.

The study sample will include 100 Israeli Jewish patients with early idiopathic PD who were not treated with anti-parkinson drugs. The clinical diagnosis will be based on the criteria of the United Kingdom Parkinson Disease Society Brain Bank.5 All patients will undergo Tc-99m-Trodat1 SPECT. The severity of the motor symptoms will be assessed with the Unified PD Rating Scale (UPDRS). Genomic DNA is extracted from peripheral blood leukocytes for genetic analysis.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were

1. early Israeli PD patients
2. Of jewish origin, males or females
3. Undergoing DAT-scan examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS evaluation at that stage,performed by a trained neurologist
4. Patients did not use any type of anti-parkinsonian drug type, at time of DAT-scan performance and UPDRS evaluation
5. DNA sample was obtained
6. Patients were able to sign an informed consent form to participate in this study.

Exclusion Criteria:

* Patients were excluded if they features secondary parkinsonism or if they were treated with medications that block dopamine receptors.