cyrilzakka/clinical-trials huggingface dataset:
Influence of Osmotic Stimulation of Vasopressin on Autonomic Function

The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. This project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females between the ages of 18 - 35

Exclusion Criteria:

* 1) evidence of clinically relevant diseases that may alter body water regulation (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and other potential fluid balance covariates such as habitual use of non-steroidal anti-inflammatory drugs or serotonin reuptake inhibitors,

  2) previous surgery on the digestive tract that may impair the body's ability to normally regulate body water,

  3) regular drug treatment within the previous 15 days,

  4) actively attempting to gain or lose body weight,

  5) For female participants, testing will take place during the early follicular phase of their menstrual cycle (days 1-8) to maintain consistency in the hydration status measures as total body water fluctuates over the course of the menstrual cycle. Females who are currently using contraceptives (e.g., IUD) that limit the number of menstrual cycles occurring in a given year will be excluded from this study to ensure accuracy in the testing periods for this study.
ACEIs and ARBs Treatment in Diabetic Patients -Drug Interactions and Adverse Drug Effects

Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients. Hypertenshion treatment and decreasing urine protein excretion, slow down renal deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.

The study group- men and women with diabetes mellitus type 2,who were hospitalized in the department of internal medicine in Assaf- Harofeh Medical Center.

During hospitalization, data regarding the clinical history,chronic diseases and drugs were collected from the medical files. Blood tests results were recorded during hospitalization .The patients were asked about adverse drug effects.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients admitted to department of Internal Medicine in Assaf Harofeh Medical Center

Exclusion Criteria:

* Type 1 diabetes mellitus
Comprehensive Approach to Hypertension Management in Nepal

Hypertension is a global risk factor for cardiovascular diseases. Approximately 80% hypertension burden is in low-and-middle income countries. Hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. In Nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. A comprehensive intervention strategy for hypertension management has shown promising results in high income countries. Therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as Nepal. The objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. The investigators are proposing a cluster randomized controlled trial conducted in government health facilities from Budhanilakantha, an urban municipality in the Bagmati Province of Nepal. Trial arms: 1) control (routine hypertension care); 2) Comprehensive approach to hypertension management that includes blood pressure (BP) audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change. Eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. Those from the intervention arm will receive the home visits for 6 months. Participants from both arms will provide follow up data in 7 to 8 months.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension patients (systolic blood pressure 140 mmHg or more and/or diastolic blood pressure 90 mmHg or more on at least two separate visits, or use of antihypertensive medication)
* Living in the area served by the participating health facilities

Exclusion Criteria:

* Pregnancy
* Not able or willing to give informed consent,
* Critically ill from depilating conditions such as dialysis, cancer, palliative care
* Not likely to continue living in the area served by the health facility during trial follow up period (8 months)
Implementation Toolkit to Enhance EBP Among Marginalized Families

Although the efficacy of early intervention (EI) for autistic children and their families has been established, many marginalized families with diverse cultural and linguistic backgrounds still report inequitable access to evidence-based practices (EBP). There are several strategies to increase EBP implementation that are especially relevant to marginalized families who report inequitable access to coaching from EI providers, such as increasing the capacity of EI providers to coach families in a culturally responsive way. However, EI providers are provided with limited professional development in both family coaching and cultural responsiveness, which results in perpetuation of EBP implementation failure. Thus, it is crucial to develop and validate an implementation toolkit that comprises strategies to enhance cultural responsiveness in the uptake of EBPs among EI providers. Therefore, the overall purpose of this research is to identify facilitators and barriers of EBP implementation among marginalized families in EI to aid the development an implementation toolkit with a focus on capacity building of EI providers to implement EBP with cultural responsiveness. This will involve conducting individual interviews with EI providers.


Eligibility Criteria:
There are two sets of inclusion criteria for both types of participants.

Inclusion Criteria for EI providers:

* Currently working with minoritized families of young children within Part-C
* Willing to complete I-TEAM as instructed
* Over the age of 18

Exclusion Criteria for EI providers:

* Not able to complete I-TEAM as instructed

Inclusion Criteria for families:

* Having a minoritized backgrounds (e.g., migrant/refugee background, primarily speaks another language other than English at home)
* Having a young child eligible for early intervention services

Exclusion Criteria for EI providers:

* Not currently receiving early intervention services
The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function

Abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. However, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.

The moderate hyperventilation resulting in hypocapnia as well as hyperoxia are common features of mechanical ventilation during general anesthesia. While mild hyperventilation is routinely advocated in laparoscopic surgical interventions, increased FiO2 is set to reinforce safety of respiratory support. Hypocapnia may cause disturbances of cerebral blood flow due to narrowing of cerebral vessels and a decrease cerebral blood flow. Hypocapnia is particularly injurious to the brain in premature infants. Factors that may predispose the immature brain to such injury include poorly developed vascular supply to vulnerable areas, antioxidant depletion by excitatory amino acids, and the lipopolysaccharide and cytokine effects that potentiate destruction of white matter. Data from neonates clearly suggest that severe hypocapnia after hyperventilation contribute to adverse neurologic outcomes. The use of high concentrations of oxygen can lead to a number of events such as the formation of harmful free radicals and activation of lipid peroxidation, resulting in secondary brain injury due to hyperoxia, particularly after suffering anoxia of the brain in resuscitated victims of sudden cardiac arrest. It is recommended to use the fraction of oxygen to maintain saturation at the level of 94-98% when performing cardiopulmonary resuscitation (CPR), due to the risk of reperfusion injury. These disturbances of gas exchange, yet transient can interfere in cerebral blood flow and therefore mental functions.

The primary aim of this study was the assessment of the impact of intraoperative gas exchange (hypocapnia, hyperoxia and their combinations) on the state of higher nervous activity

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \> 18 years and below 80 yrs
* Elective abdominal endoscopic intervention

Exclusion Criteria:

* Known cerebral disorder, incl. traumatic injury and severe vascular impairment
* Known psychiatric illness
* Severe drug or alcohol abuse
* Resent stroke (during last 6 months)
* Pregnancy
* Within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ALI. Patients must not participate in such studies for at least 30 days after enrolment into this study.
ProCaLung: Project on Cancer of the Lung

ProCaLung is a national registry collecting radiation treatment parameters of patients having lung cancer that extends to mediastinal lymph nodes. The project includes a peer review activity.

The purpose of this public health program is similar to an audit whose objective is to promote quality of radiation oncology in Belgium. It is run by Institut Jules Bordet on behalf of the College of Physicians for Radiotherapy Centers of the Belgian Health Federal Public Service, in close collaboration with the Belgian Cancer Registry.

All Belgian radiotherapy centers are invited to participate in ProCaLung but their participation is not mandatory. The centers who accept to participate show a commitment to quality assurance as the radiotherapy-treatment-related parameters they generate will be analyzed to establish national statistics. It includes a peer-review process based on international guidelines for mediastinal nodes delineations given for informational purposes. The public interest program also collects technical parameters as they were planned and delivered during the course of chest radiation treatment. This includes the delineations of tumors, nodes and chest organs on simulation-CT images, PET/CT images, chest-CT images and the clinical information related to the lung cancer. Results/statistics will be published at the end of the project.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC only
* Locally advanced disease (Stage III) with positive mediastinal nodes
* PET/CT staged
* Curative intent radiotherapy
* Chemotherapy (ChT): Without, Sequential ChT - Radiotherapy (RT) (max 2 cycles), Concurrent (± induction ChT)
* Prescription dose ≥ 60 Gy (EQD2)

Exclusion Criteria:

* Prior history of thoracic RT
* Malignant pleural effusion
* History of malignancy in the last 3 years, except basal-cell skin cancer and intra-epithelial neoplasia
* Progression after induction chemotherapy
* Use of concurrent targeted, immunomodulating or anti-angiogenic agents except if the patient is included in a clinical trial
A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors

This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors.

The study consists of dose escalation and dose expansion. The preset dose of Donafenib is 50 mg BID, 100 mg BID and 200 mg BID, and the preset dose of KN046 is 5 mg/kg Q3W. Dose expansion will enroll subjects who with advanced hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-70 years;
* Phase I dose escalation: Advanced gastric cancer, esophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer (other than pancreatic neuroendocrine tumors) and intrahepatic cholangiocarcinoma that failed standard treatments confirmed by histopathology and/or cytology; Among them, the Child-Pugh score of liver function in patients with hepatocellular carcinoma is less than 5,
* Phase II advanced hepatocellular carcinoma Dose expansion: Patients with advanced hepatocellular carcinoma who are clinically diagnosed or confirmed by histopathology and/or cytology and are not suitable for surgical resection; The patient has not undergone first-line systemic treatment \[small molecule targeted drugs (such as sorafenib, lenvatinib, etc.), systemic chemotherapy\] and tumor immunotherapy (anti-PD-1/L1, CTLA-4, etc.); Child-Pugh score of liver function ≤ 6;
* Has at least one measurable lesion based on RECIST 1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* Life expectancy ≥12 weeks;
* Patients must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
* History of interstitial lung disease or non-infectious pneumonia;
* Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
* Has received vaccination within 4 weeks prior to the first dose.
* Has participated in other anticancer drug clinical trials within 4 weeks.
* According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

The REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. A study period of 1 year and extended follow up period of up to 3 years is planned , to enable a thorough and complete assessment of the performance of the device when implanted to replace removed or damaged meniscal tissue in humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus.


Eligibility Criteria:
Inclusion Criteria:

* The subject (or guardian, if appropriate) has signed and dated a specific informed consent form;
* The subject is over the age of 18 and ≤55 years of age;
* The subject is able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the Investigator;
* The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial meniscus defect;
* The meniscal defect should represent 25% or more of the meniscus and be amenable to implantation;
* The peripheral meniscal rim must be present;
* The subject has a functionally intact ACL (Anterior Cruciate Ligament);
* Haemoglobin \>9g/dL and platelet count \>100,000/mm3 prior to Day 1;
* No contraindication to general anaesthetic;
* Female subjects of child-bearing potential: a negative urine pregnancy test.

Exclusion Criteria:

* Subject is \>55 years of age;
* The subject has a functionally deficient ACL;
* The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject's ability to comply with the recommended rehabilitation programme;
* The subject has a diagnosis of Grade IV Outerbridge Scale degenerative cartilage disease in the involved knee joint;
* Patients demonstrating an active local or systemic infection;
* Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Meniscus scaffold and clinical outcome;
* The subject has a history of confirmed anaphylactoid reaction;
* The subject has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery;
* The subject has evidence of osteonecrosis of the involved knee;
* The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis;
* If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months;
* Current or recent (\<3 months) participation in another device or drug study.
Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors

SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This Phase I trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subject has the ability to understand, able, willing to comply with study procedures and follow up visits, and has provided written consent
* Pathologic evidence of solid tumor
* Failed standard therapy and deemed by the Investigator to be suitable for participation into the trial
* Laboratory values (obtained within 10 days prior to enrollment): ANC: \>= 1.5 × 109/L; Platelets: \>= 100 × 109/L; Hemoglobin: \>= 10.0 g/dL (without transfusions); Bilirubin: within normal range; AST, ALT, and alkaline phosphatase: \<= 2.5 x ULN without tumor liver involvement; Serum creatinine: within normal limits; Calculated creatinine clearance: \>= 60 mL/min/1.73 m2 for patients with creatinine \> Institutional Normal Values; PT/PTT/INR: within normal limits..
* Have IHC evidence of phospho-MET expression on tumor material no more than 12 months old. This is a requirement only for entry into the MTD dose expansion phase.
* Have no residual toxic effects of previous therapy, and undergo a washout period of at least 5 half-lives from the time of administration of the previous therapy.

Exclusion Criteria:

* Pregnant, lactating, or may become pregnant
* Cardiac disease requiring medical therapy
* Have had a major surgery within 4 weeks prior to Day 1 of the study
* Have an active, uncontrolled bacterial, viral, or fungal infection that requires ongoing systemic therapy
* Have a known active infection with HIV, hepatitis B or C
* Have psychiatric or seizure disorders that would require therapy or interfere with study participation
* Have other severe concurrent nonmalignant disease that could compromise protocol objectives, including malabsorptive conditions
* Patients receiving prohibited medications as listed in Appendix E, including drugs categorized as strong inhibitors of CYP3A4 and A5 and drugs known to have a high potential risk of liver toxicity
* Have known allergy to SGX523 formulation or its excipients (croscarmellose sodium, lactose monohydrate and magnesium steareate)
* Patients receiving anti-coagulant therapy
Role of Adipose Tissue in Pathogenesis of Insulin Resistance

The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body composition and insulin resistance are measured before and during the diet.

The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.

Eligibility Criteria:
Inclusion Criteria:

* Obesity

Exclusion Criteria:

* Diabetes
* Coronary heart disease
* Eating disorders
* Medication of beta blockers
* Medication of antiobesity drugs