cyrilzakka/clinical-trials huggingface dataset:
Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer

The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC). The The Coordination and Data Management Center (CDMC) will provide high quality, efficient and consistent leadership and services in all aspects of data quality and assurance; data harmonization and management; while providing assistance to the projects in disseminating and interpreting those data. The CDMC PI will provide statistical (study design, analysis plans, data analysis, and interpretation), data management, and data monitoring/auditing (data quality assurance and harmonization) expertise for the proposed projects. The Cancer Center will have access to identifiable data from studies; analysis of this data will not be conducted under this protocol. Any future analysis conducted on data or specimens as part of CPDPC protocols will be conducted under a separate IRB approved data or lab protocol.

The CDMC will leverage existing support, infrastructure, and resources from the Data Management and Coordinating Center for the Global Cancer Early Detection and the clinical expertise of the Division of Pathology/Lab Medicine at MDACC.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic pancreatis, diabetes, and pancreatic cancer recruited through Consortium.

Exclusion Criteria:

* N/A
Evaluation of Ocular Comfort With ISTA Tears vs Systane

To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)


Eligibility Criteria:
Inclusion Criteria:

* OSDI \>12

Exclusion Criteria:

* Presence of any active ocular disease other than dry eye
Evolution of Memory Related Activity

The purpose of this study is to begin the process of validating fMRI (functional magnetic resonance imaging) as a biomarker for use in clinical trials and longitudinal studies of clinical progression in mild cognitive impairment (MCI) and Alzheimer's disease (AD).

The development of biomarkers is now especially critical, as there are a number of promising disease-modifying therapies entering early phase clinical trials, with additional novel therapeutic strategies in development. It is essential to develop biomarkers that can detect a "signal of efficacy" over a relatively short time frame for use in Phase II trials. Ideally biomarkers are needed that can reliably detect the earliest brain alterations due to AD pathology, perhaps at a point when there is synaptic dysfunction but not yet widespread neuronal loss. Functional neuroimaging, in particular functional MRI (fMRI), has significant potential, having already shown promise in detecting regionally specific pharmacological effects on memory related neural activity, and as a sensitive marker of very early cognitive impairment.

This study, a parallel ancillary study of the Alzheimer's Disease Neuroimaging Initiative (ADNI), will first examine reproducibility of fMRI activation, using a face-name associative memory paradigm, and then the alterations in memory-related activation that occur over the course of MCI and mild AD. The study will also examine the relationship of fMRI activation to clinical variables, memory task performance, genotype, and other imaging techniques cross-sectionally and longitudinally, sampling at multiple time points over a 3-year period.

Eligibility Criteria:
Inclusion Criteria:

* Ages 55-90
* General good health or stable medical problems
* Study partner/caregiver able to provide an independent evaluation of the participant's daily functioning
* No contraindications to MR scanning
* Modified Hachinski Ischemic Score ≤4
* Geriatric Depression Scale ≤10

Exclusion Criteria:

* Diagnosis of Parkinson's disease or other neurological illness
* Presence of clinically significant/uncontrolled medical conditions
* History of stroke, brain tumor, brain surgery, seizures, significant head trauma with loss of consciousness, depression or other psychiatric illness, alcohol or drug abuse in the past 2 years
* Significant uncorrectable visual impairment
SuperSaturated Oxygen Comprehensive Observational Registry

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.


Eligibility Criteria:
Inclusion Criteria

Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label or All Others) Cohorts must meet ALL the following baseline criteria:

* Men or women aged 18 years or older
* Presentation with AMI and successful revascularization of the infarct-related artery with PCI
* The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB)

Treatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study.

Subjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria:

* The primary culprit lesion must be in the left anterior descending (LAD) coronary tree
* Successful primary PCI within 6 hours of symptom onset, as documented by \<50% diameter residual angiographic stenosis and Thrombolysis in Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel
* No major complications such as perforation, serious bleeding, or cardiogenic shock
* Not pregnant or nursing

Exclusion Criteria

* Subjects will be excluded if they meet any of the following criteria:
* Life expectancy of less than 2 years
* No access to medical records from either the index hospitalization or subsequent outpatient visits
* Currently participating in an investigational drug or device trial
Celsius TCS Hyperthermia System PMCF Trial

Based on the basic data of all patients foreseen for a local hyperthermia in the participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the complication rate (injury to the patients) will be recorded.

During this PMCF Trial from each participating center the internal data of all Celsius TCS Hyperthermia devices are collected. The participating centers are obligated to report any device-related failure and Adverse Event (injury to the patient). The center reports together with the device-internal data allows to calculate the failure and the complication rates. It will be analyzed regarding the kind of tumor and the concomitant treatment (radiotherapy and/or chemotherapy). The outcome groups (with/without failure or complication) will be analyzed regarding demographic and treatment parameters.

Eligibility Criteria:
Inclusion Criteria:

* treatment performed with the Celsius TCS Hyperthermia System

Exclusion Criteria:

* not applicable -
A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)

24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized, crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1 as detection indicators. Establish the "blood drug concentration-time " curve, compare the bioequivalence of the main effective ingredients of the two preparations during the absorption process in human.


Eligibility Criteria:
Inclusion Criteria:

* The healthy male volunteers aged 18-40 years old;
* The body mass index is within 19-24, and the body weight is not less than 50kg( body mass index=body weight (kg)/height (M)2);
* All the examination indicators such as heart, liver, kidney, blood and so on are within normal range;
* The subjects should be without the addiction to smoking or alcohol, without drug abuse history and agree not to drink beverages containing caffeine during the trial;
* The subjects fully understand the objective, method and content of the trial, as well as the test preparation and reference preparation, and are willing to sign informed consent.

Exclusion Criteria:

* The subjects that are found to have any significant clinical diseases by direct questioning and comprehensive physical examination and laboratory examination before study;
* Allergic constitution, such as the patients with allergy history to two or more food and drugs; or those known to be allergic to the ingredient of the drug.
* The individuals with low possibility of enrollment (such as physically weak and so on) according to investigator's judgement;
* The patients that have any reasons considered by the investigator to prevent the subjects from finishing the study.
Investigation of Tumour Spectrum of Germline Mutations in Breast and Ovarian Cancer Genes.

TUMOSPEC is a national family study designed to measure the relative and absolute risk of cancer for carriers of deleterious mutations to these "new" breast cancer (BC) susceptibility genes. Index cases will be enrolled consecutively from patients attending an appointment at one of the Unicancer centres, with no other inclusion criteria, and offered a BRCA1/2 analysis as part of their care plan. A panel of 24 TUMOSPEC genes, chosen in advance by a steering committee, will be tested as the same time as the BRCA1/2 genes, at one of the usual BRCA1/2 analysis laboratories belonging to the same network and participating in the study. If a mutation is found, the index cases will be asked to invite their first and second degree family members and their cousins to take part in the study, regardless of whether they have cancer. Saliva samples will be then taken and used for a targeted analysis of the familial abnormality. Each participant will also complete an epidemiological questionnaire in order to gather information about his/her medical history and any exposure to various risk factors. All medical and genotype data will be centralised at the Genetic Epidemiology Research Platform (PIGE, INSERM). The cumulative mutation frequency for all genes is estimated at 10%. Penetrance will be analysed using methods designed to minimise selection bias. The expression spectrum of the mutations will also be described. For genes where the number of mutated families is too low, the data may be contributed to international consortia. The main project will be preceded by a two-year feasibility study, using the same inclusion criteria and logistic circuits. It is this pilot study to which the current funding application relates.


Eligibility Criteria:
Inclusion criteria:

Index case eligibility:

Any person with an indication for a BRCA1/BRCA2 gene analysis and who has been offered TUMOSPEC panel screening.

Age ≥18 years.

Family member eligibility:

Family members will be eligible if the mutation identified in the Index Case is considered deleterious.

Any family member to the first and second decree or a cousin of the Index Case. Family members from both sides of the family will be invited to take part.

Age ≥18 years.

Exclusion Criteria:

People deprived of their civil liberties or who are under judicial protection or guardianship.

Patients unable to answer the questionnaire for social or psychological reasons.

Children of the index cases, of any age.
Rare Variation and Remote Gene Regulation of Osteoporosis Related Phenotypes in Han Chinesse

Bone density is recognized as the most important factor to measure osteoporosis, and the prevalence of osteoporosis increases with age. Risk factors for osteoporosis include age, weight, exercise, diet, smoking and alcohol consumption. What's more, osteoporosis has a strong familial aggregation, and the genetic value of bone density is between 0.6 and 0.85. Therefore, it is necessary to conduct large-scale collection of population samples of osteoporosis fractures and relevant genetic studies.

From past linkage analysis and candidate gene association studies to genome-wide association studies and second-generation sequencing technologies, researchers have found hundreds of genes and SNPs associated with bone mineral density and osteoporosis fractures. However, current studies on osteoporosis and related phenotypes are mainly concentrated in the European and American populations, rare in Asia and other regions, and even less in the Chinese han population. It is one of the problems to be solved in this project whether the genes and SNP loci associated with these strengths can also be applied to han Chinese population due to the existence of racial differences. This project aims to collect the patients with primary osteoporosis and osteoporosis fracture in the Chinese han population through the orthopaedics department, and verify the identified osteoporosis susceptibility genes in the Chinese han population.

Eligibility Criteria:
Inclusion Criteria:

1. From July 2018 to July 2021, patients admitted to the outpatient or inpatient clinic were diagnosed as primary osteoporosis fracture;
2. Aged between 50 and 100;
3. This fracture was not treated with any anti-osteoporosis drugs before
4. Subjects will participate in the study voluntarily and have signed the informed consent
5. Patients with clear mind and independent behavioral ability

Exclusion Criteria:

1. Patients with malignant tumors are associated with bone metastases, such as lung cancer, prostate cancer, thyroid cancer, etc
2. Hyperparathyroidism, Cushing syndrome, hypogonadism, hyperthyroidism, pituitary prolactinoma, diabetes
3. Systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, dermatomyositis, mixed connective tissue disease, etc.;
4. Renal osteodystrophy caused by various chronic kidney diseases;
5. Gastrointestinal diseases and nutritional diseases: malabsorption syndrome, subtotal gastrectomy, chronic pancreatic diseases, chronic liver diseases, protein-calorie malnutrition, long-term intravenous nutrition support treatment, etc.;
6. Leukemia, lymphoma, multiple myeloma, hyperthermia and myelodysplastic syndrome;
7. Hemiplegia, paraplegia, motor dysfunction, muscular dystrophy, catalepsy and myotonic syndrome caused by various reasons;
8. Glucocorticoids, immunosuppressants, heparin, anticonvulsants, anticancer drugs, aluminum-containing antacids, thyroid hormones, gnrh-a or dialysate, etc.
9. Unwilling to accept dietary management or unable to sign the informed consent
Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma

Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for the trial and randomized to two different surveillance programs. These programs differ greatly in the frequency of diagnostic imaging. They have similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are overall survival and QoL.

Minimal program for colon cancer: Office visit and CEA at 4,8,12,16,20,24,30,36,42,48, and 60 months. Colonoscopy at 12, and 48 months. Liver echography\* at 8, and 20 months.

Intensive program for colon cancer: Office visit, CBC, CEA+CA 19.9 at 4,8,12,16,20,24,30,36,42,48, and 60 months. Colonoscopy at 12, 24, 36, 48,and 60 months. Liver echography\* at 4,8,12,16,24,36,48, and 60 months. Chest X-ray at 12,24,36,48,and 60 months.

\* Abdominal-pelvis C.T., as an alternative to echography, was a 2° level exam only (doubtful results of physical examination or echography; increasing levels of CEA; predictable poor sensitivity of echography due to obesity or other anatomic-clinical conditions)

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven adenocarcinoma of the colon or rectum with Dukes Astler-Coller modification stage B2-C who had been treated with curative intent (radical excision ± adjuvant radio-chemotherapy) .
* Eligible patients had to be free of known cancer prior to study entry as attested by negative results of endoscopy, liver ultrasonography, chest roentgenography and serum CEA level performed \< 4 months before randomization

Exclusion Criteria:

* Inability to undergo testing (disability, allergy to contrast agents, etc.) and patients geographically not amenable to full follow-up.
* Patients enrolled onto any other research protocol that requires strict adherence to any specific follow-up practice.
* A history of any previous malignancy in the last 10 years (other than carcinoma in situ of the cervix or non-melanoma skin cancer).
* No informed consent to participate in the trial according to local regulatory guidelines.
Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. However, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. For some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. Other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.

The purpose of this research study is to better understand how this potential treatment option, oral steroids, affects biochemical substances that have been associated with the development of chronic sinusitis and polyps. In order to do this, we need to study people with different forms of chronic sinusitis and compare them to individuals without allergies or sinus disease. We will also look at patients with chronic sinusitis who are treated with oral steroids and compare them to chronic sinus patients who have not received oral steroid therapy prior to surgery. This study may help pave the way to new treatments that address specific parts of the chronic sinus inflammatory pathway.

Hypotheses

1. Oral steroid treatment of patients with CRS will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage.
2. Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
3. Changes in inflammation will correlate with clinical variables.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years to 70 years
* Diagnosis of chronic rhinosinusitis (CRS) with nasal polyps (NP) and will be undergoing sinonasal surgery for this condition
* Diagnosis of CRS without NP and will be undergoing sinonasal surgery for this condition
* No diagnosis of CRS and NP and will be undergoing nasal surgery (septoplasty/rhinoplasty, nasal fracture repair,etc.)

Exclusion Criteria:

* Ages younger than 18 years and ages older than 70 years
* Diagnosis of an established immunodeficiency, pregnancy, coagulation disorder, a diagnosis of allergic fungal sinusitis (AFS), or cystic fibrosis
* Those with CRS with or without NP in whom systemic steroid therapy would be contraindicated
* Those who are dependent on systemic steroid therapy for sinonasal disease or any other condition
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD

15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.

Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.


Eligibility Criteria:
Inclusion Criteria:

* Stable respiratory situation
* Clinically required NIV
* Capable of giving consent

Exclusion Criteria:

* Invasive ventilation
* Any other severe physical disease that requires immediate medical assistance
* Acute hypercapnic decompensation with pH \<7.30 in routine BGA
* Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
* Participation in a clinical trial within the last 4 weeks
* Pregnancy or nursing period
* Drug addiction
A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

A Phase 1b/2 Study of Repotrectinib in Combination with Other Anticancer Therapies for the Treatment of Subjects with KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)

Phase 1 Dose Escalation: To evaluate tolerability of repotrectinib at increasing dose levels in combination with other anticancer therapies for the treatment of subjects with locally advanced or metastatic KRAS-mutant solid tumors

Phase 2 Efficacy Evaluation: Investigate the anti-tumor efficacy and safety of repotrectinib in combination with other anticancer therapies for the treatment of patients with locally advanced or metastatic KRAS-mutant solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 (or as required by local regulation).
* Histological or cytological confirmation of unresectable or metastatic solid tumor malignancy harboring a KRAS mutation.
* No more than 3 prior standard treatments appropriate for tumor type and stage of disease.
* ECOG performance status ≤ 1.
* Existence of measurable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria).
* Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
* Adequate organ function.

Exclusion Criteria:

* Major surgery within four weeks of the start of treatment.
* Previous other cancer requiring treatment within the previous two years.
* Clinically significant cardiovascular disease.
* Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
* Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
* Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
* Subjects being treated with or anticipating the need for treatment with strong CYP3A inhibitors or inducers.