cyrilzakka/clinical-trials huggingface dataset:
A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer

The study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. The patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven metastatic, advanced, or locally recurrent fluorouracil (5-FU) and oxaliplatin refractory adenocarcinoma of the colon or rectum; Progression of disease within 6 months of receiving adjuvant 5-FU and oxaliplatin chemotherapy OR Progression of disease during or following completion of 5-FU and oxaliplatin chemotherapy for metastatic disease
* Evaluable lesions with indications of radiotherapy
* No other metastatic lesions in the radiation field
* Karnofsky Performance Status\>=70
* UGT1A1\*28 6/6 or 6/7
* Subject blood routine and biochemical indicators meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L
* Able to follow the protocol during the study period
* Sign the inform consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
* Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
* Organ transplantation requires immunosuppressive therapy
* Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
* Anyone who is allergic to any research medication
Discovery of Sirolimus Sensitive Biomarkers in Blood

Background:

Lymphangioleiomyomatosis (LAM) is a rare, progressive disease. It usually affects women in the prime of their lives. It typically results in lung destruction. Studies have shown that a drug called sirolimus stabilizes lung function in people with LAM. But researchers do not know what drug dose and blood serum levels are needed to reach this stability. Researchers want to learn more about the right dose of sirolimus for people with LAM.

Objective:

To determine if blood and urine markers after 1 dose and again after 9 months can be used to evaluate the correct dose of sirolimus for people with LAM.

Eligibility:

Women ages 18-90 with LAM whose doctors have decided they should start taking sirolimus to treat it.

Design:

At visit 1, participants will take their first dose of sirolimus by mouth at the clinic. They will have blood and urine collected.

Participants will take 1 tablet of the study drug each day.

Visit 2 will be 3 months after visit 1. Participants will have blood and urine collected.

Visit 3 will be 9 months after visit 1. Participants will have blood and urine collected.

Participant samples will be stored in a secure place. No personal data will be connected to them.

Sirolimus (rapamycin), which acts as a targeted inhibitor of the protein mechanistic target of rapamycin (mTOR), has been shown to be effective in patients with lymphangioleiomyomatosis (LAM). It stabilizes lung function, resolves chylous effusions and lymphangioleiomas and shrinks angiomyolipomas. The current study is to understand better the short-term action of the drug by following the effects on potential biomarkers in blood and urine. Patients with LAM will have samples taken prior to administration of first dose of the drug, at 1 hr and then at 23 hours after the drug (trough level). At 3 and 9 months, samples will be obtained at trough and 1 hour after the dose. Molecular and cellular analyses will be performed to look for potential biomarkers.

Eligibility Criteria:
* INCLUSION CRITERIA
* Female 18 to 90 years of age
* Diagnosis of LAM
* Initiation of sirolimus therapy (2mg daily) based on standard-of-care pulmonary indications and the advice of the patient s local physician

EXCLUSION CRITERIA

* Unable to travel to the NIH
* Unable to provide informed consent
* Advanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures
* Women who are pregnant or lactating
AI Chatbot for Migraine Management in Hong Kong Women

The goal of this randomized crossover trial is to examine whether the AI-empowered chatbot will effectively collect comprehensive migraine feature data and demonstrate higher compliance, accuracy, utilization, acceptability, feasibility, and validity in migraine feature tracking compared to traditional paper-based migraine diaries among Hong Kong women with migraine.

Participants will use different tools (AI-empowered voice-interactive chatbot or paper migraine diary) for migraine tracking. Participants will be randomly allocated to one of two intervention sequences: (1) AI-empowered voice-interactive chatbot followed by paper migraine diary, or (2) paper migraine diary followed by AI-empowered voice-interactive chatbot. The study will consist of two intervention periods, each lasting one month, with a 1:1 allocation ratio.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older
* Meet diagnostic criteria for migraine according to ICHD-3
* Experiencing at least 2 headache days per month
* Living in Hong Kong
* Fluent in Cantonese
* Owning a smartphone with internet access
* Willing to provide informed consent

Exclusion Criteria:

* Individuals with severe cognitive impairments or communication difficulties
* Those unable to use a smartphone or the chatbot due to physical or mental limitations
* Using another alternative electronic migraine diary during recruitment or in the past 12 weeks
Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts which stimulate bone formation by the processes of osteoinduction and osteoconduction.

Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti oxidant properties.

Very few studies exist evaluating the beneficiary effects of grafts if combined with the statins which might enhance the regeneration by bone grafts.

Hence, the present study was carried out in an attempt to comparatively evaluate clinically and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the treatment of intrabony defects.

A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by radiographs, were selected for the study after taking an informed consent. The selected sites were randomized in 2 treatment groups.

Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with allograft (DFDBA) in combination with Atorvastatin gel.

Clinical parameters like probing depth and clinical attachment level and radiological assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy individual based on personal and medical history.
2. Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss.

Exclusion Criteria:

1. Patients diagnosed and treated for systemic disease
2. Pregnant and Lactating women
3. Smokers
4. History of allergy to statin group or patients on systemic statin therapy.
5. History of antibiotic or periodontal therapy for the past 6 months.
Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)

BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (\<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of hypertension.
* An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator).

  * 1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).
* Suboptimal adherence (self-report).

Exclusion Criteria:

* Incarcerated
* Pregnant
* Unable to use study software (Way To Health) in English or Spanish
* Unable/unwilling to consent
* Clear barrier to technology use (e.g. visual or hearing impairment)
* Projected life expectancy \<12 months
TYK2 Inhibition in Paradoxical Psoriasis

Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.

This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with Investigator Global Assessment ≥ 2 and Body Surface Area ≥ 2%
2. Females who are of child-bearing potential should be practicing highly-effective contraception methods throughout the study and for 28 days after the last dose of study drug;
3. Male subjects with a mechanical contraceptive method;
4. be in good health
5. be willing to have skin biopsies taken

Exclusion Criteria:

1. Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs to be respected
2. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit;
3. A positive serology test for hepatitis B, hepatitis C, HIV;
4. History of lymphoproliferative disease or of malignancy within the past 5 years.
5. Chronic recurring bacterial infections or active tuberculosis;
6. Positive pregnancy test at Screening and at the Baseline visit;
7. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
8. History of clinically significant alcohol or drug abuse in the last 12 months
9. Known hypersensitivity to Deucravacitinib or any of its excipients
10. Current severe progressive or uncontrolled disease
11. Live vaccine within 12 weeks before Baseline Visit.
Health Effects of CLA Versus Industrial Trans Fatty Acids

The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.

The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.

It will be a double-blind randomized multiple cross-over trial with 3 treatments:

* CLA;
* Industrial trans fatty acids (as a positive control);
* Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.

Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* healthy

Exclusion Criteria:

* serum total cholesterol \>= 6,5 mmol/L
* serum triglycerides \> 2,3 mmol/L
* chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
* use of cholesterol lowering medication
* use of blood pressure lowering medication
* high alcohol intake
* BMI \> 30
* pregnant and lactation women
* unusual dietary requirements
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be of Japanese descent (both biological parents are ethnically Japanese).
* In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
* Women should be of non-childbearing potential.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
* Any major surgery within 90 days of study drug administration.

Other protocol-defined inclusion/exclusion criteria apply.
Vocal Demands Among Classroom Teachers

The purpose of the study "A comparison of vocal demands with vocal performance among classroom teachers" is to gather information about the voice production of teachers using three separate strategies: (a) measures of voice assessed with the Computerized Speech Lab (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab.

(a) measures of voice assessed with the Computerized Speech Lab (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in teaching education programs; active teachers.

Exclusion Criteria:

* Current diagnosed with voice disorder.
A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 infection is confirmed on antigen test or PCR test
* Pulmonary infiltrative shadow is confirmed on chest X-ray test
* PaO2/FiO2 \<=200mmHg at the time of screening

Exclusion Criteria:

* Continue treatment for Pneumonia before SARS-CoV-2 infection
* SOFA score \>= 15
* Infection type on DIC diagnosis criteria \>= 4
* Deep Venous Thrombosis
Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer

RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer.

OBJECTIVES:

* To determine the association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) in women with newly diagnosed breast cancer that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development.

OUTLINE: Urine and blood samples are collected for DNA, mutation, and polymorphism analysis. The biological samples may be stored and used for future research.

Patients complete a Baseline Questionnaire to collect basic risk/exposure information, including demographic factors (e.g., age, weight, height, and body mass index), menstrual/reproductive history, medical history, medication use, smoking history, alcohol consumption, exposure to chest x-ray, and family history of breast cancer in first-degree relatives. Patients also complete a Second Hand Smoke Questionnaire to collect information on cigarette smoking history and second hand smoke exposure and a Food Frequency Questionnaire to collect information on the frequency of use of specific fruits and vegetables (e.g., cruciferous vegetables) and to estimate usual dietary intake of 33 nutrients during the past year (e.g., total fat, saturated fat, oleic fat, linoleic fat, carbohydrates, protein, vitamins \[e.g., A, B1, B2, niacin, B6, folate, C, and E\], minerals \[e.g., calcium, magnesium, iron, and zinc\], electrolytes \[e.g., sodium and potassium\], and dietary fiber). Patients' medical charts are also reviewed to collect information on age, gender, ethnic background, medical history, and medical care.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer
* Planning to undergo a diagnostic biopsy or surgery
* Must have tumor tissue available
* Hormone receptor status not specified
* More than 6 months since prior chemotherapy or radiotherapy
* Pre- or post-menopausal

Exclusion Criteria:

-Psychiatric history that would preclude giving informed consent
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)

This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.

Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Biopsy proven IgAN
3. Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
4. eGFR ≥ 45 mL/min per 1.73 m2 or eGFR \< 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing \< 50% tubulointerstitial fibrosis
5. Agree to comply with contraception requirements during and for 90 days after study completion.

Exclusion Criteria:

1. Any secondary IgAN as defined by the investigator
2. Patients who have undergone a kidney transplant
3. Any history of kidney disease other than IgAN
4. Any history of diabetes (Type 1 or Type 2)
5. Seated blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
6. Pregnancy or breastfeeding.
A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis.

The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 into the knee of subjects with mild to moderate knee osteoarthritis (OA).

Approximately 6 to 18 subjects will be enrolled into 3 successive dose-escalating groups in a 3+3 study design, whereby 3 study subjects in each group will be dosed sequentially with ICM-203 and 3 additional subjects will be dosed at the same dose level if a dose limiting toxicity (DLT) occurs in any of the first 3 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening.
2. Kellgren-Lawrence grade 2 or grade 3 OA of target knee.
3. Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable), at the time of screening.
4. KOOS function in daily living score \>25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems), at the time of screening .
5. A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening.

Exclusion Criteria:

1. History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee.
2. Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1.
3. Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening.
4. Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk.
5. Surgery on the target knee within 180 days prior to day 1.
6. Total knee arthroplasty or other knee surgery planned in the next 12 months.
7. Active joint infection or other concurrent medical or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.