cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older, no gender limitation;
2. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
3. Expected survival of ≥ 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. At least one measurable lesion outside the stomach (RECIST 1.1);
6. Patients informed about the purpose and course of the study and provided a written consent to participate.

Exclusion Criteria:

1. Use of taurine agent within 1 month prior to randomization on this study;
2. Patients received prior systemic therapy for gastric cancer;
3. Patients with operable gastric cancer;
4. Patients with positive HER-2 and willing to receive herceptin treatment;
5. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
6. Patients with active autoimmune disease that has required systemic treatment in past 2 years;
7. Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
8. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
9. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
10. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.
Study of Epratuzumab in Systemic Lupus Erythematosus

The purpose of the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.


Eligibility Criteria:
Inclusion Criteria:

* Has SLE by ACR revised criteria (meets \<4 criteria);
* Has SLE with at least one elevated lupus antibody;
* Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

Exclusion Criteria:

* Active severe CNS or Renal disease defined by BILAG as Level A
* Allergy to murine or human antibodies
* Antiphospholid antibodies AND a history of thrombocytopenic events
Digital Sleep Program for College Students with Insomnia

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.

This is a parallel-group, randomized controlled trial (RCT). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled.

Eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (N = 45) and a waitlist control group (N = 45).

The primary outcome is insomnia severity, assessed using the Insomnia Severity Index (ISI). The secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the Epworth Sleepiness Scale (ESS), a wearable sleep tracker, the Ford Insomnia Response to Stress Test (FIRST), the Brief Resilience Scale (BRS), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Index II (BDI-II), respectively. Additionally, chronotype will be assessed using the Morningness-Eveningness Questionnaire (MEQ) as a moderating role to be tested in this study. All outcomes will be measured at three time points: T0 (baseline assessment), T1 (immediately after the 4-week intervention period), and T2 (4 weeks after the intervention period).

Eligibility Criteria:
Inclusion Criteria:

1. Registered as a full-time student
2. Aged 18 to 26 years old
3. Experiencing insomnia for at least three months
4. Currently own and use a personal mobile device
5. Ability to read and speak Chinese
6. Not taking hypnotics, sedatives, or antidepressants
7. Not pregnant or lactating

Exclusion Criteria:

1. Using a smartphone model that cannot support the app
2. Currently using other sleep program apps
3. Meeting a STOP-BANG score of ≥3
A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients

The purpose of this study is to evaluate the safety and tolerability of paliperidone palmitate over a 9-week period for participants with schizophrenia in Korea.

This is an open-label (all people know the identity of the intervention), multi-center, prospective (look forward using observations collected following participant enrollment), non-comparative, non-randomized (the study medication is not assigned by chance), study. Safety and efficacy of paliperidone palmitate will be observed in Korean schizophrenic participants for 25 weeks. Approximately 3000 participants will be observed in this study and the study duration will be 25 weeks. Safety evaluations will include assessment of adverse events, concomitant medications, physical examination, and psychiatric history.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with schizophrenia
* Participants prescribed with paliperidone palmitate for acute or maintenance treatment

Exclusion Criteria:

* Participants who received paliperidone palmitate for other than the approved indication
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration \[FDA\] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a documented fibroblast growth factor receptor (FGFR) alteration
* Participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment)
* Life expectancy is greater than (\>) 3 months (determined by treating physician's assessment)
* Participant has exhausted treatment options for their disease (review of prior treatments)
* Participant is not eligible for other erdafitinib clinical trials including but not limited to BLC3001/NCT03390504 and BLC2002/NCT03473743
A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening

The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.

The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.

In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
* 2. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
* 3. Fully informed and agreed to participate in the study.
* 4. No history of cervical cancer disease and cancer in other parts.

Exclusion Criteria:

* 1. Cannot meet all Inclusion Criteria.
* 2. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
* 3. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
Ecg & Echo Changes in Children With DKA

Diabetic ketoacidosis (DKA) is an important complication of childhood diabetes mellitus and the most frequent diabetes-related cause of death in children.

Diabetic ketoacidosis (DKA) is caused by a decrease in effective circulating insulin associated with increases in counter regulatory hormones including glucagon, catecholamines, cortisol, and growth hormone. This leads to increased glucose production by the liver and kidney and impaired peripheral glucose utilisation with resultant hyperglycaemia, and hyperosmolality. Increased lipolysis, with ketone body (beta-hydroxybutyrate, acetoacetate) production causes ketonaemia and metabolic acidosis. Hyperglycaemia and acidosis result in osmotic diuresis, dehydration, and obligate loss of electrolytes.

DKA can affect cardiovascular function through several mechanisms. The effect of acidosis on the heart depends upon the pH level. In mild acidosis, there is increased catecholamine release which is compensated by increased inotropy, chronotropy, cardiac output and peripheral vascular resistance. When acidosis is severe, i.e. pH is less than 7.2, the H+ ions have a direct cardiac depressant action.

Fluid and electrolyte imbalance is very common in DKA, Potassium deficit is one of the most important of electrolyte imbalances seen in DKA as it can lead to fatal arrhythmias. The most common and perhaps the earliest ECG finding in hypokalemia is a prominent U wave, usually evident in leads II and III. The most common cardiac arrhythmias are atrial premature contractions, atrial tachycardia with or without atrioventricular block, supraventricular and ventricular premature contractions.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged : 1 month -18years with diabetic ketoacidosis

Exclusion Criteria:

* Pediatric Patients who have associated cardiovascular disease. ( congenital or rheumatic).
* Pediatric patients with hyperglycemic hyperosmolar state.
* Pediatric patients with other causes of metabolic acidosis.
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors

The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-11 years old
* BMI for age and gender \> 10th percentile (but no greater than 100% overweight)
* Sleep 9.5 hours or less nightly
* Attend elementary school
* Like at least 1 food used in the reinforcement paradigm
* Able to understand and complete the reinforcement paradigm

Exclusion Criteria:

* Existence of a diagnosable parasomnia, sleep disordered breathing
* Medical or psychiatric condition that could influence sleep or weight
* Inability to complete study materials, including diagnosed disabilities
* Dietary restrictions/allergies to foods used in the study that preclude them from study participation
Metformin to Reduce Heart Failure After Myocardial Infarction

The investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following ST-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.

In this trial, the investigators will evaluate the effect of metformin therapy following ST-elevation myocardial infarction (STEMI) in a total of 380 non-diabetic patients. This trial is a randomized, double blind, controlled trial. The intervention, which consist of metformin 500mg twice daily or placebo twice daily, will commence within three hours after the percutaneous coronary intervention, and will be continued for 4 months. The primary endpoint is the difference between the two intervention groups (metformin vs placebo) in left ventricular ejection fraction, as measured with magnetic resonance imaging after 4 months. The investigators hypothesize that metformin therapy results in a significantly higher ejection fraction in this population.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads.
* Successful primary PCI (post-procedural TIMI 2/3);
* At least one stent sized ≥ 3.0 mm;
* Eligible for 3T CMR imaging;
* Verbal followed by written informed consent.

Exclusion Criteria:

* rescue PCI after thrombolytic therapy;
* need for emergency coronary artery bypass grafting;
* creatinin \>177 μmol/L measured pre-PCI;
* Younger than 18 years;
* Mechanical ventilation;
* Diabetes;
* Prior myocardial infarction;
* Contra-indication to metformin (see safety);
* The existence of a life-threatening disease with a life-expectancy of less than 6 months.
A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial

This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.

OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.

ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
* Age 18 and older
* Smoking combustible cigarettes daily in the past year
* Interest in quitting smoking
* Interest in learning skills to quit smoking
* Willing to be randomly assigned
* Have daily access to their own Android or iPhone smartphone
* Ability to download a smartphone app
* Ability to read English
* Not currently (i.e., within past 30 days) using other smoking cessation interventions
* No prior participation in our studies
* No prior use of SFT
* No household or family member participating
* US residency for the next twelve months
* Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
* Providing email, phone number(s), and mailing address

Exclusion Criteria:

* The reverse of the inclusion criteria
* Pregnant or breastfeeding
* Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability
Characterization of Methylation Patterns in Hepatocellular Carcinoma

This study is being performed as part of the development process of the Liver EpiCheck test which includes the identification of different methylation profiles in HCC (hepatocellular carcinoma) patients compare to cancer free control in blood samples

This is a prospective, multi-center, observational study aimed to collect blood samples and de-identified clinical data from subjects diagnosed with HCC (cases arm) and subjects with high risk for HCC which are undergoing routine surveillance for HCC.

Eligibility Criteria:
Inclusion Criteria - Case Group:

* Age ≥ 22 years
* Subjects who are willing and able to provide written informed consent
* Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy

Exclusion Criteria - Case Group:

* Subjects with current cancer of any kind, other than hepatocellular carcinoma
* Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected
* Coinfection with HIV
* Prior solid organ transplant

Inclusion Criteria - Control Group:

* Age ≥ 22 years
* Subjects who are willing and able to provide written informed consent
* Subjects diagnosed with one of the following:

  i. Subjects with HCV and cirrhosis ii. Subjects with HBV and cirrhosis iii. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL Clinical Practice Guidelines for the management of hepatocellular carcinoma iv. Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD) with cirrhosis. v. Cirrhotic patients due to any other reasons, including alcohol disease
* Subjects currently undergoing surveillance for hepatocellular carcinoma
* HCC surveillance imaging (e.g., US, CT, MRI) performed within 3 months prior to baseline visit
* Subjects with compensated liver function as measured by Child-Pugh Score A or B7 without ascites (all measures should be from the last three months)

Exclusion Criteria - Control Group:

* Subjects with current cancer of any kind, other than hepatocellular carcinoma
* Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected
* Coinfection with HIV
* Prior solid organ transplant
* Current substance abuse
A Study of Minirin Melt in Patients With Nocturia

This is a confirmation of safety profile for Minirin Melt in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from Nocturia

Exclusion Criteria:

* habitual or psychogenic polydipsia
* known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics
* moderate and severe renal insufficiency
* know hyponatremia
* syndrome of inappropriate ADH secretion
Mind Body Intervention for Long COVID-19

The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 years of age)
2. Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing)
3. Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc)
4. A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains
5. Symptoms present at least 3 day a week for a minimum of 3 months
6. Willingness to engage in a Mind-Body intervention

Exclusion Criteria:

1. Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis
2. Hospitalization in an intensive care unit for acute COVID-19 infections
3. Age greater than 65 years
4. Diagnosis of dementia or similar cognitive impairment
5. Active addiction disorder (e.g. cocaine) that would interfere with study participation
6. Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category