cyrilzakka/clinical-trials huggingface dataset:
A Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma（PTCL）

This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory peripheral T-cell lymphoma who have received at least 1 lines of therapeutic schedules. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.


Eligibility Criteria:
Inclusion Criteria:

* 1. Understood and signed an informed consent form; 2. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, life expectancy ≥ 3 months; 3. Diagnosis of peripheral T-cell lymphoma (PTCL); 4. Has received at least one line systemic treatment and disease progression after the last treatment; 5. Has at least one measurable lesion; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.

Exclusion Criteria:

* 1. Other types of T-cell lymphoma; 2. Has central nervous system violation; 3. Has received other PI3K inhibitors or CAR-T treatments; 4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. Has type I diabetes or uncontrolled type II diabetes; 6. Has history of interstitial lung disease; 7. Has history of interstitial lung disease; 8. Has multiple factors affecting oral medication; 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received systemic steroid treatment within 7 days before the first dose; 11. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 12. Has active infections which need drug treatment; 13. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 14. Has a history of autologous hematopoietic stem cell transplant within 3 months; 15. Has a history of allogeneic hematopoietic stem cell transplant; 16. Grade II or higher cardiovascular disease within 6 months before the first administration; 17. QTCF \> 480ms, left ventricular ejection fraction (LVEF)\<50%; 18. Urinary protein ≥ 2 +, and 24-hour urinary protein quantity\>1g within 7 days; 19. Has active hepatitis B or C; 20. Has psychotropic substances abuse or a mental disorder; 21.Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery

Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Therefore, this study has been designed to assess the performance of a new score that includes pre-operative frailty, and per-operative ElectroEncephaloGram (EEG) in predicting post-operative delirium.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 75 yo or more undergoing a major non-cardiac surgery

Exclusion Criteria:

* Patients of less than 75 yo
* Cardiac surgery
* Minor surgery
* Opposition to the study protocol
* Presence of a delirium prior to the surgery
Pancreatic Adenocarcinoma Gene Environment Risk Study

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Some participants may also be asked to provide a urine sample. Individuals undergoing procedures that require collection of biological samples for clinical purposes may have these samples saved for research purposes. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed or CT confirmed diagnosis of pancreatic adenocarcinoma
* Subjects with abnormal imaging study (CT, MRI, MRCP, EUS)
* Control subjects with a clinical diagnosis of a pancreas, liver, or intestinal condition
* Control subject with acute pancreatitis
* Control subject with chronic pancreatitis
* Control subject with biliary obstruction
* Control subject with pancreatic cyst
* Member of a high risk family (≥ 1 close relative with pancreatic cancer)
* Healthy control (without any of the above conditions)

Exclusion Criteria:

* Under the age of 18 years
* Unable to give informed consent
* Inability to travel to Pittsburgh for in-person enrollment
Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole

The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent:

1. Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?
2. If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?
3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?

Hypoxic (low oxygen) cells have long been known to exist in animal tumors. It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen (normoxic cells). However, the extent to which hypoxic cells limit the curability of human tumors is uncertain. To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy, this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug, 18F-fluoromisonidazole (18F-FMISO), visualized with PET scanning. 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content.

Before beginning radiotherapy, a PET scan (series of pictures, 20 min. scan) will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug, 18F-fluoromisonidazole (18F-FMISO) to observe the active hypoxia tumors areas. Upon completion of the 18F-FMISO PET scan, direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic (CT) guidance. The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. The measurement obtained by 18F-FMISO PET scanning (non-invasive technique) and by direct needle measurements (invasive technique) will be correlated with the eventual treatment outcome for future use.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm
* Karnofsky performance status greater or equal to 60%

Exclusion Criteria:

* No prior irradiation or surgery to head/neck area
* No prior chemotherapy within 1 month of participation and have recovered from associated related effects
* Not pregnant
* Any intercurrent medical or physiologic disorder which would prevent informed consent
* Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy
* Patients with PT or PTT over 1.5 times normal
Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Protamine remains the anticoagulant of choice for cardiopulmonary bypass (CPB). The process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. The adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. The true mechanism reaction is difficult to defined and the complexity of the clinical situation The classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction.

The reaction from pharmacologic histamine release is the most common type of reaction. Protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells From the hypothesis that the systemic hypotension cause by the released of histamine. The investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. Comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given.

There for the hypothesis of this study is administrating of H1 and H2 blocker helps attenuate the drop in MAP after protamine is given.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3
* Schedule for open heart surgery

Exclusion Criteria:

* History of allergy to the study drugs or protamine
* History of previous cardiac surgery or received protamine
* History of diabetes with insulin therapy
First-in-human Study of VE303 in Healthy Adult Volunteers

This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.

VE303 is a rationally-defined bacterial consortium candidate being developed for the prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under GMP conditions.

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects who are judged to be in general good health
* Body mass index between 18.5 and 30 kg/m2
* Women either of non-child bearing potential or using a highly effective form of contraception
* Men using a highly effective method of contraception

Key Exclusion Criteria:

* Past or present clinically significant diseases that may affect the outcome of the study
* Taking any medications, herbal preparations, or natural substances, live bacteria products, or food that impacts or alter GI flora
* Use of proton pump inhibitors or other short or long acting antacid medications
* Taking or has received an investigation drug or treatment within 60 days of inpatient admission
* Known allergies to involved study drugs
* Chronic constipation or diarrhea
* History of or active IBD
A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.

Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In order to facilitate formulation of effective regional drug policies and to provide a database for decision-making on the implementation of combination therapy (CAT), it is essential that the in vivo response to CAT be investigated. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is a comprehensive evaluation of the phased introduction of combination anti-malarial therapy in Mozambique. As a component of this evaluation, in selected Mozambique sites where intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate plus SP) will be conducted according to this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, older than 12 months.
* Weight \> 10 kg.
* Diagnoses of pure uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than or equal to 37.5°C or history of fever (defined as within the previous 24 hours).
* Documented informed consent.
* Lives close enough to the study site for reliable follow up.

Exclusion Criteria:

* Has received anti-malarial treatment in the past 7 days.
* Is infected with other malarial species (such subjects may be excluded retrospectively from the analysis).
* Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated) or other danger signs.
* Has received cotrimoxazole, trimethoprim, chloramphenicol, folate or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
* History of G6PD deficiency.
* Is pregnant or breastfeeding.
* Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, other artemisinin derivatives e.g. co-artemether).
* Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
Prospective Validation of AKI Prediction

The purpose of this prospective observational study is to implement, deploy, and quantify accuracy of an existing Pediatric Early AKI Risk Score algorithm. The implementation will be facilitated using a Health Level 7 (HL7) Fast Healthcare Interoperability Resource (FHIR)-based architecture. Investigators will deploy this model and store results in a manner not viewable to the clinical team caring for the patient. To determine the accuracy of the implemented prediction model, Investigators will prospectively identify patients with AKI at 72 hours following ICU admission. Investigators hypothesize that this model will prospectively detect AKI with a sensitivity \>70% and a positive predictive value \>20%, both chosen a priori as 10% improvement over the initial Pediatric AKI Risk Score tool.

This is a single-center prospective observational study validating an AKI predictive model. Each model feature will be mapped to an appropriate FHIR-based resource. To mitigate the latency issues seen in other distributed CDS systems, Investigators have developed an asynchronous design where algorithm calculations are performed offline (e.g., not within the EHR) and risk scores are subsequently written back to the EHR. Importantly, in this deployment, model output and resulting clinical risk score will not be communicated to the treating clinicians.

During the study period, Investigators will review charts daily for all patients admitted to the Golisano Children's Hospital PICU, a 12-bed facility adjacent to our 15-bed Pediatric Cardiac Intensive Care Unit (PCICU). Using a standard protocol to screen and identify patients by chart review, Investigators will generate a list of patients who meet AKI KDIGO criteria by SCr and urine output, along with recorded clinical information about these patients. At the conclusion of the study period, this list will be used as the "gold standard" and compared to the automated screening tool to determine the tool's test characteristics.

Model assessment outcomes include sensitivity, positive predictive value (PPV), and number needed to alert (NNA) to prospectively identify AKI in a population of critically ill children. Additional outcomes include timeliness of identification based on model implementation (e.g., measured timestamps of algorithm prediction compared to manual, prospectively identified AKI development). Additionally, Investigators will report interventions and clinical outcomes of the prospectively identified patients with AKI, stratified by those predicted early by the model (within 24 hours of admission) versus not.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Pediatric Intensive Care Unit or Pediatric Cardiac Intensive Care Unit
* Age \> 30 days and \< 18 years

Exclusion Criteria:

* Discharged less than 12 hours after admission
* AKI at 12 hours of admission by KDIGO Serum Criteria
The Therapeutic Effect of Different Exercise Intensities on Weight Loss in Obese Children

The incidence of childhood obesity is increasing, followed by metabolic diseases related to overweight and obesity in children. High intensity interval training (HIIT) has recently been shown to improve the body composition and cardiovascular health of obese children. Currently, there is little evidence on the impact of exercise intensity on endocrine and metabolic indicators and quality of life in obese children.

The main purpose of this study is to compare the effects of short-term supervised high-intensity interval training and moderate intensity continuous training (MICT) on metabolic indicators in obese children under an energy limited balanced diet. A multicenter prospective randomized controlled trial was conducted on 388 obese children in South China. The experimental group will be randomly assigned to (1) HIIT and energy limited balanced diet, and (2) MICT and energy limited balanced diet. The experimental group will participate in a 3-month (supervised) exercise training. The measurement of the study endpoint will be followed up at baseline, 3 months (after supervised intervention), 9 months, and 1 year. The primary endpoint is the percentage of weight loss (△ Wt%). Secondary endpoints include waist to height ratio, body mass index (BMI), body fat percentage, insulin resistance index (HOMA-IR), insulin secretion index (ISI), and Δ HtSDSBA. The results of this study will generate a wealth of information on the impact of exercise intensity on weight loss and endocrine metabolism in obese children, and develop more effective evidence-based exercise prescription guidelines in this population.


Eligibility Criteria:
Inclusion Criteria:

1. The guardian understands and signs the informed consent. If the subject is at least 8 years old, the informed consent must be signed.
2. Age 6\~16 years old, male and female;
3. BMI≥ \&#34;sex-age BMI reference point for obesity screening of school-age children aged 6-18 years\&#34;;
4. no disability;
5. Joint cardiopulmonary function assessment showed that participation was safe;
6. At least one year of follow-up is expected.

Exclusion Criteria:

1. Have high blood pressure (defined as systolic or diastolic blood pressure values above the 95th percentile), any history or evidence of heart disease and/or abnormal resting or stress echocardiography or a combined cardiopulmonary function assessment indicating that participation is not safe;
2. have any chronic disease, such as chronic asthma, kidney disease, type 1 diabetes, epilepsy, etc.;
3. suffering from organic diseases, such as ovarian tumors, hamartoma, etc.;
4. A smoking habit or orthopedic/neurological condition that may limit exercise ability;
5. Confirmed attention deficit hyperactivity disorder and steroid use.
Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery

The goal of this interventional study is to learn if carbohydrates loading improves overall outcome in adolescent patient undergoing scoliosis curgery

The main questions of the study are as follows:

1. Does carbohydrates loading improves gastrointestinal related problems such as improvement in return of bowel function measured by first passage of flatus, reduce constipation by patient's time to first bowel opening and reduce incidence of post post operative nausea and vommiting
2. Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger
3. Does carbohydrates loading affects gastric residual volume by measuring residual gastric volume with ultrasound


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior spinal fusion
* Age between 10 to 19 years old
* ASA 1 \& 2

Exclusion Criteria:

* Patient diagnosed with diabetes mellitus (either type I or type II)
* Patient with intellectual disability
* American Society of Anesthesiologists (ASA) class 3 and above
* Significant risk of aspiration (diagnosed with hiatal hernia, presence of GERD, BMI \> 35 kg/m2 , poor GCS, swallowing abnormality, gastrointestinal abnormality)
Educational and Cultural Engagement and Incidence of Health Adverse Events

This study evaluated if the social and cultural activities decrease the incidence of dementia and frailty conditions.

The past decade has been characterized by the involvement of Museums in individual health prevention and promotion by using art-based activities to improve quality of life and well-being. Visiting museum or over cultural and educational activity could be used for health prevention and promotion. For the development of appropriate educational and cultural activities, there is a need, first, to improve knowledge about social and health condition of older adult, and second to examine the effects of engagement in educational and social activity on incidence of health adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Being 50 years and over
* Being enrolled in the Canadian Longitudinal Study on Aging
* Actively involved in social and cultural activities

Exclusion Criteria:

* Never enrolled in the Canadian Longitudinal Study on Aging
* Less than 50 years old
Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force

Emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. These field expedient tests have not been validated in a military setting or across different military occupational specialties. In this prospective study the investigators plan to screen 300 combatants for a 1-year time frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable risk factors which are hypothesized to predict injury risk during the military service.

Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations. Moreover, these results will assist in creating individualized preventing physical training program.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-21 years old
* A combat medical profile according the IDF Medical Corp regulations
* Hebrew speaking and reading.

Exclusion Criteria:

* Currently seeking medical care for musculoskeletal injuries or has sought medical care for musculoskeletal injury in the last 30 days.
* Currently unable to participate in routine physical training due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
* Cardiac or pulmonary problems limiting physical activity.
* Known history of balance or visual impairment, neurological disorders, or chronic musculoskeletal conditions precluding their involvement in military training, physical training, or sports.
* Pregnancy, subjects that become pregnant during the course of the study will be excluded based on the different injury risk factors that are associated with musculoskeletal injury during pregnancy.