cyrilzakka/clinical-trials huggingface dataset:
Newly-diagnosed Pediatric T-cell ALL Protocol

This is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).

The CCCG-T-ALL-2025 protocol will be modified as following based on the above analysis of the CCCG-ALL-2020 protocol.

1. All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy.
2. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy.
3. non-ETP T-ALL patients with MRD ≥ 0.01% on day 46 will be stratified and randomized to receive different doses of homoharringtonine during early intensification.
4. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in induction therapy.
5. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in interim therapy 2 and 4.
6. CAT will replace CAT+ during early intensification, and will be administrated to all ETP/near-ETP patients, as well as non-ETP patients with MRD\< 0.01% on day 46.

2.11.7 In maintenance therapy 2, the CTX+Ara-C treatment cycles are reduced to 5, in order to minimize the impact of alkylating agents on fertility.

2.11.8 Add drug sensitivity testing for T-ALL.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 1 month to younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of T-ALL by immunophenotyping.

Exclusion Criteria:

1. B-ALL
2. AML
3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
4. ALL evolved from chronic myeloid leukemia (CML).
5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
6. Secondary leukemia
7. Known underlying congenital immunodeficiency or metabolic disease
8. Congenital heart disease with cardiac insufficiency.
9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)
10. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.
11. Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.
Screening Protocol for Research Participants

The Screening Protocol is a system devised to evaluate potential research participants for National Institute on Drug Abuse/Maryland Psychiatric Research Center (NIDA/MPRC) studies.

The MPRC/NIDA collaborative research program attempts to: elucidate the nature of serious mental illnesses, drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse on the development, maturation, function, and structure of the brain and other organ systems. In support of this work, the scientific goal of this screening protocol is to assess potential research participants' eligibility for research studies. Screening will include medical and psychological tests and procedures. The data collected during screening are a unique and valuable source of information that aids in the research mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting NIDA about research participation and to analyze data so obtained, such as that on the prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases and issues of selection and sample bias in clinical research.

The screening process will be done in two stages, a telephone interview and an in-person evaluation. The telephone interview will last approximately 20 minutes and be conducted solely via the NIDA call center. Answers provided during the phone interview will indicate whether a caller is eligible for in-person screening. Those who appear eligible will be given an appointment at either NIDA or MPRC. This protocol pertains only to the in-person participants at MPRC. Written informed consent will be obtained when the person arrives. The screening process can involve up to 5 visits to MPRC.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Ability to read and understand and answer questions posed.

Exclusion Criteria:

* Inability to provide valid informed consent
* Below Age 18, and above age 64.
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.


Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
* Participant is aged ≥ 60 days to ≤ 75 days.
* Participant without preventive inoculation of polio vaccine and previous history of Polio.
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
* Body temperature ≤ 37.5℃.

Exclusion Criteria:

* Known allergy to any constituent of the vaccine.
* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
* Known bleeding disorder.
* Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
* Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial.
* Participation in any other intervention clinical trial.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors

This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced and/or metastatic histologically solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting, and in expansion part, no more than two prior systemic therapies.
2. At least 18 years of age.
3. ECOG performance status of ≤1.
4. Adequate organ function

Exclusion Criteria:

1. For patients with Non Small Cell Lung Cancer (NSCLC):

   a. Known actionable mutation or rearrangement (including but not limited to the epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations or BRAF mutations)
2. For patient with Hepatocellular carcinoma (HCC):

   1. Hepatic encephalopathy in the past 12 months.
   2. Ascites that requires repeated paracentesis in the past 2 months.
   3. Main portal vein thrombosis.
   4. Active or prior history of gastrointestinal bleeding in the past 12 months.
   5. Prior hepatic transplantation.
3. Patients with known spinal cord compression.
4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Post-marketing Surveillance of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
* Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® metered dose inhaler
Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functions

There will be a long term effects of action observation therapy and mirror therapy on upper limb functional outcomes after subacute stroke.

However, no study is conducted to check the retention rate of both therapies. My study will check the retention rate of these interventions in stroke. If we are able to know long lasting effects of this particular regime, we can incorporate this cost-effective intervention into our clinical setups for stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* 1 to 6 months since unilateral stroke onset
* Age between 40 and 70 years.
* Baseline score of the FMA motor score between 20 and 40
* Ability to follow the study instructions according to Montreal cognitive scale and score should be \>24.

Exclusion Criteria:

* Patients with depression who will be unable to cooperate during treatment and Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
* Visual and auditory abnormalities
* Major medical problems or comorbidities that influenced the usage of the upper limbs or caused severe pain.
Pharmacokinetic Study of Levosulpiride

The aim of this study was to characterise the pharmacokinetic properties and assess the safety of different formulations of levosulpiride in healthy Chinese volunteers.

Levosulpiride was administered to 42 healthy male and female (1:1) subjects as tablet (orally) and injection (intramuscularly and intravenously) formulations. Blood samples were collected at regular intervals after single and multiple drug administration. The concentration of levosulpiride in plasma was determined using a validated high performance liquid chromatography-tandem mass spectrometry method. Non-compartmental analysis was performed to estimate pharmacokinetic parameters. The analysis of variance was used to test for linearity and assess the effect of gender on the pharmacokinetic properties of the study drug. Adverse effects were monitored using investigators' questionnaires and subjects' spontaneous reports, vital sign measurements, hematology, clinical chemistry, and electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* body mass index between19 and 24 kg/m2
* negative for HIV and hepatitis B
* had no clinical important findings on health tests
* thorax radiography and ECG with no abnormalities
* normal blood pressure values
* heart rate

Exclusion Criteria:

* any drug treatment within 2 weeks before starting the study
* participation in another clinical study within the previous 3 months
* alcoholism and smoking
* pregnancy
* breast-feeding
* hypocalcemia
* blood donation or participation in other clinical trials within 3 months before enrollment in the study
* sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
* A ventricular rate \<60 beats/min or \>100 beats/min at rest
A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery

To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* ≥ 75 years old.
* Comply with the indication of non-cardiac surgery under general anesthesia.
* Anesthesia grade of American Society of Anesthesiologist (ASA) as III\~IV grade.
* The estimated operation time ≥ 2 hours.
* Voluntarily sign the informed consent form.

Exclusion Criteria:

* Patients with impaired renal function (Cr is 1.5 times higher than the upper limit of the normal value of the central laboratory) or abnormal liver function (Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) are 2 times higher than the upper limit of the normal value of the central laboratory).
* Patients who are positive for infectious diseases.
* Patients accompanied with central nervous system injury.
* Patients with previous history of delirium and epilepsy, long-term use of psychoactive drugs or preoperative assessment of delirium.
* Patients who involved diseases with drug taboos, bronchial asthma, mechanical intestinal obstruction and urinary tract obstruction, or serious systemic diseases, especially circulatory diseases: such as myocardial infarction, heart failure, angina pectoris, history of sinus bradycardia.
* Patients who are known to be allergic to narcotic drugs or Huperzine A Injection, or must use drugs that are not compatible with Huperzine An Injection.
* patients who participated in other clinical trials within 3 months before this study, for any reason, who could not tolerate the test or cooperate with the examination, or who has any aphasia, audio-visual dysfunction, etc.
* the investigators think that the patients is not suitable to participate in this study.
Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking

The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions.

Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).

The investigators want to show that the short term autonomic nervous system (ANS) response, after a nociceptive action in the new-born in maternity depends on whether it is preceded by non-nutritive sucking and / or sucrose administration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Newborn in maternity unit of the Saint-Etienne University Hospital (France), to receive venipuncture for blood tests or neonatal screening test
* Establishing consent form signed by the holder of parental authority

Exclusion Criteria:

* Children suffering from a disease affecting the central nervous system.
* Children treated with paracetamol oral solution (if cephalohematoma for example) or other analgesics (nalbuphine) or sedative, at the time of registration.
* Newborns impregnated with a prepartum maternal analgesia.
Deep Learning for Preoperative Pulmonary Assessment in Thoracic CT

The trial was designed as a single-centre, non-interventional prospective observational study to utilize deep learning technology combined with computed tomography (CT) images to precisely predict the pulmonary function indicators of thoracic surgery preoperative patients.

Preoperative pulmonary function tests are crucial in assessing perioperative complications or mortality risks and providing decision support for thoracic surgery. However, traditional pulmonary function assessment methods have significant limitations, including long testing durations, difficulties in patient cooperation, high false-negative rates, and numerous contraindications. Thus, our study optimized the final model based on 1500 single inspiratory phase CTs by transferring model parameters trained on 500 dual-phase respiratory CTs, enhancing its predictive capabilities for pulmonary function. This adjustment suits real-world application demands, offering more convenient, comprehensive, and personalized preoperative pulmonary function assessment support. Our study optimized the final model based on 1500 single inspiratory phase CTs by transferring model parameters trained on 500 dual-phase respiratory CTs, enhancing its predictive capabilities for pulmonary function. This adjustment suits real-world application demands, offering more convenient, comprehensive, and personalized preoperative pulmonary function assessment support.

Eligibility Criteria:
Inclusion Criteria:

* (1) Signing of the informed consent form;
* (2) Male or female, aged 18-75 years;
* (3) Undergoing elective thoracic surgery;
* (4) Good preoperative pulmonary function cooperation and complete reporting;
* (5) Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
* (6) The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion Criteria:

* (1) Poor preoperative pulmonary function cooperation or missing reports;
* (2) Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
* (3) The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
* (4) Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
* (5) Coexisting with other severe functional impairments;
* (6) Patients with obstructive lesions such as airway or esophageal stenosis;
* (7) Height beyond the predicted equation range (Female \< 1.45m; Male \< 1.55m);
* (8) Medication use before pulmonary function testing that does not meet the cessation guidelines;
* (9) Pulmonary function report quality graded D-F.
Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients

This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

The testing will be conducted in three periods. In the Accuracy Tests (periods

1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being compared with the Patient Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.

The primary hypotheses for HR, are as follows:

Adults HO: μ = 3.25 vs. HA: μ \< 3.25

The primary hypotheses for RR, are as follows:

Adults HO: μ = 2.25 vs. HA: μ \< 2.25 where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contract-free devices will be performed on the recorded results via statistical analysis. The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion in or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years old and above.
2. Provide written informed consent.
3. Weight ranging from 20 to 150 kg inclusive.
4. Are located in a non-ICU hospital setting.
5. Agree to not eat during the testing period.
6. Agree to keep still.

Exclusion Criteria:

1. Are connected to a device which may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. Sleep apnea.
4. Pregnant or breastfeeding.
5. A likely need to receive or undergo a procedure during the testing period.
6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
7. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
8. Are wearing pacemaker or defibrillator.
A Mobile Health Intervention to Increase Uptake of Prenatal Care in Syrian Refugee Population in Turkey

The purpose of this study is to assess the effectiveness of mobile phone based appointment reminder notifications sent through Health Recording App (HERA) in increasing the uptake of 4 World Health Organization recommended prenatal visits among Syrian refugee population.

Background: 12 million Syrians have been forcibly displaced from their homes since the start of Syrian Civil War in 2011. Despite Turkey providing free healthcare services through national insurance to nearly 4 million refugees that it hosts, pregnant Syrian women are less likely to attend prenatal visits and more likely to die during and after labor. An increase in the uptake of prenatal care may improve quality of life through healthy pregnancies and safer labor conditions in this population with double vulnerability.

Mobile phone-based reminders have been shown in randomized controlled trials and systematic reviews to increase the uptake of various services, including prenatal care. Mobile phone penetration is high among Syrian refugees in Turkey and qualitative studies demonstrate that mobile health interventions are acceptable and feasible for Syrian refugees.

Primary objective: To evaluate the impact of mobile phone-based reminders on the uptake of prenatal care among pregnant Syrian refugee women. More specifically, the study assesses the effectiveness of mobile phone-based reminders by measuring the percent increase in the number of prenatal appointments attended by intervention arm participants compared to the control arm participants.

Study design: This is a behavioral intervention study using an un-blinded, parallel groups, randomized controlled study design.

Primary Outcome:

The primary outcome of this study is the number of medical visits, following the initial baseline prenatal care visit, over the 6 month period prior to childbirth.

Secondary outcomes:

Secondary outcomes are based on the Sociodemographic and Health History form. The form gathers information about demographics of the participants (age, education, employment, marital status, number of children) and health history (previous pregnancies, delivery methods, miscarriages, stillborn, chronic conditions and medications. We will further examine these risk factors on the number of medical visits during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Having the status of "Syrian under temporary protection"
* Being in the first trimester of the pregnancy
* Initial prenatal visit
* Age equal or greater than 18 years and less than or equal to 49

Exclusion Criteria:

* Having a citizenship or a status other than "Syrian under temporary protection"
* Not owning a mobile phone
* Being unable to read and write
* Not initial prenatal visit
* Having a chronic disorder or high-risk pregnancy that requires the individual to go to the hospital frequently. Frequently is defined as more than 3 visits post the baseline visit.
* While gestating, those that develop a high-risk pregnancy that requires more than 3 visits post the baseline visit.