cyrilzakka/clinical-trials huggingface dataset:
A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia

Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal analgesia. This medication is generally safe, well tolerated and effective within recommended daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 70 years inclusively, male or female;
* Patients scheduled for open abdominal surgery(such as gall bladder, lower abdominal investigative surgery), gynecologic surgery(such as trans-abdominal hysterectomy), orthopedic surgery(such as replacement and reconstruction of knee, hip or shoulder joint), with anticipated need for post-operative iv. morphine analgesia≥24h;
* 18kg/m2≤BMI≤30 kg/m2;
* Classified as ASA risk class I, II according to the American Society of Anesthesiologists;
* Able to understand the study procedures and the use of the pain scales, able to operate a patient controlled analgesia (PCA) device and to communicate meaningfully with the study observer and staff;
* Patients free of any contraindication to the study drugs, morphine and to the standardized anesthesia protocol;
* Clearly understand the procedure of study, voluntarily participate and provided written consent form.

Exclusion Criteria:

* Impaired liver function (ALT and/or AST \> 2 x upper limit of normal range, or TBIL≥1.5 x upper limit of normal range);
* Impaired renal function(Serum Creatinine \>176μmoL/L), or undergoing dialysis within 28 days before surgery;
* Patients at high risk for bleeding, including congenital hemorrhagic disease(such as Hemophilia), Thrombocytopenia(CBC PLT\<30×109/L), Qualitative Plateletdefects(such as ITP, DIC, congenital abonormal platelet), or clinically significant active bleeding;
* Abnormal resting ECG, judged as not eligible for entry by investigator;
* Hypertensive patients not achieving satisfactory BP control under hypertensive medication(Sitting SBP≥160mm Hg, and/or DBP≥105mm Hg during screen period);
* Sitting SBP≤90mm Hg during screening period;
* Diabetic Patients not achieving satisfactory blood glucose control(FBG≥11.1moL/L during screening period);
* Known history of bronchial asthma, pulmonary heart disease or heart failure;
* Participation in other trials within 30 days;
* Pregnant women or women in lactation;
* Patients not eligible due to other reasons judged by the investigator.
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) and preliminary efficacy of DS-6051b will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

* Previously had or currently has any of the following diseases:

Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.

* Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects must have a PiZZ genotype confirmed at screening
* Plasma AAT levels indicating severe deficiency at screening

Key Exclusion Criteria:

* History of a medical condition that could negatively impact the ability to complete the study
* Solid organ, or hematological transplantation or is currently on a transplant list
* History of use of gene therapy or RNAi therapy at any time previously

Other protocol defined Inclusion/Exclusion criteria may apply
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children

This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.


Eligibility Criteria:
Inclusion Criteria:

* Male and female Jewish and Bedouin children.
* Patients can be either ambulatory or hospitalized.
* Presenting with acute otitis media.
* Tympanocentesis was performed at least in one ear for a clinical indication.
* Culture of middle ear fluid was obtained.
* Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.

Exclusion Criteria:

* Having another infection that is likely to be caused by S. pneumoniae.
* Known immunodeficiency.
* Known previous recent pneumococcal infections (\<1 month prior to current visit).
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer

Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (\>50%) risk of future life-threatening recurrences and death.

This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.

Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.

Blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
* Surgically resectable disease following neoadjuvant systemic treatment.
* At least one of the following must be true:

  1. Received at least 2 weeks of neoadjuvant endocrine therapy
  2. Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
  3. Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination
* Provide written informed consent.
* Willing to return to enrolling institution for breast cancer surgery.
* Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
* Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
* Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.

Exclusion Criteria:

* Ineligible for surgery.
* History of prior malignancy \<3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).
Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries

The primary purpose of this research is to evaluate the impact of a telehealth-based, cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult informal military family/friend caregivers of OIF/OEF service members with a deployment-related TBI.

Traumatic brain injury (TBI) has gained increasing attention in American society as it is now considered the "signature injury" of the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) campaigns. The chronic changes that often occur in the wake of TBI along with possible physical injuries may run a chronic, unremitting course, imposing great strain and distress upon family members who often assume a caregiver role with little preparation and no formal training for these wounded service members as they reintegrate back into civilian life post-deployment. Unfortunately, research has not adequately addressed the unique long-term needs of informal military caregivers of deployed service members with TBI (i.e., family members/close friends).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years old
* Meets study project definition of a military caregiver
* Documentation or determination of an OIF/OEF deployment related TBI
* Service member will have presented to a Veterans Administration Medical Center (VAMC) or military medical center
* English-speaking
* Has access to a telephone for the administration of measures and/or intervention calls
* Has no significant cognitive or communication problems that might significantly interfere with adequately understanding information or talking on the telephone which will be determined by the clinical judgment of the person consenting the participant.

Exclusion Criteria:

* Has a life-threatening or other serious disease that impacts the ability to participate for the duration of the project
* No determination or documentation of a deployment-related TBI related to OIF/OEF for the injured service member
* Has a severe hearing impairment that impedes communication and standardized implementation of the intervention and telephone follow-up
* Formal caregiver
* Caregiver does not want to participate
Pharmacogenomic Testing Of the Elderly To Reduce Morbidity

The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.

The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as "Pharmacogenomics."


Eligibility Criteria:
Inclusion Criteria:

* Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
* Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
* Subject is able and willing to provide written informed consent
* Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
* Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug

Exclusion Criteria:

* Subject is currently hospitalized
* Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
* Subject is unable to provide an accurate history due to mental incapacity
* Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.

CAPTURE is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the Vine™ permanent carotid filter. The trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. All enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Atrial fibrillation (AF): documented persistent or permanent
2. CHA2DS2-VASc score ≥ 4
3. Age \> 50
4. Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
5. Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
6. CCA accessibility: up to 60mm from skin to CCA center, safe approach
7. Patient is willing to provide informed consent
8. Patient is willing to complete all scheduled follow-up

Exclusion Criteria:

1. Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)
2. Evidence of any atherosclerotic disease in CCA above the clavicles
3. Evidence of carotid dissection
4. Pre-existing stent(s) in CCA
5. Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
6. Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
7. Female who is pregnant or who is planning to become pregnant during the course of the study
8. Life expectancy of less than 1 year
9. Active systemic infection
10. Known sensitivity to nickel or titanium metals, or their alloys
11. Known hereditary or acquired coagulation disorders
12. Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure
13. A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
14. Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
15. Active participation in another investigational drug or device treatment study
16. Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
Community-Based Diabetes Care for Korean American Immigrants

The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a comprehensive, culturally tailored DM management intervention, in improving glucose outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care skills and psycho-behavioral outcomes related to DM control, to develop tangible infrastructures for the dissemination of valid and effective education materials to a wider population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based intervention materials, mobile telephone-based intervention materials) and to explore the feasibility and acceptability of each dissemination module, utilizing the delayed intervention group participants. The secondary aims are to obtain preliminary cost-effectiveness data related to the proposed intervention, including cost estimates for this type of DM intervention, and to establish a systematic, long-term dissemination plan, including documenting effective methodologies, to facilitate faster translation of research findings and products to direct consumers in non-research settings.

Inclusion Criteria

1. Self-identified as a first generation Korean American
2. Type 2 diabetes
3. Age 30-75 years
4. Resides in Washington-Baltimore area
5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening
6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

1. Unable to give informed consent
2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
4. Past experience in diabetes group education

Eligibility Criteria:
Inclusion Criteria:

1. Self-identified as a first generation Korean American
2. Type 2 diabetes
3. Age 30-75 years
4. Resides in Washington-Baltimore area
5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening
6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion Criteria:

1. Unable to give informed consent
2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
4. Past experience in diabetes group education
Randomized Controlled Trial of the Effectiveness of Group Treatment With War-Exposed Bosnian Adolescents

Context: This is the first multi-site randomized controlled study of the effectiveness of a group treatment for war-exposed adolescents delivered in-country within a public school system.

Objective: To evaluate the effectiveness of a trauma/grief-focused group treatment program in reducing symptoms of posttraumatic stress disorder (PTSD), depression, and traumatic grief in war-exposed Bosnian youths attending 10 secondary schools located in Central Bosnia.

Design: A randomized controlled trial conducted during the 2000-2001 school year, with 4-month follow-up, compared group treatment to a psychoeducation/skill-based school milieu intervention.

Setting and Participants: Students attending 10 Bosnian secondary schools exposed to severe trauma, traumatic loss, and severe adversity, reporting severe persisting symptoms of PTSD, depression, or traumatic grief, and functional impairment.

Intervention: Students were randomly assigned to either 17-session Trauma and Grief Component Therapy (n=71), or a school milieu intervention (n=73), both conducted by trained school counselors.

Eligibility Criteria:
Inclusion Criteria:

* Significant trauma exposure before, during, or after the war (e.g., serious physical injury, life threat, witnessing death or serious injury, traumatic bereavement);
* Significant current distress, especially severe persisting symptoms of PTSD, depression, or traumatic grief;
* Significant functional impairment in family or peer relationships and school performance

Exclusion Criteria:

* Acute risk status (e.g., suicidal plans and intent)
* Psychosis
* Severe substance abuse (severe enough to interfere with engagement in treatment).
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
* blood work criteria

Exclusion Criteria:

* patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
* positive HIV, hepatitis B or C
* impaired intestinal function
* impaired heart function
* pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23

The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted.

The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18 years old and older
* Over 6 months after primary immunization with COVID-19 vaccines
* Can understand and sign the consent
* Can provide effective personal identification

Exclusion Criteria:

* Has a history of COVID-19 infection
* Less than 6 months after primary immunization with COVID-19 vaccines
* Already vaccinated with influenza vaccines of that year
* Vaccinated with pneumococcal vaccines within 5 years
* Has a history of severe hypersensitivity reaction to vaccines
* Has uncontrolled seizure or other severe neural system illnesses
* Has a fever, chronic disease, or acute disease during immunization
* Gestation period, lactation period, or planning to get pregnant within 3 months
* Administrated with other drugs under research within 30 days before vaccination
* Received attenuated vaccines within 14 days before vaccination
* Received subunit vaccines or inactivated vaccines within 7 days before vaccination
* Other conditions based on researcher's judgement