cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes of Tislelizumab Combined with Chemotherapy As Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC

This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes in Stage III (cTNM-IIIB/IIIC) Non-Small Cell Lung Cancer.Patients meeting inclusion and exclusion criteria were enrolled, with treatment modalities and clinical outcomes of stage III non-small cell lung cancer (NSCLC) patients from multiple tertiary hospitals in real-world settings since August 2020 being collected and analyzed.

Key Inclusion Population： Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.

No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.ECOG PS scores of the enrolled patients ranged from 0 to 2.

Neoadjuvant/Induction Therapy Regimen:

Tislelizumab combined with platinum-based doublet chemotherapy was administered for 2-4 cycles, followed by surgical resection or other therapeutic interventions (e.g., radiotherapy/chemotherapy). Real-world clinical outcomes were collected and analyzed based on patients' subsequent treatment pathways.

Eligibility Criteria:
Inclusion Criteria:

Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.

Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.

No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.

ECOG PS scores of the enrolled patients ranged from 0 to 2.

Exclusion Criteria:

Patients with other previous malignancies did not require additional treatment. Patients with incomplete key baseline and treatment information:including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.

Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.

Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
Influence Mechanism of Tumor Microenvironment Changes on Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma

To evaluate the predictive value and mechanism of inflammatory factors in peripheral blood on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer. To explore the predictors of neoadjuvant therapy in patients with esophageal squamous cell carcinoma.

Patients with esophageal cancer admitted to Hubei Provincial People's Hospital from May 2023 to December 2024 were collected (the estimated number of patients included is 60). Collect research objects: 1. Baseline information: gender, age, tumor location, T stage, N stage, and BMI, etc. The tumor staging and grading are determined according to the eighth edition of American Joint Committee on Cancer esophageal cancer staging; 2. Laboratory data; Blood routine, liver and kidney function, electrolyte, coagulation function, tumor markers and cytokines were collected before neoadjuvant chemotherapy combined with immunotherapy, after 2 cycles of treatment and after 4 cycles of treatment (if applicable). After every two cycles of treatment, the remission status of the disease was evaluated by CT or gastroscopy in the routine treatment. To evaluate the predictive value and mechanism of peripheral blood inflammatory factors on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer.

Eligibility Criteria:
Inclusion criteria：

The patient's age between 18 to 80 years old; Esophageal squamous cell carcinoma with definite pathological diagnosis and II-IVA clinical stage Preoperative neoadjuvant chemotherapy combined with immunotherapy The score of eastern cooperative oncology group is 0 \~ 1 Exclusion criteria

The estimated survival time is less than 6 months; The first diagnosis had distant metastasis Suffering from malignant tumor or accompanying malignant disease in the past 5 years Pregnant or pregnant women. Vulnerable groups (those without informed ability, minors, vagrants, students and subordinates of researchers, employees of bidders)
A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects

This study aimes to medical data, musculoskeletal data and functional data over time of stroke patients and healthy subjects to compared the clinical differences between stroke and healthy subjects.


Eligibility Criteria:
1. For stroke patients 1) Inclusion Criteria:

   * Adults over 20 years of age
   * More than 1 month after onset of stroke
   * After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions 2) Exclusion criteria:
   * Patients who correspond to one or more of the following cannot participate in the study.
   * Patients with systemic infectious symptoms at the time of participation in the study
   * In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person who is not accompanied by a guardian
   * Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
   * Other cases where the researcher judges that participation in this study is not suitable(Patients who are participating in other clinical trials or studies, or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
2. For healthy voluteers 1) Inclusion Criteria:

   * Over 20 years of age
   * A person who is performing an independent daily life
   * A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this study and fully understanding it

     2) Exclusion criteria:
   * Patients who correspond to one or more of the following cannot participate in the study.
   * MMSE score less than 20 points (from 19 points onwards excluded from study)
   * Those who remain disabled due to brain disease (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
   * Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
   * Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other clinical trials or studies, or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
Pulse Wave Analysis in Advanced Heart Failure

A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.

Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:

1. That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
2. That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
3. That clinical events involving LVAD will have characteristic frequency spectra.

Eligibility Criteria:
Inclusion Criteria:

1)18 years of age or older

2)Advanced heart failure as defined by need for IABP or LVAD

3)One or more of the following:

* Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group

  •≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group

  •≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group
* Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group

  4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

1. Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)
Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)

Trastuzumab deruxtecan (T-DXd) is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations.

This real world, prospective study will assess the effectiveness and safety of T-DXd in patients with locally advanced or metastatic, HER2 mutation-positive NSCLC in real-world setting.

T-DXd is an approved therapy in China for locally advanced or metastatic NSCLC patients with human epidermal growth factor receptor 2 mutations (HER2m). In previous clinical trials, T-DXd demonstrated efficacy and manageable safety profiles in the ≥ second-line setting for NSCLC harboring HER2m. However, patient populations are more diverse in routine practice and no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations exist.

This study will assess the effectiveness of ≥ second-line treatment of T-DXd in real-world setting as the primary objective. Secondary objectives will further assess the effectiveness and overall survival of ≥ second-line treatment of T-DXd in real-world setting as well as evaluate the safety and tolerability of any-line treatment of T-DXd in real-world setting.

Eligibility Criteria:
The key inclusion criteria for this study are:

1. Age ≥18 years at signing informed consent form (ICF).
2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
3. Documented any known activating HER2 mutation.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
5. Patients who receive T-DXd based on physicians' discretion (Newly received or just have started the first dose no longer than 2 months before enrollment).

The key exclusion criteria for this study are:

1. Previously treated with HER2-targeted/directed therapies, including:

   * tyrosine kinase inhibitors \[TKIs\] targeting HER2 mutations, except for pan-HER class TKIs.
   * an ADC, containing a chemotherapeutic agent targeting topoisomerase I
2. Has spinal cord compression or clinically active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.
A Study to Evaluate the Benefits of Using a Range of Wound Care Products From a Single Manufacturer

This study is designed to investigate whether the adoption of the use of a range of wound care products from a single manufacturer makes training in appropriate product selection more effective and results in more accurate selection of the appropriate product for the wound and for the patient's lifestyle, thereby incurring less waste and reducing the number of referrals by the community nursing team to the Tissue Viability Team.

One community nursing team will switch to using a full range of dressings and compression products from BSN medical UK for three months. Nurse training on the products will be given and nurse competencies and confidence in woundcare and appropriate product selection will be tested at the start and end of the study.

The number and type of referrals to the Tissue Viability Team will be measured.

Total anonymised data on numbers of referrals, wound closure, numbers of wounds and quantity and cost of products used will be collected and compared with the historical record for three months prior to the study. Patients will complete a Quality of Life questionnaire at enrolment and exit from the study.

Patients for whom BSN medical UK products are not appropriate or not desired by the patient will not be enrolled and will receive the usual range of products available to the community nursing team.


Eligibility Criteria:
All healthcare professionals of the Billericay team responsible for dressing changes who are willing to take part in this study and give their written informed consent.

Inclusion Criteria for the patients:

* Patients giving their informed consent and with an open wound being treated by the community nursing team
* All patients whose wounds can be treated with BSN medical UK Product range for wound and leg ulcer management.

Exclusion Criteria for the patients:

* Age \<18 years
* Subjects who do not give their consent for any reason
* Subjects who are unable to read and understand patient information sheet and consent form
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

Screening phase:

* A male or female ≥ 18 years of age at the time of study entry.
* Written informed consent obtained from the subject prior to study entry.
* Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation.
* Subjects who the investigator believes can and will comply with the requirements of the protocol
* If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

Active phase:

* Patients who are confirmed to have undergone autologous peripheral stem cell/ bone marrow transplantation.
* If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

Exclusion Criteria:

Screening phase:

* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
* History of allergy to any component of the vaccine.
* Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
* Current drug and/or alcohol abuse.

Active phase:

* Use of any investigational or non-registered product (drug or vaccine) during the active phase of the study period.
* Use of immunosuppressants or other immune-modifying drugs within 14 days preceding the administration of the first dose of the study vaccine or planned use during the active phase of the study period.
* Use of rituximab (MabThera) more than 60 days after transplant.
* Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
* History of allergy to any component of the vaccine
* Patients with VZV disease after transplantation and prior to vaccination.
* Ongoing requirement for antiviral therapy with anti-VZV activity beyond 4 months post-transplantation
* Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
* Current drug and/or alcohol abuse.
A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy

The investigators hypothesize that using carbon dioxide for PEG placement versus using room air will decrease post-procedure pneumoperitoneum as well as improve post-procedure bloating/pain, and waist circumference.

Background and study aims: Pneumoperitoneum following PEG placement has been reported in up to 60% of cases, and while usually benign and self-limited, it can lead to evaluation for suspected perforation. This study was designed to determine whether using CO2 compared to ambient air for insufflation during PEG reduces post-procedure pneumoperitoneum.

Patients and Methods: Prospective, double blind, randomized trial of 35 consecutive patients undergoing PEG at a single academic medical center. Patients were randomized to insufflation with CO2 or ambient air. Primary outcome was pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement. Secondary endpoints included abdominal distention, pain, and bloating.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy

Exclusion Criteria:

* None
Development of a Family-Based Treatment for Adolescent Methamphetamine Use

The AIMS study compares a methamphetamine-specific treatment intervention to a treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19. Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use; or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving group and individual therapy sessions; Families are assessed using questionnaires and interviews, and adolescents participate in neuropsychological testing, before, during, and after treatment to provide information about family functioning, the adolescent's drug use, the adolescent's peers, and other factors that may contribute to treatment success. Adolescents also provide urine specimens for drug screening at assessment visits. Through a partnership with Oregon Health and Science University (OHSU), adolescents will participate in functional magnetic resonance imaging appointments at the hospital to examine regional brain blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a treatment development grant, study investigators will study adolescents' acceptance of and response to the newly developed methamphetamine-specific treatment approach.


Eligibility Criteria:
Inclusion Criteria:

* 15 to 19 years of age.
* Have at least one parent or parent figure willing to participate.
* Meet DSM-IV diagnostic criteria for drug-abuse or dependence, including a specific meth use disorder.
* Reports meth use on at least 5 of the previous 90 days.
* Have contact with the parent on at least 40% of the past 90 days.
* With their parent be willing to accept randomization to one of the two treatment interventions.
* Be willing to participate in the imaging task in the fMRI pilot study.
* Have basic English competency.
* Have sufficient residential stability to permit probable contact at follow-up.

Exclusion Criteria:

* Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
* Have a medical or psychological condition that would preclude undergoing the fMRI scan.
* Have a sibling who is participating in the study.
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage

Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings. We hypothesized that effective rotavirus vaccination could reduce diarrhoeal episodes and thereby unnecessary antibiotic usage in young children in low-income settings.

The study aimed to evaluate the impact of rotavirus vaccination on antibiotic usage. Specifically, the study quantified how differences in rotavirus vaccine efficacy would impact days of prescription and nonprescription antibiotic usage in the first 2 years of life among two large cohorts of children in Zambia and Ghana.

The key goal was to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. The goal was to generate evidence needed to inform policymakers seeking to introduce new rotavirus vaccines into national vaccination programs, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage.

The study was conducted within a Phase III randomised controlled trial comparing the efficacy of a new parenteral trivalent P2-VP8 subunit rotavirus vaccine to the oral live attenuated vaccine, Rotarix®, against severe rotavirus gastroenteritis in the first 2 years of life in Zambia and Ghana.


Eligibility Criteria:
Inclusion Criteria:

Healthy infants as established by medical history and clinical examination before randomisation into the study Age: ≥6 and \<8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) Parental ability and willingness to provide written informed consent. Intention of the participants' parents to remain in the area with the child during the study period

Exclusion Criteria:

Acute disease at the time of enrollment/first study vaccination - temporary exclusion Presence of fever on the day of enrollment/first study vaccination (axillary temperature \>37.6oC) Concurrent participation in another clinical trial (other than the parent study) throughout the entire timeframe for this study.

Presence of severe malnutrition (weight-for-height z-score ≤-3SD median (per WHO published child growth standards) History of premature birth (\<37 weeks gestation) and/or birth weight of \<2.5 kg History of congenital abdominal disorders, intussusception, or abdominal surgery Prior receipt of rotavirus vaccine
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.

The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females
* \> or = to 18 years of age
* On a stable dose of simvastatin for 4 or more weeks
* LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
* TG \< 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception

Exclusion Criteria:

* BMI \> 40
* Allergic to colesevelam HCl
* History of swallowing disorder
* History of gastrointestinal motility disorder
* Any disorder that might interfere with the study
* History of drug or alcohol abuse