cyrilzakka/clinical-trials huggingface dataset:
Escorting Octogenarian for Gastric Cancer Surgery

An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.

An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. Detailed data on surgical indication, assessment for proposed surgery and perioperative management are analyzed for future guidelines in senile.

Eligibility Criteria:
Inclusion Criteria:

- Pathologically confirmed gastric cancer patients Clinically fit for gastric cancer surgery

Exclusion Criteria:

- Non gastric cancer patients Clinically unfit for gastric cancer surgery
Deep Learning Radiogenomics For Individualized Therapy in Unresectable Gallbladder Cancer

The goal of this observational study is to learn about deep learning radiogenomics for individualized therapy in unresectable gallbladder cancer. The main questions it aims to answer are:

(i) whether a deep learning radiomics (DLR) model can be used for identification of HER2status and prediction of response to anti-HER2 directed therapy in unresectable GBC.

(ii) validation of the deep learning radiomics (DLR) model for identification of HER2 status and prediction of response to anti-HER2 directed therapy in unresectable GBC.

Participants will be asked to

1. Undergo biopsy of the gallbladder mass after a baseline CT scan
2. Based on the results of the biopsy, patients will be given chemotherapy either targeted (if Her2 positive) or non-targeted
3. Response to treatment will be assessed with a CT scan at 12 weeks of chemotherapy

This study aimed at investigating the treatment option for patients with unresectable GB cancer. Presently the treatment of unresectable GB cancer mainly palliative with chemotherapy regime limited to generic form of chemotherapy offer to patients with other GI cancer. There is evolving data regarding the role of genetic mutation in cancers. Recent studies have also shown multiple somatic and germline mutation in GB cancer. Some of these mutations are amiable to targeted therapy. The era of precision medicine assured new hopes for patient with unresectable cancer. There is some preliminary data that shows benefit of precision medicine in GB cancer as well. The estimation of targeted therapy relies on obtaining biopsy therapy on cancer which can often be challenging, associated with complication and less acceptable by the patients. Studies in some other cancer shows that genetic mutation can be predicted based on imaging characteristics, however no such study has been done in GB cancer. The fundamental hypothesis is that prediction of HER2 status and response to anti-HER2 directed therapy using deep learning radiomic models in unresectable GBC will allow researchers to fully harness the potential of targeted therapy in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable mass-forming GBC
2. Patients willing to give informed consent

Exclusion Criteria:

1. Patients with prior chemotherapy for GBC
2. Patients with deranged RFTs
3. Patients with contrast allergy
A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza

The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:

* The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
* The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 to ≤64 years of age at the time of signing the ICF.
* Patients in the screening period met the following criteria: (1) rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; (2) fever ≥ 37.3℃ (axillary temperature) at screening; if taking antipyretics, axillary temperature ≥ 37.3℃ after taking the drug (more than 4 hours). (3) At least one of flu-related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever. (4) At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.
* The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.

Exclusion Criteria:

* Patients with influenza virus infection requiring hospitalization.
* High-risk population.
* Bronchitis, pneumonia, pleural effusion or interstitial disease suspected by a clinician or confirmed by chest imaging \[X-ray (anteroposterior or anteroposterior)/CT\] and judged clinically significant by the investigator at screening.
* Patients who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
* Patients with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) \> 10.0 × 109/L.
* Patients with purulent sputum or suppurative tonsillitis.
* Those who have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption.
* Medications against influenza virus within 7 days prior to Screening.
The Relationship Between the Tumor Markers and Interstitial Lung Disease

The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients.

This study was undertaken to investigate the source of these serum tumor markers.

The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 are often increased in interstitial lung disease patients.

This study was undertaken to investigate the source of these serum tumor markers.We hypothesis that these tumor markers are released from the lung.

The broncholveolr lvge fluid levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125 were measured in the interstitial lung disease patients before lung transplantation. The immunohistochemical test was performed in the specimen lung after lung transplantation.

Eligibility Criteria:
Inclusion Criteria

1.Interstitial lung disease patients for lung transplantation

-

Exclusion Criteria:

1. tumor
2. Interstitial lung disease patients could not be performed by lung transplantation
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism

This study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics of AZP-3601 following single and repeated administration in both healthy volunteers and patients with chronic hypoparathyroidism (cHP)

The protocol includes 3 parts:

* Part A: first-in-human single ascending dose (SAD) study in healthy volunteers
* Part B: multiple ascending dose (MAD) study with 2 weeks of treatment in healthy volunteers
* Part C: open-label MAD study with a total treatment duration of 3 months in patients with cHP.


Eligibility Criteria:
Main inclusion criteria

* Part A: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2
* Part B: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a Body mass index of 19 to 28 kg/m2
* Part C:

  1. Male and female patients aged 18 to 75 years inclusive
  2. History of cHP for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (PTH).
  3. Requirement for therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day (both are active vitamin D supplements), and requirement for supplemental oral calcium treatment ≥1000 mg per day over and above normal dietary calcium intake at baseline assessments.

Main exclusion criteria

* Parts A and B:

  1. Clinically significant abnormal lab values, as judged by the investigator
  2. Using tobacco products with 3 months prior to first drug administration
  3. History of alcohol abuse or drug addiction
* Part C:

  1. Known history of autosomal-dominant hypocalcemia (ADH resulting from gain-of-function calcium-sensing receptor \[CaSR\] or GNA11 mutations) or pseudohypoparathyroidism (impaired responsiveness to PTH)
  2. Any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than HP
  3. Use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides (e.g., digoxin or digitoxin) or systemic corticosteroids within 4 weeks prior to start of treatment.
  4. Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34), or abaloparatide, within 3 months prior to screening.
Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

The purpose of this study was to compare the efficacy of method Lumbar Segmental Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional disability and ability to activate the transversus abdominis (TrA) of individuals with chronic back pain caused by disc herniation.

Objective: To contrast the efficacy efficacy of method Lumbar Segmental Stabilization and TENS on pain, functional capacity and ability to activate the TrA of individuals with chronic back pain caused by disc herniation.

Design: Sixty patients are being randomized into two groups namely: Lumbar Segmental Stabilization (LS ) (specific exercises for the muscles transversus abdominis and lumbar multifidus) (n = 30) and TENS group (TG) (n = 30) receiving assistance under a current of transcutaneous electrical nerve stimulation (TENS). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasts for 8 weeks, and sessions happen twice a week, with duration of one hour each. Evaluations will be performed before, after and with a follow-up six months after treatment. Significance level is established at 5%.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain (pain for more than three months) or sciatica caused by disc herniation diagnosed by magnetic resonance imaging or computed tomography

Exclusion Criteria:

* prior back surgery,
* cancer,
* rheumatic diseases or infection.

Patients involved in sports or resistance training for the lumbar spine during the three months prior to the beginning of treatment or other causes of pain and sciatica such as lumbar spinal canal stenosis and lumbar spondylolisthesis have also been excluded.
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.

A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* request for permanent sterilization at the time of cesarean delivery
* 24 weeks' gestation or beyond
* 21 years old or older
* Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).

Exclusion Criteria:

* vaginal delivery
* history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)
* placenta accreta spectrum
* placenta previa
* history of bleeding diathesis.
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis

As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk. As cancer therapy improves, some AS patients suffering active malignancy (including advanced metastatic diseases) may be more endangered by their untreated valvular disease than their oncological disease. Among these patients, TAVI may be indicated before cancer related surgery or cardiotoxic anti-cancer therapy in order to achieve better anti-cancer therapy outcomes. Individualized life expectancy assumptions should be evaluated by the heart team in the clinical decision-making process as an essential factor in weighing the risk-benefit ratio for oncologic patients undergoing TAVI. A multicenter, international TAVI in Oncology Patients with AS (TOP-AS) registry was designed to collect data on patients with an active malignancy and severe AS undergoing TAVI. The aim of the study is to evaluate the outcomes, benefits and risks of oncology patients undergoing TAVI, mainly the patients' survival and cause of death and also the interactions between the valvular and the oncologic conditions.

The TAVI program was initiated in Rabin Medical Center in 2008 and the institutional review board approved the prospective collection of our TAVI Database (i.e. RECORD TAVI). During these years, several oncology patients were treated with TAVI. Also, in daily practice a few asymptomatic AS patients in whom TAVI was indicated before cancer related surgery / cardiotoxic anti-cancer therapy underwent TAVI.

This study will initiate a multicenter, international registry designed to collect data on TAVI in cancer patients in correspondence to medical records within each center. Data will be collected retrospectively for cases performed before registry initiation and prospectively thereafter. All inconsistencies regarding data collection will be resolved directly with local investigators and on-site data monitoring. Patients' inclusion approval is by a local ethics committee in each center.

Saving Data: Data will be recorded in Excel table; each center and patient will receive a unique code so the data file will be anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active malignancy (all types excluding non-melanoma skin Ca)
* Severe aortic stenosis undergoing native valve TAVI (any transcatheter heart valve type).

Exclusion Criteria:

* TAVI for conditions other than severe AS.
* Valve in valve TAVI patient.
* Patients cured /in remission from cancer during the index TAVI.
A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients

Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone.

This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere.

This study has been completed and a publication is pending.


Eligibility Criteria:
Exclusion Criteria:
The Utility of Cell-free Methylation Markers in Blood for Hepatocellular Carcinoma

Patients with liver cancer expected to undergo radiofrequency ablation or transvascular embolization. Relevant tumor markers (AFP and methylation analysis) were performed. The two data are then counted and compared.

The subjects of this study were patients who were diagnosed with liver cancer by physicians based on AASLD clinical criteria or pathological biopsy.

Patients are those who received radiofrequency ablation or transvascular embolization in National Taiwan University Hospital. Which excludes weakness and inability to cooperate Patients with blood test, under the condition of fully informed consent, complete blood test related tumor indicators (AFP and methylation analysis). The two data are then counted Compare.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with liver cancer by AASLD clinical criteria or pathological sections are planned to receive treatment at National Taiwan University Hospital Liver local treatment such as radiofrequency ablation or transvascular embolization.
2. Be over 20 years old.
3. Under the condition of informed consent, willing to sign the consent form of the subjects.

Exclusion Criteria:

1. Patients who are weak and unable to cooperate with blood test.
2. Kidney dysfunction, serum creatinine greater than 1.5mg/dl, it is judged that computer tomography or MRI cannot be performed Vibrate the injector.
VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)

This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.


Eligibility Criteria:
Inclusion criteria:

* age 18 or older
* men and women locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)
* after first line chemotherapy. This includes also combinations of immune- and chemotherapy.
* standard 21-day-cycles docetaxel treatment according to SmPC possible
* written informed consent

Exclusion criteria:

* contraindications according to the SmPC of Vargatef or Docetaxel
* more than one chemotherapy for treatment of NSCLC in palliative setting
* current partcipation in a clinical trial
* pregnancy
* breastfeeding
Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease

Parkinson's disease (PD) impacts an individual's fitness to drive in a number of ways that increase the crash risk in this population. Current vehicle automation technologies are available, that although designed for the general public, may help drivers with PD stay on the roads longer and safer than currently possible. Using a driving simulator (a safe and cost-effective alternative with no impact on licensing for participants), this study will investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology (i.e., a simulated lane change assistance system) to address critical driving errors in individuals with mild to moderate Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 21 years of age or older (as a feasibility study, this study will provide the opportunity to participate to those diagnosed with early onset PD)
* Have been diagnosed with Parkinson's disease by a neurologist or movement disorder specialist
* Currently hold a valid G driver's license
* Meet provincial visual acuity (20/50 binocular) and visual field (120 continuous along the horizontal meridian with both eyes examined together) requirements for driving
* Be proficient in English reading and speaking (self-reported).

Exclusion Criteria:

* Have any other neurological or psychiatric conditions that would interfere with full participation in the study
* Be taking psychotropic medication(s) that affect their mental and/or physical functioning
Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke

Therapeutic hypothermia (TH) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial. The investigators propose this trial to study the clinical and radiological effects of therapeutic hypothermia in acute ischemic stroke patients treated with intravascular thrombectomy (IVT).

The study intervention is therapeutic hypothermia. After intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline will be circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. This system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. After central venous catheterization, patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C, which is superior to surface methods in cooling performance in terms of faster rate of cooling, shorter induced cooling time, precise control during maintenance. Thereafter, hypothermia will be maintained for 24 hrs from the start of hypothermia. The patients will be rewarmed slowly at a rate of no greater than 0.5 °C every 4 h. What's more, patients in TH group will execute anti-shivering protocol during awaking and extubation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-85 years(inclusive);
2. Patients have clinical signs consistent with acute ischemic stroke,
3. Patients with acute large vessel occlusion including internal carotid artery and middle cerebral artery M1 and M2 demonstrated by CTA，MRA or DSA
4. The possibility to receive arterial thrombus removal treatment （within6 or24 hr of large vessel occlusion ）;
5. Provide the informed consent form of the patient or the patient's agent.

Exclusion Criteria:

1. Coma or altered vigilance defined as a score ≥2 on the level of consciousness 1A subscale of the NIHSS.
2. Associated cerebral hemorrhage.
3. There is dysfunction before the onset, mRS score \>= 2 points;
4. Accompanied by severe comorbidities (such as severe cardiopulmonary insufficiency, the expected survival period of advanced malignant tumors is less than 90 days);
5. Multi-mode CT/MRI examination of the corresponding contrast agent use contraindications (such as contrast agent allergy, etc.);
6. Women during pregnancy or lactation;
7. Patients currently participating in other clinical research trials;
8. Other conditions judged by the investigator as not suitable for inclusion in the clinical study.