cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.

Study was designed to evaluate efficacy of OsrhCT and Dimethicone emulsion before upper endoscopy on visibility of gastric mucosa.

A total of 336 subjects (both male and female) are expected to be enrolled in this trial.

This is a monocentric, double-blind, randomized study involving 336 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of three arms, with OsrhCT 4000U+ Dimethicone emulsion 4ml , with OsrhCT 8000U+ Dimethicone emulsion 4ml , and with placebo for OsrhCT+ Dimethicone emulsion 4ml. During the examination, each photograph was individually taken in 5 defined areas. The first 30 cases were collected to establish standards and method validation. The visibility score was given by the sum of the score 1-4 from 5 defined localities evaluated by a blinded endoscopist and subsequently by two or three blinded endoscopists. Other parameters monitored were examination time and a semiquantitative evaluation of residual gastric fluid.

Eligibility Criteria:
Inclusion Criteria:

1. Patients indicated for gastroscopy examination;
2. Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent;
3. Able to complete the research according to the requirements of the experimental plan;
4. Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug;
5. Aged 18-75 years (inclusive), male or female;

Exclusion Criteria:

1. Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination;
2. Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc;
3. Subjects accessed not to stand sedation anesthesia or gastroscopy examination;
4. Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices;
5. Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery;
6. Abnormal laboratory values:: alanine aminotransferase (ALT)\>2 × ULN, aspartate aminotransferase (AST)\>2 × ULN, serum creatinine\>1.5 × ULN;
7. Female subjects who had unprotected sex within 14 days prior to screening;
8. Pregnant or breastfeeding women;
9. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months;
10. Any other conditions deemed unsuitable for the study by the investigator.
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptides URLC10, KOC1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

URLC10 and KOC1 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 and KOC1 are upregulated in human gastric tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. The patients will also receive oral chemotherapy (S-1) simultaneously. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent gastric cancer
* Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*2402
* Laboratory values as follows 2000/mm3\<WBC\<15000/mm3 Platelet count\>100000/mm3 Bilirubin \< 3.0mg/dl Asparate transaminase \< 150IU/L Alanine transaminase \< 150IU/L Creatinine \< 3.0mg/dl
* Able to receive oral TS-1 therapy
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Unhealed external wound
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal metastasis
* History of allergy to Tegaful, Gimeracil and/or Oteracil
* Decision of unsuitableness by principal investigator or physician-in-charge
Long-Term Follow-up of Arthroscopic Biceps Tenotomy and Subacromial Decompression in Chronic Massive Rotator Cuff Tears

Chronic massive rotator cuff tears (MMRCTs) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. While surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. Arthroscopic debridement, subacromial decompression, and biceps tenotomy are frequently employed procedures, but their long-term effectiveness in managing MMRCTs is not fully understood. A comprehensive understanding of the long-term outcomes of these procedures is crucial for guiding clinical decision-making and patient counseling.

The study aims to evaluate the long-term clinical and functional outcomes of arthroscopic debridement, subacromial decompression, and biceps tenotomy in patients with chronic massive rotator cuff tears. By analyzing a cohort of patients who underwent these procedures, we will assess factors influencing long-term outcomes, such as patient demographics, preoperative functional status, and surgical technique. Furthermore, we will compare the long-term results of this surgical approach to other treatment modalities, including open repair and conservative management.


Eligibility Criteria:
Inclusion Criteria:

* Patient who had arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears

Exclusion Criteria:

* Patient who hadn't met the requirements for arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears
ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care

Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. nd through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.

In this study, the ED90 of the loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.


Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-3
* Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with remimazolam

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with hypersensitivity to benzodiazepine or flumazenil
* Patients with severe renal/hepatic disease
* Patients with drug/alcohol abuse
* Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
* Patients with difficulty in communication
* Patients with severe obstructive sleep apnea or other airway problems
* Patients contraindicated to regional anesthesia
* Patients judged to be inappropriate for this study
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age \>= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
* Left ventricular ejection fraction (LVEF) \> = 45%
* Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.

Exclusion Criteria:

* Acute myocardial infarction within 3 months;
* Heart revascularization procedure within 3 months;
* Hospitalization for angina within 3 months;
* Other heart surgery
* Life-threatening or uncontrolled arrhythmia
* Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
* Stroke or surgery of the arteries in the brain within 3 months;
* Serious lung disease which requires use of home oxygen.
* Significantly low blood pressure
* Significantly high blood pressure
* Other known diseases that may limit life expectancy to \<3 years;
* Known or suspected bilateral kidney artery narrowing;
* Geographic or social factors making study participation and follow-up impractical.
Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).

The study shall mainly help to better evaluate the performance the ME-APDS device and secondly it may help the development of additional future versions of the ME-APDS.

Primary endpoints

* Clear video of the colon or the stomach or the esophagus achieved during the test.
* Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.

Secondary endpoints

• A recorded video of at least 80% of the actual test duration.

Primary objectives • To support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters of its results achieved from running it on the collected recorded videos of Colonoscopy and Gastroscopy tests of the general population.

Secondary objectives

• Some of the data might be used also for the development of future versions of the ME-APDS

Each subject will pass regular colonoscopy and/or gastroscopy test during which an external recording system connected to the secondary "video out" connector of the endoscopy processing device will record the video presented on the endoscopy device screen from the beginning of the test till its end. The standard off-the shelf recording device will be connected to the endoscopy device's connector by the testing physician or his/her assistant during the test's preparation phase. At the beginning of the test the testing physician or his/her assistant will press on recording start button, and at end of the test, the testing physician or his/her assistant will press on recording stop button. At the end of each week, the recorded video will be backed-up from the recording device to an external storage with two copies, one for record keeping of the main investigator, and one for the sponsoring entity.

Pathology and procedure reports without any identification details will sent to the sponsor with the recorded video.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all the - criteria related to regular colonoscopy and/or gastroscopy according to the standard of care at the Gastroenterolgy Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:

1. Able to read, understand and provide written Informed Consent;
2. Females or males - older than 18 years old

Exclusion Criteria:

Any of the following colonoscopy/gastroscopy related exclusion criteria will exclude the subject from the study:

* Bleeding disorder or unacceptable risk of bleeding
* Terminal illness or life threatening malignancy
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma

To explore whether the adjuvant therapy of metronomic capecitabine could improve the disease-free survival of locoregionally advanced hypopharyngeal carcinoma (stage IV：T4N0-1M0，anyTN2-3M0).


Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 18 and 65 years old. 2. Histologically confirmed hypopharyngeal carcinoma, staged as IV (T4N0-1M0，anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy ).

  3. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy.

  4. Within 8 weeks after completion of the last radiation dose. 5. Performance status of ECOG grade 0 or 1. 6. Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9 /L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min).

  7. Patients must be appraised of the investigational nature of the study and provide written informed consent.

Exclusion Criteria:

* 1.Patients who were known to be intolerable or allergic to capecitabine. 2. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

  3. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control).

  4. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.
Global Syphilis Sequencing

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab.

In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of syphilis

Exclusion Criteria:

* No PCR positive clinical sample
A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma

The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated)
2. ECOG performance status of 0-2
3. Measurable or evaluable disease (RECIST 1.1.)
4. Adequate laboratory findings

   * Hb ≥ 9.0 g/dL
   * Absolute neutrophil count ≥ 1000 /µL
   * Platelet ≥ 75,000/ µL
   * Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
   * Serum Creatinine: ≤1.5 X upper limit of normal (ULN) OR ≥ Creatinine Clearance 60 mL/min (Cockcroft-Gault) for patients with creatinine levels \> 1.5 X institutional ULN
   * AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
   * Alkaline Phosphatase : ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
   * Prothrombin time and partial thromboplastin time : ≤1.5 X ULN
5. Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior

Exclusion Criteria:

1. More than 3 prior cytotoxic agents
2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
3. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
4. Patient has known hypersensitivity to the components of study drugs or its analogs.
5. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
6. Long QT Syndrome ≥480 ms
7. peripheral neuropathy ≥2 with previous treatment
8. unstable cardiovascular disease
9. Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray
Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma

A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry.

A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed including overall survival, recurrence-free survival, association between clinical parameter with mortality, patient characteristics by pre-lymphopenia and post-lymphopenia levels and lymphocyte status of HCC patients with usage of different immunosuppressants. In prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry to identify the major immune cell subsets and the characteristics of patients in the prospective cohort between pre-LT lymphopenia and non-lymphopenia groups.

Eligibility Criteria:
Inclusion Criteria:

* liver transplant patient

Exclusion Criteria:

* End-stage liver disease scoring system score (MELD score) \> 25
* Have received care in the intensive care unit (ICU) before transplantation
* Poor cardiovascular function.
* Patients suffering active infection.
* Other complications affecting living donor liver transplantation
Bovine Pericardial Patch and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction.

This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with I\~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
2. Do not smoking in the last 4 weeks or more
3. Mental health patients
4. Signed consent to participate

Exclusion Criteria:

1. Locally advanced stage patients or patients with distal metastasis
2. Patients received thoracic wall radiotherapy or will receive radiotherapy
3. Smoking in the last 4 weeks
4. Anticipated implant volume more than 600cc
5. Patients of pregnancy or lactation
6. Patients received neoadjuvant therapy
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.


Eligibility Criteria:
Inclusion Criteria:

Newly implanted and existing recipient Groups (Groups 1 and 2):

* Age 12 and older
* Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
* Group 2: 3 months or greater combined experience with commercially available sound processors
* Fluent spoken English skills

Exclusion Criteria:

* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
* Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
* Unwillingness or inability of the subject to comply with all investigational requirements
* Use of an acoustic component in the implanted ear
* Less than 18 active electrodes
* Hybrid L Cochlear Implant
Impact of Social Support and Coping Strategies on Post-Surgical Pain

The purpose of the study is to evaluate the impact of social support and pain coping strategies in the development and evolution of post-surgical pain.

This is a longitudinal study. After giving their informed consent, patients will answer online questionnaires assessing pain and different psychosocial variables at these time points: before surgery, one to three days after surgery, and one, three, and six months after surgery.

The psychosocial variables evaluated are the following ones :

* Depression,
* Anxiety,
* Stress,
* Pain Coping Strategies,
* Social Support,
* Couple Support.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years of age.
* Capacity to understand and voluntarily sign an informed consent form in French.

Exclusion Criteria:

* Insufficient French language skills.
* History of psychotic disease.
* History of neurodegenerative pathology.
* History of neurological disease (e.g. stroke)
* Pre-existing pain condition related to the reason for surgery