cyrilzakka/clinical-trials huggingface dataset:
Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension

This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe hypertension

Exclusion Criteria:

* Diastolic blood pressure (DBP) \< 60 mm Hg
* Serum potassium \< 3.5 or \> 5.5 mEq/L in the absence of all potassium supplements
* Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens

Other protocol-defined exclusion criteria may apply.
Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy

(1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate, LARS score, urination function and sexual function score, local recurrence rate, and 3-year DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the diagnosis and treatment guidelines for rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70;
* Histologically confirmed adenocarcinoma of rectum;
* The distance from the lower edge of the tumor to the anus is ≤ 10cm;
* ECOG score ≤ 1;
* Have not received any anti-tumor treatment before;
* Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis)
* Hematological indicators and liver and kidney function within 7 days are within the normal range;
* Sign the informed consent form and be able to follow the research and /or follow-up procedures.

Exclusion Criteria:

* Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer;
* The patient had a history of malignant tumor within 5 years;
* Pregnant or lactating women;
* The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;
* The patient has had radiotherapy and chemotherapy records before this visit;
* Distant metastasis was found during operation;
* Patients with poor radiotherapy compliance and difficult cooperation;
Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia

Acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring.

MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers.

In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.


Eligibility Criteria:
Inclusion Criteria:

* dementia (Folstein scoring between 0 and 25)
* older than 75
* health necessitating of painful care for example eschar care

Exclusion Criteria:

* bullous emphysema
* pneumothorax
Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors

This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who failed prior immune checkpoint inhibitor therapies.


Eligibility Criteria:
Inclusion Criteria:

* The participants must be required to sign an informed consent
* Hepatocellular carcinoma patients confirmed by pathological or cytological examination, or who meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of primary hepatocellular carcinoma" (2022)
* At least one measurable lesion (RECIST 1.1)
* Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after local treatment
* The previous treatment plan for patients before enrollment was a standard treatment plan containing immune checkpoint inhibitors, and patients with progression or intolerance were evaluated based on the RECIST v1.1 standard
* Child-Pugh Score, Class A or better B
* ECOG performance status 0 or 1
* Adequate organ function
* Life expectancy of at least 3 months

Exclusion Criteria:

* Patients who have received local treatment (including TACE, ablation, HAIC, radiotherapy) and are less than 1 month after enrollment
* Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens
* Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe immune-related AEs requiring permanent cessation of immunotherapy
* Pregnant or lactating wome
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer

As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health Authorities, is therefore warranted. In addition, safety and efficacy will be also evaluated.

The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be characterized.


Eligibility Criteria:
Inclusion Criteria:

* ER(+), HER2(-), postmenopausal adult (ages 18-65 years, inclusive) Chinese women with proven diagnosis of adenocarcinoma of the breast with evidence locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.

  a. Postmenopausal women: i. Prior bilateral surgical oophorectomy; or ii. Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause b. Documentation of histologically or cytologically confirmed diagnosis of: i. ER(+) breast cancer. c. Documentation of HER2(-) breast cancer. d. Previously untreated with any systemic anti cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
* Measurable disease as defined per RECIST v.1.1 or bone-only disease. - Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.

Exclusion Criteria:

* HER2-positive tumor as defined by documentation of erbB-2 gene amplification by FISH (as defined by a HER2/CEP17 ratio ≥2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of HER2 overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory results
* Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement).
Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People

The objective of this Interventional case-control clinical study is to evaluate the effectiveness of physiotherapy combined with the administration of Alpha Lipoic Acid, L-acetylcarnitine, Resvelatrol, Vit D3 in the treatment of sciatica due to herniated disc in young patients.

The main questions we intend to answer are:

* Is this combined treatment more effective in reducing pain?
* Is the combined treatment useful for improving postural alterations, reducing the intake of painkillers and the number of days of absence from work and improving the quality of life?


Eligibility Criteria:
Inclusion Criteria:

* age 18-45 years
* pain with NRS scale score between 5 and 7 points
* symptoms attributable to lumbosciatica which occurred no more than 4 weeks ago
* pharmacological wash out of NSAIDs and corticosteroids for at least a week
* presence of L4-L5, L5-S1 disc herniation diagnosed with lumbar MRI performed within 3 months
* absence of ongoing infectious episodes;
* written consent for participation in the study.

Exclusion Criteria:

* Altered states of consciousness;
* Sciatica not of disc origin
* Neurological disorders
* Presence of scoliosis \>20° of Cobb
* Previous spinal surgery
* Pregnancy and/or breastfeeding
Evaluation of cfDNA as a Marker of Response in Rectal Cancer

A pathological complete response (pCR) after surgery occurs in approximately 20% of rectal cancer patients submitted to neoadjuvant chemotherapy, with apparent survival benefit. This group could, potentially, be spared the morbidity of surgery.

The diversified response to neoadjuvant chemotherapy (nCRT) amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity.

Accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response, in liquid biopsy, for rectal cancer. The concentration of baseline plasma cell-free DNA (cfDNA) appears significantly higher in responders compared to non-responders.

The objective of this study is to investigate the potential role of cfDNA as a marker of pCR (or partial response) to nCRT as well as a marker of outcomes (overall survival and disease-free survival).

The investigators are conducting a prospective, observational, cohort, non-randomized study of consecutive patients with locally advanced rectal cancer submitted to nCRT, followed by surgical excision 6-12 weeks later. Patients are assigned to groups according to their pathological response to nCRT. A total of 20 patients with complete pathological response, 50 partial response and 50 non-responders will be selected over a year and followed for another year. Participants will be observed and examined during the entire course of treatment and the follow-up period.

Serial analysis of cfDNA through liquid biopsies will be performed in consecutive patients at specific time points (pre-nCRT, post-nCRT and postoperative week 1), incorporating analysis of concentration, dimension of DNA fragments, % of mutation frequency (CIN, APC, p53, MSI, KRAS, BRAF, EGFR, cKIT) and next-generation sequencing of tumour biopsy and surgical specimens.

This study will serve as the feasibility of a larger, comparative study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged over 18 years old, ECOG 0-2
2. High-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy and who are potentially eligible for curative surgery
3. Patients who can fully understand the content of the informed consent form and sign it upon their own opinion
4. Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-up

Exclusion Criteria:

1. Patient has any underlying or current medical condition, which would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosus etc.).
2. Patient has severe mental illness.
3. Patient has any other conditions, which would interfere with the evaluation of the subject.
To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children

The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

Primary objective:

To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

Secondary objectives:

* To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
* To evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
* To evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj.
* To evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy boys and girls aged 10 to 12 years
2. Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6)
3. Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study

Exclusion Criteria:

1. 2 weeks have not passed since recovery from an acute disease
2. Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination
3. History of a severe allergy to any component of the investigational product
4. History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine
5. Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years
6. Unable to verify diphtheria and tetanus vaccination completed until the age of 6
7. History of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed)
8. Current chronic disease that impedes implementation or completion of the clinical study
9. Scheduled surgery during the study period
10. Acute fever with a tympanic temperature exceeding 38.0ºC within 72 hours before administration of the investigational vaccine
11. Administration of other vaccines within 28 days before screening
12. Use of immunosuppressants or immune modifying drugs within 3 months before screening
13. Those who have received immunoglobulin therapies or blood derived products within 3 months before screening, or are expected to receive them during the study period
14. Use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine
15. Participation in other clinical studies within 28 days before screening
16. Those who were determined by the investigator to be ineligible for other reasons
Radiation Therapy Following Surgery to Remove Brain Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases.

PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.

OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cerebral metastases post surgical resection
* No greater than 3 cerebral metastases postresection
* Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated
* No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)
* Age: 18 and over
* Karnofsky 60-100%
* Life expectancy: At least 3 months
* Prior or concurrent required steroids allowed
* Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites
* Prior surgery of cerebral metastases allowed

Exclusion Criteria:

* severe asthma requiring therapy
* allergy to iodine or contrast media
* pregnant
* concurrent chemotherapy
* prior whole brain irradiation or focal irradiation to current sites of disease
Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery

The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are candidates for routine, uncomplicated cataract surgery
* Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

* Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
* Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
* Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
* Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
SBRT for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience

Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.

Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.

Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven diagnosis of prostate cancer
* Radical prostatectomy (± salvage radiotherapy)
* PSA relapse (defined by two consecutive rising PSA values \>0.2 ug/l)
* one to three lymphnodes positive on Choline-PET
* no recurrence in prostatic bed on Choline-PET
* WHO performance status of 0-1
* no previous chemotherapy or ADT for prostate cancer.

Exclusion Criteria:

* primary treatment for prostate cancer by RT or brachytherapy
* bone (M1b) metastases
* visceral (M1c) metastases
* any symptomatic nodal lesion
Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE

The aim:1) To test the correlation of pCLE-obtained features with histological findings in UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To test the accuracy of the investigators previously proposed simplified four-grade classification system of crypt architecture in evaluating inflammation activity in UC by pCLE.

Patients with acute inflammatory infiltrates seen on histological assessment are more likely to experience relapse than are those without infiltrates,studies suggest that severity of inflammation is a risk factor for colorectal neoplasia in UC.

The assessment of inflammation activity by conventional colonoscopy is inaccurate in the prediction of acute inflammation in some cases. Confocal laser endomicroscopy (CLE) allows for real-time endoscopy and histological diagnosis of gastrointestinal diseases. In our previous study, we confirmed a simplified four-grade classification system of crypt architecture(Grade A :normal; Grade B: an irregular arrangement of colonic crypts with normal size and shape, and enlarged spaces between crypts; Type C: an enlarged crypt opening and a more irregular crypt arrangement than type B; Type D: crypt destruction and / or crypt abscess) by eCLE in predicting acute inflammation, and found a good correlation with histology. In this study, the investigators aimed to test the accuracy of the proposed tne four-grade classification system in evaluating inflammation activity in UC by pCLE.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18-80;
* patients previously or in-process diagnosed as Ulcerative Colitis

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding, and advanced esophageal cancer;
* Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), lactation, food retention, oesophageal stenosis, postoperative cases, leiomyoma, impaired renal function (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent and other situations that could interfere with the examination protocol.