cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC.

In metastatic esophageal cancer, radiotherapy is often administered for palliative purposes to alleviate the symptom of dysphagia. Recent studies have shown that the combination of radiotherapy and immunotherapy may have a synergistic effect on treatment outcomes. The study aims to investigate the benefit of LDRT in combination with conventionally fractionated radiotherapy (CFRT) in improving the outcome of metastatic ESCC concurrently treated with first-line immunochemotherapy. The recruited patients will be randomly (1:1) assigned to receive either PD-1 inhibitor plus chemotherapy (paclitaxel and platinum regimen) (arm B) or in combination with LDRT and CFRT (arm A). The primary endpoint is median progression-free survival (PFS).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18;
2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
3. ECOG performance status: 0-1 point;
4. No prior anti-tumor treatment;
5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.

Exclusion Criteria:

1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
2. Patients who are potentially curable with surgery as assessed by investigators;
3. Pleural metastasis or malignant pleural effusion, pericardial effusion;
4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
5. High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
7. Unstable cardiac diseases or symptoms;
8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
9. Active autoimmune disease or history of autoimmune disease;
10. Conditions of immunodeficiency or active infection requiring systemic therapy;
11. Pregnant or breastfeeding;
12. Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).
Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering

Shivering is an early postoperative complication during the postoperative recovery period, and there is no clear consensus about the best way for its prevention. The aim of the study was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with that of parecoxib or placebo for reducing postoperative shivering.

154 patients with American Society of Anesthesiologists physical status I-II, who were scheduled for colorectal operation under general anesthesia, were randomly assigned to receive flurbiprofen (Group F), parecoxib sodium (Group P ) or normal saline(Group S)40min before the end of surgery. Hemodynamic parameters were monitored. The occurrence of shivering postoperative nausea and vomiting were recorded during the recovery period. And visual analogue score (VAS) and ramsy sedation scale (RSS) were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* One hundred and sixty-six, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the prospective, randomized, double-blind clinical study.
* All patients who were from 21 to 62 years old and body mass index 19-35 in tumor hospital of Guangxi medical university (State of China) from April 2014 to April 2015 were included.

Exclusion Criteria:

* Patients with cardiac, pulmonary, hepatic, renal, thyroid, or neuromuscular disease, and those who took chronic drug or abused alcohol were excluded.
* Another patients with hypertension, gastrointestinal bleeding, an initial core temperature \>37.5℃ or \<36.5℃, a history of allergy to non- steroidal anti-inflammatory drugs (NSAIDs) or other agents to be used, and inability to cooperate were also excluded in this study.
* Another patients with blood loss during operation\>400ml, a need for blood transfusion during surgery, duration of operation\>4h and surgical procedures changed were excluded.
Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019

The outbreak of coronavirus disease 2019 (COVID-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ALI), which developed into severe respiratory distress syndrome (ARDS). The mortality was as high as 20% -40%. Due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for COVID-19 pneumonia. Its cure is essentially dependent on the patient's immunity. While the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases.

Mesenchymal stem cells (MSCs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of COVID-19 pneumonia. MSCs prevent cytokine storms by retarding the TNF-α pathway, alleviate sepsis by modulating macrophages, neutrophils, NK cells, DC cells, T lymphocytes and B lymphocytes. After infused, MSCs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.

In vitro, Mesenchymal stem cells were revealed to inhibit the secretion of inflammatory cytokines by spleen lymphocytes and up-regulate regulatory T cells, thereby inhibiting the secretion of interferon-γ(IFN-γ) induced by lymphocytes and Tumor Necrosis Factor(TNF) induced by macrophage.

Animal models and preclinical studies have shown that mesenchymal stem cells (MSCs) were implanted into inflammatory lung tissues after infusion, which significantly improved the clinical manifestations and histopathological lesions caused by acute lung injury. Mesenchymal stem cells inhibited the effects of interleukin-1 (IL-1) through regulatory T cells (CD4 + CD25 + FOXP3 + Treg cells) and by antagonizing the expression interleukin-1 receptor (IL1-RA). Mesenchymal stem cells significantly down-regulated pro-inflammatory factors by inhibiting the expression of IL-1, TNF and IFN-γ in lung tissue, and up-regulated anti-inflammatory factor by enhancing the expression of IL -10 and regulatory T cells, respectively, thereby dampening the inflammatory response.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe COVID-19 pneumonia
* willing to give informed consent

Exclusion Criteria:

* patients with mild COVID-19 pneumonia
* liver dysfunction
* concomitant with other active infection
* renal dysfunction
* Heart failure \>grade 2
* pregnant
* history of COPD
Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study

The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is:

• If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity.

Participants admitted for stoma reversal will be divided into two groups:

1. EE: Conventional Hand-sewn end-to-end anastomosis, and
2. SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:

   1. HSSA: Hand-sewn side-to-side anastomosis
   2. SSSA: Stapled side-to-side anastomosis

Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see:

1. Rates of major post-operative complications
2. Rates of short-term complications (within 30 days of surgery)
3. Rates of re-operation
4. Post-operative length of stay in the hospital


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were all the patients admitted in general surgical wards of SMS Hospital, Jaipur, for stoma reversal, after taking written informed consent

Exclusion Criteria:

* Pre-operatively diagnosed malnutrition or cachexia
* Bleeding disorders
* Patients undergoing stoma reversal along with a concurrent abdominal surgery
* Rectal anastomosis
* Use of circular stapler for anastomosis.
Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma

This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases
* Have measurable disease
* Have previously been treated with an irinotecan based chemotherapy
* Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer
* Be at least 18 years of age
* Have laboratory data as specified below:

  * Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal
  * Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L)
  * Creatinine less than 1.5 mg/dL (SI units, 132 mol/L)
  * White blood cell (WBC) count greater than 3,000/mm3
  * Platelets greater than 100,000/mm3
  * Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L)
  * International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits
* Have a life expectancy of at least 3 months
* Have a KPS score of 70 or greater
* Use contraceptive methods, if sexually active
* Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments

Exclusion Criteria:

* Be pregnant or nursing
* Have only symptomatic locally recurrent colorectal cancer
* Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer
* Have received any prior anticancer immunotherapy
* Have central nervous system metastasis, whether treated or not
* Have bone metastases as sole manifestation of metastatic colorectal cancer
* Have received chemotherapy within the previous 21 days
* Have had major surgery within 21 days
* Have immunodeficiency (primary or acquired)
* Have undergone bone marrow transplantation within the last year
* Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed
* Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids
* Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration
* Have contraindication to irinotecan based therapy
* Have hypersensitivity to diphtheria toxoid
* Use in the past 14 days or chronic concomitant use of proton pump inhibitors
* Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness
* Have any condition that is likely to detrimentally affect regular follow up
Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (\> 3 hepatic segments).


Eligibility Criteria:
Inclusion Criteria:

* Signature of the consent form
* Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)

Exclusion Criteria:

* Absence of signature of the consent form
* Patient with cirrhosis
* Minor hepatectomy (\< 3 hepatic segments)
* Hepatectomy associated with vascular resection
* Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection
* Pregnant or lactation
Single Incision Laparoscopic Cholecystectomy Compared with Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study

Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.


Eligibility Criteria:
Inclusion Criteria:

* Benign gallbladder disease

Exclusion Criteria:

* Combined with liver cirrhosis (Child grade B and above)
* Upper abdominal surgical history;
* Gallbladder gangrene perforation;
* Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.)
* patients and their families do not agree with the treatment lost follow-up
Long-Term Follow-up After Ventral Hernia Repair With Strattice Mesh

This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.

Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Hernia repair with Strattice Mesh
* Age 18 or older

Exclusion Criteria:

* Under age 18
* No history of hernia repair
Alcohol Monitor Validation

This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

The overarching goal of this research program is to improve alcohol intervention and eventually related clinical outcomes (e.g., liver function) among HIV+ drinkers through biosensor-assisted intervention. Research shows HIV infection can influence alcohol metabolism (i.e., higher blood alcohol levels), so it's necessary to validate the new alcohol biosensor in HIV+ drinkers rather than in general population. The primary goal of this project, as a step toward the development and evaluation of a biosensor-assisted alcohol intervention, is to validate the newly available wrist worn transdermal alcohol biosensor (BACtrack Skyn). The two specific aims are: (1) To assess validity and reliability of the Skyn biosensor using fixed-dose lab administration of alcohol through comparison with laboratory grade breathalyzer, and (2) To validate Skyn biosensor in daily life using a 2-week ecological momentary assessment (EMA) to compare self-reported drinking and the Skyn derived transdermal alcohol concentration (TAC) readings.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
* HIV- consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks

Exclusion Criteria:

* non-drinkers
* recent addiction treatment or treatment seeking
* urine positive for illegal drugs except THC (not applicable to those who are only invited to do field test);
* past \& current alcohol withdrawal
* severe alcohol use disorder (DSM-5)
* meeting criteria for current nicotine dependence (not applicable to field only participants) or current substance use disorder (excluding mild cannabis use disorder and mild/moderate alcohol use disorder)
* medical conditions (other than HIV) contraindicating alcohol
* pregnancy/breastfeeding in women
* psychosis or other severe psychiatric conditions.
Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)

Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. The aim of this study is to to test if Paula Method (circular muscle exercise) can be an another treatment modality.

Paula method is based on circular muscle exercises. The theory behind the Paula method is that all sphincters in the human body work simultaneosly, mutually affecting one another possibly mediated by "oscillation" of the spinal cord. According to this theory, exercising the ring muscles in a certain area of the body will result in strengthening the circular muscles in other areas. This method was found to to be efficacious for treatment of urinary stress incontinence in women.

Eligibility Criteria:
Inclusion Criteria:

1. age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
2. informed consent

Exclusion Criteria:

1. UTI
2. neurological diseases or syndromes
3. metabolic disesaes
4. congenital disease or malformation of the urinary tract
Effect of a Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty

The aim of this study is to investigate the impact of a preoperative pulsed electromagnetic field and abdominal exercises on muscle strength post ventral hernioplasty.

Sixty patients, 25-40 years old, diagnosed with a ventral hernia and consulted for surgical hernia repair, preoperatively, were randomly assigned either into pulsed electromagnetic therapy and graduated abdominal strengthening exercises group (group A), graduated abdominal strengthening exercises group (group B), pulsed electromagnetic therapy group (group C) or group D who is instructed to presume in normal activities of daily living preoperatively, without any abdominal exercises or PEMF. All treatment interventions were applied at a frequency of three sessions per week for six weeks preoperatively. Abdominal muscle torque was measured by a biodex isokinetic dynamometer preoperatively at baseline and after six weeks of intervention and after four months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Being subjects of both genders.
* Between the age of 25-40 years.
* Diagnosed with a ventral hernia (Grade II \& III) based on surgeon assessment and desired an elective surgical repair.
* Able to act in the abdominal training program.

Exclusion Criteria:

* Patients with a strangulated hernia.
* Bowel obstruction, peritonitis or perforation.
* Urgent surgery indication.
* Less than one-year abdominal surgery.
* Infection (local or systemic).
* Orthopedic problem, or neurological impairment that interfere with patient ability to act in the abdominal training program.
* Pregnant women.
Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel

Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor, on the anti-platelet action of clopidogrel.

The main decision criterion will concern change in VASP protein phosphorylation under treatment. Phosphorylation will be measured before and after administration of omeprazole versus placebo in patients undergoing clopidogrel treatment.

Type of study: Single center, double blind, randomized parallel group study versus placebo, comparing two treatment groups:

* clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin)
* clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin)

Study population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test.

Study period: 7 days' treatment per patient. Total study period estimated at 6 months.

Expected findings: The results should confirm the suspected negative effect of omeprazole on clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to be drawn up for this association.

Preventing recurrence of thrombosis following angioplasty relies on dual-therapy associating the anti-platelet agents aspirin and clopidogrel. This regime is kept up for between 1 and 6 months, depending on the type of stent deployed in the angioplasty. The biological effectiveness of the clopidogrel treatment can be assessed by the VASP test, a new platelet test, results on which have been shown to correlate with risk of thrombosis. A study we ran recently strongly suggested that omeprazole was associated with a poor response to clopidogrel. Omeprazole is an anti-ulcer agent frequently prescribed to prevent unwanted side-effects of aspirin, making it frequently associated to clopidogrel in the aftermath of angioplasty.

Study population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test.

Study period: 7 days' treatment per patient. Total study period estimated at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patient with indication of aspirin and clopidogrel treatment

Exclusion Criteria:

* patient\<18 years
* liver disease
* drug eluting stent
* gastrointestinal ulcus
* bleeding
* pregnancy