cyrilzakka/clinical-trials huggingface dataset:
The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers

Cardiovascular diseases (CVD) and neoplasms are the main causes of death in Brazilian women. Coronary artery disease (CAD) and stroke were responsible for approximately 54% of deaths from CVD in this population. In Brazil, cancers were the second cause of death and in 2017 were responsible for 58% of deaths in women. CVD and cancer share some risk factors, and control of these factors is associated with a significant reduction in cancer incidence. These two causes of death, although apparently disparate, share similar lifestyles and health risk factors, suggesting some common pathways and basic molecular networks. In women, the presence of estrogen has protective effects against atherosclerosis and, with the decline in hormone production at menopause, the incidence and prevalence of CAD increase substantially. Although the estrogen pathway is supposed to have a central effect on this increased risk, it is still debated whether other non-estrogenic mechanisms are related, since hormone replacement alone does not reduce cardiovascular events. Sirtuins and soluble advanced glycation product receptors (sRAGE) are associated with increased vascular protection, while the role of apoptosis inhibiting proteins, a pathway linked to increased cancer incidence, is still unclear in the context of atherosclerosis. Resveratrol is a key activator of sirtuins and potentially modulates these metabolic pathways, reducing cardiovascular risk. This randomized, double-blind, parallel, placebo-controlled clinical trial will be carried out in 80 postmenopausal women with CAD to analyze the effect of treatment with resveratrol on serum concentration and gene expression of sirtuins-1 -3, in the serum sRAGE concentration and in the gene expression of apoptosis inhibitory proteins.

The objective of the study is to evaluate the influence of sirtuins stimulation by resveratrol on inhibitors of apoptosis proteins gene expression of circulation angiogenic cells of postmenopausal women with stable coronary artery disease.

A randomized, double-blind, parallel, placebo-controlled clinical trial in postmenopausal women with CAD submitted to 90 days of daily resveratrol supplementation days of daily supplementation with 1000 mg of resveratrol. Eighty women aged ≥55 years, with overweight or obesity grade 1 (BMI between 25 and 35 kg/m2) will be selected. The participants will be randomized into two groups, control (CON) and resveratrol (RES). After the screening, the participants will undergo the first clinical and laboratory evaluation including lipid and glucose metabolism, inflammatory biomarkers, serum concentrations and gene expression of sirtuin-1 and sirtuin-3 and soluble receptor of advanced glycation end products, and the gene expression of inhibitors of apoptosis proteins.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women;
* Diagnosed coronary artery disease;
* Stable coronary disease;

Exclusion Criteria:

* hypo or hyperthyroidism,
* rheumatic disease,
* use of alcohol,
* hepatic failure,
* renal failure
* hormone replacement therapy
* use of insulin
Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers

The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers. Additionally, to assess whether the intervention increases use of professional obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies (SEPs).


Eligibility Criteria:
Inclusion Criteria:

* have an infant in the NICU at Children's Memorial Hermann Hospital (CMHH)
* have a positive urine drug screen at delivery or have an infant with a positive urine or meconium drug screen or self-reported drug use to a healthcare provider or had a documented positive drug screen during pregnancy
* have access to a telephone.

Exclusion Criteria:

* currently attending substance abuse treatment
* severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
* inability to read, write, speak English or Spanish
* inability or unwillingness to provide signed consent for participation; (5) inability or unwillingness to meet study requirements.
Bougie Sleeve Trial

Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.

The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years
* Sleeve gastrectomy as a primary bariatric procedure
* Body Mass Index (BMI) \> 40 kg/m² or \> 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis)
* Decision for intervention after multidisciplinary discussion
* Written informed consent

Exclusion Criteria:

* Previous upper abdominal surgery (cholecystectomy excepted)
* ASA (American Society of Anesthesiologists) score \> 3
* Ongoing pregnancy or breast feeding
* Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures)
* Coagulation disorder
* Patient not covered by social security service and patient on AME
* Patient under legal guardianship and trusteeship
* Patient with known silicon allergy (calibration bougie contains medical silicon)
* More generally, all other contraindications to the use of esophageal bougie MID-TUBE that have been the subject of a scientific paper or have been identified by the practitioner or practitioners
The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Adult Patients

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in adult patients. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (20-70 years of age) scheduled for elective surgery undergoing general anesthesia using LMA-classic size 3-5

Exclusion Criteria:

* patients with an abnormal airway,
* patients with reactive airway disease,
* patients with gastroesophageal reflux disease,
* patients with chronic respiratory disease,
* or a history of an upper respiratory tract infection
Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children

Inevitable problems were reported following the injection of local anesthesia in pediatric dental procedures, which can last until the elimination of soft tissue anesthesia.

Purpose of the study: To evaluate the effectiveness of diode laser photobiomodulation therapy on the reversal of soft tissue anesthesia (STA) in children following inferior alveolar nerve block anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of operative dental procedures, requiring inferior alveolar nerve (IANB) anesthesia.
* Healthy patients (physical status ASA I).
* Definitely positive or positive patients on the Frankl behavior scale.
* No reported allergies to LA, epinephrine or sulfites.
* Normal lip sensation before administration of LA

Exclusion Criteria:

* Patients requiring surgical procedures (i.e. extractions).
* Patients who will show excessive fear to the Transcutaneous Electric Nerve Stimulator (TENS) device and provide a false-positive response on inactivated electrode (absence of current) using the Venham scale.
* Patients who will not be trainable in the standardized lip tapping procedure (could not learn to distinguish the anesthetized numb side from the non-anesthetized side).
* Patients who will not achieve profound numbness after initial LA administration, requiring additional anesthesia using SEM scale.
Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study

This study included group (A) (60 patients with liver cirrhosis and complaining of gall stone) in whom LC was done using traditional method (TM) by clipping both cystic duct and artery and dissection of gall bladder from liver bed by diathermy, and group (B) (60 patients with liver cirrhosis and complaining of gall stone) LC was done using harmonic scalpel (HS) closure and division of both cystic duct, artery and dissection of gall bladder from liver bed by harmonic scalpel. The Intraoperative and postoperative parameters were collected included duration of operation, postoperative pain, and complications.

Under general anesthesia, and same antibiotics (3rd generation cephalosporin) Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitoneum at pressure 12 mmHg was used.

In group (A) LC was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. Then dissection of gall bladder from its bed by hook using electrocautery technique. Finally we insert abdominal drain in Morrison pouch.

In group (B) LC was done using harmonic ACE (Ethicon Endo-Surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ACE. For closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. And when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. And control of any bleeding from the bed using the active blade of harmonic ACE. Finally we insert abdominal drain in Morrison pouch.

The Intraoperative parameter observed included duration of the operation, bile escape and volume of blood loss were recorded The patients started oral feeding 8 h postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. The patients were usually discharged after removal of drain, and when the patient surgically free.

Postoperative pain was evaluated at 12 h, 24h, 48, 1 w after operation using a visual analog scale (VAS)

Eligibility Criteria:
Inclusion Criteria:

* patients with liver cirrhosis with symptomatic gall bladder stone

Exclusion Criteria:

* patients above 80 years old,
* patients with history of upper laparotomy,
* patients with common bile duct stones
* and pregnant females.
Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer

Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.

In patients undergoing hepatic resection for liver cancer (with cirrhosis or fibrosis liver), mortality rate can reach 10% and morbidity (ascites, icteria, infections) 70%. These complications are mainly due to hepatic insufficiency: surgery leaves a reduced parenchyma, with oxidative stress lesions due to reperfusion injury. A good preoperative nutritional state has been shown to reduce complications and mortality. This can be amplified by preoperative nutrition with supplements containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides which boost immune responses, resistance to infections and liver function recovery. In this context, the study randomly assigns 50 patients who were scheduled to undergo hepatic resection, to receive either an oral immune-enhancing nutritional supplement or a placebo, for the 7 last preoperative and the first 3 postoperative days. The aim of the study is to evaluate the effects of this supplementation on liver function, immunity, and incidence of infections after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult over 18 years
* Hepatectomy of at least 2 segments
* For primary or secondary cancer
* With cirrhosis (Child Pugh \<8) or liver fibrosis (fibrosis score of 3)
* Informed written consent

Exclusion Criteria:

* Pregnancy
* Recent weight loss of more than 10% of body weight
* Immunological deficiency
* Portal or hepatic arterial thrombosis
* Biliary duct dilation
Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis

The purpose of the study was to analyze the resolution rate of benign biliary strictures due to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully covered self-expandable metal stents.

Endoscopic treatment of benign biliary strictures include the placement of plastic stents or Self-Expandable Metal Stents. Long term results of placement of a single plastic stent are disappointing. Better results have been obtained by endoscopic insertion of multiple plastic stents.

Biliary Self-Expandable Metal Stents used for malignant strictures are uncovered or partially covered with a plastic coating. More recently, fully covered SEMS have been developed and are now available on the market and due to their removability are proposed also for benign indications.

Uncovered and partially covered biliary Self-Expandable Metal Stents for chronic pancreatitis-related benign biliary strictures on long-term may clog due to tissue ingrowth through the uncovered meshes.

Removable fully covered Self-Expandable Metal Stents seem to be an attractive option for CP-related BBS, but scarce data are available in the literature.

The investigators conducted a feasibility, prospective, tertiary single-centre trial to investigate the durable resolution of chronic pancreatitis-related benign biliary strictures after temporary insertion of FC SEMS with unflared-ends and flared-ends.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years,
2. symptomatic (persistent cholestasis, jaundice, cholangitis) common bile duct strictures secondary to CP, that persist 3 months or more after placement of a single 10 French plastic stent and
3. patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.

Exclusion Criteria:

1. benign biliary strictures secondary to compression from a pancreatic pseudocyst;
2. patients with associated pancreatic neoplasia
3. ongoing alcohol abuse (ethanol \> 80 g/day).
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors

This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedure being performed;
2. Age 18 years or older;
3. Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
4. Patients with life expectancy ≥3 months;
5. Patients must have at least one measurable lesion as defined by RECIST v1.1;
6. Eastern Cooperative Oncology Group performance score 0 or 1;
7. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
3. Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
5. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
6. Patients who have impaired cardiac function or clinically significant cardiac diseases;
7. Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
8. Use of an investigational drug during the past 30 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
9. No other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy radiotherapy (except for palliative local radiotherapy), biological therapy or other novel agent is to be permitted while the patient is receiving study medication.
Study of Airway Inflammation in Relation to Exercise in Elite Athletes

High school elite training programs are today more and more under development in several 'elite sport schools' in Belgium, in order to select and train future elite athletes already at young age. Little is known about the effects of sustained training on the potential development of asthma in adolescents during lung growth. It would be of great importance to be able to select the individuals at risk to develop exercise-induced asthma, already at the start of their enrollment in the 'elite sport school. This would allow physicians to follow their lung function parameters very closely and regularly; and, if necessary, start treatment early after the first signs of exercise-induced asthma.

Competitive swimmers, competitive indoor athletes and control individuals performing sports at a recreational level will be recruited for the study.

They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes, indoor athletes: basketball or volleyball for 90 minutes)

Baseline measurements:

* Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
* Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
* Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
* Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
* Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.

Measurements immediately after training:

* Collection of nasal fluid
* Assessment of upper airway symptoms (Visual Analogue Score)
* Spirometry and Fraction of Exhaled Nitric Oxide measurement
* Peak Nasal Inspiratory Flow measurement

Measurements 24 hours after training:

* Collection of nasal fluid
* Assessment of upper airway symptoms (Visual Analogue Score)
* Spirometry and Fraction of Exhaled Nitric Oxide measurement
* Peak Nasal Inspiratory Flow measurement
* Sputum induction
* Venous puncture (1 tube of 10 ml)

Eligibility Criteria:
Inclusion Criteria:

* Performing sports at national or international level (swimmers and indoor athletes)

Exclusion Criteria:

* Performing sport at recreational level (not more than 4 hours/week for healthy individuals)
Long-Covid in Patients Post Rehabilitation Treatment and Reintegration Into Everyday Life

The aim of the first study is to investigate how often a long Covid syndrome occurs after an inpatient rehabilitation due to previous hospitalization because of after acute Covid and whether there might be a connection with the severity during acute illness. 3 clusters of acute cases have been identified to be studied with regard to the long-term symptoms

1. Mild course (medication, oxygen)
2. Moderate course (IPS-IMC with NIV but without intubation)
3. Severe course (intubation)

The aim of the second study is to use a catamnestic survey and subsequent evaluation of the information to gain an insight into the existing functional deficits relevant to everyday life and restriction of the ability to participate in the workplace after rehabilitation treatment. The assessment of functional deficits is carried out in relation to:

1. Deficits in everyday skills (ADLs)
2. Restrictions in the ability to participate in the profession.

All patients who had been infected with Walenstadtberg after acute Covid infection were included.

Patients were hospitalized for inpatient rehabilitation in the period from 01.04.2020 to 30.06.2022.

A written follow-up survey was carried out with regard to a possible persistent long Covid symptoms and possible persistent deficits in everyday skills and Restrictions in the ability to participate in the profession. There are 2 cohort studies.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* treated at a rehabilitation facility after being hospitilized for covid-19 infection
* complete questionnaire
* written consent to use collected data

Exclusion Criteria:

* \< 18 years
* incomplete questionnaire
Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients

Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response rate in hemodialysis patients.

Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to HBV vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on Td vaccine response rate in hemodialysis patients. In this randomized double-blind placebo-controlled trial 40 hemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin G (IgG) levels (\<0.1 International Unit \[IU\]/ml) were enrolled. These patients were randomized into two equal groups to receive one dose of intramuscular Td vaccine supplemented with either levamisole 100 mg or placebo daily, six days before and six days after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* being under regular hemodialysis for more than 3 months
* unprotective baseline levels of antitetanus IgG

Exclusion Criteria:

* tetanus diphtheria (Td) vaccination in past year
* leukopenia (WBC\<1500 cells/mcL)
* immunosuppressive drug exposure in past 2 months
* recent hospitalization or history of transfusion of blood products in the past 3 months.