cyrilzakka/clinical-trials huggingface dataset:
The Application Value of Intercostal Suturing in Preventing Postoperative Thoracoscopic Lung Resection Chest Wall Pulmonary Hernia

The purpose of this trial is to understand whether intercostal suture can effectively prevent postoperative chest wall lung herniation, mainly to verify the following questions Can intercostal suture reduce postoperative chest wall lung herniation The hemostatic effect and hemostatic time of intercostal suture on intercostal muscle incision bleeding during surgery The researchers will divide the participants into two groups, one group will receive intercostal suture, and the other group will not receive intercostal suture, that is, conventional suture The participants will Receive or not receive intercostal suture during surgery Hemostatic effect and hemostasis time of rib intermuscular incision bleeding during surgery Chest CT will be reviewed 3 months after surgery to observe the chest wall incision


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lung resection via multiport thoracoscopic surgery:The intercostal muscles at the main incision site need to be dissected using an electrocautery knife.Intercostal incisions should be used with a retractor and an incision protector to prevent damage to intercostal nerves and blood vessels,as well as rib fractures.

Age greater than or equal to 18 years No history of thoracic surgery

Exclusion Criteria:

* During the operation,if a patient's multiport thoracoscopic surgery needs to be converted to a thoracoscopic-assisted mini-thoracotomy,a rib retractor becomes necessary.

During the operation,conversion to thoracotomy or a conventional posterolateral incision may be necessary based on the specific intraoperative circumstances.

Uniportal thoracoscopic surgery History of ipsilateral thoracic surgery
Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.

Randomised Controlled Study with two arms. All cases following up for post operative Hirschsprungs surgery are included in this study. First arm will receive a probiotics in the form of sachet for 6 months. Second arm will receive a multivitamin as placebo. Comparative analysis between the two groups for baseline and followup prevalence of Hirschsprungs associated enterocolitis.

Eligibility Criteria:
Inclusion Criteria:

* Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria:

* Other cases of Enterocolitis and constipation
Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial

This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.


Eligibility Criteria:
Inclusion Criteria:

* (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score \< III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.

Exclusion Criteria:

* patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.

This study received agreement from the FDA, under a special protocol assessment.

Eligibility Criteria:
Inclusion Criteria:

* Documented evidence of active acromegaly
* Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
* Biochemically controlled

Exclusion Criteria:

* Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label
* Pituitary surgery within six months
* Conventional or stereotactic pituitary radiotherapy any time in the past
* Patients who previously participated in CH-ACM-01 or OOC-ACM-302
* Any clinically significant uncontrolled concomitant disease
* Symptomatic cholelithiasis
* Pegvisomant, within 24 weeks
* Dopamine agonists, within 12 weeks
* Pasireotide, within 24 weeks
Shockwave Assisted Large Bore Access

Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging.

The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Indicated for planned procedure requiring large bore (\>12 French sheath) access
* Mental capacity to provide informed consent
* Iliac access vessel demonstrates \>50% circumferential calcium
* Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
* Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required
* Preoperative CT angiogram, \</= 5mm slices
* Preoperative ABI/TP
* Unsuccessful delivery of large bore sheath without adjunctive intervention

  o Definition of unsuccessful = operator assessment of the following
* Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device
* Adverse forward pressure application by operator
* Failure of device to track with external pressure applied to abdomen
* Patient intolerance of advancement (pain response) in awake patient

Exclusion Criteria:

* Contraindicated for antiplatelet therapy (aspirin or plavix)
* Planned iliofemoral surgical reconstruction in next 30 days
* Prior common or external iliac artery stent placement
* Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
* Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
* Inability to obtain preoperative CTA (contrast allergy, CKD, etc)
* Inability to traverse iliac segment with wire
* Emergent procedure
Effect of Severe Renal Impairment on Pharmacokinetics and Metabolism of a Single Administration of Licarbazepine

This study will assess the influence of severe renal impairment on the pharmacokinetics of licarbazepine and its glucuronide conjugate after single oral administration in healthy subjects and in subjects with stable impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects/patients from 18-60 years of age
* Body mass index (BMI) must be within the range of 18 and 30 kg/m². Subjects/patients must weigh a minimum of 50 kg.
* Female subjects/patients must either have been surgically sterilized or hysterectomized at least 6 months prior to screening.
* Subject/patient must be able to provide written informed consent prior to study participation.

Exclusion Criteria:

* Clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, for patients excluding those normally associated with severe degree of renal impairment or the primary cause of renal insufficiency.
* Use of any over-the-counter medications or herbal / natural supplements during 2 weeks prior to dosing. (acetaminophen is acceptable, but must be documented in the Concomitant Medications / Non-Drug Therapies page of the CRF).
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject/patient if previous history of anemia exists.
* Significant acute illness within the two weeks prior to dosing.
* History of any significant cardiovascular events (M.I., angioplasty, angina) within 6 months of study start.
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
* History of hyponatremia.
* History of seizures.
* Any surgical or medical condition which might significantly alter the absorption,distribution, metabolism or excretion of drugs other than renal impairment or which may jeopardize the subject/patient in case of participation in the study. The investigator should be guided by history of any of the following: inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding gastropathy (gastroparesis) or enteropathy major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection clinical evidence of pancreatic injury or pancreatitis
* History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result .
* History of drug or alcohol abuse within the 6 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.

Other protocol-defined inclusion/exclusion criteria may apply
Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 \[week 26\]) in japanese patients with type 1 diabetes mellitus

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia

The duration of study will consist of:

* Up to 2-week screening period;
* 6-month open-label comparative efficacy and safety treatment period;
* 6-month open-label comparative safety extension period;
* 4-week post-treatment safety follow-up period

Eligibility Criteria:
Inclusion criteria:

* Patients with type 1 diabetes mellitus

Exclusion criteria:

* Age \< 18 years at screening visit;
* HbA1c \< 7.0 % or \> 10.0 % (national glycohemoglobin standardization program \[NGSP\] value) at screening visit;
* Patients less than 1 year before screening visit on any basal plus mealtime insulin;
* Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
* Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;
* Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;
* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eq, laser, surgical treatment or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Vascular Risk Factors in INPH-patients

Idiopathic normal pressure hydrocephalus (INPH) is a treatable and a common disease of the elderly. The overall objective of this work is to describe cardio- and cerebrovascular risk factors and vascular disease in shunted INPH-patients compared to an age- and sex matched elderly population, as well as the impact of vascular risk factors and vascular co-morbidity on clinical symptoms and outcome of surgery in INPH-patients. The hypothesis is that INPH-patients have a higher level of vascular risk factors and subclinical organ damage than a normal elderly population, and that the higher the level of existing vascular risk factors, the more severe the symptoms of the hydrocephalic disease.


Eligibility Criteria:
Inclusion Criteria:

* INPH-patients who underwent surgery 2008-2010 and registered in the Swedish National Register of Hydrocephalus
* age \<60 and \>85
* (only for controls) living in Umeå

Exclusion Criteria:

* death
* a known mini mental state estimation \<23
* inability to communicate (because of severe stroke, aphasia, dementia)
* (only for controls) individuals with INPH who has not yet underwent surgery, or has not been chosen to undergo surgery.
Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis

Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks later).

The purpose of this study is to determine whether this vaccination schedule induces sufficient protective immunity (serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) response rates) in AAV-patients receiving immunosuppressive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ANCA-associated vasculitis: diagnosis of granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
* Indication for pneumococcal vaccination according to French recommendations (statement of the Haut Conseil de Santé Publique regarding pneumococcal vaccination for adults and children older than 2 years old at risk for invasive pneumococcal disease, April 25Th 2013)

Exclusion Criteria:

* History of pneumococcal immunization 36 months to 24hours before VO.
* Patients with known, or suspected pregnancy
* Patients planning to get pregnant in the year following inclusion
* Splenectomy
* Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss) flare
* Infection during the week before inclusion
* Patient without social security coverage
* Individuals opposal
Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary blepharoplasty

Exclusion Criteria:

* use of anticoagulants
microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer

In our study, the investigators want to find correlation between circulating miRNAs associated with prostate cancer metastases to bones and to lymph nodes separately with results of 68Ga-PSMA ligand PET (positron emission computed) imaging.


Eligibility Criteria:
Inclusion Criteria:

* Proven Adeno-carcinoma
* Underwent prostatectomy and still present high PSA levels
* Refered to PSMA exam.

Exclusion Criteria:

* Below 18 years old
* HIV/HBV (hepatitis B virus)/HCV (hepatitis C virus) positive
* Additional malignancy during the past five years.
A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old.
* Locally advanced or metastatic solid tumor with KRAS G12D mutation.
* For Part 1 and Part 2 Combination Group 1: Disease progression on or after prior standard treatment, or intolerance to or ineligibility for standard treatment, or no standard available treatment to improve the disease outcome.
* For Part 2 Combination Groups 2 and 3: No more than 1 prior standard treatment.
* Cohort-specific requirements as follows:

  * Parts 1a and 1d: histologically or cytologically confirmed malignant solid tumor of any tissue origin.
  * Part 1b

    * Disease Group 1: diagnosis of PDAC and at least 1 but no more than 2 prior standard systemic regimens for pancreatic cancer.
    * Disease Group 2: diagnosis of CRC.
  * Part 1c: Confirmed diagnosis of PDAC or CRC.
  * Parts 2a and 2b

    * Combination Group 1 (INCB186748 in combination with cetuximab):

      * Diagnosis of PDAC or
      * Diagnosis of CRC and ∘ Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and

        * In Part 2a: ≤ 3 prior standard regimens.
        * In Part 2b: ≤ 2 prior standard regimens.
    * Combination Group 2 (INCB186748 in combination with GEMNabP) and
    * Combination Group 3 (INCB186748 in combination with mFOLFIRINOX):

      * Diagnosis of PDAC.
      * ≤ 1 prior standard systemic regimen for pancreatic cancer.
* Measurable disease according to RECIST v1.1.
* ECOG performance status score of 0 or 1.

Exclusion Criteria:

* Prior treatment with any KRAS inhibitor.
* Known additional invasive malignancy within 1 year of the first dose of study drug.
* History of organ transplant, including allogeneic stem cell transplantation.
* Significant, uncontrolled medical condition.
* History or presence of an ECG abnormality.
* Inadequate organ function.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

To determine the stage of Diabetic Retinopathy (DR) and the presenting symptoms at the time of ophthalmological examination of diabetic individuals .

Diabetic retinopathy (DR) is the main cause of decreased vision and blindness in patients with diabetes throughout the world . In Egypt, the estimated prevalence of diabetes mellitus (DM) is expected to rise from 5-10% in the 1990s to\>13% of the population over 20 years old by 2025 .

The estimation of the prevalence of diabetic retinopathy (DR) is challenging due to the great variation in the study populations, methodologies, and grading schemes .

Globally, the prevalence of DR and diabetic macular edema (DMO) is expected to rise from the estimates for the period 2015-2019 (27%) due to the expected increase in the life expectancy of people living with DM .

Diabetic retinopathy is now the 5th leading cause of blindness worldwide and is the main cause of blindness in working population .

Blindness due to diabetic retinopathy is more common in type 1 diabetics (4%) than in type 2 (1.6%) .

The exact mechanism of how prolonged hyperglycaemia causes retinopathy is still unclear, however studies have shown that prolonged hyperglycaemia alters retinal perfusion thereby disturbing the normal physiological and homeostatic state of the retina, in turn causing retinopathy .

Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have steadily declined over the past few decades. Such improvements in visual outcomes for DR are multifactorial, and are due in large part to a combination of better systemic risk factor control, coupled with advances in ocular disease assessment, screening, imaging and treatment in recent years .

Eligibility Criteria:
Inclusion Criteria:

* All known diabetic patients ( type 2 ) or patients who were later on diagnosed with type 2 diabetes mellitus as per American Diabetes Association (ADA) criteria who presented for the first time to Assuit university hospital opthalomolgy outpatient clinics during study duration (one year) will be included in the study . Diabetic retinopathy will be classified according to Early Treatment Diabetic Retinopathy Study (ETDRS) classification as mild, moderate, severe and very severe non proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR). Patients with vitreous hemorrhage, rubeosis iridis, neovascular glaucoma or tractional retinal detachment will be classified as having advanced diabetic eye disease (ADED).

Exclusion Criteria:

* Type 1 Diabetic patients or patients with diabetes below 25 years old will be excluded from the study .