cyrilzakka/clinical-trials huggingface dataset:
Frequency of Surgical Site Infection in Abdominal Hernia With Gentamycin Spray on Mesh Versus no Spray

Patient diagnosed with Para umbilical hernia, umbilical hernia, epigastric will be selected for the study. Sampling technique will be systematic with every 2nd patient being exposed to Gentamycin spray during mesh repair. . Each procedure took 90 to 120 minutes approximately. All patients underwent open abdominal hernioplasty operated on elective list. After placing onlay polypropylene mesh fixed with 2-0 prolene and gentamicin 160 mg injection will be sprayed over the secured mesh. Close active suction drain will be placed in subcutaneous space. Finally we will close the skin with Prolene 2-0 with vertical mattress suture or stapler.

Patients and methods:

The study will be conducted at Dow University Hospital Karachi, Ojha Campusa. The subjects included were elective patients operated for abdominal hernias. Sample size calculated for a larger study with 50% frequency, and 99% confidence levels, using Openepi was found to be 664. According to Connelly\*, the sample size of pilot study should be 10% of the sample size of a larger pilot study. As it is a pilot study, the sample size for this study was found to be 66.

We will take the informed consent before including the patient in the study. Inclusion criteria Following hernia operated on elective list

* Para umbilical hernia
* Umbilical hernia
* Epigastric hernia

Exclusion criteria

* All above hernia operated in emergency
* Inguinal hernia

Sampling technique will be systematic with every 2nd patient being exposed to Gentamycin spray during mesh repair. . Each procedure took 90 to 120 minutes approximately. All patients underwent open abdominal hernioplasty operated on elective list. After placing onlay polypropylene mesh, fixed with 2-0 prolene and gentamicin 160 mg injection will be sprayed over the secured mesh. Close active suction drain will be placed in subcutaneous space. Finally skin will be close with Prolene 2-0 with vertical mattress suture or stapler. All patients discharge on a day care basis with follow-ups in the OPD Out patient Department for any post-operative SSI Surgical site infection for a period of two weeks. Drains will be remove once no or less than 20 ml serosanguinous/ serous discharge in 24 hours.

Eligibility Criteria:
Inclusion Criteria:

Elective surgery; Para umbilical hernia, umbilical and epigastric hernia,

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

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ITBS in MCI and Mild AD

This study aims to examine the effects of iTBS on cognitive function in individuals with MCI or mild AD, with a secondary objective of exploring prefrontal TBS mechanisms for cognitive function and the effect of iTBS on BDNF.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5)
* Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)

Exclusion Criteria:

* History of stroke
* History of uncontrol seizure
* History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality
* Mental illness
* Drug abuse
The Safety and Dose Response to Single Anal Doses of NRL001

Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.

This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.

The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.

Eligibility Criteria:
Inclusion Criteria:

* No previous history of ano-rectal conditions/diseases.
* No history of heart disease.
* 18 to 75 years of age.
* Males and females but pre-menopausal females of child bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study.

Exclusion Criteria:

* Use of medication in the last 30 days with vasodilatory activity.
* Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV)
* Regular intake of more than 21 units of alcohol per week.
* Pregnant females.
* Breast feeding mothers.
* Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac)dysfunction.
* Volunteers whom the investigator feels would not be compliant with the requirements of the trial.
Periodontal Disease Prediction System

The purpose of this study was to develop a periodontal disease prediction software and a patient-based gingival recession simulator for clinical practice aiming at improving oral hygiene motivation of patients with periodontal problems.

Periodontal Disease Prediction (PDP) software has three components: a) Data Loading Window (DLW) b) Three-Dimensional Mouth Model (3DM) and c) Periodontal Attachment Loss Indicator (PLI). Demographic and clinical examinations of 1057 volunteers were recorded to DLW. An unsupervised machine learning K means clustering analysis was used to categorize the data obtained from the study population and identified the periodontal risk groups. An intraoral scanner was utilized to capture direct optical intraoral data of a patient and transferred to the 3DM. The intraoral model went under two algorithm steps for obtaining a recessed model. First, gingival curves separating gingiva and tooth were extracted using a Dijkstra's algorithm. Limit curves determining boundaries of recessed regions in the intraoral model were then obtained using gingival curves. The gingival recession was then mimicked by losing gingiva and disappearing tooth roots at proper locations in the intraoral model and Additionally, the final four different 3 dimensional recessed model (maxilla, mandibula, anterior teeth and posterior teeth) belonging to the same patient were scored based on the similarity to the real gingival recession by 25 periodontology specialist via online survey.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years,
* Periodontal status ranging from no clinical periodontal disease (\<10% with bleeding on probing) to periodontitis (stage I to IV)
* Patients having at least one teeth in each quadrant were included.

Exclusion Criteria:

* Patients undergoing orthodontic treatment and using anti-inflammatory drugs were excluded.
PASCAL Trabeculoplasty

Argon laser trabeculoplasty (ALT) with 100 ms pulses is an effective therapy for lowering intraocular pressure (IOP). Similar reductions in IOP have been achieved using ns (SLT) and microsecond (MLT) pulses, which produce less thermal damage to trabecular meshwork (TM). Lack of clinically visible changes may make the accurate alignment of subsequent pulses difficult. We describe a novel technique - Patterned Laser Trabeculoplasty (PLT) using the PASCAL Photocoagulator system, and its preliminary evaluation in patients with open angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* 18-year-old patients
* Uncontrolled Open angle (Shaffer IV)
* No previous surgical trabeculoplasty or glaucoma surgery

Exclusion Criteria:

* Patients not willing to participate
* Angle-closure glaucoma
* No clear optical media
Quality of Life in Patients With Difficult-to-Treat Basal Cell Carcinoma: An Evaluation of Impact and Surgical Outcomes.

FACE-QoL is an observational, prospective, multicenter study aimed at evaluating the impact of surgical treatment on quality of life in patients with stage IIA and IIIB difficult-to-treat basal cell carcinoma of the face, according to the European Academy of Dermato-Oncology classification, using patient-reported outcomes.

The main questions the study seeks to answer are:

Can surgery, as the gold standard treatment, lead to an improvement in the quality of life of patients with difficult-to-treat basal cell carcinoma in functionally and cosmetically challenging sites of the face (i.e., stage IIA and IIIB)? Which clinical and individual variables have the greatest impact on patients' quality of life? Participants will complete questionnaires assessing their quality of life and the impact of the disease on their daily lives.


Eligibility Criteria:
Inclusion Criteria:

* Clinical or histological diagnosis of difficult-to-treat basal cell carcinoma (DTT-BCC) classified as stage IIA or IIIB according to the EADO classification.
* Tumor location: face.
* Intervention: surgical treatment of facial stage IIA and IIIB difficult-to-treat basal cell carcinoma.
* Sufficient knowledge of spoken and written Italian by the patient.

Exclusion Criteria:

* Known psychiatric or substance abuse disorders that may interfere with cooperation and compliance with trial requirements.
* Inoperable or metastatic difficult-to-treat basal cell carcinoma.
* Contraindications to surgery related to the patient's condition.
* Previous radiation therapy involving the field of the target lesion.
Coenzyme Q10 and Dentoalveolar Cyst

10 patients in each group will undergo cyst removal under local anesthesia. After cyst removal, the cystic cavity will be filled with placebo gel in the control group or coenzyme gel in the coenzyme group.

Bone density and volume will be assessed by cone beam CT immediately postoperative and 6months later for all patients


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with critical-size jaw cysts
* Medically stable
* No cystic lesion recurrence

Exclusion Criteria:

* Cystic lesion recurrence
* Medical problem
Risk-adapted Therapy for Primary Systemic (AL) Amyloidosis

High-dose melphalan (MEL) with autologous stem cell transplant (SCT) is an effective therapy for systemic AL amyloidosis (AL), but treatment-related mortality (TRM) has historically been high. The investigators performed a phase II trial of risk-adapted SCT followed by adjuvant dexamethasone (dex) and thalidomide (thal) in an attempt to reduce TRM and improve response rates. Patients with newly diagnosed AL involving £2 organ systems were assigned to MEL 100, 140, or 200 mg/m2 with SCT, based on age, renal function and cardiac involvement. Patients with persistent clonal plasma cell disease 3 months post-SCT received 9 months of adjuvant thal/dex (or dex if there was a history of deep vein thrombosis or neuropathy). TRM was 4.4%. Thirty-one patients began adjuvant therapy, with 16 (52%) completing 9 months of treatment and 13 (42%) achieving an improvement in hematological response. By intention-to-treat, overall hematological response rate was 71% (36% complete response) with 44% having organ responses. With a median follow-up of 31 months, 2-year survival was 84% (95% confidence interval: 73%, 94%). Risk-adapted SCT with adjuvant thal/ dex is feasible and results in low TRM and high hematological and organ response rates in AL patients.

High-dose melphalan (MEL) with autologous stem cell transplant (SCT) is an effective therapy for systemic AL amyloidosis (AL), but treatment-related mortality (TRM) has historically been high. The investigators performed a phase II trial of risk-adapted SCT followed by adjuvant dexamethasone (dex) and thalidomide (thal) in an attempt to reduce TRM and improve response rates. Patients (n=45) with newly diagnosed AL involving £2 organ systems were assigned to MEL 100, 140, or 200 mg/m2 with SCT, based on age, renal function and cardiac involvement. Patients with persistent clonal plasma cell disease 3 months post-SCT received 9 months of adjuvant thal/dex (or dex if there was a history of deep vein thrombosis or neuropathy). Organ involvement was kidney (67%), heart (24%), liver/GI (22%) and peripheral nervous system (18%), with 31% having two organs involved. TRM was 4.4%. Thirty-one patients began adjuvant therapy, with 16 (52%) completing 9 months of treatment and 13 (42%) achieving an improvement in hematological response. By intention-to-treat, overall hematological response rate was 71% (36% complete response) with 44% having organ responses. With a median follow-up of 31 months, 2-year survival was 84% (95% confidence interval: 73%, 94%). Risk-adapted SCT with adjuvant thal/ dex is feasible and results in low TRM and high hematological and organ response rates in AL patients.(British Journal of Haematology 2007;139:224-33)

Eligibility Criteria:
The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* 20 Years and older
* Patients undergoing thoracic surgery

Exclusion Criteria:

* Emergency surgery
* Heart failure
* Pulmonary hypertension
* Forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values
* Coagulation disorder
* Pulmonary or extrapulmonary infections
* History of treatment with steroid in 3 months before surgery
* History of recurrent pneumothorax
* History of lung resection surgery
CD34+ Transplants for Leukemia and Lymphoma

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.


Eligibility Criteria:
Inclusion Criteria:

* Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:

  1. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).
  2. Secondary AML in 1st remission
  3. AML in 1st relapse or 2nd remission
  4. ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission
  5. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
  6. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:

     1. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
     2. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.
  7. Chronic myelomonocyte leukemia: CMML-1 and CMML-2.

The following inclusion criteria are also required:

* Patient's age includes from ≥18 to ≤74 years old.
* Patients may be of either gender or any ethnic background.
* Patients must have a Karnofsky (adult) Performance Status of at least 70%
* Patients must have adequate organ function measured by:

Cardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise.

Hepatic: \< 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.

Renal: serum creatinine: s; 1.2 mg/dL or if serum creatinine is outside the normal range, then CrCl \> 30 ml/min (measured or calculated/estimated).

Pulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin).

Each patient must be willing to participate as a research subject and must sign an informed consent form.

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Active viral, bacterial or fungal infection
* Patient seropositive for HIV-I /II; HTLV -I /II
* Presence of leukemia in the CNS
Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension

In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance.

To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.

The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.


Eligibility Criteria:
Inclusion Criteria:

* more or equal than 18 years old,
* patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment:
* in the last two months,
* expected in the next three months,
* renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR
* chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation
* patient affiliated to social security or similarly regime
* patient who signed the consent to participate in the study

No Inclusion Criteria:

* renal artery anatomy against-indicating the procedure including:
* 3 homolateral renal arteries
* kidney surgery including bypass surgery or renal artery reimplantation
* volume-dependent type of hypertension
* secondary hypertension (not included nephropathy)
* orthostatic hypotension associated with symptoms during the previous year
* medical history including:

  * acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion,
  * surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study period
  * chronic alcoholism
* anticoagulants or antiplatelet agents for which a therapeutic window can not be considered (except aspirin dose less than or equal to 160mg / day)
* contraindication to the realization of an MRI
* included in another trial assessing a medicament or a medical device or a surgical procedure
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years.
* Confirmation of ER positive; HER2 negative Advanced breast cancer
* Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
* Receipt of ≤2 lines of prior chemotherapy for advanced disease.
* Any menopausal status.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.

Exclusion Criteria:

* Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
* Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
* uncontrolled central nervous system metastatic disease.
* Any evidence of severe or uncontrolled systemic diseases.
* Inadequate bone marrow reserve or organ function.
Improving Pain and Function in Hip Fracture

The purpose of this study is to compare two different methods of treating pain after a hip fracture.

This project examines the efficacy and effects of 2 regional anesthesia techniques, femoral nerve blocks (FNB) and fascia iliaca blocks (FIB), on the treatment of peri-operative acute hip (femoral neck, intertrochanteric) fracture pain. Patients age 60 years and over presenting to two New York City emergency departments with hip fracture will be randomized to receive the intervention or usual care. The intervention includes single injection FNB in the ED followed by insertion of a continuous FIB catheter within 24 hours of the single injection FNB plus "as needed" non-opioid/opioid analgesia. Usual care patients will receive conventional therapy with regularly scheduled intravenous or oral opioids plus "as needed" non/opioids/opioids. We will examine the impact of the intervention on patients' self reported pain intensity; systemic opioid requirements; post-operative function; incidence of delirium, treatment related side effects; and hospital length of stay and participation in physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients 60 years of age and over that present to the MSMC ED from 8:00 to 20:00 with a radiographically confirmed hip fracture (femoral neck, intertrochanteric, or peri-capsular) will be screened for study eligibility.

Exclusion Criteria:

* History of advanced dementia
* Presence of multiple trauma, pathological fractures, bilateral hip fractures, or previous fracture or surgery at the currently fractured site
* Patients transferred from another hospital
* Patients with cirrhosis or liver failure.
* The investigators exclude patients with advanced dementia because the investigators will require patients to self-report their pain intensity.
* The investigators exclude these categories of hip fracture because they represent patients with atypical or often problematic clinical circumstances.
* The investigators exclude patients under age 60 because our focus is on treatment of pain in older adults. Younger adults (less than age 60) typically present with fractures of different cause (severe and multiple trauma), are less sensitive to the side effects and complications of opioid therapy, are less likely to have delayed or prolonged functional recovery, and are less sensitive to the adverse and sometimes permanent effects of prolonged bed rest (i.e., from pain) on function.
* The investigators exclude patients with hepatic dysfunction because the intervention protocol includes administration of acetaminophen which can provoke liver failure in patients with advanced liver disease.