cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis

This study was performed to evaluate the safety and efficacy of a locally designed Assiut Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety

The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI instead of conventional 6 hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure till distal pulse is palpated. Each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 85 years of age,
* Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.
* Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Exclusion Criteria:

Patients were excluded from the study if the patient has

1. Any procedural complication included:

   * prolonged chest pain,
   * transient coronary artery closure, no-flow or slow-flow phenomenon,
   * hemodynamic instability,
   * persistent electrocardiographic changes,
   * side-branch occlusion of \>1.5 mm, or
   * an angiographically suboptimal result,
2. Arterial access other than the right or left femoral artery ,
3. Vascular perforation, thrombosis during procedure ,
4. Patients with high risk of puncture site complications as:

   * Bleeding diathesis,
   * International normalized ratio \>1.5,
   * Recent thrombolysis,
   * Low platelet count,
   * Hematoma at the end of the procedure,
   * Previous iliofemoral artery surgery or any peripheral vascular Surgery,
   * Previous femoral artery complication from angiography, and
5. Uncontrolled hypertension at time of procedure (\>180/\>110).
Factors Influencing Cardiovascular Prognosis

The purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years.

Inclusion criteria

* Age \> 50 years volunteers (2 towns of 15000 residents one in the north and one in the south of Greece)
* End points
* 5-10 years cardiovascular morbidity and mortality

Measurements at baseline

* Anthropometrics

  * Age (M\>55 years; W\>65 years)
  * Weight-height- BMI
  * Abdominal obesity (Waist circumference\>102 cm(M), \>88cm (W) Family history
  * Family history of premature CV disease (M at age\<55 years; W at age\<65 years)

History

* Smoking
* Diabetes Mellitus,
* Established Heart disease: myocardial infarction; angina; coronary revascularization; heart failure
* Established renal disease \[diabetic nephropathy; renal impairment (serum creatinine M\>133, W\>124 mmol/l); proteinuria (\> 300 mg/24 h)\]
* Cerebrovascular disease: ischaemic stroke; cerebral haemorrhage; transient ischaemic attack
* Peripheral artery disease
* Advanced retinopathy: haemorrhages or exudates, papilloedema
* Treatment

Measurements

* Measurements Blood pressure

  * Clinic BP
  * 24h ABPM
  * Home BP

Heart

* Electrocardiographic LVH
* Echocardiographic LVH

Vessels

* Carotid wall thickening or plaque
* Carotid-femoral pulse wave velocity
* Ankle/brachial BP index

Lipids or other risk factors

* Total cholesterol, Tg, HDL, LDL
* Plasma creatinine, estimated glomerular filtration rate
* Fasting plasma glucose or postload plasma glucose
* Microalbuminuria and albumin-creatinine ratio
* Glucose tolerance test

  * Follow up each 3 year with all the above measurements

Eligibility Criteria:
Inclusion Criteria:

* All age \>50 volunteers

Exclusion Criteria:

* None
Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer

Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type.

Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration.

Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects


Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated by post dilution on-line HDF for at least three months.
* Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks,
* Patients who are on a stable anticoagulation and anemia management,
* Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator,
* Patients who are on a regular thrice weekly HDF schedule,
* Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (\> 300 ml/min),
* Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent,
* Patients who are aged 18 years or older.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria,
* Patients with active HBV, HCV, HIV infection,
* Patients who are severely malnourished patients as judged by the principal investigator,
* Patients who are known or suspected to have allergy to the trial products or related products,
* Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages),
* Patients who have been diagnosed a current active malignant disease,
* Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month,
* Patients who are uncooperative.
Management of Fournier Gangrene at Ibn Rochd University Hospital Center

Case series with retrospective data collection of patients treated for Fournier's gangrene between January 2010 and March 2017. The main etiologies, risk factors, postoperative complications outcomes and long term follow up results were analyzed.

Eight four (84) patients were recruited. The average age of our patients was 49 years (with limits of 20 to 76), the male gender dominates our series (83.33%) with a sex ratio of 5M / 1W, the most frequently found risk factor was diabetes mellitus (37%). The most common etiology was anal abscesses (32%). The average time to consultation was 8 days (limits ranges from 3 to 30 days). All patients were admitted at a necrosis stage (100%). Anemia was identified in 85% of cases. The low platelets were noticed in 44.03% of cases. Hypoalbuminemia was found in 93% of cases. All patients (100%) benefited resuscitation initially and antibiotic therapy on their admission. They received emergency surgical debridement with a cleansing stoma. The average length of hospital stay was 13 days and complications occurred in 33% of cases. The mortality rate was 7.14%. then we conclude that Fournier's gangrene is a medico-surgical emergency with a high morbidity and mortality rate. Early diagnosis as well as antibiotic therapy and the quality of debridement save the patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Fournier Gangrene

Exclusion Criteria:

* Other perineal diseases which are differential diagnosis of Fournier gangrene
Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

The researchers are trying to evaluate how much medication is required for allergy skin testing and to determine the likelihood that patients with a negative test truly don't have an allergy to the tested drug of skin testing to commonly used antibiotics.

This study will be a prospective study to accurately determine the negative predictive value of skin testing with beta lactam containing antibiotics other than penicillin .

It is hypothesized that the concentrations that should be used for beta lactams are actually much lower than previously recommended and that the higher incidence of identifiable beta lactam induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Eligibility Criteria:
Inclusion Criteria:

* All adults \> or = to 18 y/o undergoing surgery

Exclusion Criteria:

* Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.
Pediatric Epilepsy Study

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.


Eligibility Criteria:
INCLUSION CRITERIA: To enter this study, patients must:

* Have a diagnosis of partial seizures
* Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication
* Be willing to be hospitalized for up to 5 days
* Weigh a minimum of 6.6 lbs
* Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease
* Have normal laboratory results

EXCLUSION CRITERIA: To enter this study, a patient must not have or be:

* Seizures caused by metabolic disturbance, toxic exposure, or active infection
* A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures)
* A history of status epilepticus within 30 days
* Seizures not related to epilepsy
* This study has some AED restrictions
* Serum sodium levels \<135 mEq/L
* Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy
* A history of chronic infection (e.g., hepatitis or HIV)
* Significant electrocardiogram (ECG) abnormalities
* A nursing mother taking anti-convulsant drugs
* A history of substance abuse (including alcohol)
* Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
* Used experimental medication within 30 days of entering this study
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Patients who will undergo caesarean section under general anesthesia will be included in the study.

In the study; preoxygenation is applied to the caesarean sections under general anesthesia in two ways. Group1 includes preoxygenation masked patients.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old;
* Patients undergoing elective ceserian operation

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients under emergency conditions.
Health Economics Evaluation of the Management of Severe Postpartum Hemorrhage: Comparison of Recombinant Activated Factor VII Strategy to the Reference Strategy

The main objective of this project is to assess the average cost of the treatment of bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in some cases very costly invasive procedures. It will be interesting to compare the average cost of the complete strategies supported.


Eligibility Criteria:
Inclusion Criteria:

* Severe haemorrhage is defined by the following criteria: blood loss greater than 1500 ml graduated measured in the bag and / or hemodynamically unstable and / or requiring transfusion of packed red blood cells (3);
* Sulprostone (Nalador®) ineffective;
* Age over 18 years;
* The term is more than 27 SA (child's viability);
* Without anthropomorphic limit;
* The outcome of the pregnancy is normal or pathological;
* Informed consent "emergency procedure" is signed by the husband or family.

Exclusion Criteria:

* minors, majors in guardianship, with a personal history of venous or arterial thrombosis may cons-indicate treatment with rFVIIa or refuses to sign the consent
Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study

In order to determine the Efficacy of Betaglucin 0.2% in gel vs Imiquimod 5% cream in the treatment of 102 individuals older than 18 years with anogenital warts trials in two arms 51 with Betaglucin 0.2% and 51 with Imiquimod 5%.

Betaglucin soluble gel at 0.2% is produced in Costa Rica by a biochemical researcher. Obtained by chemical process improves the immune response by increasing 80 times the number of macrophages and Natural Killer cells. Specifically in human papillomavirus-related anogenital warts.

As clinical researchers, the investigators pretend to determine the therapeutic efficacy of betaglucin 0.2 % gel compared with Imiquimod 5% cream in two groups of individuals from 18 to 50 years old males and females.

Based in mathematics and biostatistics formula used by Professor Roman Fentin, French academic working in the University of Costa Rica. Medicine Faculty in San Jose the number of participants should be 102.

Divided into two arms. Arm betaglucin 0.2% 51 individuals treated with betaglucin soluble gel at 0.2% Arm imiquimod 5% 51 individuals treated with imiquimod cream at 5 % After three months of follow-up of all individuals, will be classified as clearance, partially cured and not cured.

The plan of analysis will be:

* Chi-square test between the two groups (depending on the treatment) and the success or not of the treatment.
* Logistic model with a dependent variable the success or not of the treatment and with independent variables the treatment, sex, age. It will make it possible to verify that the differences observed in 1 are not due to another factor.
* Logistic model with a dependent variable the success or not of the treatment and with independent variables the treatment, the sex, the age, and an interaction sex-age. It will allow us to observe if there is a difference in the result according to the patient's sex.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 50 years with anogenital wart visible on physical examination and positive for HPV 6 and 11 by polymerase chain reaction (PCR) test with detection by agarose gel electrophoresis.

Exclusion Criteria:

* Pregnant women.
* Vaccinated against human papillomavirus (Gardasil, Gardasil 9 or Cervarix).
* Patients Immunosuppressed by drugs (Chemotherapy, Corticoids, use of antibiotics for more than 7 days and/or antituberculous treatment.)
* Molluscum contagiosum.
* Skin Appendages.
* Urethral prolapse.
* Botryoid sarcoma.
* Herpes type II.
* History of anogenital surgery in the last 4 weeks.
* Intake of natural products or immunomodulators.
* Patients who have received 5% imiquimod cream.
Pharmacokinetics of HR17031 Injection in Healthy Subjects

To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ranges from 18 to 27 kg/m2 (both ends included), and the body weight is ≥50 kg for men and ≥45 kg for women；
2. Fasting blood glucose during the screening is \< 6.1 mmol/L；

Exclusion Criteria:

1. It has clinical significance for abnormalities Laboratory examination, if there is a clear reasonable reason, can be retested within a week, with the retest results Whether the subject meets the requirements
2. Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening;
3. Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)
Pelvic Osteotomy Of The Total Hip Replacement

This observational study aims to learn about the outcomes in the previously operated patient and whether pelvic bone rearrangement surgery was a success.

The main question it aims to answer is:

• Should the investigators perform pelvic rearrangement surgery on a patient if there's not enough bone stock to accomplish the exchange of the components?

As the research started the participant was asked to attend outpatient clinics regularly and keep in touch. The investigators were able to observe the outcomes and closely explore probable risks for failure.

A 56-year-old female patient had a hip operation one year previously and experienced her first dislocation two months postoperatively. The patient underwent closed reduction three times. The patient presented to us due to a fourth hip dislocation that had occurred one month previously. Hip X-ray images revealed acetabular component malposition, with an 80-degree inclination and 20 degrees of cup anteversion with a posterior hip dislocation. The investigators treated the patient via pelvic osteotomy, using a modified Stoppa approach to reduce acetabular inclination. The patient had no dislocation at the 2-year follow-up. At the last follow-up, the Harris Hip Score was 85.

Eligibility Criteria:
Inclusion Criteria:

* Previously Replaced Total Hip
* Minimum 1-year follow-up
* 18-45 years, both sexes
* otherwise healthy

Exclusion Criteria:

* Any debilitating disorder
* Neurological or genetic disorders
* Pediatric or geriatric age
A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
2. ECOG Performance Status less than or equal to 2
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
4. EPd Cohort:

   * must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
   * Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
5. EN Cohort:

   * Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.

Exclusion Criteria:

1. Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
2. Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
3. Subjects with Central Nervous System involvement with multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply.
Interventional Study for Detection of Prognosis of Blood Based Biomarkers in Intracerebral Hemorrhage

Explore blood based biomarkers in patients with intracerebral haemorrhage \[cbc. Pt. LDH.CRP. Cholesterol. Na. K.. Mg. Urea Ca. Uric acid\]

Spontaneous intracerebral hemorrhage (ICH) is a common subtype of stroke and accounts for nearly 10% to 30% of all strokes \[1\]. ICH posed a significant health burden in China in 2019, contributing to 25 million disability-adjusted life years (DALYs). It is associated with an early mortality rate of approximately 30-40% and has shown no reduction in prevalence in recent decades \[2\]. The higher incidence and mortality of ICH in middle-income and low-income countries may be attributed to limited public awareness regarding preventive measures, as well as challenges in accessing healthcare services \[3\]. So far, few treatment possibilities have yielded conclusive benefits. However, numerous predictors of poor outcomes after ICH have been suggested, including hematoma volume, hematoma expansion, perihematomal edema (PHE), and the presence and quantity of intraventricular hemorrhage growth \[4,5,6,7\]. Similarly, researchers continue to search for various blood-based biomarkers to guide management and predict outcomes after acute ICH \[8,9,10,11,12\]. A growing number of studies have shown that many novel biomarkers, such as C-reactive protein (CRP), S100A12, and interleukin-6, are associated with adverse outcomes in patients with ICH \[8,9,10\]. Thus, the application of blood-based biomarkers may improve risk stratification and aid clinical decisions in patients with ICH.

Therefore, in this review, we assessed the data available in the literature regarding the diagnostic and prognostic value of circulating blood biomarkers in patients with ICH. For each biomarker, we depicted the detailed characteristics in order to shed light on potential future clinical applications Intracerebral hemorrhage (ICH) is the second most common subtype of stroke and a critical disease usually leading to severe disability or death. ICH is more common in advanced age, male sex, and low- and middle-income countries. The case fatality rate of ICH is high, and only 12% to 39% of survivors can achieve long-term functional independence. Risk factors of ICH are hypertension, current smoking, excessive alcohol consumption, hypocholesterolemia, and drugs. Clinical presentation varies according to the size and location of hematoma, and intraventricular extension of hemorrhage.

Eligibility Criteria:
* Inclusion criteria:

  1. both sex
  2. Age between 25 to 40 years old.
  3. symptoms suggestive of intracerebral hemorrhage

     Exclusion criteria:

  <!-- -->

  1. Age group below 25 years and above 40 years
  2. traumatic cerebral haemorrhage
  3. extradural,subdural,subarachnoid hemorrhage
  4. Hemorrhagic infarction
RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY

The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18
* Laparoscopic sigmoidectomy
* Informed consent firmed

Exclusion Criteria:

* ASA IV
* Urgent surgery
* Sigmoid tumour stage IV
* Cronic pain treatment
* No informed consent firmed
* Paliative surgery