cyrilzakka/clinical-trials huggingface dataset:
Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.

After approval of local ethical committee, consent will be obtained from 90 patients scheduled for laparoscopic cholecystectomy in GEC center, Mansoura University, Egypt. Patients will be of either ASA I and II, with Age ranging from 18-40 years, and BMI less than 35. Patients will be randomized into 3 groups (using closed envelope technique in blocks of 18); Controlled group (C group), Bupivacaine group (B group), Bupivacaine Magnesium group (M group).

Anesthesia induction will be the same in the three groups (Propofol 1-1.5mglkg, Fentanyl 1 mic/kg, Atracrium 0.5 mg/kg) then Sevoflorane inhalational anesthesia for maintainace in 0.4 oxygen/air mixtures.

In both M group and B group, preemptive US guided Subcostal TAP block (Toshiba Xario, Japan) was performed on both sides using 20 ml volume (0.25 Bupivacaine in B group or 0.25 Bupivacaine plus 0.5 gm MgSo4 in M group). Surgical sterilization will be started 5 minutes after the block and surgery started5 minutes later. Hemodynamic data (HR, MAP) will be collected immediately after induction, at start of surgery, and each 10 minutes later.

At the end of surgery, and after closure of surgical ports, anesthesia was terminated and extubation done when patients fulfilled the required criteria. Postoperative hemodynamic data (HR, MAP), VAS, and PONV will berecorded at 0, 1, 2, 6, 12, 24 hours after surgery, Ramsay sedation was recorded at 0, 1, 2, 6 hours postoperatively. Boluses of Morphine (0.02 mg/kg) will be given whenever VAS ≥4.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II for lap cholecystectomy

Exclusion Criteria:

* ASA III, IV
Treatment of APAP Toxicity With IV and Oral NAC 2008-2011

Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP) toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology and Toxicology division in the management of APAP ingestions.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to CHMCA between June 1, 2008 to June 30, 2011
* Qualifying ICD-9 diagnosis code for the following APAP overdose situations: poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
* Serum APAP concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained \> 4 hours post ingestion
* Between ages 0-21 years on date of admission
* Acute APAP ingestion

Exclusion Criteria:

* Serum APAP concentrations not actually documented
* Did not receive the oral or IV NAC treatment
* Preexisting liver disease such as cirrhosis or hepatitis C
* Patient \> 21 years of age on the date of admission
* Chronic APAP ingestion
Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study

This is a single arm, pre/post intervention study to a larger trial that will examine the effect of health education with comic books and videos on COVID-19 preventive behaviors (masking, social distancing, testing and vaccine uptake). The participants are students, ages 3-5 years old and their parents.

This is a single arm, pre/post intervention study to a larger trial that will examine the effect of health education with comic books and videos on COVID-19 preventive behaviors (masking, social distancing, testing and vaccine uptake). The participants are students, ages 3-5 years old and their parents.

Students will receive the intervention from November 2023 to March 2024.

Eligibility Criteria:
Inclusion Criteria:

* Must have a child attending the Early Learning Program in the Yakima School District
* Must be able to provide informed consent and legal guardian assent either virtually, on the telephone, or in-person.
* Must have a permanent mailing address available for study staff to mail necessary materials OR a working email address.
* Must speak English or Spanish.

Exclusion Criteria:

- Not in Early Learning program in Yakima School District
Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
3. Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
4. Subject has already been selected for flow diversion therapy as the appropriate treatment.
5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
6. Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).

Exclusion Criteria:

1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
4. Subject with target aneurysm previously treated with a stent or flow diverter.
5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
6. Subject with a confirmed stenosis in parent artery.
7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
8. Subject has a pre-procedure mRS \>2.
9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
11. Known serious sensitivity to radiographic contrast agents.
12. Known sensitivity to nickel, titanium metals, or their alloys.
13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
14. Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30.
15. Subject who has a contraindication to MRI or angiography for whatever reason.
16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
17. Subject with any known allergy to heparin, ASA or other antiplatelet medications.
18. Subject with coagulation disorder
19. Pregnant woman or breast feeding.
20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.
A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed NHL (DLBCL only for Parts B and C)
* Relapsed or refractory disease following at least 1 prior systemic therapy
* Measurable disease of at least 1.5 cm as documented by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

* History of another primary invasive malignancy that has not been in remission for at least 3 years
* Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
* B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
* Known cerebral/meningeal disease
A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous infusion of LPM3480392 injection in healthy subject

A total of 80 healthy subjects will be allocated to 1 of 8 cohorts (cohort 1\~8) in the study, each cohort including 10 subjects (8 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single dose of LPM3480392 or placebo intravenously.

Eligibility Criteria:
Inclusion Criteria:

* The subject voluntarily signs the informed consent;
* Healthy male, aged 18-45 years (including boundary values);
* Body mass index (BMI) 19-26kg/m2 (including boundary value), weight ≥50kg;
* Subjects are willing to take contraceptive measures and promise not to donate sperm during the study period and within 90 days after administration;
* Willing to accept cold pain test, and the non-dominant hand can be soaked in ice water bath at 2℃ (± 0.2℃) for \> 10s, \< 120s.

Exclusion Criteria:

* Known history of allergy to any component of the investigational product or similar drugs, or allergic constitution \[subjects with previous allergy to two or more foods or drugs\];
* Past or present with any clinically significant disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, hematology, psychiatry, dermatology, orthostatic hypotension, etc.; or any disease that may interfere with the test results or interpretation of the results;
* Patients with Raynaud's syndrome;
* The skin wounds or skin diseases that may affect the cold pain test results; Sitting systolic blood pressure (SBP) \< 90 mmHg, ≥ 140 mmHg or diastolic blood pressure (DBP) \< 60 mmHg, ≥ 90 mmHg; subjects with heart rate \< 60 beats/min, \> 100 beats/min;
* QTc \> 450 ms on electrocardiogram;
* Positive urine nicotine test;
* History of alcohol abuse within 3 months prior to Screening, defined as consumption of more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits of 40% alcohol content, or 150 mL of wine), or a positive breath alcohol result;
* History of drug abuse or drug abuse or positive result of urine drug screening;
* Those who consume more than 100 g of xanthine-rich foods such as chocolate per day on average; those who consume more than 100 g of foods containing grapefruit and/or pomelo; those who consume more than 1000 mL of strong tea, coffee, cola and beverages containing caffeine and/or grapefruit ingredients.
Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Age: 24-37
* Gestational week: 7- 12
* Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
* Ultrasound evidence of subchorionic hematoma

Exclusion Criteria:

* Lack of fetus
* Absence of fetal heart tone
* Uterine anomaly or fetal anomaly
* Presence of multiple pregnancy
* Gestation pathology
* Therapies with anti-coagulants or anti-hypertensive drugs
A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged greater than 40 years with COPD Current or ex-smokers

Exclusion Criteria:

* Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects

Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in healthy adult subjects.

Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of febrile illness within 5 days prior to first dose.
* Treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days.
* Known immediate family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. "Immediate" is considered "first degree".
* Known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis).
* History of intolerance to azithromycin or chloroquine.
Stroke Ready - Optimizing Acute Stroke Care

The study aims to increase acute stroke treatment rates in Flint, Michigan through a two-pronged approach of hospital and community level interventions. It also aims to inform future stroke preparedness interventions by exploring the relative importance of hospital optimization and community interventions.


Eligibility Criteria:
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.
Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin, Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid: A Clinical, Dermoscopic and Immunohistochemical Study.

Keloids are macroscopic cutaneous scarring that result from disturbance of wound healing, that occurs on predisposed individuals .

Keloid shows a kind of over-healing, producing over abundant wound matrix responsible for raised, inflexible red scar tissue, that causes pain and itching .

Multiple hypotheses have been proposed for keloid formation. Though the pathogenesis of keloids is not fully understood, it involves the dysregulation of complex inflammatory pathways .

Several studies reported that IGF-IR was overexpressed in keloid ﬁbroblasts . Current treatment options include intralesional and topical therapies, surgical interventions, radiation, and laser-based therapies.

Intralesional corticosteroid is the most commonly used nonsurgical treatment for keloids . Fractional laser combined triamcinolone acetonide with may minimize collagen production by decreasing fibroblast activity, with a low recurrence rate of 15.4%, which is superior to each modality.

In recent years, physicians were using botulinum toxin A (BTX-A) as a modality for prevention and treatment of keloids. Botulinum toxin type A, isolated from Clostridium botulinum, is a potent neurotoxin that blocks neuromuscular transmission. It has been shown to improve scar cosmesis by decreasing tension on healing wound edges.

The role of topical insulin in wound healing has been under search in literature since 1970s .

Zhang et al. explored the effect of local insulin injection on systemic blood glucose level and wound healing in patients with diabetic foot ulcer.

As far as the investigatorrs are aware, this is the first study to assess the effectiveness and safety of intralesional insulin for the treatment of keloid.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged equal or more than 10 years old
* with keloids diagnosed clinically
* with any size less than 10 cm2

Exclusion Criteria:

* Pregnancy
* Hypertrophic scars
* Diabetes mellitus
* Kidney or liver disease
* Active infection at site of lesion
* Lesions suspicious for malignancy
* Patients use medications that reduced tissue healing during the study or in a period less than sex months ago (immunosuppressants and isotretinoin)
* Patients received any treatment for keloid in the last 3 months
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

To compare the effectiveness (efficacy, safety \& tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) \<200 copies/mL at Week 48.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive patients who have maintained an HIV-1 viral load \<200 copies/mL, for at least 3 months.
* Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
* HAART must consist of either:

  1. A PI (with or without ritonavir) + at least 2 NRTIs or
  2. An NNRTI + at least 2 NRTIs.
* Negative serum pregnancy test.

Exclusion Criteria:

* Patients who have taken any NNRTI prior to their current therapy.
* Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
* Patients who are currently taking EFV+FTC+TDF.
* Patients who have a creatinine clearance of \<60 mL/min by Cockcroft-Gault estimation.
* Patients who have experienced virologic failure with any previous ARV therapy.
* Patients who have documented resistance to any of the study agents at any time in the past.
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)

A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between 18 and 55 years (inclusive) of age.
* Non-smoking (by declaration) for a period of at least 6 months.
* Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
* Haematology and Chemistry values within normal ranges or with no clinical significance
* Subjects who provide written informed consent to participate in the study

Exclusion Criteria:

* Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
* Ongoing flu symptoms or influenza
* Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit.
* Treatment with immune immunosuppressant drugs or other immune enhancing drugs.
* Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit.
* Administration of any vaccine 30 days before the screening visit.
* Known history of drug or alcohol abuse.
* Known history of HIV, hepatitis C or B virus (HCV or HBV)
* Subjects with known Guillain Barré Syndrome in the past
* 2 or more hospitalization within the last year prior to screening visit
* Increased liver enzymes 2.5 times above the upper reference level
* Known hypersensitivity and/or allergy to any drugs
* Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
* Subjects who participated in another clinical study within 30 days prior to study entry
* Subjects who are non-cooperative or unwilling to sign consent form.
* Pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study
The Primary Endpoint is to Compare the Incidence of Forearm RAO Between Distal and Traditional Radial Access Assessed by Vascular Ultrasound At Discharge

The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention

Trans radial access (TRA) has become the standard vascular access for coronary angiography and percutaneous coronary intervention (PCI) and is currently endorsed with a class IA recommendation in the latest European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on myocardial revascularization, irrespective of clinical presentation Several clinical and procedural characteristics have been linked to the occurrence of RAO, and best practices recommendations for the prevention of RAO include reduction of the sheath/catheter size, adequate procedural anticoagulation, non-occlusive hemostasis (4) and a minimal pressure strategy with short (≤ 120 min) hemostasis time. The use of the distal radial artery with arterial access in the anatomical snuffbox or on the dorsum of the hand, has recently emerged as a promising alternative access route to further reduce the risk of RAO (5) The distal radial artery may be punctured proximally to the tendon of the extensor pollicis longus muscle in the anatomical snuffbox or distally to it in the dorsum of the hand.(6) the distal radial artery lies in the subcutaneous space superficial to the fascial compartments of the hand, thus favoring a faster, and safer hemostasis as compared to conventional TRA(7) The study will enroll 228 patients who will undergo a diagnostic coronary angiography and/or a PCI using a 6 Fr Sheath as the standard access sheath will be divided into two groups DRA versus TRA (114 cases in each group) The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure The secondary endpoints as successful sheath insertion, access site cross-over, total procedure time, sheath insertion time, puncture site bleeding overall bleeding, vascular access-site complication and radial artery spasm.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 y
2. Signed informed consent form
3. Indication to diagnostic coronary angiography or PCI
4. Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath

Exclusion Criteria:

1. Chronic hemodialysis
2. Treatment of a coronary chronic total occlusion (CTO) lesion
3. Patients who underwent CA or PCI with radial access before