cyrilzakka/clinical-trials huggingface dataset:
An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density

The purpose of this study is to assess the safety, tolerability, and potential immune response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose administrations in healthy men and postmenopausal women with low bone mineral density.


Eligibility Criteria:
Inclusion Criteria:

* Low bone mineral density as determined at the time of screening \[as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4), or total evaluable vertebrae (if fewer than L1-L4); or femoral neck between -1.0 and -2.5, exclusive\]
* 25-hydroxyvitamin D ≥ 20 ng/mL
* Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 800 IU (but ≤ 1,000 IU) vitamin D daily upon enrollment

Exclusion Criteria:

* Osteoporosis, as defined by BMD T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ 2.5
* History of vertebral fracture, or fragility fracture (a fracture resulting from no or minor trauma; ie, fall from standing height or less) of the wrist, humerus, hip, or pelvis after age 50
* Diagnosed with any condition that will affect bone metabolism
* Diagnosis of clotting factor deficiency or history of bleeding or coagulation disorder
* History of spinal stenosis
* History of facial nerve paralysis

Exclusion Criteria for Cohort 7 Sub-study (Transition to Alendronate):

* Contraindicated or intolerant of alendronate therapy
Using Simulation-Based Training to Incorporate Lung Ultrasound Into Physical Examination

Dyspnea is a common symptom encountered frequently by medical practitioners. The differential diagnosis for a patient with such a symptom is broad and time consuming, while immediate management for distressed patients is what is desired. Lung ultrasound (LUS) is a relatively new technique that will help physicians more accurately diagnose and manage patients who present with dyspnea.

Focused medical ultrasonography education is becoming integrated into many physician residency training programs. Recent studies indicate a possible relationship between focused ultrasonography training in medical school curricula and improved physical examination accuracy. Thus, a short-term training program in LUS during medical school will have a major impact on physicians to be comfortable in using this skill when dealing with distressed patients in their prospective residency training. It will reduce educational burdens for physician residency programs and improve overall physician competency.

Simulation-based medical education (SBME) is ideally suited for offering effective training in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing with stressful clinical scenarios without exposing patients to any additional risk. SBME has also been shown to be a reliable tool for assessing learners' procedural skills and for teaching topics such as teamwork and communication.

The investigators hypothesize that simulation-based training of medical students will enable them to more effectively evaluate patients with shortness of breath using LUS.


Eligibility Criteria:
Inclusion Criteria:

* Third year medical students who signed the consent

Exclusion Criteria:

* a medical student who is not a third year and/or didn't signed the consent
Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure

The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation (HSCT).

Occult hepatitis B virus (HBV) reactivation has been documented in bone marrow transplantation recipients who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.

Eligibility Criteria:
Inclusion Criteria:

* Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).
* Documented anti-HBc (total)-positive.

Exclusion Criteria:

* Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
* Significant alcohol intake (\>30 grams per day)
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥18 years of age at the time of informed consent.
2. Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment.
3. Part 2 (Dose Expansion)

   * Previously treated, triple-negative breast cancer.
   * Recurrent platinum-sensitive ovarian cancer.
   * Histologically confirmed pleural or peritoneal malignant mesothelioma.
4. ECOG performance status of ≤2.
5. Able to provide an archival tumor tissue sample.
6. Adequate organ function and bone marrow reserve.
7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.
8. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures.

Exclusion Criteria:

1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose.
2. Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
3. Peripheral neuropathy of any etiology \>Grade 1.
4. Concurrent malignancy.
5. Known active CNS metastases.
6. Use of systemic corticosteroids.
7. Known retinal neovascularization, macular edema or macular degeneration.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. QTcF \>450 ms in males or \>470 ms in females.
10. Left ventricular ejection fraction (LVEF) \<50% at screening.
11. Arterial thrombotic or embolic events.
12. Symptomatic venous thrombotic event.
13. Active infection ≥Grade 3.
14. Known HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
15. Use of proton pump inhibitors.
16. If female, the patient is pregnant or lactating.
17. Major surgery 4 weeks prior to the first dose of study drug.
18. Malabsorption syndrome or other illness which could affect oral absorption.
19. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
20. Any other clinically significant comorbidities.
A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World

The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.


Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiary either with Original or Medicare advantage
* Authorize electronic access to their healthcare claims data
* Authorize sharing of device sensor, health, and Heartline app data from their iPhone and Apple Watch (if applicable). This includes Apple Watch and iPhone sensor data that is not publicly available
* Willing and able to provide informed consent by electronically signing the remote e-consent directly in the Heartline app prior to any study-related activities. Electronically signing the remote e-consent indicates that he/she understands the purpose of, and activities required for the study and is willing to participate for the 2-year Active Engagement Phase, with continued passive collection of their device and healthcare claims data for an additional 1 year in the Post-Engagement Follow-Up Phase
* Current resident of the US at the time of eligibility screening, defined by self-reported state of residence within the 50 states or the US or District of Columbia
* Own an iPhone 6s or later with iOS Version 12.2 or later

Exclusion Criteria:

* Limited life expectancy and/or current diagnosis of terminal cancer
* Unable to confirm meeting inclusion criteria, including ability to consent and participate in human participant's research
* Own an Apple Watch Series 0 paired with an iPhone at the time of screening eligibility (these participants are not eligible for any study cohorts \[randomized or observational\])
* Have a confirmed diagnosis of Atrial Fibrillation (AF) at study entry and currently taking a direct oral anti-coagulant (DOAC) for less than (\<) 30 days, currently taking other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking medication for AF
Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section

The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar healing after cesarean section by using saline contrast sonohysterography

This is a triple blind randomized placebo controlled prospective clinical trial that will be conducted in Ain Shams University Maternity Hospital.

in which a consecutive series of participant attending emergency room 102 women undergoing cesarean section for the first time will be randomized into two groups.

Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy (gestational age between 37-41 weeks).
* Women undergoing cesarean section for the first time.
* Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
* Uncomplicated cesarean section.
* Lower uterine segment cesarean sections while the women not in labor.

Exclusion Criteria:

* Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
* Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
* Women who will use intrauterine device as a contraceptive method
* Women with uterine abnormality as cervical stenosis or fibroid uterus
* Women with pelvic infection at the time of saline sonohysterography
Comparison of Oral Isotretinoin vs Ancomparison of Oral Isotretinoin vs Antibiotics on Corneal Thickness With AV

Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris

Acne is the most common skin disease requiring attention of health practitioners. It is a self-limiting disease of the pilosebaceous unit, which can lead to devastating and frustrating scars and pigmentary alterations.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender shall be enrolled for this study.
* Acne vulgaris patients taking oral isotretinoin and oral antibiotics shall be included.

Exclusion Criteria:

* Patients with any ocular pathology shall be excluded.
* Patients with any systemic pathology other than acne vulgaris shall be excluded.
* Patients with history of contact lens wear, previous refractive surgery or injury shall be excluded.
Cangrelor Neonatal PK/PD and Safety Study

The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.


Eligibility Criteria:
Inclusion criteria:

1. Males and females with congenital heart disease, and ranging in age from birth through 28 days of life
2. Postoperative neonatal cardiac participants with placement of systemic-to-pulmonary artery palliative shunts, right ventricle to pulmonary artery palliative shunts, or ductus arteriosus stents who are at risk of thrombotic events after repair for structural congenital heart disease.
3. Written informed consent from a parent/legal guardian
4. Life expectancy of at least 15 days at study entry

Participants will be excluded from the study if any of the following exclusion criteria apply:

1. History of intracerebral bleed (confirmed by a ultrasound (US) of the head prior to surgery), or cerebral arteriovenous malformation, or any prior bleed with neurological deficit
2. Gastrointestinal or urinary bleeding
3. Cerebrovascular accident or any cerebrovascular accident with a residual neurological deficit
4. Known congenital or acquired bleeding or clotting disorder
5. Weight less than 2.5 kilograms (kg)
6. Adjusted gestational age less than 37 weeks
7. Platelet count less than 100,000 cells/microliter (µL)
8. Chest and/or mediastinal tube blood output of greater than 3 milliliters (mL)/kg/hour (hr) at the time of cangrelor administration
9. Participants with evidence of severe hepatic or renal failure \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times normal for age or total bilirubin greater than 20 milligrams (mg)/deciliter (dL); creatinine greater than 2 times the normal upper limit\]
10. Known allergy to cangrelor or known sensitivity to any component of cangrelor
11. Any condition that in the investigator's opinion would constitute a contraindication to participation in the study or cause inability to comply with the study requirements
12. Participation in another investigational therapeutic drug or investigational therapeutic device trial within 30 days of starting study
13. Participants who have been receiving warfarin (Coumadin®) therapy
The Role of Simvastatin in the Epithelial-Mesenchymal Transition Process of Breast Cancer

Introduction: Most cases of Triple Negative Breast Cancer (TNBC) have a high proliferation rate. TNBC is associated with a poor prognosis, a high recurrence rate, and a high incidence of distant metastases. The Epithelial-Mesenchymal Transition process (EMT) plays an essential role in the metastatic process. EMT markers were also more abundant in TNBC and contributed to a poorer TNBC prognosis. As an important EMT marker, the increased expression of vimentin also contributed to the increase in TNBC aggressiveness and resistance to chemotherapeutic agents. Through the mechanism of action in inhibiting the mevalonate pathway, statins can help inhibit the EMT process in metastases. Notably, simvastatin promotes the down-regulation of vimentin in breast cancer cells. The combination of statins and neoadjuvant chemotherapy (NAC) improves the cancer patient's response. This study is expected to evaluate the role of a combination between NAC and simvastatin on therapeutic response in TNBC patients through vimentin expression.

Methods: This study is a double-blind, randomized, placebo-controlled trial conducted in Dr. Cipto Mangunkusumo National Central General Hospital. An expected total of 26 TNBC patients will be assessed for eligibility and asked for informed consent. Patients with the plan to have ACT (Doxorubicin hydrochloride, Cyclophosphamide, Paclitaxel) chemotherapy regimen will receive either a combination of ACT-Simvastatin (40 mg/day) or ACT-Placebo. The biopsy will be taken pre-NAC to make the histopathological diagnosis and examine the expression of vimentin. Patients will be evaluated for adverse effects reaction every cycle and the clinical response after 8 cycles. The post-intervention biopsy will be conducted after the cycle finish. The pathological response and vimentin expression will be reviewed from the obtained samples.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with advanced breast cancer (locally advanced and distantly advanced) with triple-negative molecular type confirmed by biopsy and immunohistochemical examination.
2. The patient planned to receive 8 cycles of AC-T chemotherapy.
3. Patient age \> 18 years.
4. Willing to participate in research by signing informed consent.

Exclusion Criteria:

1. The patient is pregnant or breastfeeding.
2. Patients who have received chemotherapy or are on simvastatin therapy.
3. Allergy to statins.
Study of Molecular-targeted Therapy Using Zinc Finger Nuclease in Cervical Precancerous Lesions

This research study is being carried out to study a new way to possibly treat human cervical intraepithelial neoplasia (CIN) without invasion.

Persistent infection with specific types of human papillomavirus (HPV, most frequently types 16 and 18) may lead to precancerous lesions(CIN). If untreated, these lesions may progress to cervical cancer within many years. In the infected cells, HPV expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies has demonstrated that E7 alone, but not E6, is sufficient to immortalize human keratinocytes in vitro and induce high-grade cervical dysplasia in a transgenic mouse model. These data indicated that E7 may dominate the malignant progress in HPV-infected cells.

The agents zinc finger nucleases (ZFNs), called ZFN-603 and ZFN-758, which can cleave the HPV16 and HPV18 E7 oncogene specifically. ZFN-mediated disruption of HPV16 and HPV18 E7 DNA directly decreased the expression of E7, induced type-specific apoptosis in HPV16- and HPV18-positive cells, and inhibited cell growth.

The purpose of this study is to determine whether ZFN-603 and ZFN-758 are effective in the treatment of HPV16- and HPV18-positive cervical intraepithelial neoplasia.

Laboratory studies have shown that ZFN-603 and ZFN-758 could induce significant cleavage of E7 DNA in HPV16- and HPV18-positive cells. The disruption to viral DNA directly led to downregulation of E7 expression and restoration of the tumor suppressor genes retinoblastoma 1 (RB1), resulting in apoptosis and growth inhibition of ZFN-treated HPV16- and HPV18- positive cell lines. On the basis of these laboratory results, there is the potential that this may work in humans infected with high-risk HPV (especially HPV16 and HPV18) and block the progression of CIN The new treatment to be studied will involve transfecting ZFNs into HPV-infected cervical epithelials. Cells modified by ZFN-603 and ZFN-758 will lose the ability of immortalization and progress to apoptosis.

Researchers hope that these agents will be able to block the malignant progression of CIN and reduce the incidence of cervical cancer

Eligibility Criteria:
Inclusion Criteria:

* Documented HPV16 or HPV18 infection.
* Married and fertile, no fertility requirements.
* Without administration of hormone in the last six months
* Subjects must be meet the ethical requirements and have signed informed consent

Exclusion Criteria:

* Pregnancy and breast feeding
* Any bacterial vaginitis
* Any Fungal vaginitis
* Any sexually transmitted diseases
* Active drug or alcohol abuse
* Any HPV medications within the past 12 weeks
* Allergy to active or non active ingredients in the study of drugs
* Cardiac insufficiency
* Liver and renal insufficiency
* Hypertension and severe complications
* Serious illness in past 30 days
* Currently participating in another clinical trail or any prior gene therapy
Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair

According to the EHS classification, at least 80 patients who will undergo TEP repair for the first time with the diagnosis of M2 and M3 direct inguinal hernia will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data, clinical/radiological seroma rate, postoperative pain (VAS values),quality of life(SF36 questionnaire), recurrence and other complications at postoperative 1st, 7th day, 3rd and 6th month will be monitored. When the desired number of patients and the follow-up period are reached, the data in the 2 groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Clinical or/and radiological diagnosis of primary inguinal hernia
* EHS type M2 and M3 direct hernias
* Laparoscopic totally extraperitoneal (TEP) repair

Exclusion Criteria:

* Indirect hernias
* M1 direct hernias
* Recurrent hernias
* Patients with previous groin operations on same side
* Pregnant women
* Patients who did not accept to participate in the study
* ASA score of 3 or higher,
Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

The main aim of work is to compare between subtotal and total thyroidectomy intra and postoperatively to identify which technique is better for patient of graves disease

Graves' disease is an autoimmune disease that affects the thyroid gland\[1\] and it's the most common cause of hyperthyroidism. \[2\] Treatment of Graves' disease includes antithyroid drugs ; radioiodine ; and thyroidectomy . patients with Graves' hyperthyroidism can be treated with any of these treatment options. There is a wide geographic variation in the choice of therapy.\[3\] Medical treatment with antithyroid drugs is often accepted as first-choice modality in Europe, followed by radioiodine in case of recurrence. Although surgery offers the advantage of quick control and low morbidity in experienced hands, it is infrequently recommended as initial treatment. Therapy with radioiodine is the most common treatment in the United States, while antithyroid drugs and/or thyroidectomy are used more often in Europe, Japan, and most of the rest of the world.recent literature shows that the relapse rate was the highest among patients who received antithyroid drugs (40%) as compared to those who received radioiodine (21%) or Surgery (5). \[4\] Two different surgical techniques are used for the treatment of Graves' hyperthyroidism: a total thyroidectomy (TT) in which the entire gland is removed and a subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams. Although thyroidectomy has been broadly considered as a viable alternative theapy for patients with Graves' disease , the resection extent and remnant size of thyroid gland remains controversial.\[6\] Although total thyroidectomy has a lower recurrence rate it has raised a concern that a more radical operation would increase the complications.\[7\] we intend to perform this analysis based on the published literatures of randomized controlled trials to evaluate the specific risks of thyroid surgery including recurrent hyperthyroididm , post-operative bleeding , recurrent laryngeal nerve injury , hypoparathyroidism and opthalmopathy progression.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed clinically, biochemically and immunologically with Graves' disease who will undergo thyroidectomy at general surgery department in AUH.

Exclusion Criteria:

* 1- previous thyroid or parathyroid surgery.

  * 2- recurrent hyperthyroidism after radioiodine therapy.
  * 3- preoperative recurrent laryngeal nerve palsy.
  * 4- patients unfit for operation.
  * 5- inability to comply with the follow-up protocol.
  * 6- suspicious thyroid nodules.