cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of trimetrexate glucuronate, fluorouracil, and leucovorin in treating patients with recurrent or metastatic colorectal cancer.

OBJECTIVES: I. Evaluate tumor response and duration, one-year progression-free survival, and one-year overall survival in patients with recurrent or metastatic colorectal carcinoma when treated with trimetrexate glucuronate, fluorouracil, and leucovorin calcium.

OUTLINE: Patients receive trimetrexate glucuronate (TMTX) IV over 1 hour on day 1. Beginning 18 hours after the TMTX dosage, patients receive leucovorin calcium (CF) IV over 2 hours. Immediately after the completion of the CF infusion, patients receive an IV bolus injection of fluorouracil (5-FU). Beginning 4 hours after the 5-FU infusion, patients receive oral CF every 6 hours for 6 doses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity or as long as the disease remains inoperable. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma Inoperable advanced recurrent or metastatic disease Measurable disease outside previously irradiated area No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: WHO 0-1 Life expectancy: More than 12 weeks Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) SGOT less than 1.25 times ULN Albumin greater than 3.5 g/dL Renal: Creatinine clearance greater than 70 mL/min Cardiovascular: No history of congestive heart failure, myocardial infarction within the past 6 months, active ischemic heart disease, or uncontrolled hypertension Other: No weight loss more than 10% in the last 2 months No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer No history of alcohol abuse No uncontrolled medical or psychiatric disease Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) Chemotherapy: No prior chemotherapy for advanced disease Recovered from prior adjuvant therapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for advanced disease Surgery: See Disease Characteristics Other: No other concurrent therapy
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)

The DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary syndromes (ACS) .

Patients with ACS and indications for percutaneous coronary intervention were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a Zotarolimus-Eluting Coronary Stent(ZES) . Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, 12 months, and 24 months after discharge, and coronary angiography and FFR measurements will be carried out at 9 months.The primary objective is to show non-inferiority of DCB versus drug-eluting stent(DES) regarding the functional assessment of target lesion by FFR at 9 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 Years and \<80 years;
2. ACS patients eligible for percutaneous coronary intervention;
3. Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
4. Vessel diameter from 2.25mm-4.0 mm ;
5. Lesion length ≤ 28 mm;
6. A single culprit lesion or 1 lesion in each of two vessels ;
7. Eligible for enrollment and provide written informed consent.

Exclusion Criteria:

Clinical Exclusion Criteria：

1. Stable angina or asymptomatic myocardial ischemia;
2. Cardiogenic shock or requiring mechanical support for breathing and circulation;
3. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
4. Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
5. A history of stroke within 6 months;
6. History of severe renal insufficiency;
7. Life expectancy \< 12 months;
8. Pregnant women;
9. Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
10. Patients not suitable for enrollment considered by researcher;
11. Currently participating in another trial before reaching the primary endpoint;
12. Inability to provide informed consent. Image Exclusion Criteria

1. Chronic total occlusion (CTO); 2. Left main lesion; 3. Bifurcation lesions treated with double stents; 4. Moderate to severe distortion, angulation or severe calcification lesions; 5. Coronary artery graft stenosis; 6. In-stent restenosis; 7. To be re-hospitalized for the other scheduled PCI treatment; 8. Myocardial bridge at the target lesion.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants

MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.

The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants.

In recent years, high-dose psilocybin has gained attention for its potential therapeutic benefits in many psychiatric indications, however existing clinical data for low psilocybin doses are limited.

Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner.

As a foundational study of the therapeutic use of low doses of psilocybin, this study will evaluate the safety, tolerability, pharmacokinetics, and sensorial effects using a prospective, controlled, single ascending dose/multiple ascending doses in healthy volunteers.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females aged 18 to 65 years old (inclusive) at the time of signing the informed consent form. Standard contraception measures are required for this clinical trial.
2. Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.
3. Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.
4. Body mass index (BMI) within the range 18-32 kg/m2, inclusive.
5. Normal blood pressure.
6. Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol.

Key Exclusion Criteria:

1. Prior known exposure to psilocybin within the past 10 years.
2. Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
3. History of or presence of cardiovascular disease.
4. Abnormal and clinically significant ECG.
5. History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.
6. Use of medications that have CNS effects or affect performance.
7. Use of medications with serotonergic activity.
8. History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.
9. History of substance or alcohol abuse disorder in the last 1 year.
10. Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
* Detectable metastases
* Any Gleason score
* ECOG performance status 0-2

Exclusion Criteria:

* Prior treatment with chemotherapy
* Prior Immunotherapy
* Prior treatment with gene therapy
* Significant cancer related pain
Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.


Eligibility Criteria:
Inclusion criteria

* Age between 18 and 65 years;
* First or second renal transplant within at least 12 weeks;
* Clinical stability, in the opinion of the investigator, during at least 8 weeks before inclusion in the study;
* Women of reproductive age must use contraceptive methods and present negative results in pregnancy test Serum creatinine \< 2.5 mg/dE; Patients in use of a immunosuppression regimen based on tacrolimus and mycophenolate mofetil (generic or not, in any dose), who present gastrointestinal symptoms Capacity to complete the study requirements;

Exclusion criteria History of acute rejection,

* Proven or not by biopsy, in the last 2 months before the study;
* Recipients of multiple organs;
* Participation in any clinical investigation in the last 6 months before the present study;
* Thrombocytopenia (platelets \<75,00O/mm3), leucopenia (total leukocytes \<4,000/mm3)and/or anemia (hemoglobin \<9.0 gldL) before inclusion in the study;
* Clinically important disease, in the opinion of the investigator, including systemic infection, within 2 weeks before inclusion in the study;
* Presence of any neoplasia, current or past, except resected basal cell carcinoma;
* Any surgical or medical condition that could significantly alter the absorption, distribution, metabolism or excretion of medicines or that could put the patient in danger as a result of participation in the study;
* History of drug or alcohol abuse within previous 12 months of inclusion in the study, Current or prior use in the last 2 months of bile acid-adsorbing resins(cholestyramine and colestipol).
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study

Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment remains challenging. There exist effective pharmacological therapies for chronic constipation, however, many patients do not well respond to current medications. Evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®) in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) in patients with chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female outpatients aged from 20 to 75 years old.
* Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation\*:

A. Must include two or more of the following:

1. Straining in \> 1/4 defecations;
2. Lumpy or hard stools \> 1/4 defecations;
3. Sensation of incomplete evacuation in 1/4 defecations;
4. Sensation of anorectal obstruction/blockage in \> 1/4 defecations;
5. \<3 defecations/week.

B.Loose stools are rarely present without the use of laxatives. C.There are insufficient criteria for irritable bowel syndrome. \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

Exclusion Criteria:

* Pregnant or lactating woman
* Known organic gastrointestinal disease
* Subjects who diagnosed advanced adenoma within 3 years
* Prior gastrointestinal surgery (except appendectomy, herniotomy)
* Subjects who diagnosed irritable bowel syndrome
* Use of one or more of listed medications within 2 weeks (Laxative, Metoclopramide, Domperidone, Itopride, Levosulpride, Cisapride, Mosapride, Tegaserod, Prucalopride, Renzapride, Erythromycin, buspirone, Sumatriptan, Alosetron, Cilansetron, ondansetron, Citalopram, Paroxetine, Baclofen, Sildenafil, Nitroglycerin)
* Subjects who diagnosed lactulose malabsorption
* Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency
* Suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

* Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
* Positive serology results for HBsAg, HCV, and HIV at Screening.
* Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of \<65 mL/min
* Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months.
* Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
* Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.
Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA)

This study will employ a phase Ib design using the established dose of CAVATAK with pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be important in amplifying the T-cell potentiating effects of pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection.
* At least one tumor must qualify to be an index lesion for modified WHO criteria.
* Subjects must have adequate hematologic, hepatic and renal function.
* ECOG performance status of 0 or 1.
* Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

* Ocular primary tumors.
* Presence of any central nervous system tumor that has not been stable for at least 4 weeks off corticosteroids.
* Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord.
* Subjects with active, known or suspected autoimmune or immunosuppressive disease.
* Subjects previously treated with CVA21.
* Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to the first treatment.
* Subject has received chemotherapy within the last 4 weeks prior to first treatment.
* Clinically significant cardiovascular disease.
* Females of childbearing potential must have negative serum or urine pregnancy test.
* Subjects requiring or using other investigational agents while on treatment in this trial.
* History of other malignancy within the last 3 years (with exceptions).
* Active infection requiring systemic therapy.
* Known history of HIV disease, active hepatitis B or hepatitis C.
* History or evidence of other clinically significant disorders that would pose a risk to subject safety.
* Inability to give informed consent and comply with the protocol.
Evaluation of the Effectiveness of a Program on Breastfeeding for Medical Interns Assiut University

The WHO and UNICEF advocate for infants to start nursing within the first hour post-birth and to be exclusively breastfed for the first six months of life. Commencing at six months of age, children should start the consumption of safe and sufficient supplemental meals while maintaining breastfeeding for up to two years or longer (WHO), 2025) . Abd El Khalek et al. assessed the impact of instructional guidelines on 100 pregnant women at South Valley University Hospital. Initially, most had poor knowledge, negative attitudes, and inadequate practices. After one month of guidelines implementation, significant improvements in women awareness regrading breastfeeding were observed . Bahaa et al. reported that breastfeeding is a critical concern for the entire community. Their study assessed the knowledge and practices of 261 lactating mothers at Awlad Saqr Center Al Sharkia governate.

Findings showed that 73.2% practiced EBF, while only 45.2% had sufficient knowledge. Intentions for EBF for six months were high (86.2%). The study concluded that despite acceptable EBF rates, knowledge gaps remain, highlighting the need to enhance counseling services during antenatal and postnatal care .

One of the best ways to improve the survival and condition of newborns is breastfeeding . Ensuring ideal breastfeeding habits depends significantly on the encouragement and assistance of healthcare workers, especially physicians. A program on breastfeeding for medical interns is crucial to find gaps and helping to enhance medical support and education within the healthcare system. The overall aim is to evaluate the effectiveness of an educational program on breastfeeding for the medical intern at Assiut University.

Specific objectives:

1. Evaluation of the knowledge regarding breastfeeding for medical interns.
2. Implementing an educational program based on the UNICEF Baby-Friendly Initiative for the medical intern.
3. Measuring the effectiveness of the educational program on breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

Unmarried intern doctors Both male and female intern doctors Intern doctors integrated system (5+2) Intern doctors graduated from Assiut University September 2024

Exclusion Criteria:

* Intern doctors who have previous health education sessions about breastfeeding. Intern doctors
Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants With High-Risk Prostate Cancer

This trial studies how well magnetic resonance whole body diffusion-weighted imaging works in finding cancer that has spread to the bone or lymph nodes (metastasis) in participants with high-risk prostate cancer. Diagnostic procedures, such as magnetic resonance whole body diffusion-weighted imaging (a method to show how water moves in a certain area) may help find bone or lymph nodes metastasis.

PRIMARY OBJECTIVES:

I. To compare accuracies of whole body magnetic resonance imaging (MRI) versus bone scan plus computed tomography (CT) scan in detecting bone or lymph node metastasis in high risk prostate cancer patients.

OUTLINE:

Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance whole body (WB)-diffusion-weighted imaging (DWI) over 20-30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Prostate carcinoma patients at high risk for metastasis with prostate-specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ \> 8.
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Patient is at low risk for metastasis with Gleason score at diagnosis \< 8.
* Currently receiving or history of systemic therapy with testosterone suppressing medication (i.e., lupron, degarelix, abiraterone, enzalutamide) or local radiation therapy.
* Contraindication to magnetic resonance imaging (MRI).
An Extension Study of Belcesiran in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATLD)

This is a Phase 2, multicenter, open-label extension of Study DCR-A1AT-201, designed to evaluate the long-term safety and further characterize the pharmacodynamics (PD) of belcesiran in adult patients with PiZZ AATLD.


Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 to 75 years of age inclusive, at the time of signing the Informed Consent Form (ICF).
2. Documented diagnosis of PiZZ-type Alpha-1 Antitrypsin deficiency (AATD), confirmed by genotyping.
3. Lung, renal and liver function within acceptable limits.
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

1. Any condition that, in the opinion of the Investigator, would make the participant unsuitable for enrollment or could interfere with participation in or completion of the study
2. Routine use of acetaminophen/paracetamol
3. Use of systemically acting steroids in the month prior to Screening and throughout the study period.
4. Positive SARS-CoV-2 virus test at Screening
5. Any other safety laboratory test result considered clinically significant and unacceptable by the Investigator
6. Inability or unwillingness to comply with the specified study procedures, including lifestyle considerations
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years old
* be willing and able to avoid all disallowed medications and contact lenses
* must have a pregnancy test if of childbearing potential
* must be able to read an eye chart from 10 feet away

Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial