cyrilzakka/clinical-trials huggingface dataset:
A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.

The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for UC, and have had an inadequate response with, or lost response to antibiotic therapy. This study will evaluate the safety and effectiveness of Kynteles injection (Vedolizumab) in a routine clinical practice setting under real world conditions.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs).

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Eligibility Criteria:
Inclusion Criteria:

1. With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
2. With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Exclusion Criteria:

1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
3. Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.
Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.

The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to 75 years) suffering from oral potential premalignant lesions. Patients will be randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)

The present randomized, controlled, parallel-grouped trial included 48 patients (aged 18 to 75 years) suffering from oral potentially premalignant lesions. Patients were randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Patients with age range 18-75 years.
* Patients with any known potentially malignant lesion confirmed histologically and clinically.

Exclusion Criteria:

* Patients with systemic illness.
* Patients received previous treatment for the condition.
* Current malignancy.
* Pregnant or lactating women.
* Hypersensitivity to the intervention.
18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma

This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.

PRIMARY OBJECTIVES:

I. Evaluate the potential of 18F-fluoromisonidazole (\[18F\] FMISO) as a non-invasive indicator of tissue hypoxia to provide tumor-imaging data that correlates with tissue markers of hypoxia in patients with soft tissue sarcoma treated with neoadjuvant chemotherapy with or without radiotherapy.

SECONDARY OBJECTIVES:

I. Test \[18F\] FMISO tumor uptake as an independent predictor of patient outcome and if it provides additional predictive power over fludeoxyglucose F 18 PET scan.

II. Test \[18F\] FMISO tumor uptake as a predictor of response in the subgroup of patients treated with radiotherapy and chemotherapy.

III. Test the reproducibility of \[18F\] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.

IV. Determine the relationship between hypoxia-related biomarkers (HIF1-a and VEGF), proliferation biomarkers (microvascular density, p53, and Ki-67), and regional \[18F\] FMISO uptake in tumor.

OUTLINE:

Patients undergo fludeoxyglucose F 18 \[18F\] FDG and 18F-fluoromisonidazole (\[18F\] FMISO) positron emission tomography (PET)/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

NOTE: Some patients may undergo repeat \[18F\] FMISO PET/CT scan within 48 hours after the first \[18F\] FMISO scan to evaluate the variability (test-retest) of this imaging measurement.

Blood samples are collected after completion of \[18F\] FMISO and \[18F\] FDG PET/CT scans for laboratory biomarker studies by IHC assays. Tumor samples from biopsy or surgery are also collected for biomarker studies.

After completion of study procedures, patients are followed up periodically for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed intermediate- or high-grade soft tissue sarcoma

  * Biopsy proven or highly suspicious primary or recurrent disease
  * Tumor size ≥ 2 cm
* Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
* Life expectancy ≥ 12 months
* Negative pregnancy test
* Willing to undergo PET scanning
* Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)
* Able to lie on the imaging table for up to 1.5 hours
* Weight ≤ 400 lbs
* Not pregnant
TMAO in Patients With Severe Aortic Stenosis

Trimethylamine N-oxide (TMAO) has recently gained increasing scientific interest in the field of cardiovascular disease, including its role in cell protection against osmotic and hydrostatic stress. Aortic stenosis (AS) is the most common valvular heart disease, affecting about 7.6 million people over 75 years of age in North America and Europe alone. We hypothesized that TMAO plays a role in protection of the cardiomyocytes against pressure overload in patients with AS. The primary aim of this study is to assess the correlation between the serum and urine TMAO concentration, and (i) echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure in patients with severe AS. The secondary aim of this study is to evaluate a correlation between the baseline TMAO concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the study
* Severe aortic stenosis, defined as aortic valve area \<1.0 cm2 or aortic valve area index \<0.6 cm2/m2 as calculated by the continuity equation on transthoracic echocardiography, regardless of the transvalvular gradient, with or without coexisting symptoms of heart failure
* Qualification for surgical aortic valve replacement or transcatheter aortic valve implantation by the Heart Team in accordance with European Society of Cardiology guidelines

Exclusion Criteria:

* Heart failure of etiology other than aortic stenosis
* Coexisting, haemodynamically significant aortic regurgitation
* Myocardial infarction within the last 3 months
* Coronary revascularization within the last month or planned during transcatheter aortic valve implantation or surgical aortic valve replacement
* Chronic kidney disease with estimated glomerular filtration rate \<45 ml/min/1.73 m2
* Acute gastrointestinal disease within the last month
* Active neoplastic disease
* Chronic inflammatory disease
* Autoimmune disease
* Chronic intestinal disease
* Antibiotic therapy within the last 2 months
* Dietary supplements within the last 7 days
Non-pharmaceutical Motion Sickness Mitigation

The purpose of this study is evaluate the effect of timing and magnitude on the administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the effect of Galvanic Vestibular Stimulation (GVR) amplitude on functional fitness task performance.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to consent to participate themselves.
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
* No racial ethnic groups will be excluded.
* Must be fluent speakers of English.

Exclusion Criteria:

* History of vestibular disease, migraine, or significant balance disorder.
* Traumatic brain injury.
* Recent middle ear infection or recent motion sickness (within 72 hours).
* History of severe motion sensitivity.
* Women who are pregnant.
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs

The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years of age,
* ASA classification class I and II,
* Patients assigned for Whipple procedure.

Exclusion Criteria:

* Preoperative renal failure,
* Severe liver dysfunction (Child-Turcotte-Pugh grade C),
* Hyponatremia (Na+ \<132mmol/l),
* Severe valvular heart disease,
* Heart failure,
* Symptomatic coronary heart disease,
* Bradycardic arrhythmia (heart rate \< 60/min),
* Peripheral artery occlusive disease (clinical stadium II-IV),
* Uncontrolled arterial hypertension (Blood pressure \>160/100mmHg despite intensive treatment),
* Pregnancy.
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
* Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
* Negative surgical margins ( ≥ 0.2 cm) after final surgery.
* Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
* Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
* Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
* Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
* Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.
* Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
* PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
* Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Have collagen-vascular disease.
* Inadequate surgical margins ( \< 0.2 cm) after final surgery.
* Subjects with persistent malignant/suspicious micro-calcifications.
* Gross multifocal disease and microscopic disease greater than 3.0 cm.
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.

The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.

Eligibility Criteria:
Inclusion criteria:

* Age 45-75 years
* Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection)

Exclusion criteria:

* Undergoing chest wall resection, gastroesophageal surgery
* Enrolled in another post-thoracotomy analgesic research protocol
* Pre-existing pain syndrome
* Current gabapentin or pregabalin therapy
* Inability to understand the study protocol
* Coagulopathy
* Current use of anticoagulants
* Allergy to medications on protocol
* Creatinine \>1.3
* Moderate or severe aortic stenosis
* Severe psychological disorders
* Bacteremia, osteomyelitis, or infection at site of thoracic epidural placement
* History of previous thoracotomy
* Patient declines preoperative epidural catheter placement
* Prisoners or other institutionalized individuals
* Severe hepatic, renal or cardiovascular disorders
* Women who can become pregnant
Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults

The purpose of this study is to analyze and compare the immunogenicity of Bivalent and Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive subjects.
* Age above 18 at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Subjects whom the investigator believes can and will comply with the requirements of the protocol.
* If currently on antiretroviral therapy (ART), subjects must be compliant to triple therapy (highly active ART) and have undetectable viral load for a period of six months prior to study entry.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period.

Exclusion Criteria:

* Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 12).
* Pregnant or breastfeeding female.
* Previous enrollment in the study.
* Subjects whom the investigator believes cannot and/or will not comply with the requirements of the protocol (i.e. because of abuse of drugs or alcohol, dementia or given medical, psychiatric, social or work related conditions).
* Chronic administration of immunosuppressive drugs
* Cancer or autoimmune disease
* Previous allergic reaction to vaccination
* Known allergy towards on or more components of either of the test drugs.
Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J

RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer.

PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.

OBJECTIVES:

* To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J.

OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens

  * No meningeal leukemia or lymphoma
  * No HIV-related lymphoma
  * No lymphoproliferative diseases
* Received treatment on protocol NCI-00-C-0070J
* Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available

PATIENT CHARACTERISTICS:

* See NCI-00-C-0070J

PRIOR CONCURRENT THERAPY:

* See NCI-00-C-0070J
PET-DECT for Staging and Imaged Based Radiotherapy Planning in Lung Cancer

The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image guided radiation therapy (IGRT) planning.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

1. Subject must have a suspected SCLC or NSCLC.
2. Subject must be 18-90 years of age.
3. Subject must have been referred for a clinically indicated PET-CT.
4. Subject must provide written informed consent prior to any study-related procedures being performed.
5. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

   * By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
   * By surgical sterilization, or
   * Post-menopausal, with minimum one (1) year history without menses.
2. Subject has impaired renal function (eGFR\<30 mL/min).
3. Subject has an acute psychiatric disorder or is cognitively impaired.
4. Subject is using or is dependent on substances of abuse.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has an allergy against iodinated contrast agents and cannot be premedicated.
7. Subject is in acute unstable condition.
Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy

The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).


Eligibility Criteria:
Inclusion Criteria:

* CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough
* Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB
* Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH

Exclusion Criteria:

* Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB
* Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus
* Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance

Other protocol defined inclusion/exclusion criteria could apply
Two Doses of Dexmedetomidine as Adjuvent to Bupivacaine in Tap Block

The aim of this study to determine the optimal dose of dexmedetomidine as an adjuvant to bupivacaine in U.S guided TAP block for preemptive analgesia In patients undergoing lower abdominal cancer surgeries.

The transversus abdominis plane (TAP) involves innervations of the anterolateral abdominal wall derived from T6-L1. The block can be given either by anatomical landmark technique or by using an ultrasound probe. The local anesthetic is deposited in a plane between internal oblique and transversus abdominis muscle. It provides adequate postoperative analgesia following various abdominal surgeries.Dexmedetomidine is an alpha-2 agonist that has been approved as a venous sedative and an adjuvant for pain relief .In previous studies, the addition of dexmedetomidine to bupivacaine in the TAP block has prolonged the effect of this block . So far, the optimal dose of dexmedetomidine for the TAP block has not been determined.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 65 years old
* lower abdominal cancer surgery

Exclusion Criteria:

* patient refusal
* the local anesthetic allergy
* coagulopathy
* local infection at the procedure site
* psychic patients
* patient on chronic opioid use
Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)

A multicentric, observational, open-design study conducted to evaluate the efficacy and safety of Sofosdac® 400mg/60mg tablets treatment in 100 patients with chronic hepatitis C (HCV)

BEKER laboratories developed the generic drug Sofosdac® 400 mg/60 mg Tablets as fixed dose combination that contains two direct antiviral agents (400 mg Sofosbuvir and 60 mg Daclatasvir) known to be pangenotypic in order to fulfill WHO plan to eradicate HCV by 2030. BEKER conducted an observational clinical trial to evaluate the efficacy and safety of FDC Sofosdac® 400 mg/60 mg treatment in Algerian patients with chronic hepatitis C (HCV).

Eligibility Criteria:
Inclusion Criteria:

* Men and women age of 18 years old and older.
* HCV chronic Infection, genotype 1 or 2 or 3 or 4 or 5 or 6
* Naive
* Bi-therapy failure, Tri-therapy 1st generation Telaprévir and Boceprevir, Sofosbuvir - pegIFN - RBV failure
* Evaluation of fibrosis by non-invasive methods (Fibroscan, Fib 4, APRI) performed during the pre-inclusion period (of at least one month) or A Liver biopsy puncture of at least 24 months before the inclusion visit.
* Fibrosis according to Metavir score: F0, F1, F2, F3, F4.
* Compensated Cirrhosis Child-Pugh A or
* Decompensated Cirrhosis (This point is applicable for patients who have cirrhosis)

Exclusion Criteria:

* Patient under amiodarone
* Hepatocellular carcinoma HCC
* Haemodialysis
* Creatinine Clearance \< 30ml/min
* Breastfeeding
* Impossibility of using effective masculine or feminine contraception during the study and 6 months after treatment cessation.
* Medications triggering conduction disturbances with long QT, 30 days prior to inclusion
* QT prolongation \> 450 ms
* Personal or familial history of torsade de pointes
* Allergies to nucleosi(ti)des analogues.
* Advanced cardiopulmonary pathology
* Malignant neoplasia
* The intake of anticonvulsants: Carbamazepine, eslicarbazepine, fosphenytoin, phenytoin, oxcarbazepine, pentobarbital, phenobarbital, primidone or the antimycobacterial agents: Rifabutin, rifampin