cyrilzakka/clinical-trials huggingface dataset:
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions

To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT

To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of GlaxoSmithKine's Zofran 8 mg ODT under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting all of the following criteria may be included in the study.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
* Males and Females aged from 18 to 50 years ol with a body mass index (BMI)within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF (laboratory tests are presented in section 7.1.3.
* Healthy according to the laboratory results and physical examination.
* Normal cardiovascular function according to ECG.
* Non or ex-smokers.

Exclusion Criteria:

* Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
* Females who are pregnant, lactating or are likely to become pregnant during the study phases.
* Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body.
* Positive pregnancy test before and during the study.
* Maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease.
* Any clinically significant illness in the previous 28 days before day 1 of this study.
* Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
* Participation in another clinical trial in the previous 28 days before day 1 of this study.
* Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
* Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4).
* Positive results to HIV, HBsAg or anti-HCV tests.
* History of fainting upon blood sampling.
Study for AZD4360 in Participants With Advanced Solid Tumours

The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be ≥ 18 at the time of signing the ICF.
2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.

4 Adequate organ and marrow function, as defined by protocol.

5. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.

6. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.

7. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.

8. At least one measurable lesion according to RECIST v1.1.

Exclusion Criteria:

1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
3. Participants with clinically significant ascites that require drainage.
4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
5. With spinal cord compression or with high risk of paralysis.
6. History of non-infectious interstitial lung disease/pneumonitis.
7. Participant has cardiac abnormalities, as defined by protocol.
8. History of another primary malignancy within 2 years prior to screening.
9. Known serologic status reflecting active hepatitis B or hepatitis C.
10. Known HIV infection that is not well controlled.
11. Active tuberculosis infection.
Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients

The aim of the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems.

The present study investigates Internet-delivered CBT as a tertiary intervention. This is motivated by the fact that many pain patients relapse after rehabilitation and some may be in need of additional treatment. The persons who fulfills the inclusion criteria undergoes a structured telephone interview. The study is a experimental design with a treatment and an active control group measured before and after a treatment period. The control group were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* to have been medically investigated (within one year)
* completed the multidisciplinary rehabilitation program
* have residual symptoms after the rehabilitation treatment (defined as functional impairment caused by their pain)
* have Internet access

Exclusion Criteria:

* planned surgery
* ongoing medical investigation that could impede participation in the study
* suffering from acute physical or psychological conditions
* people confined to wheelchairs
* people not fluent with the Swedish language
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately

Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.

Refractory ascites is one of the complications associated with portal hypertension in the cirrhotic patient. To date, its treatment consists of evacuating punctures, performed in day hospitalisation, whose frequency is adapted to the rate of ascites synthetis. Paracentesis, which does not affect the mechanisms of ascites formation, contributes to protein catabolism and undernutrition. They also have an inconvenience linked to the gesture, making frequent hospital stays necessary. For all these reasons, the patient's quality of life is diminished. The Alfapump® system is a new method for the treatment of refractory ascites. It is a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder, where ascites is eliminated by urinary tract.

Eligibility Criteria:
Inclusion Criteria:

* Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.
* Patient with an estimated life expectancy of at least 6 months on the day of inclusion.
* Patient with contraindication to the application of a TIPS or who has expressed a refusal of the procedure or a non-functional TIPS
* Patient affiliated with or in receipt of social security
* Informed and written consent signed by the patient.

Exclusion Criteria:

* Local or systemic infection in the month preceding the procedure
* Hepatocellular carcinoma with palliative care
* MELD Score \> 18
* Child Pugh C Score \> 10
* Creatinine Clearance \< 50 ml/mn
* Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion
* Contraindication to general anesthesia
* Contraindication to implant surgery of the device:

  * Obstructive urological impairment
  * Partitioning of ascites
  * Coagulopathy
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure).
* Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.
Ultrasound-guided Radiofrequency Ablation of the Genicular Nerve Versus Physical Therapy for Chronic Knee Osteoarthritis

The aim of this study is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis.

Patients diagnosed with Chronic Knee Osteoarthritis according to the American College of Rheumatology criteria, and with radiological osteoarthritis at Kellgren-Lawrence grades 2 and 3, within the age range of 45-70, and meeting the study criteria will be included in the study. After providing information about the procedures to be performed and potential risks to the patients, if they give their written informed consent, treatment methods will be applied to the patients. Eligible patients will be divided into two groups. In one group, Radiofrequency Ablation of the Genicular Nerve under Ultrasound Guidance will be performed, while the other group will receive physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* VAS ≥ 5
* To be aged between 45 and 70 years old
* Patients diagnosed with chronic knee osteoarthritis using the American College of Rheumatology criteria and having radiological osteoarthritis of Kellgren-Lawrence grade 2 and 3
* Cognitive functions being intact
* Being willing to participate in the study and signing the consent forms

Exclusion Criteria:

* Having received physical therapy for chronic knee osteoarthritis in the last 6 months
* Having received glucocorticoid or hyaluronic acid injections in the last 6 months
* Having taken oral glucosamine
* Undergoing knee surgery
* Having current neurological or mental disorders
* History of pacemaker usage
* Presence of local infections or sepsis
* Progressive neurological deficit
* Presence of oncological diseases
* Hemorrhagic diathesis or anticoagulation
* Uncontrolled diabetes or other serious internal comorbidities
* Allergy to medications or materials used
* Pregnancy
* Lack of cooperation
* Not willing to participate in the study.
Pediatric Chronic Rhinosinusitis in Asthmatic Children

The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.

This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

Age 6-12 at time of study enrollment. Presence of chronic sinusitis: \>90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.

Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist

Exclusion Criteria:

* Exclusion criteria include previous sinus surgery, previous adenoidectomy, or presence of cystic fibrosis, antrochoanal polyp, immunodeficiency, or fungal infection.
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis

This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old at the time of signing the informed consent, regardless of gender;
2. Diagnosed with moderate to severe plaque psoriasis;
3. The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
4. Patients who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the Chinese Guidelines for the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy.

Exclusion Criteria:

1. Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
2. Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
3. Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
4. Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after the last receipt of the study drug;
5. Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
6. Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
Is the 4MGS a Useful Outcome Measure Post-PPCI

This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to assess whether this can predict future cardiovascular events and death.


Eligibility Criteria:
Inclusion Criteria:

* Any patient hospitalised with an acute myocardial infarction who has undergone primary percutaneous coronary intervention
* Capacity to consent
* Able to walk
* Age over 18 years

Exclusion Criteria:

* Significant co-morbidities that would limit exercise capacity or make exercise unsafe (e.g. neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)
DLSCT for Breast Cancer Detection in Women With Dense Breasts

The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.

Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histopathologically proven locoregional advanced primary breast cancer:

  1. Tumors \> 5 cm (= T3) or
  2. Tumors with invasion of the skin or chest wall (= T4) or
  3. Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
* Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon

Exclusion Criteria:

* History of allergic reactions to iodinated contrast agents
* Pregnancy or breast feeding
* Treatment of thyroid disease with radioactive iodine
* Use of metformin
* Creatinine clearance \< 45 ml/min
* Chronic or acutely worsening renal disease
* Patients who are declared incompetent
Natural History of Carotid Atherosclerosis

A prospective study of 700 patients with coronary artery disease will undergo non invasive evaluation of their carotid arteries by ultrasound and microwave radiometry. The patients will be followed up for 3 years and their outcome regarding the cardiovascular events (death, cardiac events, cerebrovascular events) will be recorded

Carotid artery Thermal heterogeneity recorded by MR will be corelated to cardiovascular events (death, cardiac events, cerebrovascular events) as well as to all demographic (age, sex, hypertension, dyslipidemia, smoking status, etc) factors

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with coronary artery disease admitted in our hospital

Exclusion Criteria:

* Patients with history of previous cerebrovascular event,
* History of vasculitis, intermittent inflammatory, infectious, or neoplastic conditions likely to be associated with an acute-phase response.
'4C' Intervention to Reduce SARS-CoV-2 (Covid-19) Transmission

Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Advancing our understanding of the transmission of SARS-CoV-2 within these facilities for vulnerable populations deserves urgent and further investigation. Environmental contamination with SARS-CoV-2 that is reported in limited studies highlights the potential importance of transmission between patients, their environment, and healthcare providers via direct and indirect contact.

This study seeks to characterize the epidemiology of SARS-CoV- 2 in the NH patient room environment over time and the risk of transmission to near and far environments, with the explicit intent of developing integrated, simple COVID-19 infection prevention strategies that can be reported to and implemented throughout other nursing homes and long-term care facilities.

In order to achieve these goals the study is being performed at four different nursing homes and will include patients with active or with recent COVID-19 infection, as well as nursing home staff members. The study will test a multimodal aging-friendly intervention including four components and hypothesizes that the implementation of this organizational, educational, quality improvement program will be associated with lower odds of SARS-CoV-2 transmission to the environment.

Eligibility Criteria:
Inclusion criteria for nursing home patients:

* 18 years of age or older
* Residing in a participating nursing home facility
* Active or recent (last 14 days) COVID-19 infection

Exclusion criteria for nursing home patients:

* Not located in a participating nursing home facility

Inclusion criteria for healthcare workers:

- Healthcare worker at a participating nursing home facility

Exclusion criteria for healthcare workers:

- None
ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital
* ASA Class 1, 2, 3 (American Society of Anesthesiologists physical status classification system)
* Age 18 to 80 years (male or female)
* BMI \< 40kg/m2
* Desires regional anesthesia for postoperative pain control

Exclusion Criteria:

* Any contraindication for neuraxial analgesia or ESP block procedure

  * Contraindications for neuraxial analgesia include: Elevated intracranial pressure (except in cases of pseudo-tumor cerebri), infection at the site of injection, lack of consent from the patient, patient refusal, true allergy to any drug used in the spine, and uncorrected hypovolemia.
  * Contraindications for ESP block procedure include: Infection at the site of injection, patient refusal, true allergy to any of the drugs used in the block, and lack of patient consent.
* Any patient undergoing a laparoscopic abdominoperineal resection.
* Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex)
* Takes over 30 mg of oral morphine equivalents daily
* Any history of substance abuse in the past 6 months
* End stage liver disease, end stage renal disease
* Body weight of \< 50 kg
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).

Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA (+) and ALT \> 40 U/L
* Compensated liver
* HOMA-IR \> 2

Exclusion Criteria:

* neutrophil \<1500/mm3
* male: Hb \< 13 g/dl, female: Hb \< 12 g/dl
* platelet \< 80,000 /mm3
* Cr \> 2.5 mg/dl
* Alcohol use \> 20 gm per day
* uncontrolled depression, thyroid disease, autoimmune disease
* Pregnancy
* Hepatocellular carcinoma
* allergy to interferon or ribavirin
* Diabetes
* HBV/HIV co-infection