cyrilzakka/clinical-trials huggingface dataset:
Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease
Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. The researchers also want to learn if patients who have robot-assisted surgeries have fewer complications during recovery.

Information Collection:

If you agree to take part in this study, the following information will be collected from your medical record after surgery:

* The reason you had or are scheduled to have robot-assisted surgery.
* How long the surgery took to complete.
* What procedures were performed during the surgery.
* If cancer was or was not found in the tissue that was removed.
* How long you were in the hospital.
* What complications, if any, happened that are related to the surgery.

Follow-Up Questionnaires:

Depending on when you enroll in the study, you may be asked to complete a short questionnaire 3 different times, each questionnaire will take less than 10 minutes to complete. If you had surgery for cervical cancer, you will complete the questionnaire 2 weeks after surgery. All patients will complete the questionnaires 4-6 weeks after surgery, and again 3-6 months later.

If you have your follow up care with a doctor outside of MD Anderson, you will be called to complete the questionnaires over the phone. Each phone call should last about 10 minutes This questionnaire and/or phone calls will ask questions about any side effects you have experienced that you think may be related to the surgery.

Length of Study:

After the last questionnaire is completed, your participation in the study is over.

This is an investigational study.

Up to 1,000 patients will take part in this study at MD Anderson Cancer Center and Banner MD Anderson Arizona.

Eligibility Criteria:
Inclusion Criteria:

1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at MD Anderson Cancer Center and MD Anderson Banner - Arizona are eligible for inclusion in this study. They should be able to speak either English or Spanish.

Exclusion Criteria:

1) None
Sulfasalazine and Endothelial Function

Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and atherosclerosis. This study will examine the effects of the anti-inflammatory drug sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period, subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated dilation of the brachial artery will be studied before and after each drug. We hypothesize that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* History of coronary artery disease

Exclusion Criteria:

* G6PD deficiency defined by red blood cell G6PD activity assay
* Sulfa allergy
* Aspirin allergy
* Allergy to furosemide (lasix), hydrochlorthiazide, sulfonylureas, acetazolamide (Diamox) or other carbonic anhydrase inhibitors
* SGOT, SGPT, alkaline phosphatase, total bilirubin greater than 2 times the upper limit of normal
* WBC less than 4.0 or greater than 11.0 K/UL
* Platelet count less than 150 K or greater than 450K
* Hematocrit less than 30% 7
* Serum creatinine greater than 1.5 mg/dl
* Unstable angina or acute MI within 2 weeks
* Warfarin treatment
* Immunosuppressive treatment (methotrexate, cyclosporine, etc.)
* Digoxin treatment
* Phenytoin (Dilantin) treatment
* Methenamine (Mandelamine, Urex) treatment
* Probenecid or sulfinpyrazone (Anturane, Aprazone) treatment
* Porphyria
* Symptomatic GI obstruction
* GU obstruction (not including clinical evidence of benign prostatic hypertrophy)
* Pregnancy
Celebrex Total Knee Arthroplasty Study

This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female 18 years or older with osteoarthritis of the knee scheduled to undergo elective unilateral primary total knee arthroplasty because of OA, performed under a standardized regimen of anesthesia and procedure.

Exclusion Criteria:

* Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) other than osteoarthritis.
Efficacy Evaluation and Recurrence Monitoring of Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.

This project is focusing on who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. The exclusive MRD (Minimal residual disease) probe consists of an exclusive "molecular label" formulated according to the individual genome mutation profile and 21 critical tumor driver genes. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.

The goal of this project is to recruit 50 patients who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. Initially, tumor tissues from all patients will undergo a more comprehensive NGS sequencing process (WESPlus) than whole-exome sequencing. This will provide a complete genomic mutation profile for each patient. Subsequently, a specific algorithm will be used to accurately select 20 mutation sites as the patient's unique "molecular label." Additionally, 21 critical driver genes related to tumors will be combined, leading to the creation of an exclusive MRD probe. This will enable ultra-high-depth capture sequencing of ctDNA samples from patients at 100,000x. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 80 years old;
* Patients diagnosed with locally advanced esophageal squamous cell carcinoma by imaging or pathological examination: cT2-4N1-3M0, cT3-4N0M0 II-IVA (including IVB stage with supraclavicular and abdominal lymph node metastasis);
* Receive neoadjuvant therapy;
* Must be able to obtain the patient's clinical information and clear pathological diagnosis results;
* Able to cooperate with long-term follow-up, regular review, and blood sample collection;
* Patients agree to participate in the tracking and follow-up of the group and provide follow-up information;
* Must obtain the informed consent of the patient or their legal representative, and the patient has the ability to cooperate to complete the requirements of the study.

Exclusion Criteria:

* Patients with other cancers or severe illnesses that result in shorter survival than the trial follow-up period;
* Received other treatments (such as radiotherapy, etc.) before receiving neoadjuvant therapy;
* Have contraindications to chemotherapy;
* Patients who received blood transfusions within three months prior to enrollment;
* HIV-positive patients or those with other immune system deficiency diseases;
* Pregnant patients;
* Alcohol or drug abusers;
* Other situations that the researchers believe may affect the experimental results or are unethical.
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject aged \>=10 and \<19 years at the time of enrollment.
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
5. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
7. Current chronic use of systemic antibiotics.
8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS

The aim of the present study is to research whether subjects with irritable bowel syndrome (IBS) display epigenetic/genetic changes or altered microbiota compared to a non-IBS control group. Further, we will investigate if these parameters as well as subjective IBS symptoms are affected by a 4-week long dietary intervention within the IBS patient group.

The study will be performed on 140 subjects with verified IBS. Patients will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study patients will fill out protocols concerning Rom IV criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales. They will be examined by a physician/researcher who will complete protocols of clinical data. Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals will go through the same procedure as described above.

Study participants with IBS will thereafter be randomized to receive an alternative diet resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130), or to continue with their regular diet (control group; n=20). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.

Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide association studies), gut microbiota and inflammatory parameter analyses.

Statistics

To study differences in the above-mentioned parameters between patients and controls as well as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Verified IBS according to Rom IV criteria.

Exclusion Criteria:

* Serious mental or somatic disease
* Abuse
* Inability to understand he Swedish language
* Already on a diet (e.g. vegan, FODMAP, gluten-free).
Effects Among Smokers Who Use and Do Not Use E-Cigarettes

This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.


Eligibility Criteria:
Inclusion Criteria:

* \> 21 years of age
* Smoked cigarettes on \> 25 of past 30 days
* Smoked \> 5 cigarettes per day on days smoked
* Smoked cigarettes \> 6 months
* Carbon monoxide \> 5 PPM at baseline
* Hispanic/Latino or African American/Black
* Fluent in English or Spanish
* Willing to switch from smoking cigarettes to ECs for 6 weeks
* Regular access to telephone
* Transportation to attend appointments (KC Only)

Exclusion Criteria:

* Primary use of other tobacco products or equal use of cigarettes and other tobacco products
* Electronic cigarette use on \> 4 of the past 30 days
* Currently in a smoking cessation program or another clinical trial
* Use of nicotine replacement therapy or medication which aids smoking cessation in the past 30 days
* Hospitalization for a psychiatric issue in the past 30 days
* Heart-related event in the past 30 days. Examples include heart attack, stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular disease
* Uncontrolled blood pressure at baseline
* Planning to move out of San Diego or Kansas City in the next 6 weeks
* Another person in the household enrolled in the study
* Women: pregnant, breastfeeding, or planning to become pregnant in the next six months
* Unstable mental status or health status
HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT

This randomized-control trial is designed to determine the recurrence rate of HS abscesses following drainage via two methods: I\&D with a linear incision and PD with an 8mm punch biopsy. In this context, recurrence is a newly described HS abscess adjacent to or within the previously operated area, for which a second intervention is deemed necessary. We hypothesize that PD may yield a more favorable recurrence rate. In addition to comparing recurrence rates, this randomized-control trial will also evaluate postprocedural pain, the occurrence and type of complications, and patients' quality of life associated with both procedures. These additional factors are crucial in assessing the overall effectiveness and patient satisfaction associated with each method, further informing the potential establishment of PD as the new gold standard for draining small, painful, acute HS abscesses.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HS
* Has an abscess requiring drainage with a maximum diameter of 5 centimeters.
* Age 16 years or older
* Willing and able to provide informed consent

Exclusion Criteria:

* Has other conditions that could interfere with the study, as estimated by physician
* Unable to comply with follow-up visits
* Allergic to lidocaine and/or adrenaline.
Impact of Work Activity on SUD Outcomes

To date, there are no studies of the therapeutic effects of varied work-focused programs in Veterans undergoing outpatient substance use disorder (SUD) treatment. The investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in Veterans early in the course of recovery from SUD. Veterans will be randomized to either receive or not receive referral for work-focused therapeutic programs. Primary aim is to examine effects of work-focused programs on sobriety outcomes, namely sobriety and global functioning. Secondary aim is to examine effects of work-focused programs on psychiatric symptoms, self esteem/efficacy, and quality of life.

The investigators propose a trial to test the effects of Incentive Therapy (IT) and Other Therapeutic and Supported Employment Services (Other TSES) on improving SUD outcomes in newly recovering Veterans in outpatient treatment. In line with eligibility criteria for different TSES programs, the investigators will employ a two branch study: One branch will be for Veterans who are not interested in pursuing competitive employment, and will be a two arm RCT with randomization (2:1) to referral for IT + treatment as usual (TAU; including usual SUD outpatient treatment) or TAU alone. The second branch will be for Veterans who express interest in competitive employment, and will be a two arm RCT with randomization (2:1) to referral for TSES competitive employment services + TAU or TAU alone. Total Intent to Treat sample will be 140 (n=70 per branch). Primary outcomes will be percent days abstinent during 3 month active phase and clinical global impression scale scores at 6 months. Secondary outcome will be psychiatric symptoms, self esteem/efficacy and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be Veterans enrolled in VACHS substance use treatment, who at time of consenting into the study are within 30 days of detoxification or last substance use as per medical record.
* Additional criteria will be as follows:

  * 18 years of age and older,
  * meeting DSM-V criteria for any current Substance Use Disorder (SUD) (e.g., opioids, cocaine, marijuana, amphetamine, or alcohol),
  * competent to give written informed consent and HIPAA authorization.

Exclusion Criteria:

* involvement in a legal case that may lead to incarceration during study period;
* developmental disability or medical illness that would prevent therapeutic work activity, as judged by PI or clinical staff providing this service;
* plans to relocate outside geographic area that would make follow-up unlikely;
* and/or lack of willingness to provide contact information of someone who can help us contact the participant in the event that we are unable to maintain contact directly.
A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry

Exclusion Criteria:

* Macroscopic or microscopic residual tumor
* Evidence of metastatic disease including tumor cells in ascites
* Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
* Active cardiovascular disease
* Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
* Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
Improving Attention in Individuals With Long COVID-19

This study is to find out if the Attention Processing Training program is a potential treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating the feasibility of completing this program virtually.

The goal of this project is to test the feasibility, acceptability and efficacy of an attention training intervention (Attention Process Training; APT-3) as a potential treatment for brain fog symptoms experienced by people with Long-Covid. There already is good empirical evidence to support the idea that the APT-3 treatment is feasible and effective in improving attention in people with acquired brain injuries, but information about its efficacy and acceptability in people with Long-Covid brain fog is lacking.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years. Live in the Chicagoland area
* A history of confirmed SARS-CoV-2 infection.
* Subjective reports of cognitive symptoms that interfere with everyday activities, starting on or shortly after SARS-CoV-2 infection.
* Continuation or development of Long-Covid brain fog 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.
* Objective attentional deficits as measured by the Conners CPT-312, and/or the Digit Span subtest (WAIS- III13).
* Able to use a keyboard.
* Able to understand and communicate in English.
* Able to consent independently.

Exclusion Criteria:

* Being hospitalized due to COVID-19 diagnosis for more than 3 days.
* Pre-morbid neurological conditions that could potentially affect cognition, such as Parkinson's Disease, Alzheimer's Dementia, acquired brain injury.
* Severe depression.
* Currently enrolled in cognitive training or physical exercise training.
* Receiving chemotherapy or radiation within last 6 months.
* Active substance abuse.
Objective Evaluation of Shoulder Pathology and Surgery

The goal of this study was to clinically validate a new device for the objective outcome evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and rotator cuff disease, using the activities of daily living described in the Simple Shoulder Test (SST) as a reference.

The study was set up as a clinical trial including patients over an observation period of one year and a control group of subjects. Clinical evaluations will be made at baseline, 3 months, 6 months and 1 year after surgery by two independent observers. Miniature sensors each containing three 3D gyroscopes and three 3D accelerometers will allow computing new kinematic scores. They will be compared to the regular SST, DASH, ASES and Constant scores.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* patients with a unilateral rotator cuff disease implying a transfixiant supraspinatus rupture of at least 1 cm2, as determined by Magnetic Resonance Imaging (MRI), or a unilateral glenohumeral osteoarthritis stage II or III according the radiologic criteria published by Koss
* informed and signed consent

Exclusion Criteria:

* Patients who had a previous shoulder surgery (open or arthroscopic)
* Patients who had a contralateral shoulder pathology
Wormwood in Chronic Progressive Disorders With Reduced Appetite

Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders such as old age, immune disorders and cancer.

Trial aims at observing beneficial effects of wormwood supplementation in various chronic disorders associated with reduced appetite

Supplementation with wormwood in chronic disorders associated with reduced appetite.

Examples:

1. Cancer
2. Autoimmune diseases such as Crohns disease and IgA Nephropathy
3. Old age
4. Chronic stress and depression

Eligibility Criteria:
Inclusion Criteria:

* Appetite and weight loss
* Chronic progressive disease

Exclusion Criteria:

* Life expectancy less than 3 months