cyrilzakka/clinical-trials huggingface dataset:
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.

Eligibility Criteria:
Inclusion Criteria:

* 1-24 months, inclusive
* Concurrent 1 or 2 antiepileptic drugs
* Receiving regular enteral feedings
* Weigh between 3.5 and 15 kg
* Clinical or EEG evidence of simple or complex POS

Exclusion Criteria:

* Exclusively breast fed and cannot take medicine by mouth
* Surgically implanted and functioning vagus nerve stimulator
* Renal stones
* Medically uncontrolled illnesses or conditions
* Infantile seizures as a result of a correctable medical condition
* Progressive neurologic disorder
Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

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 combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed pancreatic or biliary duct adenocarcinoma Metastatic or locally advanced No cerebral metastasis Surgically unresectable

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: More than 12 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular: No severe cardiac failure Pulmonary: No severe respiratory failure Other: No other malignant tumor considered incurable or untreatable No uncontrolled pain No psychological, familial, social, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids except as antiemetic Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy

The investigators will assess how the use of toradol and pregabalin affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay.

Perioperative pain management is a significant challenge following surgery. Many pathways contribute to perioperative pain, including nociceptive, inflammatory, and neuropathic sources. Although opioids have long been a mainstay for perioperative analgesia, other non-opioid therapies have been increasingly used as part of a multimodal analgesic regimen to provide improved pain control while minimizing opioid-related side effects

TORADOL (ketorolac tromethamine), is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.

Anecdotal evidence has shown that the use of Toradol (Ketorolac) is safe in renal surgery patients. The study team aims to further evaluate this in a pilot study specifically in the population of patient who have donated their kidney in live kidney transplants. The study team will assess how the use of toradol affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay. The study team will assess differences in visual analog pain scores and total narcotic consumption, whereas secondary endpoints of urine output, serum creatinine and hemoglobin levels to assess for efficacy and safety.

Pregabalin is prescribed for neuropathic pain. In many studies, preoperative administration of pregabalin reduced postoperative morphine consumption and early postoperative pain.

There will be two arms of the study including:

Arm 1 (pure placebo group): Placebo oral preop then Saline placebo IV x 1 in the OR, then saline placebo IV every 6 hours for 7 doses.

Arm 2: Pregabalin 75mg oral preop, then Ketorolac 30 mg IV x 1 in the OR, then ketorolac 15 mg IV every 6 hours for 7 doses.

Toradol and Lyrica will be used consistent with its FDA approval in terms of dosing, route of administration, etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients anticipating donating a kidney in a live kidney donor transplant.

Exclusion Criteria:

* Patients not receiving a donor nephrectomy
* Pregnant, lactating, or nursing mothers
* Medical allergies or history that would otherwise be contraindicated for of a non-steroidal anti-inflammatory drug.
Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Prospective non-randomized intervention case control study on patients with a BMI \> 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.


Eligibility Criteria:
Inclusion Criteria case group:

* Age \> 18 years
* BMI \>35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
* Able to give written informed consent.

Inclusion criteria control group:

* Age \> 18 years
* BMI \>35 kg/m2 with no wish to undergo bariatric surgery.
* Able to give written informed consent.

Exclusion Criteria:

* Active viral hepatitis
* Not willing or able to consent
* Contraindications to liver biopsy
Combined THC and CBD Drops for Treatment of Crohn's Disease

There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.

The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's disease. Both studies have shown significant symptomatic improvement of disease. However, objective parameters of inflammation were not measured. The question arises as to whether the observed improvement is merely symptomatic or due to a real change in inflammation. In addition, administration per os is a healthier option than smoking but the efficacy of oral cannabis was not investigated.

The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's disease patients compared to placebo. Treatment success will be defined as a decrease of at least 100 points in CDAI after 8 weeks of treatment.

Secondary aims:

1. Remission of disease i.e CDAI of less the 150 points.
2. Improvement of at least one point in Endoscopic disease activity index
3. Improvement of CRP and calprotectine
4. Improvement of blood cytokine levels
5. Improvement of at least 30 points in quality of life as measured by the SF 36. In addition the investigators will monitor side effects by questionnaires addressed to the patients and to a significant relative of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
2. Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects.
3. Age 20 or older.
4. Able to sign informed concent
5. Active Crohn's disease with a CDAI 200 or more.

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Exclusion Criteria:

1. Patients with a diagnosis of a mental disorder
2. Patients who by the judgment of their physician are likely to develop drug addiction.
3. Pregnant women or women who are intending to become pregnant
4. Patients with a known cannabis allergy
5. Patients who are not capable of giving an informed consent
6. Patients with an impending operation due to Crohn's disease.

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Testing Product Messages in Colombia

Purpose: To better understand the impact of different front-of-package labels (FOPLs) on consumer purchasing intentions and ability to identify unhealthy foods.

Participants: \~8,000 Colombians, recruited from Offerwise, that are 18 years or older.

Procedures (methods): Participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, Guideline Daily Amount label, Nutriscore label, or no-label control. They will be asked a series of questions about the products and the labels (excluding control group) on them. Questions will also include standard demographic and health related variables.

Participants will be recruited from Offerwise (an online panel research company). Following online consent, participants will be randomly assigned to view different labels (explained below) on food and drink packaging. Participants will answer self-reported responses to the content (e.g., elaboration, beliefs, perceived healthfulness). After being randomized to one of the four groups and answering questions (e.g. which product is healthier, which product would you buy), the participant will see all three labels and select which is most dissuading from consuming a product high in a nutrient. At the end, the participant will answer demographic questions.

Participants will be randomized to see either a no-label control or 1 of 3 nutrient labels. The participants will see 5 types of products with the labels (fruit drinks, yogurt, sliced bread, cookies, and breakfast cereal).

Nutrient labels:

1. Guideline Daily Amount label
2. Nutriscore label
3. Adapted Peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* Resident of Colombia
* Offerwise panel member (recruitment platform)

Exclusion Criteria:

* \<18 years old or \>64 years old
* Not a resident of Colombia
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).
2. Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:

   * mNAPSI score of ≥20.
   * ViSENPsO ≥3
3. Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:

   * s-PGA score of at least 3.
   * Body Surface Area (BSA) involvement of ≥10%.
   * PASI ≥12
4. Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. Subjects who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
2. Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.
3. Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turns out to be positive for fungal infection, the subject should be excluded from the study. At the discretion of the investigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also be considered to rule of fungal infection of the nails. Direct microscopy or fungal culture are not required if fungal infection is diagnosed in PAS staining.
4. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
5. Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.
Functional Recovery After Cardiac Surgery : Does Delirium and Calorie Intake Matter?

The aims of the cohort study is to describe the rates of 30-day surgical complication, functional decline, frailty and one-year mortality for patients experienced cardiac surgery and to delineate the trajectory of functional capacity 1 year after surgery for the patients. It also will test whether the trajectory of functional varied significantly according to delirium status and its type over the follow-up period and examine the patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery as well as evaluate whether activity levels, dietary diversity, and depressive symptoms at 3,6, and 12 months affect patient outcome.

In Taiwan, 54.2% of cardiac surgical procedures in 2010 were performed on older patients (≧65 years) with higher rates of surgical complications, functional decline, and even death reported. Despite the large number of older patients undergoing cardiac surgery with the goal of improving functional capacity, the literature in this area is limited. Specifically, there is little information about the functional outcomes 1 year after cardiac surgery for older patients.

A prospective, longitudinal cohort study will be conducted to assess and follow patients aged 65 years and older who undergoing elective or non-elective cardiac surgery for one year after surgery. All patients on the cardio-surgical wards of 5A, 5B, and 5CVI at National Taiwan University Hospital will be screened for eligibility. Every patient ≧65 years admitted for cardiac surgery will be approached and invited to participate. This cohort study aims to 1)describe the rates of 30-day surgical complication, functional decline, frailty, and one-year mortality for older patients underwent cardiac surgery; 2) delineate the rajectory of functional capacity 1 year after surgery for these patients; 3) test whether the trajectory of functional capacity varied significantly according to delirium status and its type over the one-year follow-up period; 4)examine patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery; and 5) evaluate hether activity levels, dietary diversity, and depressive symptoms at 3, 6, and 12 months affect patient outcomes. Estimated 236 participants will be enrolled to ensure the power of study.

Data will be analyzed using the SAS package. The Generalized Estimating Equation (GEE) will be performed to identify the risk factors and to delineate the trajectory of functional capacity 1 year after cardiac surgery for older patients. The findings will add to the development of nursing intervention program to promote functional recovery for older patients after cardiac surgery

Eligibility Criteria:
Inclusion Criteria:

* patients over 20 years old
* admitted for elective or non-elective cardiac surgery

Exclusion Criteria:

* incapable of verbal communication
* sensory impairment
* intubation or respiratory isolation
* patients with critical condition or coma
BMAC Nerve Allograft Study

This study is a prospective, multi-center, proof of principle, phase I human safety study evaluating the sequential treatments of the Avance Nerve Graft, a commercially available decellularized processed peripheral nerve allograft, with autologous Bone Marrow Aspirate Concentrate (BMAC), a source of stem cells, for the repair of peripheral nerve injuries up to 7 cm in length. The purpose of this study is to establish a knowledge product, evaluating the safety profile of the Avance Nerve Graft, followed by the application of BMAC to support further investment into the promising area of using stem cells in conjunction with scaffolds.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female 18 to 74 years of age.
* Undergoing peripheral nerve exploration or grafting with allograft in the upper extremity.
* Subjects must be inpatients or scheduled for surgery at the time of study enrollment.
* Has nerve conduction block injuries to the ulnar, median, radial or musculocutaneous nerve of either upper extremities that is less than two years from injury.
* Be willing to undergo tension free end-to-end nerve graft coaptation on both the proximal and distal portion of the nerve gap with the Avance Nerve Graft.
* Be willing to have bone marrow harvested from own body, concentrated, and applied to the site of nerve injury following the insertion of the Avance Nerve Graft.
* Be willing to participate and able to comply with all aspects of the treatment and evaluation schedule over a 18-month duration.
* Capable of giving their own consent to participate in the study, and willing to sign and date an IRB-approved written informed consent prior to initiation of any study procedures.
* Nerve conduction injury affecting sensory and motor function or solely motor function in the upper extremity.
* Nerve gaps following resection, up to 7 cm, inclusive.

Exclusion Criteria:

* Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy.
* Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system.
* History of neurodegenerative disease, neuropathy, or diabetic neuropathy.
* History of chronic ischemic condition of the upper extremity.
* Cognitive limitation or mental illness preventing informed consent.
* Nerve injuries \>2 years post initial injury.
* Any participant who at the discretion of the Investigator is not suitable for inclusion in the study.
Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis

This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy.

This study employs a multicenter, retrospective cohort design, collecting and analyzing plasma and tissue exosome protein data from patients with upper gastrointestinal tumors (Stage I-II), upper gastrointestinal benign diseases, and a healthy control group who have visited Beijing Friendship Hospital, and other relevant sub-center hospitals over the past five years. Concurrently, relevant clinical and pathological information is recorded.

Samples from the training cohort undergo traditional quantitative exosome proteomic analysis (Data-Independent Acquisition, DIA) and single-vesicle membrane protein analysis (PBA). A comprehensive upper gastrointestinal tumor-specific exosome protein database is constructed, incorporating extensive information. Subsequently, bioinformatics methods are employed to conduct in-depth analysis of the extensive protein data, screening for proteins with high specificity for upper gastrointestinal tumors, capable of direct detection on the exosome membrane surface. By establishing and evaluating diagnostic models, we aim to quantify the diagnostic potential of these markers, providing a scientific basis for future early screening methods for upper gastrointestinal tumors.

Finally, external validation of these protein markers in an independent validation cohort ensures their reliability and stability across different patient populations. The academic significance of this research lies in its thorough exploration of exosome proteomics in early cancer diagnosis, offering potential innovative breakthroughs for academic progress and clinical practice in this field.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of upper gastrointestinal cancers or benign upper gastrointestinal diseases through gastroscopy and pathological examination.
* Collection of plasma samples prior to surgical treatment.
* Availability of complete clinical data.

Exclusion Criteria:

* Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
* Coexistence of other systemic tumors.
* Absence of plasma sample collection before surgical treatment.
* Incomplete clinical data.
* Pregnancy status