cyrilzakka/clinical-trials huggingface dataset:
Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patient who have malignant or benign disease which needs pancreatoduodenectomy
* patient age: ≥20 and ≤85

Exclusion Criteria:

* patient who had chemotherapy or radiotherapy previous to operation.
* patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular)
* patient who had past medical history of chronic pancreatitis.
* pancreatic stent size \<1mm or \>5mm
Clinic-based Versus Hotspot-focused Active TB Case Finding

This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. The two strategies differ in the location where ACF activities are performed: A "facility-based" ACF/TPT strategy will perform ACF, plus linkage to TPT, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of TB suspicion or symptoms. Alternatively, a "hotspot-based" strategy will use routine notification data and local expertise to identify local TB hotspots - defined as the geographic areas though to have the highest burden of undiagnosed TB per estimated population. The same infrastructure (personnel, equipment, supplies, etc.) for ACF/TPT will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to TPT.

The two interventions will be compared in a Type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. The study will evaluate whether hotspot-focused ACF/TPT results in a greater number of TB patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based ACF/TPT. Secondarily, it will also compare the two interventions in terms of number of people initiated on TPT, and it will compare TB cases detected in regions performing ACF/TPT (either approach) against cases detected in regions that continue to perform the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,
* Provision of oral informed consent, or, if age \<18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study
* Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant

Exclusion Criteria:

* On treatment for, or diagnosed with but not yet treated for, active TB
Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer

The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.

Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs as Mitomycin C (MMC).This treatment approach is limited due to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.

TheraCoat core technology is based on a reverse thermal (low viscosity at 5°C) degradable gel (TC-3)for MMC retention in the urinary bladder.

Prior to instillation, the TC-3 hydrogel,in a liquid state, is mixed with MMC.TC-3 mixed with MMC is instilled to the bladder by a catheter.Following gel insertion to the bladder, the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the gel dissolves and is cleared out from the bladder.

Intravesical MMC using TheraCoat gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Patients with bladder cancer designated to undergo Radical Cystectomy

Exclusion Criteria:

* Sensitivity to MMC
* Acute urinary Tract Infection (UTI)
* Upper urinary tract obstruction.
* Patient received neoadjuvant treatment previous to Radical Cystectomy
* Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be pregnant
* Breastfeeding women
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 diabetes treated with insulin for at least 12 months
* BMI (Body Mass Index) between 18.0-29.0 kg/m\^2
* Negative fasting C-peptide (below or equal to 0.6 ng/mL)
* HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
* Current treatment with insulin below or equal to 1.2 U/kg/day
* Subject should be in good health based on medical history, physical examination and routine laboratory data

Exclusion Criteria:

* Any known/suspected allergies to trial medication or similar products/devices
* A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Clinically significant active disease of any kind
* Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
* Blood donation (more than 500 mL) within the previous 9 weeks
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors:

* Anal canal cancer-No longer enrolling this tumor type
* Cervical cancer
* Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
* Merkel Cell Cancer
* Penile cancer-No longer enrolling this tumor type
* Vaginal and vulvar cancer-No longer enrolling this tumor type
* Nasopharyngeal Cancer - No longer enrolling this tumor type
* Head and Neck Cancer - No longer enrolling this tumor type


Eligibility Criteria:
Inclusion Criteria:

* Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):

  1. Merkel Cell Carcinoma
  2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type)
  3. Nasopharyngeal Carcinoma
  4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva
  5. Squamous cell carcinoma of the Head and Neck
  6. Squamous cell carcinoma of the anal canal and penis
  7. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort
* Measurable disease by CT or MRI
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
* Men and women of age 18 or older

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Patients with active, known or suspected autoimmune disease
* Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Patients with hepatitis
* Patients with HIV
* Pregnant or breastfeeding women
Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty

This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Primary diagnosis of osteoarthritis
* Surgical indication for index total knee arthroplasty

Exclusion Criteria:

* Previous surgery about the knee
* Systemic corticosteroid use
* Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
Cognitive Impairment Following Elective Spine Surgery

Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.

It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years
* scheduled for elective spine surgery without opening the dura
* patient can give informed consent him-/herself
* German native speaker

Exclusion Criteria:

* dementia or neurodegenerative disease
* psychiatric disease
* prescription of CNS-active medication (e.g. antidepressants, antipsychotics, sedatives, alpha-1-antagonists)
* impossible to participate in follow-up
* participation in an interventional trial
* electronic or displacable metallic implants
* active neoplasm
Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders

Failure to adapt to stress leads to functional impairments in various areas, including social, occupational, educational, and other significant domains, necessitating therapeutic intervention. Interventions through mobile app in the form of software can provide a new alternative for alleviating symptoms caused by psychological trauma by increasing accessibility to early intervention for trauma patients. This study aims to preliminarily assess the safety and feasibility of a psychological traum intervention by developing SAT-014 to help patients with trauma and stress-related disorder continue effective treatment in a stable environment.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (19 years and older)
2. Have experienced clinically significant psychological trauma within the 6 months prior to screening visit
3. Met the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) category as evaluated by MINI (Mini-International Neuropsychiatric Interview)
4. Score between 17 and 38 points on the IES-R (Impact of Event Scale-Revised)
5. Score of 4 or less on CGI (Clinical Global Impression)
6. Capable of complying the activity instructions provided the app

Exclusion Criteria:

1. Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder
2. Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder
3. Severe depression (PHQ-9 score of 20 or greater)
4. Comorbid with severe personality disorder
5. Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder
6. Have made a suicide attempt within 3 months and are judged to be at high risk for suicide by a psychiatrist
7. Pregnant or lactating
8. Currently participating in another clinical trial or have participated in another trial within 90 days from screening
9. Others deemed unsuitable for participation in this clinical trial at the discretion of the investigator due to ethical concerns or potential impact on the trial outcome
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy

Thyroidectomy is a frequent procedure. This surgery is well known but not devoid of risks. The most common postoperative complication is transitory hypocalcemia. Some studies have reported that preoperative vitamin D deficiency (VDD) is a risk factor for hypocalcemia after total thyroidectomy (TT) in patients with non toxic multinodular goiter or graves's disease. Although the association between VVD and postoperative hypocalcemia in thyroid cancer patients undergoing TT plus central compartment neck dissection (CCND) remains unclear. This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing TT.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient shall be operated on for a total thyroidectomy in one time for any indication
* Written informed consent (IC) obtained
* Patients with affiliation to the social security system

Exclusion Criteria:

• Medical history of : Thyroid or parathyroid surgery Hyperparathyroidism Granulomatosis flare-up

* Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies
* Chronic kidney disease grade ≥4
* Severe liver failure
* 25OHD supplementation within last 3 months before surgery
* Malabsorption syndrome
* Known hypersensitivity to vitamin D
* Medical history of calcic lithiasis
* Pregnant women
* Vulnerable populations (guardianship or trusteeship)
* Allergies to one of the components of the fruit juice
The Clinical Trial for Primary Chronic Venous Insufficiency

A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* PCVI patients with III degree back flow in deep vein that is confirmed by color doppler or phlebography

Exclusion Criteria:

* age over 70 years old
* pregnancy
* patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)

This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.


Eligibility Criteria:
Inclusion Criteria:

1. All participants with unresectable thyroid cancer and administrated Lenvatinib.
Mode of Action of Butyrate in the Human Colon

Butyrate has recently gained attention as an important microbial compound in human colon health. Several diseases, including Irritable Bowel Syndrome (IBS), have been linked with a loss of butyrate in the colon resulting in the hypothesis that butyrate is important for disease resistance. However, despite a plethora of preclinical evidence about butyrate's role in colon health, data from human studies are insufficient, largely due to the lack of available tools for colon-specific butyrate delivery and sampling. This project will elucidate butyrate's mode of action in the human colon and its implications for gut functioning in IBS and healthy participants by employing a unique in vivo human setting. Specifically, the regulatory capacity of butyrate on intestinal barrier function and the transcriptional host responses that are associated with an increase of butyrate in the colon will be determined. Moreover, butyrate's role as a signalling molecule for gut hormones and serotonin release will be studied.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* Fulfilled Rome IV diagnostic criteria for IBS (for IBS participants)

Exclusion Criteria:

* known gastrointestinal diseases
* previous complicated gastrointestinal surgery (including e.g. appendectomy or cholecystectomy)
* pregnancy or breast-feeding
* use of antibiotics within the last 12 weeks before the colonoscopy procedure
* regular consumption of probiotics within the last 4 weeks before the colonoscopy procedure
* use of laxatives or anti-diarrhoeals within the last 4 weeks before the colonoscopy procedure
* use of serotonin selective re-uptake inhibitors (SSRI) or serotonin nor-epinephrine re-uptake inhibitors (SNRI) with the last 12 weeks before the colonoscopy procedure
* alcohol or drug abuse
* latex allergy
* any other clinically significant disease/condition which in the investigator's opinion could interfere with the results of the study.
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80

The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can relieve the symptoms of low testosterone in men aged 55-80. These symptoms include reduced muscle strength, increase fat mass, low libido, feeling blue or moody

Background - In the context of hypogonadism, androgen supplementation is clearly beneficial, particularly in younger males. The benefits of therapy in men with milder degrees of hypogonadism, and elderly males with testosterone deficiency, are less clear-cut. Several options are available for androgen replacement in adult men. Oral testosterone, intramuscular injections, subcutaneous implants and transdermal therapy have all been used. Each mode of delivery has advantages and drawbacks. Several alkylated derivatives of T are available for oral or sublingual use, including methyl testosterone and fluoxymesterone. However, they are not recommended for use as replacement therapy because of their associated adverse effects.

Study Design - This is a multi-center, double-blind, placebo-controlled, parallel group, randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism. Total enrollment for this study will be approximately 120 subjects (40 subjects for each treatment group). Subjects will be treated with 35 mg/day DHT, 70 mg/day DHT, or placebo gel for 6 months. All subjects will apply the gel once daily. Up to 9 months of study participation, including up to 2 months of screening and a 1-month follow-up period, will be required by the protocol.

The primary efficacy endpoint in this study is change in body composition as determined by DEXA scan. Secondary endpoints in this study include change in sexual libido, and overall function and mood, and normalization of serum androgen levels. A subset of sites will perform strength assessments, which will include handgrip dynamometry, and upper and lower body strength tests.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 55-80 Serum Testosterone \< 275 Symptoms of Hypogonadism as determined by AMS scale In good overall health

Exclusion Criteria:

* Abnormal Prostate Exam for age Prostate or Breast Cancer Significant illness Weight \>300lbs Generalized skin disease Unstable sleep apnea
A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health

This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.

Obesity poses substantial health challenges contributing significantly to chronic metabolic disorders such as type 2 diabetes mellitus, cardiovascular disease, and diminished quality of life for people worldwide. Central to obesity-related metabolic dysfunction is dysregulation of appetite control, glucose homeostasis, insulin sensitivity, and systemic inflammation. Evidence indicates a strong connection between these metabolic disturbances and alterations in the gut microbiome, implicating microbiota dysbiosis as a potential target for intervention. Microbiome-based interventions underscore a promising approach in weight management and metabolic health.

Eligibility Criteria:
Inclusion Criteria:

1. Provide voluntary signed and dated informed consent.
2. Be in good health as determined by medical history.
3. Age between 18 and 65 yr (inclusive).
4. Body Mass Index of 25.0 - 40.0 (inclusive).
5. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
6. Agree to refrain from other probiotic and postbiotic supplement products throughout the duration of the trial.
7. Subject is willing and able to comply with the study protocol.
8. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion Criteria:

1. History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
2. Alcohol abuse (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
3. Previous bariatric surgery.
4. Current smokers or smoking within the past month.
5. History of hyperparathyroidism or an untreated thyroid condition.
6. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
7. Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
8. Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
9. Previous medical diagnosis of gout or fibromyalgia.
10. Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Any woman that is sexually active will have to take report their pregnancy status prior to enrolling and during the trial if they become pregnant.
11. Known sensitivity to any ingredient in the test formulations as listed in the product label.
12. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.