cyrilzakka/clinical-trials huggingface dataset:
Treatment of Mirizzi Syndrome

Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Patients with a preoperative diagnosis of Mirizzi Syndrome
* Patients with a common bile duct dilatation

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with an inconclusive biliary diagnosis
* Patients without a diagnosis of Mirrizi Syndrome
* Patients without common bile duct dilatation
The Lymphoid Tissue Pharmacology of Antiretroviral Drugs

Hypothesis:

Antiretroviral drugs (ARVs) with enhanced LT penetration characteristics in vitro and in macaques will translate into an ARV regimen with increased LN and GALT concentrations and a faster decay and more potent suppression of HIV replication in LT in HIV-infected persons.

Objectives:

1. Determine lymph nodes (LN) and gut-associated lymphoid tissue (GALT) pharmacokinetics (PK) in HIV-infected persons on an antiretroviral drug (ARV) regimen.
2. Determine virological responses of antiretroviral therapy in plasma, peripheral blood mononuclear cells (PBMCs) and lymphoid tissue (LT).

This is a single-center study of 18 ARV naïve, HIV infected persons to assess impact of an ARV regimen on lymph node (LN) and (GALT) virus reservoirs.

All participants will give informed consent. At baseline, plasma and PBMCs will be obtained and all subjects will have an incisional biopsy of an inguinal LN and pinch biopsy of ileum and rectum via colonoscopy. The selected LT-enhanced ARV regimen will be initiated. Participants will return to the clinic at weeks 2 and 4 and then monthly for safety evaluations, CD4 T cell counts, plasma HIV-RNA and ARV drug concentrations in plasma and PBMCs. An intensive PK study will be performed at week 2. At months 3 and 6, the inguinal LN biopsy and pinch biopsies of ileum and rectum will be repeated.

Eligibility Criteria:
Inclusion Criteria:

1. Antiretroviral drug (ARV)-naive, HIV-infected individuals
2. Aged 18 years or over
3. Agree to initiating ARV therapy
4. BMI ≤ 30
5. Inguinal lymph node(s) identifiable by ultrasound at enrollment
6. Screening plasma HIV RNA \> 40,000 copies/mL
7. Screening CD4 count \> 200 cells/mm3
8. Women of child bearing potential must agree to use effective contraception while on the study.
9. Screening viral isolates demonstrate genotype sensitivity to chosen antiretroviral therapy (ART) regimen.
10. Able to provide voluntary written consent

Exclusion Criteria:

1. Previous ARV therapy
2. Contraindications to ARV regimen (e.g., comorbid conditions or drug interactions), or study procedures as determined by the principal investigator.
3. Planning or current pregnancy or breastfeeding
4. History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the enrolling physician, may put the participant at risk because of participation in the study, influence the results of the study, or affect the participant's ability to participate in the study.
5. Inability to comply with study procedures per enrolling physician discretion
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2

Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic subdural hematoma (CSDH)
* Written informed consent (patient, power of attorney or substitute decision maker)
* Competence to take study medication properly and regularly or access to caregiver that is able to comply with accurate study medication administration

Exclusion Criteria:

* Hypersensitivity to TXA or any of the ingredients
* Pregnancy
* Irregular menstrual bleeding with unidentified cause
* Acquired colour vision disturbances
* Acute and chronic renal insufficiency indicated by GFR ≤ 30 mL/min
* Hematuria, caused by diseases of renal parenchyma
* Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
* History of angioplasty with cardiac stent placement, or cardiac (including mechanical) valve placement
* Active history of stroke (hemorrhagic and ischemic), or subarachnoid hemorrhage, within the past 6 months
* Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
* History of malignant brain tumors (glioma, metastasis and others) or seizures within the 6 months
* Contraindication to stopping full therapeutic doses of non-ASA antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
* Inability of oral drug intake or missing support to guarantee oral drug intake
* SDH as caused by intracranial hypotension resulting from CSF shunt placement
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract

This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.

Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract.

This study, as an exploratory trial, does not required statistical hypothesis


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>55 kg for male, \>45 kg for female (within 80-120% of Ideal body weight)
* Give written informed consent and voluntarily decide participation

Exclusion Criteria:

* Acute or chronic disease symptom on screening
* Existing active and clinically significant disease involving more than one organ system
* Known allergy to Mulberry or other berries
* Positive drug or alcohol screening
* Smokers of 10 or more cigarettes per day
* Participation in a clinical trial during last 2 month prior to the start of the study
* Pregnancy
Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

The purpose of this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution.

Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).

Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.

6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* Malignancy of the uterus, cervix or adnexa
* pre-malignant changes of the uterus, cervix or adnexa
* history of severe cervical dysplasia (CIN II or above)
Ultrasound-guided Supraclavicular Brachial Plexus Blockade

Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study

Exclusion Criteria:

* Contraindication to brachial plexus anesthesia
* Informed consent not obtained
Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with \[11C\] sertraline positron emission tomography (PET) study.

Open, one arm, single sequence, 3-period, dose escalating study for healthy volunteers are investigated. Ten subjects may be enrolled.

Subjects receive baseline \[11C\] sertraline PET.

Period 1 Subjects receive 5 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.

Period 2 Subjects receive 25 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.

Period 3 Subjects receive 50 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.

Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
* Weight: Over 55 kg, within ±20% of ideal body weight
* Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
* History of a significant surgical resection of gastrointestinal tract except appendectomy
* Abnormal clinical laboratory findings, especially for AST or ALT \> 1.25 fold of upper normal limit
* Subject who has phobia for PET scan
* History or evidence of drug abuse
* Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included)
* Participation in clinical trials of any drug within 2 months prior to the participation of the study
* Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study
* Judged to be inappropriate for the study by the investigator
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score ≥ 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
* Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD):

  i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD

Exclusion Criteria:

* Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
* Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy
* Participant has extensive small bowel resection (\> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition

Other protocol-defined inclusion/exclusion criteria apply.
The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

The study is designed to answer the following questions:

1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.

2/ What is the effect of testosteron replacement on the bone mineral metabolism.

this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Congenital hypogonadism
* Treatment Naive

Exclusion Criteria:

* Previous history of androgen replacement
* Hypertension
* Diabetes mellitus
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod.

All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer.

The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and \< 65 years at baseline
2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
3. Evidence of a personally signed and dated ICD indicating that the patient has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. The presence of clinical findings suggestive of Crohn's disease
2. Severe extensive colitis evidenced by:

   1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks
   2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
3. Patients with a stoma or planned UC surgical intervention requiring hospitalization
4. Prior/Concomitant Therapy:

   1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program
   2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
   3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator
5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family
Improving Dietary Habit and Weight Loss in Young Adults With Overweight and Obesity: The Healthy Eating for Young Adults (HEYA) Study

This study aims to examining the effectiveness of a psychoeducational program (Healthy Eating in Young Adults; HEYA) on improving the dietary habits and body composition (e.g. weight and percentage fat mass) in young adults in Singapore.


Eligibility Criteria:
Inclusion Criteria:

1. have a body mass index (BMI) ≥23kg/m2; and
2. are between the ages of 21 and 35 years old; and
3. can understand and read the English language; and
4. use a smartphone that can download apps; and
5. willing to travel to the National University Singapore.

Exclusion Criteria:

1. Pregnant or lactating; and
2. Participating in a structured weight loss program; and
3. Planning or receiving pharmacotherapy or bariatric surgery within the next 6 months; and
4. Has existing diagnosed mental disorder besides eating disorders.
Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)

The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy.
* Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023

Exclusion Criteria:

* Patients who have received oral cashew nut immunotherapy for less than 18 months.
* Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 2020 or earlier
Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.


Eligibility Criteria:
Inclusion Criteria:

* Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
* Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
* Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
* Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
* It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
* Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
* Symptomatic or uncontrolled metastases in the central nervous system (CNS).
* Peripheral neuropathy.
* Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dL.
* Inadequate liver function.
* Inadequate kidney function.
Influenza Vaccine Effectiveness of a Quadrivalent Vaccine in Pregnant Women and Young Infants, 2019-2020

Influenza is associated with an increased risk for serious illness, hospitalization and death in pregnant women and young infants. The investigators estimated the effectiveness of a quadrivalent inactivated influenza vaccine (QIV) in pregnant women and their infants in 2019-2020 influenza season. Women were activelly followed during the influenza season on a weekly basis through telephone call in order to collect data about the onset of fever and/or respiratory symptoms by them or their young infants. Polymerase chain reaction testing in pharyngeal samples was offered to pregnant women and infants with influenza-like illness (ILI). A total of 636 pregnant women and 474 infants were studied. A Bayesian beta-binomial model was used.

Study period: Influenza 2019-2020 season

The investigators followed actively the pregnant women and their infants in order to collect prospectively data on a weekly basis through phone calls during the entire influenza season.

Definitions:

* ILI was defined as the sudden onset of symptoms and fever, malaise, myalgia or headache, and cough, sore throat or shortness of breath.
* ARI was defined as the presence of at least one respiratory symptom, regardless of fever.
* Febrile episode was defined as the presence of fever only.
* Fever was defined as a temperature of 38.0 C in at least two measurements within 24h.
* The diagnoses of pneumonia and AOM were accepted as reported by the physicians who provided care to the women or their infants.

The 2019-2020 QIV Vaxigrip-Tetra was used to vaccinate pregnant women.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women \>18 years old and \<45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020

Exclusion Criteria:

* \<18 years old or \>45 years old
* not in stable health
* already vaccinated against influenza
* history of Guillain-Barré syndrome
* history of hypersensitivity to influenza vaccines
* immunosuppression
* history of investigational drug \<30 days
* history of immunoglobulins or blood products \<3 months
* fever at day of interview (enrollment day)