cyrilzakka/clinical-trials huggingface dataset:
EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP

Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients.

Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery.

Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.10-21 There has been no comparative study between the outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.

The researchers investigated the technical success of EUS-BD and PTBD in patients with malignant biliary obstruction after failed conventional ERCP as a prospective randomized comparative study in multicenters. Secondary endpoints were the cost-effectiveness and complications rates between EUS-BD and PTBD.


Eligibility Criteria:
Inclusion Criteria:

* Presence of unresectable malignant distal biliary obstruction (greater 2cm than distal to hilum, i.e., pancreatic cancer, common bile duct cancer, ampulla of Vater cancer, gallbladder cancer, duodenal cancer, and metastatic biliary obstruction)
* Failed conventional ERCP and inaccessible papilla because of accompanying duodenal obstruction, periampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation.)
* Histologic or cytologic diagnosis of malignancy, d) A Karnofsky index of ≧30%, e) No serious or uncontrolled medical illness
* Provided informed consent.

Exclusion Criteria:

* patient age of less than 18 years
* uncorrectable coagulopathy
* history of allergy to radiocontrast agents
* refusal to participate in this study.
Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation

To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation

Randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with preterm labor admitted to hospital and treated with tocolysis
* pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length \< 15 mm
* single pregnancy
* normal amniotic fluid
* normal arterial ductus

Exclusion Criteria:

* Age below 18 years
* previous use of indomethacin in the index pregnancy
* chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery.
* oligohydramnios
* allergy to NSAID
* previous history of gastrointestinal bleeding
* use of NSAID contraindicated
* not adherence to the study
Tele-Assessment and Face-to-Face Evaluation of Functional Gait Assessment in Multiple Sclerosis

The aim of the study is to examine the reliability of the method by applying the Functional Gait Assessment in patients with Multiple Sclerosis via online video conferencing. For this purpose, walking of each patient to be included in the study; The evaluation results will be compared and the intra-rater reliability will be investigated by evaluating both face-to-face and online video conferencing methods. Since the Functional Gait Assessment is not available in Turkish, the scale will also be validated by adapting it to Turkish within the scope of the study.

As with all neurological diseases, it is important to use appropriate outcome measurements in the assessment of balance and gait disorders in patients with Multiple Sclerosis (MS), in order to determine the appropriate program for the patient in physiotherapy and rehabilitation applications, both face-to-face and through telerehabilitation. The scale recommended by a clinical practice guide developed with the support of the American Physiotherapy Association (APTA) and the Academy of Neurological Physiotherapy (ANPT) is the Functional Gait Assessment (FGA). According to this proposal, a Turkish version will be made within the scope of the study so that functional walking evaluation can be used in our country. A 2017 study on functional gait assessment and Multiple Sclerosis investigated the validity and sensitivity to changes in the original English version of the test in multiple sclerosis, and as a result, its validity was found for MS. Functional gait assessment does not have a reliability study for Multiple Sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Having a definite diagnosis of MS of any clinical type according to the 2017 Mc Donalds criteria by a neurologist,
* 18 years and over
* Expanded Disability Status Scale (EDSS) score of 2,5-6
* Not having an attack within the last 30 days
* Voluntarily giving consent to participate in the study
* Absence of visual and auditory impairment for completion of assessments

For Tele-assessment:

* Having a walking area of at least 3 meters at home to evaluate walking
* Providing a care provider's supervision to ensure walking safety
* The patient or the caregiver can use the video conferencing software application from the phone or computer

Exclusion Criteria:

* Diagnosis of another neurological disease that affects the level of ambulation other than MS
* Receiving corticosteroid therapy within the last 1 month
* Limitation in range of motion of the lower extremities, which may affect standing and walking
* Pain that negatively affects walking in the lower extremity and lumbar area (etc., coxarthrosis, gonarthrosis, sciatica)
* Inability to stand up from a sitting position (Timed Up \& Go Test requirement)
Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.
* Subject must to be the first experience of TACE.
* Subject has no extra-hepatic tumor and no obstruction of main portal vein.
* Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
* ECOG performance status 0-2
* Child-pugh Class A or B
* Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:

  1. Serum Total Bilirubin 2.0mg/mL
  2. WBC 3000/mm3
  3. PLT 50000/mm3
  4. Hb 9.0g/dL
  5. Creatinine ; upper normal limit (UNL)
  6. BUN 25mg/dL
* Written informed consent

Exclusion Criteria:

* Subject has extra hepatic metastasis.
* Tumor thrombosis exists at main portal vein.
* Remarkable artery-portal vein shunt or veno-arterial shunt.
* Uncontrollable ascites or pleural effusion.
* History of severe hypersensitivity.
* Any previous TACE or TAE for HCC.
* Any previous chemotherapy using epirubicin or CDDP.
* Complications as below (except chronic hepatitis or liver cirrhosis)

  1. Severe heart disease
  2. Myocardial infarction within 6 months
  3. Renal insufficiency
  4. Active infections (except virous hepatitis)
  5. Gastrointestinal bleeding
  6. Active double cancer
  7. Hepatic encephalopathy or heavy mental disorder.
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
* Any subject judged by the investigator to be unfit for any reason to participate in the study.
Li-Fraumeni Syndrome Imaging Study

Li-Fraumeni Syndrome (LFS) is a cancer predisposition disorder in which most affected individuals develop cancer during their lifetime. The majority of LFS patients carry a mutation in a gene called TP53, whose normal function is to control cell growth and prevent cells with damaged DNA from becoming cancerous. There is currently no way to determine when, where or what type of tumour will develop. This project will use novel techniques utilizing magnetic resonance imaging (MRI) to determine how sensitive they are at detecting very small tumors and how specific they are in terms of distinguishing malignant tumors from benign tumors.


Eligibility Criteria:
Inclusion Criteria:

* LFS kindreds who either carry a known TP53 mutation or are obligate mutation carriers

Exclusion Criteria:

* General contraindications for an MRI scan (ferromagnetic prostheses, pacemaker, or other implants incompatible with the magnetic field of the MR scanner), claustrophobia.
Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer

RATIONALE: Collecting and storing samples of blood and studying them in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average risk of breast cancer.

OBJECTIVES:

Primary

* Identify and validate serum biomarkers that can distinguish malignant from benign and normal breast conditions in women at high risk or average risk for breast cancer.

Secondary

* Standardize procedures for recruitment, characterization, and follow-up of participants and collection, processing, storage, and analysis of specimens.
* Assess marker variability over time in healthy controls.
* Develop a shared specimen resource to support ongoing early detection research.

OUTLINE: Blood samples are collected every 6 months and assayed for the presence of biomarkers.

PROJECTED ACCRUAL: A total of 625 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planning to undergo outpatient annual mammogram or biopsy AND meets 1 of the following criteria:

  * High risk for breast cancer
  * High risk with newly-diagnosed\* breast cancer
  * Average risk for breast cancer
  * Average risk with newly-diagnosed\* breast cancer
  * Benign breast disease NOTE: \* Diagnosed at time of study enrollment
* No other breast cancer diagnosis within the past year
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 25 and over

Sex

* Female

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* No hemophilia
* No other bleeding disorders

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* At least 6 months postpartum
* No planned pregnancy within the next year
* No history of medical conditions that would increase participant risk of blood draws
* No psychiatric, psychological, or other condition that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior double mastectomy

Other

* No concurrent treatment for breast cancer
Identification of Predictors for the Evolution of COVID-19 Related Pneumonia by Transcriptomic and Seroproteomic

The investigating group aims at performing an observational, prospective study that involves the evaluation of circulating biomarkers predictive of clinical evolution in patients suffering from COVID-19 disease.

In particular, the aim will be to verify whether there are transcripts or cytokines / chemokines in peripheral blood, modulated differently in patients with COVID-19, distinguished on the basis of the evolution towards more severe clinical pictures that require patient intubation or that show signs of cardiovascular damage.

The study will be based on the transcriptional analysis of the entire genome and serum protein to evaluate the expression of a broad spectrum of cytokines and chemokines. Genome analysis will allow the genotype to be correlated to the identified gene expression profiles.

Study design This observational, prospective, monocentric study will make use of the recruitment of consecutive patients with COVID-19. Enrollment will last 6 months or, considering the desirable drop in infections in the next few weeks, until exhaustion of enrolled patients. Enrollment will be followed by 18 months dedicated to transcriptomics and seroproteomics investigations, for a total duration of the study of 24 months.

All patients will receive optimal medical therapy, and will undergo laboratory or instrumental examinations (chest x-ray, CT, echocardiography) as needed.

Blood samples will be taken at the entrance and then twice a week for the duration of the hospitalization (generally 2-3 weeks).

Anamnesis will be noted for all patients. In addition, at all times, patients will undergo clinical evaluation and the following laboratory tests, which include:

* blood count
* biochemistry
* standard coagulation and thrombin generation, fibrin generation and fibrinolysis (INR, PTT, D-dimer, Tissue Plasminogen Activator TPA, Plasminogen Activator Inhibitor PAI-2, Plasmin-AntiPlasmin complex PAP, Thrombin activated Fibrinolysis Inhibitor TAFI, Thrombin-AntiThrombin complex TAT, Prothrombin Fragment PF 1+2, Fibrinopeptide A)
* inflammation/infection (IL-6, procalcitonin, ferritin, PCR, sCD14, TLR3 and 4, RANTES, CCR3 and 4
* other (troponin I, NT-pro-BNP, Hb1Ac). A subgroup of patients will undergo a microcirculation analysis with SDF (Sidestream Dark Field imaging).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Positivity to the test for SARS-Cov-2
3. Informed consent to enrollment in the study.
4. For Intensive Care patients: entry into the intensive unit and / or endotracheal intubation for no more than 4 days.
5. For patients in the COVID19 wards: home hospitalization or emergency room for no more than 4 days.

Exclusion Criteria:

1. Age less than 18 years
2. Pregnant women
3. Patients with malignant neoplasm, autoimmune diseases.
4. Hospitalization as transfer from another hospital or other similar facility.
Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction

Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don\&#39;t fully prevent OA from developing. This study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. The goal is to reduce joint inflammation and prevent the development of OA in patients who have had knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Underwent anterior cruciate ligament reconstruction (ACLR) due to an acute knee injury in the past 12 months
* ACLR patients with aberrant gait profiles who exhibit all three aberrant characteristics (knee flexion angle, knee flexion moment, and knee adduction moment)

Exclusion Criteria:

* Previous trauma or surgery (other than ACLR) to any weight-bearing joint,
* Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
* Body mass index ≥ 30 kg/m2;
* Inflammatory arthropathies;
* Immunosuppression due to illness or medication;
* Sepsis or hemostasis disorders;
* Severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.);
* Having malignancy and undergoing treatment including chemotherapy, radiotherapy, or immunotherapy;
* Unable to freely give their informed consent (e.g., individuals under legal guardianship).
* Currently enrolled in or has not yet completed a period of at least 5 times as the half-life time of the drug used in the previous trial since ending other investigational device or drug trial(s)
* Patients who are dependent on the sponsor, investigator, or study site;
* Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index \&amp;lt; 1);
* Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel;
* Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities;
Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia

The purpose of this study is to determine which drug makes lower intraocular pressure

Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.

Exclusion Criteria:

difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%
Stress Management Training for Healthy Aging

This study is a two-arm randomized controlled trial comparing two 8-week stress management programs for reducing inflammation and improving well-being among older adults.

A growing body of literature has demonstrated how stress can affect social relationships, health, and well-being during the aging process. Here, the investigators will test how two different programs can be used to facilitate healthy aging by helping individuals manage stress. One program will teach participants mindfulness meditation techniques while the other will educate participants about how to manage their health.

N=188 older adults will visit the study's central laboratory for a baseline visit and complete several days of daily experience sampling before being randomized into one of the two 8-week stress management programs. Participants will complete several days of daily experience sampling at the midpoint and conclusion of the intervention before returning to a study site to complete a follow-up assessment at both 1-week and 3-months after the end of the program.

This project will provide important information about how each training program can be used to promote well-being, health, and better social functioning in older adults. This work will ultimately inform the design of more efficacious and efficient stress-management interventions to facilitate healthy aging.

Eligibility Criteria:
Inclusion Criteria:

* English speaking

Exclusion Criteria:

* \[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.\]
A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS

The purpose of this study is to understand how the study medicine (PF-07293893) affects muscle biomarkers. Biomarkers are like clues or signs in our body that can help doctors understand our health. PF-07293893 is being studied as a possible treatment for people with heart disease who have reduced ability to exercise. This study aims to see how the study medicine affects muscle biomarkers related to the ability to exercise.

This study is seeking participants who:

1. Are males 18 to 65 years of age and females who are not able to become pregnant;
2. Have body mass index of 16 to 32 kilograms per meter square and a total body weight of more than 50 kilograms (110 pounds);
3. Over prior 4 weeks have an average of less than:

   -150 minutes of moderate-intensity aerobic physical activity throughout each week. Moderate-intensity physical activity feels somewhat hard. Your breathing becomes faster, but you are not out of breath. You can hold a conversation, but you cannot sing.

   AND

   -75 minutes of vigorous-intensity aerobic physical activity throughout each week. Vigorous-intensity physical activity feels challenging. You are breathing fast and deep. You cannot say more than a few words without pausing.

   OR

   -An equivalent combination of moderate-and vigorous-intensity activity.

   Participants will stay at the study clinic for about four days. On the third day, participants will take the study medicine or placebo (dummy pill) by mouth once at the study clinic and then stay at the study clinic for another day. During this time, the study team will check the treatment and take some blood and muscle tissue samples from the leg. This will help to understand if the study medicine affects muscle biomarkers. Participants will return to the study clinic for a follow-up visit or receive a follow-up telephone call about a month later.


Eligibility Criteria:
Inclusion Criteria:

1. Males 18 to 65 years of age and females of non-childbearing potential;
2. Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb);
3. Over prior 4 weeks an average of less than 150 minutes of moderate-intensity aerobic physical activity throughout each week, and less than 75 minutes of vigorous-intensity aerobic physical activity throughout each week, or an equivalent combination of moderate- and vigorous-intensity activity.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease;
2. History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C;
3. Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m²;
4. A positive urine drug test;
5. Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.