cyrilzakka/clinical-trials huggingface dataset:
Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.

Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis.

Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months.

Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Moderate to severe knee pain (visual analog scale (VAS) \> 70 mm)
* Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections)
* Localized pain on physical examination
* Kellgren-Lawrence (KL) Score on knee X-Ray
* Patients 50 years old and over : grade 1, 2, 3 or 4
* 18-50 years old: KL grade 3 or 4

Exclusion Criteria:

* Current local infection
* Life expectancy less than 6 months
* Known advanced atherosclerosis
* Rheumatoid or infectious arthritis
* Prior knee surgery
* Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
* Iodine allergy
* Renal dysfunction as defined by GFR \< 60ml/min obtained within the past 30 days.
* Diabetic patient
* Previous embolization of the geniculate arteries during the last year
Determination of ClotPro Paediatric Reference Range Study

A new thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) with improved technology was developed. This device has an improved new-generation viscoelastometric testing technique and enables the detection and assessment of factor deficiencies, low fibrinogen, platelet contribution (to whole blood coagulation), heparin and direct oral anticoagulants effects, fibrinolysis and antifibrinolytic drugs. This study aims to determine reference ranges for the ClotPro device for all paediatric age groups.

Viscoelastic testing as a relatively novel method to assess coagulation status appears favourable in reducing blood product transfusions. The tests are performed on whole blood instead of plasma, which saves time and gives a quick sight at the interaction between cellular and plasmatic clotting factors.

Reviews of the literature suggest that transfusions of packed red blood cells (pRBC), plasma, and platelets are all decreased in patients whose transfusions were guided by viscoelastic tests rather than by clinical judgement or conventional laboratory tests.

The benefits of viscoelastic coagulation monitoring have been described in many fields of surgery and intensive care. Current literature and a guideline for the treatment of massive haemorrhage in perioperative bleeding and trauma patients recommend the use of viscoelastic tests to guide haemostatic resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* paediatric patients attending hospital for elective surgery or diagnostic imaging undergoing general anaesthesia are going to be eligible to participate.
* children whose parents agree to participate are provided with oral and written information and written informed consent has to be obtained.

Exclusion Criteria:

* problematic blood collection
* age over 16 years
* emergency surgery
* systemic infection
* known bleeding disorders
* history of congenital or acquired coagulopathy including renal, liver and bone marrow disease,
* any medication interfering with haemostasis
* prophylactic or therapeutic anticoagulant therapy (acetylsalicylic acid within the last 10 days or low-molecular-weight heparins within the last 48 h)
* administration of colloids hydroxyethyl starch (HES)/albumin, or blood products before the blood withdrawal
Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

This study will test feasibility, in smokers with lung, head \& neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.

The aim of the study is to determine the appeal of e-cigarettes compared to combustible cigarettes as measured by the degree to which patients succeed in reducing their cigarette consumption over the 9 weeks they are supplied with product, along with their consumption of e-cigarettes. We will measure past use of e-cigarettes and cigarettes at baseline, 3, 6, 9, and 12 weeks. We will also assess the effect of e-cigarette substitution on toxicity by measuring expired carbon monoxide and urine NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) , a carcinogenic metabolite of cigarette smoke.

Eligibility Criteria:
Inclusion Criteria:

1. Histological or cytological diagnosis of lung, head \& neck, or bladder cancer within the past 5 years.
2. AJCC (American Joint Committee on Cancer) stages I-IV
3. Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm
4. Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program)
5. May be receiving anti-cancer agents
6. Age 18 or older
7. Fluent in English;
8. Patient must be capable and willing to provide informed written consent for study participation;
9. Able to participate in study visits

Exclusion Criteria:

1. Cancer surgery planned in the next 9 weeks;
2. Treatment with radiation planned for the next 9 weeks,
3. Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.)
4. Any use of e-cigarettes in the past 30 days,
5. Pregnant or trying to get pregnant.
Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients

NEXPREM is a single-center non-blinded randomized controlled trial investigating preoperative exercise and nutrition for sarcopenic patients in major hepatic surgery for liver malignancies. Patients with sarcopenia undergoing major hepatectomies have high rates of postoperative complications. Previous studies have demonstrated that preoperative rehabilitation with exercise and nutrition may help reduce the negative impact of sarcopenia. The investigator's hypothesis is that preoperative nutrition and exercise may reduce complications in sarcopenic patients undergoing major hepatectomies. Sarcopenic patients at diagnosis will be randomized in Group A undergoing upfront surgery and Group B undergoing preoperative rehabilitation. Outcome will be overall 90 day morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18.
* Sarcopenic patients diagnosed by both qualitative and quantitative analysis.
* Patients with primary or secondary liver malignancies.
* Patients undergoing major liver resections intended as 3 or more contiguous segments
* Patients undergoing open, laparoscopic, or robotic resections.

Exclusion Criteria:

* Minor liver resections intended as less than 3 contiguous segments.
* Patients with intrahepatic, hilar, or extrahepatic cholangiocarcinomas.
* Patients with liver tumors for whom 6 weeks interval from diagnosis to surgery could not be waited (i.e., large HCCs on healthy livers not requiring preoperative portal vein occlusion, CRLM without preoperative administration of anti-VEGF drug who therefore do not require 6 weeks of chemotherapy washout)
* Patients with benign liver lesions.
* Patients undergoing extrahepatic liver resections.
* Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) procedure.
* Patients with physical disabilities, unable to exercise.
* Patients with inadequate kidney function.
Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery

Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.

* Group 1: conventional general anaesthesia with morphine
* Group 2: general anaesthesia without opiates

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age who has read and signed the consent form for participation in the study
* Patient candidate for laparoscopic colectomy (planned or emergency) with possible conversion to laparotomy

Exclusion Criteria:

* Severe renal failure with baseline clearance\<30, hepatic failure with baseline PT\<40%, cardiac failure with LVEF\<20%.
* Patient under court protection, guardianship or curatorship
* Pregnant or breastfeeding patient
* Patient not affiliated to the French social security system
* Impossible to give the subject informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
* Contraindication to anaesthesia or to the administration of one of the products used in the anaesthesia protocol
* Patient participating in another interventional research or in a period of exclusion from a previous research
Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis

The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.

2 Phase 2 arm study

Phase A:

Baseline HVPG (Hepatic Venous Pressure Measurement) measurement, followed by 1 capsule of 10mg Vardenafil or Placebo (randomization 1:1) daily per oral for 7 days, HVPG measurement at day 7

Phase B:

1 capsule of 10mg Vardenafil or Placebo (randomization 1:1) ad libidum per oral for 28 days

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged older than 18 years with mild to moderate (Child´s Grade A or B) cirrhosis scheduled for hepatic hemodynamic investigation.
* Erectile dysfunction in medical history
* Following beta-blocker therapy will be allowed: carvedilol (up to the max. dose of 25 mg) and propranolol (up to the max. dose of 160 mg)
* Patient living in a stable relationship
* HVPG (Hepatic Venous Pressure Measurement)\>= 10 mmHg

Exclusion Criteria:

* HVPG \<10
* HVPG \> 20 mmHg and varices, unless ligated and treated in an eradication program within 6 months
* history of variceal bleeding without secondary prophylaxis with beta blocker or endoscopic band ligation
* History of endoscopically diagnosed large varices with red spots without previous bleeding and without prophylactic beta blocker or endoscopic band ligation
* History of hypersensitivity to the trial drugs and contrast agent or to drugs with a similar chemical structure
* Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systemic antibiotics one week before the study
* Exclusion criteras for hepatic hemodynamic investigation
* Cardiac, renal or respiratory failure
* previous surgical or transjugular intrahepatic portosystemic shunt
* insulin-dependent diabetes
* Child´s Grade C cirrhosis
Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements

The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build a special system that recognizes spoken letters.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) who come to Ophthalmology Clinic.
* Willing and able to provide consent.

Exclusion Criteria:

* Individuals \< 18 years of age.
* Unable to provide consent.
Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
* Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

* Subjects with a hypersensitivity to Victoza® or to any of the excipients
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
* Subjects with personal or family history of medullary thyroid carcinoma (MTC)
* Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

This study is a double-blinded randomized study examining the effectiveness of the dual-site repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex. Assessments of FOG, gait function, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention, six month post intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
2. Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
3. Age between 40 and 80 years old.
4. Mini-Mental State Examination score \>24.
5. Ability to walk 30 meters independently.
6. Stable medication.
7. Patients experienced FOG during an interview.

Exclusion Criteria:

1. Other neurological or psychiatric disorders.
2. Severe personality disorder. History of epilepsy, seizures, or convulsions.
3. History of head injury or stroke.
4. Metal remains of the skull or inside the brain (outside the oral cavity).
5. Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
6. Severe dyskinesia, tremor, cognitive, visual or auditory impairment.
7. Patients who could not complete the follow-up.
Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)

The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Patients who diagnosed as ESRD with hemodialysis
* Fixed hemodialysis cycle (average 3 times a week)
* Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.)
* Agree to sign the informed consent form

Exclusion Criteria:

* Taking antibiotics or antifungal drugs within 30 days before the study
* Have serious allergic reaction to skim milk powder
* Researcher are not sure whether the subjects are willing or able to complete the study
* Subject participated in other research projects within two months before the study
CareConekta: A Pilot Study of a Smartphone App in South Africa

Population mobility is frequent in South Africa and disrupts the continuity of HIV care. Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are highly mobile. This pilot study aims to engage peripartum, HIV-positive women as potential users to evaluate a novel smartphone application to assist these women with linkage to new HIV facilities and prospectively describe the mobility of this population.

South Africa is home to the world's largest antiretroviral therapy (ART) program, but sustaining high retention along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is frequent in South Africa and mobility likely disrupts retention in HIV care. In the absence of a facility-linked national electronic health data system, clinic switching as unreported transfers also obscures the true magnitude of loss to follow-up, hindering national evaluation efforts. Postpartum women in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile, partly due to cultural traditions of returning to one's rural home after giving birth. To address these challenges to retention in care, the investigators will enroll 30 peripartum, HIV-positive women as potential users to assess the acceptability and feasibility of deploying in a real-world setting a novel mHealth application to improve retention in HIV care. The app will operate on users' own smartphones and will serve two primary functions: 1) as a service tool to inform postpartum, HIV-positive women of ART services in their area so that they may access continued HIV care, even while traveling, and 2) as a research tool to prospectively characterize travel and mobility patterns of these women. During this pilot study, women will be passively followed for 90 days following app installation at enrollment. After 90 days, they will be interviewed to determine acceptability and feasibility, and electronic user data will be analyzed. This information will be used to develop an app poised for nationwide adoption. The research team comprises leaders in the study of HIV implementation science, maternal/child health and biomedical informatics, with experience designing effective mobile health (mHealth) interventions in low-resources settings. This pilot study aims to engage potential users to test a smartphone application that both improves linkage to HIV care and provides essential research data to inform future health system strengthening efforts.

Eligibility Criteria:
Inclusion Criteria:

* Willing to enroll and provide written informed consent
* ≥18 years old
* HIV-positive
* Pregnant (\>36 weeks gestation)
* Able to read basic written English
* Currently own a smartphone that meets the technical requirements
* Willing to opt-in to installation of the app on her personal phone and to mobility tracking

Exclusion Criteria:

-
The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs

This study was planned to investigate the effects of eye patch and headphones on sleep quality, anxiety, fear and vital signs in coronary intensive care unit patients.

In intensive care units, it can be much easier to change the environment perception of patients with simple tools such as headphones and sleep bands, rather than changing the environment of the patients. The use of sleep bands and headphones, which are non-pharmacological methods, can reduce sleep deprivation by changing the environmental perception of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* New York Heart Association (NYHA) functional class II and III,
* Not having received any general anaesthesia for the previous 24 hours,
* Not having received any sedative medications or opioids for the past 24 hours,
* Not having a verbal communication disability (hearing and speaking),
* Absence of pain,
* Not having a previously diagnosed sleep disorder,
* Not having psychiatric problems,
* Not having a cognitive problem,
* Being healthy enough to put on and take off earplugs independently, in addition to wearing an eye mask and removing it when necessary, and continuing to be hospitalized for at least three days.

Exclusion Criteria:

* Diagnosed with delirium (Intensive care delirium screening checklist \>=5),
* Unconscious (Glasgow coma scale\<13),
* Presence of additional chronic diseases,
* Having consumed coffee, alcohol and hypnotic drugs at least 12 hours before the study,
* Patients whose condition suddenly worsened,
* Those who cannot use earplugs and eye masks effectively at night,
* Those who voluntarily withdrew from the study and were transferred from the intensive care unit.