cyrilzakka/clinical-trials huggingface dataset:
Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding

Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.

Gastric variceal bleeding is a lethal complication of portal hypertension. The rebleeding rate ranged between 30% to 50% in patients after initial hemostasis. Endoscopic cyanoacrylate injection is currently the choice of endoscopic therapy of acute gastric variceal bleeding and prevention of recurrent bleeding. However, the rebleeding rate is still high in the patients undergoing repeated endoscopic cyanoacrylate injection.

Non-selective β-blockers are frequently used for the secondary prophylaxis of variceal bleeding. In the case of esophageal varices, combination of non-selective β-blockers and endoscopic therapy significantly lowers the rebleeding rate compared with endoscopic therapy alone. However, propranolol failed to decrease the rebleeding rate as an adjunct to endoscopic cyanoacrylate injection and was associated with a higher incidence of adverse effects in gastric variceal bleeding patients. A more potent non-selective β-blocker than propranolol might further decrease portal pressure and decrease the rebleeding rate.

Carvedilol is a potent non-selective β-blocker with both beta and alpha-1 blocker effect. It significantly lowers portal pressure even in propranolol non-responders. However, it is unclear weather carvedilol will play a role in the prevention of recurrent gastric variceal bleeding. The investigators conducted a randomized controlled trial to compare the efficacy of carvedilol combined with endoscopic cyanoacrylate injection with endoscopic cyanoacrylate injection alone in secondary prophylaxis of gastric variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Age of 20 to 80 years
* Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
* Stable hemodynamic condition for at least 3 days after cyanoacrylate injection

Exclusion Criteria:

* Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
* Contraindications to non-selective beta-blockers or cyanoacrylate injection
* Serum total bilirubin \>10 mg/dL
* Grade III/IV hepatic encephalopathy
* Hepato-renal syndrome
* Severe heart failure (NYHA Fc III/IV)
* Chronic kidney disease under renal replacement therapy
* Refractory ascites
* Malignancy other than hepatocellular carcinoma
* Pregnancy
* Pacemaker use
* Refusal to participate
Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users

The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* 15 to 30 years old
* A-n tympanogram

Exclusion Criteria:

* muscular tinnitus
* vascular tinnitus
* somatosensorial tinnitus
* concomitant TMJ disorders
* external and middle ear diseases
* professional or recreative exposure to other noise sources other than mp3 players
Recovery After Critical Covid-19 Infection

The study focuses on the recovery of respiratory, cardiovascular and neurological/neuropsychological recovery after intensive care treatment for covid-19. The results will be compared with those obtained from patients treated in the regular wards for covid-19, persons with home treated covid-19 and non-covid controls.

Eligible patients who have been treated in the intensive care units of Helsinki University Hospital are invited to participate. Controls are recruited from follow-up clinics, and with announcements in media and websites.

The participants receive an invitation to a follow-up clinic where their experiences from the ICU treatment and recovery will be discussed. The investigators will perform neuropsychologic testing (6 months post-discharge), a telephone interview (3 months) and send written questionnaires (3, 6 and 24 months) to the participants. The participants will undergo MRI imaging of the brain and laboratory tests will be taken. The olfactory function will be tested at a follow-up clinic. Data on the patients´ respiratory function from clinical spirometry and diffusion capacity testing 3 and 6 months after discharge are collected. The patients will perform a 6 min walk test.

Data on coagulation laboratory values will be registered from acute phase and 6 months after discharge. The investigators will also analyse ApoE alleles, neurofilament light and NAD-metabolites and study their correlation with neuropsychologic findings and long term symptoms (up to 5 years after hospital discharge).

Participants will also undergo magnetic resonance imaging of the heart at 6-12 months after the hospital discharge, and laboratory samples, a symptom questionnaire and electrocardiogram are collected. Inflammatory parameters and variables associated with regulating inflammation and coagulation will be analysed.

Clinical data from the acute and post-acute phase and demographic data are collected from the patient data management systems.

The target patient number is 75 intensive care treated patients and 50 control persons in each three control group.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-100
* Positive PCR for Sars-CoV-2 (except non-covid controls, who must be negative)
* Native language Finnish or Swedish
* Informed consent to study to study participation

Exclusion Criteria:

* Age under 18
* Pregnant or lactating
* Major neurologic diagnosis (TBI, dementia, stroke, Parkinson´s disease before covid-19)
* Substantially impaired hearing or vision
* Developmental disability.
* No consent to study participation
* Contraindication to MR imaging (such as cardiac pacemaker, allergy to contrast)
Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.


Eligibility Criteria:
Inclusion Criteria:

1. Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
2. Stable coronary artery disease or non ST segment elevation acute coronary syndrome
3. Reference segment diameter in range of 2.5-4.5mm

Exclusion Criteria:

1. Cardiogenic shock
2. Contraindications to prolonged dual antiplatelet therapy
3. Female of child birth potential unless on effective contraception
4. Other medical condition that may limit survival
Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer

The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged over 18 years old.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. Plan to receive or has received Sacituzumab Govitecan monotherapy
4. Available medical history.

Exclusion Criteria:

1. Incomplete medical history.
2. Pregnancy or breast-breeding
Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.

This is a multicenter, randomized, blind evaluation, parallel-controlled, and superiority clinical trial. The objective of this study is to evaluate the effectiveness and safety of a spinal robot in assisting surgeons in laminectomy. The experiment included 3 centers with a total sample size of 70. The experimental group is the robot laminectomy group (RL group), and the control group is the manual laminectomy group (ML group). Laminectomy in the RL group is performed robotically, while laminectomy in the ML group is performed by the physician using an ultrasonic osteotome. The primary outcome measure is the accuracy of laminectomy. Secondary outcome measures included JOA score, VAS score, laminectomy success rate, laminectomy time per spinal segment, total laminectomy time, operative time, amount of surgical bleeding, number of X-ray exposures and total dose, and planned area excision rate. The evaluation was completed by comparing the outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
* Patients with complete clinical data, willing and able to sign informed consent;
* Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；
* Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:

  1. It was not effective after 3 months of conservative treatment
  2. Symptoms seriously affect the quality of life
  3. cauda equina nerve injury
* Lumbar spondylolisthesis occurs in one of the following:

  1. Symptoms of II° and below slip were not relieved by non-surgical treatment
  2. Lumbar spondylolisthesis III° and above
  3. Symptoms of lumbar spinal stenosis
* The TLISS score of lumbar spine fracture is greater than or equal to 4 points.

Exclusion Criteria:

* Patients who are not suitable for robot-assisted surgery;
* Patients with existing implants in or near the vertebral body of the lesion;
* Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
* Pregnant and lactating female patients;
* the subject is unwilling or unable to restrict activities or follow medical advice;
* Patients with infection near the focal area;
* The patient is mentally incapable or unable to understand the requirements for participating in the study;
* The patient is critically ill, the expected survival period is not more than 2 years, and it is difficult to make an accurate assessment of the effectiveness and safety of the device;
* Patients with coagulation dysfunction;
* Other researchers did not consider it suitable for admission.
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.

The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise. During the the visits, meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated. Bolus confirmation by the physician/nurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
* Age 12 to 65 years
* Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
* For females, not currently known to be pregnant
* Demonstration of proper mental status and cognition for the study
* An understanding of and willingness to follow the protocol and sign the informed consent or assent

Exclusion Criteria:

* Diabetic ketoacidosis in the past 6 months
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
* History of a seizure disorder (except hypoglycemic seizure).
* Coronary artery disease or heart failure.
* Cystic fibrosis
* Active infection
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
* Current use of a beta blocker medication
* Hematocrit \<30%
* Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission
Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)

Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.

This study will enroll men between the ages of 18 and 65 with corporal cavernosal firmness on elastography. The participants study duration is 3 months long and includes eight visits at the study center. Study visits consist of physical exam, vital signs, questionnaires, blood draws, and administration of low-intensity shockware therapy (LiST).

Low intensity extracorporeal (i.e., outside the body) shockwave therapy (LiST) is a treatment that has been in use since 2010 and has become commonly used Internationally and in the United States since 2015. The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent.

The study will evaluate changes in corporal cavernosal firmness and changes in penile vascular blood flow.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Men aged 18-64
4. Sexually active men and evidence of increased firmness on elastography during their standard evaluation for erectile dysfunction.

Exclusion Criteria:

1. Within two weeks of Visit 1 using erectogenic medications including PDE5 inhibitors and/or penile injection therapy
2. Presence of a penile implant.
3. Presence of cardiac pacemaker or defibrillator
4. Patients who are using devices which are sensitive to electromagnetic radiation.
5. Screening ultrasound positive for testicular cancer
6. Presence of untreated prostate cancer
7. Patients with severe coagulation disorders
8. Patient that in the opinion of the Principal Investigator would be non-compliant with the study
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic

The broad objective of this investigation is to assess the safety and efficacy of oral therapy with dexmedetomidine for the induction and maintenance of restful sleep.

Sleep is a basic human function that occupies approximately one-third of our lives. Much of what is known about the benefits of sleep in humans has been obtained from studies of patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to 15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction, coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are associated with side effects such as daytime sedation, delirium, anterograde memory disturbance, and complex sleep-related behaviors. We recently found that a nighttime intravenous bolus administration of dexmedetomidine was associated with normal sleep architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with improved next-day psychomotor vigilance performance compared to zolpidem. Presently, dexmedetomidine is only available in an intravenous formulation. The goal of this project is to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with a neurocognitive sparing profile.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50
* Native English speaking
* ASA physical status classification P1 and P2 (stable chronic condition)
* Normal body habitus.

Exclusion Criteria:

* Abnormal sleep habits
* Sleeping less than 5 hours each night
* Going to sleep before 9:00 PM or after 2:00 AM on a regular basis
* Waking up before 5:00 AM or after 10:00 AM on a regular basis.
* Takes medication that alters sleep, cognitive function, or both. -Has a history of a known neurological or psychiatric problem.
* Younger than 18 or older than 50 years of age.
* Known or suspected sleep disorder(s).
ERGT for Women Engaging in NSSI - an Effectiveness Study

The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.


Eligibility Criteria:
Inclusion Criteria:

* NSSI a minimum of three times in the last six months
* Meets at least three criteria for Borderline Personality Disorder according to DSM-IV-TR
* Contact with an other individual therapist, psychiatrist, "case manager" or equal

Exclusion Criteria:

* Insertion/withdrawal of psychopharmacological substances within two months prior to the treatment
* Other acute primary axis I diagnosis (e.g. anorexia nervosa) that demand treatment in first hand
* Bipolar disorder I or primary psychosis
* Current substance dependence (the last month)
* Current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse)
* Insufficient Swedish language skills
* Cocurrent treatment with Mentalization based therapy (MBT) or Dialectical behavioral therapy (DBT)
Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Bleeding peptic ulcer

Exclusion Criteria:

* Patient is: \< 18 years of age
* Patient is unable to consent
* Patient is contraindicated to undergo endoscopy
* Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
* Patient is pregnant or lactating
* Patinet has an INR \> 2.5
Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

The objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of The patient and observer scar assessment scale 3.0 (POSAS 3.0), degree of erythema and pigmentation, area size, thickness and density of human keloids.

After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. One group will receive the topical application of 5% losartan gel, while the other will receive an injection of triamcinolone acetonide 10mg/ml. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. To measure the subjective and objective changes that occur in the keloid before and after treatment, outcome assessors will be blinded. Measurements will be taken four times over the course of three months.

Eligibility Criteria:
Inclusion Criteria:

* keloid patients who came to the outpatient clinic of general hospital Syafira Pekanbaru during 2023-2024,
* age is greater than or equal to 18 year
* keloid scar than or equal to 25 cm2
* duration of keloids longer than or equal to 6 months
* no drug interventions or not currently on keloid medications for the last two months.

Exclusion Criteria:

* subjects who do not understand the rubric of The patient and observer scar assessment scale (POSAS) and were not willing to participate
* subjects with nodular keloids
* subjects within antihypertensive therapy, pregnancy, malignancy, history of allergies, active skin lesions or bleeding in the keloid area.
* subjects in the treatment of keloid within the last month.