cyrilzakka/clinical-trials huggingface dataset:
Development and Application of a New Balloon Catheter for Intraairway Hemostasis

Massive hemoptysis is a serious disease of respiratory system, which seriously endangers the life of patients.

There are obvious difficulties in the treatment of hemoptysis. In the traditional treatment, patients still have the risk of massive hemoptysis and suffocation, and the risk control in the treatment process cannot be ensured.

Intra - airway interventional therapy, especially the hemostatic technique of intra - airway balloon catheter, is an important means to control the risk of hemoptysis.

However, the current intraairway balloon catheter therapy technology is immature, complicated and difficult to operate, and the cost is high. There is a lack of special balloon for hemostasis, and the balloon borrowed for other purposes cannot meet the needs of hemoptysis treatment.

Therefore, it is urgent to develop a new balloon catheter for airway hemostasis, which has simple technical operation, easy to master and popularize, efficient and safe function and structure.

According to this requirement, this project designed and developed hemostatic balloon catheter with multiple functions such as self-guiding, anti-displacement, anti-leakage and detachable rear end, so as to make the treatment of massive hemoptysis more safe and effective, simpler and faster, so as to be widely applied in clinical practice.

This study are aimed to investigate the safety and effectiveness of the new intraairway hemostatic balloon catheter in the treatment of massive hemoptysis, as well as the superior efficacy compared with the traditional treatment strategy of massive hemoptysis.

Eligibility Criteria:
Inclusion Criteria:

* The patients were 18-75 years, male or non-pregnant female;
* Meet the clinical definition of massive hemoptysis (blood loss ≥100ml each time or ≥500ml 24h);
* The patient/legal authorized representative understood the purpose and procedure of the test and voluntarily signed the informed consent.

Exclusion Criteria:

* Patients and their family members have no subjective treatment intention;Patients fail to cooperate or sign preoperative informed consent;
* The obvious effect of balloon catheter therapy is not ideal;
* Severe arrhythmia, acute myocardial ischemia;
* blood pressure is not effectively controlled (diastolic blood pressure ≥95mmHg or systolic blood pressure ≥150mmHg);
* Severe coagulopathy;
* Severe organ insufficiency (except respiratory insufficiency);
* Allergic to narcotic drugs;
* Pregnant women, those who are breast-feeding or trying to conceive;
* Patients who do not wish to sign informed consent;
* Patients who failed to follow up;
* Other patients deemed unsuitable for the study by the investigator.
Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy

The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation.

Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.


Eligibility Criteria:
Inclusion Criteria:

* severe sepsis or septic shock
* adult patients
* possibility of transcranial Doppler ultrasound

Exclusion Criteria:

* traumatic brain injury
* known cerebrovascular diseases
* Infection of the brain
* chronic renal failure
* pregnancy
"Living an Active Life with Osteoporosis" - a Digital Patient Education Program on Osteoporosis. a Feasibility/pilot Study As Part of the PATOS Project (Patient Education in Osteoporosis).

In this feasibility and pilot study, the investigators aim to evaluate the effectiveness and safety of a digital patient education program for individuals with osteoporosis. The study involves a 5-week intervention period during which participants will have access to the digital education program. Patients will be assessed both before and after the intervention.

The digital patient education program comprises eight modules covering essential topics related to osteoporosis self-care. The program includes both psychoeducation and support for behavioral changes. Patients will progress through the program at their own pace.

The name of the digital patient education program is: program is: "Att leva ett aktivt liv med benskörhet" (translated to english "Living an Active Life with Osteoporosis")


Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis diagnosis with or without a previous low-energy fracture
* Age \> 50 years
* Women and men
* Basic computer skills

Exclusion Criteria:

* Patients with difficulty understanding the Swedish language to the extent that they cannot comprehend the content of the patient education program.
* Cognitive impairment/dementia where the patient is not deemed to understand the implications of study participation
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet.

The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.

Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity.

Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years.
2. Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

Further inclusion criteria apply.

Exclusion criteria:

1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
2. Type 1 diabetes.
3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

Further exclusion criteria apply.
Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation

Investigators would like to see the amh values after uterine artery ligation

Group/cohort:

Uterine artery ligation (UAL) Investigators would like to invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.

Participants would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Control Group:

Investigators would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication.

Participants would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Eligibility Criteria:
Inclusion Criteria:

* age 18- 35 years
* no systemic or endocrine diseases
* patients who had uterine artery ligation due to atony
* healthy postpartum patients as controls

Exclusion Criteria:

* patients with PCOS

  * Pregnancy with IVF or oosit donation
  * Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.
  * Patients with BMI \>40
Association Between Inflammatory Activities and Gap Density

The study aims to:

1. To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
2. To demonstrated the alteration of local barrier function in IBD using CLE.

The primary end-point of this study was the cohort comparison of epithelial gap density and local barrier function as determined by CLE of subjects with IBD versus controls. Despite discontinuities in the cellular layer, the intestinal barrier function is maintained during this high cell turnover rate at the apical pole of the epithelial layer. Gaps first identified in vivo through acriflavine have pivotal definitions (lacked nuclei or cytosol, appeared to be filled with an impermeable substance). However, Current endoscopic technology does not identify whether there is material present in human gaps, so investigators could not formally resolve whether human epithelial gaps compromise or defend the epithelial barrier.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18-80
* IBD： Patients previously diagnosed as having IBD
* Health control: Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
* Subjects who experienced successful intubation of the terminal ileum.

Exclusion Criteria:

* Subjects age \< 18 or \>80 years
* Subjects under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), cirrhosis, renal dysfunction (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, acute gastrointestinal bleeding, jaundice and known allergy to fluorescein sodium.
Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet

To evaluate the impact of a Low Carbohydrate Ketogenic Diet (LCKD) weight loss program and compare to the standard of care program established for patients with Non-Alcoholic Fatty Liver Disease (NAFLD) on: (1) Liver fat and liver stiffness scores, (2) lipid profile and insulin sensitivity; and (3) depression scores and quality of life, and (4) Cardiometabolic measures such as cardiopulmonary exercise test (CPET) and transthoracic echocardiogram (TTE).

This prospective pilot pragmatic trial will investigate the role of a LCKD weight loss program for obese patients (BMI ≥30 kg/m2) and compare it to the group of known obese NAFLD patients who receive dietetic counseling as part of their standard of care in a dedicated NAFLD program. All participants (n=50) will be recruited at Virginia Commonwealth University (VCU).

Patients will do initial paperwork including

Questionnaires QOL, eating disorder screen, depression screen:

QOL, eating disorder screen and depression screen.

Labwork:

Data will be collected from routine care labwork to include a fasting cholesterol panel, insulin, A1c and comprehensive panel (if they have not received these labs in the preceding 3 months), and at 6 and 12 months. A1c will be collected at 3,6,9 months as well (if A1c \>/=7), or just additionally at 6 months if A1c \<7

Study labs will be collected:

Blood at 0, 3, 6 and 12 months Urine, stool and saliva at 0, 1, 3 and 12 months

Fibroscan will be done at 0, 3, 6 and 12 months

Echo/CPET testing and Room calorimetry will be offered and the patients agreeing to do this will have them done at 0, 3 and 12 months

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria include patients aged 18 years and older, BMI ≥ 30, ALT (alanine transferase) \> 19 (female) and \> 30 (male) or radiographic evidence of hepatic parenchymal disease and seen in either the PIs weight loss clinic or a patient in the VCU NAFLD (non-alcoholic fatty liver disease) program.

Exclusion Criteria:

* Patients will be excluded if they have known other liver disease such as viral hepatitis, autoimmune hepatitis, liver transplant, severely ill, weekly alcohol use (\>14 drinks in men and \>7 drinks in women), HIV, pregnant females, those\< 18 years, and prisoners.
Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy

Introduction: Symptoms as heartburn and/or reflux is frequent consultations in community pharmacies, the characterization of them is crucial to provide appropriate patient counseling. To facilitate the assistance work of the community pharmacist and its coordination between different levels of care, a group of experts in Community Pharmacy, Primary Care, and Gastroenterology has recently worked on an algorithm to manage these symptoms.

Objective: Analyse the epidemiological characteristics of patients who consult for symptoms of heartburn and/or reflux in Spanish community pharmacies, and evaluate the clinical and humanistic results of the protocolization of a Professional Pharmaceutical Service in said patients.

Methods and analysis: The study design consists of a cross-sectional descriptive part, in which the clinical and sociodemographic characteristics of the patients who come to the community pharmacy will be evaluated for consultation derived from heartburn and/or reflux symptoms and a before-after descriptive study in which will evaluate the clinical and humanistic results in patients who come to the pharmacy after receiving pharmaceutical care.


Eligibility Criteria:
Inclusion Criteria:

* Population´s age ≥ 18 years
* Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.

Exclusion Criteria:

* Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person
* Women with high-risk pregnancies
Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

This research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or an intensive lifestyle modification. Participants will be closely followed for one year to compare the effects of these treatments on diabetes remission.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 65 years old.
* Diagnosis of type 2 diabetes.
* Individuals with a BMI of 30-40 kg/m2
* Approval for bariatric surgery (as confirmed by medical evaluation)
* Insurance coverage for bariatric surgery
* Willingness to change diet, physical activity and weight.
* Ability to communicate with the investigator and be legally competent, provide written informed consent.

Exclusion Criteria:

* Diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA) (all of which are associated with ß-cell destruction), daily insulin requirements \> 100 units, and poor preoperative glycemic control, as indicated by a HbA1c \> 6.5 - ≤ 8.5 or HbA1c \> 8.6 - \< 9.5 (individuals with this HbA1c value will require medical clearance and approval from the study physician).
* Children and adolescents are not eligible to participate in the study.
* Pregnant women (or those who intend to become pregnant during the study period) and women who are currently breastfeeding are not eligible to participate.
* Use of medications known to significantly increase body weight, such as chronic systemic steroids or certain psychiatric medications (e.g., lithium tricyclic antidepressants and anti-psychotic agents).
* Non-ambulatory individuals, defined as those who are unable to walk at least one city block without a cane or walker.
* Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
* Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly controlled, or, in the opinion of the Investigators, significantly interferes with daily living and functioning.
* Any current (past 12 months) substance abuse or dependence disorder.
* Participants with moderate anemia (Hgb \< 12 mg/dl for men and Hgb \< 11 mg/dl for women)
* Conditions that may falsely elevate or decrease HbA1c values, including hemolytic or iron-deficiency anemia, hemoglobinopathies, and uremia.
* Abnormal laboratory tests which are clinically significant per the investigator.
Concurrent Vestibular Activation and Postural Training Using Virtual Reality

Postural instability is a common symptom of vestibular dysfunction that impacts a person's day-to-day activities. Vestibular rehabilitation is effective in decreasing dizziness, visual symptoms and improving postural control through several mechanisms including sensory reweighting. As part of the sensory reweighting mechanisms, vestibular activation training with headshake activities influence vestibular reflexes. However, combining challenging vestibular and postural tasks to facilitate more effective rehabilitation outcomes is under-utilized. The novel concurrent headshake and weight shift training (Concurrent HS-WST) is purported to train the vestibular system to directly impact the postural control system simultaneously and engage sensory reweighting to improve balance. Healthy older adults will perform the training by donning a virtual reality headset and standing on the floor or foam pad with an overhead harness on and a spotter present to prevent any falls. The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular-ocular reflex (VOR) gains, eye movement variability, sensory reweighting and promoting postural balance. The findings of this study may guide clinicians to develop rehabilitation methods for vestibular postural control in neurological populations with vestibular and/or sensorimotor control impairment.


Eligibility Criteria:
Inclusion Criteria:

* Able to stand independently (without an assistive device)

  * This study requires participants to perform postural assessments including reactive balance following mechanical perturbations.
  * Participants will also perform headshake activities and weight shift training in standing for 20 mins will mini breaks.
* Participants must be between the ages of 55-80.

Exclusion Criteria:

* Participants with evidence of:

  * Concussion, vestibular, balance or oculomotor issues for the prior 6 months.
  * Neuropathic conditions, particularly affecting the lower extremities. Participants with this issue will have sensory impairments which can affect their sensory assessment.
  * Current musculoskeletal deficits including significant postural abnormalities (signs of spinal, pelvic and leg length discrepancies).
  * Pain or limitations in neck range of motion.
* Recent (within 6 months) orthopedic surgery that impacts postural training.
* Visual Impairment ○ Participants must be able to see and follow targets in the virtual reality environment. Therefore, subjects must have 20/50 (corrected) vision. Subjects who are blind cannot participate.
SOLX Titanium Sapphire Laser for Trabeculoplasty

Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.

This is a multi-center, outpatient study assessing equivalence of the Titanium Sapphire laser (TiSaLT) to the Argon laser (ALT) in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications and/or prior failed glaucoma surgery. Approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. One half of the eyes will be randomized to treatment with the Argon laser (ALT) as the concurrent control group and the other half will be treated with Titanium Sapphire (TiSaLT) laser.

Eligibility Criteria:
Inclusion Criteria:Clinical Diagnosis of Open Angle Glaucoma

* Patient is aged 18 years or older, with 2 sighted eyes.
* Eye to be treated have average IOP greater or equal to 22 mmHg, measured at 2 pretreatment visits.
* Eye to be treated either exhibits:
* poorly controlled open angle glaucoma and on maximal tolerated medical therapy
* OR poorly controlled open angle glaucoma and failed previous laser trabeculoplasty (180° available to treat if previous ALT; can treat over previous SLT)

Exclusion Criteria:

Patients are not eligible for enrollment if any of the following exclusion criteria are met:

* Eye to be treated has any of the following:

  1. evidence of glaucoma other than open-angle glaucoma;
  2. severe paracentral or generalized field defect;
  3. any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
  4. prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
* Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
* Patient is pregnant.
* Patient might require other ocular surgery within the 6-month follow-up period.
* Patient has a medical history that suggested the potential for complications from TiSaLT.
* Having concurrent treatment with systemic steroids.
Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension

This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement (ABPM)


Eligibility Criteria:
Inclusion Criteria:

* Hypertension

Exclusion Criteria:

* SBP \> 180 mm Hg, DBP \> 114 mm Hg
* Subject has a hypersensitivity to trandolapril or verapamil