cyrilzakka/clinical-trials huggingface dataset:
Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?

Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small hepatic veins to the confluence between inferior vena cava and right atrium, which often leads to the life-threatening complications, such as liver failure and portal hypertension-related complications. At present, a stepwise treatment strategy is employed, including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous transluminal angioplasty \[PTA\] alone or in combination with stent placement), transjugular intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization is the most common treatment modality used in China.

Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with stent placement group (31% versus 7.7%, p\<0.001). In addition, re-occlusion was regarded as the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might have a worse survival than PTA combined with stent placement in Chinese patients with primary BCS.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent.
2. Age 18-75 years old.
3. Budd-Chiari syndrome
4. Child-Pugh score \<13 points.
5. Eligible for percutaneous recanalization.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Malignancy.
3. HIV infection.
4. Severe cardiac or lung diseases.
5. Severe renal dysfunction (serum\> 265.2 umol/l).
6. Uncontrolled systemic infection.
7. Allergic to contrast agents.
8. Poor compliance.
9. A prior history of percutaneous recanalization.
10. Ineligible for percutaneous recanalization.
11. Liver cirrhosis with severe portal hypertension-related complications.
12. Acute liver failure.
13. Progressive deterioration of liver function.
Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.

This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. It will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using PRO endpoints.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of secondary hypogonadism
* Mild to moderate erectile dysfunction
* Ability to read, understand and complete diaries and questionnaires
* Ability to safely make sexual attempts during the course of the study

Exclusion Criteria:

* Primary hypogonadism
* Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary
* History or current diagnosis of breast cancer, prostate cancer and/or PSA level above ≥3.5 ng/mL
* Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea
* Elevated prolactin level
* Hemoglobin \>17 g/dL or Hematocrit \>50%
* Use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone therapy within 6 weeks, and testosterone pellets within 6 months prior to Screening and at any time throughout the study
* Use of another SERM or past participation in a trial with Fispemifene
* Use of medications known to alter the HPG axis
* Clinically significant findings on physical exam, screening labs, or other findings which would prevent safe participation in the study
* Participation in another clinical study in the last 30 days
Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are between 20-80 years old.
* Anesthesiologists rated ASA as between I and III.
* Patients undergoing upper gastrointestinal endoscopic examination or therapy.

Exclusion Criteria:

* Allergy to Propofol, Remimazolam, or opioid medications.
* Emergency surgery.
* Pregnancy.
* History of malignant hyperthermia.
* Impaired liver or kidney function.
* Airway difficulties due to pharyngeal tumors.
* Refusal to participate.
Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.


Eligibility Criteria:
Inclusion Criteria:

* SLE by ACR criteria (revised 1997)
* African American, participating in the SLE in Gullah Health (SLEIGH) Study
* Outpatient
* Stable disease with no BILAG A or B in any system for the past 4 weeks
* Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
* Baseline 25(OH)D concentration of \< 30 ng/ml
* Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
* Age 18 - 85 years
* Ability to complete questionnaires in English
* Ability to give informed consent

Exclusion Criteria:

* Presence of hypercalcemia (\>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
* Liver disease (serum ALT, AST \>2x normal) or total serum bilirubin \>1.5x normal
* History of renal stones
* Current treatment with any dose of cyclophosphamide
* Dialysis or creatinine \> 2.5 mg/dL
* Pregnancy
* Current drug or alcohol abuse
* Anticipated poor compliance
Steri-strips for Reducing Radial Artery Compression Duration

The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Consequently, the frequency of radial artery occlusion (RAO) will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration.

Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch. Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis. The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method. In a study conducted by Faravash et al. in 2016, showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid, malar and cheek soft tissues with use of steri-strips with no reported safety concerns.

Therefore, the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression.

Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.

Treatment group. Pneumatic TR band compression with use of steri-strips

Control group. Pneumatic TR band compression alone

Method of radial artery compression after sheath removal:

Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.

Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.

END POINTS:

Primary endpoint will be the time duration of achieving hemostasis with radial artery patency

Secondary endpoint will be Hematoma or Bleeding

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary angiography through transradial approach
* Either gender with age ≥18 years
* Positive Barbeau test (type A to C)

Exclusion Criteria:

* Patients refuse to give consent
* Negative Barbeau test (type D)
* Patients with bleeding diathesis or on oral anticoagulation
Physical Exercise for Prevention of Dementia

The principal aim of this study is to verify whether a program of supervised, multimodal physical exercise improves cognitive function and/or reduces the rate of cognitive decline in older adults

Community-dwelling volunteers, recruited from social centers, were invited to an in-person assessment that included a medical history questionnaire and examination, anthropometric measurements, blood tests for cardiovascular risk, and several outcome measures. Participants meeting the inclusion criteria were divided in 3 groups (participants without subjective or objective cognitive impairment, with subjective memory complaints and with mild cognitive impairments) and randomly assigned (1:1) to an experimental group or a control group, using a list of random numbers generated by a statistical software. The list was kept in a sealed envelope and a researcher, not directly involved in the recruitment and in the evaluation of the participants, assigned the allocation numbers.

Eligibility Criteria:
Inclusion Criteria:

Age \> 50 years old

Exclusion Criteria:

* Medical conditions that compromise survival or limit physical activity
* Geriatric Depression Scale-15 score of 6 or higher
* Alcohol intake \> 4 units/day
* Mini- Mental State Examination \< 24
* Clinical Dementia Rating score of 1 or more
Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)

Study Design: Double-blind placebo-controlled clinical trial

Study Duration:2 years

Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)

Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in patients with cirrhosis and SBP

Number of Subjects: 30

Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau

Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2 every 12 hours during hospitalization (n=15), or placebo (n=15)

Duration of administration: During hospitalization due to SBP episode

Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could decrease bacterial translocation and systemic and cerebral proinflammatory state. This would result in a faster SBP resolution, a decrease in the incidence of complications and an improvement in cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau.

Cirrhosis will be diagnosed by clinical, analytical and ultrasonographic findings or by liver biopsy. SBP will be diagnosed by an ascitic fluid neutrophil count \> 250/mm3 with or without positive culture .

Exclusion Criteria:

* Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy.
* Advanced liver insufficiency \[MELD (model for end-stage liver disease) \>25\].
* Active alcohol intake (in the previous 3 months).
* Neurological disease.
* Marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression, HIV infection).
* Previous antibiotic treatment, including norfloxacin and rifaximin.
* Septic shock, ileus, need for tracheal intubation or intensive care unit.
* Immunomodulatory drugs.
Blood And Tears in Alzheimer's Disease

This study aims to investigate whether biomarkers of Alzheimer's disease can be found in tearfluid, as well as dried bloodspots in patients with Alzheimer's disease, other dementia diagnoses compared to controls.

Participants under investigation of a neurodegenerative disease who have a planned lumbar puncture in the Memory clinic will be invited to this study. On the same day of the lumbar puncture, tear fluid and dry blod spots will be collected.

Tear fluid is collected using Shirmer's test. Dried blood spots are obtained by a small prick in the finger with a lancet. The blood droplet is transferred onto a special piece of filter paper, where it dries.

As a sub-study, participants who have provided written consent specifically for this purpose will repeat the test with dried blood spots at home one week after participating in the study. The samples are submitted to the Memory Clinic at the participant's next scheduled appointment.

Tear fluid, dried blood spots, as well as blood and cerebrospinal fluid will be examined for AD-related pathology.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients:

* Lumbar puncture with CSF avaiable for analysis
* Diagnosis of Alzheimer's disease, Dementia with Lewy Bodies (DLB), Frontotemporal dementia (FTD), vascular dementia (VaD) or Normal pressure hydrocephalus (NPH)
* Of legal age.

Inclusion criteria for controls:

* Lumbar puncture with CSF avaiable for analysis
* No neurological disease.
* Of legal age.

Exclusion Criteria:

* No lumbar puncture
* Clinically assessed as unfit to participate in the project.
Influence of a Combined Pharmacogenetic Score on Through Plasma Voriconazole Concentrations in Haematological Patients

Hypothesis: A pharmacogenetic score integrating both CYP3A genotypes could be influence initial trough voriconazole plasma concentrations and thus useful to adapt a priori voriconazole dosing in order to get adequate voriconazole exposure as possible after starting treatment.

Main Objective: To determine predictive value of a combined pharmacogenetic score on onset of trough voriconazole plasma concentration inferior than lower therapeutic target.

Voriconazole (VRC), the gold-standard treatment of invasive aspergillosis is characterized by variables and nonlinear pharmacokinetics, causing many under- or over-dosing. A link exist between trough plasma concentrations (Cmin) of VRC and effectiveness but also its toxicity. Thus the longitudinal therapeutic drug monitoring of VRC is now recommended with a therapeutic range between 1 and 5 mg/L. The pharmacokinetic variability of VRC is in part explained by its metabolism, mainly dependent on cytochrome P 450 (CYP), particularly CYP2C19, 3A4, 3A5; all these CYP exhibiting genetic polymorphisms. The authors, recently shown, and for the first time , in a retrospective study conducted in 29 patients allogeneic hematopoietic stem cell that initial VRC Cmin adjusted the dose was not only influenced by the route of administration but also by a pharmacogenetics score whose determination is to assign each genotype CYP2C19 and CYP3A a score expressed in a arbitrary units.

The combined pharmacogenetic score was strongly correlated with the original Cmin (r= -0.748; p = 0.002) and was the only independent predictor of initial Cmin (after adjusting the dose and the route of administration). In addition, none of the patients having a genetic score \<2 (ie metabolizing capacity of reduced VRC) did not show an initial Cmin below 1 mg/L, while the initial Cmin was below this threshold efficiency in 47% of patients with a genetic score \>2. The aim of this new study is to confirm the impact of the pharmacogenetic score on the initial VRC Cmin over a larger prospective cohort of 60 adult patients with onco-hematological diseases.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from haematological cancer

Exclusion Criteria:

* less than 18-years old
Evaluation of the Medical Psychiatry Alliance Senior's Outpatient Collaborative Care Project

This study evaluates the effectiveness of a collaborative care model designed to treat frail seniors with both a mental (anxiety and/or depression) and a physical health condition impacting function with a comparison group that receives a psychiatric mood consult and a letter of recommendation but who are mainly cared for by their PCP.

Literature suggests seniors with co-existing mental and physical health concerns encounter challenges with accessing care including limited availability of geriatric specialists, inadequate navigational support, disjointed communication, and limited provider knowledge/ capacity to manage these complex patients. In conjunction with primary care, a new program was created to assist in addressing these concerns. A novel collaborative care model was developed integrating Geriatric Medicine and Geriatric Psychiatry anchored in primary care, where primary care remains the most responsible provider. Care managers (CMs) work with seniors in the community, for up to 16 weeks, who have at least one chronic health condition affecting function and depressed mood and/or anxiety. The care model focusses on 4 main components: integrated therapeutic care management, systematic case reviews (SCRs), integrated care planning, and education/capacity building. CMs provide comprehensive assessments, system navigation, monitoring using symptom rating scales, and a problem solving psychotherapy for seniors using reward exposure to form action plans (ENGAGE). CMs present cases weekly at SCRs, where the team includes a geriatrician, geriatric psychiatrist, primary care, and allied health. Recommendations are made then sent to the PCP for implementation. In the current evaluation study we will compare levels of depression, anxiety and functioning of seniors receiving the collaborative care model with those receiving a one time mood consultation.

Eligibility Criteria:
Inclusion Criteria:

* Depressive mood PHQ-9 \>9 or anxiety GAD-7 \>9
* One or more chronic medical condition(s) impacting function
* Had a one time mood consultation at CAMH or has been a patient in the Medical Psychiatry Alliance Senior Outpatient Program
* Able to speak English

Exclusion Criteria:

* Moderate to severe cognitive decline
* Positive psychotic symptoms
* Active suicidal ideation or attempt within the last year
* Psychiatric admission within the last year
Physiotherapy on Pneumonia in Childrens

The children's susceptibility to respiratory problems is due to their anatomical and physiological characteristics; therefore, children with more severe clinical conditions may undergo invasive mechanical ventilation (IMV). However, its prolonged use favors tracheal injury, barotrauma and / or volutrauma, decreased cardiac output and oxygen toxicity, and especially the accumulation of respiratory secretions due to ineffective cough due to non-closure of the glottis and damage in the transport of mucus by the presence of the tracheal tube. Thus, triggering the development of mechanical ventilation-associated pneumonia (VAP), which is defined as a pulmonary infection that arises 48 to 72 hours after endotracheal intubation and the institution of invasive mechanical ventilation. As a consequence, respiratory work is performed by IMV, reducing the work exerted by spontaneous ventilation, causing neuromuscular disorders after 5 to 7 days of IMV, changes in muscle mechanics, reducing the capacity of the diaphragm to generate force, thus contributing to changes in modulation autonomic heart rate, changes in muscular trophism, generating physical deconditioning due to weakness and, finally, an increase in the length of hospitalization and immobilism. From this perspective, early mobilization emerges as a rehabilitation mechanism to improve muscle strength and joint mobility, as well as to improve lung function and respiratory system performance, as well as improved autonomic heart rate modulation. It can facilitate the weaning of IMV, reducing hospitalization time and promoting quality of life after discharge.

We will select 40 volunteers of both sexes and between the ages of 1 and 8 years, with clinical diagnosis of VAP hospitalized in an intensive care unit, which will be submitted, together with the hospital protocol, the protocol of early mobilization. For these patients will be performed physical therapy evaluation in the pre-protocol period, on the second and fourth day of application of the protocol and 1 week at the end of the proposed protocol. For statistical analysis will be compared the pre and post-treatment data found in the evaluations and tabulated in a Microsoft Excel worksheet. BioStat 5.2 software will be used to analyze the results, and the choice of tests for this will depend on the types of distributions found and the homogeneity of the variables.

Eligibility Criteria:
Inclusion Criteria:

* patients on invasive or non-invasive mechanical ventilation for less than 96 hours
* with pneumonia due to invasive mechanical ventilation,
* aged between 1 year and 8 years

Exclusion Criteria:

* Severe Respiratory Failure
* active bleeding
* acute cerebral disorder
* presence of orthopedic contraindications (bone fractures, dislocations, subluxations, postoperative, unstable spine)
* neurological impairment with minimal functionality
* neuromuscular disease