cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis

The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.

A prospective analysis will be conducted on 60 patients with primary PBC who were admitted to our Infectious Diseases Department and outpatient clinic. All patients will take UDCA capsules orally and divide into two groups: the experimental group, which received UDCA combined with Vitamin D(1200 IU per day) treatment, and the control group. The control group will receive UDCA treatment alone for one year, selected through a random number table method. After one year, the control group will be further divided into two groups using the same method. One group will continue to receive UDCA alone, while the other will receive a combination of UDCA and vitamin D for an additional year. Clinical data, clinical manifestations, blood tests, and imaging tests will be collected during the initial and subsequent treatments. The efficacy will be evaluated using the Paris I and Barcelona standards.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must meet the diagnostic criteria for PBC ;
2. The patient must have been diagnosed at the age of 18 or older;
3. The patient must have completed at least 2 years of treatment and have complete and accessible clinical data;
4. The patient must have strictly followed the doctor's prescription during the treatment period and not have interrupted the treatment arbitrarily.

Exclusion Criteria:

1. The study excluded patients with autoimmune hepatitis or primary sclerosing cholangitis.
2. Patients with other acute and chronic liver diseases were also excluded.
3. Patients with serious cardiopulmonary diseases were excluded as well.
4. Pregnant or lactating women were not included in the study.
5. Patients who randomly interrupted or adjusted their medication during the treatment period were excluded.
6. Patients who lacked follow-up were also excluded.
CGM Use in Preterm Infants

Preterm infants (gestational age (GA) at birth \< 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants (gestational age (GA) at birth \< 31 weeks)
* admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
* written informed consent can be secured from a parent within 96 hours of birth.

Exclusion Criteria:

* Infants born at ≥31 weeks GA
* infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development
* children experiencing severe birth asphyxia,
* children enrolled in another nutritional study,
* children likely to be transferred out of the NICU
Effect of Bosentan on Exercise Capacity at High Altitude

This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude.

We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.

Both the prostacyclin and the nitric oxide pathways are important in modulating hypoxic pulmonary vasoconstriction (HPV). There is little information about the role of the endothelin pathway at high altitude. The endothelin pathway involves the activation of two distinct receptors, A and B. Bosentan is a nonpeptide, specific, competitive, dual antagonist of both endothelin receptor subtypes. The primary objective of this study will be to determine the effect of endothelin receptor blockade with bosentan on exercise performance and HPV. This is a prospective, double blind, placebo-controlled, randomized cross-over study involving healthy subjects aged 25-55 years of age. Subjects will undergo echocardiography and exercise testing at low altitude (\< 500m) and at 3800m. Subjects will receive either bosentan vs. placebo and will be studied at low and high altitude on two occasions in a crossover design. Primary outcome measures will be pulmonary artery systolic pressure measured by echo-Doppler and exercise capacity. A better understanding of the role of the endothelin pathway in HPV may lead to improved treatments for some patients.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy subjects aged 18 - 55 years

Exclusion Criteria:

* Pregnancy
* Heart, lung or liver disease
* Use of glyburide, cyclosporin A
The Role of Biofeedback in Improving Continence After Anterior Resection

The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

See above

Eligibility Criteria:
Inclusion Criteria:

* Rectosigmoid or rectal cancer

Exclusion Criteria:

* Inoperable
Pathological Crystallization of Cholesterol in Atherosclerosis

Endarterectomy of the carotid artery procedure will be performed at Sheba Medical center vascular surgery department, followed by fixation and histology. Tissues will then be transferred to Weizmann Institute of Science for observation implementing advanced electron microscopy techniques. Finally, joint evaluation of the results will be carried out, in relation to the patient clinical history.

Human atherosclerotic tissues will be obtained from the Department of Vascular Surgery, Sheba Medical Center. Tissues will be taken from donors undergoing routine endarterectomy procedures.We chose carotid artery as the source for the atheromas, due to its high prevalence and its considerable size.All speciemnts will be studied in Cryo-Scanning Electron Microscopy (Cryo-SEM). Tissues will be observed in hydrated vitrified state, after High Pressure Freezing (HPF) and freeze fracture, as well established in the WIS group. Samples will be observed at -120°C. Cathode-Luminescence (CL) detects a luminescence signal induced by electrons in cholesterol crystals and CE condensed states. It will be implemented herein under cryogenic conditions. Sample preparation is as for cryo-SEM. Cryo-FIB-SEM block face serial imaging allows the acquisition of serial images over large volumes (tens of cubed micrometers), at a relatively high imaging resolution (up to 5nm3 voxel size). Volumes of up to 40x40x40 ml will be imaged with a resolution of up to 10nm. The data will be minimally processed and aligned using FIJI, reconstructed and manually segmented using Avizo Lite 9.2.0 software.

Eligibility Criteria:
Inclusion Criteria:

* all patients that are being operated on for carotid endarterctomy due to carotid stenosis

Exclusion Criteria:

* none
Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus

Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication.

Investigators will collect in 4 ICUs the data from consecutive patients hospitalized between january 2016 and january 2023. Included patient were those treated by Isoflurane for refractory status epilepticus.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, hospitalized in ICU between 2016-01-01 and 2023-01-01, suffering refractory status epilepticus treated by inhaled Isoflurane as third anticonvulsive therapy

Exclusion Criteria:

* post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Urinary incontinence (UI) is a very common condition affecting women of all ages. The objective of this pilot study is to better understand the urinary microbiome and associated inflammatory markers in blood and urine in women with urgency UI. The study will assess how inflammation may affect response to standard of care anticholinergic medication treatment for urgency urinary incontinence.

This study is designed as a prospective pilot study of women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms who are offered treatment with a standard of care anticholinergic medication for six weeks. The patient will be asked to provide a catheterized urine sample at baseline and 6 weeks and blood draw only at baseline. Study participants will fill out a Urinary Distress Inventory-6 (UDI-6) questionnaire at baseline and fill a bladder diary for 48 hours before starting the anticholinergic medication.

The urine will be assessed by standard and enhanced urine cultures and DNA amplification and 16S rRNA sequencing for urinary microbiome along with inflammatory markers in the urine. Inflammatory markers in both the blood and urine will be measured using immunoenzyme assays.

Measurements for microbiome will be repeated for all patients at 6 weeks. Baseline urinary symptoms at enrollment and variation of symptoms after 6 weeks of anticholinergic treatment will be assessed using the UDI-6 questionnaire and a bladder diary.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)
* English speaking
* Willing to take anticholinergics for at least 6 weeks
* Willing to complete UDI-6 and voiding diary at baseline and 6 weeks
* Willing to give urine and blood for study at baseline and 6 weeks

Exclusion Criteria:

* Have taken anticholinergic medication within the last month
* Have taken antibiotics within the last month
* Urinary Tract Infection (UTI) in the last three months
* Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)
* Immunological deficiencies
* History of sexually transmitted disease (STD)
* Lack of consent
* Not ambulatory (e.g. uses a wheelchair)
Quality of Life the Danish Multiple Myeloma Patients

The aim of the project is to improve quality of life for multiple myeloma patients in the future.

Multiple myeloma is an incurable malignancy of the bone marrow and the second most common type of haematological cancer. In Denmark, about 320 patients are diagnosed annually with multiple myeloma, and the cancer often affects older people, but 30 % of the patients living with MM are of working age. The prognosis has improved markedly over the last two decades and is expected to improve further.

Systematic monitoring of symptoms, side effects and complications over time outside clinical trials has not been performed yet. Knowledge of the elderly and frail patients´ perspective on the multiple myeloma disease is lacking, and the time after anti-myeloma treatment is left unstudied. A common side effect (up to 55 %) to specific types of anti-myeloma drugs is peripheral neuropathy (nerve injury), which can be temporary or permanent in the form of long-term sequelae of pain and numbness. Information on this side effect from the patients´ perspective is missing.

The design of the project is a prospective, population-based, national, longitudinal survey with retrospective data collection from more Danish registers. We will include 800 previously untreated and relapsed multiple myeloma patients at treatment-demanding disease recruited from all Danish haematological departments. At inclusion, demographic data and patient-related prognostic markers will be obtained. The patients will complete four validated QoL instruments (EORTC QLQ-C30, MY20, CIPN20 and SF12v2) at 13 measuring points over a period of 24 months. The questions are concerning cancer and MM symptoms, peripheral neuropathy, other side effects, quality of life and functional capacity of a social, emotional and physical character.

This project will provide real-time data collection of the symptoms, side effects, complications and quality of life from the general multiple myeloma patients´ perspective during and after anti-myeloma treatment. It will illuminate the reason for the patients´ high loss of working ability. The findings will be integrated in the future Danish National treatment guidelines, and recommendation for rehabilitation in aspects of shared decision making.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated or relapsed multiple myeloma patients AND
* Treatment demanding multiple myeloma disease

Exclusion Criteria:

* Inability to understand the Danish language or
* Psychic or mental illness that prevents the patient from answering the questions in the questionnaires.
Tai Chi and Hip School for Patients With Hip-OA.

A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip osteoarthritis (OA). The patients were randomized to 1 of 3 groups; namely Hip School, Tai Chi for Arthritis (TCA), or a group receiving no intervention. The results showed significant improvement in physical function and self-efficacy within the interventions groups Tai Chi and Hip School. The Tai Chi group showed improvement in body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. The Hip School group showed significant improvement in body awareness and quality of movements between baseline and 6-month follow-up.

A randomized, controlled study was conducted in southern Sweden with two intervention programs for individuals with X-ray-verified hip OA. The patients were randomized to 1 of 3 groups; namely Hip School, TCA, or a group receiving no intervention. A total of 89 subjects attended the baseline appointment and were randomized to one of the three groups. Physical function was assessed using, the Hip Osteoarthritis Outcomes Score (HOOS, Swedish version L.K 1.1), an observational assessment of movements the Body Awareness Scale Movement Quality (BAS MQ) and the Six Minute Walk Test (6MWT). For assessment of HRQL the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used. The Arthritis Self-Efficacy Scale (ASES) records the patient's self-reported judgment of what he/she can do regardless of the degree of functional limitations or skill. Six months after the final intervention all subjects were examined and assessed following the same procedure as at baseline. The 12 months follow-up contained the three questionnaires, HOOS, ASES and SF- 36 were sent out by mail. The results showed significant improvement in physical function and self-efficacy within the interventions groups Tai Chi and Hip School. The Tai Chi showed improvement in BAS MQ, focusing on body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. The Hip School group showed significant improvement in BAS MQ between baseline and 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* X-ray-verified hip OA, no walking aid and no joint replacements in the hips or knees.

Exclusion Criteria:

* no OA, joint replacement
Microarray Analysis of microRNA Expression in Basal Cell Carcinoma

Perturbations in microRNA (miRNA) expression profiles has been reported for a variety of cancers. This study will be an exploratory analysis of miRNA expression in basal cell carcinoma by miRNA expression profiling using microarrays.

Perturbations in the expression profiles of microRNAs (miRNAs) have been reported for a variety of different cancers. Basal cell carcinoma (BCC) of the skin has not been systematically evaluated regarding differentially expressed miRNAs. Patients with BCC are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* Basal Cell Carcinoma

Exclusion Criteria:

* Other Skin Cancer than Basal Cell Carcinoma
The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers

The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).

The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Age: minimum 18 years
* Positive rectal PCR and/or culture for MRO
* Ability to speak and understand Danish or English
* Capable of swallowing the capsules

Exclusion Criteria:

* Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.
* Severe immune deficiency (defined as current chemo treatment or neurofilocytes \< 1000/mm3
* Pancreatitis, defined by pancreatic amylases above the upper reference limit
* Planned or recent abdominal surgery (within 14 days)
* Parenteral nutrition
* Current antibiotic treatment of the same MRO as intestinal carriage
* Terminal disease with expected survival under three months
* Sepsis defined according to Surviving Sepsis Campaign guidelines
* Pregnant or lactating women
Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo


Eligibility Criteria:
Inclusion Criteria:

* Male and female inpatients, 18-65 years of age, meeting DSM-IV-TR criteria for schizophrenia and having a Total Positive and Negative Syndrome Scale (PANSS) Score \>=80 and \<=120. A score \>=4 on item P1 (delusions) or P3 (hallucinatory behavior) and a score of \>=4 on item P2 (conceptual disorganization) or P6 (suspiciousness/persecution) of the PNASS

Exclusion Criteria:

* Patients with documented disease of the central nervous system that can interfere with the trial assessments, including but not limited to stroke, tumor, Parkinson's, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who have suffered a traumatic brain injury resulting in significant impairment
The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment

The chronic obstructive pulmonary disease (COPD) patients with type II respiratory failure always needs PaCO2 test to monitor the changes of disease. Method used mostly nowadays to detect PaCO2 is arterial puncture which is accurate but is invasive, painful and non-dynamic. Noninvasive measurement methods includes end-tidal CO2 (PetCO2), transcutaneous CO2 (PtcCO2) which can monitor the PaCO2 dynamically and noninvasively, but their accuracy is in controversy. Common PetCO2 is especially inaccurate in COPD patients while our team find that the accuracy can be improved by prolong expiration method (PetCO2 (P)).So the investigators want to compare the accuracy of PtcCO2 and PetCO2(P) in AECOPD patients during noninvasive ventilation(NIV).


Eligibility Criteria:
Inclusion Criteria:

* AECOPD patients with type II respiratory failure who need NIV treatment

Exclusion Criteria:

* hemodynamics is unstable;
* any other lung disease despite COPD;
* other diseases influencing experiments: Cognitive impairment disease mouth and nose trauma.
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

68 patients will be included in this 5 years interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG Schafer 3 or 4
* Medicated IOP ≥ 21

Exclusion Criteria:

* Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
* Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, ...)
* Medical treatment having intraocular hypotensive effect