cyrilzakka/clinical-trials huggingface dataset:
Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are chronic cholestatic lesions and is deemed as autoimmune liver disease. PSC are immune abnormalities that occurs in patients with genetic susceptibility. No other pathogenesis is revealed yet. Ursodeoxycholic acid is used as an empirical treatment, and there is no approved drug or a acceptable treatment regimen. The disease often progresses to liver decompensation and requires liver transplantation. In recent years, the clinical application of stem cell therapy has seen many important advances. Stem cells are characterized with properties of multiple differentiation, repair of damaged tissue and immuno-modulation. This study aims to employ UCMSCs to treat PSC patients and observe its efficacy and safety, and to explore the possible therapeutic mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* progressive PSC
* willing to give consent

Exclusion Criteria:

* decompensated liver cirrhosis
* total serum bilirubin \>5ULN
* refractory ascites
* serum creatinine \>1.5mg/dL
* Cirrhotic nodules with malignant tendencies
* primary biliary cholangitis
* IgG4-associated sclerosing cholangitis
* non-PSC induced bile duct stones
* biliary tract trauma
* recurrent suppurative cholangitis
* neoplastic disease
* pancreatic disease
Opioid Sparing Pain Management Strategy

The purpose of this research study is to compare the amount of morphine milligram equivalents consumed post operatively until discharge between the control cohort and intervention cohort.

Retrospective data will be collected on patients admitted to Prisma Health-Upstate Greenville Memorial Hospital in the Cardiovascular Intensive Care Unit following cardiovascular surgery. They will be divided into two cohorts, a control cohort from September 1, 2018 - October 31, 2018 and an intervention cohort from March 1, 2019 - April 30, 2019. A study investigator will assess each participant's electronic medical record through the electronic medical record database - EPIC to determine eligibility per the protocol. Demographic information will be collected, including age, date of birth, race, sex, height, weight, and ethnicity. Extubation and reintubation status will be collected along with medical history, type of cardiovascular procedure, medications, length of stay, pain scores, complications, and labs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 and over
* Patients who underwent cardiac surgery requiring a coronary pulmonary bypass machine during September 1, 2018 - April 30, 2019

Exclusion Criteria:

* Patients being placed on Extracorporeal Membrane Oxygenation
Chest PNF on Pulmonary Function in Parkinson Disease

Background: Parkinson disease (PD) is a progressive neurodegenerative disorder and characterized by tremor, rigidity and bradykinesia. Almost 84% of PD patient develops respiratory abnormalities and pointed as the most common cause of death. Airway obstruction, trunk muscle rigidity is the common cause of respiratory abnormalities.

Purpose: The main purpose of the study will evaluate the efficacy of chest PNF on pulmonary function and chest wall mobility in PD.

Methods: 20 participants will be recruited for study purpose and divide into two groups. Group= A will be the control group and participants will receive conventional treatment which includes deep breathing exercise and segmental breathing exercise, incentive spirometry etc for one week. Group= B participants will receive chest PNF exercise along with conventional treatment for a week. Pretreatment and post-treatment data will be recorded by the help of PFT (FVC, FEV1 \& FEV1/FVC) and chest wall expansion at axillary and xiphisternal level for data analysis. Data analysis will be done by paired t-test for within group and independent t-test will be used for the between-group variable. The level of significance will be set at 0.05.


Eligibility Criteria:
Inclusion Criteria:

1. Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
2. MMSE score \>23.
3. Age 50-70 yrs.
4. Both Male and Female.

Exclusion Criteria:

1. Previous history of cardiac and pulmonary surgery.
2. History of flail chest.
3. Individual affected by neurological disorder other than PD.
4. Uncooperative patients.
5. Individual with the psychosomatic disorder.
Mindful Awareness Practices for ADHD Pilot Open Trial

It is estimated that 25-40% of youth with ADHD have co-occurring cognitive disengagement syndrome (CDS; previously sluggish cognitive tempo), a set of behavioral symptoms characterized by excessive daydreaming, slowed thinking, and mental confusion and fogginess. A growing body of research demonstrates CDS to be associated with functional impairment above and beyond that which can be accounted for by ADHD severity. However, no treatment currently exists that directly targets CDS symptoms. This is a critical clinical and scientific gap, leaving youth with ADHD and co-occurring CDS at risk for experiencing negative immediate and long-term outcomes. In considering intervention approaches, mindfulness meditation involves regular practice to catch oneself when the mind wanders, and may thus an ideal intervention for youth with CDS. However, mindfulness interventions, including the Mindful Awareness Practices (MAPs) for ADHD, have never been tested in adolescents with ADHD and co-occurring CDS specifically. This study will recruit up to 15 adolescents with ADHD and co-occurring CDS symptoms to enroll in an open trial of MAPs to evaluate its feasibility, acceptability, and preliminary efficacy. Findings will provide key pilot data regarding treatment of CDS in adolescents with ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Between 13 and 17 years of age at the first MAPs session.
2. Estimated IQ ≥ 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
3. Meet full DSM-5 criteria for ADHD (per protocol).
4. SCT Total score \>85th percentile (T-score \>60) on the Child and Adolescent Behavior Inventory (CABI) SCT Module.
5. Sufficient English language ability necessary to complete study measures and intervention per parent and/or research staff judgment.
6. If applicable: If the adolescent is taking a medication for ADHD or another psychiatric disorder (e.g., anxiety, depression), the adolescent must be on a stable medication dose/schedule for at least one month, and families will also be asked to not change/add medications the adolescent takes during the intervention period.

Exclusion Criteria:

1. Children who have participated in behavioral therapy treatment in the past year will be ineligible.
2. Children with a parent-report diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, or psychosis will be excluded.
3. Significant visual, hearing, or speech impairment not helped with corrective or assistive devices (e.g., glasses, hearing aids) per parent report or study staff judgment.
Resection or Ablation of Small Kidney Tumors

Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.

Kidney cancer represents approximately 2-3% of all cancer cases, with about 400,000 new cases and 175,000 deaths worldwide in 2018. In Sweden, about 1,200 new cases of kidney cancer are detected each year. The most common age for diagnosis is between 60 and 80 years, and it is more prevalent in men than in women. Many cases are incidentally discovered during imaging studies for unrelated issues. There has been an increase in incidentally detected tumors in Sweden, from 43% in 2005 to 69% in 2021. Nephron-sparing surgery, i.e., partial nephrectomy, is recommended for preserving kidney function in localized tumors.

Ablative treatments are recommended for patients with significant comorbidities, multiple tumors, a single kidney, or other situations where surgery is not considered suitable. Prior to treatment, a biopsy is usually performed to confirm the diagnosis. Studies show variations in oncological outcomes based on the subgroups of kidney cancer treated with ablative techniques. Ablative techniques seem to have a lower risk of complications compared to surgery concerning perioperative complications, bleeding, and maintaining kidney function for a longer time. However, there are no randomized controlled studies comparing ablative treatment with nephrectomy for T1a tumors in the kidney.

3. Hypothesis

Ablative treatment of small kidney tumors may result in shorter hospital stays with fewer complications compared to surgical resection.

There is no difference in long-term oncological outcomes between the methods.

4. Outcome Measures

The primary purpose of the study is to compare surgical complications, findings of remaining tumors after primary treatment, and the time patients are hospitalized after each procedure. Secondary outcomes include oncological outcomes in the short and long term, as well as functional factors

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 99 years
* Patient suitable based on clinical status for both ablative treatment and surgery
* Primary kidney tumor
* Tumor size ≤ 3 cm
* Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion)
* Tumor location suitable for both ablative treatment and resection
* Absence of radiological signs of metastasis
* Biopsy with malignant pathological analysis (PAD)
* ISUP grade I-III"

Exclusion Criteria:

* Radiological signs of metastasis
* Synchronous kidney tumors
* ISUP grade IV or sarcomatoid growth in the biopsy
* Other metastasized cancer in the last 5 years
* Patient unable to make an informed decision to participate in the study
Neochordae Technique in Mitral Valve Repair

Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.

In our novel technique,Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.

Mitral regurgitation (prolapse) and mitral stenosis are examples of diseases that affect the mitral valve. In mitral regurgitation, the leaflets do not close tightly and sway up and down allowing the blood to flow backward from the left ventricle into the left atrium. on the other hand, the mitral stenosis is caused by folding of thick leaflets of the valve which fuses together leading to low blood flow from the left atrium into the left ventricle and these cases are excluded from our trial. In mitral regurgitation, Surgeons prefer the mitral valve repair over the mitral valve replacement, But still, there are a lot of challenges towards this technique.

For decades, Surgeons used a lot of techniques to determine the length of neochordae includes that:

Determination of neochordal length by transoesophageal echocardiography or by using a landmark as a direct measurement. Previously, the surgeon applying the fixed loop length technique by using a custom-made caliper, and on the distance between the edge of a non-prolapsing segment and the tip of the papillary muscle (usually P1) to define the correct loop length. There are different types of papillary muscle and chordae as regards the shape, morphology, and length. So this reference distance is not fixed.

Adjusting neochordal length according to valve function. Length is chosen when the regurgitation is completely removed. Existing of a large number of neochordae will make this process more complex for the surgeon to decide.

Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.

In our novel technique, Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.

Eligibility Criteria:
Inclusion Criteria:

* Prolapsed or ruptured chordae
* Either degenerative or ischemic

Exclusion Criteria:

* Patient with redo Mitral Valve surgery
* Patient with severe rheumatic mitral stenosis (MS).
Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria
* Disability equivalent to an EDSS of 6.0 or less at screening
* Neutralizing antibody titre \> 20 and \<500 in two consecutive NAb tests. One must be from before screening
* previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment
* A priori has been decided to be treated with AVONEX

Exclusion Criteria:

* Is NAb positive on AVONEX
* History of major depression
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP \> 180/110 mmHg)
* Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
* Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
* Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate

This is a prospective clinical trial examining the use of MRI to measure internal organ motion and any resulting changes in the target volume (shape and location) during a course of post-operative radiation therapy for prostate cancer. The goal is to better understand and characterize these physiologic variations so that they can be accounted for during the treatment planning process. The ultimate longer-term clinical goal here is to provide a form of adaptive radiation therapy in the future, such that if major changes are seen over an 8-week course of radiation therapy in our study. This may argue for hypofractionating those patients who are most likely to have major shifts over time.

PRIMARY OBJECTIVES:

I. To evaluate the use of MRI in delineating clinical target volumes, as well as endorectal balloon target immobilization in patients treated with radiation following radical prostatectomy.

SECONDARY OBJECTIVES:

II. Trends over time in CTV, bladder and rectum volumes and percent change from baseline at each time point. III. Frequency of events in which the CTV falls outside the PTV. IV. Proportion of the total CTV which falls outside the PTV at each event. V. Trends over time in dose-volume exposures for bladder and rectum.

OUTLINE: Patients undergo MRI and CT scan-based simulation for treatment planning with endorectal balloon target immobilization. The treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved.

Patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. Patients also undergo weekly MRI scans of the pelvis (in the planned treatment position) during radiotherapy.

Eligibility Criteria:
Inclusion

* Completion of a radical prostatectomy for adenocarcinoma of the prostate
* Scheduled post-operative radiation therapy as part of the patient's treatment for prostate cancer
* Subjects are capable of giving informed consent

Exclusion

* The presence of grossly visualized or palpable disease recurrence
* Patients who are unable to undergo an MRI scan such as those with an implanted permanent pacemaker or ICD
* Patients with metastatic disease or an increasing PSA
Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification

This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape Classification for evaluating a patient's lower facial shape.


Eligibility Criteria:
Inclusion Criteria:

-sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror

Exclusion Criteria:

* infection of the mouth or gums, or facial skin infection requiring antibiotics
* planned dental or facial procedure
* unwillingness to be photographed and have the photos used for research, training, or educational purposes
Dietary Fiber Intake in Alcohol-dependent Patients

The alcohol problem affects 7.5% of the population in Europe and represents a major public health problem. Alcoholism is also a major cause of undernutrition. Diet is a major factor influencing the composition of the intestinal microbiota and previous studies, carried out at Saint-Luc clinics and catholic university of Louvain, show that alcoholic patients suffer from dysbiosis, that is a significant alteration of the gut microbiota. The investigator's preliminary studies, carried out at the Integrated Unit of Hepatology of Saint-Luc Clinics, have shown that alcohol represents more than 40% of total caloric intake in alcohol-dependent patients. In addition, alcoholic patients have an insufficient intake of dietary fiber, that is to say a contribution lower than the Belgian nutritional recommendations. Indeed, the Conseil Supérieur de la Santé recommends a total amount of dietary fiber equal to or greater than 25 grams per day to ensure correct intestinal function. Fructan-type dietary fiber (inulin and fructo-oligosaccharides) is found naturally in many fruits and vegetables (Jerusalem artichokes, asparagus, artichokes, onions, garlic, chicory roots, bananas). They are neither absorbed nor digested by human enzymes but fermented selectively by intestinal bacteria.

A good digestive tolerance to dietary fiber supplementation has been observed in healthy subjects as well as in obese patients, in previous studies conducted at catholic university of Louvain and Saint-Luc clinics. However, a nutritional rebalance via fiber supplementation and digestive fiber tolerance have never been tested in an alcohol-dependent population.

The primary objectives of this academic research project in nutrition, carried out in alcohol-dependent patients, are as follows:

1. restore a nutritional balance as recommended by the Conseil Supérieur de la Santé via a dietary fiber intake
2. to study digestive tolerance to fibers
3. to study the intestinal and psychological well-being related to a fiber intake

Depending on the results obtained during the achievement of the primary objectives, the biological samples (blood, stool) collected during the study will be used to analyze the composition of the intestinal microbiota and the plasma markers associated with intestinal function.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* aged between 18 and 65
* caucasian
* French speaking
* alcohol drunk less than 48h before day 1

Exclusion Criteria:

* another addiction, except smoking
* psychiatric comorbidity on axe 1 of Diagnostic and Statistical Manual-IV
* antibiotic, probiotic or fibers recent (\<2 months) treatment (or other molecule modifying intestinal transit)
* Non-steroidial anti-inflammatory drug or glucocorticoids recently taken (\<1 month)
* obesity: Body Mass Index\<30
* bariatric surgery
* Type 1 or 2 diabetes
* chronic inflammatory diseases (Crohn disease, coeliac disease, rheumatoid arthritis)
* cirrhosis or Advanced hepatic fibrosis (Fibroscan \> or = F3)
* pregnancy
Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty (3 days before and 10 days after) combined with cognitive testing preoperatively, on postoperative day 1,2,10.


Eligibility Criteria:
Inclusion Criteria:

* above 60
* ASA classification I-IV

Exclusion Criteria:

* general anaesthesia within 90 days
* daily use of sedatives, hypnotics og anxiolytics
* alcohol abuse
* insufficient written and verbal Danish
* severe hearing loss and poor sight
* Parkinsons Disease or other functional neurological deficits
* Mini mental status \< 24
* Shift work
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients

Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to be conducted in renal allograft recipients was requested by State Food and Drug Administration (SFDA) to provide further guidance for clinical use.

To minimize risk to patients, this study is designed to collect blood PK samples from renal allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or without concomitant medication(s). PK samples will be collected from these patients to characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This study will not involve any changes to the established treatment regimen for the patients who enroll in the study


Eligibility Criteria:
Inclusion Criteria:

* Male or female, above 18 years of age and Body Mass Index (BMI) of 18.0 to 25.0 kg/m2, inclusive;
* Subjects must have received a primary or secondary renal allograft for at least 2 months prior to Screening;
* Subjects must be currently taking Rapamune tablets for prophylaxis of renal rejection. The dosages of any medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.

Exclusion Criteria:

* Acute rejection or vascular rejection episode in the 4 weeks prior to Screening; or patients dependent on dialysis; or inadequate renal function (in the opinion of the investigator);
* Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant);
* Current use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to collection of the first PK sample and until collection of the final PK sample;
* Any clinically significant medical or psychiatric condition or laboratory abnormality, in the judgment of the investigator.