cyrilzakka/clinical-trials huggingface dataset:
Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus

The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in China.

Diabetes Mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. Recently，researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. However, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures.

This study will enroll type 2 diabetes mellitus patients follwing Roux-en-Y gastric bypassing surgery and obese persons without type 2 diabetes surgery. The defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. Blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. The long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
* age:18-65yr
* HbAlc\>8%

Exclusion Criteria:

* diabetes (applies for control patients)
* chronic inflammatory disease
* malignant disease
* pregnancy
* prior gastric, duodenal, proximal jejunal surgery or pancreas resection
* current use of thiazolidinediones
* treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
* HbAlc\<8%
* any condition felt by the investigator to interfere with ability to complete the study
Capillary Dysfunction and CD46-immunoreceptor (CD46) Type in MS

This project aims to contribute knowledge to early MS disease mechanisms at the brain-blood interface using a combined immunological and neuroimaging approach.

The aim is to provide a novel vascular model to assess MS disease activity, and to explore its potential as an early diagnostic biomarker, prior to blood-brain barrier disruption. Additionally, the investigators want to investigate influence of immune receptor defects upon disease activity and MS brain vascular system. These aims are addressed by investigating immune receptor signals and vascular imaging modalities acquired in newly diagnosed untreated MS cohort, followed at our institution.

Multiple sclerosis (MS) is considered a virus-mediated autoimmune disease in the central nerve system characterized by blood brain barrier (BBB) disruption. Conventional magnetic resonance imaging (MRI) is currently an invaluable diagnostic tool as structural lesions are accepted biomarkers. However, MRI lesions correlate poorly with disease burden underlining the clinical-radiological paradox. Therefore, more advanced MRI are needed to provide additional information beyond what is obtainable from conventional scans. Perfusion MRI alterations preceding overt BBB disruption and lesions have been described suggesting a microvascular pathology as an etiological contributor to MS lesions. Transient diffusion decrease observed by diffusion MRI support the hypothesis of a hypoxic event prior to BBB disruption. A new model of perfusion MRI (DSC) enables microvascular function assessment in MS. This model is yet to be tested on MS patients. Furthermore, emerging evidence suggest that virus receptor CD46 affects immunologic susceptibility to MS. CD46 is highly expressed on cerebral vascular endothelium and may protect BBB integrity.

The hypothesis for this project is that CD46 activity is modulator of MS disease development, where CD46 modifications increases vulnerability to BBB disruption by attenuation of normal flow responses in MS brains.

Aims: Besides testing correlations between microvascular dysfunction and MS clinical outcome, this have prompted the investigators to investigate DSC-metric and predicted microvascular dysfunction in relation to defective CD46-driven immune responses.

Method: For this the investigators conducted our MRI study performed in a clinical research setting, and the - immunological study performed in a laboratory setting. Both studies are based on newly diagnosed MS patient assessments conducted at Department of Neurology, Aarhus University Hospital. All subjects undergo clinical examination, blood/cerebrospinal fluid samples and a comprehensive 3Tesla (3T) MRI protocol. MRI parameters and immune responses are compared between study groups and related to clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

Patients \> 18 years Patients suspected with MS.

Exclusion Criteria:

Pregnancy. Drug/alcohol abuse. Cerebral tumor. Previous head injury. Previous use of immunosuppressing or modifying treatment within 6 months. Contraindications against contrast media. Baseline image analysis not available.
Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

The purpose is to determine the economic, clinical and quality of life outcomes of bariatric surgery and describe the consequences of protracted wait-times (\~ 2 years) for this procedure.

Severe obesity affects approximately 3% of Canadians (nearly 1 million people) and is becoming increasingly common and costly. Surgery for severe obesity, known as bariatric surgery, substantially reduces weight and the risk of death, decreases obesity-related health problems and increases quality of life. However, surgery carries a 0.5-2% up-front risk of death, has potentially serious short and long-term complications, and an uncertain cost-to-benefit ratio. Surgery is becoming increasingly popular, programs are being initiated or expanded across the country, and waiting lists are several years long. Provincial governments, unable to keep pace with surgical demand, are sending patients to the US for surgery and patients are petitioning governments for increased access to care.

By collecting data from a clinical obesity program that services an entire Canadian health region of over 1 million people and linking these data to provincial and regional data sources, this study aims to:

1. Determine whether surgery improves 2-yr medical and patient-centered outcomes (such as quality of life, satisfaction, and others) compared to both medical and community wait-list control patients;
2. Comprehensively compare the 3-yr costs of surgical and non-surgical care;
3. Determine the impact of 2-yr wait times for surgery on patient health and wellness, including quality of life and patient satisfaction.

This study will provide essential data to accurately determine the benefits, risks, and costs of bariatric surgery in the Canadian context for patients, care providers, and decision makers. Equally important, it will determine whether the health and quality of life of Canadians waiting for surgery is adversely affected because of extended wait-times. Results will directly influence and streamline patient care, will be applicable to similar programs across the country, and serve as an important foundation for future research and data collection.

Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years old
2. Male and Female
3. BMI Levels greater than or equal to 35 kg/m2 and a major medical comorbidity OR BMI levels greater than or equal to 40 kg/m2
4. Able to provide written informed consent

Exclusion Criteria:

1. Pregnant or nursing
2. Previously enrolled in this study (e.g Community Control Arm)
3. Currently participating in a clinical trial
4. Individual expected to have difficulty with follow-up visits, completion of questionnaires, etc.
5. Any contraindications to bariatric surgery and/or anti-obesity medical treatment
6. Ability and willingness to complete questionnaires.
7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
8. Patients in whom protein sparing very low calorie diet therapy is planned.
Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients

An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.

The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Treatment with fluconazole
* Admitted to an ICU ward

Exclusion Criteria:

* \< 18 years
* DNR 2 or 3
Letrozole Versus Clomifene Citrate for Ovulation Induction

The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 - 39
2. BMI \< 36
3. Infertility due to anovulation
4. PCOS: At least two of the following diagnostic criteria of:

   1. Oligo/amenorrhoea
   2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
   3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of \> 10 ml)
5. No recent (within 6 months) treatment for induction of ovulation
6. Normal semen analysis (WHO 1999)
7. Proven patency of at least one Fallopian tube

Exclusion Criteria:

1. Inability to give informed consent
2. Contraindication to letrozole or clomifene citrate
3. Absence of any inclusion criteria
Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction

Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal malignancies, but emergent surgical decompression is associated with high morbidity and mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an alternative to surgery and effectively decompress the colonic obstruction and allow for bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents and covered stents. Covered stents have the advantage of less frequent stent occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered stents are associated with less stent migration, although they appear to be more prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered combination covered stent was developed. In the present study, the investigators evaluated the efficacy and safety of the newly designed covered stent by comparing it with the uncovered stent in patients with malignant colorectal obstruction.


Eligibility Criteria:
Inclusion Criteria:

* 20\~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy
* Patients with clinical obstructive symptoms confirmed by CT or colonoscopy

Exclusion Criteria:

* Patients with evidence of bowel perforation or peritonitis
* Cause of obstruction other than malignancy (bowel adhesion or benign stricture)
* Multiple stricture
* Lower rectal cancer obstruction (AV \<5cm)
PSMA-PET Imaging Before and After ADT in Advanced SDC Patients

Explorative study, which evaluates the effect of androgen deprivation therapy (ADT) on the PSMA ligand uptake on 68Ga-PSMA-PET/CT in salivary duct carcinoma patients.

Rationale: Prostate specific membrane antigen (PSMA) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. Recently, several ligands have been developed that target PSMA. Linked to Gallium-68, this enables diagnostic 68Ga-PSMA-PET/CT scans. Linked to Lutetium-177 enables therapeutic 177Lu-PSMA Radioligand therapy. Most research on the diagnostic and therapeutic possibilities of PSMA has been conducted in patients with advanced prostate cancer.

This research group investigates whether these findings also apply to salivary gland cancer (SGC), a rare cancer. Previously the investigators conducted a phase II 68Ga-PSMA imaging study (NCT03319641), to evaluate PSMA ligand uptake in locally advanced, recurrent and metastatic ACC and SDC (two subtypes of SGC). A relevant PSMA-ligand uptake was observed in 93% of ACC patients and 40% of SDC patients. However, since 60% of SDC patients showed low ligand uptake, these patients are not suitable for PSMA radioligand therapy. For advanced SDC, androgen deprivation therapy is often given as first-line treatment, because the majority of SDCs are androgen receptor positive. In prostate cancer, androgen deprivation therapy (ADT) can increase PSMA-ligand uptake. Therefore the aim is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC, as has previously been demonstrated in prostate cancer.

Objective: The primary objective is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC.

Study design: Interventional clinical trial, an explorative study. Study population: Patients with locally advanced, recurrent or metastatic (R/M) SDC AR+ and who will start ADT as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have the ability to provide written informed consent.
* Patients must be ≥ 18 years of age.
* Patients must have histological, pathological, and/or cytological confirmation of salivary duct carcinoma, androgen receptor positive.
* Only patients with locally advanced, recurrent or metastatic salivary duct carcinoma can participate.
* Patients must have at least one lesion with a diameter of ≥ 1.5 cm.
* Patients whom intend to start androgen deprivation therapy, after this has been recommended by the treating physician as standard treatment.

Exclusion Criteria:

* Contra-indication for PET imaging (pregnancy, breast feeding severe claustrophobia)
* Impaired renal function: MDRD \<30 ml/min/1,73 m2
* Impaired liver function: AST and ALT ALT ≥ 2.5 x ULN (≥5 x ULN for patients with liver metastases)
Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia

Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.

Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. And we are going to get the permission of the enrolled patients. Besides the present clinical treatment, UC-MSCs treatment will be applied to those fulfilling the enrollment. After a period of UC-MSCs treatment, the analysis of UC-MSCs treatment will be completed from related aspects.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old ,no gender restriction
* According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV infection(Trial Version 6), patients are diagnosed with severe or critical 2019-nCoV pneumonia
* Women of childbearing age should have a negative blood pregnancy test before the start of dosing and agree to take effective contraceptive measures during the trial until the last follow-up (28 days)
* Previous detection of Nucleotide or antibody of 2019-nCoV pneumonia was positive
* Voluntarily participate in this clinical study and sign a written informed consent. If the patient cannot obtain informed consent, he can authorize his legal representative.

Exclusion Criteria:

* Liver SOFA score of more than 3 points;
* HIV positive
* Highly allergic constitution or history of severe allergies;
* Pregnant and lactating women;
* Patients with malignant tumors;
* Patients with previous history of pulmonary embolism;
* Participating in clinical trials of other drugs within 3 months before enrollment.
* be thought by researchers to be inappropriate to participate in this clinical study.
Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnostic colonoscopy

Exclusion Criteria:

* Colorectal cancer
* Colic surgery
* Preparation of average or poor quality
* Rectal polyp of hyperplastic type \<2 mm
Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee

Previous clinical trials have demonstrated the human body's own healing and regenerative cells can relieve the pain of arthritis. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. Both techniques have been shown to relieve pain and with this study the Investigators wish to compare the two treatments.

Participants will be randomized into two groups. Concentrated Bone Marrow Aspirate (BMAC) or Platelet-Rich Plasma (PRP). BMAC subjects will have bone marrow aspirated from the subjects iliac crests and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee. BMAC patients will also have a venous whole blood drawn from the antecubital vein to simulate a PRP procedure. PRP subjects will have the same venous blood draw from the antecubital vein with subsequent platelet concentration. The resulting PRP will be injected into the symptomatic knee. PRP subjects will also undergo a bone marrow aspiration from the iliac crest to simulate the BMAC procedure. Follow-up at 1 week, 6 weeks, 6 months, and 12 months after injection, with repeat radiographs at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have bilateral OA and pain in one knee.
* Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3.
* Subjects must have previously tried 6 weeks of one of the following conservative treatments: Activity modification, weight loss, physical therapy, anti-inflammatory, or injection therapy.
* Patients must be able to provide written informed consent after the nature of the study is fully explained.

Exclusion Criteria:

* Patients with abnormal hematology, serum chemistry, or screening laboratory results.
* Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
* Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
* Patients receiving injections to the treated knee within 3 months prior to study entry.
* Patients who are pregnant or currently breast-feeding.
* Patients with systemic, rheumatic, or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
* Patients with ongoing known infectious disease.
* Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, or cancer.
* Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele

This is a Phase 2 open-label, dose-escalation study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele.

In total, up to 16 patients will be enrolled in the trial; up to 4 patients will be homozygotes for G542X, and the remaining patients will be compound heterozygotes with one G542X or phenotypically similar nonsense allele and any Class 1 or Class 2 mutation.

Each patient will receive up to 5 escalating doses as follows:

* ELX-02 0.3 mg/kg per day SC
* ELX-02 0.75 mg/kg per day SC
* ELX-02 1.5 mg/kg per day SC
* An individualized dose of ELX-02, as high as 3.0 mg/kg per day SC, based on the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests.
* ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18 years and above
2. A confirmed diagnosis of nmCF with a documented G542X mutation, homozygote, or compound heterozygote with one of the specified mutations. For heterozygotes, one mutation has to be G542X or phenotypically similar nonsense allele, and the second mutation has to be any Class 1 or Class 2 mutation. Patients with one G542X allele or phenotypically similar nonsense allele and a second allele that is not a Class 1 or Class 2 mutation may be potentially allowed but only after discussion on a case by case basis with and written approval from the Sponsor.
3. Documented SCC ≥60 mEq
4. FEV1 ≥40% predicted normal for age, gender and height at Screening (Knudson Equation)
5. Body mass index (BMI) of 19.0 to 30.0 kg/m2 (inclusive). Patients with a lower BMI may be entered into the study at the discretion of the investigator following consultation with the Sponsor.

Exclusion Criteria:

1. Participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study
2. History of any organ transplantation
3. Major surgery within 180 days (6 months) of Screening
4. Patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides
5. Known allergy to any aminoglycoside
6. Patients with any abnormality at ENT screening, that indicates the presence of a vestibular toxicity associated with prior exposure to aminoglycosides.
7. Dizziness Handicap Inventory (DHI)-H score at screening must be \>16.
8. Patients receiving CFTR modulators within 2 months of study treatment