cyrilzakka/clinical-trials huggingface dataset:
A Study of FolateScan in Patients With Knee Osteoarthritis

The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear Medicine imaging technology that enables localization of activated macrophages in the joints of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows: knee radiography, FolateScan of the knees and whole body, musculoskeletal exam, questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory markers. Data analysis will be cross-sectional and include a comparison of the location and intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures of disease severity, cytokine expression, and synovial fluid cell count.

Each study day will on average last one day per individual and each individual will be followed for development of an Adverse Event for 7 days

Eligibility Criteria:
Inclusion Criteria: Unilateral or bilateral knee OA; Kellgren Lawrence grade 1-4; Knee pain on most days of any one-month in the last year in at least one knee; Age \> 18 years old.

Exclusion Criteria: Arthroscopic knee surgery within the previous 12 months; Intra-articular injection or systemic (oral, IV, IM) steroid within previous 6 months; Any knee replacement; Current enrollment in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study); Pregnancy; Positive serum beta HCG within 48 hours prior to 99mTc-EC20 administration and/or lactation; Rheumatoid arthritis or other inflammatory arthropathy; Avascular necrosis; Periarticular fracture; Current anticoagulant therapy; Current immune modulator therapy, or any such therapy within 4 weeks of study procedures; Inability to discontinue use of NSAIDS within 3 days of study procedures (low dose aspirin of up to 325 mg per day is permitted); Must be able to stop Folic Acid containing vitamins 24 hrs before study; Paget's disease; Villonodular synovitis; Joint infection; Ochronosis; Neuropathic arthropathy; Acromegaly; Hemochromatosis; Wilson's disease; Osteochondromatosis; Personnel directly affiliated with this study or their immediate family members; Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
An Observational Study Evaluating Efficacy, Safety and Convenience of NovoNorm® in Treatment of Type 2 Diabetes in Routine Clinical Practice

This study is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes management in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Newly diagnosed or not adequately controlled with current therapy
A Study of MG-K10 in Subjects With Atopic Dermatitis

This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).

Eligibility Criteria:
key Inclusion Criteria:

1. Aged 18 - 70 years (inclusive), male or female;
2. Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria:

   * EASI score ≥ 16 at the screening and baseline visits;
   * IGA score ≥ 3 at the screening and baseline visits;
   * AD affected body surface area (BSA) percent ≥10% at the screening and baseline visits;
   * Documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks;

Key Exclusion Criteria:

1. Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
2. Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring;
3. Subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant；
4. Patients with ocular diseases that are not suitable for enrollment by the investigator；
5. Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)；
6. Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization;
7. chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection；
8. History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and to compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.


Eligibility Criteria:
Key Inclusion Criteria:

* Informed consent and assent as appropriate
* Must have a body weight of ≥30 kg
* Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric multiple sclerosis (MS)
* Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive

Key Exclusion Criteria:

* Primary progressive, secondary progressive, or progressive relapsing MS.
* History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
* History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (DMF) or fumaric acid esters.
* Prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
* Prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV) immunoglobulin, plasmapheresis or cytapheresis.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Nipocalimab in Moderate to Severe Sjogren's Disease

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (\>=) 18 years of age with moderate to severe SjD.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
* Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
* Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
* Total ClinESSDAI score greater than or equal to (\>=) 5 at screening
* Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization

Exclusion Criteria:

* Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \[e.g.\], monoclonal antibodies, intravenous immunoglobulin)
* Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML

A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.

Randomized,Open Label,Control


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-75 year-old
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
3. Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
4. Adequate organ function

Exclusion Criteria:

1. received TKIs drug treatment before enrollment
2. Central nervous system leukemia
3. Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
4. Cardiac dysfunction
5. Previous splenectomy
6. History of congenital or acquired bleeding disorders unrelated to CML
7. Previous malignancy except CML
8. Acute or chronic liver or severe kidney disease unrelated to CML
9. Pregnant, breastfeeding, child bearing potential but failed to take effective contraception
Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.

With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age between 30-65 years old.
* Primary aldosteronism with resistant hypertension.
* Informed consent signed and agreed to participate in this trial.

Exclusion Criteria:

* Secodary hyertension due to other causes.
* History of depression,schizophrenia or vascular dementia .
* History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
* Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
* Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
* Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
* Fertile woman without contraceptives.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs.
* Allergic to or have contraindication to the contrast agents and alcohol.
Etomidate Induction in Hysteroscopic Surgery

This study intends to study the optimal dose induced by etomidate in outpatients undergoing painless hysteroscopic surgery. At present, the dosage in the user manual is 0.1-0.3mg/kg. In clinical use, it is found that 0.1mg/kg often fails to achieve sedative effect, and 0.3mg/kg is prone to muscle twitching. Therefore, three groups of doses of 0.15mg/kg, 0.2mg/kg and 0.25mg/kg are set. It is hoped that this study will provide a basis for clinical evaluation of etomidate in anesthesia induction of hysteroscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients to undergo hysteroscopic surgery

Exclusion Criteria:

Hemo-dynamically unstable patients Allergic to egg protein Patients with epilepsy
High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.


Eligibility Criteria:
Inclusion Criteria:

* must have been diagnosed with type 2 diabetes mellitus during the last 5 years
* must have BMI 18.5-24.9

Exclusion Criteria:

* receive dietary supplements
* extreme dietary habits
* chronic inflammation disease
* cancer
* autoimmune disease
Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients

A prospective, randomized and controlled study is proposed to establish whether an enteral nutrition support regimen based on pressurized whey protein and glucose improves the postoperative utilization of amino acid substrates compared to a drink based on glucose alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino acid oxidation) will be investigated using stable isotope methodology before and after surgery in patients undergoing colon resection. Stable isotope infusions will be conducted one week before surgery and on the second postoperative day for two hours in the fasted state and for four hours while sipping the enteral nutrition support regimen. Patients will consume one of two enteral nutrition support regimens consisting of a drink containing either pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral nutrition support regimen based on pressurized whey protein and glucose promotes positive protein balance through increased protein synthesis or reduced protein breakdown compared to glucose alone.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* ASA class I to III
* colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total and hemicolectomy and low anterior resection)
* body mass index \>17 and \<30 kg.m-2
* stable weight over the preceding three months (\<10 % body weight loss)
* serum albumin \>35 g/L

Exclusion Criteria:

* severe cardiac, renal or hepatic failure
* diabetes
* hyper and hypothyroidism
* active inflammatory bowel or diverticular disease
* musculoskeletal or neuromuscular disease
* anemia (hematocrit \<30)
* albumin \< 25 g/l
* pregnancy
* use of steroids.
Bioequivalence of a Diabetes Specific Tube Feed

Nutricia has a range of nutritionally complete tube feeds on the market including some specific for diabetes patients. A new product is currently under development. The aim of the present study is to assess whether the postprandial glucose response of the new product is equivalent to the postprandial glucose response of an original product. In addition, the Glycaemic Index (GI) and Glycaemic Load (GL) of the adapted product will be determined. The study will have a crossover design with healthy volunteers taking one serving of both products in a randomized order. To determine GI and GL of the adapted product subjects will also receive a reference product. Subjects will visit the study site six times: one screening visit, three study visits to measure the glucose response to the reference product and two study visits to measure the glucose response to the test and control product.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 65 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health

Exclusion Criteria:

1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that interferes with glucose metabolism
2. Any use of anticoagulants, systemic steroids, protease inhibitors or antipsychotics and/or any medication known to affect glucose tolerance and/or to influence digestion and absorption of nutrients within 1 week of screening, in opinion of the Investigator
3. Any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the Investigator)
4. Allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the Investigator
5. Adherence to a strict vegan diet
6. Adherence to a weight loss program
7. Picky/fussy eater (being very selective about what to eat) or eating disorder
8. Known pregnancy and/or lactation
9. Current smoking or stopped smoking for \< 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month)
10. Average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women (on average during the last 6 months)
11. Drug or medicine abuse in opinion of the Investigator
12. Any known bleeding disorder
13. Active participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before study visit 1, in the opinion of the Investigator
14. Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator
15. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
16. Employees of Nutricia Research and/or family members or relatives of employees
Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis

The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment.

Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. Depression, or major depressive disorder, is highly prevalent in people with MS and often has a serious impact on quality of life. MDD can be difficult to treat with medications in MS. Transcranial magnetic stimulation (TMS) is a safe and approved treatment for treatment-resistant depression in the general population. However, little is known about the use of TMS for MDD in people with MS. This pilot study will evaluate the safety, feasibility, and preliminary efficacy of TMS for MDD in MS. Participants will receive outpatient neuronavigated-TMS for MDD. Various measures of MS and MDD symptoms will be monitored over the course of treatment. Clinical brain imaging will also be compared before and after TMS.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of multiple sclerosis (any subtype) by 2017 McDonald criteria
* Established diagnosis of major depressive disorder (MDD) by DSM-5 criteria
* Eligible for transcranial magnetic stimulation (rTMS) for depression

Exclusion Criteria:

* MS relapse and/or steroid use within 3 months
* Active suicidal ideation
* History of seizure/epilepsy, brain tumor, or stroke
* History of bipolar disorder or psychosis
* Currently or planning to become pregnant
Evaluation of Palliative Care Co-treatment by Attending Physicians and Nurses: an Online Survey as Part of the Project

The subject of the study is an online survey of doctors and nurses who provide (intensive) medical care to patients.

Charité will support this international survey as part of the preparatory phase of the "Europe-wide harmonized and recommended palliative care practice for ICU" approved HORIZON grant application EPIC (EA2/291/23), to which this ethics application refers.

Participants will be contacted via the mailing list of ESAIC (European Organization for Anaesthesia, Intensive Care, Pain and Perioperative Medicine), ESICM (European Society of Intensive Care Medicine), DIVI (German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) and the European Association for Palliative Care (EAPC).

Eligibility Criteria:
Inclusion Criteria:

* All doctors or nursing staff involved in the intensive medical care of patients and consent to the survey via the distribution list of a specialist association

Exclusion Criteria:

* Incomplete data