cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
* Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

* Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
* Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

* Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply
Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea

Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using sulfonylureas (SUs). The frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous studies have reported total hypoglycemia as measured by continuous glucose monitoring system (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these events. As with age hypoglycemia perception is reduced and consequences can be increased due to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation of the total number of hypoglycemia is a relevant objective to really appreciate the potential impact of SUs in the Canadian context.

The investigators propose a multicenter observational prospective study in order to study the incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment, including medical history measures, quality of life and diabetes treatment satisfaction.

In patients with T2DM not at goal (A1c \>7.0 mmol/L), and newly prescribed a SU, the objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period following the initiation of the SU.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes according to Canadian Diabetes Association definition
* Initiation of a SU at baseline
* A1c: 7.0% to 10.0%
* Willing and able to comply with study procedures

Exclusion Criteria:

* Current or previous usage (during the last 3 months) of insulin or repaglinide
* Use of medication known to interfere with glucose metabolism
* Insulin requiring patient: catabolic state and/or ketonuria
* Currently using CGMS or within the last 3 months
* Recent severe hypoglycemia (\<3 months)
* Pregnancy or breast-feeding
* Limited life expectancy, high level of functional dependency, extensive coronary disease at high risk of short term ischemic events or multiple major co-morbidities
The Role of Synovectomy in Pain Reduction Following Total Knee Arthroplasty

Osteoarthritis (OA) is the most common joint disease, causing severe pain due to joint inflammation (synovitis). While total knee arthroplasty (TKA) is commonly performed to reduce pain, 20% of patients are dissatisfied with their outcome post-surgery. This dissatisfaction is caused by persistent pain post-TKA due to synovitis that is not routinely removed during surgery. To address this problem, a synovectomy can be performed during TKA, which involves resecting the inflamed layer of tissue lining the joint, called the synovium, and its associated sensory nerve endings. Since the synovium will regenerate in the months post-surgery, synovectomy only transiently reduces pain after TKA. The proposed study will help ascertain the benefits and effects of synovectomy in patients who are more likely to experience poor satisfaction (driven mostly by pain) post-TKA. This study will include 62 patients undergoing TKA due to end-stage OA who have moderate to severe synovitis, as determined by ultrasound assessment. Patients will be randomized (1:1) to undergo a TKA with synovectomy or without synovectomy. Primary and secondary outcomes will be assessed through patient-reported levels of pain and function, results from physical performance tests, and quality of life (QOL) scores. These measures will be recorded pre- and post-surgery for comparison. Through demonstrating that synovectomy can at least transiently reduce pain post-TKA, this study will provide evidence for the development of medical therapies that target the synovium to slow its regrowth. This will be transformative for the long-term management of joint pain and synovitis post-surgery, thus significantly improving patients' overall QOL.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females over the age of 40 diagnosed with knee osteoarthritis
2. Scheduled for first unilateral total knee arthroplasty
3. Moderate to severe (at least grade two) synovitis and synovial hyperplasia, as determined by ultrasound assessment
4. Referred to the Pre-Admission Clinic at University Hospital

Exclusion Criteria:

1. Bilateral, uni-compartmental, or revision total knee arthroplasty
2. Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
3. Known inflammatory arthropathy, another rheumatic disease, or disease-modifying anti-rheumatic drug (DMARD) use (e.g. methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, TNF inhibitors, etc.) - note: Gout is NOT an exclusion
4. Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment date
5. Cannot read, write, or understand English (printed instructions are provided in English only)
6. Any factors precluding patients from attending follow-up appointments (e.g., socio-economic limitations, distance from clinic, no access to home/cell phone, etc.).
7. Cognitive impairment or psychological problems that preclude the ability to understand instructions
8. Not able to follow up at routine standard of care post-operative visits
Association Between cd163 Gene Polymorphisms and Sepsis Among Chinese Han Population

CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. This study was designed to investigate whether CD163 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When analyzing the results of sequencing, we found five gene polymorphisms located in exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis and in 200 healthy control subjects. This study was explored that whether or not polymorphisms detected within the CD163 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.


Eligibility Criteria:
Inclusion Criteria:

* Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.

Exclusion Criteria:

* (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (\< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy

To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of obesity
* diagnosed ORG by renal biopsy
* LDL\>3.37mmol/L
* Proteinuria 0.5-3.5g/d
* eGFR (CKD-EPI formula) \> 30ml/min

Exclusion Criteria:

* Other concomitant renal diseases
* Endocrine or drug-induced obesity;
* Type 2 diabetes
* eyes or obvious microscopic hematuria;
* Swallowing difficulty / severe gastrointestinal dysfunction
* intestinal obstruction;
* severe arrhythmia;
* Hypophosphatemia (\<0.7mmol/L);
* allergic to Sevelamer Carbonate
* unable to well cooperate
* Females who are in the period of gestation or lactation, or refuse to use contraception;
* participated in other clinical trial of drug within three months
RCT for the Efficacy of Soothing Cream Jel in Improving Upper Limb Pain and Motion

This is a randomized, double-blinded, placebo-controlled clinical trial. This trial is used to evaluate the efficacy of soothing cream jel on chronic upper limb pain and the range of motion.

Potential subjects will be screened according to the eligibility criteria after signing the informed consent form. Subjects who fulfill the requirements will be randomized into either the treatment group or the placebo group. And receive either soothing cream jel or placebo cream jel for 2 weeks. Then followed by a post-treatment for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60;
2. Participates in regular physical activity, at least once a week for 30 minutes;
3. Chronic pain in the shoulder or elbow longer than 3 months;
4. 11-items Numeric pain rating scale ≥4; and
5. Willing to provide written informed consent.

Exclusion Criteria:

1. The patient had received previous physiotherapy, acupuncture, Tui Na massage, or bone-setting treatment for distal upper limb pain within the past 2 weeks;
2. The pain was due to a fracture or known complex regional pain syndrome.
3. History of upper limb surgery;
4. Known severe medical conditions (e.g. rheumatoid arthritis, osteoporosis, cardiac, renal, hepatic, hematological diseases, vertigo, seizure, infection, malignancy, neurological impairment);
5. Concomitant drugs of NSAIDs, any kind of painkillers, or anti-inflammatory drugs 15 days prior to randomization;
6. Known impaired hematological profile and liver / renal function;
7. Known allergic history to any topical cream;
8. Known pregnant or lactating; or
9. Unable to complete questionnaires
Prospective Evaluation of Topical Anesthesia in Children

This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine.

Pain caused by repair of torn skin is usually an unpleasant experience for pediatric patients. Analgesia or pain control is conventionally achieved by local anaesthetic infiltration. Local anaesthetics are a class of drugs that interrupt the transmission of electrical impulses along sensory nerves by inactivating sodium channels (Eidelman et al., 2011). However, the infiltration of local anaesthetics, which involves injecting the medication into the skin, may itself cause significant pain and fear in children (Kundu and Achar, 2002, Boettcher et al., 2012).

Pain management has been increasingly recognized as an element of high quality patient care, yet studies have shown deficiencies in pediatric emergency department (PED) pain management in children (Lawton and Hadj, 2014, Fein et al., 2012). Resolution of pain and perception of pain have been documented as one of the top indicators of patient and parent satisfaction and measure of quality of care in the PED (Magaret et al., 2002). Children are particularly susceptible to pain, even when caused by simple procedures (Boettcher et al., 2012). Well-managed pain has been associated with faster recoveries, fewer complications, and decreased use of health care resources (Zhu et al., 2012).

LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. LET gel offers many advantages for repair of tissue laceration including epinephrine-induced vasoconstriction, promotion of dry surfaces required for tissue adhesive laceration repair, and reduction of discomfort (MacLean et al., 2007). Topical anesthetics have been shown to improve procedural success rates and reduce procedural times, likely due to decreased patient movement and pain reduction (Taddio et al., 2005). LET has been shown to significantly reduce the need for injecting local anesthetics to the wound site, which is a cause of much anxiety and pain in children (Taddio et al., 2005, Singer and Stark, 2001).

In many PED - as in our department - LET solution and EMLA pretreatment and subsequent lidocaine infiltration are used depending on the personal experience and preference of the physician. The objective of this study is to determine if LET solution is as effective as EMLA and lidocaine infiltration in terms of comfort and effectiveness.

Primary Hypothesis:

LET solution is as effective as EMLA and lidocaine infiltration in controlling pain.

Secondary Hypothesis:

LET solution is superior to EMLA and lidocaine infiltration in terms of comfort.

Eligibility Criteria:
Inclusion Criteria:

1. Chronological age above 3 and below 18 years
2. Dermal laceration that needs surgical repair
3. Signed informed consent by the parent or guardian of the patient

Exclusion Criteria:

* Skin laceration of nose tip, fingers, genitalia
A Pilot Study to Explore the Role of Gut Flora in Celiac Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Celiac Disease.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Celiac Disease

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of Celiac Disease

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Exercise in Patients With Osteoarthritis of the Hip

According to Danish and international guidelines the recommended first-line of management for people with osteoarthritis consist of exercise, education, analgesic medication, and, if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in patients with knee OA, but the effect of exercise on hip OA is sparsely investigated.

Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking, and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical activity, and health related quality of life in patients with osteoarthritis of the hip.

The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e., disease activity, inflammation, and cartilage degradation, are investigated in a subgroup (n=45) of the participants.

Study hypotheses: Strength training will have a greater effect on physical function and muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a greater effect on endurance than strength training and unsupervised home based exercise; 3) Strength training and Nordic Walking will have a greater effect on pain level and health related quality of life than unsupervised home based exercise.


Eligibility Criteria:
Inclusion Criteria:

1)Home-dwelling 60+ year old persons with primary, symptomatic hip OA who meet the clinical criteria of hip OA according to American College of Rheumatology (ACR), and who are not on a waiting list for hip joint replacement.

Exclusion Criteria:

1. symptomatic OA in the knee or the big toe,
2. joint replacement of the knee or the hip,
3. other types of arthritis, e.g., rheumatoid arthritis,
4. previous hip fracture,
5. limitation in physical function to the extent that using public transportation is impossible,
6. co-morbidity that prevents exercising,
7. physiotherapy related to hip problems within the last 3 months,
8. steroid injections in the hip joint within the last 3 months,
9. performing exercise/sports 2+ times weekly, and
10. inability to cooperate.
Combined Constraint Therapy and Bimanual Therapy for Children With Unilateral Brain Injury

To examine efficacy of combined unimanual and bimanual intensive therapy in children with unilateral brain injury. A key question in hemiplegia therapy is whether the affected hand should be trained alone or in tandem with the other hand. In constraint-induced movement therapy (CIMT), a participant's less-affected upper extremity is restricted with a sling, cast, or mitt, while the participant actively uses the affected arm and hand in skill-based therapeutic activities. Bimanual therapy, in contrast, engages both hands in therapeutic movement. Since constraint and bimanual therapy target different aspects of hand use, they could have synergistic effects on hand function when given in combination.

Children with hemiplegia will be given an intensive hand therapy protocol for six weeks (6 hrs/day, 5 days/week - total of 180 hours. Therapy will be given in two blocks.

In one block (3 weeks, 90 hours of therapy), children will receive constraint-induced movement therapy (CIMT), also known as constraint therapy. During CIMT, children wear a mitt over their less-affected hand, which restricts use of that hand. Children engage in intensive therapy to improve active range of motion, strength, motor control and sensory awareness of the affected hand. Activities are functional and play based. Daily structure of therapy includes: morning gym, fine motor, gross motor, sensory motor, therapeutic feeding, sports and self care activities. During training, children perform play-based and functional activities with the affected hand. Example activities include playing card and board games, arts and crafts, and activities that provide sensory stimulation to the affected hand, such as finger painting. Activities also include stretching and strengthening exercises.

In one block (3 weeks, 90 hours of therapy), children will receive bimanual therapy. During bimanual therapy, children do not wear a mitt over the less-affected hand. Children will be provided individualized activities that facilitated active use of both hands. Therapists will adapt and grade activities and guided children to problem solve for success. Bimanual activities include self-care (tying shoes, zippering, cutting food), sports activities, and manipulation of classroom tools (cutting with scissors).

Before the intervention begins, children will be randomized to one of two arms. In Arm 1, children will receive 3 weeks of CIMT followed by 3 weeks of bimanual therapy. In Arm 2, children will receive 3 weeks of bimanual therapy followed by 3 weeks of CIMT.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemiplegia.
* Wrist range of motion of at least 10 degrees.
* Able to follow directions.
* Experience attending day programs without the child's home caregiver present (i.e. school, daycare).

Exclusion Criteria:

* Uncorrected vision problems.
* Inability to communicate or follow directions.
Leg Muscle Activity Measured Via Electromyography in Back Squat Variations

The purpose of the study is to see how different forms of the squat exercise change my body's leg muscle activity. Four forms of the traditional back squat will be used: traditional back squat, barefoot squat, box squat, and traditional back squat with chains.

Resistance exercise has various benefits that promote health and reduce the chance of chronic disease, but the biggest benefit may be found in the effects on maintaining muscle mass throughout the aging process. The implications resistance training has on an individual's ability to function throughout the day with less fatigue whilst performing tasks at an easier level can all be related to improved strength and endurance that comes with resistance training. Furthermore, how the nervous system adapts and sends signals to the working muscles are of great interest as neuromuscular adaptations help in coordination, balance, and agility. Variations of the same style of exercise have been theorized to improve and/or change the adaptations that can occur. Thus, the purpose of this study would be to assess surface electromyography (sEMG) activations on 4 anatomical sites simultaneously during the squat exercise under varying conditions.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be males and females between the ages of 18 - 30 years
* Participant has provided written and dated informed consent to participate
* Participant is willing and able to comply with the protocol
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire
* Participant agrees to abstain from lower body exercise 3 days prior to each testing visit
* Participant has completed at least 1 lower body workout every week for the past 6 months

Exclusion Criteria:

* Participant reports any unusual adverse events associated with this study that in consultation with their physician recommends removal from the study
* Participant begins consumption of new supplement during the timeline of this study
* Participant is unable to refrain from consuming pre-workout supplement prior to testing sessions
* Participant is unwilling to refrain from lower body exercise at least 3 days prior to each testing session