cyrilzakka/clinical-trials huggingface dataset:
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

* Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks.
* During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.

* Treatment duration was 24 weeks in total.
* However, at Week 12, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment until Week 24.
* Participants in the other groups maintained their randomized treatment until Week 24.

Eligibility Criteria:
Inclusion Criteria:

* male or female subjects who are ≥18 years of age on the day of signing informed consent,
* have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
* have ≥6 swollen joints (from a 66-joint count) and

  ≥8 tender joints (from a 68-joint count) at Screening and at Baseline,
* Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN),
* have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
* have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.

Exclusion Criteria:

* current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening,
* current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
* previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties

This study will examine the effects of a care management program on the health and health spending outcomes of patients residing in Michigan's Washtenaw and Livingston Counties.

In 2017, the State of Michigan will offer enrollment in care management services to a set of patients in Washtenaw and Livingston Counties who are predicted to be high-frequency users of emergency departments. This is a quality improvement initiative. The Center for Healthcare Research and Transformation (CHRT) will administer this enrollment and collect patient data. The Principal Investigators will conduct a study that uses the data from this quality improvement initiative to compare the outcomes of the treatment and control groups. Specifically, the study will examine whether the care management services had an effect on the number of emergency department visits and the total healthcare spending of the patients in the treatment group.

The present study therefore is the second of two related projects - the first is the CHRT-administered random assignment and enrollment of patients into care management services. The present study is a secondary analysis of the data produced by the first project.

This Protocol Registration and Results submission refers to the secondary analysis component wherever applicable, and where not applicable, describes the information relevant to the CHRT project. For example, while the present study does not assign anyone into treatment or control groups, the Sample Description indicates "Probability Sample" to describe the way in which CHRT intends to enroll patients.

Eligibility Criteria:
Inclusion criteria:

1. reside in Washtenaw or Livingston counties or have an unknown address;
2. Have a probability of being admitted to an emergency department (ED) in Washtenaw or Livingston counties that exceeds a threshold value in a predictive model;

Exclusion criteria

1. Patients referred by a community provider
2. Patient declines to consent
Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT

Objectives:

This study aims to explore the feasibility and acceptance of group-based dual-task training for prevention of cognitive decline in a pragmatic setting for community-dwelling older adults.

The primary objective is to assess recruitment rate, attendance rate, retention rate and satisfaction rate of participants.

Study design and participants:

This is a pilot pragmatic RCT with waitlist control. First, a co-design approach will be adopted to develop the intervention with the older adults. Then, about six participating community centres will nominate staff or volunteer to receive the training in order to lead the intervention. Informed consent will be sought from the participants and baseline assessment will be conducted. The participants will be randomly allocated to the intervention and control groups in 1:1 ratio using block randomisation with varying block size. At the end of the study, one representative of each participating centre will be invited to provide qualitative feedback.

Measurements:

The primary outcomes are the feasibility outcomes, namely the recruitment rate, attendance rate, the retention rate, and satisfaction rate of participants. Secondary outcomes include completion rate of the interventionist, time to recruit target sample size, factors influencing older adults' decision to participate and staff of the community centre to organise the activity, subjective memory complaints, working memory, executive function, and cognitive status of participants. A structured questionnaire will be used to collect quantitative outcomes related to effects and satisfaction. Qualitative feedback from representatives of the elderly community centres will be collected according to a semi-structured interview guide.

Expected results: The intervention is feasible and highly accepted by the participants and staff of the community centres. Potential effect-related outcomes are to be demonstrated.


Eligibility Criteria:
Inclusion Criteria:

(i) aged 65 years and above,

(ii) eligible to enrol in activities organised by the community centres,

(iii) no communication problems,

(iv) able to understand and follow instructions,

(v) able to read and write Chinese.

Exclusion Criteria:

contraindications to chair-based or stepping exercises.
Identification of Airway Structures Necessary for Airway Access Via the Skin

Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.

The study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods including application of ultrasonography.

Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.

The researchers will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage of a healthy subject with different methods including application of ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Anaesthesiologist

Exclusion Criteria:

* unvillingnes to participate
A Study of the Effects of External Stimulations on Postural Stability

In view of the long-term exercise, you can maintain your health and strengthen your physical strength. It can also improve your body's balance and help maintain your body's coordination so that you can reduce the chance of falls.

Therefore, in the face of aging, stroke rehabilitation or balance of power caused by balance of power decline, sports injuries or falls related issues, this study will focus on "balance ability" to explore a range of impacts and relationships.

Considering the standardization comparison in the study, this study will collect data on the balance of young people under different external stimuli, and hope to understand the balance control ability by objectively collecting the physiological signals of the Center of Pressure (COP).

The change, and the use of the Berg scale as a benchmark for the assessment of balance ability, and then return to the issue of balance ability training.

Therefore, this study divides the experiment into two major stages. The first stage will focus on healthy young people, and explore how external stimuli affect balance, and then assist balance ability training to find the most appropriate adjustment of body posture control.

The second phase explores the appropriate exercise training for stroke patients, such as the use of Modular Interactive Tiles System (MITS) training, to track the effectiveness of external stimulus impact balance training.

Eligibility Criteria:
Inclusion Criteria:

* Stage1 Subjects were included in the condition of adults with good health and no mobility disorder. They will be considered by healthy young people over the age of 20.

It is estimated that 12 males and 12 females will be called.

* Stage2 Forty patients with a stroke of more than six months have been admitted.

Subjects were included as follows:

1. stroke for more than 6 months;
2. current stable condition;
3. able to walk independently for more than 5 meters, and if necessary, use auxiliary equipment;
4. before and after the two feet Stand in a straight line for more than 10 seconds;
5. can understand spoken instructions.

Exclusion Criteria:

* Stage1

  1. unable to stand with the feet and the walker;
  2. pregnant;
  3. within six months will affect the walking or standing surgery (such as limbs, spine or brain surgery);
  4. other Physical and mental state is not suitable.
* Stage2

  1. unable to stand and walk with both feet;
  2. suffering from diabetes or other diseases combined with peripheral neuropathy, causing a poor sense of body or a neurological disease affecting lower limb movement and sensory function;
  3. suffering from hemophilia Patients with diseases, other blood-related diseases or severe peripheral vascular diseases;
  4. those who are pregnant;
  5. those who have been affected by walking or standing within six months (such as limb, spine or brain surgery);
  6. Other physical and mental states are not suitable.
Pathogenesis of Non-alcoholic Steatohepatitis and Liver Regeneration After Bariatric Surgery

Obesity and obesity related health problems are globally recognized as one of the major threats to public health. Bariatric surgery is the most effective and durable therapy option for obesity and the improvement of obesity related co-morbidities. "Non alcoholic steatohepatitis" (NASH) is an important comorbidity of obesity and improves after surgical intervention. In this study investigators try to enlighten the weight independent mechanism for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will be observed for at least 24 month. A liver and adipose tissue samples are gained during the operation. Liver function and morphology are observed before and after operation with LiMAx, FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after surgical intervention. In order to check the microbiome stool samples are collected throughout the entire observation period.

Every patient who is scheduled for bariatric surgery in the university hospital Aachen will be evaluated for this study. After informed consent baseline measurements are performed preoperative. Baseline measurements involve blood and stool samples, LiMAx, FibroScan and ultrasound. During the operation a liver, a subcutaneous and visceral fat sample are taken to analyse liver histology and inflammation as well as fatty tissue signaling. After the operation patients are observed 24 month. Further blood samples are taken on the first postoperative day, 2 and 4 weeks, 3, 6, 12, 18 and 24 month after the operation. Stool samples are taken 2 and 4 weeks, 3, 6, 12, 18 and 24 month after the intervention. The LiMAx test, a test analysing the liver function, is performed 4 weeks, 6, 12 and 24 month after the operation. The morphologic liver structure is evaluated by FibroScan and ultrasound 4 weeks, 6, 12 and 24 month postoperative.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* scheduled for bariatric surgery
* informed consent

Exclusion Criteria:

* pregnancy
* substance abuse
* liver disease other than NASH
Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration

The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.


Eligibility Criteria:
Inclusion Criteria:

1. ability to provide written informed consent and comply with study assessments for the full duration of the study;
2. age \>40 years;
3. presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.

Exclusion Criteria:

1. any previous intravitreal treatment;
2. previous laser treatment in the study eye;
3. myopia \>7 dioptres in the study eye;
4. concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
5. concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
6. known sensitivity to any component of the formulations under investigation.
Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique

This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
* Patient undergoes arthroscopic rotator cuff repair
* Age 18 or older

Exclusion Criteria:

Pre-operative exclusion criteria

* Patient has had a previous arthroscopic rotator cut repair
* A previous diagnosis of Rheumatoid Arthritis
* Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
* Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
* Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
* Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
* Inability to speak or read English
* Psychiatric illness that precludes informed consent.
* Pregnant patients.
* Age 17 or younger
* Unwillingness to be followed for 2 years.
* Bilateral Rotator cuff tear confirmed by clinical exam and MRI
* Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.

Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)

* Irreparable cuff tears or tears extending into the subscapularis or teres minor
* Isolated teres minor or subscapularis tears.
* Inelastic and immobile tendon which cannot be advanced to articular margin
Impulsivity and Stimulant Administration

Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 - 50 years,
2. voluntary, written, informed consent,
3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
5. recent street cocaine use in excess of amounts to be administered in the current study,
6. intravenous and/or smoked (crack/ freebase) use,
7. positive urine toxicology screen for cocaine,
8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.

Exclusion Criteria:

1. Other drug dependence (except nicotine) as determined by urine toxicology or interview
2. \< 1 year of cocaine dependence,
3. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
4. a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
5. current use of psychotropic and/or potentially psychoactive prescription medication,
6. seeking treatment for drug abuse/dependence (for experimental cocaine component),
7. physical or laboratory (β-HCG) evidence of pregnancy.
8. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients

This study evaluates the predictor value of manual test in lumbar chronic patients blocks. Bibliography has show limited evidence of clinical predictors in lumbar blocks. Prior to lumbar facet block or medial branch denervation patient will be evaluated with manual provocative segmental movements, lumbar sagittal range of motion, manual segmental movement and slump neural test . Immediate, one and six months effect will be registered.

Clinical tests have sown limit evidence to predict efficacy of lumbar facet blocks. Segmental mobility tests have been included into the protocol to evaluate the efficacy of the lumbar blocks.

Chronic low back pain patients will be tested to evaluate the predictor value of manual clinical tests.

Patients from the "Lozano Blesa" Hospital pain clinic will be evaluate before, one month and six months after the lumbar facet block.

Eligibility Criteria:
Inclusion Criteria:

* more than 3 months of low back pain.
* lumbar with or without leg pain.
* patient treated with a lumbar facet block or medial nerve denervation.
* capable to be physically explored.
* capable to fill a questionaire.

Exclusion Criteria:

* no mechanical pain.
* severe medical condition.
* severe lumbar trauma.
* severe lumbar instability.
* severe lumbar deformity
* psychiatric disorder.
Acute Responses to a Potentiation Warm-up Protocol in Female Football Players.

This study aims to determine if the performance of female football players is affected after exposure to a potentiation protocol. It is hypothesized that performance in the selected physical tests will improve significantly and meaningfully after performing the chosen potentiation protocol compared to the control group's warm-up.


Eligibility Criteria:
Inclusion Criteria:

* players from any playing position (except goalkeepers) able to train without limitations.

Exclusion Criteria:

* players with any existing medical conditions that could compromise participation.
A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin

The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 25 to 50 years old inclusive
* Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria:

* Clinical skin atrophy, telangiectasia or striae on volar arms
* Presence of any skin condition or colouration that would interfere with test sites or the response or assessment
* Fitzpatrick skin type IV - VI
* History or current evidence of infection, eczema or other relevant skin disease
Effect of Hibiscus and Lippia Extract on Blood Pressure

Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a dietetic intervention and physical exercise, supplemented with a polyphenolic extract, decreases blood pressure in hypertensive volunteers.

Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs.

Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure

Exclusion Criteria:

* Minors (under 18 years of age)
* volunteers with high cardiovascular disease risk
* pharmacological treatment for blood pressure
* presence of any chronic disease/condition
* known allergies regarding the supplement and/or placebo