cyrilzakka/clinical-trials huggingface dataset:
Metabolomic Analysis of Systemic Sclerosis

Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.

The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (\<3 years) to established forms (\> 3 years).

Secondary purposes:

* Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs
* Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls
* Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients


Eligibility Criteria:
Inclusion criteria:

* Group 1 (scleroderma) : Patients with ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001)
* Group 2 (UCDT) : Patients with criteria proposed by Mosca et al. (1998)
* Group 3 (Raynaud) : Patients with primary and isolated Raynaud disease
* Group 4 (vascular disease) : Patients with type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke
* Group 5 (healthy control) : healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease)

Exclusion criteria:

* Group 1 (scleroderma) : Patients not fulfilling ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001), or with another auto-immune disease
* Group 2 (UCDT) : Patients not fulfilling criteria proposed by Mosca et al. (1998)
* Group 3 (Raynaud) : Patients with no Raynaud disease
* Group 4 (vascular disease) : Patients with no vascular disease
* Group 5 (healthy control) : Patients with sign of connective tissue disease, Raynaud, or vascular disease)
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages 18 to 65, with generalized anxiety disorder.

On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GAD (Diagnostic and Statistical Manual IV \[DSM IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM IV) or dysthymic disorder will be allowed in the study.
* Subjects must have a HAM A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of ≥9 and a Raskin Depression Scale score ≤7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
* Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnosis: Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Anorexia, Bulimia, Caffeine induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
* Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
* Antisocial or borderline personality disorder.
* Serious suicidal risk per the clinical investigator's judgment.
A Study to Investigate the Effect of HMB on Skeletal Muscle Wasting in Early Critical Illness

This study aims to investigate the effect of beta-hydroxy-beta-methylbutyrate (HMB) on skeletal muscle wasting, physical function, strength and quality of life in survivors of critical illness. In addition, protein turnover, muscle biology and muscle histology will be investigated.

This is a double blind, placebo controlled, randomised controlled trial with the primary objective of investigating the effect of HMB on skeletal muscle wasting in early critical illness. Secondary objectives include determining the effect of HMB on skeletal muscle quality, strength, function and quality of life in survivors of critical illness. In addition, the effect of HMB on muscle protein turnover, muscle protein signalling, muscle fibre size and protein:DNA ratio will be investigated in a sub-group of participants.

Eligible participants will be randomised to receive either 3 g/day HMB or 3 g/day placebo within 24 hours of admission to the Intensive Care Unit (ICU). This will be continued until hospital discharge or 28-days, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

(i) ≥18 years old (ii) Due to receive enteral nutrition via a nasogastric or naso-jejunal tube as part of routine care (iii) Receiving mechanical ventilation and likely to continue this for more than 48 hours (iv) Likely to remain on the ICU for \>7 days (v) Likely to survive intensive care admission. (vi) Admitted to recruiting ICU \<24 hours from hospital admission and referring ICU ≥7 days from hospital admission (vii) Agreement obtained from legal representative (viii) Able to comply with protocol and study procedures (ix) No known allergy to IMP or any of its excipients

Participants in other trials can be recruited where protocols are not deemed likely to interfere with endpoints of either study and agreement has been obtained from the respective Chief Investigators.

Since participants in the trial will be abstaining by virtue of their illness, contraception is not required as an eligibility requirement.

Exclusion Criteria:

(i) Pregnancy or breast feeding (ii) Active disseminated malignancy (diagnosed) (iii) Bilateral lower limb amputees (iv) Non-ambulant or acute unilateral lower limb amputees (v) Patients with a primary neuromyopathy (vi) Patients entered into trials of interventions which would affect muscle mass (vii) Patients assessed as requiring sole parenteral nutrition (viii) Admission to ICU within the previous 3 months (ix) Any reason excluding ultrasound measurement being performed (x) Insufficient understanding of the trial by the legal representative (xi) Intolerance to lactose and/or milk protein allergy
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.


Eligibility Criteria:
Key Inclusion Criteria:

* Calculated body mass index from 18 to 40 kg/m\^2
* Not pregnant
* Normal electrocardiogram
* Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.

Key Exclusion Criteria:

* Participation in another clinical study (current or within last 30 days)
* HIV, hepatitis B virus, or active hepatitis C virus infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
[18F]MC225-PET in Neurodegenerative Disease

P-glycoprotein, an efflux transporter at the blood-brain barrier plays an important role in de development of neurodegenerative disease. A novel PET tracer (\[18F\]MC225) was developed to measure the function of P-glycoprotein and was tested with succes in healthy volunteers. This study aims to evaluate \[18F\]MC225 in neurodegenerative disease.

A decrease in P-glycoprotein (P-gp) function is associated with the onset of neurodegenerative disease. New treatment strategies in neurodegenerative disease, including Parkinson's disease and Alzheimer's disease, aim to restore the P-gp function. To evaluate the effect of these potential therapies, measurement of the P-gp function is necessary. Up until now \[11C\]verapamil is considered to be the gold standard to measure P-gp function. However tracer uptake in the brain of \[11C\]verapamil is too low for adequate measurement of treatment effect, especially of restoring P-gp function. A novel PET tracer to measure P-gp function, \[18F\]MC225, has the potential advantage of higher brain uptake values at baseline and might therefore able to measure both up- and down regulation P-gp function. \[18F\]MC225 was recently studied in healthy volunteers and a method to quantify P-gp function was developed. This study aims to evaluate \[18F\]MC225 to measure P-gp function in neurodegenerative disease.

To this aim 10 MCI patients, 10 patients with Alzheimer's disease and 10 Parkinson's disease patients will be included and undergo one 60 min dynamic \[18F\]MC225 PET scan, combined with a 10 min \[15O\]H2O PET. Tracer uptake values (Vt) and influx (K1) in several brain regions of interest, representing local P-gp function will be compared with the \[18F\]MC225 uptake values in the brain of healthy volunteers obtained in a previous study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with Alzheimer's disease, Parkinson's disease or Mild Cognitive Impairment

Exclusion Criteria:

* Use of any medication influencing the P-glycoprotein function
* History of neuropsychiatric disorders
* Contra-indications MRI
* Allergy contrast agent
Predicting and Addressing Colonoscopy in Safety Net Settings

The prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. The investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. Phase II will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in Washington State.

The study will fulfill the following aims:

Aim 1: Validate externally the predictive risk score using Sea Mar CHC's robust data including 29,000 patients age-eligible for colorectal cancer screening; stratify patients according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation program for the local context.

Aim 2: Assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or high risk for non-adherence.

Aim 3: Assess differences in the intervention arms in secondary outcomes (e.g. time to colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of intervention effectiveness (e.g. probability level, intervention dose, and patient age, ethnicity, and sex)

Eligibility Criteria:
Inclusion Criteria:

* Positive FIT test

Exclusion Criteria:

* Prior colorectal cancer
* Dialysis patient
Steroids Added to Dithranol and Narrow Band UVB(Ultraviolet B) (UVBnb) in Psoriasis

Objective(s):

(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.

(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).

* Trial with medicinal product

(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.

(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).

* Trial with medicinal product

Eligibility Criteria:
Inclusion criteria:

* Moderate to severe psoriasis of the chronic-plaque and / or guttata type

Exclusion criteria:

* Participation in a Goeckerman therapy regimen within 6 months previous to the present study
Vtama in Psoriasis Patients Being Treated With Biologics.

Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. Patient with ≥3% BSA
4. Patient has been treated with biologic for a minimum of 24 weeks
5. Able and willing to give written informed consent prior to performance of any study-related procedures.

Exclusion Criteria:

1. ≤3% BSA
2. Patient not receiving biologic agent, or receiving biologic agent \<24weeks
A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female age 18 to 85 years
* female of childbearing potential on appropriate method of contraception and not nursing
* Body Mass Index (BMI) less than or equal to 30 kg/m2
* subject is in good health

Exclusion Criteria:

* mental or legal incapacitation
* received bisphosphonate treatment within 3 months of enrollment.
* unable to sit or stand upright for at least 2 hours
* unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration
* unwilling to limit alcohol consumption to no more than 2 drinks per day
* unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent.
* unwilling to refrain from smoking during the study
Hip Impingement - Understanding Cartilage Damage

Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics and joint degradation to better identify 'at-risk' patients requiring corrective surgery will be scrutinized to gain a better understanding of the condition's natural history. The influence of certain morphologies (e.g. size and location of the deformity) will be analyzed to determine if this leads to aberrant loading of regions of the cartilage and subchondral bone, resulting in cartilage damage and joint degradation. Additionally, this research will determine if changes in the subchondral bone precede cartilage degeneration.

The methodology for establishing the morphology/cartilage degeneration relationship includes Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer simulation/finite element analysis.

The outcomes of this research may lead to a reduction in total hip replacement cases by as much as 70%, saving many Canadians from a painful and debilitating condition and reducing costs to the Canadian health care system by as much as $290 million annually.

The research objectives are:

1. To determine the factors of cam deformities, including morphological, functional and bone quality, that are associated with cartilage degeneration through shape analysis, kinematic analysis, MRI imaging and bone densitometry.
2. To determine whether subchondral bone changes occur before detectable cartilage degeneration by examining magnetic resonance images of asymptomatic subjects who have an identifiable deformity.
3. To use 3D motion and finite element analysis to examine differences in mechanical stimuli in the subchondral bone and cartilage that are associated with FAI, thus expanding our understanding of the pathomechanisms of associated degeneration.

Three subject cohorts will be recruited: subjects with bilateral cam deformity and unilateral symptoms (Group I, 'active cartilage damage stage'), asymptomatic subjects with cam deformity (Group II, 'early stage') and asymptomatic control subjects with no deformity (Group III).

Eligibility Criteria:
Inclusion Criteria:

* Group I: Subjects with bilateral cam deformity and unilateral symptoms; Hip pain longer than 6 months referred to the groin/lateral aspect of hip; Positive impingement sign (determined by the surgeon); Plain radiographs: absence of arthritis (Tonnis Grade 0 or 1), absence of dysplasia (center edge \>25 degrees) on AP radiograph, α-angle greater than 55 degrees on the Dunn view.
* Group II: Asymptomatic subjects with cam deformity; These patients will be recruited from our prevalence study (2006.813) with 200 asymptomatic individuals using MRI with radial sequences.
* Group III: Asymptomatic control subjects with no deformity; These patients will be recruited from our prevalence study (2006.813) which established their hip joint as having a normal femoral head neck contour. These subjects will be age-matched to Group I.

Exclusion Criteria:

* Participants who do not meet the criteria above.
Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.

The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.

Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.

Keratoconus is a common bilateral progressive corneal ecstatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation. CXL has changed the natural evolution of keratoconus. It creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. The corneal stroma is soaked with a riboflavin solution before being exposed to ultraviolet-A radiation.

In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infection and stromal opacity due to corneal scarring.

Iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of riboflavin into the cornea. The iontophoresis technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, combining the efficiency of the standard procedure without the side effects of epithelial debridement.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Corneal thickness ≥ 400 µm
* Progressive stage 1 to 3 keratoconus (Krumeich classification)

Exclusion Criteria:

* Corneal thickness \< 400µm
* Stage 4 keratoconus (Krumeich classification)
* Concomitant corneal disease
* History of corneal surgery
Comparison of Four Methods for Entering the Gap Position of Landolt Cs

The aim of this study is to investigate and compare the validity of four different input methods for Landolt Cs, i.e. the proportion of correct gap positions in relation to the total number of performances. The four input methods are a numeric keypad, an eight-positions rocker switch, a remote control and voice feedback.

The measurement of visual acuity is the most frequent and one of the most important ophthalmological functional investigations. Therefore, it is particularly important to find a measuring procedure with as little input errors as possible.

The 8-position Landolt C (LC) is the internationally accepted, well-standardised optotype for the determination of visual acuity.

Usually, the subjects informs the examiner verbally about the perceived position of each LC. According to the current literature, about 20 to 30 % of the population suffers from a right/left weakness. Furthermore, language barriers are an additional considerable hurdle.

Therefore, it is important to find an input method for the LC gap positions with minimal entry mistakes. In oder to avoid the thresholding procedure and its inherent difficulties, highly supra-threshold (10 times above the previously determined individual central visual acuity threshold) 8-position LCs are presented.

The study compares four input methods for entering of the Landolt C gap positions: a modified numeric keypad, an 8-position rocker switch, a modified TV remote control and voice/verbal feedback.

Each subject will perform all four input methods, with 2 test runs of 16 Landolt C presentations, each. A forced-choice method will be applied, i.e. the test is not continued until the test person has responded ot each single presentation. Regardless of whether the entry was correct or incorrect, the next Landolt C is displayed.

The optotypes are presented using modified version of the Freiburg Visual Acuity and Contrast Test (FrACT), which allows to present the 8-position Landolt Cs in a standardized way on a video display unit (VDU).

The sequence of the input methods is randomized. This study is carried out in a "within-subject design", i.e. all test persons go through all test conditions and serve as their own controls.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* Informed consent
* (Distance) visual acuity with best correction: ≥ 0.8
* (Distant) ametropia: ≤+8.0 Diopters (spherical equivalent)
* Anisometropia ≤ 3 dpt
* Astigmatism ≤ 2.5 dpt

Exclusion Criteria:

* Prolonged reaction time caused by drugs (medications)/ drugs/alcohol
* Movement disorders (of hands) such as Parkinson's disease
* Indication of amblyopia (strabismus surgery, occlusion therapy etc.)
* Eye movement disorders/double vision
* Defective stereo vision (according to LANG \[I\] stereo test)
* Presence of a relative afferent pupil defect ("swinging flashlight test)
* Any hint of visual pathway lesion or other chronic or progressive eye disease