cyrilzakka/clinical-trials huggingface dataset:
Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis

Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc.

An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics.

Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.

Raman spectroscopy will be performed on patients with SSc, according to the ACR criteria, and control patients without SSc, on 3 different areas of the skin. Patients with SSc and controls will be matched by gender and age. These measures will be performed at 6 months, 12 months, 24 months and 36 months.

Eligibility Criteria:
inclusion criteria :

* patients with SSc, according to ACR criteria
* older than 18-years-old exclusion criteria :
* younger than 18-years-old
* patient protected by law
Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians

This study represents Phase II of a research program involving an international collaboration with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive behavior therapy for the treatment of anxiety and depression in French-speaking Canadians from the Atlantic Provinces.

The primary objective is to establish the clinical efficacy of a French-Canadian self-guided format version of the Wellbeing Course by conducting a randomized-control trial where an experimental group will be compared to a waitlist control group. A secondary objective is to demonstrate the course's acceptability through participants' satisfaction with the course.


Eligibility Criteria:
Inclusion Criteria:

* Residing in New-Brunswick, Nova-Scotia, Prince Edward Island, or Newfound land \& Labrador
* Having identified French as the first official language spoken and having good reading comprehension in French.
* Reliable Internet access
* Clinically significant levels of depression or anxiety reflected by significant scores on the following measures: PHQ-9 \> 9, GAD-7 \>7, Penn Stage Worry Questionnaire ≥ 45, Social Phobia Inventory ≥ 19, Panic and Agoraphobia Scale ≥ 19, or by answering yes to the question "Is anxiety or low mood a problem for you"
* Not currently participating in cognitive-behavioral therapy
* No changes in medication for 4 weeks prior to the study, nor any changes in medication for the next 2 months
* Willing to disclose personal information

Exclusion Criteria:

* Presence of psychotic symptoms
* Presence of severe depression as indicated by scores ≥ 23 on the PHQ-9, or a score \> 2 on item 9 of the PHQ-9
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)

Eligibility Criteria:
Inclusion Criteria:

* Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
* Weight greater than or equal to 40.0 kg.
* Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
* Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
* Active moderate to severe SLE disease based on SLE disease activity score.

Exclusion Criteria:

* Active severe or unstable neuropsychiatric SLE.
* Active severe SLE-driven renal disease or unstable renal disease.
* Clinically significant active infection including ongoing and chronic infections.
* Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
* Confirmed positive tests for hepatitis B or positive test for hepatitis C.
Parent-Based Treatment for Pediatric Overweight

The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.

Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.

Eligibility Criteria:
Inclusion Criteria:

* Ages 13-17
* Male and female
* Living with at least one parent or guardian who is willing to participate in treatment
* A BMI percentile \>85% for gender and age (e.g., overweight or at risk for overweight)

Exclusion Criteria:

* Current psychotic illness
* Current alcohol/drug dependence
* Active suicidality
* Eating disorders (e.g., binge eating disorder)
* History of bariatric surgery
* Medication associated with significant weight changes (e.g., antipsychotics)
* Serious medical or physical conditions resulting in significant weight changes (e.g., pregnancy, genetic disorders).
* Complications of obesity that contraindicate moderate physical activity (e.g. orthopedic disorders)
Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)

Cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (COPD). Existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in COPD. MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study is to test if MitoQ can improve cardiovascular health in COPD.

In this study, a mitochondria-specific antioxidant will be compared to a placebo. Participants will be assigned randomly to receive either the antioxidant or the placebo for 6 weeks. A comprehensive assessment of cardiovascular health will be conducted before and after the administration of the supplement.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed of COPD
* Global Initiative for obstructive lung disease (GOLD) Stages II to IV

Exclusion Criteria:

* Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) \>0.7
* Heart Disease
* Diabetes
* Vasoactive medications
* Uncontrolled high blood pressure
* Fluid in lungs
* Sleep apnea
* Raynaud's Phenomenon
* Gangrene of the digits
* History of coagulation
* Pregnant women
* Children
Distribution of Risk Factors in Ocular Hypertension and Open-Angle Glaucoma Patients in Canada

This descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed at study visit or within 3 months of visit with OH
* OAG (to include POAG, NTG, pigmentary and pseudoexfoliation glaucoma)

Exclusion Criteria:

* No prior treatment for OH or OAG
* No prior ocular surgery or history of ocular trauma
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk

Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to further investigate dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to define the extent to which dairy milk, and its whey and casein protein fractions, protect against postprandial vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

This study consists of four, 3-hour postprandial trials in response to consuming the following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in combination with non-fat milk, 3. oral glucose challenge in combination with whey protein isolate, and 4. oral glucose challenge in combination with sodium caseinate. For three days preceding each trial, participants will be provided all meals to standardize physiologic responses to test meals. On each trial day, vascular function will be assessed and blood samples collected prior to and at 30 minute intervals for 3 hours following test meal ingestion.

Eligibility Criteria:
Inclusion Criteria:

1. hemoglobin A1c 5.7-6.4%
2. non-dietary supplement user
3. no medications affecting vasodilation, inflammation, or energy metabolism
4. no CVD
5. nonsmokers
6. individuals having blood pressure \<140/90 mmHg and total cholesterol \<240 mg/dL

Exclusion Criteria:

1. unstable weight (±2 kg)
2. vegetarian or dairy allergy
3. alcohol intake \>3 drinks/day or \>10 drinks/week
4. ≥7 hours/week of aerobic activity
Study of Conservative Versus Surgical Treatment of Appendicitis

The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction.

In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date.

Patients in "the surgery group" are treated according to standard routines. Patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated.

Parameters that will be analyzed are:

* primary healing in the antibiotic group
* frequency of relapse in appendicitis in the antibiotic group
* complications in both groups
* economical analysis (hospital stay, sick leave time, time off work) in both groups

Eligibility Criteria:
Inclusion Criteria:

* Suspected appendicitis in patients over 18 years

Exclusion Criteria:

* Under 18 years
Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose

The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
* AGe: 18-60 years
* BMI: 18-27.5
* No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
* Written informed consent

Exclusion Criteria:

* Pregnant women or patients planning to become pregnant during the investigation period
* Reduced eyesight; i.e. visus \> 0.3 evaluated at the latest eye exam.
* Patient lacking the ability to sens insulin sensitivity
* Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
* Suspicion of abuse or non-compliance
* Participation in another clinical trial
Innovation in Tuberculosis

Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. Therefore, a transition from programmatic to personalized management of TB is needed.

INNOVA4TB proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Immunosuppression will not be considered an exclusion criterion

Exclusion Criteria:

* Patients who are not able to give their informed consent to participate in the study will be excluded
Digital Auscultation Test - IPF Data Collection

The aim of this study is the data collection for patients with IPF and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Age ≥ 45 years at the day of the study visit
* Diagnosis:

  * For patients with confirmed Idiopathic Pulmonary Fibrosis (IPF) diagnosis - a clinical diagnosis of IPF within the last 24 months from the day of the study visit, according to the American Thoracic Society (ATS)/ European Respiratory Society (ERS) 2011 guideline \[P11-07084\] or
  * For the symptom matched control - patients without a IPF diagnosis but with one of the confirmed current conditions as:

    * asthma diagnosed according to GINA guidelines,
    * COPD diagnosed according to GOLD guidelines,

      * pneumonia,
      * upper respiratory tract infection, or
      * acute bronchitis.
* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the study

Exclusion Criteria:

* Any other current respiratory condition other than the pulmonary disease which qualified the patient eligibility based on inclusion criterion 3
* Any condition, according to investigator's assessment, which will not allow the patient to comply with protocol assessments or need a legal representative
* Patients with a history of lobectomy, pneumonectomy or lung transplant
* Patients with a Body Mass Index (BMI) \>30,0 kg/m²
* Previous enrolment in this study
* Women who are pregnant
SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver

The purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. This radiation may cause the tumor cells to die.


Eligibility Criteria:
Inclusion Criteria:

* must have diagnosis of metastatic melanoma liver disease by histological confirmation
* one measurable untreated or progressed liver lesion
* less than 50% liver involvement
* must have ECOG performance status of 0-1
* must have adequate renal and bone marrow function as: serum creatinine ≤ 2.0 mg/dl, granulocyte count ≥1000/mm3 and platelet count ≥100,000/mm3
* must have adequate liver function as: total bilirubin \<1.6 mg/ml and albumin \>3.0 g/dl

Exclusion Criteria:

* failure to meet any of the inclusion criteria
* solitary liver metastasis that is amenable to surgical removal
* previous treatment with isolated hepatic perfusion
* systemic chemotherapy within 2 weeks of study entry
* significant shunting to the lung (\>20%) as identified on Technetium-99m-macro-aggregated albumin nuclear medicine break-through scan
* unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted organs such as the GI tract
* symptomatic liver failure including ascites and hepatic encephalopathy
* metastasis outside of liver requiring systemic treatment within 3 months
* untreated brain metastasis
* main portal vein occlusion or inadequate collateral flow
* uncontrolled hypertension or congestive heart failure
* acute myocardial infarction within 6 months
* medical complications with implication of less than 6 month survival
* uncontrolled severe bleeding tendency or active GI bleed
* significant allergic reaction to iodinated contrast
* previous radiation that includes the liver in the main radiation field
* pregnant or breast-feeding women
* biliary obstruction, stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
* children under the age of 18
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation

To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal Asian women with osteoporosis defined by low BMD

Exclusion Criteria:

* Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome

This study evaluates the effects of prone positioning on homogenization of ventilation.

After initiation of mechanical ventilation and assessing the eligibility of the patient, informed consent will be taken from the closest kin. If eligible, following steps will be performed which are part of standard ARDS patient care.

1. Low-flow Pressure Volume curve and assessment of airway opening pressure
2. Calculation of recruitment to inflation ratio
3. Optimizing Positive End-Expiratory Pressure

Afterwards, phase III slope of the patient will be recorded at four timepoints:

Supine 1 (immediately before turning to prone position) Prone 1 (immediately after prone position) Prone 2 (at the end of the 16-24 hour prone cycle) Supine 2 (immediately after turning to supine position)

Eligibility Criteria:
Inclusion Criteria:

* ARDS criteria met
* intubated and mechanically ventilated as a result of respiratory failure
* PaO2/FiO2 \<200

Exclusion Criteria:

* age older than 18
* Chronic pulmonary disease, pneumothoraces, intraabdominal hypertension (\> 12 mmHg), pregnancy, not expected to survive \>24 hours, hemodynamic instability
Graft-versus-host Disease Associated Myelosuppression

The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* acute myeloid leukemia
* myelodysplastic syndrome
* hematopoietic stem cell transplantation

Exclusion Criteria:

* not willing to take part
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
* 2 12 to 75 years of age.
* 3 ECOG performance of less than 2.
* 4 Life expectancy of at least 3 months.
* 5 Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
* 6 Subjects must have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
* 7 Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

* 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
* 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
* 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
* 4 Prior organ allograft.
* 5 Women who are pregnant or breastfeeding.
* 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration.
* 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.