cyrilzakka/clinical-trials huggingface dataset:
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab

The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

This two-part open-label study was to assess 2 different canakinumab taper regimens in patients with clinical remission (inactive disease for at least 24 continuous weeks) on canakinumab treatment without concomitant corticosteroids (CS) or methotrexate (MTX). The study was also to collect long term safety and tolerability data on SJIA patients treated with canakinumab.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

• Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1

Cohort 2:

* Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with an onset of disease \< 16 years of age.
* Active SJIA defined as having 2 or more of the following:
* Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day within 1 week before first canakinumab dose;
* At least 2 joints with active arthritis
* C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L)
* Rash due to SJIA
* Serositis
* Lymphadenopathy
* Hepatosplenomegaly
* Negative TB screen (QuantiFERON or, if required by local guidelines, Purified Protein Derivative).

Exclusion Criteria:

* With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
* With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
* With neutropenia (absolute neutrophil count \< 1500/mm3) at screening.
Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder

The aims of the current study are to examine gene-environment interactions associated with norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic changes in norepinephrine pathway are associated with differences in functional connectivity of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore, this study aims to examine neurobiological markers, such as intermediate neuroimaging phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD. Through evaluating drug responses and side effects with the associated measures of clinical, neuropsychological and neuroimaging characteristics, investigators would like to investigate predictors of treatment response associated with NE system genes in ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Attention-deficit Hyperactivity Disorder
* 6-18 years old

Exclusion Criteria:

* History of neurological diseases, including convulsive disorders or brain damage
* IQ below 70
* Pervasive developmental disorder (autism)
* Language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).
* Tourette's syndrome
* Bipolar disorder
* Psychosis
Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)

This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa


Eligibility Criteria:
Inclusion Criteria

1. Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS or INFANRIX hexa as part of the V419-007 or V419-008 study respectively.
2. Informed consent signed by the participant's parent(s) or legal representative.

Exclusion Criteria:

1. Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study.
2. Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.
3. Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.
4. Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.
5. Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure\*.
6. Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion\*.
7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies.
8. Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.

   * Criteria 5 and 6 are temporary exclusion criteria. If a participant meets criteria 5 and/or 6 at the time of Visit 1, a further appointment is to be scheduled to reassess the participant's eligibility.
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed with Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®

The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5

The investigator hypothesize that

- The bony fusion rate on a 12-month CT scan (or earlier at 6-month CT scan) is less than 10% lower in the intervention group compared to the bony fusion rate in the control group

For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery.

Eligibility Criteria:
Inclusion criteria:

Patients who have an indication for a monosegmental ALIF procedure on the L5/S1 segment or a monosegmental XLIF procedure on L4/5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain

* Patients must be 18 - 70 years of age
* Patients must have understood and signed the study information and the informed consent form
* Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the Informed Consent

Exclusion criteria:

* Patients under 18 years and over 70 years of age
* Patients with tumour / spine trauma / known bone disease / Parkinson's disease and similar CNS disorders / diseases or injuries of the peripheral nerves
* Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery
* Current smokingPregnant or breastfeeding patients
* Insufficient language skills in German
* Inability to give informed consent
* Refusal to participate in the study, unsigned study consent
* Participation in another interventional study within the 30 days preceding and during the present study
Bariatric Surgery and Pharmacokinetics of Gabapentin

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on gabapentin are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Implementation of Harmonized Depression Outcome Measures in a Health System

Working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the PHQ-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). The PHQ-9 will be captured either at an office visit or directly from patients. The investigators will build and implement an open-source SMART on FHIR app to collect key data from the EHR, combine that data with the PHQ-9 results, and present the measurements back to the clinicians. The investigators will then obtain feedback from clinicians on the value and usefulness of the app.

The study is a longitudinal, observational pilot study that will assess the utility and value displaying the harmonized outcomes data to clinicians in the clinical workflow using an open-source, SMART on FHIR app. The app will connect with the site EHR, aggregate EHR and PRO data, calculate the outcome measure results, and return the results to the EHR so that they are viewable within the clinician workflow. Baseline data on patient characteristics, treatments, and symptoms will be combined with longitudinal data on outcomes during the study timeframe. All data will be collected from institution electronic medical records (EMRs), PRO portals, and other existing data sources, as needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 and older
* Diagnosis of major depression or dysthymia
* Willing and able to provide informed consent

Exclusion Criteria:

* There are no exclusion criteria for this study.
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Stage IV chronic kidney disease, on haemodialysis
* Chronic renal anemia, on maintenance ESA treatment
* Hemoglobin concentration between 10.0 an 12 g/dL
* Continuous maintenance epoetin therapy with the same dosing interval during the previous month

Exclusion Criteria:

* Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Anemia due to hemolysis, pure red cell aplasia
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery

The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years of age
* Body Mass Index \< 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug.
* Received gastric bypass surgery more than 1 year before dosing
* Occurrence of postprandial hypoglycemia (blood glucose less than 60mg/dL) during the Baseline provocation assessments and/or by continuous glucose monitoring, as defined in the protocol.

Exclusion Criteria:

* History of type 1 diabetes
* Planned use of the following medications on or after Day -3 (Part 1):

  * Any agent for hypoglycemia, such as diazoxide or octreotide
  * Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, SGLT2 inhibitors, and GLP-1 agonists
  * Systemic glucocorticoids or β agonists that may affect glucose metabolism
  * Long-acting somatostatin analogs or glucose-affecting medications
* During Part 2, the following therapies are prohibited as specified below:

  * Tramadol and any other medications not used in the treatment of post-bariatric surgery hypoglycemia that may cause hypoglycemia or fluctuations in blood glucose levels.
  * Acetaminophen-containing products during periods of continuous glucose monitoring.

Medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. Acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring.

* Major general surgery within 3 months before study entry or anticipated during the study period

Other protocol-defined inclusion/exclusion criteria may apply
Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis

Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to objectively evaluate the composite measurement of ROM, pain and basic activities like walking or performing daily activities (QoL) in a population with a large coverage of age and levels of physical activity (from no physical activity history to athletes).

After giving their consent, subjects will undergo a screening visit to determine eligibility for study entry. After randomization, subjects will have administered medical device Iracross or Iraline. For subjects allocated to Iracross, medical device will be administered only at first visit and for subjects allocated to Iraline, medical device will be administered at visit 1, visit,2, visit 3 and optional for visit 4 and visit 5.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 40 and 80 years
2. Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria; (for subjects with OA at both knees, the most painful one will be included in the study only, respecting KL grade II or III);
3. Ambulant without assistance;
4. Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
5. VAS knee pain ≥40 at screening and 30 days before;
6. At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration.
7. Signed Informed consent

Exclusion Criteria:

1. Unstable knee;
2. Varus or valgus ≥ 15 degrees;
3. Active malignancy;
4. Knee trauma or lose body parts 1 year before screening;
5. Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
6. Use of potent analgesics 15 days (different from ≤ 10 mg prednisone);
7. Intra-articular HA or corticosteroid injection within 6 months before screening;
8. Arthroscopic or knee open surgery within 12 months before screening;
9. Body Mass Index (BMI) ≥ 40 kg/m2;
10. Active infection around the injection site;
11. Use of anticoagulants or history of thrombocytopenia;
12. Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
13. Known sensitivity to HA or DVS;
14. Pregnancy, breast feeding.
Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea

Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.

This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older with clinical diagnosis of rosacea
* must have 10-40 facial inflammatory lesions and less than 2 nodules
* women of child bearing potential must be non lactating
* must have negative urine pregnancy test
* must use effective form of birth control

Exclusion Criteria:

* The use of systemic antibiotics within 30 days of study start
* the use of topical medications within 14 - 30 days of study start depending on type of topical medication
* Patients with known sensitivity to tetracyclines
* Patients who have had gastric bypass surgery or are considered achlorhydric
* Patients taking drugs known as photosensitizers
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19

this R01 project titled "Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19" is a Hybrid II RCT/implementation study to modify and test two of our alcohol smartphone interventions to address the fallout from COVID. We propose a three-arm RCT comparing a smartphone control group vs. a drinker-focused intervention vs. a family-focused intervention. All study arms recruit dyads comprising a person who drinks and a family partner.


Eligibility Criteria:
Inclusion Criteria:

* Drinkers and their family partners must give informed consent; agree to complete interviews at baseline, 4, 8, and 12 months; and not have a mental or physical condition that limits smartphone use. Drinkers must be age 18 or older and meet criteria for risky drinking (for men, \>14 standard drinks in a week or \>4 in a day; for women, \>7 in a week or \>3 in a day),76 or meet criteria for AUD (any severity) defined by DSM-5 and have had at least 1 drink in the past 3 months .77 Partner must be a committed romantic partner, spouse, or family member (e.g. sibling, parent, grandparent, adult child age 21 or older).

Exclusion Criteria:

* Current (last 6 months) evidence of unstabilized serious mental illness (active psychosis, delusions, hallucinations, active manic phase). We will also exclude dyads if either partner reports serious interpersonal violence in the past year, because of potential safety risk owing to access to a partner's smartphone or computer.
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors

A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
* ECOG performance status 0-1
* At least 4 weeks between surgery or last dose prior anti-cancer therapy

Exclusion Criteria:

* Symptomatic brain metastases
* Any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow, liver or kidney function
* Evidence of \> Grade 1 peripheral neuropathy
A Predictive Technology for Prevention of Diabetic Foot Ulcers

The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.

Diabetes has become a major health issue in the United States and globally, particularly among older populations. There are currently 400 million diabetics worldwide, with 30 million diagnosed diabetics living in the US.

The standard of care today in treating complications of diabetes is a reactive one: doctors often wait for a problem to occur and then treat it. This waiting approach results in high medical expenses and an increase in pain for patients.

This study is testing a predictive technology system (investigational bluetooth-enabled thermometer and mobile app) to see if it can identify potential foot complications before the damage becomes irreversible. The thermometer being used in this study is the Exergen DermaTemp (DT) Thermometer. Participants will check the temperature of each foot daily for a period of three months. These results will sync directly from the thermometer to the mobile app.

Patients are notified when temperature levels indicate a potential complication that may lead to a developing foot ulcer. The study doctor is available to determine if any trauma or vascular obstruction has occurred and will follow up with the participant.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetes
* ambulatory
* smart device

Exclusion Criteria:

* non-ambulatory
* no smart device
Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.

Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. In the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time.

Questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. In 1993, the Department of Health and Human Services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. The panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. These analyses require preference-weighted measures of health-related quality of life. Such measures are needed in order to adjust survival time for health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
* Forced expiratory volume in 1 second (FEV1) \< 45% predicted
* Total lung capacity (TLC) \> 100% predicted
* Residual volume (RV) \> 150% predicted
* Post rehabilitation 6 minute walk test \> 140m
* Non-smoking for 4 months

Exclusion Criteria:

* Prior lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy or lobectomy
* History of recurrent respiratory infections
* Evidence of large bullae (\> 30% of either lung) in a non-target lobe
* FEV1 \< 15% predicted
* Diffusing capacity of the lung for carbon monoxide (DLCO) \< 20% predicted