cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients

This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.

The study will be conducted on a population of patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care.

For each included patient, blood samples will be collected at different time points.

If feasible, an optional tumor biopsy specimen will be collected during baseline visit.

All included patients will be followed-up for tumor response and toxicity until Week 12.

After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of study entry.
2. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 8th edition), including mucosal melanoma, without intracranial active disease.
3. Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus ipilimumab) has been decided.
4. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
5. Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started).
6. ECOG Performance status 0-2.
7. Life expectancy of at least 3 months.
8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
9. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patient pregnant, or breast-feeding.
2. Uveal melanoma.
3. Any condition contraindicated with sampling procedures required by the protocol.
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Effect of Weight Loss on Psoriasis

Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. No controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting.

Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic comorbidities such as arterial hypertension, coronary vascular disease, stroke, hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of early death. Lately the role of inflammation in the atherosclerotic process has been highlighted and the link between psoriasis and atherosclerosis may be explained by the concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation is seen in obesity where macrophages and adipocytes begin to show overlap in function and gene expression. This leads to an increased migration of macrophages into the adipose tissue and an increased secretion of pro-inflammatory cytokines. In summary, these data and theoretical considerations suggest that weight loss in obese patients with psoriasis may improve skin manifestations and reduce the risk of atherosclerotic comorbidity.


Eligibility Criteria:
Inclusion Criteria:

* moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive therapy
* BMI \> 27

Exclusion Criteria:

* pregnancy/breast feeding
* diabetes requiring insulin treatment
* severe heart/kidney/liver disease
* gout
* high potassium intake
* obesity due to medical conditions/medications
* use of medical treatment for obesity
* previous bariatric surgery
* intentional/unintentional weight loss up to 3 months prior to inclusion
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

This study (TOPAZ-II; M14-222), was a Phase 3b, open-label, multicenter study conducted in the United States which, together with its companion study TOPAZ-I (M14-423; NCT02219490) conducted outside of the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
3. HCV genotype 1 infection per screening laboratory result

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing
2. Abnormal laboratory tests
3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
4. History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
5. Presence of hepatocellular carcinoma at screening
Virtually Assisted Home Rehabilitation After Acute Stroke-2

The purpose of this study is to assess feasibility of a virtual rehabilitation program in stroke patients and to assess treatment effects, patient goal attainment with self-guided rehabilitation activities, barriers to and facilitators of telerehab, hospital readmission events, and social determinants of health


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by the subject or legally authorized representative.
* Diagnosed with hemorrhagic or ischemic stroke
* Pre-stroke mRS is less than 3
* Qualifying Stroke Event must be confirmed by CT or MRI
* Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
* Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
* Able to access the internet
* Mild-moderate impairments in motor or cognitive function

Exclusion Criteria:

* History of neurological or other disease resulting in significant functional impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality).
* Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
* Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.
Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion

The value of lung ultrasound in the work up of pleural effusion (fluid in between the thin doublet layered film surrounding the lungs) is unknown. The researchers will perform a systematic lung ultrasound scan including a scan for extra thoracic metastasis (spread of cancer to other organs) in the lymphnodes of the neck and metastasis lever in 56 patients one-sided pleural effusion. The researchers will measure if the interventions change the diagnostic plan for the patient and leads to faster diagnostics of the underlying course.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Unilateral pleural effusion of unknown course.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Bilateral pleural effusions.
* Known cause of pleural effusions.
* Life expectancy \<3 months.
* Inability to understand written or spoken Danish.
Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension

30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED \</-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.

Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
* Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
* Age ≥18 years
* ECOG performance status \>/= 2 (Karnofsky≥60%)).
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with more than \>/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
* Patients who are receiving any other investigational agents.
* Patients with active systemic, pulmonary, or pericardial infection.
* Pregnant or lactating women
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Chemotherapy concurrent with SBRT is not allowed
Continuous Monitoring and Control of Hypoglycemia

Evaluate safety of non-adjunctive CGM use in CGM naive participants.

The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.

Eligibility Criteria:
Inclusion Criteria:

* Naïve to real-time CGM
* Type 1 or insulin-requiring Type 2 diabetes
* ≥ 2 years old

Exclusion Criteria:

* Use of RT-CGM, within the past 12 months
* Pregnancy
* Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
* Known (or suspected) significant allergy to medical grade adhesives
* Dialysis
Cranial Blocks for Postoperative Anesthesia

This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.

Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.

The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Need for elective supratentorial craniotomy
* Preoperative GCS \> 13

Exclusion Criteria:

* Preoperative GCS ≤ 13
* Child (\<18 years of age)
* Inability to understand or use the visual analog scale (VAS)
* Proven or suspected allergy to local anesthetics
* Craniotomy incision extending beyond the field of the block
* Patients chronically (more than 2 wk) treated with narcotic medications
* Previous scalp incision
* Bilateral craniotomies
* Allergies to local anesthetics
* GCS verbal score \< 4 after extubation
* Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)
* Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants
* Lactating Mothers
Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.

This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and ROC analysis were performed

Eligibility Criteria:
Inclusion Criteria:

* group I : oral squamous cell carcinoma lesions (OSCC)
* group II: oral lichen planus lesions (OLP)
* group III: systemically healthy volunteers

Exclusion Criteria:

* oral lesions other than OSCC / OLP in group I and II
* any oral lesion in group III
* pregnant females
Neurophysiological and Functional Mechanisms of Motor Control and Learning

Noninvasive stimulation of the central nervous system, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly used in the investigation of cortical plasticity. The purpose of our study is to understand mechanistically-at the neurophysiological and systems levels-how the brain learns new motor skills. We propose to study the acquisition, consolidation, and retention of motor skill learning in healthy subjects. At the behavioral level, we will use movement kinematics to quantify and characterize movement, which allow us to infer functional strategies used by the brain to reduce movement errors. At a neurophysiological level, we will use TMS to document changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly subserving these strategies. At a systems level, we will enhance motor system excitability using tDCS, which will enable us to infer the contribution of the stimulated area to the motor system's ability to learn new skills.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed dominance
* Ability to give informed consent

Exclusion Criteria:

* active and/or chronic neurological, psychiatric (including depression), or medical conditions
* psychoactive medication use
* active drug/alcohol dependence or abuse history
* homelessness or other social situation that would preclude consistent visits
* history of head injury (including neurosurgery)
* history of seizure
* inability to comprehend or participate in the procedures involved
* metal in the head (besides in mouth), such as implanted electrodes or devices, shrapnel, surgical clips, or fragments from welding/metalwork
* implanted devices (such as cardiac pacemakers, medical pumps, or intracardiac lines) in the thorax
Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

The effectiveness of glabellar injection of botulinum toxin type A (BTA) in treating depression has not yet been investigated in elderly patients. The study aims in addressing the question if glabellar injection of BTA is effective in treating geriatric depression.

Feedback from facial expressions is known to influence emotional experience. Treatment of muscles involved in facial expression of sadness, anger or anxiety with botulinumtoxin showed a quick, strong and sustained improvement in the symptoms of depression. As considerable proportion of patients do not sufficiently respond to existing treatment options. Especially in the elderly current treatments show limited response or are associated with side effects. Injections with BTA are considered as a very safe treatment without lasting side effects. The aim of the study is to investigate effectiveness of BTA in treating major depression in the elderly in a cross-over designed, placebo-controlled manner.

Eligibility Criteria:
Inclusion criteria: Clinically relevant depressive symptoms ( defined as MADRS \> 12)

Exclusion criteria: cognitive deficits that impair the participant´s ability to provide written informed consent severe depression MADRS \>34 suicidality treatment with more than 3 psychotropic medications recent changes (4 weeks) in current psychotropic medication previous treatment with study drug active substance abuse bipolar disorder schizophrenia unstable medical condition usage of warfarin or NOAC bleeding disorder known hypersensitivity to study drog or any of the excipients of the formulation myasthenia gravis or Eaton Lambert syndrome presence of infection at the proposed injection sites
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.

Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.

Eligibility Criteria:
Inclusion Criteria:

* both gender
* patient with limb-length discrepancy
* Age:18-65

Exclusion Criteria:

* Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
* Known allergic reaction to components of study treatment and/or study injection procedure
* Patients infected with hepatitis B,C or HIV
* pregnancy
A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

The main purpose of testing: To confirm the effectiveness and safety of the drug Ingaron when used in patients hospitalized at the research center for various reasons.

Monitoring of a patient in a hospital is carried out daily by the attending physician during the entire period of the patient's stay at the research center. When prescribing the drug Ingaron, the researcher must follow the instructions for use of the drug. As part of 4 control observations to assess effectiveness and safety:

* 1st on the 1st day of using the drug Ingaron and starting anti-tuberculosis therapy
* 2nd on the 30th - 31st day of therapy
* 3rd after 2 months of therapy
* 4th (final) after 3 months of follow-up After each of the 3 visits, the research doctor saves the data necessary for further evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 78 years inclusive
2. Bacterioscopically and/or molecularly genetically verified diagnosis of tuberculosis
3. Stay in the intensive phase of treatment
4. Consent to inpatient anti-tuberculosis therapy until the end of participation in clinical observation

Exclusion Criteria:

1. Serious condition
2. Pregnancy
3. Breastfeeding
4. Treatment with immunomodulatory drugs before inclusion in the observation program
5. Presence of medical history of an allergic reaction or individual intolerance to the drug Ingaron
6. Severe diseases of the liver, kidneys (creatinine more than 150 mmol/l)
7. Presence of contraindications to the administration of the drug Ingaron
8. Patients with HIV infection with a CD4 lymphocyte count less than 350 cells/ml
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.

The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are:

1. SAP=sensor-augmented pump only
2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes for at least one year
* using insulin for at least 1 year
* an insulin pump for at least 6 months
* willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).

Exclusion Criteria:

* a medical condition or being been treated with medications that might interfere with the study