cyrilzakka/clinical-trials huggingface dataset:
Testing Financial Incentive Interventions in Dyadic-Smoker Couples

The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples \[DSCs\]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control \[CTL\], dyadic target \[DT\] FIT or single target \[ST\] FIT) and tracked across 3 months. The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up.

The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples \[DSCs\]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control \[CTL\], dyadic target \[DT\] FIT or single target \[ST\] FIT) and tracked across 3 months. During this time, participants will complete a baseline session and a follow-up. Between these visits, all participants will have access to a voluntary brief cessation program (i.e., online psychoeducation created for this study using Beat the Pack materials and resources from NCI, NIH + Nicotine Replacement Therapy \[NRT\]). The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up. In the ST condition, one member of each couple (i.e., the target) will receive monetary incentives; in the DT condition, both members of the couple will receive monetary incentives. This design allows for preliminary consideration of FITs in DSCs and tests whether FITs for both members of the dyad synergistically enhances outcomes.

Eligibility Criteria:
Inclusion Criteria:

both members:

* age of 18+
* smoke 5+ combustible cigarettes/day
* may not have participated in pilot study

Exclusion Criteria:

* \< 8th grade capacity to read/write in English
* hospitalization in recent 6 months
* current drug or alcohol use disorder
* psychotic symptoms
* medical exclusion for use of NRT
Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects

The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
Exploration of Cluster Headache in a PET-MRI Study

Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer \[18F\]F13640.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 20 to 45 years old
* Weight between 50 to 90 kg
* No psychiatric or neurologic pathological history
* No cranial trauma history with loss of consciousness
* No juridical protection
* Free and informed consent
* Affiliated with a social security scheme or similar

Exclusion Criteria:

* Subject with present or past dependence on alcohol or any other addictive substance according to the DSM-IV-TR criteria, with the exception of nicotine, caffeine and cannabis
* Subject already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation
* Subject with a contraindication to MRI exams
* Subject with a contraindication to PET scans using \[18F\] F13640: hypersensitivity to the active substance or to one of the excipients (sodium chloride)
* Subject with a contraindication to sumatriptan
* Patients with an active infectious disease or associated serious and progressive medical pathology
* Subjects with an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc...) as judged by the investigator
* Patient having exceeded the annual amount of compensation authorized for participation in research protocols.
Abdominal Computed Tomography and the Blood Reactive Oxygen Species Level

The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body \[ref. 1-5\]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the routinely applied abdominal X-ray computed tomography examination may induce a higher level of ROS in the peripheral blood.

Study subjects will be patients who are admitted to our hospital because of abdominal diseases that need to receive abdominal X-ray computed tomography examination for diagnosis. In total, sixty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families several hours before the performance of abdominal X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood will be sampled just before the performance of computed tomography.ROS level in the sampled peripheral blood, before and after the performance of abdominal X-ray computed tomography, will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples just before and 60 samples 2 hours after the performance of computed tomography, will be collected from 60 study subjects within 5 months (August 10 \~ December 30, 2008). Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).


Eligibility Criteria:
Inclusion Criteria:

* patients with abdominal illness that needs a computed tomography examination

Exclusion Criteria:

* none
Central Sensitization in Chronic Whiplash Patients

The purpose of this study is to determine whether the metabolite concentrations within the anterior cingulate cortex and periaqueductal gray matter predict the intensity and interference of neuropathic pain after the development of chronic whiplash syndrome.

Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life. Little information is available regarding changes in brain processing areas and change in central sensitization to noxious input during the chronic phase of whiplash. Metabolite concentrations in the anterior cingulate cortex and periaqueductal gray matter may be predictors of neuropathic pain and these changes may explain the development of central sensitization in people with chronic whiplash.

Until now, there is not any study that show this approach.

Eligibility Criteria:
Inclusion Criteria:

* Whiplash syndrome
* Chronic pain
* Age between 18 to 65 years
* 4 months to 2 years after the whiplash syndrome

Exclusion Criteria:

* Neurological disease
* Claustrophobia
Experimental Study to Validate the Modified Glucose Disposal Test

Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes
* Clinically healthy
* Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue

Exclusion Criteria:

* Type 1 Diabetes
* History of significant heart disease.
* Bariatric surgery
* Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors
Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers

Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers between 18 and 30 years
* With skin type II or skin type III
* BMI \< 25
* Non-smokers
* Volunteers who have given their written informed consent according to Good Clinical Practice (GCP) and local regulations

Exclusion Criteria:

* Any serious disorder that may interfere with her participation to the trial and evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.), and/or treatment with chronic medication
* Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
* Relevant allergy or known hypersensitivity to the investigational drug or its excipients
* High performance sports
* Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV (DSM-IV)
* Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine devices (IUDs), sterilisation)
* Pregnancy and/or lactation
* Known abnormal values of the lab tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
* Abnormal values of low density lipoproteins (LDL) and triglycerides (TGL) levels in blood
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
* Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study
Validation of a Smartphone App for Anemia Screening Among General Population

The current standard for anemia screening, complete blood count, presents invasiveness, infrastructure requirements and high costs, leading to serious underestimation of anemia prevalence and insufficient care for anemia patients. Here, the investigators established and validated an artificial intelligence system to achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. This system has been integrated into a smartphone app to be further validated through hospital-based and population-based clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* Patients who underwent ophthalmic or fingernail surgery in the past 30 days
Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting

This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the treatment of child sexual abuse, can be effectively transported to a state-contracted community mental health agency in the state of Delaware and used effectively by clinicians with little prior TF-CBT experience. The sample is comprised of youths receiving public mental health services and with diverse trauma histories.

This investigation aims to examine the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in treating child traumatic stress when implemented in community settings on a state-wide level in Delaware. Youth (ages 7-16 years) with a history of documented trauma (sexual or physical abuse, traumatic loss, domestic or community violence) and symptoms of Posttraumatic Stress Disorder (PTSD) receive approximately 10 sessions of TF-CBT delivered in a state-contracted mental health agency. Children and adolescents are recruited from a public mental health population. PTSD symptoms and internalizing and externalizing behavior problems have been assessed in the first 72 participants at pre-treatment and then at 3-, 6-, 9-, and 12-months after intake; subsequent participants (n=38) are only being assessed for symptoms and problems at pre-treatment and then at 3-, 6-months after intake.

Eligibility Criteria:
Inclusion Criteria:

* child is 7-17 years old
* positive screen for PTSD
* child qualifies for public insurance
* parent willing to co-participate in treatment
* English-speaking (child and parent)

Exclusion Criteria:

* intellectual disability (child)
* untreated psychosis (child)
* untreated substance abuse (child)
* sibling already in study
* unable to participate in year-long follow-up (e.g., moving out of state)
A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients who are 18 years of age or older at the time of signed informed consent.
* Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
* Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \[LN\]) that is amenable to serial RP2 injections.
* Must be willing to provide tumor biopsy samples.
* LDH ≤ 2 × upper limit of normal (ULN).
* Has adequate hematologic, hepatic and renal function
* Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \[INR\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
* Life expectancy of \> 6 months as estimated by the Investigator.

Key Exclusion Criteria:

* Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
* Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
* Current active significant herpetic infections or prior complications of HSV-1 infection.
* Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
* Major surgery ≤ 2 weeks prior to the first dose of study intervention.
* Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy.
* Active, known, or suspected autoimmune disease requiring systemic treatment.
* Prior treatment with an oncolytic virus.
* Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
* Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.
* Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.
* Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.

Additional inclusion/ exclusion criteria are outlined in the study protocol
Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes

We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting

Cycle 1 :

* Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
* Bortézomib 1,5mg/m2 days 1,4,8,11

Cycles 2, 3, 4 :

* Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
* Bortézomib 1,5mg/m2 days 1,4,8,11

Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles

Responding patients may continue the treatment for 2 further cycles

Eligibility Criteria:
Inclusion Criteria:

* MDS with IPSS scores Int-2 or High
* Life expectancy greater than 6 months
* No other available treatment options

Exclusion Criteria:

* MDS with IPSS scores Low or Int-1
* \> 30% bone marrow blasts
* clinical neuropathy of greater than grade 2
* ECOG Score 3 or 4
* Creatinine clearance of \< 30 ml/min
* LMMC
* Pregnant patients or lactating mothers
* Patients having received intensive chemotherapy in the 3 months prior to inclusion
* Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders
Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis

The objective of this study is to evaluate the safety and efficacy of allogeneic adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 19 years.
2. Patients who are diagnosed as lateral epicondylitis (Pain≥4 of VAS during activity).
3. Patients who has sustained pain more than 6 months
4. Patients who lasting for pain in spite of conservative therapy
5. Patients who have one lesion under ultrasonic photography
6. Negative for urine beta-HCG for women of childbearing age
7. Patient who is able to give written informed consent prior to study start and to comply with the study requirements

Exclusion Criteria:

1. Patients who has been experienced steroid and prolotherapy or other treatment within 3 months at screening time
2. Patients who have lesion size of width and length more than 1 cm using ultrasonic photography test
3. Patients who were accompanied by the disease as follows: A. Arthritis of related joint to the target lesion (ex, cubital osteo- arthritis), B.Synovitis of related joint to the target lesion, C.Entrapment of related nerve to the target lesion(ex, radial tunnel syndrome), D.Generalized pain syndrome, E.Radiculopathy related to the target lesion(ex, cervical spodylosis ,cervical radicular syndrome), F.Rheumatoid arthritis, G.Previous fracture of arm causing limitations in arm function, H.Impaired sensibility, I.Paralysis
4. Patients who are pregnant or breast-feeding
5. Patients who have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
6. Patients who have history of fracture and dislocation at Ipsilateral upper extremity within 2 years recently
7. Patients who have operation history in tendon, ligament and bone at Ipsilateral upper extremity within 2 years recently
8. Patients who are unwilling to use an "effective" method of contraception during the study
9. Patients who have a clinically relevant history of abuse of alcohol or drugs
10. Patients who are considered not suitable for the study by investigator
11. Patients who have experienced treatment with stem cell before this study
12. Patients who currently enrolled in another investigational drug study within 30 days of screening
A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse

Our goal in this study is examine if a program designed to decrease the severity of Post-Traumatic Stress Disorder symptoms in sexually abused children between the ages of 8-12 was effective.


Eligibility Criteria:
Inclusion Criteria:

* History of sexual abuse
* Aged 8 - 12 years
* Developmentally able to be on-site in a "camp-like" treatment facility for 3 weeks with their parent/guardian (or without if family is not available to join the child at the Be Brave Ranch)
* Able to perform skills of daily living for self care
* Good physical health

Exclusion Criteria:

* Severe mental health issues including (but not limited to):
* Recent suicide attempt
* History of psychosis
* History of significant self-harm
* History of homicidal thoughts or actions
* History of violent behaviours sufficient to be considered a threat to others
* Acute eating disorder.
* Significant risk of absconding, or history of absconding
* Serious behavioural problems
* Significant use of drugs or alcohol
* History of sexual violence or sexual behaviour towards others
* Any significant interaction with the justice system or police
* Cognitive impairment that would interfere with treatment benefits
* Medical conditions that are not stable
* Severe medical conditions
Personalized Risk Estimator for Rheumatoid Arthritis Family Study

The purpose of this study is to understand how personalized risk factors for rheumatoid arthritis (RA) may impact willingness to change behaviors associated with RA. The investigators have developed a personalized risk estimator for RA based on demographics, family history, biomarkers and behaviors related to RA risk. Eligible participants have a first degree relative with RA but do not have RA themselves. Participants who meet eligibility and consent to the study will be randomized to receive either standard information about RA, the online personalized RA risk tool, or the online personalized RA risk tool with guidance from a health educator. Participants will be followed to measure willingness to change RA risk behaviors. The investigators hypothesize that participants who receive the online personalized RA risk tool and health education will be more willing to change RA risk behaviors compared to participants that receive standard RA information.

A risk tool for rheumatoid arthritis (RA) was developed to provide personalized risk communication that includes biomarker, genetic and lifestyle RA risk factors. This risk calculator is referred to as the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) which will be used in the PRE-RA Family Study. A 3-arm randomized trial will be conducted among 222 RA first degree relatives that will be followed for one year. Participants will be surveyed before and after RA education concerning (i) knowledge and attitudes about RA risk, (ii) decisional balance related to behaviors, and (iii) stage of behavior change concerning lifestyle risks.

At the initial study visit, participants will be randomly assigned to one of three arms. Arm 1 participants will receive general education about RA (comparison group). These participants will be followed to assess for willingness to change behaviors associated with RA risk. Arm 2 participants will receive personalized risk by the personalized RA risk tool (PRE-RA). These participants will be followed to assess for willingness to change RA risk behaviors. Arm 3 participants will receive personalized risk by the online risk tool along with health education and counseling (PRE-RA Plus group). These participants will be followed to assess for willingness to change RA risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* First degree blood relative (parent, sibling, or child) with diagnosis of RA
* Age between 18 and 70 years old

Exclusion Criteria:

* Non-English speaking
* Sign/symptoms of rheumatoid arthritis (assessed by screening questionnaire and study staff)
* Rheumatoid arthritis
* Systemic lupus erythematosus
* Juvenile Idiopathic Arthritis
* Psoriatic Arthritis
* Ankylosing Spondylitis
* Mixed Connective Tissue Disease
* Reactive Arthritis
* Adult-Onset Still's Disease
* Sjogren's Syndrome
* Dermatomyositis
* Polymyositis
* Polymyalgia Rheumatica
* ANCA-associated Vasculitis
* Giant Cell Arteritis
* Polyarteritis Nodosa
* Behcet's Disease
* Relapsing Polychondritis