cyrilzakka/clinical-trials huggingface dataset:
MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

This randomized control trial (RCT) aims to test the effect of a 12 weeks tailored behavioral intervention on stroke survivors living in the community and compare the results to a control group of stroke survivors participating in standard care. The intervention's purpose is to lower the time spend with sedentary behavior and raise the level of physical activity in stroke survivors throughout their everyday life. The intervention contains two motivational interviews with a focus on goal setting, action planning, motivation, fatigue management, and general information on life after stroke. The primary outcome for behavior change is objectively measured physical activity using an activity tracker (ActivPal4 Micro) and secondary glycohemoglobin and changes in quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Verified ischemic stroke or intracerebral hemorrhage
* Modified rankin score (mRS) 1-3 at discharge
* Discharged with at rehabilitation plan within 1-14 hospitalization days
* Able to ambulate independently
* Speak and understand Danish

Exclusion Criteria:

* Aphasia
* Unable to give informed consent
* Unable to ambulate independently
* Mental illness
* Other co-morbidity like terminal cancer.
In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory hyper-pigmentation and hypo-pigmentation. Confocal Microscopy is a recent diagnostic technique that has been used for observation of skin conditions that affect the superficial layers of the skin.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 20-70 years of age.
2. Clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation.
3. Willing and able to understand and sign informed consent.
4. Able to complete study and comply with study procedures.

Exclusion Criteria:

1. Use of topical therapies such as corticosteroids, protopic, hydroquinone and azelaic acid within the past 2 months.
2. Use of light therapy such as narrow-band-UVB, PUVA or laser within the past 2 months.
3. Intake of medications that can cause pigmentary changes within the past year. Examples are:

   * Antimalarials (chloroquine, hydroxychloroquine)
   * Chemotherapeutics (bleomycin, busulfan, doxorubicin, daunorubicin, fluorouracil, cyclophosphamide, and carmustine)
   * Heavy metals (gold, silver, bismuth, and mercury)
   * Tetracyclines (including minocycline, doxycycline)
   * Amiodarone
   * Azidothymidine
   * Clofazimine
4. Clinically significant abnormal findings or conditions (other than the pigmentary disorder), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
5. Subjects who are known to be pregnant or planning a pregnancy.
18F-PBR06/Total Body PET Imaging in Patients With STEMI

The study will use 18F-PBR06/uExplorer to study the activation of macrophages and systemic perfusion in patients with ST-segment elevation myocardial infarction (STEMI) or stable angina (SA). Participants will receive the total-body PET/CT scan on the seventh day (Day 7, D7) and D180 of enrolment.

The aim of our study is to explore the activation of macrophages in patients with ST-segment elevation myocardial infarction (STEMI) or stable angina (SA) using the 18 kDa translocator protein (TSPO) radioligand 18F N-fluoroacetyl-N-(2,5-dimethoxybenzyl)-2-phenoxyaniline (18F-PBR06) in combination with the world's first commercially available total-body PET/CT (uExplorer). The investigators expect to enroll 10 patients diagnosed with STEMI and 10 patients with SA who receive coronary angiography (CAG) and the percutaneous coronary intervention (PCI), and 5-10 healthy individuals diagnosed with SA but presenting negative CAG at Renji Hospital, Shanghai. The activation of macrophages (TSPO uptake) and blood perfusion in different organs will be studied using 18F-PBR06/uExplorer.

With written consent from eligible participants, the investigators will review past medical records and document the medical history for each participant. Patients will undergo PCI on the day of enrolment (12 hours within the symptom onset for STEMI patients). Screen procedures will be performed at the seventh day of enrolment (Day 7, D7) and Day 180 (D180). Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 and receive a whole-body scan by uExplorer. TSPO uptake and blood flow in the heart, kidney, liver, brain, and lung will be recorded. All participants will be followed for 1 year after enrolment. Blood samples will be collected and echocardiography will be performed at D7 and D180. Major adverse cardiovascular events (MACE) will be recorded throughout the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years old
* Diagnosed with STEMI, NSTEMI or suspected SA (ACC/AHA guidelines)
* Half male and half female
* Undergo CAG and PCI treatment if necessary (primary PCI for STEMI patients within12 hours after symptom onset)
* Written informed consents will be offered and signed by all participants

Exclusion Criteria:

* History of myocardial infarction/vascular disease/heart failure/systemic inflammatory diseases before enrolment
* Patients who are pregnant/breastfeeding, or in a plan to have a baby during the year after CAG/PCI
* People under the age of 18 years old
* Inability to lie or maintain posture during the scanning procedure
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.

The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
* Patients over eighteen years old
* Free subject, whitout tutorship or curatorship or subordination
* Informed consent and signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
* Patients with preoperative recurrent paralysis
* Patients with hypersensitivity to prednisolone or any of the excipients.
* Patients with contraindication to use Solupred
* Patients with anti-inflammatory of acetylsalicylic acid
* Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Eligibility Criteria:
Inclusion Criteria:

1. Subject understand and voluntarily sign the written Inform Consent Form (ICF).
2. Male or female ≥ 18 to ≤ 80 years of age.
3. The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
4. TG ≤ 4.5 mmol/L (400 mg/dl).

Exclusion Criteria:

1. Known homozygous familial hypercholesterolemia.
2. Received PCSK9 inhibitors within 6 months before randomization.
3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
4. Severe renal dysfunction.
5. Previously received organ transplantation.
6. Uncontrolled hypothyroidism or hyperthyroidism.
7. Uncontrolled hypertension.
8. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
9. History of malignancy of any organ system within the past 5 years.
10. Pregnant or lactating women.
Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.

Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug.

A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Allergic conjunctivitis diagnosis
* Both genders
* Age between 6 and 60 years
* Patients with no treatment 2 years prior to study inclusion

Exclusion Criteria:

* Patients with one blind eye
* Visual acuity \< 20/40 in any eye
* Patients with any active ocular disease that would interfere with study interpretation
* Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
* Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer
* Patients with history of hypersensitivity or contraindication for any drug used in the study
* Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients without birth control treatment
* Patients who had participated in any clinical trial in the last 90 days
Brief Motivational Enhancement Therapy for Concurrent Disorders

The investigators are proposing a project that will examine the effectiveness of brief motivational enhancement therapy in a population with concurrent psychotic disorders and substance use disorders. This study will represent an emerging line of inquiry, as best practice interventions with this concurrent disordered (CD) populations are yet to be established.

Motivational enhancement therapy (MET) is grounded in research that explores the process of change. The MET approach assists individuals to move through increasingly higher levels of change towards action (making change) and maintaining change. The MET approach aims to invoke rapid and internally motivated change.

The Two MET sessions adapted from Sampl and Kadden (2001) are prepared as two individual sessions to reflect the original design of MET, allowing for client's to be met at their respective stage of change. Further, individual sessions allow the treatment to be tailored to client's individual reasons for change and personal coping strategies. The use of the Personalized Feedback Report (PFR) further encourages treatment around client's personal concerns and goals (Ramchand et al., 2011; See appendix 1 for further detail).

In the first treatment session, the therapist provides feedback from the initial CD consultation, using the PFR to stimulate discussion about personal substance use and reasons for change. Rapport building is also a key element to the first session, during which a strong therapeutic alliance is initiated. The second session is aimed at strengthening the commitment to change, exploring goal setting, and preparation for group.

The Centre for Addiction and Mental Health (CAMH) Schizophrenia Division introduced a CD service in 2009. Since the time of its inception, more than 200 consultations have been conducted. Of those consultations, more than 80%recommended attending CD groups offered with the Schizophrenia Program. However, less than 10% have followed those recommendations and attended the CD group.

Based on what is known about challenges surrounding engagement of CD clients in recommended treatments coupled with guidelines for evidence-based treatment with this population (Ledgerwood et al., 2008; Tsuang et al., 2006; Roncero et al., 2011), the purpose of the current study is to explore the ability of MET to increase engagement in CD interventions for clients diagnosed with psychotic and substance use disorders.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 16-65
* DSM-IV Diagnoses of a psychotic disorder and a substance use disorder (tobacco, alcohol and/or drug)
* Fluent English speaker
* Capable of giving written informed consent

Exclusion Criteria:

* Any medical or neuropsychiatric condition, illness or disorder (e.g. unstable angina, severe dementia) that could compromise attendance to outpatient appointments.
* Inability to provide informed consent.
Ozone Reaction Products and Skin Health

This is a randomized controlled human exposure study. Investigators aim to investigate the products of ozone-sebum reactions and their acute effects on skin health of healthy young adults.

The investigators will conduct a randomized, controlled human exposure study involving 40 healthy young adults in Shanghai, China. Each participant will have both forearms simultaneously exposed-one in a clean air chamber and the other in an ozone chamber-for 2 hours. The ozone concentration at the ozone chamber inlet will be maintained at 200 ppb. The temperature and relative humidity in both chambers will be maintained at 27±2℃ and 45%±5%, respectively. Health examinations will be conducted at three time points: immediately before exposure, immediately after exposure, and 24 hours after exposure. These examinations will include skin measurements and sampling.

Eligibility Criteria:
Inclusion Criteria:

* Living in Shanghai during the study period;
* Having healthy skin conditions on both forearms.

Exclusion Criteria:

* Subjects with a history of smoking and alcohol abuse;
* Subjects with a regular use of medication and dietary supplements within 2 months prior to enrollment;
* Subjects with severe skin diseases, such as atopic dermatitis, eczema, or severe acne;
* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, or atopy, or history of allergic reactions within 2 months prior to enrollment;
* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, or hypertension;
* Subjects with respiratory diseases, such as asthma, acute or chronic bronchitis, or pneumonia;
* Subjects with chronic diseases, such as diabetes, chronic hepatitis, or kidney disease;
* Subjects with cutaneous abnormalities on forearm, such as severe pigmentation, multiple nevus, or tattooing;
* Subjects who underwent cosmetic intervention on forearms within 2 months prior to enrollment, such as whitening treatments, UV exposure therapies, depigmentation procedures, or tanning;
* Females in pregnancy or lactation status.
Delphi Study on Rehabilitation Following Lumbar Arthrodesis

Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.

The investigators aim to engage all care providers in Belgium and the Netherlands who are at some point involved in the rehabilitation path related to single and double level lumbar arthrodesis.

Eligibility Criteria:
Inclusion Criteria:

* The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Exclusion Criteria:

* N/A
BE Intervention for Naloxone Uptake

The overall objective of this study is to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend an opioid overdose reversal training.

This study aims to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend opioid overdose reversal training. The study consists of two distinct randomized controlled trials (Aim 2 and Aim 3) and has three primary objectives:

Aim 1: To diagnose behavioral bottlenecks to naloxone acquisition and carrying. This aim involves analyzing data from naloxone training sessions to identify barriers to acquiring and carrying naloxone. These barriers will be mapped to cognitive biases, such as optimism bias and overconfidence, and will inform the behavioral interventions in Aims 2 and 3.

Aim 2: To test the impact of a behavioral economics intervention on naloxone acquisition. This aim involves a randomized controlled trial with 60 participants. The intervention group will receive commitment pledges, acquisition plans, and tailored text message nudges to increase naloxone acquisition within one week of training. The control group will receive standard training. The primary endpoint is the time it takes for participants to acquire naloxone post-training.

Aim 3: To test the impact of a text nudge intervention on naloxone carrying. This aim also involves a randomized controlled trial, where all participants receive naloxone at the training. The intervention group will receive tailored text message nudges to encourage consistent naloxone carrying. The control group (n=30) will not receive these nudges. The primary endpoint is the consistency of naloxone carrying post-training.

Eligibility Criteria:
Inclusion Criteria:

* Living in the Philadelphia area
* Attended the study naloxone training.

Exclusion Criteria:

* Unable to consent
Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults

Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults

The investigators will perform a double blind, randomised controlled study to determine whether cherry polyphenols improve peripheral vascular function and cerebral perfusion resulting in improved task related brain activation and cognitive function. 30 healthy elderly men and women 60-85y years will be recruited to complete 8-week supplementation with MC concentrate or an isoenergetic cherry placebo concentrate. Participants will be pair matched for age, sex, and cognitive function (Adenbrooke's Cognitive Examination III, ACE-III) and then randomised using a sealed envelope system to receive either placebo or cherry.

Eligibility Criteria:
Inclusion Criteria:

* physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score \>88

Exclusion Criteria:

* physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score \<88 Contraindications for MRI
Evaluation of an Interventional Module to Assist Physicians Introducing ACP to Cancer Patients

Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients

Investigators hypothesize that compared to ACP brochure alone, educational module plus ACP brochure is effective in assisting the physicians to introduce ACP to the patients and completion of AD documentation

Eligibility Criteria:
"Inclusion Criteria" and "Exclusion Criteria"

Inclusion Criteria

1. Older than 20-years-old
2. Diagnosed with cancer
3. Have not signed any form of AD or DNR

Exclusion Criteria

1. Under 20-years-old
2. Can not speak or listen, difficult communication
3. Signed AD or DNR
Dose Adjustment of Tacrolimus Based on Home Sampling in Renal Transplant Recipients

Repeated 12-hour pharmacokinetic (PK) investigations in renal transplant recipients for parallel sampling of standard venous bloods samples and finger prick micro samples (Mitra tips). Primary aim to validate the micro sampling tacrolimus concentrations against venous blood concentrations.

Renal transplant recipients using Prograf® as part of their immunosuppressive regimen will be included in the study. Patients will receive oral and written study information and sign the informed consent before entering the study. A 12-hour pharmacokinetic investigation will be performed when Tac doses have been stable for at least 7 days (approximately 3-4 weeks posttransplant). They will continue on unchanged doses of tacrolimus as before PK investigation 1 (PK1). After at least another 7 days a second 12h PK-investigation (PK2) will be performed. If Tac doses needs to be changed after PK1 and before PK2 the second PK will not be performed.

Tac doses and blood concentration obtained as part of standard follow-up of the patients will be included in a non-parametric population model to obtain individually optimal sampling times for each patient using the MMopt function in Pmetrics®. During both PK1 and PK2 the patients themselves will be instructed to take two "home sampling" micro samples (Mitra® microsampling device) just prior to the standard vacutainer samples are obtained. Both the micro- and vacutainer samples will be drawn in 2 parallel samples right after each other and one will be mailed to the laboratory via standard mail. During PK1 the sampling times will be the same and standardized for all patients; before (0h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours after dose administration. During PK2 individually optimized sampling times based on 2, 3 and 4 samples will be determined using the MMopt function in Pmetrics and utilizing all individual dose and concentration information from before PK2, including the rich sampling during PK1. Spread over the entire study period, at least 6 real life home samplings for trough (C0) of Tac will also be performed by the patient and mailed to the hospital.

Tacrolimus induced tremor will be measured with a center-developed method utilizing infrared determined positioning (sampling ever 5 ms) of hand joints in the x-, y, z axis.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients
* Females and males
* Patients receiving tacrolimus as part of their immunosuppressive therapy (clinical decision not influenced by this study)

Exclusion Criteria:

* Patients on concomitant drugs with known pharmacokinetic interaction with tacrolimus