cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with the complete or incomplete type of Behcet's disease according to "The criteria for a diagnosis of Behcet's disease, Ministry of Health, Labour and Welfare in Japan (partially revised in 2010)"
* Patients who have special lesions despite having received conventional treatments for special lesions, or patients who cannot receive conventional treatments due to intolerability.
* Patients who have clinical symptoms associated with each special lesions.

Exclusion Criteria:

* Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential diagnosis of each Behcet's disease from other conditions．
* Patients who have received treatment with infliximab within 1 year before enrollment for another purpose than treating special lesions; or patients whose previous treatment with infliximab was discontinued due to adverse events.
* Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving acquirement.
Undetectable = Untransmissible in Thailand (888/64)

This is a cross-sectional study to assess awareness, knowledge, and implementation of the concept of U=U among Thai PLHIV and Thai HIV healthcare providers, as well as associated factors. Data will be collected on an online survey platform called Alchemer. Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants, as well as collect sociodemographic information of participants.

Recruitment

Recruitment will start with the distribution of a brief description of the survey, along with the link to the questionnaire itself. This will be distributed systematically through the use of the snowball sampling method on popular social networking platforms (such as Line, Instagram, WhatsApp, Facebook and Twitter), where 'seed' distributors, who may be categorised into different groups (such as age, gender identity and treatment facility for PLHIV or healthcare facility and type of healthcare provider for HIV healthcare providers), will share out links to a number of friends. Participants will be enrolled into the study once they click on the link leading them to the survey and complete the questionnaire.

Informed consent process

Consent will be obtained by action. A brief description of the survey will be distributed, along with the online link to the survey, which will be on SurveyGizmo. All data will be collected anonymously. A digitalised consent form will be presented to participants before they start the survey, which will outline the potential risks and benefits. All participants will be equal to or over the age of 18; therefore, parental consent is not needed.

Questionnaires

The questionnaire should take no more than 15 minutes to complete. The survey will be completed on Alchemer (formerly SurveyGizmo), a flexible, cross platform online survey software, or other popular online survey platforms with similar features, with the participant giving consent through action. Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants, as well as collect sociodemographic information of participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. There will be two different questionnaires, one for PLHIV and one for HIV healthcare providers; each survey will be slightly altered to for the appropriate participant category. After the questionnaire is completed, participants can choose to be redirected to educational webpages with more information on U=U.

Data analysis

Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data

Eligibility Criteria:
Inclusion Criteria:

1. Thai HIV healthcare providers or Thai PLHIV on ART medication
2. ≥ 18 years of age
3. Can read, understand, and write Thai
4. Provide consent to participate in the study

Exclusion Criteria:

* None
Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness

Cannabis use can lead to addiction in about 5 to 10 % of users in France. Currently, behavioral interventions are the most dependable but effectiveness is still reduced. Mindfulness meditation has demonstrated an effectiveness in several meta analysis (anxiety and depressive disorder) and seems to be relevant to reduce anxious and impulsive symptoms found in cannabis use disorders.

This study proposes to determinate the mindfulness effectiveness in reduction of cannabis use in regular consumer. The consumption decrease is estimated with a retrospective diary, TLFB (Timeline Follow Back) which collect cannabis use every week until the 12th. Urine (week 0/baseline, 2, 4, 6, 8, 10, 12) and hair (week 0/baseline, 10) analyses are regularly effected.

Patients included in control group get classic cares in an addictology center in CHRU of Nancy. Patients included in mindfulness group receive one session a week during eight weeks (MBRP protocol : Mindfulness -Based Relapse Prevention). The study process goes on for 12 weeks.

An ancillary study measures the impact of cannabis decreases on retinal electrophysiological and architectural markers, usually disturbed by cannabis uses.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 55
* cannabis use: more than 7 joint a week or diagnostic of abuse/dependence at MINI (mini international neuropsychiatric interview)
* Recent use authenticated in urine
* patient voluntary to stop cannabis use
* patient with social security
* written consent for study

Exclusion Criteria:

* alcohol dependence (AUDIT: alcohol use disorders test)
* other psychoactive substance abuse or dependence (DSM 4)
* Progressive psychiatric disorder (MINII) excepted anxious disorder)
* Current neurologic disorder
* Patient deficiency with difficulty or impossibility to understand informations
* protection of vulnerable adults as guardianship or judicial protection
* pregnant or breastfeeding woman
* vital emergency
* no social security
* participation in another interventional study
* current retinal disorder (ancillary study)
* chronic glaucoma (ancillary study)
* opthalmologic disease decreasing visual acuity (ancillary study)
* current ocular infection
Determinants and Effects in the Use of NOHARM Pain Management

The objective of this study is to enrich the ongoing Non-pharmacological Pain Management After Surgery (NOHARM) pragmatic trial (NCT04570371) with a mixed methods analysis of patient and care team factors that affect the routine adoption, implementation, and meaningful and sustainable use of the NOHARM intervention.

Aim 1: Explore differences in patient engagement with the NOHARM intervention, use of non-pharm modalities, and clinical outcomes by key patient demographics, including surgical procedure type, gender, and opioid abuse risk. This aim will provide information about patient characteristics that may better predict who will use and/or benefit from the NOHARM intervention and who will not.

Aim 2: Qualitatively explore determinants of patient-level factors contributing to their ability to effectively engage with the NOHARM intervention in a diverse subgroups that adopt and use the intervention as intended and those that do not, respectively. This aim will provide information that helps us explain why some patients tend to use and/or benefit from NOHARM and others do not.

Aim 3: Characterize, using mixed methods, the relative fidelity and sustainability of implementation of NOHARM among ambulatory and inpatient surgical practices and test for associations with patient engagement and clinical outcomes. This aim will provide information about the characteristics of care teams that tend to adopt and maintain use of the NOHARM intervention and those that do not. It will also provide information about whether care teams play an important role in prompting patients to engage with and benefit from the NOHARM intervention.

Eligibility Criteria:
Inclusion Criteria:

* Participants eligible for this study will be patients on the NOHARM trial registry (e.g., patients that were automatically assigned to receive the NOHARM intervention as part of their surgical care) and/or their charts and members of their care teams, including nurses, doctors, physical therapists, nurse practitioners and physician assistants, and medical assistants.

Exclusion Criteria:

* Individuals not on the NOHARM trial registry.
Period Tracker at Home Study

This study will assess the usability of a Period Tracker product when used by lay users in their own homes.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 45 years
* Menstrual cycles are 21-60 days long
* Seeking to predict when her next period will start
* Seeking to give informed consent and comply with the investigational procedures
* Has a compatible iPhone with internet access that they are willing to use for the study (iPhone 7+ and iOS 13 and above)

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Used Clearblue® me (Period Tracker app), Persona Contraception Monitor or Clearblue Advanced Fertility Monitor within the last six months
* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate\* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
* Is a qualified or trainee healthcare professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
* Using hormone replacement medications containing LH or hCG (e.g. Pregnyl®)
* Is currently seeking to conceive
* Has been diagnosed with polycystic ovarian syndrome (PCOS)
* Has PCOS symptoms e.g. very irregular cycles, hirsutism \*Immediate relatives are defined as parents, children, siblings or partner/spouse
Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep

Participants will be recruited and screened through ongoing studies in the sleep and anxiety disorders clinic. Participants with insomnia will be consented to complete several questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study. Each of the two treatment conditions (active versus sham) will be conducted on two consecutive nights. There will be no more than 7 days between the adaptation night and the first treatment condition and no more than 7 nights between each of the two-night treatment conditions . Thus, each participant who completes the full study will spend a total of 5 nights in the sleep laboratory and the time interval from the first adaptation night to completion of the study may range from 5-19 days for any particular individual.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia diagnosis per DSM-5 criteria
* Performing tasks in a timely manner (compared to the person's usual level of performance)
* Pittsburgh Sleep Quality Index (PSQI) \> 6 and one of the following:
* Sleep Efficiency \< 85% (per Consensus Sleep Diary)
* Insomnia Severity Index (ISI) score \> 15
* Sleep latency (subjective) and/or time awake after sleep onset (subjective) \>30 minutes.
* Not currently depressed (previous major depressive episodes and current antidepressant medication permitted as long as remission and current medication dosage has been stable for ≥ 1 month).
* Willing to refrain from alcohol for twenty-four hours before presenting to sleep lab for sleep studies
* BMI \> 18 and \< 50 kg/m2

Exclusion Criteria:

* Current major depressive episode
* Current substance-induced depressive disorder
* Self-reported use of benzodiazepines or hypnotic drugs in last two weeks
* Self-reported use of marijuana in previous 72 hours
* Alcohol Use Disorders Identification Test (AUDIT) score \> 10
* Fagerstrom Test for Nicotine Dependence (FTND) score \> 4
* Insomnia limited to early morning awakening (without difficulty initiating or maintaining sleep),
* Narcolepsy
* Seizure Disorder (not including childhood febrile seizures)
* Recent treatment with anticonvulsant medications
* Obstructive or central sleep apnea
* Circadian rhythm sleep-wake disorders
* Recurrent isolated sleep paralysis
* Current substance-induced insomnia
* Chronic pain disorder
* Daily Caffeine Consumption \> 500 mg/d (Uhde, 1989)
* Restless legs syndrome
* Periodic Leg Movement Disorder
* Benzodiazepines or antipsychotic medications during past 30 days
* Presence of drugs of abuse (excluding marijuana, urinalysis)
* Pregnancy or plans to become pregnant
* History of severe allergic reactions to adhesive tape
* History of neurological disorder
* Conductive, ferromagnetic or other magnetic-sensitive metals in the head, neck, chest, upper arms, or any area that will be within 18 inches of the treatment coil.
Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

Rationale:

Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators hypothesize that progression-free survival could be improved by combination of gefitinib and berberine.

Strong lipogenic activity and high expression of sterol regulatory element-binding protein 1 (SREBP-1) were found in gefitinib-resistance NSCLC cells. Berberine, an effective suppressor of SREBP1 and lipogenesis regulated through ROS/AMPK pathway, selectively inhibited the growth of gefitinib-resistance NSCLC cells but not that of normal cells. It effectively caused mitochondrial dysfunction, activated reactive oxygen species (ROS)/AMPK pathway and finally suppressed cellular lipogenesis and cell proliferation. Addition of ROS blocker, AMPK inhibitor and palmitic acid significantly reduced the effect of Berberine. In in vivo study, treatment of Berberine led to significant inhibition of mouse tumor xenograft growth.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ECOG performance status 0-2
* Adequate haematological function, coagulation, liver function and renal function
* Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
* TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
* Measurable or evaluable disease (according to RECIST 1.1 criteria).
* Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)

Exclusion Criteria:

* Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.

Patients with any known significant ophthalmologic anomaly of the ocular surface

* Patients who received prior chemotherapy for metastatic disease
* Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
* Pregnancy
Mechanistic Effect of Ketones on Cerebral Blood Flow

Oral supplements containing exogenous ketones have recently become available and represent a novel tool for increasing plasma ketone bodies without the need for dietary restriction. Early evidence suggests that oral ketone supplements may enhance cerebral blood flow (CBF). However, a higher dose of a ketone monoester has been shown to slightly lower blood pH and reduce end-tidal CO2 (PetCO2) due to compensatory hyperventilation, which is accompanied by parallel reductions in CBF. Whether reductions in PetCO2 causes reductions in CBF is currently unknown.

The purpose of this study is to investigate the effect of manipulating PetCO2 at normocapnia (PetCO2 maintained at baseline) or poikilocapnia (no PetCO2 targeting; breathing room air), following the ingestion of a dose of a ketone monoester on CBF and cerebrovascular reactivity to CO2 in young adults.


Eligibility Criteria:
Inclusion Criteria:

* Having a normal blood pressure (≤125/≤85 mmHg)
* Between the ages of 18 and 35

Exclusion Criteria:

* Individuals who are obese (body mass index \> 30 kg/m\^2)
* Individuals who smoke
* Individuals with respiratory illnesses
* A history of type 2 diabetes, hypoglycemia, or cardiovascular diseases (i.e. heart attack, stroke)
* Individuals currently following a ketogenic diet or taking ketone supplements
* Individuals with a history of concussion(s) with persistent symptoms
* Individuals participating in elite-level physical training (i.e. varsity athletics)
Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression

Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III

This study explores efficacy of HCQ (400mg BD on D0 and 200mg BD D1-D5) in reducing progression of Mild Covid-19 patients and decreasing viral load.

Participants of study will be randomized 2:1 to receive either Active drug or standard of care (SOC) treatment respectively. We aim to demonstrate reduced COVID-19 progression and early viral clearance in individuals on HCQ therapy.

Eligibility Criteria:
Inclusion Criteria:

* Mild Corona virus disease (COVID-19)
* PCR confirmed infection
* Hospital admitted patients

Exclusion Criteria:

* Moderate, severe and critical COVID-19
* day 0 CRP greater than 6mg/dl, ALC \< 1000 or evidence of infiltrates on X-ray chest
* comorbidity with life expectancy less than 6 months
* Contraindications to HCQ therapy
Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement

This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an ASA score of 1, 2, or 3
* Elective unilateral total knee replacement surgery was planned,
* Patients who are able to read and write in Turkish

Exclusion Criteria:

* Using \>30 mg of oral oxycodone or equivalent daily
* Long-term opioid use (\>12 weeks)
* Substance use disorder
* Scheduled for emergency surgery
* Scheduled for revision surgery
* Requiring postoperative intensive care
* Patients with visual or hearing impairments
* Individuals experiencing motion-related nausea or dizziness
* History of stroke or dementia
* Pregnant or breastfeeding women
* Patients with a history of epilepsy or seizures
A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.

To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.


Eligibility Criteria:
Inclusion Criteria:

* Both genders, BMI ≥ 30 kg/m² and \<40 kg/m².

Exclusion Criteria:

* Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2

The investigators study aims to test the correlation between the Hemochron Signature point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
* Age ≥ 18 years

Exclusion Criteria:

* Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
* Low-molecular weight heparin ≤ 24 hours
* Unfractionated heparin ≤ 12 hours
* Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.)
* History of coagulopathy
Dental Extractions in Patients Under Dual Antiplatelet Therapy

The purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions.

Postoperative hemostasis is a fundamental patient management issue in the oral and maxillofacial surgery setting. The risk of excessive bleeding prompts physicians to stop multiple antiplatelet agents before minor surgery, which puts coronary stenting patients at risk for adverse thrombotic events. Adequate hemostasis must be achieved in order to make oral surgeries possible for these patients without discontinuation of the antiplatelet regimen. The HemCon Dental Dressing (HemCon Medical Technologies, Inc, Beaverton, OR) is a novel chitosan-based hemostatic agent which may greatly improve upon the efficacy of wound healing and hemostasis both in extent and time for minor oral surgeries. Dental extractions will be performed in patients under dual antiplatelet therapy without altering their medication regimen. All patients will require to have two or more surgical sites so they will have internal surgical control sites. Cutaneous bleeding time and platelet aggregation tests will be obtained prior to extractions. The primary hemostasis will be evaluated by measuring the intraoral bleeding time after each extraction and further bleeding and healing outcomes will be ascertain by phone questionaires and clinical evaluations. The aim of this study is to evaluate the effectiveness of HemCon Dental Dressing in controlling post extraction bleeding and to ascertain its role in healing of extraction wounds compared to a standard haemostasis method.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring two or more dental extraction procedures.
* Patients must be under dual antiplatelet therapy of any kind.
* Patients must be 18 years of age or older.
* Patients must be available for a minimum of one post operative evaluation to be scheduled at the time of the procedure approximately 7 days post surgery.
* Extraction sites do not require primary closure of suturing.
* Willingness and ability to provide informed consent

Exclusion Criteria:

* Patients who are currently undertaking other anticoagulant medications (e.g., aspirin, coumadin, heparin) or have discontinued their anticoagulant medications.
* History of heart attack in less than 1 week.
* Patients with seafood allergy.
* Unable of unwilling to provide informed consent.