cyrilzakka/clinical-trials huggingface dataset:
Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People with Dementia

Evidence showed that both TENS and passive body heating are potential treatment strategies for improving cognitive functions in people with dementia. It is hypothesized that hat device (Warmth +TENS) over the 4 acupuncture points would induce a greater improvement in cognitive functions and behavioural symptoms when compared with other hat devices (Warmth + placebo-TENS; TENS only; Warmth alone) and Control (hat device with no warmth and no TENS).

Acupuncture, a primary therapeutic method in traditional Chinese medicine, has been used for patients with dementia to improve memory, orientation, calculation, and self-managing ability in patients having dementia and prevent decline of cognitive functions. Results of animal studies have demonstrated that electroacupuncture on the head region is effective in managing the symptoms associated with dementia, including vascular dementia.

A review of 8 studies on effects of TENS on non-pain related cognitive and behavioural functioning in patients with Alzheimer's disease and non-demented patients concluded that TENS could improve memory, affective behaviour and rest-activity rhythm in patients having Alzheimer's disease.

Passive body heating is another novel physical intervention strategy which potentially can relieve the symptoms of dementia. A previous study demonstrated that the attention function of 15 elderly, measured by the reaction time in the Rapid Visual Processing Test, improved after passive body heating via a thermal suit. Moreover, 30 minutes of hot-water immersion improved the sleep quality in 13 people with vascular dementia.

Eligibility Criteria:
Inclusion Criteria:

1. are currently diagnosed having Alzheimer's disease, vascular dementia or mixed-type mild to major neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM -5) by psychogeriatrician with more than 3 years of experience in dementia diagnosis;
2. are categorized in the mild or moderate degree of dementia based on the Global Deterioration Scale;
3. have a stable drug intake for the past 3 months;
4. live with at least 1 caregiver in the community;
5. are able to follow simple instructions;
6. are able to give informed consent by them or their family members.

Exclusion Criteria:

1. have unstable medical conditions or severe behavioural disturbances, which do not allow participation in the study as judged by the study psychogeriatrician,
2. have any additional medical, cardiovascular , orthopedic or cognitive conditions, such as having uncontrolled hypertension unstable angina and comorbid schizophrenia, that would hinder proper assessment and treatment.
3. use a cardiac pacemaker,
4. live in old age home, elderly home or care and attention homes,
5. receive long term nursing home placements of patients during the treatment phase
Macular Detachment Associated With Intrachoroidal Cavitation

Evaluation of clinical characteristics and surgical outcome for macular detachment associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.


Eligibility Criteria:
Inclusion Criteria:

* Eyes with macular detachment or macular retinoschisis

Exclusion Criteria:

* Optic pit maculopathy, vitreomacular traction syndrome
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.

All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.

Eligibility Criteria:
Inclusion Criteria:

1. Children and adolescents aged 8 years to 17 years at time of consent
2. Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

Exclusion Criteria:

1. Patients with known hypersensitivity to Enbrel or any component of the product
2. Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)
RESIST-2: 2nd-line ART for HIV-2 Infection

Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.

Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.

DURATION

Up to 3 years

SAMPLE SIZE

150

POPULATION

HIV-2-infected adults (≥18 years old); ARV-experienced, with virologic failure on 1st-line 2NRTI+LPV/r in the ISAARV program.

STRATIFICATION

By ARV resistance

REGIMEN OR INTERVENTION

Intervention: Implement real time ARV resistance testing using rapid DBS/CS ARV Regimens: Based on ARV resistance testing

1. No resistance: Current ART: Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID (AZT/3TC or TDF/3TC or TDF/FTC + LPV/r) +Enhanced Adherence Counseling
2. NRTI resistance only: Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC + LPV/r + RAL) + Enhanced Adherence Counseling
3. NRTI-PI resistance: Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC +DRV/r2 + RAL) + Enhanced Adherence Counseling

Eligibility Criteria:
Inclusion Criteria:

1. HIV-2 infection: confirmed by Determine (Alere, Inc.) \& Immunocomb II (Alere, Inc.) or equivalent
2. Failing 1st line antiretroviral therapy (e.g. AZT/3TC or TDF/XTC + LPV/r; previous 3 NRTI or 2 NRTI regimens; previous Indinavir (IDV) use, current or previous Atazanavir (ATV) use; previous NNRTI use)
3. For females of reproductive potential: negative serum or urine pregnancy test
4. Men and women age \>/=18 years
5. Ability and willingness of subject to provide informed consent

Exclusion Criteria:

1. HIV-1 or HIV-1/HIV-2 dual infection
2. Pregnancy or Breast-feeding
3. Lab Abnormalities

   * AST/ALT \>2.5 X ULN
   * CrCl \<30
4. Current or previous use of Integrase Inhibitors or Darunavir
Intraoperative Analgesia Based on ANI

Osteoarthritis of the knee joint is common and total knee arthroplasty (TKA) is performed in patients with advanced joint degeneration, no response to conservative treatments, severe pain and joint instability. Severe pain levels between 4 and 8 in visual analog pain scale (VAS) scores have been reported in the postoperative period. Multimodal analgesia is considered to be the best option for pain control after total knee arthroplasty. Multimodal analgesia is defined as the combined use of different analgesia techniques such as neuraxial analgesia, peripheral nerve blocks, patient-controlled analgesia and different analgesic drugs. For this purpose, peripheral nerve blocks are effectively applied as a component of multimodal analgesia. Thus, side effects such as nausea, vomiting, pruritus and sedation that may occur due to opioid use are reduced. At the same time, in addition to providing effective analgesia, peripheral blocks contribute to early initiation of rehabilitation of the knee joint, early ambulation, reduction of pulmonary complications and early discharge from the hospital.

Recently, objective methods such as skin vasomotor reflex analysis, pupilometry, pulse plethysmographic signals and analgesia nociceptive index (ANI) have been used to standardize the need for intraoperative analgesia in patients under general anesthesia. Among these methods, ANI is a non-invasive method that provides continuous measurement of parasympathetic tone, which is a part of the autonomic nervous system. Electrodes are placed on the chest wall on both sides of the heart and the patient is monitored.

The investigators aimed to compare the analgesia nociception index (ANI) and the conventional method to determine perioperative analgesic needs in patients undergoing total knee arthroplasty under general anesthesia with femoral nerve block.


Eligibility Criteria:
Inclusion Criteria:

1.18-75 years old, 2.ASA I-II-III risk group 3.undergo knee operation under general anesthesia 4. Patients with preoperative femoral nerve block 5. Patients whose informed consent was read and consent was obtained from them and their guardian

Exclusion Criteria:

1. Those who do not want to participate in the study,
2. ASA IV-V patients
3. Those with central or autonomic nervous system disease
The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds

Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.

1. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.
2. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds when this gel is used in conjunction with the current standard of care infection controls to treat microbial infection at the wound site.
3. Determine the effect on wound treatment outcomes using standard of care treatment. (SOC).

Eligibility Criteria:
Inclusion Criteria:

1. The subject must have a full-thickness chronic wound for greater than one month.
2. The subject must be at least 18 years of age.
3. The ulcer to be biopsied must be greater than 1 centimeter in area.
4. The subject must be able to give informed consent.

Exclusion Criteria:

1. Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.
2. Those patients that have significant contributions from other disease processes such as arterial disease (Ankle Brachial Index \[ABI\] less than .7, OR Transcutaneous Partial Oxygen Pressure \[TCpO2 \] less than 20) will be considered to have mixed vascular disease producing their wound and will be excluded from the study.
Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children

This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is \< 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.


Eligibility Criteria:
Inclusion Criteria: Caregiver and child must meet all of the following:

1. Caregiver must be a parent or legal guardian of a child less than 7 years old, and the child must have their first tooth showing
2. The child must receive medical care at one of the participating pediatric clinics.
3. Speak, understand, and read either English or Spanish
4. Have a mobile phone.

Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study

1. Children with severe congenital tooth malformations: At screening the caregiver will be asked if their child has known systemic diseases associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, amelogenesis imperfecta, or dentinogenesis imperfecta.
2. Children who cannot complete the baseline oral health exam.
dCBTi for Adults With ADHD

The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition.

Participants would be randomly assigned to the experimental or sleep diary self-monitoring (control) group. Participants in the experimental group would use a digital application for seven weeks, whereas participants in the control group would watch psychoeducation videos on sleep hygiene and enter sleep diary measures using the application for seven weeks.

Question 1:

Does dCBTi work better than the active control?

Hypothesis 1:

Improvement in insomnia (immediately after treatment and at 1-month follow-up) would be greater for the experimental group than the active control group.

Question 2:

Does improvement in insomnia due to dCBTi lead to improvement in ADHD outcomes?

Hypothesis 2:

Improvement in ADHD outcomes would be greater for the experimental group than the active control group. The effect of dCBTi on ADHD outcomes would be mediated by improvement in insomnia.

Question 3:

Does improvement in insomnia due to dCBTi lead to improvement in mental well-being?

Hypothesis 3:

Improvement in outcomes related to mental well-being would be greater for the experimental group than the active control group. The effect of dCBTi on outcomes related to mental well-being would be mediated by improvement in insomnia.

Eligibility Criteria:
Inclusion Criteria:

* (a) Hong Kong resident,
* (b) Aged between 18-60,
* (c) Diagnosed with ADHD,
* (d) Able to read and write Chinese,
* (e) Has regular access to a smart phone and internet,
* (f) Insomnia severity index ⩾10

Exclusion Criteria:

* (a) Having comorbid bipolar disorder, psychosis, suicidality, moderately severe to severe depression, narcolepsy, and/or hypersomnolence disorder,
* (b) Having medical conditions that might affect sleep (e.g., serious physical concerns necessitating surgery, risk of falls, epilepsy),
* (c) Having night shift schedules at work,
* (d) Currently receiving psychological intervention for insomnia
Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.

Hypovitaminosis D is generally defined as 25(OH)D levels of \< 20ng/ml, while levels of 21-29ng/ml indicate insufficiency and those above 30ng/ml are regarded as sufficient.

The rational behind the observations associating vitamin D deficiency with CVD is that on the one hand, hypovitaminosis D was found to be associated with traditional risk factors such as hypertension (HTN),diabetes mellitus (dm),obesity, dyslipidemia and metabolic syndrome , on the other hand, experimental data demonstrated that vitamin D could affect cardiac muscle cells directly, control parathyroid (PTH) hormone secretion, regulate the rennin- angiotensin- aldosterone system and the immune system, all of which could influence cardiovascular risk.

Epidemiological studies further support this association, demonstrating high prevalence of hypovitaminosis D among U.S. adults with cardiovascular disease (74%). An association between low vitamin D levels and increased myocardial infarction risk as well as total mortality has been also observed.

Low 25hydroxyvitamin D\[ 25(OH)D\] levels were also independently associated with all cause and CVD mortality among patients scheduled for coronary catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* CCT \> 60 ml/min
* No IHD
* No hyper/hypoparathyroidism
* No active malignancy
* Not taking calcium, phosphate

Exclusion Criteria:

* Under 18 years of age
* Not fulfilling inclusion criteria
Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients

This is a Phase 0/1 study of MS patients to determine the safety and potential efficacy of a novel, small human peptide designated as JM-4. The study will involve treatment for 5-7 days with JM-4 to determine the effects of Gadolinium(+) lesion number and volume in the brains of patients.

This study is the first study of JM-4 in patients with Multiple Sclerosis and is intended to show safety and potential efficacy in changing the size and/or number of GAD(+) lesions in the brain. The initial dose level of 1 mg/kg/ will establish safety of JM-4 treatment after 5-7 days of treatment via intravenous infusion over 30 minutes daily in3-5 patients with Multiple Sclerosis. MRI examinations will be conducted prior to treatment with JM-4 and 8 days after the initiation of treatment for the purpose of quantitating GAD(+) brain lesions. Once initial safety is established, the next group of 3-5 patients will receive 4 mg/kg/ of JM-4 daily for 5-7 days via 30 minute intravenous infusions, with MRI scans conducted prior to treatment and 8 days after the initial dose of JM-4. Once safety is established in this cohort of patients, a third group of patients may receive 9 mg/kg/ of JM-4 daily for 5-7 days via 30 minute infusions, with MRI scans conducted prior to the initial treatment and 8 days after the initial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Definite MS (McDonald criteria) or CIS
* GAD(+) MRI brain lesion on screening exam, with or without clinical activity followed by a baseline MRI
* EDSS of 0-5.5 inclusive
* Weight of 40-115 kg
* Females must be post-menopausal or surgically sterilized or use a hormonal contraceptive, intra-uterine device or diaphragm with spermicide during the study
* Not be pregnant or breast feeding
* Males must be willing to use contraception during each day of the study
* Be willing to comply with study procedures and protocols for the duration of the study
* Voluntarily provide informed consent
* Be wiling and physically able to attend the study center as required for all study screening and procedures

Exclusion Criteria:

* Taking Tysabri, Gilenya, Tecfidera, Aubagio, Ocrevus or other immunosuppressive drugs within the prior 3 months
* Received Mitoxantrone or Lemtrada at any time
* Consumption of corticosteroids within the past 30 days
* Current or less than 5 years prior malignancy (excluding basal cell or squamous cell skin cancer)
* Serious systemic disorder which might, in the opinion of the investigators, interfere with safety, compliance, treatment or evaluation of efficacy. Conditions would include but not be limited to significant cardiac, liver, kidney, lung or cerebrovascular disease, HIV, serious infections, serous psychiatric disease or poorly controlled diabetes mellitus
* aversion, intolerance or allergy to repeated MRI with gadolinium administration
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.
The (Cost-)Effectiveness of Generalist Versus Specialist Treatment for Severe Personality Disorders'

The goal of this clinical trial is to investigate if generalist treatment (GIT-PD) is non-inferior in improving level op personality functioning compared to specialist treatment (MBT/ST) in patients with severe personality disorders. The main questions it aims to answer are:

1. Is generalist treatment (GIT-PD) non-inferior in improving level of personality functioning compared to specialist treatment (MBT/ST) in patients suffering from severe personality disorders (PD)?
2. What patient characteristics predict which patients will benefit more from specialist or generalist treatment?

Participants will be randomized to either specialist or generalist treatment. Interventions included in specialist treatment are Mentalization-Based Treatment (MBT) and Schema Therapy (ST). Generalist treatment will be offererd following the principles of the Guideline-Informed Treatment for Personality Disorders (GIT-PD), a principle-driven treatment framework based upon common factors and allowing personalized treatment according to patients' needs. All participating institutions offer GIT-PD and MBT and/or ST. Before, during and after following this treatment participants will complete measurements at 8 distinct time points.

Participants will be asked to:

* complete a range of instruments at baseline to enable the construction of a personalized advantage index to predict treatment response based on patient characteristics
* complete questionnaires at all 7 post-randomization time points
* undergo a semi-structured interview at 3 time points
* follow treatment for personality disorders (either GIT-PD or MBT/ST)


Eligibility Criteria:
Inclusion Criteria:

* 'severe' or 'extreme' personality disorder (PD) according to the alternative model for PDs

Exclusion Criteria:

* IQ \< 75
* legal incapacity
* Any mental state disorder that requires prior treatment