cyrilzakka/clinical-trials huggingface dataset:
Analytic Treatment Interruption (ATI) to Assess HIV Cure

This study is designed to determine if individual patients with HIV infection have been cured of the infection. To do this, antiretroviral therapy is discontinued under close medical supervision and the patient monitored over time for reactivation of infection.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years
* HIV-1 infected with the potential to have been cured of infection in the course of routine clinical care in the opinion of the treating physician and study team
* Have an undetectable plasma HIV-1 RNA and undetectable proviral DNA on suppressive antiretroviral therapy on at least two consecutive measures for at least 6 months
* Able and willing to either abstain from sexual activity or use barrier contraceptives during the ATI
* Negative serum β-HCG pregnancy test in women with childbearing potential
* Have the ability to give appropriate informed consent.

Exclusion Criteria

* Women who are pregnant or nursing
* Women who can become pregnant who are unable or unwilling to use both barrier and pharmacologic contraceptives during the ATI
* Previous or current infections that are at high risk of reactivating with immune suppression, in whom there are no effective antimicrobial prophylaxis options
* Advanced cardiopulmonary or liver disease
* History of untreated solid or hematologic malignancies
* Evidence of active viral replication in patients co-infected with Hepatitis B virus (HBV). Treatment should be provided to suppress HBV replication with agents that do not have activity against HIV (ie entecavir) prior to consideration for ATI.
* Evidence of viral replication with Hepatitis C virus (HCV), together with evidence of any hepatic fibrosis or inflammation. Such patients should be offered HCV treatment first.
Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment

Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded. In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems. Objective: The objective of this study was to compare effectiveness of skit video, pictorial and sign language interventions to improve oral hygiene status of children with hearing impairment. Methods: Sixty children were completed the study and allocated randomly into each group with twenty children as follows: group A: Skit video, group B: Pictorial, and group C: Sign language. Mean gingival and OHI scores were recorded before and after implementation of interventions. Oral hygiene habits, oral hygiene and gingival index scores were recorded by structured questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Children with hearing impairment and total hearing loss at birth
* Aged 7 to 20 years for both genders,
* Minimum of 20 teeth in the oral cavity
* Children with mild, moderate, and severe gingivitis

Exclusion Criteria:

* Children with dental plaque covered more than two-thirds of their tooth surface, had a plaque score of \>1.0
* Children with fair to poor oral hygiene
* Children who had previously participated in any activity or programme promoting oral health within the previous six months
* Children with mild to moderate hearing loss
* Children taking long-term antibiotics
* Children who had used mouthwash within the previous three months
* Children with any known systemic diseases
* Presence of extensive dental calculus
* Uncooperative children
Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR)

The purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).

Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the links provided in More Information.

Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than or equal to 18 years of age
* Have a diagnosis of hATTR
* Meet Karnofsky performance status and Polyneuropathy Disability (PND) score requirements
* Have adequate complete blood counts, liver function tests and coagulation tests

Exclusion Criteria:

* Participated in an interventional hATTR amyloidosis clinical trial involving RNA interference (RNAi) therapeutics within the last 12 months
* Are currently eligible to participate in or currently enrolled in an ongoing interventional hATTR amyloidosis clinical trial
* Have inadequate cardiac function
* Known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
* Have known serious comorbidities or considered unfit for the program by the investigator
* Prior or planned liver or heart transplantation
Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision \[DSM-IV-TR\])
* Baseline score ≥ 13 on the QIDS-C
* Stable medication regimen (\> 4 weeks)

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of psychotic disorders and/or bipolar I or II disorders
* Substance or alcohol abuse/dependence in the past 6 months
* Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
* Uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease

The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.

To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.

Eligibility Criteria:
Inclusion Criteria:

* Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
* Having active ocular lesions (posterior and/or retinal vasculitis)
* Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg

Exclusion Criteria:

* Visual acuity less than 1/10 on Snellen chart
* Antecedent of allergic reaction to any component of the therapeutic regimen
The Effect of Acupressure on Dyspnea and Anxiety Levels

The aim of this study is to determine the effect of acupressure applied to individuals with COPD on dyspnea and anxiety. It is important for the transfer of nonpharmacological methods to clinical applications.

The pathophysiological changes that occur in the airways and alveoli in chronic obstructive pulmonary disease can cause many symptoms such as dyspnea, cough and sputum, which restrict the daily lives of individuals. Dyspnea and anxiety are at the top of the list among these symptoms, which affect individuals in many ways and limit them in many areas. While physiological, psychological and sociological factors cause dyspnea, the anxiety that develops in patients along with dyspnea also accompanies the symptoms. These symptoms seen in individuals with COPD not only negatively affect the quality of life of individuals, but also bring about psychological, cognitive, economic and social problems. Therefore, reducing anxiety and dyspnea in patients with COPD is of great importance in controlling the symptoms. Recently, acupressure has been frequently preferred among non-pharmacological methods in symptom control. As a result of studies conducted with different patient groups in the literature, it has been stated that acupressure reduces dyspnea and anxiety levels. In this study, five tools will be used: Patient Identification Form, Modified Borg Dyspnea Scale (MBS), Medical Research Council (MRC) Dyspnea Scale, Beck Anxiety Scale (BAÖ) and Patient Follow-up Schedule. Individuals will be applied acupressure once a day for two minutes at LI4, HT7, LU1, ST36 points, for a total of 20 sessions. It is of great importance for nurses to follow current care methods, include them in nursing care and improve themselves in this regard. No current study has been found in the literature investigating the effect of acupressure applied to individuals with COPD on dyspnea and anxiety. The purpose of this study is to determine the effect of acupressure applied to individuals with COPD on dyspnea and anxiety.

Eligibility Criteria:
Inclusion Criteria:

Patients who are literate,

Have moderate and severe stage COPD according to GOLD criteria,

Score 8 and above on the Beck Anxiety Inventory,

Patients who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Patients using psychiatric medication (anxiolytic, antidepressant), Those with serious pulmonary, cardiological or malignant diseases, Those with vision and hearing problems, Those with communication problems, Those with nerve, soft tissue and vascular diseases in the areas where acupressure will be applied, Those with infections and surgical operations in the areas where acupressure will be applied, Patients in the exacerbation period were not included in the study.
Promotion and Support for Physical Activity Maintenance Post Total Hip Arthroplasty

Total hip arthroplasty (THA) is considered an efficacious procedure for relieving pain and disability in patients with hip osteoarthritis. However, 6-12 months post-surgery physical activity level is unchanged compared to pre-surgery and still considerably lower than that of healthy peers. Increasing physical activity after THA may enhance the outcome of the THA because a graded relationship between physical activity level and functional performance has been documented. Six-8 months after THA physical function is only recovered to about 80% of that of healthy peers and older adults still seem to be at increased risk of frailty. Furthermore, these patients continue to impose higher healthcare costs than an age- and sex-matched reference population which potentially could be related to the functional status that is not completely regained. Finally, patients with hip osteoarthritis can have extensive comorbidity thus increasing physical activity after THA could be a simple and relatively inexpensive method for improving general health, which in turn may decrease healthcare costs.

The reasons for the lack of increase in physical activity despite increased capability after THA are unknown but it may be related to the sedentary behavior adopted by the patients prior to surgery and uncertainty. A systematic review has illuminated that patient-reported barriers to engaging in physical activity after THA are largely related to limited or inadequate information or education culminating in uncertainty about 'doing the right thing' for both the individual's recovery and the longevity of the joint replacement.

Few studies have investigated the effects of specific interventions to increase physical activity after THA. Promising results have been shown from physical activity sensors in combination with e.g. goal setting. None of these studies have addressed the patient-reported barriers to physical activity regarding uncertainty and limited education.

This trial aims to investigate the effect of adding a pedometer-driven, behavior change intervention to usual rehabilitation care 3 months after THA to increase physical activity compared to usual rehabilitation care alone (control). Outcomes are taken 3 (baseline), 6 (after the intervention period) and 12 months after THA (follow-up).

Hypothesis: the behavior change intervention will increase the proportion that completes ≥8,000 steps per day 6-month post-surgery to 50% versus 30% in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Home dwelling, independent and self-reliant adults
* Patients who has received primary total hip arthroplasty because of hip osteoarthritis
* Informed consent to participate

Exclusion Criteria:

* Planned joint arthroplasty in the lower extremities within the next 6 months
* Patients who are unable to read, understand and speak Danish
* Complications in relation to total hip arthroplasty e.g. dislocation, fracture or infection
* Any other condition that in the opinion of the investigator makes a potential participant unfit for participation
Assessment of Acupuncture on Eye Fatigue

The study is designed to assess the effiacy of acupuncutre on eye fatigue. The indicator of eye fatigue is eye accommodation ability. Patients will be randomly assigned to the experimental group and the control group. The experimental group will receive acupuncture treatment, while the control group will receive sham acupuncture stimulation. The eye accommodation ability of both groups will be easured before and after the intervention, and the differences in eye accommodation ability before and after treatment will be analyzed.

A dual-arm, parallel, randomized single-blind, sham-controlled trial will be conducted. The aim of the study is to assess the effiacy of acupuncutre on eye fatigue. Patients will be recruited from outpatient clinics. Subjects will be assessed at a Traditional Chinese Medicine (TCM) outpatient clinic and then have their accommodation function tested in an optometry room . This will determine if they meet the inclusion criteria.

Those who meet the inclusion criteria will be randomly assigned to the experimental group or the control group. The experimental group will receive treatment at seven acupuncture points: Fengfu (GV16), bilateral Fengchi (GB20), Yumen (TH2), and Hegu (LI4), using Jiasun 42G 1-inch acupuncture needles. The needles will be inserted perpendicularly to achieve the "De Qi" sensation, with a depth of 0.5 inches, and retained for 25 minutes before removal. The control group will undergo sham acupuncture at the same points using specially designed acupuncture needles from the manufacturer, which give the sensation of needling but retract into the handle without penetrating the skin, thus providing no real stimulation. Both groups will be treated by TCM physician .

After needle removal, visual acuity will be tested again to compare the differences in values between the pre- and post-test measurements of both groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjective experience of eye fatigue after using electronic devices at least twice a week.
* Age ≥ 18 years.
* Agreement to sign the informed consent form for this study.

Exclusion Criteria:

* Accommodation assessment: Interocular accommodation difference greater than 3 diopters (D).
* History of metabolic diseases with accompanying retinal conditions (e.g., diabetic retinopathy, hypertensive/hyperlipidemic patients with macular edema, retinal hemorrhage, glaucoma, etc.).
* Current treatment for ocular inflammation or infection (e.g., conjunctivitis, orbital cellulitis).
* Underwent eye surgery within the last 3 months (including LASIK surgery).
* Received acupuncture treatment for eye-related symptoms in the past month.
* Diagnosed with severe ophthalmic conditions (e.g., optic atrophy) and deemed unsuitable for the trial by an ophthalmologist.
* Diagnosed with anemia, hypotension, or chronic fatigue in the past three months, making them unsuitable for acupuncture due to a tendency to faint.
* Pregnant women.
* Major diseases such as renal insufficiency, cerebrovascular disease, or cancer, deemed unsuitable for clinical research participation by the principal investigator.
Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study

Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients, 55\~85 years
* Adequate vision, hearing and speaking for neuropsychological testing
* No difficulty in using mobile application using smartphone
* Patients with subjective memory complaints, confirmed by informants
* Cognitive impairment of SD 1 or greater from the age-adjusted normal range in Memory domain in CERAD-NP battery
* Global CDR 0.5 \~ 1
* Korean speaker
* Have an identified trial partner
* All subjects signed written consent

Exclusion Criteria:

* Those unable to provide consent
* History of transient ischemic attack, stroke, brain tumor
* History of diagnosis of major depression
* Symptoms that may interfere with the subject's testing procedure
* Cerebral hemorrhage
* Central nervous system infections
* Prohibited concomitant medication
* Known or suspected history of drug or alcohol abuse
Comparison of Cross-cylinder and Conventional Photorefractive Keratectomy(PRK) in Correcting Medium-high Astigmatism

The purpose of this study is to determine whether cross-cylinder approach is more effective than routine method in laser correction of astigmatism.

Both eyes of 50 patients(100 eyes) with medium-high compound myopic astigmatism and inclusion criteria,will be treated by photorefractive keratectomy (PRK) using excimer laser.It breaks chemical bonds within corneal stroma.It's wavelength is 193 nm that is in the ultraviolets range with high energy and very low tissue penetrance. The right or left eye of every patient would be allocated randomly to one of the study groups using RandList 1.1. In spite of recent advances in excimer laser machines and surgical techniques,correction of astigmatism is not more successful compared to myopia. In this study we will compare two methods of laser correction of astigmatism regarding to visual acuity,residual error and aberrations.

Eligibility Criteria:
Inclusion Criteria:

* \>20 years of age
* refractive stability for at least one year
* regular and symmetric astigmatism of \>1.5 diopters

Exclusion Criteria:

* corneal thickness\<470 microns
* keratoconus or suspected keratoconus
* active ocular disease and systemic collagen disease
rhDNase Eye Drops in Patients With Ocular Graft-Vs.-Host Disease

The purpose of this study is to evaluate the tolerability and preliminary efficacy of rhDNase I eye drops in patients with ocular Graft-vs.-Host disease (oGVHD).


Eligibility Criteria:
Inclusion Criteria:

* The PI and other members of International Chronic Ocular GVHD Consensus Group have established the consensus diagnostic criteria and classification for chronic ocular GVHD.

Table 1: Severity scale in chronic ocular GVHD

Severity scores (points) Schirmer's test (mm) CFS (points) OSDI (points) Conj (points) 0 \>15 0 \<13 None

1. 11-15 \<2 13-22 Mild/Moderate
2. 6-10 2-3 23-32 Severe
3. ≤5 ≥4 ≥33

CFS; corneal fluorescein staining, OSDI; Ocular Surface Disease Index. Conj; conjunctival injection. Severity classification; Total score (points); (Schirmer's test score+ CFS score+ OSDI score+ Conj injection score) = None;0-4, Mild/Moderate; 5-8, Severe, 9-11.

Table 2: Diagnosis of chronic ocular GVHD None (points) Probable GVHD (points) Definite GVHD (points) Systemic GVHD(-) 0-5 6-7 ≥8 Systemic GVHD(+) 0-3 4-5 ≥6

Based on these criteria (Tables 1 and 2),40 patients with definite ocular GVHD will be enrolled. Additionally, all of the following criteria should be met to be eligible for the study:

* Aged 18 years or older.
* Capable of giving informed consent and does provide informed consent.
* Schirmer I \<10
* Corneal/ conjunctival (Rose Bengal) staining ≥1
* Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).
* Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. If the test is positive, she will be discontinued from the study immediately.

Exclusion Criteria:

* Subjects will not be eligible for the study if any of the following criteria are met:

  * Allergic to rhDNase I or any similar products, or recipient of rhDNase I eye drops 0.1%.
  * Receiving or have received within 30 days any experimental systemic medication.
  * Active ocular infection or ocular allergies.
  * Any history of eyelid surgery or ocular surgery within the past 3 months.
  * Corneal epithelial defect larger than 1 mm2 in either eye.
  * Have active drug/alcohol dependence or abuse history.
  * Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.