cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma

To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .

A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .

Eligibility Criteria:
Inclusion Criteria:

* Primary Angle Closure Glaucoma (PACG) with visible trabecular meshwork from 90︒ to 180︒ on gonioscopy and IOP couldn't be controlled ≤21mmHg with pilocarpine eye drop only.
* willing to accept the antiglaucoma surgery
* volunteer to participate in this study and be able to follow up on time
* previous antiglaucoma filtering surgery or laser surgery(LPI, SLT) and previous cataract surgery were not ruled out
* Exclusion Criteria:
* visual acuity lower than HM or central tubular visual field
* corneal edema or large pterygium affecting the observation of anterior angle
* the demarcation of the scleral process and trabecular meshwork is not clear on gonioscopy
* new vessels on the iris surface or in the anterior angle chamber
* the eye received surgery is the only eye with visual function, that is the contralateral eye is blind
* requiring long-term use of anticoagulant drugs for systemic reasons
* abnormal coagulation function
* with specific clear scar physique
* cannot participate in follow-up
Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old

This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense.

Exclusion Criteria:

* History of allergy to any vaccine ingredient or gentamycin;
* Fever, or acute disease, or acute stage of chronic disease;
* Having serious chronic diseases, or allergic constitution;
* Refusal of follow-up for safety concern.
Ventavis® Registry Protocol

The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.

The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.

Eligibility Criteria:
Inclusion Criteria:

1. Have a current diagnosis of WHO Group I PAH
2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302
3. Age \> or = 18 years old at the time of enrollment

Exclusion Criteria:

1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH
2. Are not currently on commercial Ventavis®
3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment
An Open-label Study on the Clinical Efficacy of tDCS Intervention in PD

To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease.

Rapid eye movement sleep behavior disorder (RBD) is one of the most common accompanying symptoms of Parkinson's disease (PD). PD-RBD patients have more severe clinical manifestations, require larger drug doses, and have more non-motor symptoms. Although several strategies using transcranial direct current stimulation (tDCS) have been investigated for the treatment of sleep disorders, the efficacy of high-definition tDCS (HD-tDCS) in PD-RBD patients remains unclear.

We conducted an open-label study using the RBD-SQ to identify individuals with possible RBD (pRBD), and recruiting the patients at the First Affiliated Hospital of Anhui Medical University to receive cathodal HD-tDCS intervention. On the basis of conventional anti-PD drugs, cathodal HD-tDCS treatment was performed on the left M1 area once a day for 20 minutes, and the treatment was continued for 10 days. The International Movement Disorders Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the Hoehn \& Yahr staging scale (H\&Y), REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), RBD Screening Questionnaire Hong Kong (RBDSQ- HK), Pittsburgh sleep quality index (PSQI), Epworth Sleepiness Scale (ESS), and Parkinson disease sleep scale (PDSS) were assessed on intervention Day 1 and Day 10, and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of PD was determined by neurologists with rich clinical work experience, and was in line with the diagnostic criteria for Parkinson's disease in China (2016 edition).
2. The total score of RBD Screening Questionnaire (RBDSQ) is ≥6 points.
3. All patients took the drug stably and had no history of drug adjustment within 2 months before treatment. The test was conducted 2 hours after taking the drug.
4. Good compatibility, with a certain degree of compliance;
5. Normal mental condition, able to cooperate with behavioral tests and transcranial electrical stimulation treatment;

Exclusion Criteria:

1. The patient has a metal object or skull brace device or any similar metal object on the scalp;
2. Head tremor or limb shaking is so severe that it is difficult to calmly receive treatment;
3. The presence of other serious mental illness (such as major depression, psychosis or obsessive-compulsive disorder, physical illness or a history of substance abuse);
4. Have a head injury, stroke or other neurological disorder;
5. The diagnosis of PD dementia is difficult to complete the assessment.
ONSET and OFFSET of Ticagrelor in ESRD

Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.

Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Recently, we demonstrated that patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. One of good option to overcome high platelet reactivity in ESRD patients would be ticagrelor which has been already shown improved clinical outcomes. But little is known the antiplatelet effects of ticagrelor in ESRD patients on HD. The present study was designed to determine the antiplatelet effect as well as the onset and offset action of ticagrelor compared with clopidogrel in patients with ESRD undergoing maintenance HD.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients undergoing regular (≥ 6 months) maintenance HD
* ongoing (≥ 2 months) treatment with clopidogrel
* P2Y12 reaction units (PRUs) were more than 235

Exclusion Criteria:

* known allergies to aspirin, clopidogrel, or ticagrelor
* concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
* thrombocytopenia (platelet count \<100,000/mm3)
* hematocrit \<25%
* uncontrolled hyperglycemia (hemoglobin A1c \>10%)
* liver disease (bilirubin level \>2 mg/dl)
* symptomatic severe pulmonary disease
* active bleeding or bleeding diathesis
* gastrointestinal bleeding within the last 6 months
* hemodynamic instability
* acute coronary or cerebrovascular event within the last 3 months
* pregnancy
* any malignancy
* concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
* recent treatment (\<30 days) with a glycoprotein IIb/IIIa antagonist
Using Electrocochleography During Cochlear Implantation of the Neuro Zti.

The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications. First, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. Second, a new metric for estimating the eCochG response will be evaluated (eCochG trauma index). The secondary objective is to find other markers of the cochlear trauma insertion associated to eCochG measures. This will be used to evaluate to which extend a traumatic insertion will be deleterious for the patient's post-operative hearing, and ultimately to prevent trauma to the inner ear. Finally, the potential differences in cochlear trauma resulting of the electrode array insertion from two different surgery techniques will be investigated; Either using a manual insertion or using a robotic arm that will drive the insertion automatically.

Main study procedures and assessments:

* Visit 1 (D-30+/-14) INCLUSION: subject information/consent, inclusion/exclusion criteria, CT-scan, Tonal audiometry
* Visit 2 (D0+/-14) COCHLEAR IMPLANT SURGERY: CT-scan, Intra-op eCochG, eCAP, Impedance
* Visit 3 (D+30+/-14) FOLLOW-UP 1 MONTH: Tonal audiometry, Impedance, Fitting maps
* Visit 4 (D+60+/-14) FOLLOW-UP 2 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes
* Visit 5 (D+90+/-14) FOLLOW-UP 3 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes

Eligibility Criteria:
Inclusion Criteria:

* \> or equal 18 years ;
* Candidate for Neuro Zti EVO cochlear implant system, unilateral or bilateral recipient ;
* Preoperative residual hearing with audiometric thresholds less or equal than 80 dB at 500 Hz, or higher frequencies

Exclusion Criteria:

* Medical or psychological conditions which contraindicate surgery (e.g middle ear infection, tympanic membrane perforation) ;
* Patient with a psychological or linguistic inability to understand the information sheet ;
* Patient under legal protection or deprived of liberty
* Patient included and participating to another trial.
Valproic Acid and Its Effects on HIV Latent Reservoirs

The purpose of this study is to examine whether the co-administration of valproic acid (Epival®), with highly active antiretroviral therapy (HAART) can reduce the size of HIV latent reservoirs in infected CD4 cells.

Participants must be on HAART with a suppressed viral load (\< 50 copies/ml) for at least the previous 12 months. They will be randomly assigned to one of two groups, one group will start the valproic acid right away at week 1 for 16 weeks, and the other group will wait until week 17 to add valproic acid to their treatment for 32 weeks. Subjects will be followed every four weeks for one year and evaluated by a variety of assays, all carried out using well-established methods, to assess the main outcome defined by changes in HIV reservoir size measured by the mean frequency of resting CD4 memory cells carrying HIV proviral DNA.

Eligibility Criteria:
Inclusion Criteria:

Documented HIV seropositive infection by Western Blot, EIA assays or viral load.

* Aged 18 years old or older.
* Viral load \<50 copies/ml for at least the previous 12 months.
* Circulating CD4+ cell count ³ 200 cells/ml.
* Taking HAART.
* Vital signs, physical examination and laboratory results do not exhibit evidence of diseases such as advanced cirrhosis and advanced liver disease (ALT or AST \> 5 x upper limit of normal value).
* Karnofsky performance status 80%.
* Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with VPA.
* Willing and able to give informed consent.
* All participants will agree to abstinence or to used effective methods of contraception while on the study.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Psychiatric or cognitive disturbance or illness that could preclude compliance with the study.
* Current use or use within four weeks prior to the baseline visit, of cytotoxic agents, systemic corticosteroids or any immunomodulatory agents such as intravenous immunoglobulin, or hydroxyurea.
* HIV vaccine within six months of screening visit
* Allergic reaction to VPA.
* Active intravenous drug users.
* History of bleeding disorders.
* Unstable or treated hypertension.
* Past-history of pancreatitis or chronic liver disease (ALT or AST \> 5 x upper limit of normal value). However subject co-infected with hepatitis B or C can participate if ALT or AST is \< 5 x upper limit of normal value.
* Renal failure (creatinine \> 2 x upper limit of normal value).
* Ammonemia (\> 2x upper limit of normal value).
* Taking Zidovudine (AZT), or combination of drugs containing AZT like Combivir or Trizivir. However this subject will be asked to switch to another NRTI,at least two weeks prior to Valproic Acid initiation, to become eligible.
* Taking on daily basis: phenytoin, carbamazepine, phenobarbital, warfarin or aspirin.
* Subject has any of the following abnormal laboratory results Hemoglobin \< 100 g/L. Absolute neutrophil count \< 0.75 x 10 9 cells/L. Platelet count \< 50 x 10 9 cells/L.
* Subject suffering from urea cycle disorders.
Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate in response to variations in doses of steroid and other immunosuppressive agents. At the same time, poorly controlled hyperglycemia affects negatively graft function and survival as well as on the ability of the immunocompromised host to fight infections. The investigators hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM would help patients with post-transplant diabetes attain better control at the critical time of titration of immunosuppressive regimens. The primary objective of this proposal is to improve glycemic control of diabetes with Pramlintide in patients with post-transplant diabetes at 3 and 6 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Post-transplant diabetes (PTMD)
* Aged 20-70
* Diagnosis of diabetes within the last 6-18 months
* Stable medications
* Stable weight for 3 months
* Serum creatinine \< 1.5 mg/dL

Exclusion Criteria:

* Pre-transplant diabetes
* Major postoperative complications following transplant
* Pregnancy
* Significant GI discomfort with nausea or vomiting
* Inability to learn continuous glucose monitoring
* Development of diabetes more than 4 years after transplant
* omen of child-bearing potential who use birth control pills and have fasting triglycerides of \> 400 mg/dL
Depression and Congestive Heart Failure in Outpatients.

Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM group). Participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.

Background:

Between 4 and 5% of patients seen at Veterans Affairs Medical Centers suffer heart failure. HF is the number one discharge diagnosis within the VHA. One of the most significant comorbidities in heart failure is depression. Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators. This HSR\&D study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure.

Objectives:

To demonstrate better depression, health-related quality-of-life, and adherence outcomes for an illness management combined with psychotherapy intervention (COMBO) as compared to an illness management alone program (IMO).

Methods:

This was a two-site, two-arm, randomized controlled trial comparing COMBO to IMO. The total number of patients recruited for the study was 148. Retention was comparable between groups, though depression severity predicted drop out in the IMO condition but not the COMBO condition. Patients completed study assessments at baseline, week 4, week 8 (post-intervention) and at 26- and 52-week follow-up.

Status:

The main study analyses have been conducted. The project team is conducting analysis of secondary hypotheses

Eligibility Criteria:
Inclusion Criteria:

* Receiving treatment for NYHA Class 2-4 heart failure.
* Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.
* Life expectancy greater than 6 months.
* Must speak English.
* Must possess a working telephone.

Exclusion Criteria:

* Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).
* Life expectancy less than 3 months.
* Planned relocation to a nursing home.
* Marked visual or hearing impairment.
Replicating MamaToto in Rural Tanzania

This study aimed to adapt and implement a district-led, policy-based, low cost Maternal and Newborn Health (MNH) intervention package using the MamaToto process, proven successful in Uganda, in rural Tanzania. The investigators hypothesized that the 'MamaToto Package' will be successfully implemented in the Misungwi District and will be effective in improving key maternal and newborn health indicators of study participants.

This study collected baseline data on indicators related to pre-natal care, delivery, post-natal care, treatment of childhood illnesses and family planning. Data collection tools/strategies included 1) a mapping exercise, 2) health facility audit 3) household surveys and 4) exit interviews. Data was collected at baseline and endline. Operational data was collected throughout the life of the study. Results were used to inform implementation of interventions that aim to improve health facility capacity to deliver good quality care to women and children and to strengthen families and communities to better advocate for and engage in activities that promote healthier women and children.

Mapping data was collected in two districts 1) Misungwi and 2) Kwimba. Baseline and endline data was collected in Misungwi only. The intervention began in Misungwi in Years 1 and 2 and then rolled out to Kwimba in Year 3.

Eligibility Criteria:
Inclusion Criteria:

* Randomly selected households (30) living in selected hamlets with a competent participant of greater than 15 years of age
* All women of reproductive age (age 15-49 years old) living in selected households in selected hamlets

Exclusion Criteria:

* Households with participants that are away for an extended time or have no one home at the time of survey completion
A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria

A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated catheter.

Each participant will take part in the trial from the time the participant signs the informed consent form (ICF).

After the screening visit, the participants will be allocated to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.

During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Require insertion or exchange of a urinary catheter in a suprapubic position as a component of their routine clinical care as per guidelines
* Patients aged 18+ years will be eligible for the study.
* Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

Exclusion Criteria:

* Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.2. Patients that have asymptomatic infection (if required may need a blood test to confirm)
* Pregnant or Breastfeeding.
* Patients with a potentially immunocompromised conditions (HIV)
* Has a known silicone allergy or sensitivity
* Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
* Any medication deemed by the Investigator to potentially interfere with the study treatment
* Participation in any other clinical study.
* Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy