cyrilzakka/clinical-trials huggingface dataset:
Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy

This present research project intends to collect five quantitative test series:

* perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) \[Schiefer 2008\] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
* D-BCVA, using FrACT \[Bach 2007\] and EDTRS chart \[Ferris 1982\]
* RAPD (using swinging flashlight test).
* IOP (using applanation tonometer)
* RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic disk morphology will be documented by fundus photography. This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients.


Eligibility Criteria:
Inclusion Criteria: - physical, intellectual and linguistic abilities, in order to understand the test requirements

* willingness to comply with the protocol (4 visits)
* 41 - 80 years, informed consent
* acute N-AION (\< 7 d)
* D-BCVA \> 0.1 (2/20)
* RAPD ≥ 0.3 logE steps (neutral density filters) and:
* spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
* isocoria, pupil diameter \> 3 mm

Exclusion Criteria:

* diabetic retinopathy and any other orbital, intracranial or optic nerve disease
* history of epilepsy or significant psychiatric disease
* medications known to affect visual field sensitivity
* infections (e.g. keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drug
* amblyopia
* strabismus
* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings
* cataract with relevant impairment of vision
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or signs of any visual pathway affection other than N-AION
* history or presence of macular disease and / or macular edema
* ocular trauma
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis

This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of sarcopenia:

   * Low hand grip strength (Male: \<28 kg, Female: \<18 kg) AND
   * Low appendicular skeletal mass by bioimpedance analysis (Male: \<7.0 kg/m2 Female: \<5.7 kg/m2)
2. Diagnosed with osteoporosis by:

   * Fragility fracture or
   * T-score ≤-2.5 SDs at any site based upon BMD measurement by Dual Energy X-ray Absorptiometry (DXA) scan

Exclusion Criteria:

1. Incompetent in giving consent or following commands
2. Non-ambulatory subject
3. Unstable medical conditions contributing to sarcopenia, for example but not limited to:

   1. End stage organ failure
   2. Unstable cardiovascular, respiratory, gastrointestinal and endocrine conditions
   3. Active malignancy
4. Chronic kidney disease stage IV or above or with hyperkalaemia
5. Diabetes mellitus on medications or with unstable control
6. Terminal illness
7. Obese subjects (BMI ≥ 25.0)
8. Self-reported allergy to the ingredients of the nutrition supplement
9. Patients with metallic implants
10. Any orthopaedic pathologies affecting the strength of bilateral upper limbs
11. Any hereditary or acquired muscular diseases
12. Participation in other regular exercise programme
The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents

This study aims to examine the psychological well-being and QoL of Hong Kong Chinese adolescents with CHD by

* comparing the self-esteem level, depressive symptoms, and quality of life of adolescents suffering from CHD with healthy norms and cancer survivors.
* identifying possible factors affecting the quality of life of adolescents suffering from CHD.

Congenital heart disease (CHD) is the most common type of congenital malformation in the world with birth prevalence as 8 per 1000 live births. Survival rate has been drastically improved as a result of improvement in surgical treatments and intensive care but adolescents with CHD still suffer from limitations on their psychological functioning and restrained quality of life. Number of evidences have indicated that adolescents with CHD experience more depressive symptoms and lower self-esteem level than their healthy counterparts. In addition, adolescents with CHD are more prone to develop emotional and behavioral problems than their healthy norms. Given the above issues, It is imperative for nurses to develop psychological interventions to promote psychological well-being among adolescents with CHD, with the goal of improving their quality of life. There have been increasing concerns worldwide on the quality of life of such population especially on how does the disease pose threats on their daily living. However, at present, there is no study examining how does CHD affect the psychological well-being and quality of life in Hong Kong Chinese adolescents. It is explicit that Hong Kong has a distinctively different cultural context from that of the West. Hence, the effects of CHD and its treatments are likely to differ markedly in the two regions .To conclude, results of previous studies from the West may not fit into Hong Kong Chinese cultural context.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients with congenital heart disease
* aged at 12-17 years old
* fluent in Cantonese and able to read Chinese

Exclusion Criteria:

* pediatrics with major developmental delay or having significant co-morbid medical condition
* visiting because of altering in clinical condition
* having acquired heart disease or non-structural heart disease
Effect of Anatabine on Elevated Blood Levels of C-reactive Protein

The investigators are studying a dietary supplement called anatabine in a lozenge form named RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement on normal human inflammatory function. The investigators will see this effect in volunteers who have markers of higher levels of inflammation to begin with. The investigators anticipate that anatabine will reduce markers of inflammation. Therefore the investigators are looking for volunteers with high blood levels of C-reactive Protein (CRP) and will monitor the blood CRP levels at several time points throughout the study.

The investigators are studying a dietary supplement called anatabine which for the purposes of this study has been made into lozenges and named RCP006. Anatabine, the only active ingredient of RCP006, occurs throughout the world in the human food chain. Anatabine has been in the human food supply and in human use for centuries. Humans are exposed to anatabine in tobacco products and common and widely consumed food crops such as potatoes, peppers, eggplants and tomatoes. The main purpose of this study is to evaluate the effects of this dietary supplement on normal human inflammatory function. Compounds that are chemically similar to anatabine have been shown to reduce inflammatory responses, and laboratory studies show anti-inflammatory properties for anatabine. The investigators want to explore this further in human studies to see if anatabine can maintain normal levels of inflammatory function. The investigators will see this effect more easily if the investigators look at the effects of anatabine in volunteers who have markers of higher levels of inflammation to begin with. The investigators anticipate that anatabine will reduce markers of inflammation. To look for inflammation the investigators will test blood levels of a protein called C-reactive protein. C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Therefore the investigators are looking for volunteers with high blood levels of CRP and will monitor the blood CRP levels at several timepoints throughout the study. The investigators will also collect blood samples to measure other indicators of inflammation, and to measure blood levels of anatabine.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults with elevated blood levels of hsCRP

Exclusion Criteria:

* pregnancy or planning pregnancy
* current tobacco use
* current steroid use
* allergy to study product components
Accupressure of P6 to Reduce Nausea During Cesarean Section

The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* English-speaking
* Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (\>37 weeks' gestation)
* Patients scheduled as ERAC
* Parturients undergoing spinal anesthesia

Exclusion Criteria:

* Patients requiring emergent delivery,
* Fetal demise
* Patients with adhesive allergy/sensitivity
* Patients with allergy/sensitivity to nickel,
* Patients with inability to consent,
* Patients with known abnormal placentation
* Patients with pacemakers/defibrillators
* Patients with positive COVID-19 tests
Epiretinal Macular Membrane and Cataract Extraction

The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of 174 patients undergoing macular surgery between January 2005 and December 2006. Patients suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and cataract separately)(group 2).

Eligibility Criteria:
Inclusion Criteria:

* All patients had symptomatic visual loss and needed vitrectomy for ERM removal.

Exclusion Criteria:

* Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.
Prospective Randomized Clinical Trial Assessing the Short Term Clinical Impact of Continuous vs Flash Glucose Monitoring in Children, Adolescents and Young Adults With Type 1 Diabetes

Impaired hypoglycemia awareness, a significant problem for children with type 1 diabetes, is defined as neurogenic symptom response before autonomic response to hypoglycemia. Avoiding hypoglycemia appears to restore hypoglycemia awareness.

Investigators have previously demonstrated in a retrospective study that Flash Glucose Monitoring system decreased the risk of severe hypoglycemia in type 1 diabetic children and adolescents, even though Flash Glucose Monitoring system, unlike Continuous Glucose Monitoring system, does not provide glucose alerts.

Continuous Glucose Monitoring system, by providing real-time data with alarms, could benefit to subjects still experiencing severe hypoglycemia with Flash Glucose Monitoring system. Besides, in adults, Continuous Glucose Monitoring system reduced more effectively impaired hypoglycemia awareness compared to Flash Glucose Monitoring system.

In that context, investigators would like to assess the impact of Continuous Glucose Monitoring system instead of Flash Glucose Monitoring system on hypoglycemia in children and adolescents with type 1 diabetes.

All subjects will start with a 7 days run-in phase using their current Flash Glucose Monitoring System associated with a blind Continuous Glucose Monitoring system (Envision, Medtronic).

After one week, subjects randomized in the the interventional group will be provided with the Continuous Glucose Monitoring (Guardian Connect, Medtronic) and trained by dedicated diabetes educators for Continuous Glucose Monitoring usage including insertion of the sensor, calibration of the device twice daily and interpretation of the data. Subjects will use the sensors according to the license.

For both groups, insulin doses decisions are made by the participant according the received education.

After one week, all subjects will be contacted by phone focusing on the use of the technology. The treatment period is 8 weeks. The last week of the treatment period, subjects will use the blind Continuous Glucose Monitoring system (Envision, Medtronic) in addition to their allocated Glucose Monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged from 4 to 20 years
* Subjects with onset of diabetes before 16 years of age
* Diabetes duration of more than 1 year
* Subject currently using Flash Glucose Monitoring system in daily practice

Exclusion Criteria:

* Subject with mental disability
* Previous use of Continuous Glucose Monitoring system
* Subject currently participating to another clinical study
Evaluation of Gait Symmetry in Upper Extremity Burn Injuries

Thirty patients with unilateral burn injury, and 60 healthy subjects will be included in this study. Participants with burn injury will evaluate with the following assessment tools: Demographic data; age, gender, height, body mass index; burn characteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. Gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle). will be recorded via computerized system. And gait symmetry will be calculated via formule. Participants' kinesiophobia level will be evaluated with Tampa kinesiophobia scale. Their pain will be assessed by visual analog scale. Their arm swing will be evaluated by a scale.

Thirty individuals with lower extremity burn injury and sixty healthy subjects will be included in this study. Participants with burn injury will be included if they are aged of 18-50, able to walk independently at least 10 meters. Healthy subjects will be included if there are no orthopedic, neurological or musculoskeletal disorders that affect gait.

1. Group: 30 Patients with burn injury
2. Group: 30 healthy subjects (When evaluating the gait analysis, their arm will not be restricted (Their natural walking)
3. Group : 30 healthy subject (When evaluating the gait analysis, their arm will be restricted )

Participants will evaluate with the following assessment tools: Demographic data; age, gender, height, body mass index; burn characteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded.

All subjects' gait analysis will be conducted via GAITRite (computerized) system.

GAITRite system for gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle), Tampa Kinesiophobia scale for kinesiophobia level, visual analog scale for pain, a scale that developed by us for arm swing will be used.

These evaluations will be applied one time for participants. These evaluations will be made within 5 days following burn injury.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of upper extremity burn injury
* must be able to walk independently
* Control group consists of healthy adults with the similar demographic characteristics as experimental group.

Exclusion Criteria:

* Walking with assist device
* Having a visual deficits
* Having an orthopedic problems that affect gait
* Having a neurological disorders
* Having a musculoskeletal disorders that affect gait
* Having an undergone orthopedic surgery
Plasma Hepcidin Response to Differently Dosed Iron Supplements

The study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. By taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values.

15 healthy young women with non-anemic iron deficiency will participate in the study. On 4 different days the investigators will take two blood samples (one in the morning at 8 am, before the iron intake and one in the afternoon at 4 pm) to determine the plasma hepcidin level. The intake of the iron supplements will be at least 48 hours apart from each other, to exclude any impacts of the previous iron intake to the next measurement.

The participants will take the iron supplement supervised at 8 am after overnight fasting.

All blood samples will be performed for analysis of CRP and hepcidin. The investigators will measure the CRP in the blood sample to exclude any impacts of inflammation to the hepcidin measurement and use a CRP ≤5mg/l as a cut-off. If the CRP is higher than 5mg/l the investigators will exclude the measurement from our analyses and repeat the measurement at another day.

The first two blood samples will be taken at 8 am and at 4 pm on the same day and after overnight fasting to find the baseline hepcidin, the other blood samples will be taken at 8 am before the iron intake and at 4 pm also on the same day and also after overnight fasting.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Female gender
* Premenopausal
* Age \> 18 years
* Regular menstrual cycle
* BMI in normal range (18-25kg/m2)
* Serum-ferritin ≤30ng/ml
* No anemia
* No intake of dietary supplements

Exclusion Criteria:

* Intake of dietary supplements
* Pregnancy
* Hypermenorrhea (\> 80ml blood loss, or more than 5 unties/tampons per day)
* Anemia
* Serum-ferritin \>30ng/ml
* BMI \<18 kg/m2 or \>25 kg/m2
* Chronic inflammatory disease
* Hypersensitivity to iron supplements
Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.

The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Due to viral replication in asymptomatic HBV carriers induced by post-transplant immunosuppression, liver-related complications, such as liver failure and bleeding, account for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.

Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal allograft recipients has significantly improved patient survival rates during short-term follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine treatment.

However, limited results were known about the renal function affected by oral anti-HBV drugs when patients received kidney transplantation. Therefore, we would like to conduct this study to evaluate the renal function of Lamivudine long term used HBsAg positive patients received kidney transplantation after switch to Telbivudine treatment. The clinical and virological outcomes will provide valuable insights of clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant patients who are treated with Lamivudine over 6 months (Considering include post kidney transplantation \> 6 months with stable calcineurin inhibitors level
2. Seropositive of HBsAg for 6 months
3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Hepatitis cirrhosis patients
2. Co-infection with hepatitis C virus or HIV
3. Pregnant or nursing
4. YMDD resistant at baseline
5. ABO incompatible renal transplantation
6. Cross match positive
7. Poor renal function at baseline (eGFR\<20)
8. Known hypersensitivity or intolerance to any of the ingredients in Telbivudine
9. Known history of Telbivudine resistance
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia


Eligibility Criteria:
Inclusion Criteria:

* Over 45 years
* Benign Prostate Hyperplasia diagnosed by 20 mL \< TRUS
* Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria:

* Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
* Subjects who have acute urinary retention within 12 weeks before screening
* Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
* Subjects who have hypersensitivity to investigational product
* Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
* Subjects who have myasthenia gravis, narrow angle glaucoma
* Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* SBP \> 180 mmHg or DBP \> 100 mmHg
* HbA1c \> 9.0 %
* Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-2 at the time of inclusion
* Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment

Exclusion Criteria:

* Pregnancy
* Less than 3 mths expected survival
* Serious comorbidity
* Age above 70 yrs