cyrilzakka/clinical-trials huggingface dataset:
Retinal Investigation Using Optos OCT Device

Retinal investigation using OCT with control and diseased eyes


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
2. Participants who understand the study and patient information sheet and can follow the instructions.
3. Participants who agree to participate in the study.
4. Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.
5. Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases

Exclusion Criteria:

1. Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent
2. Ophthalmic disease other than condition under investigation.
3. Participants unable to tolerate ophthalmic imaging.
4. Cataract (unless deemed mild in the opinion of the investigator)
5. Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images.
6. Diabetes (unless part of the diabetic eye disease group)
7. Binocular visual acuity worse than 6/18
8. Strabismus (squint)
9. Age related macular degeneration groups: polypoidal choroidal vasculopathy
10. Participants with photo sensitivity epilepsy, experience of seizures, or sensitivity to flickering light (based on self-report)
11. Pregnant
Cardiopulmonary Interactions in Patients With Heart Failure

This study aims to evaluate cardiopulmonary interactions in patients with heat failure

Heart failure is one of the most common diseases, especially in ageing populations, affecting ≥10% of persons 70 years of age or older. There is a growing body of evidence that dyspnea in patients with heart failure is not only related to low cardiac output and pulmonary venous congestion, but also to functional and structural alterations of the lungs.Pulmonary hypertension is a well-known complication of heart failure, but recent evidence suggests that the alveolo-capillary membrane is also affected, at least in subgroups of patients with heart failure.

Damage to the alveolo-capillary membrane is reflected by a low diffusion capacity of the lungs for carbon monoxide (DLCO).

In this study we aim to describe the alteration of lung function and obtain morphometric data of the capillary bed of patients with heart failure.

Eligibility Criteria:
Inclusion criteria

* Written informed consent prior to initiation of any study-mandated procedures
* Male or female ≥40 years at screening
* Confirmed diagnosis of HFpEF (Heart failure with preserved ejection fraction), HFmrEF (heart failure with mid range ejection fraction) or HFrEF (Heart failure with reduced ejection fraction) in New York Heart Association (NYHA) Functional Class II, III or IV

Exclusion criteria

* Significant lung disease according to the judgment of the investigator; as a rule, the total lung capacity (TLC) should be \>70% of the predicted value and the forced expiratory volume in 1 second (FEV1) should be \>60% of the predicted value
* Significant co-morbidities expected to limit life expectancy to less than 2 years, according to the judgment of the investigator
The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure

This RCT study aims to examine effects of a NICE Support Program in heart failure patients.

The following hypotheses were tested: patients who received the NICE program will report significant improvement in frailty , social support, anxiety, and depression, quality of life, and nutritional assessment at baseline,4 weeks, 12 weeks and 24 weeks.

This study aims to develop NICE Support program, and examine the effects of an NICE program in heart failure patients. An experimental design is used. Subjects are selected using a purposeful sampling and are randomly assigned to the intervention or control group by using block size randomization method. Patients in the intervention group will receive a 12 week NICE Support program including: individual consultation, nutritional consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls. Data are collected by physical indicators and a structural questionnaire to measure frailty, quality of life, social support, anxiety and depression, symptom distress at baseline, 4 weeks, 12 weeks and 24 weeks . Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t test, chi square, one way ANOVA and generalized estimating equation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged above 20 and stable condition and had received physical activity.
2. Clear consciousness, can communicate with Chinese and Taiwanese.
3. Consent to join in this study.
4. Have a smartphone and be able to join social media(Line: heart together-go go go )

Exclusion Criteria:

1. Bed-ridden or unable to perform activities of daily living independently.
2. Unstable illness condition.
3. Emergency condition.
4. Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
5. Patients with increased nerve, muscle, bone or rheumatoid diseases due to exercise
Cervical Restorations Placed Under Two Isolation Methods

During restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. The aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of Class V restorations, as well on the periodontal conditions of restored sites. Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this study. The NCLs will be randomized into the following groups: (1) isolation performed with rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and gingival retraction cord. Both techniques will be used with a saliva suction device. All restorative procedures were performed using a self-etching adhesive system and a nanofilled composite resin according to the manufacturer's instructions. The clinical performance of restorations will be recorded in terms of fracture and retention of restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition of restored sites will be evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.


Eligibility Criteria:
Inclusion Criteria:

* more than one cervical lesion
* lesions whose apical limit located above the gingival margin
* lesions with at least 1 mm of depth
* vital permanent incisors, canines, or premolars

Exclusion Criteria:

* smoking habits
* severe systemic diseases
* active orthodontic treatment
* malocclusion (Angle Class II or Class III)
* less than 20 natural teeth in mouth
* absent of antagonist tooth
* wear facets over more than 50% of the incisal/occlusion surface as a result of tooth attrition
* or restorations in the area to be treated
* full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index (GBI) more than 20%
* probing depth (PD) and clinical attachment loss (CAL) values exceeding 4 mm with bleeding on probing (BOP)
* unwillingness to return for follow-ups or refuse to participate
Evaluation of Human Zinc Absorption From Wheat-based Meals

Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates.

Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.

The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The studies will be conducted with products based on wheat with high extraction rate (study part 1) and medium extraction rate (study part 2) in two separate groups of women of childbearing age.

The goal of study part 3 is to investigate the difference of absorption measurements between intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3 test meals.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 45 years old (Study part 1 and 2). Female or male, 18 to 45 years old (Study part 3)
* Body Mass Index in the range of 18.5 to 25 kg/m2
* Signed informed consent

Exclusion Criteria:

* Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, anemia, hepatitis, hypertension, cancer or cardiovascular diseases (according to the subjects own statement)
* Gluten intolerance, celiac disease
* Continuous/long-term use of medication during the whole study (except for contraceptives)
* Vegans
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test meal administration
* Smoking
* Pregnancy (Urine pregnancy test shall be performed before each test meal administration)
* Lactating
* Earlier participation in a study using Zn stable isotopes or participation in any other clinical study within the last 30 days
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.


Eligibility Criteria:
Inclusion Criteria:

* first episode of appendicitis
* Pain \< 48 hours
* White blood cell count \< 18,000
* temperature \< 103º F
* radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
* appendiceal diameter \< 11 mm
* ability to take oral antibiotics

Exclusion Criteria:

* Prior antibiotic treatment for appendicitis
* presence of medical condition prohibiting surgical therapy
* radiographic or clinical evidence of abscess or perforation
* appendiceal mass, positive pregnancy test
* other diagnosis equally as likely as appendicitis
* pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
* inability to take oral antibiotics.
Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

The objective of this study is to determine whether a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.

The aneurysmal subarachnoid haemorrhage (SAH) is a frequent and dangerous worldwide cause for stroke. A typical complication presents delayed cerebral ischemia as a consequence of cerebral vasospasms, which occurs in 46% of the cases. The Triple-H-therapy (Hypervolaemia, Hypertension and Haemodilution) was favoured to prevent ischaemic complications after vasospasm for a long time. However recently, the focus is mainly on hypertension, and it is recommended to maintain normovolaemia. The debate how to assure normovolaemia is still on going, therefore, this study was designed to examine whether a PiCCO-controlled haemodynamic monitoring and a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia after SAH.

The present study is a prospective randomized controlled clinical study. Patients older than 18 years with an aneurysmal SAH will be enrolled. They will be divided into two groups: a control group "C" and a PiCCO group "P". Both groups will be treated according to the current guidelines. In addition, in group P the volume and catecholamine therapy will be controlled by means of PiCCO-controlled monitoring and an algorithm.

The primary end point is the number of occurred delayed cerebral ischaemia per patient. Secondary end points are neurological, pulmonary, cardiovascular, renal, and hepatic complications as well as electrolyte and serum glucose disturbance, sepsis, and mortality, length of hospital and intensive care unit stay and the amount of volume and catecholamines administered.

All participants are to be contacted three months after discharge, and their health status is to be determined by using the GOS (Glasgow Outcome Scale).

Eligibility Criteria:
Inclusion Criteria:

* aneurysmal Subarachnoid Haemorrhage (SAH)
* Age ≥ 18 years

Exclusion Criteria:

* traumatic SAH
* congestive heart failure
* severe diseases of aorta or aortic valve
* pregnancy
* calcium antagonist intolerance
Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To evaluate gallium Ga 68 DOTA-NeoBOMB1 (68Ga-NeoBOMB1) and gallium Ga 68 PSMA-R2 (68Ga-PSMA R2) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients meeting the criterion of biochemical recurrence.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive gallium Ga 68 DOTA-NeoBOMB1 intravenously (IV) and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.

ARM II: Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.

After completion of study, participants are followed up at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

  a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation.

  (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.

(ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).

b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.

(i) A rise of PSA measurement of 2 or more ng/mL over the nadir.

* Able to provide written consent.
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent).

Exclusion Criteria:

* Inability to lie still for the entire imaging time.
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
* Metallic implants (contraindicated for magnetic resonance imaging \[MRI\]).
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

The main objective of the study is to assess the proportion of successfully treated patients (success rate).

That is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema :

Group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage).

Group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + Cellu M6 for 5 days Group 3: Bandages + Cellu M6 for 5 days

Symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (HAS 2012 ISL International Society of Lymphology, 2013).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL)
* Patients suffering from Lymphoedema for 6 months or more
* Patients with a difference between arms \>10%
* Patients who had ever had an axillary node dissection
* Patients hospitalized for intensive standard treatment.

Exclusion Criteria:

* Primary lymphoedema
* Venous insufficiency of the upper members
* severe arterial obstruction
* obliterating arteritis of the upper limbs
* Bilateral lymphoedema
* Breast cancer recurrence
* Another cancer in treatment
* Decompensated heart failure
* Pacemaker
* acute infection
* Deep venous thrombosis
* Skin atrophy of the upper member
* Bullous dermatosis
* Acute dermatitis with epidermitis or dermatitis-hypodermitis
* Infected wound
* Inflammatory scar or consequence of a recent surgery (\<1 month)
* Presence of osteosynthesis equipment under the skin with an external part in the upper member to treat
* Hyperalgesia of the shoulder
* Pregnancy.
Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury

The study aims to evaluate the diagnostic value of urinary indices in differentiating pre-renal and renal acute kidney injury among critically ill patients.

Critically ill patients with acute kidney injury (AKI) will be included. Urinary indices will be obtained immediately after defining AKI, including specific gravity (SG), urine osmolarity (Uosm), urine sodium (UNa), fractional excretion of sodium (FENa), and fractional excretion of urea (FEurea).

The patterns of renal function and hemodynamic status serve as the clinical definition of pre-renal and renal AKI. Hemodynamic status will be evaluated at inclusion and followed during patients' ICU stay. Those who are hemodynamically stable at inclusion are classified as renal AKI. Those who are hemodynamically unstable at inclusion are followed until hemodynamic stabilization. Those with AKI recovery after hemodynamic stabilization are classified as pre-renal AKI. Those without AKI recovery are defined as renal AKI.

Urinary indices are measured again after hemodynamic stability. One of the investigators objectives is to evaluate the diagnostic value of urinary indices using recovery of renal function after hemodynamic stabilization as the definition of pre-renal AKI.

Transesophageal echocardiography (TEE) has been proved to be a reliable method of measuring left renal blood flow during surgical operation. Decreased renal blood flow measured by TEE may serve as an objective definition of pre-renal AKI. The mesurement will be conducted at inclusion if the patient is sedated, intubated, and without TEE contraindication. If the patient is hemodynamically unstable at inclusion, the measurement will be repeated after hemodynamic stabilization. The investigators study also serves the following aims: (1) feasibility of measuring renal blood flow by TEE among critically ill patients; (2) the correspondence between renal blood flow measured by TEE and clinical definition of pre-renal and renal AKI; (3) the diagnostic value of urinary indices in differentiating pre-renal and renal AKI, which is judged by renal blood flow measured by TEE.

Eligibility Criteria:
Inclusion Criteria:

All patients admitted to Medical ICU of PUMCH with one of the following:

* Increase in serum creatinine by ≥ 26.5 umol/l within 48 hours;
* Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;
* Urine volume \< 0.5ml/kg/h for 1 hour.

Exclusion Criteria:

* Obstructive renal disease
* Renal replacement therapy (RRT) for chronic kidney disease
Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692)

This study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day. Patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day no-treatment observation period.


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* have been diagnosed with acute rhinosinusitis
* have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to Baseline
* have had a major symptom score \>=5 and \<=12 at the Screening and Baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe"
* be \>=12 years old
* be in good health overall and normal laboratory tests
* not be pregnant, intending to become pregnant or intending to impregnate.

Exclusion Criteria:

Subjects who:

* have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to Screening
* have fever \>=101°F and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement
* have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens
* have asthma with FEV1\<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days
* have nasal polyps, Kartagener's syndrome, and otitis or atrophic rhinitis
* have certain comorbid conditions or contraindications to certain drug therapies
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male

The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension