cyrilzakka/clinical-trials huggingface dataset:
Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study

Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy.

Ablation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall.

Because AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).

In this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic persistent atrial fibrillation
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI safe.
* Patients unable to undergo general anaesthesia for AF ablation.
* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery
* Previous thoracic surgery
* Participation in a conflicting study
* Participants who are mentally incapacitated and cannot consent or comply with follow-up
* Pregnancy
* Other cardiac rhythm disorders
Assessment of Pupil Light Responses in Patients With Parkinson Disease

Parkinson diseases (PD) is the second most common degenerative disease of the central nervous system. The development of early diagnostic biomarkers may help identify at-risk individuals and allow precocious interventions at the onset of disease and more precise monitoring of therapies that may slow disease progression.

Proof of concept studies indicated significant differences in pupil light response between PD patients and healthy controls. The feasibility of using pupillometry for assesment of PD will be examined.


Eligibility Criteria:
Inclusion Criteria:

* General inclusion criteria

  1. Age 30-75 years old
  2. Signed written informed consent
  3. Gender: Both (Male and Female)
  4. Pupillary reflex to light.
  5. Clear ocular media

Patients' Inclusion Criteria:

Patients with clinical presentations of the neurodegenerative forms of parkinsonism (bradykinesia, extrapyramidal rigidity, tremor, postural instability and gait disturbance) including: idiopathic Parkinson disease (PD), Lewy body disease (LBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD) and secondary parkinsonisms.

Control group- inclusion criteria

1. Normal eye examination
2. Best-corrected visual acuity (BCVA) of 20/20
3. Normal color vision test (Farnsworth/Lanthon D-15 Test)
4. No present ocular disease
5. No past ocular disease or surgery within last 6 months
6. No use of any topical or systemic medications that could adversely influence efferent pupil movements
7. Normal 24-2 Humphrey visual field and

   * Short duration (≤10 minutes)
   * Minimal fixation losses, False positive errors and False negative errors (less than 30% for each one of reliability indices)

Exclusion Criteria:

1. Diagnosis of dementia.
2. Cognitive decline that may impair obtaining informed consent.
3. Tremor or dyskinesia that could interfere with ophthalmic evaluation
4. History of past (last 3 months) or present ocular disease or ocular surgery
5. Use of any topical or systemic medications that could adversely influence pupillary reflex
6. Psychiatric illness, active psychosis.
7. Previous neurosurgical interventions, including stereotactic neurosurgical procedures.
8. Past or current strokes or brain injury and other brain disorders (except PD/parkinsonism for patient group)
9. Anti-dopaminergic drugs.
10. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tomometry or other schedule study procedure.
11. Visual media opacity including cloudy corneas.
12. Any condition preventing accurate measurement or examination of the pupil.
Insulin Detemir and Waist Circumference

The purpose of the study is to investigate the weight-sparing effect of detemir and assess glycemic control and treatment satisfaction when switching from NPH to detemir, to improve metabolic control.


Eligibility Criteria:
Inclusion Criteria:

* Duration of type 2 diabetes for at least 12 months
* BMI \<40 kg/m2
* HbA1c \>7.5%
* Requiring basal insulin replacement and previously treated with NPH insulin
Virtual Reality vs. Standard-of-Care for Comfort During Dental Procedures in Children

Children sometimes need dental procedures which can be painful and associated with child pain and anxiety. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (4 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during dental procedures. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Children age 4 to \< 17 years
2. Arriving to the UBC dentistry clinic and need dental assessment/procedures
3. Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, challenging communication)
2. Facial features prohibiting wearing the VR goggles
3. Children needing sedation that includes inhalation via a mask (N2O) or IV/IM sedation
Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession

A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective tissue graft harvesting compared to conventional scalpel surgical technique in the treatment of class I and II Miller gingival recession.

Twenty four patients suffering from isolated Class I and II Miller gingival recession defects in anterior esthetic region were enrolled in this study. They were randomly assigned into three groups; de-epithelialized connective tissue graft harvesting technique or; conditioning the exposed root surfaces with Er,Cr:YSGG laser before connective tissue coverage using scalpel blade harvested de-epithelialized connective tissue graft harvesting technique, or; conditioning the exposed root surfaces with the Er,Cr:YSGG laser before Er,Cr:YSGG laser harvested connective tissue using de-epithelialized technique. Clinical and radiographic parameters were recorded at baseline and at 3, 6 and 9 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Single class I, II Miller gingival recession defects (≥ 2mm in depth), presence of identifiable buccal cemento-enamel junction (CEJ) and presence of a step ≤ 1 mm at CEJ.
2. Controlled periodontal disease
3. Full-mouth plaque score of \<10%; full-mouth gingival score of \<15%
4. Patients available for 9 months follow-up period.

Exclusion Criteria:

1. Smokers.
2. Pregnant and lactating females.
3. Taking medications known to interfere with periodontal tissue health or healing.
4. Previous periodontal surgery on the involved sites.
5. Non-vital teeth.
6. Molar teeth.
7. Recession defects associated with caries or restoration.
8. Occlusal interferences.
9. Taking anti-inflammatory drugs or antibiotics in the past 6 months.
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.

Key Exclusion Criteria:

* Active COVID-19 that is unresolved
* History of SBP
* History of EVB or AKI-HRS within 6 months
* History of OHE episode (Conn score ≥ 2)
A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area

This study will evaluate the efficacy of the DIME Beauty Luminosity Eye Serum in improving the appearance of skin in the periorbital eye area. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 30, and Day 60, photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.


Eligibility Criteria:
Inclusion Criteria:

* Females age 18-65.
* Have visible dark circles under the eyes.
* Have puffy eyes.
* Have bags under the eyes.
* Have visible fine lines and wrinkles around the eyes.
* Have a smartphone or camera to take before-and-after selfies.

Exclusion Criteria:

* Anyone not in good health.
* Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
* Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
* Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
* Anyone who cannot/ will not commit to the study protocol.
* Anyone with a history of substance abuse.
The Effects of Allogeneic SLET

To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.

Simple limbal epithelial transplantation (SLET) was introduced in 2012 by Sangwan and coworkers to overcome the issues mainly related to the cost of a GMP-certified product and ease of surgical manipulations that al- lows use of smaller pieces of limbus from the contralateral eye (thus avoiding iatrogenic problems). A completely epithelialized, avascular and stable corneal surface was achieved by 6 weeks and was maintained in all recipient eyes at a mean follow-up of 9.2 ± 1.9 months. Best corrected visual acuity improved from worse than 20/200 in all recipient eyes before surgery to 20/40 or better in four (66.6%) eyes. None of the donor eyes developed any complications.Basu et al. reported autologous SLET on a population of 125 patients which included 65 adults and 60 children suffering from unilateral LSCD. 76% (95/125) of eyes maintained a successful outcome at final follow-up without progressive conjunctivalization, development of persistent epithelial defect, infection, or need for repeat SLET. Survival probability of 80% in adults and 72% in children after 1 year. So far, most of the reports have been about autoSLET, that is, the limbal explants are obtained from the unaffected eye of the same recipient, avoiding immune reaction at the later stage. Also, they demonstrated SLET had promising result both in adults and children. A study by Iyer and coworkers used alloSLET in early stages after ocular chemical injury to achieve rapid epithelialization. Instead of taking the biopsy from the recipient's healthy eye, they took it from a cadaveric donor and performed the SLET. Epithelialization and improved best corrected visual acuity and corneal phenotype were achieved at early stages; however, 7 of 18 eyes had a gradual failure of the allograft, and 5 eyes underwent subsequent limbal autograft. Symblepheron formation involving one to two quadrants was recorded in 3 eyes (16.7%). Visual rehabilitative procedures in the chronic phase of chemical injury, in most instances after alloSLET in the acute stage, did not require any keratoplasties. Unfortunately, most diseases causing limbal deficiency, e.g., surface burns (alkali/ thermal), Stevens-Johnson syndrome, contact lens-related epitheliopathy, and ocular cicatricial pemphigoid, tend to affect both eyes of a patient. Autologous SLET may not be applicable in patients with bilateral eyes involvement. In this study, the effect of allogeneic SLET will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 10 to 90 years old
2. The lesion eye has at least grade 2 limbal stem cell deficiency
3. The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth
4. The symptoms last for at least 6 months and do not improve with medication

Exclusion Criteria:

1. The symptoms improve spontaneously or with medication
2. Someone who can not be examined regularly after the operation
3. Poor prognosis
4. Severe lagophthalmos or trichiasis that has not been corrected
5. Ocular infection
Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent

To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent.


Eligibility Criteria:
Inclusion Criteria:

Pregnancy 24 weeks' gestation Preterm labor in previous pregnancies

-

Exclusion Criteria:

* No medications for PTL or any kind of progesterone.
* Cervical suture
* Multiple pregnancy
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1

The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),

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 link provided in More Information.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Primary Hyperoxaluria Type 1

Exclusion Criteria:

* Clinically significant health concerns (with the exception of PH1)
* Received an investigational agent within 30 days before the first dose of lumasiran or are in follow-up of another clinical study
* Previously or currently participating in lumasiran clinical study
* History of liver transplant
Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients

The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.

The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.

Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal tests if performed at the discretion of the treating provider (e.g. blood culture results, radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will use these other fungal tests, in addition to clinical criterion, to classify subjects as having possible, probable and proven IFD according to established criteria, and compare these categories against results from NGS analysis.

Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic load in subjects with positive results.

Eligibility Criteria:
Inclusion Criteria:

* Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated delayed neutrophil recovery
* Any findings that trigger the primary team to consider new fungal infection in a given inpatient, such as abnormal imaging results, recrudescent fevers in the setting of neutropenia or characteristic skin rashes

Exclusion Criteria:

-Those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study
Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection

This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 80 years,male or female
2. Lower extremity atherosclerotic occlusive disease
3. After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
4. Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent

Exclusion Criteria:

1. The target lesion has been stented or previously treated with bypass surgery
2. Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
3. Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
4. More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
5. The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
6. Planned amputation on the target limb
7. Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
8. Uncontrollable infections
9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
10. Participating in clinical trials of any other drug or medical device and not yet out of the study
11. Other circumstances not suitable for inclusion as judged by the investigator
High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients

the results of this study may provide an easy non pharmacological modality for dealing with diabetic polyneuropathic pain. Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of diabetic polyneuropathy. In Addition, increased knowledge of the influence of High tone power therapy on neuropathic pain

This study will be carried out on sixty diabetic male patients with polyneuropathy with ages 50-60 years . Patient will be randomly assigned to two grouos. group A will include 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced for 3 times per week, for 3 months for 30 minutes every session.

Group B :

This group will include 30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention.

Eligibility Criteria:
Inclusion Criteria:

* The patient selection will be according to the following criteria:

  1. Sixty male patients are diagnosed with diabetic polyneuropathy their ages will be ranged from 50-60 years old.
  2. All patients are ambulant independently.
  3. All patients are under full medical control
  4. HbA1c is ranged from 6.5 : 7 %.
  5. Patients has diabetes more than 10 years.

Exclusion Criteria:

* The participants will be excluded if they meet one of the following criteria:

  1. Psychiatric disorders or seizures.
  2. Visual and auditory impairment or tremors influencing balance.
  3. Other neuromuscular disorders.
  4. Foot deformities and ulcers.
  5. Lower limb operations.
  6. Feverish systemic infection
  7. cardiac pacemaker.
The Effect of Pomegranate Peel, German Chamomile or Their Combination on Gingivitis

The aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing German chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. The response will be assessed clinically and by suitable biochemical parameters.

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University.
4. The 60 participants will be randomly assigned into 5 groups. Group 1: Patients will be managed by scaling. Group 2: Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.

   Group 3: Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily.

   Group 4: Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.

   Group 5: Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.
5. All patients will be submitted to:

   * Full patient history and clinical examination.
   * Gingival index will be measured
   * Saliva samples will be obtained in order to conduct ELISA for the selected biomarkers.
   * Different mouthwashes will be provided to patients.
6. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
7. Results, conclusion, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25-50
* Patients with plaque induced gingivitis.

Exclusion Criteria:

* Patients with systemic diseases (diabetes, leukemia, anemia)
* Smokers
* Pregnant females
* Patients receiving orthodontic treatment