cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Pascal Laser Trabeculoplaty

Laser Trabeculoplasty has been shown to be effective in lowering intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). Although initially demonstrated with the Argon laser (ALT), several other laser systems have also been employed with comparable efficacy. Recently, Selective Laser Trabeculoplasty (SLT) has been shown to lower intraocular pressure comparable to ALT. The advantage of SLT is that the target eye structure, the trabecular meshwork, remains intact with minimal damage at the cellular level. In contrast, ALT lowers IOP at the expense of scarring of the trabecular meshwork. The purpose of this study is to evaluate the efficacy of lowering IOP with Pascal Laser Trabeculoplasty (PLT) employing reduced energy levels compared to ALT and a computer guided pattern of laser treatment applications.


Eligibility Criteria:
Inclusion Criteria:

1. Otherwise healthy males and females, older than 18 years of age with two (2) sighted eyes
2. Have OAG, PXG, or combined mechanism glaucoma - as long as their angles are open
3. Have uncontrolled IOP (\>24mmHg); or controlled with Medicine(s)
4. If on medical treatment, have undergone a washout period of at least one month prior to Pascal treatment
5. Able and willing to comply with the treatment/follow-up schedule and requirements;
6. Able to provide written informed consent

Exclusion Criteria:

1. Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
2. Have an advanced visual field defect within 10° of fixation
3. Have had previous glaucoma surgery, except for peripheral iridotomy
4. Have corneal disease obviating the use of corneal applanation for a reliable IOP measurement, or would cause difficulty in viewing the TM by means of gonioscopic lens
5. Using systemic steroids
6. Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
7. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
8. No concomitant use of IOP lowering medicine (Group 1)
9. No co-existing ocular pathology with the exception of Cataract.
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis

Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.

Evaluation of Safety, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.

The overall objectives are to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS 416858 in ESRD patients on hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease maintained on outpatient hemodialysis at a healthcare center for \> 3 months from screening with hemodialysis using heparin (unfractionated heparin or low-molecular weight heparin) 3 times per week for a minimum of 3 hours per dialysis session and plan to continue this throughout the study.

Exclusion Criteria:

* Documented thrombotic event (acute coronary syndrome, stroke or transient ischemic attack, venous thromboembolic event) in the past 3 months.
* Active bleeding within the past 3 months from screening or documented bleeding diathesis (history of bleeding disorder) or Screening values of:

  * Platelet count \< 150,000 cells/mm3
  * INR \> 1.4
  * aPTT \> upper limit of normal (ULN)
* Abnormal liver function at Screening:

  * ALT or AST \> 2 x ULN
  * Total bilirubin \> ULN
* Concomitant medication restrictions: Concomitant use of anticoagulant/antiplatelet agents (e.g., dabigatran, rivaroxaban, clopidogrel) that may affect coagulation (except low dose aspirin (≤ 100 mg/day) during Treatment and Post-treatment Evaluation Periods is not allowed.
* Uncontrolled hypertension as judged by the Investigator. Patients with a pre- or post-dialysis blood pressure (BP) that is \> 160 mmHg on at least 3 of last 5 dialysis treatments.
* Planned major surgery in the next 6 months (e.g. renal transplant surgery)
Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)

The objective of the study is to compare clinical outcomes from PRK and SBK using FDA-approved laser technology in the same patient

Patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with PRK and the fellow eye treated with SBK.

Eligibility Criteria:
Inclusion Criteria:

* Patients deemed to be suitable candidates for bilateral LASIK surgery

Exclusion Criteria:

* Patients who desire monovision correction rather than bilateral distance correction
Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Subject referred for a screening or surveillance colonoscopy
* Subject is aged 40 years or older
* Subject has the ability to provide informed consent

Exclusion Criteria:

* Prior history of colon cancer
* History of inflammatory bowel disease
* Prior surgical resection of any part of the colon
* Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
* History of polyposis syndrome or HNPCC
* Family history of colon cancer in a first-degree relative \< 60 years or two first degree relatives with colorectal cancer
* Inability to provide informed consent
Nonincised Papillae in the Treatment of Intrabony Defects.

The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.

Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.

In order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.

Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.
2. Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.
3. Adequate attached gingiva of 3mm and vestibular depth of 8mm. -

Exclusion Criteria:

1. Uncontrolled systemic disease.
2. Pregnancy and lactation.
3. Defects involving lingual sites.
4. Presence of restoration in the experimental teeth.
5. Smokers -
Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars

Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.

Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.

Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.

Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.

Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale


Eligibility Criteria:
Inclusion Criteria:

* Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
* Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
* Patients whose parents will give their consent to participate

Exclusion Criteria:

* Children with any systemic disease or special health care.
* History of allergy to local anesthesia.
* Radiographic evidence of periapical or inter-radicular radiolucency
* Patients with previous negative dental experience.
* Presence of soft tissue lesions at the site of injection.
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)

This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* have been previously identified through the previous study P03031 to be atopic or with chronic idiopathic urticaria and be a poor metabolizer of desloratadine.
* have clinical laboratory tests within normal limits.
* be in good health, free of any clinically significant disease that could interfere with the study.
* normal 12-lead ECG

Exclusion Criteria:

Subjects who:

* have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to treatment.
* have taken any medication that is restricted by the protocol or failed to satisfy washout requirements.
* are allergic to desloratadine.
* have used a loratadine- or desloratadine-containing product within the past 30 days.
* are female and menstruating.
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection

This study will examine whether moderate alcohol use in the context of HIV infection exacerbates inflammatory signaling in the immune system and brain. The study will recruit healthy individuals and people living with HIV infection who are otherwise in good health to participate. Participants will complete an experimental protocol that involves controlled alcohol administration and magnetic resonance imaging (MRI). Primary outcomes are plasma biomarkers of inflammation and MRI markers correlated with neuroinflammation. Results will advance understanding of the effects of alcohol use in people living with HIV infection.

A sample of 56 participants, to include equal numbers of PLWH and uninfected controls, will be recruited to complete the experimental protocol. Participants will be randomized to one of the two beverage conditions (0.60 g/kg alcohol beverage, 0.00 g/kg placebo beverage). Blood samples will be collected at baseline (prior to beverage administration) and for three hours afterward. Cognitive performance and subjective intoxication will be assessed using standardized measures. MRI scans will be collected 4-5 hours after beverage consumption to capture neurobiological outcomes on the descending limb of blood alcohol.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 60 years of age
* able to speak and read English at least at 8th grade level
* alcohol use as defined by study protocol
* body mass index of 18.5-30 kg/m2
* Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection
* HIV-1 serostatus confirmed by standard clinical testing
* HIV-specific criteria for antiretroviral medication use and lab parameters
* Able to consume soy and nuts safely

Exclusion Criteria:

* heavy drinking as defined by study protocol
* treatment for alcohol/drug use, with exception of smoking cessation
* use of specific medications in the past month
* daily use of specific over-the-counter drugs
* disorder of the lower GI tract
* positive urine drug test or screening for drug use disorder
* current major psychiatric disorder
* history of significant problems from blood draw
* safety contraindication for MRI
* head trauma with loss of consciousness \> 10 min
* inability to abstain from nicotine during study session
* inability to abstain from cannabis before and during study session
* pregnant, breastfeeding, or not using effective birth control
* any other clinical condition or therapy that, in the physician's opinion, would make the individual unsuitable for study or unable to comply with dosing requirement
Effects of PEP on IC During IT in Patients With COPD

This study will investigate the effects of positive expiratory pressure (PEP) on hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Inspiratory capacity (IC) is the primary outcome

This is a cross-over intervention assessing the effect of PEP on IC and dyspnea in patients with COPD performing an interval training (IT) session.

IC will be measured before, during and immediately after the IT session. Each participant will receive perform IT sessions including either the use of a PEP of 10 cmH2O or a PEP of 1 cmH2O. The effects on IC and dyspnea on both PEP levels will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Stable COPD since 1 month at least
* Able to understand the instructions

Exclusion Criteria:

* COPD with a forced expiratory volume at one second \> 80% of predicted values
* In exacerbation
* Orthopedic of neurological condition likely to interfere with the experimentation
* Contraindication to perform exercise
Analysis and Accuracy of Mortality Prediction Scores

Patients admitted to the ICU in a tertiary burn centre in Kuwait were analysed using multiple mortality prediction scores. The accuracy of these scores were compared to each other to ascertain which prediction modality provides the most accurate prognosis.

The aim of this study is to determine the accuracy of three established scoring systems used for burn patients admitted to the intensive care unit and to determine the risk factors associated with poor outcomes.

A total of 211 patients with who were admitted to the ICBU in a tertiary care centre in Kuwait from January 2017 to December 2019 were analysed retrospectively. Data were collected using patient medical records. The FLAMES, BOBI and revised Baux scores were calculated, and the survivor and non-survivor scores of patients were analysed to determine the sensitivity, specificity and Area Under the Receiver Operating Characteristics (AUROC) of the different scoring modalities.

Eligibility Criteria:
Inclusion Criteria:

Pediatric burn patients with partial/full thickness burns\>10% TBSA Adult patients with partial/full thickness burns \>15% TBSA Patients with electric burns Patients iwth burns involving the voice Any patient with suspected inhalational injury Burn patients with significant comorbidities

Exclusion criteria:

Patients with incomplete data records
Interest of a Period of Fasting Before Extubation in Resuscitation Patients

Orotracheal extubation in resuscitation is a situation in which there is an elevated risk of inhalation. In resuscitation, enteral nutrition that is administered in a continuous flow is likely to accumulate in the stomach. Gastric motility in resuscitation patients may be impaired for many reasons:

* Iatrogenic: Catecholamines, sedatives and opioids slow down the digestive system and decrease the tone of the lower esophageal sphincter
* Shock, polytrauma, sepsis, pain or discomfort, or mechanical ventilation again create an alteration in gastric emptying.

Enteral nutrition is commonly discontinued to manage extubation, but it is not systematic. Discontinuation leads to a decrease in caloric intake.

Gastric ultrasound is a minimally invasive, reliable and promising means of monitoring that allows the stomach to be visualized directly. Studies on healthy subjects and in anaesthesia have made it possible to validate ultrasound in the context of the study of gastric content using both quantitative (including measurement of the antral area) and qualitative criteria. Measurement of the antral area was also studied in resuscitation. Antral area and gastric volume are closely related, with a correlation coefficient ranging from 0.6 to 0.91.

Identifying patients at risk of inhalation by ultrasound could allow individualized enteral nutrition management prior to extubation in the resuscitation unit, and thus optimize nutritional management.

The objective of the study is to identify factors associated with greated antral area in patients hospitalized in the intensive care unit. The hypothesis is that continued enteral nutrition before extubation is associated with increased gastric volume as measured by ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Person or next of kin/designated representative has provided his or her non-opposition
* Patient in medical or surgical intensive care, admitted for an urgent medical or surgical reason and for whom extubation have been planned by the practitioner in charge of the patient

Exclusion Criteria:

* Person subject to legal protection (guardianship, trusteeship)
* Person subject to a justice safeguard measure
* Pregnant, parturient or breastfeeding woman
* Minor
* Anechoic patient or patient without an exploitable ultrasound window
* History of gastric or esophageal surgery
* Limitation of Care (LOC) order
Functional Exercises for Chronic Low Back Pain

Non-specific low back pain is a common condition. Exercise is effective treatment for chronic low back pain. We hypothesized the functional exercise group will present pain reduction and functional improvement.

The purpose of this study is investigated the effectiveness of an functional exercise program for people with nonspecific chronic low back pain. Patients will be randomly divided into 2 groups: control group (minimal intervention - mini back school and analgesic) and group will receive a functional exercise protocol associated with minimal intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 50 years
* Low back pain for more than 3 months
* Low back pain with numeric pain scale between 3 - 8 cm
* Understand Portuguese well enough to be able to fill in the questionnaires

Exclusion Criteria:

* Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
* Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
* Less than 6 months after lumbar spine, lower limb or abdomen surgery
* Previous spinal surgery;
* Previous spinal infiltration for pain relief in the last 3 months;
* Several scoliosis;
* Litigation;
* Pregnancy;
* Fibromyalgia;
* People who had changed physical activity or undergone physical therapy in the previous 3 months;
* Presence of any contraindication to exercise;
* Planned travel in the next 12 weeks;
* Geographic inaccessibility.
Massage for Post Breast Surgery

The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages.

Post-operative breast surgery patients may face an array of complications. Breast surgery can include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012). Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and persistent issues in this population, however it is still unclear as to how many actually suffer from these (Wallace 1996). Current treatment for each of these usually includes prescribed narcotic pain medication and/or some physical therapy, the first being a treatment with many side effects, the latter being quite expensive. Global and integrated massage techniques have been used as a way of decreasing stress, anxiety, and some self-reported pain, however a targeted massage technique geared towards the breast/chest/shoulder region has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an effective treatment for other post-surgical patients in reducing pain and increasing mobility, but efficacy has yet to be shown specifically in post-breast surgery patients (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive and non-invasive addition to current pain and mobility treatment (Cassileth 2004).

Specific Aims

Aim A.

Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain among patients who have undergone a mastectomy or other breast surgery.

Aim B.

Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in increasing self-reported mobility in the affected shoulder among patients who have undergone a mastectomy or other breast surgery.

Hypothesis: Compared to control patients receiving general full body massage, myofascial massage specific to the breast/chest/shoulder area reduces pain and increases mobility in patients who have undergone breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age range 21-79 years of age
* Female
* Breast and/or axillary surgery
* 2-18 months post-operative
* Meets minimum pain and/or lack of mobility threshold as determined by survey
* Ability to give informed consent
* Ability to complete adherence task
* Benign or malignant forms of disease

Exclusion Criteria:

* History of blood clots
* Mentally incompetent
* Non-English speaking
* Infected sites or open wounds
* Currently lactating
* Currently receiving massage therapy for breast surgery
* Currently taking anticoagulants including:

Cilostazol Clopidogrel Ticlopidine Prasugrel Ticagrelor Dipyridamole Warfarin Dabigatran Rivaroxaban Apixaban Abciximab Eptifibatide Tirofiban Dalteparin Enoxaparin Fondaparinux Heparin Tinzaparin Argatroban Bivalirudin Lepirudin