cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

* The purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair.
* Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected that could reduce postoperative pain and narcotic consumption.


Eligibility Criteria:
Inclusion Criteria:

* rotator cuff tear
* arthroscopic surgery

Exclusion Criteria:

* age\<45 or \>85
* allergies to the drugs used in the study
* acute trauma history
* history of renal disease
* history of hepatic disease
* osteoarthritis or rheumatic arthritis
* systemic condition with chronic pain
* history of infection
* could not understand the questions
* rotator cuff tear treated by the open technique, by debridement only
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females at least 6 years of age
* History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
* The more severely affected eye having had at least 2 separate recurrences
* The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion
* Visual acuity (VA) of at least 1.4 logMAR units at enrollment
* At time of enrollment, \</=10 anterior chamber cells/HPF and vitrous haze\</= grade 2.

Exclusion Criteria:

* known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
* history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
* presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP \>25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to \<25 mm Hg
* history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
* infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
* ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment
* monocularity
* AIDS
* pregnancy/lactation
* potential for noncompliance
* or participation in other clinical studies within 1 month of enrollment.
The Influence of Leg Elevation on Noradrenaline Requirements During Cesarean Delivery

Spinal anesthesia is a widely chosen technique in obstetric theaters due to several advantages, however sympathetic block results in hypotension that carry several consequences on maternal and fetal health, thus early prediction and management takes high priority. in this regards recent recommendations suggest the use of prophylactic vasopressors like noradrenaline, researchers of this study aimed to explore the impact of leg elevation on prophylactic noradrenaline dose

after spinal anesthesia, patients will be randomly allocated into 2 groups : Leg elevation group and control group.

noradrenaline will be used as variable infusion starting from 0.05 microgram/kg/min up to 0.14 microgram /kg/minute.

noradrenaline infusion will be continued till delivery of the baby

Eligibility Criteria:
Inclusion Criteria:

* full term
* singleton pregnancy
* ASA II

Exclusion Criteria:

* decline to participate
* baseline SBP \<100 mmHg
* failed spinal anesthesia
* allergy to local anesthetic
* coagulopathy
Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)

The object of this study is to measure the levels of B-type Natriuretic Peptide (BNP) in patients with congenital heart disease, normal individuals, and patients with acquired heart failure, and compare the results from each group.

Enrollment: Patients with congenital heart disease seen at Emory Clinics, Adult Congenital Heart Disease program, Crawford Long Hospital will be asked to participate in this pilot study. Sample size: 20 patients (5 in each group) Screening Phase: Demographic data, medical history, physical examination including vital signs and room air oxygen saturation, and medications will be recorded. New York Heart association functional class will be recorded.

BNP Levels: Approximately 7 cc of blood will be collected. The blood will be analyzed for B-type natriuretic peptide on a rapid assay in the clinic.

Exercise Tolerance: will be measured by a 6 minute walk test on day of visit Echocardiogram: A complete echocardiogram including assessment of anatomy, ventricular function and valvular function will be performed following the phlebotomy.

Quality of life: The minnesota living with heart failure questionnaire will be administered on the day of collection of neurohormonal levels. A research nurse will be available to assist the patient if needed.

Eligibility Criteria:
Inclusion Criteria:Patients with a systemic right ventricle and a subpulmonic left ventricle-including patients with transposition of the great arteries (d-TGA) who have undergone Mustard and Senning repairs (atrial switch procedures) and patients with congenitally corrected TGA (l-TGA) Subpulmonic right ventricle in the absence of pulmonary hypertension (repaired tetralogy of Fallot, congenital pulmonic regurgitation) 4-chambered heart Age \> 18 years Participants will have either acquired left ventricular dysfunction (ejection fraction \< 35%) or no known cardiac disease For the control group, individuals will have normal cardiac anatomy and normal left ventricular function (determined by echocardiogram) and no known cardiac disease.

Exclusion Criteria:

Single ventricle and or single atria Liver disease with portal hypertension Renal disease requiring dialysis Creatine \> 4.0 Significant pulmonary hypertension (systolic PAP \>60 mmHg by Echo) Uncontrolled systemic arterial hypertension (systolic \> 200 mmHg or diastolic \>105 mmHg) Myocardial infarction or acute coronary syndrome within 2 months D-TGA status post atrial switch procedure (Jatene) Intracardiac shunts Inadequate echocardiogram windows Coronary Angioplasty 30 days
Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma

The purpose of this study is to determine if pemetrexed is effective in the treatment of primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or has returned after completing treatment.

Despite the aggressive upfront use of methotrexate-based chemotherapy, primary central nervous system lymphoma (PCNSL) almost uniformly results in recurrence or progression and death. Palliative chemotherapy offers an improvement in time-to-progression, symptom control, quality of life, and potentially, survival. However, no established chemotherapy regimen for recurrence exists and new treatments are needed. Pemetrexed is a rationale strategy for therapeutic palliation of recurrent or progressive PCNSL, given its mechanism of action, convenient administration, single agent efficacy, its well established management algorithms, and its evidence of safety and efficacy in systemic malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of Primary Central Nervous System Lymphoma
* Male or female \> 18 years of age or older
* Negative pregnancy test (if of childbearing potential)
* Any number of previous recurrences will be allowed
* Karnofsky Performance Status \> 60
* Hematocrit \> 30,000
* Platelet \> 100,000
* Absolute Neutrophil Count \> 1,500
* Bilirubin \< 1.5 x upper limits of normal
* Transaminases (ALT and AST) \< 1.5 x upper limits of normal
* Creatinine \< 1.5 x upper limits of normal
* Creatinine Clearance \> 45 mL/min
* Adequate medical health to participate in this study
* Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
* Ability to read and understand the patient informed consent form
* Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms

Exclusion Criteria:

* Karnofsky Performance Status \< 60
* Hematocrit \< 30,000
* Platelet \< 100,000
* Absolute Neutrophil Count \< 1,500
* Bilirubin \>1.5 x upper limits of normal
* Transaminases (ALT \& AST) \> 1.5 x upper limits of normal
* Creatinine \> 1.5 x upper limits of normal
* Creatinine Clearance \< 45 mL/min
* Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
Software Refraction With Mobilerone Versus Retinoscopy

Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety.

It's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. The investigators would like to compare its refraction results with retinoscopy.

Eligibility Criteria:
Inclusion Criteria:

* • subject with ametropia on each eye ≤-12.00D

  * subject with best corrected visual acuity ≥ 20/25, no amblyopia
  * subject with normal transparency of eyes
  * subject with a healthy fundus that does not reveal major abnormalities that may affect vision due to the fluctuate situations
  * subject able to cooperate with the screen and the operator
  * subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
  * non-diabetic subject
  * non nystagmus subject
  * non-strabismus subject
  * subject who has not had eye surgery less than 1 year old

Exclusion Criteria:

* • subject with a topography showing an anomaly (keratoconus type or other)

  * subject with hyperopia or presbyopia
  * subject with mild myopia ≥ -1.00D
  * subject who cannot speak with the operator including those staff of local optometrists or ophthalmologists
Targon PH+ Follow-Up

With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.

Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap


Eligibility Criteria:
Inclusion Criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray

* older than 60 years of age
* written and signed patient consent

Exclusion Criteria: - Fractures more than 14 days old

* multiple comorbidity
* multitrauma (Injury Severity Score \> 15)
* prev. surgery on the injured shoulder
* severely deranged function caused by a previous disease head-split proximal humerus fracture
* combined humerus head and shaft fractures
* pseudarthroses
* crushed head cap of the humerus head (AO 11 C3 fractures)
* isolated avulsion fracture of a tuberosity
* unwillingness or inability to follow protocol instructions and study requirements (follow-up visits)
* no signed informed consent
* treatment not in line with Instructions for Use (IfU)
Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea

The purpose of this study is to learn more about how to improve treatment of patients with diarrhea predominant Irritable Bowel Syndrome (IBS-D) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study.

The study aims to determine whether hydrogen breath testing can be used to identify patients with IBS-D who are more likely to respond to rifaximin. Participating patients will complete a one week screening period when brief daily survey will be answered. Eligible patients will proceed with the treatment phase of the study, when patients will receive a 14 day course of rifaximin. All included patients will complete glucose and lactulose hydrogen breath tests before and after rifaximin treatment. Biological samples (e.g. blood, stool) will be collected at pre-determined time points and patients will answer daily brief survey for the duration of the study.

It is anticipated that 210 patients will be screened to reach a goal of enrolling 110 patients for the treatment phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* IBS-D (Rome IV Diagnostic Criteria)
* Diary compliance for at least 5 days and no rescue medications during baseline
* Appropriate levels of abdominal pain and diarrhea

Exclusion Criteria:

* Pregnant women or planning on becoming pregnant while in the study, or lactating women while in the study
* Inflammatory bowel disease, diabetes mellitus, systemic sclerosis, or celiac disease
* Active gastrointestinal or hematological malignancy which requires ongoing treatment
* Surgery to the GI tract in the past 3 months
* Gastrointestinal infection or diverticulitis in the past 3 months
* Severe hepatic impairment
* Any use of antibiotics in the past month
* Current use of probiotics
* Any history of allergies to rifaximin or its derivatives
* Any comitant use of P-glycoprotein inhibitors (for example. Cyclosporine)
* Known allergies to glucose or lactulose
Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia

Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not.

Antenatal corticosteroids (ACS) are widely used to enhance fetal lung maturation in pregnancies at risk of preterm birth. However, their role in early-term pregnancies (37 to 38 weeks gestation) prior to planned cesarean section has been gaining attention. Early-term neonates delivered by cesarean section are at an increased risk of respiratory complications, and studies have shown that ACS can reduce these risks by accelerating fetal lung development. The use of ACS in this population, however, has raised concerns about its potential effects on neonatal metabolic outcomes, particularly neonatal hypoglycemia.

Neonatal hypoglycemia, a common metabolic disorder in the early postnatal period, is often associated with antenatal corticosteroid exposure. ACS may increase fetal insulin production by stimulating pancreatic beta cells, leading to an increased risk of hypoglycemia after birth. Research indicates that while ACS effectively reduces respiratory morbidity in early-term neonates, it may concurrently raise the risk of neonatal hypoglycemia. For instance, a meta-analysis found a significant association between ACS and an increased incidence of hypoglycemia in term and near-term infants.

Given these findings, research is crucial to assess the balance of risks and benefits of ACS in early-term cesarean deliveries. While ACS appears to reduce respiratory complications, understanding its full impact on neonatal hypoglycemia will help guide its use in clinical practice

Eligibility Criteria:
Inclusion Criteria:

- 1. Women with singleton pregnancies at 37-38 weeks of gestation (early-term) scheduled for planned cesarean sections.

2. Participants who have received antenatal corticosteroids prior to cesarean section as part of their prenatal care.

Exclusion Criteria:

* 1. Women delivering before 37 weeks or after 39 weeks of gestation would be excluded, as the study focuses on early-term deliveries.

  2. Women with any form of diabetes, including pre-existing type 1 or type 2 diabetes, and gestational diabetes. This ensures that the study focuses on non-diabetic populations, as diabetes can independently affect neonatal glucose regulation and complicate the assessment of hypoglycemia risk due to corticosteroids.

  3. Women with severe maternal health such as preeclampsia, chronic hypertension, or other systemic illnesses, might be excluded to avoid confounding variables.

  4. Women who did not complete the full course of antenatal corticosteroids may be excluded, as the effect of partial doses could differ from complete treatment.

  5. Women with multiple gestations (e.g., twins or triplets) may be excluded due to the added complexity of multiple-birth pregnancies and their unique risk.

  6. Neonates with known congenital anomalies, genetic disorders, or other pre-existing medical conditions that could affect glucose metabolism
Comparative Effects of Instrumental Assisted Soft Tissue Mobilization and Sustained Stretching Among Hockey Players

Effect of instrumental assisted soft tissue mobilization over sustained stretching in hockey players on improving quadratus lumborum flexibility.

To find the effect of instrumental assisted soft tissue mobilization over sustained stretching in hockey players on improving quadratus lumborum flexibility.

Eligibility Criteria:
Inclusion Criteria:

Age group of 16-26 years. Male and female Deficit of thoracolumbar Range of Motion with QL tightness Participates with moderate pain as per the ODI (20%-40%)

Exclusion Criteria:

Not fit in the age group Who have muscles injury from last 6 months Who have ODI score less than 20% Who do not involve QL tightness
Depression in Alzheimer's Disease-2

The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.

Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education.

Eligibility Criteria:
Inclusion:

* Ability of the participant, caregiver or surrogate to provide written informed consent.
* Dementia due to Alzheimer's disease
* Stable treatment for Alzheimer's disease
* Ability for the participant's caregiver to accompany the participant to study visits and participate in the study.

Exclusion

* Presence of a brain disease that might otherwise explain the presence of dementia
* Clinically significant hallucinations or delusions
* Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications
* Need for hospitalization or residence in a nursing facility
Role of Pseudogene in Incontinentia Pigmenti, and Its Potential Treatment

Incontinentia Pigmenti (IP) is an X-linked dominant ectodermal dysplastic disorder. It is due to loss of function of NF-Kappa B Essential Modulator (NEMO, inhibitor of Kappa light polypeptide gene enhancer in B cells, Kinase of Gamma, IKBKG), an important regulator of the NF-kB pathway. Major clinical manifestations of IP include swirling skin pigmentary changes, and anomalies in organs including the eyes, dental, bones, nervous system, and heart. Affected male mostly die before birth. Older patients might have immunodeficiency, psychomotor retardation, and seizures. Prenatal diagnosis is difficult. IKBKG gene is 35 kb in length, and contains 10 exons. A pseudogene (∆NEMO, IKBKGP), located distal and in inverse direction to the true gene, contains only exon 3-10. In patients with IP, the most common mutation was exon 4-10 large deletion. But the investigators have found small mutations derived from the pseudogene in Taiwanese patients.

The three aims of this study are the role of pseudogene in IP, the frequency of recombination between IKBKG and IKBKGP, and possible treatment. To achieve the first aim, the investigators first develop a pseudogene-specific polymerase chain reaction (PCR). The investigators will first obtain the frequency of IKBKGP gene mutation in normal individuals. The investigators will then detect IKBKGP related mutations in IP patients presenting classical or non-classical symptoms. The latter group of patients, who may have isolated hair, teeth, retinal, or immune problems, are more likely to be caused by point mutations. The second aim of this study is to estimate the incidence of IKBKG and IKBKGP recombination. Because these two genes are in opposite position, recombination after DNA loop back is likely to occur in somatic cells. The investigators will transform lymphocytes containing IKBKGP mutation, and culture them continuously. IKBKG mutation will be check intermittently and the incidence can be estimated. The third aim is to find a treatment. The investigators will test the read-through drug gentamycin and PTC2124 for nonsense mutation. Either fibroblast or Epstein-Barr virus (EBV) - transformed lymphoblasts will be tested. The investigators hope this study with not only increases our understand to IP, and also improves the investigators' knowledge toward genetic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed to have Incontinentia Pigmenti

Exclusion Criteria:

* None
Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)

This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences


Eligibility Criteria:
Inclusion Criteria:

* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
* Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
* No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
* In good health (except for Type 2 Diabetes)
* Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
* Nonsmoker

Exclusion Criteria:

* History of stroke, chronic seizure or major neurological disorder
* History of cancer
* History of Type 1 Diabetes
* Recent history of eye infection
* Glaucoma or blindness
* Eye surgery (by incision or laser) within the past three months