cyrilzakka/clinical-trials huggingface dataset:
Genetic Component of Handedness

Some functions are generally controlled by the right side of the brain and others by the left. One of the most easily observed examples of this "lateral specialization" of the brain is handedness-that is, a person's preference for using either the right or the left hand. This study will try to determine how the genetic component of handedness is inherited. It will test the theory that a single gene is involved in determining handedness and will try to locate the gene.

Families with at least two left-handed siblings aged eight years or older and at least one right-handed parent are eligible to participate in this study.

The left-handed siblings and both parents will fill out a brief questionnaire on hand usage, obtain a tissue sample taken from inside the cheek, and return the questionnaire and the sample by mail to the study researchers. The tissue sample will be used for DNA gene mapping.

Participants will be given a kit and instructions for obtaining the sample, along with mailing envelopes. Cheek swab sampling basically involves using a small brush to gently brush a layer of cells off of the inner wall of the cheek and then dropping the brush tip into a preservative.

The information gained from this study may provide insight into aspects of brain development that can be of medical benefit in the future.

The purpose of this protocol, based on the hypothesis that human hand-use preference (handedness) is largely dependent on the action of a single locus, is to collect samples allowing us to map a "handedness gene" via detection of linkage to any of eight potential candidate genes/regions or via a whole or partial genome scan. We calculate that a full 300 marker genome scan of 100 parents and sibling pairs (allowing linkage analysis at 10 cM resolution), or the equivalent amount of data from partial scans of 300 families, has a high likelihood of allowing us to map the proposed gene. Eligible families, consisting of pairs of left-handed siblings plus at least one right-handed parent, were identified during Phase I of this study in 1996-1998, with approval from the now-lapsed FCRDC IRB. In Phase II of this study, we have collected cheek swab samples for DNA isolation from members of 100 eligible families for use in the mapping studies. DNA samples will not be linked back to individuals but grouped under a random family code that links to a database with limited information, including hand use preference and family structure. In the next phase, we wish to map the locus from cheek swab samples we have on hand.

Eligibility Criteria:
INCLUSION CRITERIA:

Members of families meeting the following criteria are eligible to participate:

Have two left-handed siblings.

Have at least one right-handed parent with no other known left-handed first degree relatives.

EXCLUSION CRITERIA:

All members of a family may be excluded if the right-handed parents or the left-handed siblings will not participate.

Individuals in families whose left-handed siblings are under the age of eight are not eligible to participate.
ERAS in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair

Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. The aim of this randomized controlled clinical trial was to investigate the feasibility of enhanced postoperative recovery pathways in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Randomization will be made at the end of the surgical procedure. Patients will be included in groups 1 or2. Group 1 is the control group and will receive standard postoperative care, and group 2 is the ERAS group.The aim of this randomized controlled clinical trial was to investigate the feasibility of ERAS in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Eligibility Criteria:
Inclusion Criteria:

1. Perforated ulcer less than 10 mm in size
2. Patients received laprascopic repair

Exclusion Criteria:

-

1. refusal to join the study or sign the informed consent form 3. age younger than 18 years 3.the presence of any psychiatric or neurologic disease 4. class 3 and 4 surgical patients according to the classification of The American Society of Anesthesiologists 5. septic shock on admission 6. pregnancy 7. multiple perforated peptic ulcers 8. spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair 9.conversion to open technique 10. perforated ulcers that were not amenable to Graham patch repair because of size or technical considerations
Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.

This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* first-ever stroke, with spasticity within 3-months (MAS=2\~3)
* independent walking 10 meters (with assistive devices)

Exclusion Criteria:

* recurrent stroke, cognition impaired
* lower limb fracture
* received anti-spasticity injection in the past
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.


Eligibility Criteria:
Inclusion Criteria:

* Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
* Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
* Study eye must:
* Have active leakage on Fluorescein Angiogram involving the fovea
* Have edema involving the fovea
* Be free of scarring, fibrosis, or atrophy involving the central foveal zone

Exclusion Criteria:

* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment
Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.

The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.

Eligibility Criteria:
Inclusion Criteria:

* Participants Inclusion:

  • Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion
* Teeth Inclusion:

  * Vital teeth with carious cervical lesions in incisors , canines ,premolars\& molars

Exclusion Criteria:

* Participants Exclusion:

  * Patients with fewer than 20 teeth
  * Poor oral hygiene
  * Uncontrolled periodontal disease
  * Xerostomia
  * Known allergy to resin-based materials
  * Medically compromised, pregnant, or breast-feeding
* Teeth Exclusion:

  * Non vital teeth
  * Teeth that are out of occlusion
  * Previously restored teeth
Electrophysiologic Changes in Blacks Treated With CBT for Insomnia

Insomnia is a highly prevalent, often debilitating, and economically burdensome condition. Reviews of the literature indicate that there are ethnic differences in sleep behavior, with African Americans objectively and subjectively reporting more disordered sleep than Caucasian Americans.Chronic insomnia can have a significant impact on mental and physical health outcomes and has been associated with impaired cognitive performance, particularly, in areas of speed, attention, working memory, and executive function. In order to understand the brain mechanisms in sleep disorder both during resting state as well as during cognitive processing, the investigators will assess resting state EEG (during eyes-closed and eyes-open conditions) as well as ERP tasks for assessing decision-making and reward processing. The primary objective of the study is to evaluate the effect of a tailored, telephone-delivered cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms of insomnia and its neurodynamic correlates.

Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to the tailored, telephone-delivered CBT-I, compared with those randomized to the self-monitoring control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia as measured by the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic improvement (ERP, ERO) in the intervention condition in response to laboratory paradigms Hyp 3: Greater improvement in psychosocial functioning including reduction in depression and increase in quality of life.


Eligibility Criteria:
Inclusion Criteria:

* A positive endorsement of insomnia items on the Sleep Disorders Questionnaire
* Self- reported race/ethnicity as black (men and women)
* Ages 30 to 50 years
* Accessible by telephone
* No plans to move away from the region within the year following enrollment
* Consent to participate.

Exclusion Criteria:

* Documented co-existing sleep apnea
* Self-reported use of sleep medication
* Impaired cognitive or functional ability precluding meaningful participation
* Stated intention to move within the same year of enrollment.
Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal

The objective of this study is to characterize the hormonal and inflammatory responses to hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in the post-dialytic phase.

Studies show that hemodialysis (HD) is a protein catabolic event per se and probably contributes to the high prevalence of protein-energy wasting among HD patients. The muscle catabolic effect of HD is probably caused by loss of amino acids (10-12 grams per dialysis session) and by exacerbation of the inflammatory and hormonal disorders already present. Activation of the immune system during HD has been linked to the contact of blood cells with the dialyzer membrane and to bacterial-derived DNA fragments in the dialysis fluid. An intradialytic increase in interleukin-6 (IL-6) has been shown to correlate with muscle protein catabolism, and because IL-6 continues to increase for 2 hours after HD has ended, there might be a considerable "carry-over effect" to the post-dialytic period. Moreover, HD induces significant changes in the insulin/insulin-like growth factor I (IGF-I) signaling pathways. Plasma insulin is cleared by HD, and the bioactivity of IGF-I is reduced by 50% during a 4-hr maintenance HD due to an up-regulation of IGF-binding protein 1 (IGFBP-1), the only acutely regulated IGFBP.

Eligibility Criteria:
Inclusion criteria:

* \> 18 years
* stable maintenance hemodialysis for at least 3 months
* well-functioning arteriovenous shunts with recirculation less than 5%
* informed consent

Exclusion criteria:

* diabetes mellitus
* body mass index below 18.5 or above 30.0 kg/m2
* malnutrition (global assessment score C)
* active malignant disease
* immunosuppressive treatment (including glucocorticoid treatment)
* evidence of an ongoing inflammatory disease (including infection and autoimmune disorders)
* pregnancy

Exclusion criteria during the study:

* myocardial infarction or arrythmia with hemodynamic derangements
* permanent thrombosis in the arteriovenous (AV) shunt
* severe infectious disease
* renal transplantation
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates

Many extremely premature infants, born before 28 weeks' gestation age, require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.


Eligibility Criteria:
Inclusion Criteria::

* GA 25+0 to 28+6 weeks using the best available obstetrical estimate
* Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care
* Received PPV as determined by the resuscitation team during the first 10 minutes of birth

Exclusion Criteria:

* Outborn birth status
* Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward)
* Known major congenital or chromosomal anomaly
* Established spontaneous respiration without receipt of PPV
Impact of Left Atrial Appendage Exclusion on Short-Term Clinical Outcomes and Long-Term Stroke Incidence

Stroke is a major cause of morbidity in western society, and an infrequent complication of cardiac surgery. The majority of thromboembolic strokes arise from the left atrium, in particular the left atrial appendage. This study aims to assess the short-term effects of left atrial appendage ligation in terms of postoperative clinical and biochemical parameters; and the long-term effects of left atrial appendage ligation in terms of stroke incidence.

In patients with non-rheumatic atrial fibrillation, the left atrial appendage is the origin of at least 90% of all left atrial clots, and the resulting systemic emboli cause approximately 25% of all strokes. The stroke rate in patients with atrial fibrillation older than 75 years of age is 8.1% per year with one clinical risk factor and is 12% per year at any age in clinical trial populations with a history of prior thromboembolism. Three-year stroke rates in elderly nursing home patients not anticoagulated are in excess of 50% (Atrial Fibrillation Investigators 1994). Anticoagulation is oftentimes withheld due to the perception of excessive risk in case of a fall; even when anticoagulation is prescribed, it is well known that therapeutic levels are not always maintained.

Left atrial appendage obliteration is commonly performed in a variety of cardiac surgical operations. There have been animal studies and theoretical arguments which demonstrate the importance of the atrial appendage in its role to support cardiac output and blood pressure, and modulate thirst and hypercoagulability (Stollberger 2003); however this has been poorly studied and documented in humans in the available literature. BNP and ANP have been shown to increase proportionately with left atrial appendage dysfunction, as have von Willebrands Factor, D-Dimer, and thrombin-antithrombin III complex (Igarashi 2001).

To date, there is not a single randomized controlled trial with adequate follow-up to assess the short- and long-term clinical effectiveness of concurrent prophylactic LAA ligation. This trial will fill that void.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mitral valve repair or replacement surgery

Exclusion Criteria:

* Patients undergoing concurrent surgical anti-arrythmia procedure
* Heart transplant patients
* Patients with known hematologic hypercoagulability disorder
Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery

The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs blocks as well as the Serratus Anterior Plane Block have extended the application of perioperative regional anesthesia to provide analgesia for breast surgery. However, to our knowledge, there are no large studies that truly delineate the optimal injection site for the Serratus Anterior Plane Block.

Analgesia for reconstructive breast surgery can be a challenging undertaking; these women have often been through painful mastectomy procedures coupled with the mental and physical discomfort of chemotherapy and its attendant side effects. Additionally, the surgery itself can provoke significant pain; often requiring extensive dissection of soft tissue and muscle to provide flap coverage as well the real discomfort of tissue expansion. The literature has described 2 possible injection sites for the Serratus Anterior Block, however, no study has defined optimal location based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing reconstructive breast surgery

Exclusion Criteria:

* Patients with allergies to the local anesthetic
* Patients who do no consent to regional anesthesia
* Patients in which serratus block would be contraindicated
* Patients whose anatomy preclude placement of the block
Lamina Cribrosa Depth Change With Change in Eye Pressure

This is a study of the compliance of the lamina cribrosa with change in eye pressure.

Glaucoma patients and control subjects will have their internal eye structure (lamina cribrosa) imaged by optical coherence tomography (OCT) standard images at two different eye pressures. In some participants, the eye pressure will be changed by one of two interventions, wearing goggles or having laser suturelysis

Eligibility Criteria:
Inclusion Criteria:

* persons who consent to drink water and be imaged

Exclusion Criteria:

* non-consenting persons
* those who cannot be imaged
Comparison of the Clinical Performance of High Strength Hybrid Ceramic Indirect Restorations Cemented on Endodontically Treated Teeth Using Bioactive Versus Conventional Self Adhesive Resin Cements.

Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically determine their success or failure. As such, this research will be conducted to elucidate if there is a viability to the cementation of indirect hybrid ceramic blocks over endodontically treated teeth using bioactive self-adhesive resin cement and determining whether it provides a clinical advantage and improved restoration serviceability in the oral cavity.


Eligibility Criteria:
Inclusion Criteria:

* Patient Related Criteria:
* Adult patients (age: 21-50 years) of both genders.
* Able to tolerate necessary restorative procedures.
* Willing to sign the informed consent.
* Accepts the follow-up period.

Tooth Related Criteria:

* Endodontically treated first and second permanent molars.
* Access cavities with one missing proximal wall i.e. Occluso-mesial/distal cavities
* Patients with proper oral hygiene

Exclusion Criteria:

* Endodontically treated anterior, premolar and third molar teeth
* Badly broken-down teeth
* Hopelessly carious/destructed teeth necessitating extraction
* Mobile teeth, indicating periodontal disease or trauma.
* External or internal resorption.
* Cervical carious lesions
* Medically compromised patients
* Patients with known allergies to Latex and/or resinous material