cyrilzakka/clinical-trials huggingface dataset:
Effects of Sleep Duration on Eating and Activity Behaviors

The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to increase their sleep first and half to decrease their sleep first. During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-11 years old
* BMI for age and gender \> 5th percentile (but no greater than 100% overweight)
* Sleep approximately 9-10 hours nightly
* Attend elementary school
* Like at least 1 food and 1 activity used in the reinforcement paradigm
* Able to understand and complete the reinforcement paradigm

Exclusion Criteria:

* Existence of a diagnosable sleep disorder
* Medical or psychiatric condition that could influence sleep or weight
* Onset of menarche
* Inability to complete study materials, including diagnosed disabilities
* Dietary restrictions/allergies to foods used in the study that preclude them from study participation
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions (PCC) on physical functioning, health-related quality of life, and adipose tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will evaluate whether a weight loss intervention, including dietary modification and exercise, in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery.

Findings of post-acute sequelae of Post-COVID Conditions (PCC) manifestations of fatigue, pain, dyspnea, and muscle weakness, provide a strong rationale for rehabilitation; yet few formal studies exist and the effects of severe acute respiratory syndrome coronavirus-2 infection on function are not well described. Notably, two-thirds of Veterans are overweight and obese, rendering excess adiposity a significant risk factor and a high-priority area related to PCC prevention and care. Obesity increases the risk of severe illness in Veterans recovering from PCC, but how it does so is not fully understood.

Recent research suggests that excess adipose tissue is associated with adverse changes in adipose cellular function, and that these variations may be involved in the biology of aging and the etiology of aging-related diseases. Adipose tissue contains cells that have undergone cellular senescence, which induces inflammation, cytotoxicity, and metabolic dysfunction in other cells and tissues. However, the precise role of adipose tissue cellular composition on PCC recovery is limited.

Thus, the investigators propose to evaluate the role of obesity and PCC on physical functioning, health-related quality of life (HRQOL), and systemic and adipose tissue inflammatory and cellular senescence profiles in ethnically diverse older Veterans from the Audie Murphy (San Antonio) and Baltimore VA Medical Centers. Further, the investigators propose a randomized controlled trial to determine whether a reduction in body weight and increased physical function by a weight loss intervention (WL), including dietary modification and exercise, in obese Veterans with PCC will reduce systemic and adipose tissue inflammation and senescence, which will have important implications for PCC recovery.

Eligibility Criteria:
Inclusion Criteria:

1. U.S. Veteran
2. No Post-COVID symptoms or at least one Post-COVID symptom lasting \>4 weeks
3. Body Mass Index: 19-25 or 30-40 kg/m2
4. Postmenopausal status for women

Exclusion Criteria:

1. Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
2. Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs \> 2.5 x WNL), renal (eGFR\<45), gastrointestinal, malignant, and psychiatric disease
3. Uncontrolled diabetes (HbA1c \>10% or the current use of insulin)
4. Weight change within the past month of \>5 kg
5. History of keloid formation
6. Self-reported alcohol or drug abuse
7. Anti-coagulant medication usage
Flow MRI in Normal Pressure Hydrocephalus

Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
* Walking disorder
* Cognitive disorder
* Participants gave their written informed consent

Exclusion Criteria:

* Contra-indication to MRI
* Obstructive tumoral hydrocephalus
* Curatorship or tutorship
* Pregnancy or lactation
* No social assurance
Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus,
* foot ulcer with duration \> 3 months,
* treatment at Diabetes foot clinic for \> 2 months,
* vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion Criteria:

* severe obstructive pulmonary disease,
* malignancy and untreated thyrotoxicosis),
* current drug or alcohol misuse,
* vascular surgery in the lower limbs within the last two months,
* participation in another study or suspected poor compliance.
Tiotropium / Respimat One Year Study in COPD.

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history \> 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) \< 60% predicted

Exclusion Criteria:

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.
Does a Safety Difference Exist Between IV Push and IV Piggyback Antibiotics?

This study compares whether or not a safety difference exists between delivering antibiotics via IV push or IV piggyback method.

This study compares whether or not a safety difference exists between delivering antibiotics via the IV push or IV piggyback method. It will be a single center, prospective, double-blinded, double-dummy, randomized controlled trial on a convenience sample of patients presenting to the ED receiving select beta-lactam antibiotics. Patients will be randomized to IV push antibiotic plus IV piggyback placebo or IV push placebo plus IV piggyback antibiotic. Patients will only be enrolled when a pharmacist who is familiar with the study is available to prepare medications. Treatment group assignment will be predetermined using an Excel random number generator. An investigator will conduct an informed consent with the patient. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. If the patient consents to the study, a pharmacist involved in the study will prepare the IV push syringe and IV piggyback. The IV push syringe and IV piggyback will be prepared in a manner that makes the contents blinded. Preparation of the IV push syringe and IV piggyback are standardized. The syringe and piggyback will be handed to the nurse for administration. The IV push antibiotic will be administered over 2-3 minutes and the IV piggyback antibiotic will be administered over 30 minutes. The IV push and IV piggyback will be administered at the same time. A research assistant will conduct surveys with the patient at the start of administration and every 15 minutes for a total of 90 minutes to observe for any adverse drug reactions. During the 90-minute observation period, other medications will be allowed to be administered to the patient. All medications received during this time period will be documented in the patient data sheet. If an adverse drug reaction occurs, the attending physician or medical resident caring for the patient will be notified to come evaluate the patient. Adverse drug reaction severity will be determined by the attending physician or medical resident based on a predetermined scale. Adverse drug reaction information will be collected to determine correlation of adverse drug reaction to drug administration. Adverse drug reactions deemed as serious will be reported to the Institutional Review Board (IRB) within 5 days of the event.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patients who present to the adult ED in whom IV aztreonam, cefazolin, cefoxitin, ceftriaxone, cefepime, ertapenem, or meropenem is ordered by the treating physician

Exclusion Criteria:

* Pregnant or breastfeeding
* Non-English speaking patient
* Attending provider excludes patient
* Unable to consent
* Prisoner
* Allergy to any beta-lactam antibiotic
Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke

The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke.

The study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. Results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment.
* Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury.
* At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior.
* Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study.
* Absence of significant cognitive impairment as determined by a Mini-Mental Status Examination score of greater than or equal to 24.
* The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke.

Exclusion Criteria:

* Unable to provide informed consent.
* Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale.
* Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale.
* History of greater than two strokes.
* Suffered a stroke less than 6-months prior to participating in the study.
* A history of, or being susceptible to, cyber-sickness (i.e., motion sickness).
* Unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and
* A history of seizures.
Tools to Improve Parental Recognition of Developmental Deficits in Children

In this study, we aim to improve child nutrition by increasing parents' awareness of their children's physical growth. We use a cluster-randomized trial design to evaluate two interventions that provide parents with regular information on their children's physical development and growth: 1) distribution of full-sized growth charts for measurement of child height within households; and 2) organization of community-based meetings, during which children's height and weight are measured by trained project staff.

The target population for the study will be children between the ages of 6 and 18 months at baseline living in small-scale farming households in Chipata District, Zambia. As part of a cluster-randomized trial titled "Food Constraints, Yield Uncertainty and 'Ganyu' Labor" funded by IZA-DFID (PI: G Fink), 3,100 farming households in approximately 180 rural villages in Eastern Province are currently enrolled in a two-year study, which aims at assessing the effect of food loan programs on agricultural productivity. The study described here uses the "Food Constraints" population as a sampling frame; all households enrolled in the "Food Constraints" program that have a child between 6 and 18 months are invited to participate in this add-on trial. We anticipate that there will be around 600 eligible households recruited for this study. Study duration is about 18 months. Selected households will be visited for study enrollment and a short baseline assessment in September 2014, at which time the two interventions will also be rolled out. Final impact of the interventions will be assessed one year later, in September 2015.

Eligibility Criteria:
Inclusion Criteria:

* All households with a child between the ages of 6 and 18 months at baseline

Exclusion Criteria:

* None
Observational Study of Vision Improvement in Late Stage Dry AMD Patients

The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device.

The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device. Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity. Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. - Male or female
2. - Any race
3. - Patient is at least 50 years old
4. - Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
5. - Treated eyes were pseudophakic at the time of treatment.
6. - Patient had moderate to severe baseline vision impairment with best spectacle-corrected distance visual acuity (CDVA) of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s).
7. - Patient CDVA records are available at baseline and at 12 month post-treatment.

Exclusion Criteria:

1. - Corneal disease or disorder in either eye.
2. - Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma.
3. - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study.

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Hemiepiphysiodesis by Eight Plate Versus Osteotomy in the Management of Pediatric Coronal Knee Deformities

Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

Eight-Plates first described by Stevens are simple to use .Moreover, owing to the flexible screw/plate connection, fewer complications in terms of implant loosening and fracture can be expected.Good results aswell as low reboundand complication rates have been recorded for the first series of cases

Eligibility Criteria:
Inclusion Criteria:

* Growth plate still open at Time of Surgery

Exclusion Criteria:

* Epiphyseal plate involved in trauma resulting in a bridging callus formation,
Trial of Tian Jiu Therapy for Allergic Rhinitis

The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.

This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a one-week run-in period, eligible subjects will be randomly assigned to the Tian Jiu group, placebo-control group and waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The total study period will be nine weeks.

Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick tests
* High circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called radioallergosorbent test (RAST)\]
* Clinical history or allergen to have been identified
* Nasal provocation (test)

Exclusion Criteria:

* Allergic asthma, moderate to severe atopic dermatitis, autoimmune disorders, severe chronic inflammatory diseases, history of anaphylactic reactions, hypersensitivity to cetirizine or related drugs, specific immunotherapy during the past 3 years or planned in the next 2 years, pregnancy or breastfeeding.
Endovascular Embolization of Chronic Subdural Hematomas After Surgery

Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.

The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of MMA (\< 72 hours after surgery). Endovascular procedures will be performed with non-adhesive embolizing fluids. The primary outcome will be the recurrence of CSH at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified Rankin scale (range, 0 \[no disability\] to 6 \[death\]) at 6 months and complications related to endovascular procedure.

Eligibility Criteria:
Inclusion Criteria:

* Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.
* Recent diagnosis or recurrence
* Surgical treatment performed \< 72 hours
* Informed consent signed by the patient or they responsible family member

Exclusion Criteria:

* Advanced disease with life expectancy \< 6 months
* Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence \< 30 ml/min, allergy to iodinated contrast.
* Unavailability for follow up st 6 months
* Patient expressly refuses treatment
Trends of Contraception Methods in Urban Medical Center in el_Balyana

family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries.


Eligibility Criteria:
Inclusion Criteria:

- currently married woman in the child bearing period (15_49) years old attending El_Balyana urban medical Center

Exclusion Criteria:

women who are divorced or widowed or beyond age of fertility will be excluded -