cyrilzakka/clinical-trials huggingface dataset:
Cooperative Huntington's Observational Research Trial

The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.

COHORT (Cooperative Huntington Observational Research Trial) is a coordinated research effort by Huntington Study Group research centers worldwide to prospectively collect data from consenting individuals who are affected by Huntington's disease (HD) and who are part of an HD family. The systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. The knowledge from these relationships will better inform us about the onset and progression of HD, help identify potential interventions for HD, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of HD. The consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of HD. Identification of biomarkers will in turn contribute to our understanding of HD and enhance the efficiency and power of disease-modifying therapeutic trials.

Eligibility Criteria:
Inclusion Criteria:

* (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.
* (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.
* (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
* (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
* (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.

Exclusion Criteria:

* (1) Anyone who does not fit the inclusion criteria
Ascending Glycan Dietary Supplementation in Healthy Adults

The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED).


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18-45 years of age
* Patients who are in general good health
* Body Mass Index (BMI) range of 18.5-25
* All individuals must have the ability to provide inform consent

Exclusion Criteria:

* Women who are pregnant, actively nursing, or pregnant within the last year
* Women who are peri-menopausal or post-menopausal
* Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days (missed, early, or late periods are also considered signs of an irregular cycle).
* Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant
* Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
* Individuals with first degree relative with history of an autoimmune condition
* Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any kind
* Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
* Individuals with phenylketonuria
* Individuals currently taking prescription medications, or have taken prescription medications within the last 3 months
* Individuals currently taking over the counter medications
* Individuals currently taking or have taken supplements including herbal, protein or vitamin supplements in the last 3 months (e.g. whey protein, St. John's Wort, green tea supplements, biotin, creatine supplements), excluding multivitamins or essential vitamins
* Individuals with prior history of severe food or drug allergic reactions
* Individuals with a diagnosis of type I or II diabetes mellitus
* Individuals with allergic reaction or adverse reaction to shellfish, N-acetyl glucosamine, galactose, or Spirulina/chlorella/algae supplements
* Individuals with social history of current use of tobacco, alcohol or other drugs
* Individuals with dietary restrictions (vegetarians are permitted to participate in the study) or to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet in our study population):

  * Actively dieting or trying to lose weight
  * Vegan diet
  * Consume equal to or greater than 2 cups of tea a day
  * Consume equal to or greater than 4 cups of coffee a day
  * Consume equal to or greater than 3 cups of fruit juice a day
  * Practice intensive exercise patterns (marathon training, workouts \>4 hours a day)
  * Consume soda or energy drinks of any amount
  * On a carbohydrate-restricted or "Paleo" diet
  * Calorie-restricted diet (less than 20%-25% of maintenance calories)
Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

a. Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.

Exclusion Criteria:

1. Glenohumeral arthrosis
2. Previous shoulder surgery
3. Psychiatric diseasesMRI
4. Rheumatologic diseases
5. Fibromyalgia
6. Spine diseases
Cervicothoracic Junction Mobilization Versus Muscle Energy Technique in Chronic Neck Pain

This study will be conducted to identify the difference between the effect of of cervicothoracic junction mobilization and autogenic Muscle Energy Technique. on neck pain, cervical range of motion, cervical proprioception and neck disability in mechanical neck pain patients with cervicothoracic junction hypomobility.


Eligibility Criteria:
Inclusion criteria:

* Patients with a primary complaint of chronic neck pain (assessed by VAS )for more than 3 months
* Subjects with pain provocation and reduced mobility at the CT junction segment (assessed by passive accessory intervertebral movements (PAIVMs) and reduced mobility at cervical spine (assessed by CROM device.
* patients with age range from 18 to 45 years old.
* patients with body mass index less than 30 kg/m2.
* Exclusion Criteria:
* previous spine surgery
* pregnancy.
* Diabetic patients
* Hypertensive patients
* Patients were excluded if neck pain was associated with cervical radiculopathy
* whiplash injuries or severe headaches
* cervical spine fracture
* vertebro-basilar insufficiency.
* red flags suggesting of cancer, infection, vascular insufficiency
* Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.
Promotion of Nurses' Lower Extremity Health by Foot(at)Work Intervention

The quasiexperimental study aims to analyse the effecs of Foot(at)Work intervention on nurses' lower extremity health. The Foot(at)Work intervention is in electronic format consisting of 5 themes. The idea is that the participants familiarizes with the foot health -related content. The primary outcome is knowledge about lower extremity self-care. Secondary outcomes are work well-being, lower extremity health and musculoskeletal health. The outcomes are measured before the intervention (M0), after the intervention (M1), one month after the intervention (M2), six months after the intervention (M3) and 12 months after the intervention (M4).

The purpose of the Foot(at)Work intervention is to support nurses ability to self-care their lower extremities. The intervention consists of text, videos, and pictures that educate nurses to self-care their lower extremities and to select proper footwear.


Eligibility Criteria:
Inclusion Criteria:

* Registered nurse
* Working in the specialized health care in surgical or internal medicine wards of one certain hospital

Exclusion Criteria:

* Nursing students
Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease

The purpose of this study is to investigate the effect of selected Osteopathic Manipulative Medicine (OMM) techniques on the respiratory system of people with Parkinson's Disease (PD) in comparison to light touch. Effectiveness will be measured through pulmonary function tests, chest wall expansion, and voice analysis. Selected subjects will be randomly assigned to one of the two groups: OMM treatment group or light touch group. Although OMM treatment has been used on PD patients, a randomized controlled study has not been done to establish its effect on PD respiratory function. The authors believe that this study will show OMM's effectiveness.

Osteopathic Manipulative Medicine (OMM) on the thoracic cage and diaphragm is commonly used in clinical practice to address myofascial imbalances, including muscle spasms to improve thoracic cage excursion. Prior research has demonstrated that manual approaches applied to the thoracic cage have positive results with lung function and reducing inflammation.

Parkinson's disease (PD) is a common disabling and progressive neuro-degenerative disorder. Morbidity and mortality are frequently associated with pulmonary dysfunction in patients with PD. Pulmonary function tests (PFT) have been utilized to document respiratory impairment in PD patients. Researchers estimate that 89% of people with PD have speech and voice disorders including disorders of laryngeal, respiratory and articulatory function.

These authors hypothesize that performing OMM on the thoracic cage of PD subjects will show improvement in PFT, chest expansion, and speech production. Subjects with PD meeting the criteria for the study will be randomly assigned to either an OMM treatment or light touch control group. Each subject will be involved in one treatment visit. During this visit, the following will be measured before and after OMM or light touch procedures: maximal and minimal chest circumference; sound pressure, duration, and perceptual measures during sustained vowel phonation and Rainbow Reading; Forced Vital Capacity (FVC), Forced Expiratory Volume/1 second (FEV1), Peak Expiratory Flow (PEF), Forced Expiratory Flow 25%-75% (FEF25-75%), and Maximal Voluntary Ventilation (MVV). Data analysis will be performed with SPSS using Analysis of Covariance to measure significance.

Eligibility Criteria:
Inclusion Criteria:

* Medically diagnosed with Parkinson's Disease
* on a stable medication dose
* over the age of 18

Exclusion Criteria:

* no clinical diagnosis of Parkinson's Disease
* - medication that might cause pulmonary dysfunction
* inability to perform PFT because of anatomical abnormalities
* clinical signs of dementia
* pacemaker that interferes with pectoral traction
* metastatic cancer
Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.


Eligibility Criteria:
Inclusion Criteria:

* History of at least one year of infertility either primary or secondary.
* Body mass index: 25-35
* Normal fallopian tubes
* Normal semen analysis of the husband
* Women who will accept to participate in the study

Exclusion Criteria:

* Body mass index above 35
* Contraindication to general anesthesia
* Previous laparoscopic drilling
* Presence of other causes of infertility
* Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
* Women who intended to start a diet program
* Women who will refuse to participate in the study.
Transverse Facial Cleft Repair Using Precise Location of Commissure

To compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

Nine patients with transverse facial cleft were treated with redesigned repair using precise location of commissure. The main outcome measurement included scar, symmetry of the commissure. They were graded in five scores by five resident physicians who had never seen the patients. The results were compared with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of transverse facial cleft disease;
* Must not received any lip surgeries before;
* Such disease can be accompanied by external ear abnormalities, hypoplastic mandible, cleft lip and palate.

Exclusion Criteria:

* Severe general diseases;
* Patients who had been treated with lip surgery;
* Patients and/or his/her family didn't want to continue the clinical trial.
Population Pharmacokinetics of Amikacin in Neonates

Aminoglycosides such as Amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli. Despite the frequency of this indication, it has not yet been possible to establish definitive dosage schedules that ensure effectiveness and low risk of toxicity, due to the high pharmacokinetic variability observed in this population.

In addition to anthropometric variables, evidence from retrospective studies suggests that sepsis could be capable of significantly modifying the pharmacokinetics of aminoglycosides in neonates, but the investigators suggest conducting prospective studies of higher methodological quality to verify this hypothesis.

Due to the lack of pharmacokinetic and pharmacodynamic (PK / PD) studies of Amikacin in this group of patients, the investigators have raised the need to develop a prospective observational study; describing a PK / PD model of amikacin in newborns with suspected sepsis.

Three blood samples will be taken from each of the 138 participants. As a standard of care, a sample will always be taken at 0.5h (Cmax) after the first dose and a sample before the second dose, which can be at 24h, 36h, or 48h as per physician indication. The third sample will be collected according to what has been assigned by a block randomization method, in one of the following moments: 1, 2, 4, 8, 12 or 18 hours after the administration of the first dose of Amikacin.

The methods used to analyze the samples will be: Particle Enhanced Turbidimetric Immunoassay (PETIA), Architect C8000; and Homogeneous Microparticle Immunoassay in Solution (KIMS), Roche systems. The determination of the susceptibility and minimum Inhibitory Concentration (MIC) will be carried out by the laboratories of each hospital by agar dilution method.

PK/PD profile of amikacin will be evaluated with NONMEM (non-linear mixed effects modelling) software for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Receive at least one dose of Amikacin
* Be at least three days old (72 hours)

Exclusion Criteria:

* Receive the first dose of Amikacin in a healthcare center other than those included in the research
* Patient on renal replacement therapy
Femoral Nerve Block for Femur Fracture Repair in Pediatrics

The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* Weight greater than or equal to 10kg
* Presenting for repair of traumatic femur fracture

Exclusion Criteria:

* ASA physical status \> II
* Co-morbid diseases (cardiac, pulmonary, neurological disease)
* Patients having concomitant procedures
* Abnormal neurovascular examination in the injured leg
* Presence of vascular compromise in the affected lower extremity
* Mechanism of sustained injury via crush injury
* Use of therapeutic dose anticoagulants or presence of a bleeding disorder
Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old

Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva as an alternative specimen for HIV testing has been explored. Today, very sensitive tests have been formulated and have been used for diagnosing HIV in adults and older children. OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as well test the saliva.

Most studies done on the use of saliva have been carried out in adults and have produced very good results. However very few such studies have been done in children, especially infants. In adults, use of saliva has also highlighted the advantages of ease of collection and increased acceptability of testing.

HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine test and oral fluid testing is more acceptable than blood testing.

BACKGROUND Serological identification of antibodies to Human Immunodeficiency virus (HIV) in blood is the most widely used method to screen for HIV infection. Use of oral fluid as an alternative to blood sample has been studies the past 20 years and extremely sensitive tests that are able to detect the very low quantities of antibodies found in oral fluid have been formulated and are currently being used. OraQuick rapid test, a combination, collection and testing device that uses both blood and oral fluid was approved for used by the U.S.A, FDA in 2002 and has been tested in adults and older children.

The value of oral fluid in screening for HIV infection in adults is now well established and has been used extensively in field survey and epidemiologic studies. However, these methods have not been studied in children in whom differences in test performance might be expected. Studies in adults have also highlighted the advantages of oral fluid testing, such as ease of collection and high degree of acceptability of testing. This would make oral fluid testing a good alternative for HIV screening in infants, a challenging population in which venipuncture is often difficult or unacceptable.

Eligibility Criteria:
Inclusion Criteria:

* Children aged less than 18 months
* Admission to the Department of Pediatrics for any condition
* Consent from caregiver for HIV testing using both oral fluid and blood r

Exclusion Criteria:

* Age of more than 18 months
* Refusal of consent by caregiver
* Outpatients
Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal

The study aims to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.

The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.

We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NUrse-led COntinuum of care for people with diabetes and pre-diabetes (NUCOD), with primary care centers (Outreach centers and Government health posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among pre-diabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis.

The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and pre-diabetes individuals, and implementation outcomes for the organization.

Eligibility Criteria:
Inclusion Criteria:

* with confirmed pre-existing type II diabetes and prediabetes at the time of our screening (i.e., pre-existing diabetes or prediabetes)
* with confirmed diagnosis of type II diabetes or prediabetes after our community screening process (i.e., newly diagnosed diabetes and prediabetes)
* is not planning to relocate outside of the current place of living in next 2 years
* is older than 18 years of age

Exclusion Criteria:

* are not psychologically capable of communication
* are diagnosed as type 1 diabetes
The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients

The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Improving balance function is considered as an important method for reducing the risk of falling after stroke and protecting bone health. Bone mineral density, a measure of bone health, has been reported to decrease after stroke, consistent with increased bone resorption and decreased bone formation. The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 50 and ≤ 75 years old
* Patients with a 10-year risk of hip fracture ≥3%, major osteoporotic fracture risk ≥20% according to the Fracture Risk Assessment Tool, FRAX, scoring
* Patients with unilateral hemiplegia as a result of first-time stroke (onset time \> 3 months)
* Patients who can stand for at least 2 minutes independently/under supervision for measurements while standing, and who can walk at least 10 meters independently/under supervision with or without walking aid for measurements taken while walking
* Patients whose cognitive status is able to understand the study instructions (Mini-Mental State Assessment score ≥ 23)
* Patients with stable medical and psychological status
* Patients willing to participate in the study

Exclusion Criteria:

* Patients with serious cardiovascular or musculoskeletal problems that prevent walking
* Patients with severe vision, hearing and language problems
* Patients with other neurological (Parkinson's, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe low back pain, knee problems) diseases that may affect balance performance other than stroke.
* Patients with peripheral vascular disease