cyrilzakka/clinical-trials huggingface dataset:
Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.

Population studied: anesthetized patients for cardiac surgery of coronary bypass.

Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)

- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation

Eligibility Criteria:
Inclusion Criteria:

* Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected

Exclusion Criteria:

* Emergency case
* Pericardial effusion
* Aortic or mitral valvulopathy
* Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
* Bad echogenicity
* Patient refusal to participate to the study
* No health insurance
Norplant and Irregular Bleeding/Spotting

Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.

A high percentage of women using progestin-only contraception experience breakthrough bleeding (BTB) and spotting that causes impaired lifestyle and results in decreased compliance with this contraceptive method. There is a need for an effective, low-cost, easily adapted treatment to reduce the bleeding and spotting in progestin-only contraceptives. The molecular environment of the endometrium of women with BTB and spotting contains abnormally high levels of pro-inflammatory cytokines (TNF-alpha and IL-1 beta) and abnormally high levels of proteases (matrix metalloproteinases \[MMPs\] and neutrophil elastase), which prevent normal tissue repair. Doxycycline (DOX) is an inexpensive, FDA approved antibiotic that inhibits MMPs and reduces nitric oxide synthesis. This study will evaluate DOX treatment of progestin-only contraceptive induced BTB and spotting, characterize the endometrial molecular biologic changes that occur in DOX treated patients, and determine the effect of Norplant on sexual functioning and testosterone levels.

All participants in this study will receive Norplant. Participants will then be randomized to receive either DOX (20 mg twice a day) or placebo for 6 months. Participants will have 9 study visits during the 24 weeks of the study. Study visits will include a medical history, physical exam, and blood and urine tests. Participants will also have three periodontal evaluations and three endometrial biopsies. At the end of the study, participants may choose to have the Norplant implant removed if they wish to discontinue Norplant use; otherwise the implant may remain in for up to 5 years.

Eligibility Criteria:
Inclusion Criteria

* Regular menstrual periods for the last 2 cycles
* Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry
* Currently not using tetracycline-class antibiotics
* Normal Pap smear

Exclusion criteria

* Pregnancy or breastfeeding within 2 months of study entry
* Chronic migraine headaches
* Uncontrolled high blood pressure
* Untreated sexually transmitted diseases
* Alcoholism or drug abuse within 12 months of study entry
* Insulin dependent diabetes
* Liver, kidney, or gallbladder disease
* Participation in another clinical trial within 30 days of study entry
* History of cancer
* History of blood clots, strokes, or heart disease
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.

In women with postmenopausal osteoporosis, PTH increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. Still, PTH is not a cure for osteoporosis in many patients because PTH-stimulated bone formation declines as PTH therapy continues. Biochemical analyses suggest that bone formation and resorption peak after 6 to 9 months of daily PTH therapy and then decline progressively.

The study will last 18 months. Blood, urine, and bone density tests will occur at screening. At the start of the study, participants will be randomly assigned to one of two PTH dose regimens. Patients will go to Massachusetts General Hospital at Months 0, 3, 6, 9, 12, 15, and 18 for blood and urine collection. In addition, bone density tests by DXA will be performed at Months 0, 6, 12, and 18, and by quantitative CT scans at Months 0 and 18. Approximately 6 weeks after any change in PTH dose, each participant's blood calcium will be checked 4 to 6 hours after that day's PTH injection, and her 24-hour urine calcium excretion will also be checked.

Participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with PTH are accompanied by changes in its absorption and/or destruction and whether reduced skeletal responses to long-term treatment with PTH are accompanied by parallel reductions in kidney responses to PTH.

Eligibility Criteria:
Inclusion Criteria:

* Three or more years after menopause
* Bone mineral density T-score \< or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae

Exclusion Criteria:

* Cannot walk without assistance
* Significant heart, kidney, liver, or malignant disease
* Current alcohol abuse
* Major psychiatric disorders
* Other current or past disorders known to affect bone
* Use of medications known to affect bone for \> 7 days in the past 12 months
* Use of bisphosphonates or fluoride
* Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count
* Elevated calcium levels in 24-hour urine collection
Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

The purpose of this study is to assess the influence of force feedback joysticks and haptic feedback in improving upper limb rehabilitation outcomes following stroke.

Upper limb paresis or plegia following stroke remains a significant cause of impairment and disability. Regaining function requires learning through repetitive movements and activities of daily living(ADLs).

The aim of the study in this application is to test the usability of the system in specialized rehabilitation hospital settings. In this first stage of development, after developing and testing the system together with expert physiotherapists, we will examine the system for usability (is it "user friendly"), comfort level, and therapeutic efficacy.

The system consists of an ordinary PC computer, specially written software, and a commercially available force feedback joystick. (Force feedback joysticks, are usually used for gaming; they contain miniature motors that allow the joystick to either help or resist the movements of the person using it). Patients who are unable to grasp the joystick will use a specially built arm rest that is attached to an ordinary office chair without wheels. Patients rest their forearm on the arm rest and thus can manipulate the joystick by means of movement of the shoulder and elbow joints instead of by movements of the wrist, since wrist movements are often difficult for brain damaged individuals.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable post first stroke patients
* Score of more than 17 on the Mini Mental Scale Test(MMST)

Exclusion Criteria:

* A history of psychiatric illness
* Inability to understand the informed consent form
* Inability to understand and follow 2-3 step instructions
* Receptive aphasia (sensory aphasia)
the Effectiveness of Task-oriented Training With Pretend Play in CP Children

the effectiveness of task - oriented training with pretend play on gross motor function, functional capacity and cognitive function in children with hemiplegic cerebral palsy.

PURPOSE: This study aims to investigate the effectiveness of task-oriented training with pretend play on: gross motor function, functional capacity and cognitive function in children with hemiplegic CP.

BACKGROUND: Children with HCP experience difficulty with the motor function of the affected lower extremity. The majority of children with hemiplegia are able to walk without restrictions but more advanced gross motor skills are often affected.

Task-Oriented Training is a contemporary neurological rehabilitation technique that has the prospects of improving the quality of life of children with CP. It is a function-based, goal directed intervention that requires active involvement of the patient in a therapy that is task and context-specific, which focused on the accomplishment of functional activities and participation.

Pretend play is defined as play in which the child acts with intent that is representational. pretend play helps children learn how to express themselves, explore social interactions, and understand things and people within a real-world context.

HYPOTHESES: There is effect of task-oriented training with pretend play on gross motor function, functional capacity and cognitive function in children with hemiplegic CP.

. ..................... RESEARCH QUESTION: Does task-oriented training with pretend play has an effect on gross motor function, functional capacity and cognitive function in children with hemiplegic CP?

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic CP children of both genders.
* Their age range will be from 6 up to 8 years.
* They will be have spasticity will range from 1+ and 2, spasticity will be diagnosed based on the modified Ashworth scale.
* They will be have gross motor function at levels II and III, gross motor function will be diagnosed based on Gross Motor Function Classification System Expanded and Revised.
* They will be able to understand and follow direction.

Exclusion Criteria:

* Any visual or auditory impairments.
* Epilepsy.
* Any cognitive disorder.
* Any fracture or orthopedic surgery in the last 6 months.
Reduction in Symptomatic Esophageal Stricture Formation

Complete endoscopic resection of early neoplastic Barrett's Esophagus (BE) is a curative procedure. However, a significant proportion of patients develop symptomatic esophageal strictures following Complete Barrett's Eradication (CBE), and this limits the technique, particularly for circumferential and longer segment disease. Oral steroid therapy may reduce stricture formation; thereby allowing CBE to be performed with minimal associated morbidity.

The main objective of the proposed randomized trial is to compare the rate of symptomatic oesophageal strictures in patients receiving placebo versus oral prednisone.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed Barretts mucosa with high grade dysplasia or early esophageal adenocarcinoma (T1a, intramucosal adenocarcinoma).
2. Barretts segment ≥ 30% circumference, ≤C3 and ≤M5.
3. The general health condition of the patient permits anesthesia for endoscopy.
4. Patient is 18 years of age or older.
5. Informed consent is obtained

Exclusion Criteria:

1. Previous (referral) biopsies show low grade dysplasia only, or invasive adenocarcinoma.
2. Barretts segment \<30% circumference, \>C3 or \>M5.
3. During initial gastroscopy there are highly suspicious areas for submucosal invasive cancer (Kudo pit pattern type V; excavated/depressed type morphology; large smooth or ulcerated nodule). In cases of significant doubt, initial resection is of the highly suspicious area only, and urgent histology processing requested. If submucosal invasion is excluded, the patient is rebooked for 1st stage complete barrett's excision (60% circumferential resection) and randomization after a 4-6 weeks interval.
4. Presence of a tight peptic oesophageal stricture that impedes safe and effective endoscopic mucosal resection using a cap (Cook Medical).
5. Active malignancy, uncontrolled Diabetes Mellitus, active or untreated major psychiatric disorder, uncontrolled infection, uncontrolled hypertension, uncontrolled or severe congestive cardiac failure, non-correctable coagulopathy (INR\>2, or platelet count \<60 x 109/L), osteoporosis, recent peptic ulcer disease, moderate-to-severe glaucoma or untreated glaucoma, or pregnancy.
6. Unable to provide informed consent
7. Allergy to compound used in tablet formulation
Multiple System Atrophy Multidisciplinary Clinic

This is a prospective cohort study to examine the disease burden of multiple system atrophy and the impact of multidisciplinary care on quality of life and caregiver burden. Data will be collected through valid rating scales completed by patients and caregivers at home or in the MSA clinic.

Study Procedures:

Participants and caregivers will attend a multidisciplinary MSA clinic one day every four months. In addition to the standard of care, they will be asked to complete both online and paper questionnaires, including the following:

* UMSARS (Unified MSA Rating Scale)
* MSA QOL
* CES-D
* OHQ
* Compass-31
* BIC
* UPDRS
* SARA
* MDS Scale
* CGI
* MoCA

Participants will be part of the study as long as they are a patient of the MSA clinic, and will be contacted for follow-up information up to five years.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a patient in the UT Southwestern MSA clinic and be able to attend the multidisciplinary clinic every 4 months
* Patients with possible or probable MSA based on established criteria
* Subjects must be 18 years or older

Exclusion Criteria:

* Patients that are unable to give consent
* Minor patients (younger than age 18)
* Non-English speaking patients
* Subjects that are diagnosed with dementia
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet

The celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.

In the oral environment the investigators see enamel defects and recurrent ulcers.

Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss).

It has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population.

In celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. These defects are classified by the grading of the CD related DED's (dental enamel defects) according to Aine. These defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. The cause is thought to be hypocalcaemia or genetic.

These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population.

Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population.

After changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.


Eligibility Criteria:
Inclusion Criteria:

* celiac disease

Exclusion Criteria:

* no other systemic condition
* age 3-18
* children on medication
Acupuncture Outcomes Based Rehabilitation

Can acupuncture be quantified. This study sets out to observe if there are measurable effects of fine motor control that are attributable to acupuncture. The study utilizes an FDA approved medical device for measurements of fine motor control called the RU-Fit.

Context: Currently there is a high demand for evidence-based research in the field of Acupuncture. The medical practice of acupuncture has existed for thousands of years and purportedly has been successful at managing a wide array of health conditions. Producing objective/quantitative data that rule out any possibility of placebo effect has proved burdensome.

Objectives: This exploratory study seeks to determine if physiological measurements of fine motor control can be changed after receiving an acupuncture treatment. Can this change demonstrate the effectiveness of the treatment? Design, Setting, Participants, Interventions: This study looked at acupuncture patients undergoing treatments for pain relief, and general minor injury to determine whether or not observable changes could be detected in the fine motor control of the hands after acupuncture treatments.

Two groups of 50 subjects were used in the study. The test group was given a fine motor control test prior to and after their acupuncture therapy to determine if any changes could be measured.

The control group was given two fine motor control tests without acupuncture treatment with a 40 minute delay between the tests to replicate the test group timing. This study was conducted at a non-profit community clinic between the dates of 9/28/16 \& 2/19/17.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 13 years old or older
* Study participants were selected from the acupuncture patient population freely visiting the clinic. Patients were asked if they would be interested in a research study. They were informed about the objectives of the study, what their role would be and that this was a free non-invasive test that they would undergo before and after their regular acupuncture treatment. Before inclusion into the program, patients are provided with informed consent forms and after agreeing and signing the form, individuals then become participants.

Exclusion Criteria:

* Younger than 13 years old
Rhythmic Interlimb Coordination in Children with Developmental Coordination Disorder

This study is a case-controlled observational study, involving children with Developmental Coordination Disorder (DCD) and typically developing children with an age from 8 up to 12 years old. The study aims to investigate interlimb coordination of the lower limbs and sensorimotor synchronization ability in children with DCD compared to age-matched typically developing children during gait and fundamental lower limb coordination task to 2 metronomes with different temporal structures. The study consists of a maximum of 4 sessions (2 descriptive sessions, 2 experimental sessions), each lasting around 60 minutes. Depending on the preferences of the child and parents, the sessions can be combined in 2 sessions of 2 hours. During the first descriptive session, the participant will perform the m-ABC2 test to assess gross and fine motor function. The MBEMA-s will be used to examine rhythm perception ability. During the second descriptive session, children will perform the Kids BESTest to examine postural control, and two cognitive tests (digit span, go-no/go test) to assess executive functioning. During the third visit (experimental session), interlimb coordination and synchronization will be investigated during three tasks with different dynamic balance demands (seated, walking and running) in three conditions: in silence, to beats in isochronous metronome (discrete structure), to beats in non-isochronous metronomes (sinusoidal structure). In the last experimental session, the tempi of the auditory metronomes will be set at higher and lower tempi than the preferred comfortable tempo of the child.


Eligibility Criteria:
Inclusion Criteria:

* are aged between 8-12 years
* have no medical conditions that could impede their motor abilities.
* Children with a diagnosis of DCD, consistent with the DSM-V (Blank et al., 2019), or total percentile score \<P16 on the movement assessment battery for children edition 2 (m-ABC-2), will be included in the group of (probably) DCD.
* The m-ABC score total of typical developing children needs to be ≥P25 for inclusion

Exclusion Criteria:

• have other neurological, orthopaedical, cardiorespiratory or intellectual impairment that could affect their motor abilities (verified using a health questionnaire)
Corneal Edema After Phacoemulsification

To compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.

Phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. Alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery.

Divide-and conquer is the parent nucleofracture technique.The subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage.

The aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. Corneal edema was determined by measuring central corneal thickness (CCT).

Eligibility Criteria:
Inclusion Criteria:

* The presence of a senile cataract with equivalent grades and history of visual acuity regression
* Informed written consent

Exclusion Criteria:

* Patients with total white cataract
* With history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma)
* With systemic diseases with the potential to affect vision