cyrilzakka/clinical-trials huggingface dataset:
What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?

To determine the prevalence of pelvic organ prolapse and urinary incontinence among women in Minnesota using a short web-based self-administered questionnaire.

The study will be administered at the 2018 Minnesota State Fair at the Driven to Discover building. The study will be administered entirely for research purposes. All data will be self-reported (see attached survey). Data collection will be through a web-based version of the EPIQ loaded into Research Electronic Data Capture REDCap, a secure web-based system for data collection. Data collection will occur over 6 half day sessions at the University of Minnesota D2D building at the Minnesota State Fair Grounds while the Fair is running.

Eligibility Criteria:
Inclusion Criteria:

* Women who are age 18 or older on the date they take the survey who are willing to take the survey. Pregnant women may participate in the survey.

Exclusion Criteria:

* Inability to provide consent to take the survey, and inability to speak and understand English.
Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)

Hypoglycemia is the most common metabolic problem faced after birth. The investigators will be studying the utility of using a continuous glucose monitoring(CGM) system to more closely monitor low blood sugars in newborns. The investigators will evaluate the number of hypoglycemic events detected using CGM and compare it to those detected using current standard of care screening methods.

A CGM will be subcutaneously inserted by trained staff on a healthy area of skin and will be calibrated according to the manufacturer's instructions. Blood glucose measurements will be taken using a blinded study glucometer to calibrate the device. Calibration by trained study staff will take place about every 12 hours. Sensor insertion sites will be monitored for infection throughout the course of the study by nursing and clinical staff or by trained study staff on an as needed basis. At the conclusion of the study, the CGM will be removed and assessed for signs of infection. Study duration will be up to 7 days while the patient is admitted to the hospital.

Participants will be randomized into 2 groups. The control group will have a blinded CGM in place for the duration of the study. The remote monitoring group will be blinded to clinical staff. This group will have a CGM connected to an iPod that sends continuous glucose data to the study phone and will be monitored 24/7 by study staff. If a blood sugar level of \<46 mg/dl is detected, the infant will first be evaluated for positioning that could be causing a falsely low value. If the infant is re-positioned and CGM continues to show a blood sugar level of \<46 mg/dl, study staff will prompt the nurse taking care of the patient to obtain a capillary glucose value to verify the low blood sugar and treat it as deemed appropriate by the clinical team.

The investigators will evaluate the number of hypoglycemic events that occur in the blinded CGM group versus the number that occur in the remote monitoring group to assess if the CGM is able to more sensitively detect low blood sugars in infants than current hospital standard of care measures.

Eligibility Criteria:
Inclusion Criteria:

* Infants who are at least 34 weeks gestation that are born to mothers with gestational or pre-gestational diabetes and are admitted to LPCH are eligible for the study.

Exclusion Criteria:

* Infants \<2,000 grams will be excluded from the study. Infants will also be excluded if they have an anomaly of the skin or subcutaneous tissue that would prevent proper adhesion, placement, and function of the sensor.
A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer

Further Study Details provided by Ascenta.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
* Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
* All patients must have measurable disease.
* No unstable or progressive brain metastases.
* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
* ECOG performance status 0-1
* Adequate hematologic function
* Adequate liver and renal function
* Ability to swallow oral medication

Exclusion Criteria:

* Prior chemotherapy regimen containing docetaxel.
* Active secondary malignancy.
* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Neuromodulation in COVID-19 Patients

This clinical study is aimed at investigating the effects of transcranial direct current stimulation (tDCS) on COVID-19 patients not admitted to the intensive care unit. The tDCS is a non-invasive brain stimulation technique which applies a low intensity electrical current in order to modulate neuronal activity. Patients included will be submitted to a single session with active or sham tDCS, aiming to modulate prefrontal or supplementary motor area (SMA). Evaluation protocol will be performed before and after stimulation to verify the incidence of adverse events related to treatment and whether tDCS would affect measures of executive functioning, mood, anxiety, autonomic response and motor function in COVID-19 patients. We hypothesize the neuromodulation would be a safety, promising treatment to reduce possible impairments in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed diagnosis for SARS-CoV-2;
* ability to understand and execute the proposed protocol;
* vital signs (body temperature \<38ºC, blood pressure between 90 x 60mmHg and 140 x 90 mmHg, respiratory rate between 12 e 30 bpm).

Exclusion Criteria:

* dyspnea or signs of respiratory effort;
* SpO2 ≤ 90%;
* hemodynamic instability;
* deep vein thrombosis, active bleeding, use of cardiac pacemaker;
* injury, pain or metallic implants in the cranium or scalp;
* seizure history;
* suspected or confirmed pregnancy;
* concomitant or previous rheumatic or neurological diseases;
* severe psychiatric diseases (schizophrenia, bipolar disorder, intellectual disability);
* severe musculoskeletal and/or integumentary disorders;
* severe psychiatric disorders;
* severe liver or kidney disease.
Setting up a Warehouse of Physiological Data and Biomedical Signals in Adult Intensive Care

The aim of this study is the establishment of a warehouse physiological data and biomedical signal in intensive care adult patients in acute situations from particular records from the Philips Intellivue MP70 monitor.

Cardiopulmonary failures are major public health concerns, due to the aging population. Each of these situations is burdened with a poor prognosis in the medium term and a source of prolonged hospitalizations, generating significant health costs. Early detection and prediction of organ failure could reduce health costs and risks for the patient, offering a reaction early and appropriate medical technology. The proposed approach aims to optimize the knowledge of a complex physiological domain and multi-system, while promoting the automatic transfer of knowledge. The approach proposed data-mining and development of algorithms for detecting and / or predicting a strong potential for disruption because it proposes to apply innovative automated analysis procedures to a fragile patient population, and then a transfer to the medical device industry.

From communicating tools of recording of the signals, the investigator envisage in a global way:

1. the constitution of a warehouse of physiological data of grown-up patients in acute situation (intensive care unit);
2. the development by data mining of a system of detection of organs failures or adverse events basing itself on the application of innovative algorithms, allowing the decision-making operational, from the fusion of arisen ill-assorted events;
3. the use of intelligent tools of auto-learning and elaboration of complex multimodal models for purposes of prediction of events;

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient admitted in Brest University Hospital's intensive care unit for monitoring of vital failure

Exclusion Criteria:

* Refusal to participate
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children

Principal aim: To determine the prevalence of Sleep Apnea- Hypopnea syndrome in obese children.

Secondary aim: 1. To fix the implication of the adenotonsillar hypertrophy, the obesity and the hormonal factors in the pathogeny of SAHS in children. 2. To determinate of clinical and neurophysiologic characteristics of childhood SAHS associated with obesity. DESIGN: A prospective transversal study.

The population of study will be make for children of both sex, between 3 and 14 years old and with body mass index (BMI) ≥ 95 percentile and with informed consent. METHODS: In all children included in the study, the investigators will carry out: previous history, history of snoring and Chervin´s screening questionnaire of SAHS, general physical and otorhinolaryngologic examination with nasopharyngoscopy, blood test with determination of glucose, lipids, insulin, leptin, adiponectin, and ghrelin, polysomnography (PSG) with transcutaneous CO2. The diagnosis of SAHS will be made if on PSG the Respiratory disturbance Index (RDI) is ≥ 3 and/or obstructive hypoventilation is present.

Eligibility Criteria:
Inclusion Criteria:

* Children of both sex, between 3 and 14 years old
* Body mass index (BMI) ≥ 95 percentile
* With informed consent.

Exclusion Criteria:

* Without informed consent
Pharmacovigilance and Patient Compliance in Hypertensive Patients

Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)

Exclusion Criteria:

- corresponding to the contraindications listed in the summary of product characteristics of the drug
Observational Study of Parental Feeding Practices to Improve Child's Food Intake and Weight Status

Background:

A topic of interest in the etiology of child obesity is if and how parental feeding behaviors are associated with child food intake and weight status.

Objectives:

The objective was to explore if and how directive (overt) and non-directive (covert and food environmental structure) types of parental feeding control were associated with children's food intake and weight status.

Design:

This was a cross-sectional, exploratory study using structural equation modeling to determine directional associations between maternal feeding practices and their child's food intakes and weight status. Researchers collected data from 330 dyads of 3-5yr children and mothers participating in a federal preschool program for low-income families (Head Start) in Michigan. Mothers' feeding practices (directive and non-directive control), children's food intakes, height and weight of both mothers and children were measured. Structural equation models tested the relationships between maternal feeding practices, the child's food intake and weight status.

Hypotheses:

1. Child weight is negatively associated with parents' directive feeding control practices.
2. Less directive control or greater non-directive control is associated with healthier food intakes in children.


Eligibility Criteria:
Inclusion Criteria:

* Dyads of child (3-5yrs) and the primary female caregiver
* Participating Head Start program in central Michigan

Exclusion Criteria:

* Children with disability except speech disorders
* Caregivers younger than 18 years old
Appetite Regulation and Mycoprotein

The purpose of this study is to investigate the effect of eating various levels of mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in overweight volunteers.

Owing to its relatively high protein and fibre content, mycoprotein presents an attractive food product to improve appetite regulation and postprandial glycaemic and insulin responses in overweight and obese individuals at risk of developing T2DM

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 65
* body mass index (BMI) 25-32kg/m2
* Weight stable over the past 6 months
* No known major illness or eating disorder nor on any medication that may impact on appetite or hormone levels.
* No paracetamol or other analgesic in the previous 48 hours
* A score of \<2.5 in the Dutch Eating Behaviour Questionnaire (DEBQ)
* A score of \<2 in the SCOFF questionnaire

Exclusion Criteria:

* Persons outside the age and BMI ranges stated above
* Pregnant and lactating women
* Weight variation of greater than 5% in the last 6 months
* Any diagnosed major illness
* Any paracetamol or analgesic intake in the last 48 hours
* Diagnosed eating disorder
* Allergy to mycoprotein or mushrooms
* Regular consumption of Quorn products
* Dislike of any of the test foods or drinks
* A score of \>2.5 in the Dutch Eating Behaviour questionnaire
* A score of 2 or more in the SCOFF questionaire
Detecting Syncope by an Integrated Multisensor Patch-type Recorder

The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.

Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min).

The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.

Method The study is a prospective intrapatient comparison between BP measured by mean of a cuffless patch BP monitor (RootiRX System, Rooti Labs Ltd., Taipei, Taiwan) and by mean of the standard method during tilt testing.

Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the RootiRX device and will be compared with the standard of reference. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients,
* \>18 years of age,
* referred for tilt testing because affected by suspected reflex syncope

Exclusion Criteria:

* Incapability to perform tilt testing
Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew

Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.

The purpose of this study is to identify what are the most effective low level laser therapy (LLLT) dosimetry parameters when treating pilots and navigators complaining of flight related neck pain.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Active Duty US Air Force pilots or onboard navigators, aged 18- 62 years of age
* maintain operational flight status at enrollment or within the last 6 months
* History of neck pain for a period of more than two months
* Score on the Neck Disability Index ranging from 15-24
* No physiotherapy or local injection in 3 months before starting the study

Exclusion Criteria:

* pregnant
* major surgery or trauma in the previous 3 months
* unstable cervical spine
* cervical radiculopathy
* rheumatoid arthritis
* open wound over neck
* pace-maker or defibrillator implantation
* overt neuropathic pain or radiation pain
* inability to express pain or quality of life.
* history of neurological disorders
* medical diagnosis of fibromyalgia; systemic disease
Exercise Capacity in Diseases and Health

Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g. ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way to measure exercise capacity is to perform a cardiopulmonary exercise testing. Normal/reference values in health and disease relate to specific population and subpopulations. The population in Israel is unique in its diversity.

Objectives: Data collection of exercise capacity assessment in health and illness in the northern of Israel for future local database.

Population: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.

Study design: Prospective observational study. Participants will answer a health related questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a treadmill or a cycle ergometer.

Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g. ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way to measure exercise capacity is to perform a cardiopulmonary exercise testing. Normal/reference values in health and disease relate to specific population and subpopulations. The population in Israel is unique in its diversity.

Objectives: Data collection of exercise capacity assessment in health and illness in the northern of Israel for future local database.

Population: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.

Study design: Prospective observational study. Participants will answer a health related questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a treadmill or a cycle ergometer .

Eligibility Criteria:
Inclusion Criteria:

* Ability to complete full exercise evaluation (including cardiopulmonary exercise testing).

Exclusion Criteria:

* Acute illness on visit day.
* for healthy volunteers: chronic disease or use of medications.
* Professional athletes.
Assessment of Color Vision in Diabetic Patients

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema


Eligibility Criteria:
Inclusion Criteria:

* Having diabetic retinopathy with macular edema

Exclusion Criteria:

* Not having diabetic retinopathy with macular edema
Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

The investigators plan a randomized control trial of all eligible patients undergoing major limb amputation at Parkland Memorial Hospital. Eligible patients undergoing an amputation will be consented for all possible interventions and randomized to either receive Targeted Muscle Re-Innervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), or standard post-amputation surgical care at the time of their operation. Key pre-operative data including patient sex, age, BMI, past medical history, past surgical history, medications, allergies, social history, social support systems, exposure to narcotic medication, and reason for amputation will be analyzed. Intra-operatively, patients randomized to the treatment arm will receive TMR or RPNI and the transected nerve ends addressed will be recorded. Post-operative data that will be recorded include hospital stay, complications related to the procedure, complications leading to reoperation, functional results, need for pain medication, incidence of phantom limb pain, incidence of painful neuromas, length of follow-up, and all adverse events/complications. Analyses will be conducted using data obtained from patient medical records from the Parkland Health \& Hospital System.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) as a primary or secondary sequela of trauma.
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for primary or secondary sequelae of malignancy.
* Secondary sequalae include but is not limited to metastatic disease and osteolytic disease.
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for vasculitic diseases.

Exclusion Criteria:

* Patients less than 18 years old
* Patients with cognitive impairment
* Patients who are imprisoned at the time of randomization
* Patients currently enrolled in other studies relating to neuropathic pain
* Patients actively undergoing radiation therapy
* Patients with existing neuroma or underwent prior neuroma surgery
* Patients with amputations scheduled congenital reasons