cyrilzakka/clinical-trials huggingface dataset:
Prematurity Education in High Risk Pregnancies

Prematurity is associated with significant morbidity and mortality. Given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child. Unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult. This study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery.

   1. Premature delivery defined as \<37 0/7 weeks gestation.
   2. Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at high risk for premature delivery.
2. Pregnant women 16 years and older.
3. Pregnancy with singleton or twin gestation.
4. No major congenital malformation.
5. Women who are English speaking.

Exclusion Criteria:

1. Pregnant women \<22 0/7 or \>35 0/7 weeks gestational age.
2. Pregnant women less than 16 years old.
3. Multiple gestation greater than twins (triplets, quadruplets, etc).
4. Known major congenital malformation.
5. Women who are non-English speaking.
Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules

The purpose of this observational research is to evaluate and compare the health-related quality of life and emotional well-being of patients with thyroid nodules before and after treatment. This is a data collection study by allowing investigators to access information generated before and after treatment.

The incidence of thyroid nodules is rising worldwide. Papillary thyroid carcinoma (PTC), the most common type of thyroid cancer, has a favorable prognosis, with a low mortality rate and over 90% 10-year survival rate. Thyroidectomy is often applied to manage thyroid nodules as a traditional method. However, thermal ablation (TA), including microwave ablation (MWA), radiofrequency ablation (RFA), and laser ablation, has emerged as an alternative option for selected patients with thyroid function. TA methods are effective, safe, feasible, and have litter influence on thyroid function. Patients with thyroid nodules frequently exhibit higher levels of emotional stress compared to the general population. Additionally, health-related quality of life (QoL) has become an important endpoint and a strong predictor of survival time in medical and health research, underscoring the importance of treatments that not only prolong life but also preserve or enhance QoL. Considering the long survival time of patients with thyroid noduls and the similar therapeutic outcomes between surgery and MWA , it is crucial to pay more attention on patients\&amp;#39; QoL and emotional well-being before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ;
* underwent microwave ablation or thyroidectomy;
* ability to understand and cooperate with the survey

Exclusion Criteria:

* serious primary diseases in the liver, kidney, hematopoietic, or endocrine systems；
* a history of mental illness, personality disorders, cognitive impairments, or organic brain disease
Measuring Physical Activity With ActivPal

This study measures the level of physical activity in participants with neuromuscular disorders. The patient wears a small button like meter on their leg for a period of 1 week every 6 months over a period of 3 years. Participants will also have a physical exam, six minute walk test,vital signs and questionnaires.

Routine physical activity can be an important indicator of health across an individual's life span. Nonetheless, the frequency of inactivity continues to be problematic for a large number of children and adolescents. Adding to that challenge, fatigue has been described as a typical symptom of neurological diseases and disorders Consumer wearables and accelerometers are becoming increasingly popular to track physical activities and monitor health and disease progression. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user's behavior and lifestyle. Although methods for objectively measuring physical activity in children and adults in naturalistic settings are well established (i.e., accelerometry), they are most widely used on healthy individuals. Due to cost and technical requirements, these technologies are limited which effects their wide-scale use. Ultimately, this undermines efforts to evaluate physical activity changes and nuances among healthy and diseased populations. This is of particular interest in rare disease populations, specifically in neuromuscular diseases, where one can study a wide range of features that can be used to monitor an individual's sleep, vertical positioning, or overall physical activity. Tracking physical activity can help provide clinicians with a more accurate disease profile and help to identify possible interventions. Collection of this data could potentially provide valuable insight into an individual's daily routines, lifestyle, and behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinically or genetically confirmed neuromuscular disorder
* Control subjects who do not have a neuromuscular disease.
* Participants at least 1 years of age.

Exclusion Criteria:

* Participant has a condition, which in the opinion of the Investigator may compromise safety
* Participant has a condition, which in the opinion of the Investigator may compromise or compliance
Project MOVE: Increasing Physical Activity Among Breast Cancer Survivors

The purpose of this research is to implement and evaluate the feasibility of Project MOVE, a program aimed to increase physical activity among breast cancer survivors through microgrants and financial incentives.

Despite the physical and psychological health benefits associated with physical activity for breast cancer survivors, up to 70% of female breast survivors are not meeting minimum recommended physical activity guidelines. The purpose of this research was to develop, implement and assess the feasibility of Project MOVE, an innovative approach to increase physical activity among breast cancer survivors through the use of Action Grants, a combination of microgrants (small amounts of money awarded to groups of individuals to support a physical activity initiative) and financial incentives. Twelve groups of 8-12 adult women who are breast cancer survivors (N=132) were recruited for the study via face-to-face meetings with breast cancer-related stakeholders, local print and radio media, social media, and pamphlets and posters at community organisations and medical clinics. Each group submitted a microgrant application outlining their proposed physical activity initiative. Successful applicants were determined by a grant review panel and informed of a financial incentive upon meeting their physical activity goals. Primary (program feasibility) and secondary (physical activity, quality of life, motivation to exercise and social connection) outcome measures were evaluated using a mixed-methods approach including focus groups, self-reported questionnaires, semi-structured telephone interviews and objective physical activity measures. Measures were collected at baseline, post-intervention (6 months) and 12-month follow-up. Findings from this study were used to asses the implementation and feasibility of Project MOVE as a strategy for increasing physical activity among breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer survivors
* 18+ years old,
* Residing in the Okanagan region of British Columbia, Canada

Exclusion Criteria:

* No specific exclusion criteria
Clinical Evaluation of COPD Butler in Patient Home Management

Chronic Obstructive Pulmonary Disease (COPD) is a worldwide common disease with high morbidity and mortality and leads to heavy social and economic burden. Health management of stable COPD patients has been suggested to be essential for delaying diseases progress, reducing acute exacerbation events and improving patient quality of life. Non-invasive ventilation (NIV) is a widely used treatment in COPD patients. There were studies shown that NIV could improve ventilation, blood gases etc., and several clinical trials have shown improvements in survival, exercise capacity, quality of life and so on. Compliance to NIV and optimal parameter setting are important factors that will affect the effect of the use of NIV, thus NIV usage monitoring might also be a crucial element in the health management of COPD patients. Many studies have been designed to study the effect of tele-monitoring program on the management of COPD patients. However, almost none of these studies were designed for specific population, and little is known about the effect of such program on the management of patients with NIV treatment.

The COPD home management program consists of 3 Philips devices (NIV BiPAP ST, Oximeter and Blood Pressure Meter), a patient mobile APP which is developed for self-management at home and a professional physician web portal which is designed for NIV usage and other vital sign data monitoring. The program is intended to manage the post-discharge COPD patient by enhancing COPD patient condition monitoring and adherence to the home therapy, e.g. NIV in this study. Besides obtaining clinical proof points of the efficacy of such program on patients with NIV treatment, it will provide potential evidence of the usability as well as the collect the insights for future product improvement.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-80, males and females
2. Stage III and IV COPD
3. Daytime hypercapnia (PaCO2 ≥ 50 mmHg) at rest without ventilatory support
4. Possess home oxygen concentrator
5. Participants/Caregivers have access to and capable of using smartphone and internet
6. Willing to participate in the study
7. Able to provide informed consent

Exclusion Criteria:

1. Subjects with NIV as routine therapy prior to the study
2. Subjects with abnormalities of the lung or thorax other than COPD
3. Subjects with obstructive sleep apnea, COPD with obstructive sleep apnea overlap syndrome, severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities
4. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
5. Subjects who participated in another trial within 30 days prior to the planned start of study
Evaluation of Depression and Sleep Disorders in Endometriosis Patients

The aim of this study was to compare the depression and sleep disturbances of operated endometriosis patients before and after the operation. The main objective here is to provide data on how patients' psychological states and sleep patterns are affected by the symptoms of endometriosis and how these effects can be corrected. In this way, it is aimed to determine whether the patients have psychological support needs and to give the planned treatment due to endometriosis in the early period. As a secondary goal, it is planned to keep the patients in follow-up with their improved sleep and psychological conditions, and to improve their adherence to treatment and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 18-49 years of age with no known psychiatric disorder and
* Endometriosis patients with indications for operation

Exclusion Criteria:

* Patients receiving only medical treatment without any indication for operation,
* those with a known psychiatric disease,
* patients with sleep disorders due to another reason,
* Patients over the age of 49, patients under the age of 18,
* Patients with malignancy,
* pregnant women
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins.

Secondary Objectives:

* To evaluate the efficacy of alirocumab versus placebo on LDL-C levels.
* To evaluate the effects of alirocumab versus placebo on other lipid parameters.
* To evaluate the safety and tolerability of alirocumab in comparison with placebo.
* To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.
* To evaluate the development of anti-alirocumab antibodies.

The study duration was approximately up to 110 weeks (run-in period \[if needed\]: up to 4 weeks \[+2 days\], screening period: up to 2 weeks \[+5 days\], double-blind treatment period: 24 weeks, open label (OL) treatment period: 80 weeks).

Eligibility Criteria:
Inclusion criteria:

* Children and adolescent male and female participants 8 to 17 years of age at the time of signed informed consent.
* Participants with diagnosis of heFH through genotyping or clinical criteria.
* Participants treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
* Participants with calculated LDL-C greater than or equal to 130 mg/dL (\>=3.37 mmol/L) at the screening visit except for participants who have previously participated in the DFI14223 (NCT02890992) study.
* A signed informed consent indicating parental permission with or without participant assent.

Exclusion criteria:

* Participant with body weight \< 25 kg.
* Participants aged of 8 to 9 years not at Tanner stage 1 and participants aged of 10 to 17 years not at least at Tanner stage 2 in their development.
* Participants with secondary hyperlipidemia.
* Diagnosis of homozygous familial hypercholesterolemia.
* Participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
* Participants with uncontrolled type 1 or type 2 diabetes mellitus.
* Participants with known uncontrolled thyroid disease.
* Participants with uncontrolled hypertension.
* Fasting triglycerides greater than (\>) 350 mg/dL (3.95 mmol/L).
* Severe renal impairment (ie, estimated glomerular filtration rate \<30 mL/min/1.73 m\^2).
* Alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal (ULN).
* Creatinine phosphokinase (CPK) \>3\*ULN.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.

The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.

Participants with any of the following acute or chronic infections or infection history:

* Any infection requiring treatment within 2 weeks prior to the dosing visit.
* Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
* Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
* Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
* History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
Effects of Snuff and/or Red Wine om Metabolic Rate

About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured every hour for four hours on each occasion starting in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal.

About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured measured before the meal and then every hour for a total of four hours on each occasion that starts in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal. Since there are four possible combinations of the wine and the snuff, all participants do the test on four occasions. Except for metabolic rate we will also analyze hormone responses regarding appetite or hunger.

Eligibility Criteria:
Inclusion Criteria: No significant disease -

Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish

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Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study

This study will treat resectable cutaneous squamous cell carcinoma patients with pramlintide for two weeks prior to surgical resection of their tumor. Pre-treatment and surgical resection specimens will then be analyzed for biological alterations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cutaneous squamous cell carcinoma. Mixed histologies (basaloid, spindle, sarcomatoid, etc.) are allowed if the pathology review favors squamous cell carcinoma as the majority component. Cancers of unknown primary sites are allowed if the clinical history and the site are highly suggestive of a skin cancer primary
* Tumor site must be amenable for surgical resection and accessible for pre-treatment biopsy
* Tumor site must be measurable by caliper measurements or by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 imaging - lesions must be ≥1 cm
* Eastern Cooperative Oncology Group (ECOG) ≤2 and be medically able to undergo surgical resection
* Laboratory Requirements: Hemoglobin ≥ 8 g/dl, Platelet count ≥ 50,000/dl, Serum Creatinine ≤ 1.5 mg/dL OR Glomular Filtration Rate (GFR) ≥ 40, Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 2.5x ULN; Total Bilirubin \< 1.5x ULN (for patients with documented history of Gilbert's syndrome, total bilirubin level should be \< 3.0 X ULN)
* Ability to understand and willingness to sign a written informed consent document
* Patients with child bearing potential must be willing to use barrier protection to prevent pregnancy while on study therapy and up to 30 days after the last dose of pramlintide
* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Patients must be willing to comply with the protocol for the duration of the treatment including daily sub-cutaneous (SQ) injections, biopsies, scheduled visits and examinations, radiologic studies, and surgical resection

Exclusion Criteria:

* Type I diabetes: Type II diabetics (DM2) on insulin are allowed, however, for those DM2 patients that are on short acting insulin, the insulin dose should be reduced 50% and need to have regular glucose monitoring (see section 6.2.1). Type II diabetics not on insulin will not be eligible.
* Patients with known gastroparesis
* Patients with known allergic reactions to pramlintide or its ingredients
* Pregnant women and/or nursing patients will be excluded from this study because of unknown risks to fetus or nursing infants
* Any serious or uncontrolled medical disorder that could interfere with the current study as deemed by the investigating physician
* Participation in any other clinical study using an investigational agent within 21 days of starting treatment on this protocol
* No prior chemotherapy, radiation, or other tumor directed therapy within 21 days prior of starting treatment on this protocol
Patent Foramen Ovale in Children With Migraine Headaches

This study will be the first to provide data about the relationship between PFO and migraine in children. By establishing the actual prevalence, we will better understand if PFO plays a role in the occurence of pediatric migraine and, thus, provide the incentive to perform additional studies evaluating whether PFO closure is an effective treatment option for pediatric migraine. For children with migraine headaches, discovering novel and effective treatments would be life altering.

Specific Aim 1 Using contrast transthoracic echocardiography, compare the prevalence of a PFO in children with migraine headache with the established incidence of PFO published for the general population.

Specific Aim 2 Using contrast transcranial Doppler, examine the relationship between the degree of right to left atrial shunting with the presence or absence of aura in children with migraine.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to six years of age and less than 18 years of age.
* Diagnosis of migraine headache based on the International Headache Society Criteria.
* English speaking patients (and parent/guardians where appropriate).
* Signed informed consent/assent (as appropriate) given by patient, parent or legal guardian.

Exclusion Criteria:

* Inability to cooperate with imaging studies.
* Known congenital heart disease.
* Parent or guardian is unwilling to have their child undergo contrast echocardiography.