cyrilzakka/clinical-trials huggingface dataset:
Group Psychotherapy in Narcolepsy Type 1

The aim of this pilot study is to test the benefit of behavior therapy-oriented, method-integrated psychotherapy in an outpatient group setting in patients with narcolepsy type 1. Therefore we collect and evaluate initial data on its effectiveness on the disease in terms of specific symptomatology, emotion regulation, health-related quality of life, and disease processing/acceptance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed narcolepsy type 1 according to AASM, examined by an experienced sleep physician including history, clinical examination, polysomnographic examination (PSG) with a multiple sleep latency test (MSLT), possibly also including determination of HLA DQB1 \* 062 and orexin A / hypocretin 1
* Age between 18 and 65 years
* Signed informed consent
* Exclusion of other clinically relevant organic sleep disorders by means of polysomnography (AHI\>10/h)

Exclusion Criteria:

* Presence of severe psychiatric comorbidity
* Other psychotherapy during the study period
* Change of medication used for narcolepsy therapy shortly before the start and during the study period including follow-up measurement. In this case, patients may still complete group therapy, but the data will not be included in the analysis.
Web-based Preconception Health Education Tool

Strong evidence supports that preconception care, or care to optimize a woman's health health prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a broad range of topics, including: desire for pregnancy, obstetric history, nutrition, vaccinations, sexual health, chronic disease, substance abuse, mental health and contraception. Despite calls from public health organizations and experts in the field for universal access to preconception care, most US women do not receive any health counseling to prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is critical that routine primary care serve as a venue for the provision of this important service. From a patient's perspective, improving preconception health involves many health behavior changes. As such, patient engagement and education regarding preconception health must be a primary focus. Several preconception health promotion tools have been developed for patients to date; few are truly patient-centered and even fewer have been rigorously evaluated.

This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is truly innovative in two key ways:

* MyFamilyPlan is a web-based preconception health self-assessment. This will allow for the employment of skip logic to individualize the questionnaire and subsequent health recommendations for each patient.
* Recognizing that preconception care is relevant to all women "at risk" of pregnancy, MyFamilyPlan has been designed for utilization in a primary care setting.

This preconception health education tool will be tested using a randomized controlled design. This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of preconception health issues in primary care encounters (primary outcome). It will also evaluate whether the intervention affects participant self-efficacy in planning a healthy pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will improve the quality of evidence for preconception health education tools. Should it demonstrate effectiveness, it will also result in a new tool that could be made more widely available to promote preconception health.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* English-speaking
* Non-pregnant
* Capable of pregnancy (i.e., no previous hysterectomy or sterilization procedure)
* Scheduled primary care visit in health system in the upcoming 7-10 days
* Active email address

Exclusion Criteria;

* Currently pregnant
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.

The primary objective of this study was to assess the treatment duration in the real life in 2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by 600 mg twice daily IV/PO (intravenous/per oral) linezolid.

Eligibility Criteria:
Inclusion Criteria:

* Adult female and male in-patients with clinical diagnosis compatible with ABSSSI (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by Gram positive bacteria (with or without laboratory confirmation).
* Patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician's routine treatment practice.
* Signed informed consent.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients who have been enrolled in this study before.
Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

Specific aim: To establish the proof of principle that treatment of "high breast cancer risk" women with recombinant human chorionic gonadotropin (r-hCG) will change their breast epithelium's high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy.

This study is based on the investigators preclinical data that have demonstrated that r-hCG exerts a mammary cancer preventive effect that is mediated by the induction of gland differentiation, which results in permanent changes in the genomic signature of this organ. This exploratory study will evaluate the genomic profile of breast epithelial cells obtained from random periareolar fine needle aspiration (RPFNA) specimens performed in high risk women treated for 90 days (an extra 4 weeks in a subgroup) with r-hCG. This knowledge will serve as the basis for establishing a novel genomic biomarker that will serve as a surrogate endpoint in future preventive clinical trials.

The objective of the proposed study is to characterize the genomic profile of breast epithelial cells obtained from 35 asymptomatic high breast cancer risk nulliparous premenopausal women carriers of BRCA1 and BRCA2 deleterious mutations. Gene expression measurements and benign breast tissue specimens will be obtained at baseline (time 0), after treatment with r-hCG at 90 days (time 1), at 270 days from baseline (time 2) and (in a subgroup) at 60 weeks (+/- 4 weeks).

The primary objective of the study is to compare the gene expression profiles of these women across the three (or four) time points and identify differentially expressed genes. The investigator is interested in comparing the expression profiles between all pairs of time points as well as across time. The comparison of profiles before and after treatment with r-hCG, both at 90 and 270 days are of particular interest. The women will receive 3x/week injections of 250 microgram r-hCG for a total of 12 weeks (an extra 4 weeks in a subgroup). Core Needle Biopsies specimens will be primarily utilized for analysis of genomic expression by cDNA microarray. In addition, a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal women
* BRCA1 carrier

Exclusion Criteria:

* History of allergic reaction to compounds of similar chemical or biologic composition to hCG
* receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin)
* previous treatment with follicle stimulating hormone for assisted reproduction
* uncontrolled intercurrent illness
* Heart disease
* Severe cognitive decline
* Psychiatric desease
* HIV positive
* Hepatitis B or C infection
Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ST-segment elevation myocardial infarction
* Undergoing primary percutaneous coronary intervention
* Aged between 20 and 80 years

Exclusion Criteria:

* Previous administration of any antagonist of the platelet adenosine diphosphate (ADP) P2Y12 receptor (clopidogrel, prasugrel or ticagrelor)
* History of stroke or transient ischemic attack
* Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dl
* Chronic oral anticoagulation treatment
* Contraindication to the antiplatelet treatment
* Severe renal insufficiency (serum creatine\>2.5 mg/dl)
* Severe hepatic dysfunction (serum liver enzyme or bilirubin\>3 times normal limit)
* Sever chronic obstructive pulmonary disease (COPD) or bradycardia
* Body weight \< 50 kg
The Deep Phenotype of Lamin A/C Cardiomyopathy

This study seeks to discover clinically useful tests to improve the diagnosis of a rare and serious heart muscle disease caused by mutations in a gene called 'Lamin'.

Patients born with lamin gene mutations have apparently healthy hearts initially, they begin experiencing symptoms in their twenties or thirties, and by age 45 the majority have undergone a heart transplant, experienced a major cardiac complication, or have died. Sudden heart rhythm abnormalities are a major cause of sudden death so earlier diagnosis can save lives by enabling timely treatment or implantation of specialised pacemakers (defibrillators). In clinical practice, diagnosis of lamin heart disease currently relies on the genetic test. Very little is known about the detailed imaging features of the hearts of patients with lamin heart disease although advanced echocardiography and cardiac MRI now offer the opportunity to study the health of the heart without the need for radiation.

* Research participants will undergo resting 12-lead ECG, 24-hour ambulatory ECG, baseline echocardiography, exercise echocardiography, cardiac MRI scan.
* Blood samples will be collected in all participants from both centers for immediate laboratory testing.
* Blood and urine samples will be collected in all participants and used for metabolomic, proteomic and lipidomic profiling and for targeted metabolite and enzyme analysis.
* Blood samples will be collected in all participants for future gene code analysis (DNA / RNA).

Eligibility Criteria:
Inclusion Criteria:

* LMNA+ cases with pathogenic LMNA mutations for LMNA+ and heart myocardial samples from the explanted hearts of LMNA+ patients who are scheduled to undergo clinically indicated heart transplantation at the Papworth Hospital NHS Trust.
* DCMWT cases: patients with heart muscle failure but with wild-type lamin gene. Heart myocardial samples from the explanted hearts of DCMWT patients who are scheduled to undergo clinically indicated heart transplantation at the Papworth Hospital NHS Trust.
* HV (controls): matched to cases.

Exclusion Criteria:

* Needle-phobia that would preclude blood-letting
* Participants unwilling to consent
* Patients that have a conventional contraindication for cardiac magnetic resonance imaging (MRI).
* Patients that have had a blood transfusion within the last month and patients having haemodialysis will be excluded.
Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

The purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.

Improved post prandial glucose control with multiple daily injections of insulin in the DCCT study demonstrated significant reductions in microvascular complication. Similar to type 2 diabetes, patients with type 1 diabetes have a paradoxical increase in glucagon after meals which contribute to worsening post prandial glucose control. This proposed study is designed to determine if altering the glucagon axis by giving sitagliptin can improve glucose control in patients with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult, aged 18 to 70 years
* Type 1 diabetes mellitus as established by medical history
* Current treatment with MDI or CSII therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month
* HbA1c ≥ 8.5%
* Subjects should routinely practice at least 2-4 blood glucose measurements per day
* BMI ≤ 35 kg/m2
* Subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for the total duration of the study
* Willing to complete a routine medical visits every 3 months
* Willing to complete a total of 7 phone visits
* Able to speak, read, and write English

Exclusion Criteria:

* On oral, inhaled or pre-mixed insulin
* On Symlin
* BMI \> 35 kg/m2
* Pregnant or intends to become pregnant during the course of the study
* Severe unexplained hypoglycemia that required emergency treatment over the past 3 months
* History of hemoglobinopathies
* Diagnosis of anemia
* HbA1C greater than 12%
* Post-renal transplantation, currently undergoing dialysis, creatinine of \>1.5mg/dl or a calculated creatinine clearance of \<50 mL/min.
* Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin
* Subjects who have a medical known allergy to adhesives
* Subjects who have an allergy to medication being used
* Currently participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to being enrolled in this one
* Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial.
An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge

This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.


Eligibility Criteria:
Inclusion Criteria:

Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications undergoing cardiovascular surgeries or liver transplantation (recipients):

1. Adult patients (18 years of age and older) who underwent cardiovascular on-pump surgeries or procedures (e.g., CABG) who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
2. Adult patients (18 years of age and older) who underwent not-on-pump cardiovascular surgeries (e.g., lead extraction) or cardiovascular procedures (e.g., minimally invasive valve or percutaneous cardiac procedures, such as PCI, LAAC, TAVR/TAVI) associated with the use of heparin who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
3. Adult patients (18 years of age and older) who underwent liver transplantation (recipients)

Exclusion Criteria:

1. Patients with hereditary chronic coagulation and/or bleeding disorders
2. Patients with hereditary fibrinolytic bleeding disorders
3. Patients deemed unfit for participation in the by the principal investigator
4. Patients participating in another clinical that would not be scientifically or medically compatible with this trial
5. Patients with currently altered coagulation due to the presence of oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran, warfarin)
Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure

Changes of thyroid function may occur after short loss of consciousness, but they haven't been systematically evaluated up to now, although occasional observations suggest temporal increases in TSH concentration.

This study aims at assessing transient changes of biomarkers of thyroid function after syncopation and seizure.

Results of the study might contribute to an improved detection rate of thyrotoxicosis.

Transient allostatic responses of thyroid function have been described in critical illness. Own observations suggest similar reactive responses after syncopation and cerebral seizures. They are marked especially by increased concentration of serum thyrotropin (TSH), suggesting a type 2 allostatic response. However, changes of thyroid function after temporal loss of consciousness haven't been systematically evaluated up to now. Current diagnostic guidelines recommend primarily the determination of serum TSH concentration for screening of thyroid function, and the measurement of peripheral thyroid hormones (T4 and/or T3) is only recommended if TSH determination results in pathological values. This TSH reflex strategy may be misleading after short-term loss of consciousness.

This study aims at assessing the prevalence of allostatic responses of thyroid function after events of syncopation or seizure and at investigating the consecutive temporal development of biomarkers of thyroid function. An additional aim includes the diagnostic value of TSH determination, compared to measurement of free thyroid hormones, for thyroid dysfunction after syncopation or seizure.

Results of this study might contribute to an improved detection rate of thyrotoxicosis. In cases of medical emergencies and in-patient treatment interventions with a significant iodine load are common, including the application of iodinated radiocontrast agents and amiodarone. In this setting, undetected hyperthyroidism may lead to thyroid storm, which is associated with a high mortality.

Eligibility Criteria:
Inclusion Criteria:

* Admission after syncope or seizure
* Age of 18 years or older
* First bleed not later than two hours after event (syncope or seizure)
* Written informed consent obtained

Exclusion Criteria:

* Results of thyroid hormones not available within two hours after event
* Pituitary dysfunction
* Thyroid dysfunction
* Use of iodinated radiocontrast agents less than three months ago
* Therapy with amiodarone in the previous three years
* Pregnancy
Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.

Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.


Eligibility Criteria:
Inclusion criteria:

* Total hip arthroplasty (THA) monolateral, first implant
* Locomotor autonomy with or without aids before surgery
* BMI (regular, overweight, Grade I obesity)
* No complications in surgery
* Orthopaedic prescription of tolerance load on the limb
* Autonomy with aids within the third post-operative day

Exclusion Criteria:

* Previous total hip replacement on contralateral hip
* Dementia or other conditions affecting patient's collaboration
* Unresolved clinical complications in the first two post-operative days
* Neurological, musculoskeletal or other disorders able to impact on functional recovery
* Visual or auditory deficits
* Total or partial revisions of THA
* Patients assigned to different groups hospitalized in the same room
tDCS Response Prediction Using EEG in Stroke

Patients with chronic stroke (\>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.


Eligibility Criteria:
Inclusion Criteria:

* age ranges from 19 to 85 yrs old
* stroke patients with unilateral hemiparesis
* 1st ever stroke
* chronic stroke (\>6 months after stroke)

Exclusion Criteria:

* recurrent stroke
* history of traumatic brain injury
* Minimental state examination score is 15 or less.
* Unstable medical conditions
* Severe delirium, disorders of consciousness
* pregnancy
* can not attach tDCS electrode on the scalp due to skin conditions
* can not maintain the sitting position
* intracranial metals