cyrilzakka/clinical-trials huggingface dataset:
Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)

This is an observational epidemiologic multicentric study of follow-up a cohort for described the situation of patients with primary ovarian insufficiency in public population with respect to the age of apparition the primary ovarian insufficiency .

iPOI (Investigators in premature ovarian insufficiency): M. Guinot, B. Roca, J. Tomás, P. Escamilla, J. Hernández, P. Llaneza, N. Mendoza Ladrón de Guevara, B. Otero García, I. Ñiguez, A. Castro, L. Baquedano, P. Romero, S. Sánchez.


Eligibility Criteria:
Inclusion criteria:

* Women between 18 years and 39 years.
* Primary ovarian insufficiency demonstrated with amenorrhea and levels of follicle stimulating hormone (FSH) over to 40 IU in two determinations measured with a difference of one moth.
* Not present linguistic barriers ,shaw attitude towards collaboration ,be able to attend the study center for all follow-up visits.
* Signed informed consent before inclusion in the study and after having been informed of the procedures performed in this study.

Exclusion criteria :

* Women with secondary hormonal alteration that do no meet the diagnostic criteria of the disease.
* Refusal to participate.
* Withdrawal of informed consent.
Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.

Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions \> 5 mm in diameter and 69% for tumors smaller than 5mm.

In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:

* Women with equivocal findings on Mammography, US and/or MRI
* Women with discrepancy between CBE(clinical breast examination)and breast imaging
* Women with dense breast
* Women in high risk for Breast Cancer

Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.

The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.

This phase will include 500 women.

Eligibility Criteria:
Inclusion Criteria:

* Age over 25.
* Equivocal breast lesions.
* Dense breast tissue.
* High-risk for breast cancer

Exclusion Criteria:

* Age under 25.
* Pregnancy.
* Patients unable to understand and sign an informed consent
Minimum Effective Volume of Ropivacaine 7.5 mg/ml for the Lateral and Sagittal Infraclavicular Brachial Plexus Block

Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA dose is one of the strategies to reduce this risk. For upper limb blocks it is well documented that ultrasound guidance allows a significant lower dose of LA for interscalene and axillary blocks than with guidance by peripheral nerve stimulation. However, a corresponding difference has not yet been found for supraclavicular and infraclavicular blocks. The aim of the present study is to define the minimum effective volume of ropivacaine 7.5 mg/ml when using the LSIB method.

The blocks will be performed as previously described, by an anesthesiologist with LSIB expertise. The lateral, medial and posterior cords are the target of infra-clavicular brachial plexus blocks. During a prescan we will record if they can be visualized by ultrasound and indicate their positions periarterially. The deep location of the cords may hamper their identification, especially that of the medial cord. We describe the cord positions with reference to the short-axis (cross-sectional) view of the axillary artery, which is compared to a clockface having 12 o'clock ventrally. In a former MRI study it was found that the cords were usually located in a sector from 3-11 o'clock (the 3-11 sector) and within a distance of 2 cm from the midaxis of the axillary artery. The point closest to the cords was at 8 o'clock, immediately outside the arterial wall. Point of needle insertion is at the intersection between the lower edge of the clavicle and the medial surface of the coracoid process. We direct the needle tip to the 8 o'clock position and observe the spread of LA from this position. On demand we adjust the needle position to secure a complete fill of the 3-11 sector with LA (multiple injections).

The block needle has an electrical cable. Prior to LA injections we test if a minimal electric output (0.2 mA/0.1 msec duration) elicits a motor response. If such a response is obtained, the needle is withdrawn (in steps of 1 mm), until the motor response disappears. This is to reduce the risk of intraneural injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anesthesiologists physical status (ASA) I-II
* Scheduled for surgery distal to the elbow.
* Duration of surgery \>1 hour.
* Age 18-65 years,
* Body mass index 20-35 kg/m2

Exclusion Criteria:

* Pregnancy
* Any contraindication to regional anesthesia
* Patients on major opioids because of chronic pain
* Atrioventricular block
* Pacemaker
* Diabetes
* Peripheral neuropathy
Cardiometabolic Care-team Integration Improves Outcomes in Diabetes

A pragmatic, quasi-experimental (non-randomized) design was used to evaluate clinical and cost outcomes among patients with type 1 or 2 diabetes (T1D or T2D) at two primary care clinics (n=1 intervention, n=1 usual care) between March 2012 and September 2014. At the intervention clinic, the 12-month Cardio-metabolic Care-Team Intervention (CMC-TI) was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months, and a process evaluation gauged CMC-TI feasibility and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* All patients with type 1 and type 2 diabetes

Exclusion Criteria:

* None
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adolescents between 14-17 years of age at the time of screening
2. Diagnosed with chronic migraine for more than three months
3. Failed other treatment options on the grounds of safety (tolerability) or efficacy, including but not limited to antidepressants (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), gabapentinoids or topiramate.
4. Females who have reached menarche should have a negative serum pregnancy test during screening.
5. Must be willing to engage with psychology and physiotherapy throughout the trial

Exclusion Criteria:

1. As per the investigator judgement, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede in the successful completion of the study
2. Participants with a history of post-concussion headache or new daily persistent headache
3. Participants with a diagnosis of medication overuse headache
4. Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
5. Participants with complex regional pain syndrome-II
6. Participants with abnormal ECG findings at baseline (as determined by the investigator)
7. Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
8. Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
9. Participants with a personal or family history of schizophrenia or psychotic disorders
10. Participants who are pregnant or breast/chest-feeding or plans to become pregnant within the study period or within three months of interventional product discontinuation
11. Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult females
* A body mass index between 18 and 30 kg/m2, inclusive
* Negative urine drug and alcohol screen .

Exclusion Criteria:

* Significant medical condition,
* Significant physical examination finding
* Clinical laboratory
* ECG abnormality
* CYP2D6 "poor metabolizer"
Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients

To improve self-care and therapy adherence by fibromyalgia (FM) patients through a nursing educational intervention. Historic diagnoses of subjects included terms such as "insane", "imaginary ill", "whiny"; as well, their physical conditions were underestimated by their immediate families. All subjects have problematic employment histories which consistently identified their varied employments as physically too demanding. Over time, increased physician- and societal-awareness, resulted in all subjects being diagnosed with FM; consequently, all subjects reported a strong desire to become well-informed about FM and its treatment. Although medical cannabis (MC) was an available therapy, twenty subjects reported that cannabis had never been proposed despite years of ineffective therapies. In this tudy the effects of a educational intervention by expert nurses on fibromyalgia and MC use were investigated.

Aims This study aims to evaluate the knowledge of fibromyalgia patients who use therapeutic cannabis or are interested in taking it, introducing the figure of the nurse in the therapeutic path of patients. The primary objective was to increase the knowledge relating to FM (in terms of symptoms, onset, treatment strategies that can improve the quality of life), self-care and adherence through a nursing educational intervention. The secondary objective was to evaluate the efficacy of the nursing educational intervention, using validated clinimetric scales.

Design We performed a qualitative study with face-to-face semi-structured interviews and patient tailored educational interventions. Two weeks before the interview, subjects were asked to complete the Fibromyalgia Impact Questionnaire Revised (FIQR) and the A-14 Scale online. Two weeks after the interview, patients were asked to complete the same questionnaires in addition the Clinical Global Impression - Global Improvement (CGI-I) Scale. This study adheres to the Consolidated criteria for Reporting Qualitative research (COREQ).

Data collection After obtaining written informed consent for participation in the study, each participant was asked to complete online the Fibromyalgia Impact Questionnaire Revised (FIQR) and The A-14 Scale. Two weeks after completing these online questionnaires, a Skype-videoconference, which included a 30 min educational intervention, was held with each subject. Two weeks after the videoconference, patients were required to complete the FIQR, The A-14 Scale, as well as the Clinical Global Impression - Global Improvement (CGI-I) Scale Data analysis Descriptive analyses were performed on study participants.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fibromyalgia syndrome carried out for more than 3 months and confirmed by the specialist (rheumatologist / algologist);
* age\> 18 years;
* ability to understand the objectives and methods of the study and to read and sign the informed consent form.

Exclusion Criteria:

• patients not in Medical Cannabis therapy and/or not interested in starting the therapy
Accuracy of Risk Prediction Scores in Pregnant Women

Management of pregnancy and risk stratification in congenital heart disease (CHD) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. We aim to compare the accuracy of the main published scores including CARPREG II score in prediction of maternal complications during pregnancy in CHD patients.

Since the end of the 20th century, surgical and medical care progresses have significantly improved prognosis and quality of life of patients with congenital heart diseases (CHD). Currently, women with CHD expect to experience a "normal" life and express a strong maternity desire.

During the last decade, several scores have been used to predict outcome of pregnancy in women with cardiovascular heart diseases. It has been suggested that the mWHO classification was more appropriate than the previous ones (e.g. Harris, Zahara and CAPREG classifications) in predicting cardiac complications in CHD. More recently, a new risk score stratification (CARPREG II) have been published to improve maternal risk stratification.

This retrospective study will include all pregnant women with CHD who were follow up in our institution from January 2007 to June 2018 until 6 months postpartum. The investigators will collect demographic and clinical data, type and complexity of CHD (Houyel and Bethesda classification), and pregnancy outcomes. Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes. The discriminatory power of each risk scores was assessed by the area-under-the receiver-operating characteristic (ROC) curve (AUC). In order to assess the reproducibility of scores classification assigned to CHD patients, all pregnancy scores from this cohort were assessed by 3 independent observers and, thereafter, estimated Cronbach's coefficient alpha.

Eligibility Criteria:
Inclusion criteria:

- All patients with congenital heart diseases who deliver in our institution during the study period

Exclusion criteria:

- Women with acquired cardiovascular diseases
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing clinically indicated pharmacological stress-echocardiography
* Willingness to participate

Exclusion Criteria:

* Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
* poor image quality
* Early termination of the stress-echocardiography examination for clinical reasons
Importance of the Current Density in TENS

The purpose of this study is demonstrate the importance of density current of TENS in the effect about H-reflex in healthy volunteers.

TENS have been used to treatment against pain and reflex modulation. However, the most part of evidence do not show the current density. This parameter has been demonstrated like a important factor in the effect of the current about the outcome measures.

This study show the difference between the same subjective sensation "strong but comfortable" in current density and the relation with the effect about H-reflex.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy.
* Sensitivity disturbance in lower limb.
Prevention of Renal Complications of Diabetes With Thiamine

Thiamine is a key component in the creation of physiologic anti-inflammatory mediators. Serum thiamine stores have been found to be deficient in diabetic patients. Thiamine deficiency may be a key pathological mechanism of inflammation that results in diabetic kidney and retinal injury. The investigators hypothesize that the repletion of a patient's thiamine by oral supplementation may result in reduced inflammation, and therefore reduced kidney injury.

Thiamine (vitamin B1) is a water-soluble vitamin. It is absorbed from the gastrointestinal tract and taken up into tissues by transport proteins and converted to thiamine pyrophosphate (TPP) by thiamine pyrophosphokinase (TPPK). TPP is a co-factor of pyruvate dehydrogenase (PDH), α-ketoglutarate dehydrogenase and transketolase (TKT)-enzymes involved in the metabolism of glucose.

Various transport proteins are involved in the transport of thiamine monophosphate (TMP) and TPP across membranes. These include thiamine transported isoform-1 (THTR1) and thiamine transporter isoform-2 (THTR2), reduced folate carrier-1 (RFC-1), which transports TMP and TPP across cell plasma membranes and the mitochondrial TPP transporter (mTHTR). Thiamine and TMP/TPP transporters may have abnormal expression in diabetes. Increased THTR1 levels are found in red blood cells (RBCs) and mononuclear leucocytes of patients with diabetes compared to those of healthy subjects. RBC precursors and leucocytes appeared to up-regulate THTR1 expression in response to decreased thiamine availability. In the presence of hyperglycemia, renal tubular epithelial cells, by contrast, have decreased expression. In both experimental models of diabetes and in human diabetics increased clearance of thiamine has been demonstrated. This precedes the development of microalbuminuria. Patients with microalbuminuria and early decline in glomerular filtration rate had higher fractional excretion of thiamine compared to patients with stable renal function.

Thiamine supplementation in STZ- diabetic mice prevented the development of microalbuminuria, decreasing urinary albumin excretion (UAE) by approximately 80%. In addition thiamine supplementation prevented diuresis and glycosuria. Human studies are limited but in one placebo controlled study the thiamine group showed a significant decrease in microalbuminuria in diabetic patients on thiamine.

Eligibility Criteria:
Inclusion Criteria:

* with a diagnosis of Type II diabetes which has been present for at least 5 years,
* persistent microalbuminuria (30-299 mg/24 h),
* HbA1c ≤ 8%, and
* BMI 19-40 kg/m2.

Exclusion Criteria:

* significant comorbidities,
* "deficient renal function" known allergy or intolerance to thiamine,
* use of thiamine supplements,
* participation in an interventional study within 30 days,
* recipients of renal and/or pancreatic transplant and
* women who were pregnant or breast feeding.
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.


Eligibility Criteria:
Inclusion Criteria:

Patients with chronic venous insufficiency who have the following are eligible for the study:

* Able to understand the study and provide meaningful written informed consent for the study.
* Willing, able, and committed to participate in the procedures for the full length of the study.
* All ethnic groups, male or female above the age of 18 years.
* Diagnosis of chronic venous insufficiency (C3-C5 CEAP Classification)
* Blood pressure currently under moderate control (\< 160/100mmHg)
* No current foot ulceration

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded:

* Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol
* Pregnant
* Has a cardiac pacemaker, AICD or other implanted electrical device
* Has an Existing DVT.
* Has recent lower limb injury or lower back pain
* Has current foot ulceration or other skin ulcers
* Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
* Has an ABPI \< 0.8