cyrilzakka/clinical-trials huggingface dataset:
Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

Serial ultrasound (US) examinations are performed to assess the number and size of follicles during controlled ovarian stimulation (COS). Ovarian folliculometry during COS is the most frequent ultrasound procedure daily performed, an also a highly time consuming and reiterative process.

However, it has been shown that manual measurement of follicles with 2D US is often inaccurate and subject to significant intra- and interobserver variability

In addition, a follicle is a three-dimensional (3D) structure and its volume is the most accurate measure of its size. Therefore, 3D transvaginal ultrasound in gynaecology and reproductive medicine has supposed a great advance, because it makes possible to obtain ovarian volumes during controlled ovarian stimulation

At each visit, IVIRMA Bilbao doctors (MF, CF) will perform routine folliculometry to the patients (standard 2D manual ultrasound) to control the ovarian stimulation. In this exam, follicles will be counted and measured (mean diameter) in millimeters, as usual clinical practice,

After the standard folliculometry, will request the patient for self-performing scan (3Dultrasound)

After each patient self-capture, IVIRMA Bilbao gynaecologists will check the saved volume (3D multiplanar mode) using ITKSnap viewer to ensure the correct acquisition saving (complete ovaries and uterus captured inside without artifacts) in order to compare 2D ultrasound (clinical reference) for number and mean follicle diameter estimations, with 3D multiplanar ultrasound (obtained with SMD) GMDN (Global Medical Device Nomenclature): 40761

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form dated and signed
2. Female, aged 18 years or above
3. Patient undergoing COS for IVF/ICSI, oocyte vitrification or oocyte donation cycles in IVIRMA Bilbao clinic
4. Willing to comply with all study requirements

Exclusion Criteria:

1. Simultaneous participation in another clinical study that, at researcher's criteria, could interfere with the results of this study.
2. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
The Oslo Stan vs Lactate Observational Study

The main aim of the study is to compare the clinical performance of two adjunctive methods to CTG in intrapartum fetal monitoring: FBS with measurement of scalp lactate and ST analysis of the fetal ECG.

We use Lactate as a standard adjunctive method in our hospital but we have STAN software available ( is demasked) in our CTG monitors. We will include all women in labour with an intern scalp monitoring and analyse the CTG, the lactate samples and the STAN signals in the same patient and

* Study the relationship between the decision-to-delivery interval and neonatal morbidity in deliveries monitored by scalp lactate measurement
* Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia
* Compare the false negative alerts from both methods
* Explore the temporal and quantitative relation between fetal lactate metabolism and ST interval changes of the fetal ECG

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Cephalic presentation
* Gestational age ≥36+0 weeks at delivery
* Presence of antpartum or intrapartum risk factors for fetal hypoxia according to Norwegian guidelines and therefore indication for electronic fetal monitoring with scalp electrode .

Exclusion Criteria:

* Multiple pregnancies
* Breech presentation
* Gestational age \< 36+0 weeks
* Contraindications for placement of a scalp electrode (HIV or HBV or HCV pos)
Integrated Care Pathway in Oncology (PASSION)

A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).

The aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.

The second aim is to assess the satisfaction of patients and health care teams.

PASSION is a french monocentric study.

For the retrospective cohort, patient will be selected through the use of data warehouse available on the HEGP.

For the prospective cohort, patient will be included according to the selection criteria.

Each patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy.

For both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the HEGP.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer
* First appointment for cancer care at the Hôpital Européen Georges Pompidou
* Intravenous antitumoral treatment

Exclusion Criteria:

* Medical care non covered by social welfare
* Radiochemotherapy
* Death in the 6 months following first oncological appointment or absence of medical care in the year following the first oncological appointment
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.

This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.

To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)

Eligibility Criteria:
Inclusion Criteria:

1. Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of sensory block
2. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
3. ASA physical status: I-II
4. Informed consent: signed written informed consent before inclusion in the study 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
2. ASA physical status: III-V
3. Further anaesthesia: patients expected to require further anaesthesia
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes or other neuropathies.
6. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
7. Drug, alcohol: history of drug or alcohol abuse
8. Blood donation: blood donations in the 3 months before this study
9. Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
10. Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents or chronic analgesic therapy) 11. Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Hormonal contraceptives for females are allowed.
Acute Kidney Injury in Premature Infants

Our first Aim is to describe how common a sudden decrease in renal function happens in premature infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.

Advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. Very little data is available on the impact that acute kidney injury (AKI) has on survival in premature infants, but adult and pediatric studies that show that even mild AKI independently impacts survival after correcting for severity of illness. The role that AKI impacts survival in premature infants is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development..

Our ability to improve outcomes in children and adults with AKI has been hampered by the inability to recognize AKI early in the disease process. Thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of AKI. Serum and urinary levels of neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin 18 (IL-18) others are markedly elevated several hours after AKI as opposed to serum creatinine which takes days to rise after the inciting event. Early non-invasive biomarkers of AKI have not been tested in premature infants.

Inclusion criteria - infants (birthweight 500-1500g) be asked to participate in the study. • Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

Eligibility Criteria:
Inclusion Criteria:

* 500-1500 grams birthweight
* \>=25 weeks gestation

Exclusion Criteria:

* infants who do not survive 24 hours of life
* infants with severe congenital abnormalities
AIDS-Associated Cardiomyopathy

To define the incidence and prevalence of AIDS-associated cardiomyopathy. Also, to conduct immunopathology and serologic studies in endomyocardial biopsies and autopsy tissues.

BACKGROUND:

In 1988, the leading cause of death in AIDS patients was respiratory mechanisms might have played a significant role in its pathogenesis.

The project was part of an Institute-initiated study on AIDS-Associated Heart Disease in Adults. The concept was approved by the National Heart, Lung, and Blood Advisory Council in September 1987. The Request for Applications was also released in September 1987. Awards were made in July 1988.

DESIGN NARRATIVE:

The prevalence study was one of three subprojects with the common failure due to chronic opportunistic pulmonary infection, primarily Pneumocystis carinii pneumonia. Drugs such as azidothymidine (AZT) and trimetrexate showed some effectiveness in prolonging the lives of some AIDS patients. With increased survival, it was believed that cardiac diseases might well become an important complication of AIDs. Reports described a syndrome of rapidly progressive cardiomyopathy associated with AIDS. The etiology of AIDS-associated cardiomyopathy was yet unknown although immunologic theme of the immunopathogenesis of AIDS-associated cardiomyopathy. The other two subprojects dealt with immunopathology studies in endomyocardial biopsies and autopsy tissues and serologic studies. The AIDS Clinical Research Center at Johns Hopkins Hospital served as the source of patients. All patients underwent serologic testing and echocardiography at time of entry and at six and twelve months. The screening electrocardiogram identified 40 to 50 patients per year with AIDS-associated cardiomyopathy. Approximately 30 patients per year had no contraindications for endomyocardial biopsy. Comprehensive tissue studies and cellular immune studies were performed on the cohort and autopsies, if possible. Immunohistochemical techniques and in situ hybridization of biopsy and autopsy material were used to determine if AIDS-associated cardiomyopathy was associated with HIV infection of the heart or with some other viral or opportunistic non-viral infection. Indirect immunofluorescence and a Western immunoblotting assay using patient sera determined the prevalence of heart autoimmunity.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study

The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* girls aged 10 to 16
* one arc right side curve
* Cobb range 12 - 40 degrees

Exclusion Criteria:

* bigger Cobb range
* double arc curve
* no parent approval
* lack of cooperation
Effectiveness of MBSR Among School Teachers

The aim is to evaluate the effectiveness of Mindfulness-Based Stress Reduction among school teachers in Danish schools on mental weii-being in the teachers and their pupils. The study is a cluster-randomised trial including 150 schools; 200 teachers; 4000 pupils from the five geographical regions in Denmark.


Eligibility Criteria:
Inclusion Criteria:

* School teacher at a Danish school that commit to participate in a trial aiming to implement and evaluate the effectiveness of ".b" (a school-based mindfulness programme)

Exclusion Criteria:

* acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
* abuse of alcohol, drugs, medicine
Nipple Aspirate Fluid in Detecting Breast Cancer

This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.

PRIMARY OBJECTIVES:

I. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.

II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.

OUTLINE:

Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.

After completion of study, participants are followed up at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* BREAST CANCER: Must be \> 1 year from pregnancy, lactation.
* BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.
* BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.
* BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy within 30 days of enrollment.
* HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with any other cancer.
* HEALTHY SUBJECTS: Must be \> 1 year from pregnancy, lactation.
* HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the James Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical breast exam result and/or mammograms must be read as not suspicious for breast cancer.
* HEALTHY SUBJECTS: Must be willing to keep the clinic informed of their breast health status for 1 year.

Exclusion Criteria:

* Subjects who are currently pregnant, lactating, or within a year of pregnancy/lactation. Pregnancy testing will not be required of any patients over 60 years of age, or any patient who has undergone bilateral oophorectomy.
* Subjects who currently are diagnosed with cancers other than breast cancer.
* Subjects who cannot give an informed consent.
* Male gender of any age.
The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial

The age-related increase in falls is strongly associated with a decline in muscle strength by the mechanism of sarcopenia. There has been great interest in developing approaches to counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle mass with vitamin D that have muscular effect. However, a limited number of studies demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted in order to determine the effect of alfacalcidol on the upper-body muscle strength in Indonesian elderly women in age group of 60 or more who had low handgrip strength.

A total 122 elderly women were enrolled to this study. It was determined subjects with handgrip strength less than 22 kg and measured using handheld dynamometer. There were 95 subjects fulfilled the eligible criteria. These subjects were randomized into two groups, one group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo. Each subject was given calcium 500 mg/day. After 12 weeks of intervention, 88 subjects had the second muscle strength measurement (7 dropped out).

Eligibility Criteria:
Inclusion Criteria:

* Elderly women in age group of 60 or more
* Subjects with handgrip strength less than or equal to 22 kg

Exclusion Criteria:

* Hypercalcemia (serum calcium \> 10.5 mg / dL)
* Can not understand instructions well (MMSE scale \< 16)
* Depression (Geriatric Depression Scale\> 10)
* Fracture, deformity, and pain with a visual analog scale (VAS) ≥ 4 on fingers and joints of the upper limb when the examination will be conducted
* Heart failure fc. III-IV or uncontrolled according to the New York Heart Association (NYHA)
* Neurological conditions (epilepsy, acute stroke, Parkinson's)
* Malignant hypertension (systolic blood pressure ≥ 200 mmHg and or diastolic blood pressure ≥ 120 mmHg)
* Blood malignancies and solid tumors
* Decreased function of the liver (cirrhosis, ALT increase above 2 times the upper normal limit )
* Refusing to follow the research / not willing controls
Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department

The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant individuals that are seeking care at University of Texas, Memorial Herman and Lyndon B Johnson sites ED or obstetrical triage units.
* No Prenatal care during index pregnancy
* No documented syphilis result during the index pregnancy

Exclusion Criteria:

* Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine, Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
* Less than 24 hours of occurrence of fever and/or occurrence of tetter or herpes.
* Age of 1-13 years.
* Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

* Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
* Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
* With history of allergies on traditional Chinese medicine.
* Patients who using glucocorticoids for based diseases.
* Patients who having history of hemolysis.
* Patients or their guardians suffering from Psychiatric diseases.
* Attending other clinical studies on HFMD after diagnosed.
The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation

Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. These patients are complex; and the ventilator´s parameters should be set-up according to the underlying disease and particular patient's characteristics. The non-invasive ventilation therapy is mostly titrated while the patient is awake, hence Problems, such as Patient-Ventilator asynchrony, arising while sleeping on the ventilator therapy would remain undetected.

Sleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide monitoring could be valuable tools to fine-tune the ventilator's settings. This could foster the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. Nevertheless the sleep studies are expensive, time-consuming and not widely available.

The aim of this study is to learn the findings of sleep studies when they are performed on stable patients on home mechanical ventilation as part of their routine check-ups. In this context, it will be assessed whether the sleep studies' findings lead to a change (adjustment) of the ventilator´s therapy. Moreover, this study aims to investigate whether the absence of sleep studies would result in missing important events that require an adjustment of therapy. The results of this study could provide information that lead to a more standardized protocol of follow-up checks of patients on home mechanical ventilation in a cost-effective manner.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases)
* Home mechanical ventilation for ≥ 6 months
* Stable condition for ≥ 1 month

Exclusion Criteria:

* Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months
* Current respiratory exacerbation
* Any current comorbidity decompensation
* Any medical or psychological condition impairing the patient's ability to provide informed consent
* Missing signed informed consent
* Total sleep time during polysomnography \<180 min