cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients

Tubal patency testing is an essential part of female subfertility evaluation . Tubal abnormalities are seen in 30-40% of female subfertility patients . Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure .

Laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia.

Traditionally, Hysterosalpingography(HSG) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain.

Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced as an alternative using either contrast media or saline. The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are either no longer available or not licensed for tubal patency testing.

Hysterosalpingo-Foam Sonography (HyFoSy) was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical Ventures BV, Rotterdam, TheNetherlands) with 5ml purified ExEm_-water.

The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing.

In 2017, HyLiFoSy combined with power Doppler (PD)(HyLiFoSy-PD) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (HyCoSy), hysterosalpingo-foam sonography (HyFoSy), and hysterosalpingo-lidocaine-foam sonography (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% with lap-and-dye test.

In addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-40
2. Sexually active
3. Infertility or subfertility primary and secondary

Exclusion Criteria:

1. Current pregnancy
2. Heavy menstrual bleeding
3. Peivic inflammatory disease
4. Allergy to lidocaine
Caudal Epidural Steroid and Trigger Point Injection

This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital. Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study. The primary output of our study was NRS scores. The study of Manchikanti. L et al. (control group NRS reduction 4.4 ± 1.8; α margin of error 0.05, power 99%) (3) was taken as the basis for determining the sample size. Using the G Power 3 calculator program, 72 patients were identified to reduce their NRS scores by 25%. With a 20% exclusion rate, the total number of patients was calculated as 90

Demographic information of all patients included in the study; name, surname, telephone number, age, gender, educational status, profession, and marital status will be recorded. The duration of the pain, the onset of the pain, the accompanying leg pain, the activities that increase or decrease the pain, the presence of neurological symptoms, the analgesic agents used in the last week, and the previous treatments will be noted. Lumbar MRI findings and the level of pathology causing low back and hip pain will be recorded. History, family history, comorbidities (hypertension, diabetes mellitus, hyperlipidemia, cardiac disease, hypothyroidism), and detailed physical examinations of the patients will be recorded. Examinations of the patients before and 3, 6, and 12 weeks after the injection will be performed, and NRS scores at 3 and 6 weeks. The procedures will be repeated for patients who are over 4 years old. During the pre-procedural evaluation, the patients will be informed about the study, information about the Numeric Rating Score (NRS), Oswestry Disability Index (ODI), Short Form-36 (SF-36) to be used for post-procedure analgesia, and both verbal and written consents will be obtained. The staff who will make the evaluation will not know which group the patients belong to, and the study will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Low back or leg pain that has been going on for at least 2 months,
* Patients between the ages of 18-70,
* Disc herniation or radiculopathy in lumbar MRI examination .To be mentally competent to understand and evaluate NRS, ODI, and SF-36 forms.

exclusion criteria

* Being pregnant or lactating,
* Presence of spinal canal stenosis,
* The presence of bleeding diathesis,
* Presence of disease with progressive neurological deficit,
* The presence of serious psychiatric illness,
* Presence of progressive neurological deficit or incontinence,
* Having an epidural steroid injection in the last 6 months, Having uncontrolled diabetes mellitus Having hypertension,
* Known history of allergy to local anesthetics or corticosteroids,
* The patient does not want treatment,
* Local infection at the injection site,
* Infections such as discitis, spondylodiscitis, and sacroiliitis.
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fasting condition in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-65 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Zinc and Iron Bioavailability From Biofortified Pearl Millet

Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron absorbed are measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets.

Nutritional deficiency of iron in 30-70% of young children in different communities in India is well documented and has proved challenging to eradicate both in India and globally. Less is known about zinc deficiency, but zinc and iron are generally present in the same foods and there is also growing evidence for the public health importance of zinc deficiency in young children on a global basis. In populations that depend primarily on plant-based foods, biofortification of major food staples by traditional selective plant breeding procedures offers an attractive strategy for preventing iron and zinc deficiency in all age groups. Pearl millet, a major food staple in several areas of India, has both naturally relatively high concentrations of iron and zinc with demonstrated potential to increase these levels further with plant breeding. Before embarking on complex, costly efficacy, effectiveness studies of the potential health benefits of this biofortified grain, the objective of this project is to determine the extent to which iron and zinc absorption is increased in very young children who consume pearl millet as the primary grain and major food staple. This is a short term, cross-sectional double-blinded study in which the test or control pearl millet is fed for a total of 9 days. Primary outcome measures are the increases in iron and zinc absorption over a two-day period. Test meals will be labeled with a zinc stable isotope on Day 8 and an iron stable isotope on Days 8 and 9 during which days participants and their mothers will stay in their community health center. Food intake will be weighed and duplicate diets obtained. Percentage iron absorption will be determined from erythrocyte enrichment on Day 23. Fractional zinc absorption will be measured from urine enrichment with orally and intravenously administered zinc isotopes from timed samples collected on Days 12-15. Daily absorption of these minerals will be determined. Increases in intake and absorption of these minerals (mg/d) will be evaluated with respect to estimated dietary and physiologic requirements.

Eligibility Criteria:
Inclusion Criteria:

* lives in one of the targeted communities
* apparently healthy
* 23 m of age \[may need modification\]
* Hemoglobin (Hb) \> 8 g/dl
* ferritin ≤ 12mg/L

Exclusion Criteria:

* Hemoglobin (Hb) \< 8g/dl
* serum ferritin \> 12 (even after correction for C-reactive protein (CRP)/ Alpha Glyco Protein (AGP)
* thalassemia
* birth weight \< 2,500 g
* birth defect affecting growth and development
* chronic infection
Retrospective Real World Oxbryta® Data Collection and Analysis Study

The aim of this study is to collect and analyze retrospective data on Oxbryta in a real-world setting. This is a multicenter, retrospective data collection and analysis study to characterize health outcomes in approximately 300 patients with SCD who have been treated with Oxbryta as part of their usual care. Any patient with SCD who received Oxbryta treatment for at least 2 weeks as part of their usual care according to the Oxbryta US Prescribing Information (USPI) is eligible to participate. Study data from 1 year before and up to 1 year after the first dose of Oxbryta will be entered in case report forms (CRFs) via an electronic data capture (EDC) system by the study staff.

The following are categories of interest in patients with SCD treated with Oxbryta:

* Clinical outcomes, as assessed by clinical and laboratory assessments of hematological parameters and end organ damage, and incidence of significant clinical events
* Healthcare resource utilization
* Health-related quality of life (HRQoL), as assessed by patient-reported outcome (PRO) measures and clinician-reported outcomes (ClinRO)

The safety objective is to assess the safety and tolerability of Oxbryta.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all the following criteria will be eligible for inclusion in this study:

1. Willing and able to provide written informed consent (ages greater or equal to 18 years) or parental/guardian consent and patient assent (age \<18 years), as required by the IRB or institution or IRB, per local regulations
2. Male or female patients with documented diagnosis of SCD (all genotypes)
3. Have been treated with Oxbryta for at least 2 weeks, according to the Oxbryta USPI

Exclusion Criteria:

-
Identification of Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression

The objective of this study is to identification of genetic markers and predictors of antidepressant-induced suicidality in youth depression. Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4) and visit 4 (week 8)


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 11 and 18 years
2. Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia
3. Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children

Exclusion Criteria:

1. presence of intellectual disability
2. presence of hereditary disorder
3. past and/or current history of acquired brain injury, like cerebral palsy
4. presence of seizure, other neurological disorder or sensory impairments
5. past and/or current history of pervasive developmental disorder
6. past and/or current history of schizophrenia, bipolar disorder or psychosis
7. presence of severe learning disorder
RV Function Evaluation Assessed by Strain and Validated by MRI

Echocardiographic assessment of right ventricular function is an important diagnostic tool, and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a new technique has been developed and used for evaluating both the left and the right ventricle function. This technique, called two dimensional (2D) speckle tracking, is based on detecting speckles in the myocardial tissue and using them as acoustic markers. The movement of these speckles represents the movement of the tissue, and allows us to evaluate its function, contraction and relaxation, this by calculating the strain rate, which is the speed of the speckles, and the strain, which is the distance between them.

In the last few years this technique has been used to evaluate the systolic function of the right ventricle in several pathological conditions, such as pulmonary hypertension, pulmonary embolism and amyloidosis. Nonetheless, so far there has been little data on the normal RV strain and strain rate values.

In this study the investigators aim to validate two dimensional (2D) speckle tracking measurements of the RV function by comparing them to strain measurements by cardiac MRI. Each patient performing cardiac MRI for any indication will perform an echocardiography examination in addition, and strain analysis performed on the cardiac MRI will be compared with two dimensional speckle tracking analysis performed on the echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Age: More than 18

Exclusion Criteria:

* Age: Children
* Unconcious patients.
Elective Coronary Angiography and Anxiety Study

Anxiety will be assessed from two aspects, the somatic and emotional. ANGST aims to determine how anxiety correlates with psychological parameters (personality traits, coping strategies and depressive symptoms) and with the outcome of elective coronary angiography (CA).

This research is a prospective cross-section study of patients undergoing elective CA. Research design will allow studying anxiety at four timepoints and its correlation with CA outcome and psychological parameters. This study will be conducted at the Coronary care unit of the department of Cardiology, General and Teaching Hospital Celje, Slovenia.

Data regarding prior to CA, during hospital stay and after discharge variables will be collected in order to control for confounding variables when testing the association between anxiety and psychological parameters. All the data needed for this study will be collected within one month from the patient enrollment in this study at four occasions: (1) 14 days prior CA - all patients will receive questionnaires by post, (2) on the day of the admission, 2-4 hours before CA, (3) 24 hours after CA, but prior to discharge and (4) 4-6 weeks after discharge. Clinical and demographical data will be collected from medical records. Data regarding anxiety and other psychological parameters will be assessed using standardized questionnaires. These will be sent to the patient together with covering letter providing instructions to complete the questionnaires 14 days prior CA without help of family members/friends. A month after CA, the questionnaires for anxiety and depressive symptoms will be sent to participants address with reply paid envelope provided.

The Republic of Slovenia National Medical Ethics Committee has approved this study.

Eligibility Criteria:
Inclusion Criteria:

* invited to elective CA because of suspected/unknown: coronary artery disease, valvular heart disease, heart failure etiology, unexplained arrhythmia, cardiomyopathy etiology;
* written consent;
* completed first set of questionnaires 14 days prior to coronary angiography

Exclusion Criteria:

* need for an urgent coronary angiography,
* coronary angiography in last 6 months,
* unable to provide written consent,
* severe physical and/or mental disease/disability,
* help needed in completing the questionnaires,
* unsigned consent form,
* incomplete first set of questionnaires 14 days prior to coronary angiography.
Tumor Response to Pemetrexed Disodium in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Enrolled in Clinical Trial MCCRC-RC0524

RATIONALE: Studying samples of blood in the laboratory from patients receiving pemetrexed disodium may help doctors learn more about the effects of pemetrexed disodium on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This laboratory study is looking at blood samples from patients with stage III or stage IV non-small cell lung cancer enrolled in clinical trial MCCRC-RC0524 to determine the effect of pemetrexed disodium on cells.

OBJECTIVES:

Primary

* Assess the intracellular level of pemetrexed disodium (PD) polyglutamates as a measure of activity of PD transport and activation enzymes in patients with stage III or IV non-small cell lung cancer enrolled in clinical trial MCCRC-RC0524.

Secondary

* Assess polymorphisms and gene expression of PD target genes and genes encoding enzymes involved in the transport, activation, and inactivation of PD in these patients.
* Correlate haplotype-tagged single-nucleotide polymorphisms (htSNPs) and gene expression levels with intracellular levels of PD polyglutamates
* Correlate htSNPs and gene expression levels with toxicity and efficacy of PD.

OUTLINE: Blood is drawn prior to and 24 hours after day 1 of course 1 of pemetrexed disodium. DNA is extracted and genotyped for known polymorphisms in genes involved in the transport, activation, inactivation, and mechanism of action or resistance of pemetrexed disodium, including reduced folate carrier-1, multiresistance proteins (particularly MRP5), folate receptor, folypolyglutamate synthase, methylenetetrahydrofolate reductase (MTHFR), methionine synthase, methylthioadenosine phosphorylase, thymidylate synthase (TS), dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase. Plasma and red blood cells are also processed for an intracellular polyglutamate assay for pemetrexed disodium by a high-performance liquid chromatography-based method.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled in clinical trial MCCRC-RC0524
* Willing to provide blood samples

PATIENT CHARACTERISTICS:

* No investigator site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study

  * Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Not employed by Eli Lilly (i.e., employee, temporary contract worker, or designee responsible for conducting the study)

  * Immediate family of Eli Lilly employees allowed, but may not participate at an Eli Lilly facility

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Azithromycin for Child Survival in Niger: Delivery Trial

This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.

Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider this intervention to improve child survival. From a pool of eligible rural and peri-urban communities in the Dosso Region in Niger, 80 will be randomly selected and randomized to receive door-to-door or fixed-point delivery of a single dose of azithromycin distribution to children 1-59 months of age via community health workers biannually. Treatment coverage, costs and cost-effectiveness, and feasibility and acceptability will be compared by arm.

Eligibility Criteria:
Inclusion Criteria:

At the community-level, eligibility includes:

* Location in one of the 80 Dosso communities randomly selected for the delivery trial
* Population 250 to 2,499\*
* Distance \> 5 km from the district headquarters town
* Verbal consent of community leader(s)

At the individual-level, eligibility includes:

* Age 1-59 months
* Primary residence in a study community
* Verbal consent of caregiver/guardian for study participation
* Weight ≥ 4 kg

Exclusion Criteria:

At the community-level, eligibility includes:

* Inaccessible or unsafe for study team
* "Quartier" designation on national census \*Population size as estimated from the most recent national census or projections

At the individual-level, eligibility includes:

• Known allergy to macrolides