cyrilzakka/clinical-trials huggingface dataset:
Long-Working Distance OCT for Children

Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye imaging. The purpose of this study is to investigate the use of a novel long-working distance swept source (SS) optical coherence tomography imaging system with fixation alignment for use first in young adults, older children, and then young children ages 6 months to 6 years. The investigator's future goal is to obtain important retinal and optic nerve information from OCT in clinic in these young children.

The overall objective of this study is to examine the utility of a long-working distance high speed SSOCT system along with technology to identify and use movies, etc. to aid with fixation. This study would be the first testing of such a system, first in adults and then moving to older children who could provide feedback, and then to young children.

This imaging data will be compared to other clinical tests and images collected during regular health care and eye examinations.

Eligibility Criteria:
Inclusion Criteria:

* Minor or adult undergoing eye examination at Duke Eye Center
* Adults with normal eye health enrolled as controls

Exclusion Criteria:

* Have any ocular disease that restricts the ability to perform OCT scanning
* Minor under the age of 6 months
HUNgarian COronaVirus Disease-19 Epidemiological Research

Hungarian CoronaVirus disease-19 Epidemiological Research

The planned large-scale, cross-sectional, representative population screening can show the prevalence of COVID-19 and the degree of infection and trans-infection in Hungary after more than one month of strict restriction. In addition, it can have an impact on further actions, and we can track the impact of the decisions we make by repeating the screenings.

Eligibility Criteria:
Inclusion Criteria:

* Hungarian male or female patients aged 14 and over who live in private households
* Inactivated social security number does not infer the exclusion of the study

Exclusion Criteria:

* Patients under the age of 14
* Patients living in institutional households
Pathways to Fatherhood and Families: The Dads' Club

The purpose of this study is to identify changes in parenting, relationship, and financial responsibility outcomes among program participants and to identify processes through which the Dads' Club program affects performance outcomes.

The Dads' Club program services North County San Diego fathers or paternal caregivers to a child 0-18 years of age, speaking English or Spanish, and being willing to attend the program's core parenting workshop.

The program consists of Parenting and Healthy Relationship Education (10 Core 24/7 workshops covering- 15 hours of education), financial and economic mobility programming, comprehensive case management, and supplemental workshops utilizing the Within My Reach curriculum.

Four research questions will be evaluated:

1. What was the magnitude of change in parenting, relationship, and financial responsibility outcomes from program entrance to exit?
2. What was the magnitude of change in parenting, relationship, and financial responsibility outcomes from program entrance to six months post-exit?
3. How was program dose related to change in parenting, relationships, and financial responsibility from program entrance to six months post-exit?
4. How was program support utilization related to change in parenting, relationships, and financial responsibility outcomes from program entrance to exit?

Inclusion in the sample for research questions involving program exit require completion of 80% of the program, defined as completing 8 out of 10 Core 24/7 workshops and a matched pre and post on each question. Inclusion in the sample for research questions involving six month follow-up requires completion of at least 20% of the program, defined as completing two Core 24/7 workshops and a matched pre and post on each question.

Eligibility Criteria:
Inclusion Criteria:

* Father or paternal caregiver of child age 0-18
* Speaks English or Spanish
* Willing to attend program workshops

Exclusion Criteria:

* None
Testing of an Electronic Patch During Mild Dehydration

The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.

The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:

* Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake.
* The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18-30
* Age: 18-60
* Willing to refrain from exercise for the duration of the study
* Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)

Exclusion Criteria:

* Hypersensitivity to diuretics
* Diarrhea
* Hypotension or orthostatic hypotension
* Urinary retention
* Pregnancy or breast feeding
* Allergy to medical adhesive or gel
* Any planned medical examination during the intervention period
* Pacemaker
* Use of medication with a significant impact on the body's fluid balance, such as diuretic
Comparison of Central and Peripheral Venous Catheters

The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization.

Critically ill patients require intravenous administration of fluids and drugs. This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances. No study prospectively compared the feasibility, merits and complications of the two possibilities (i.e., central or peripheral venous line). This study includes patients that can receive either a central or a peripheral line (see inclusion criteria): mainly patients receiving large amounts of fluid, moderate doses of catecholamines or of drugs that may cause venous injury. Patients are randomized to receive either a peripheral or a central venous catheter. Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring low to moderate doses of continuous catecholamine administration in the ICU
* Patients with 2 failed attempts at inserting a peripheral line
* Patients who require daily change of lines

Exclusion Criteria:

* Patients aged less than 18 years
* Pregnancy
* Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)
Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"

Exclusive breastfeeding during the first six months of life and continued breastfeeding for at least 24 months constitute the optimal feeding method for infants and young children.

However, breast milk and breastfeeding can be significant pathways for the transmission of certain viruses.

The objective of this study is to examine the influence of human breast milk and its composition on viral infectivity and viral transmission of the HTLV-1 virus and arboviruses such as Zika virus, yellow fever, dengue, and tick-borne encephalitis.

Exclusive breastfeeding during the first six months of life and continued breastfeeding for at least 24 months constitute the optimal feeding method for infants and young children.

However, breast milk and breastfeeding can be significant pathways for the transmission of at least three human viruses: HTLV-1, HIV, and human cytomegalovirus (CMV).

To address the following main objective: to study the influence of human breast milk and its composition on viral infectivity and viral transmission of the HTLV-1 virus and arboviruses such as Zika virus, yellow fever, dengue, and tick-borne encephalitis.The study plans to collect milk samples from lactating women who are registered with the Lactarium of Île-de-France to donate their breast milk.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Female gender
* Lactarium Ile-de-France donors
* Subjects covered by a Social Security scheme, excluding State Medical Aid

No inclusion criteria:

- Women opposing participation in the study

Exclusion Criteria:

- Positive HIV, HBV, HCV and HTLV serologies (Lactarium exclusion criteria)
Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma

The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.

This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and daratumumab. There will be a dose escalation phase (Part 1) and dose expansion phase (Part 2). In Part 1 of the study, subjects will be treated at escalating dose levels. Once the recommended part 2 dose (RP2D) of ISB 1342 is declared in Part 1, the expansion phase (Part 2) will be initiated at the RP2D.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
* Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
* Adequate hematologic, renal, and hepatic functions
* Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
* Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
* Oxygen saturation level ≥92% on room air.
* Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening

Exclusion Criteria:

* Active central nervous system involvement
* Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
* Active plasma cell leukemia
* Active infectious disease
* Clinically significant cardiovascular and respiratory conditions
* History of HIV infection
* Subjects requiring prohibited concomitant medications
The Effect of Nutrition Education Hemodialysis Patients

type of study: Clinical trial Purpose of the study: The aim of this study was to investigate the effect of nutrition education on dietary attitudes and daily consumption of essential nutrients in patients receiving haemodialysis treatment.

Patients who agree to participate in the study will be included in the experimental group and control group as a result of statistical analysis and the number of patients will be determined. Then, the patients will be assigned to the groups with the randomisation method of;simple and stratified sampling;. The experimental and control groups within the scope of the research will be determined by simple randomisation method (coin toss). In the first interview, the individuals in the training group will be administered the Individual Information Form; and the;Attitude Scale of Hemodialysis Patients towards Diet Therapy as a pre-test by the researcher using the face-to-face interview method. Then, 24-Hour Food Consumption Record will be given and all food/liquids eaten and drunk for 24 hours retrospectively will be asked to be written on this form. At this stage, the researchers will help the participants to fill in the food consumption record if needed. This process will take approximately 20 minutes and the food consumption record will be collected again. Then, the individuals in the training group will be informed about nutrition education and the first nutrition education will be started. The training will last for 4 weeks, twice a week, and the length of the training will be forty minutes. After the last of the trainings, which will last 8 times in total, the Attitude Scale of Hemodialysis Patients towards Diet Therapy will be applied as a post-test using the face-to-face interview method. In the same way, 24-Hour Food Consumption Record will be given and all food/liquids eaten and drunk for 24 hours retrospectively will be asked to be written on this form. In the control group, pretest data forms (Individual Information Form and Attitude Scale towards Diet Therapy of Haemodialysis Patients) and three-day 24-Hour Food Consumption Record will be filled out, and the Attitude Scale and three-day 24-Hour Food Consumption Record will be filled out one month later as the posttest.

Eligibility Criteria:
Inclusion Criteria:

* - Receiving treatment in the haemodialysis unit of Bayburt State Hospital, having contact addresses in electronic media,
* Maintaining haemodialysis treatment for the last 3 months
* No significant psycho-emotional problems,
* It will consist of patients who are not taking any psychotropic medication and who volunteer to participate in the study.

Exclusion Criteria:

* - Reluctance to continue co-operation,
* Moving from the haemodialysis centre to other centres for any reason,
* The emergence of acute and malignant disease,
* The need for transplantation for any reason
The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Pathology

This is a single-centre, single-blind, two-arms, controlled study to assess the efficacy and safety of food for special dietary use enriched with 5-hydroxytryptophan, L-theanine and Gamma-aminobutyric acid in generally healthy subjects with no cognitive disturbances


Eligibility Criteria:
Inclusion Criteria:

* willingness to participate;
* age of 18-50 years

Exclusion Criteria:

* pregnancy or breastfeeding;
* significant somatic or psychological disorders
High Resolution Digital Imaging of the Uterine Cervix

This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Negative pregnancy test
* 18 years and older
* Presence of a cervix

Exclusion Criteria:

* Pregnant
* Absence of a cervix
* Less than 18 years old
* Male
Miltefosine for Brazilian Visceral Leishmaniasis

Miltefosine will be administered to Brazilian patients with kala azar

Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.

  * Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years
  * Sex: male and female patients eligible (no effort to be made to balance the study for gender)

Exclusion Criteria:

Exclusion criteria

Safety concerns:

* Thrombocyte count \<30 x 109/l;
* Leukocyte count \<1 x 109/l;
* Hemoglobin \<5 g/100 ml;
* ASAT, ALAT, AP \>3 times upper limit of normal range;
* Serum creatinine or BUN \>1.5 times upper limit of normal range;
* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary);
* Immunodeficiency or antibody to HIV;
* Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus);
* Any non-compensated or uncontrolled condition;
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months.

Lack of suitability for the trial:

* Negative bone marrow aspirate (smear);
* Any history of prior anti-leishmania therapy;
* Any condition which compromises ability to comply with the study procedures;
* Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria).

Administrative reasons:

* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);
* Anticipated non-availability for study visits/procedures.
Predictors of Success Following Bariatric Surgery

This study aims to consolidate the contributions of various medical, social and psychological predictors of success following bariatric surgery amongst Singaporeans.


Eligibility Criteria:
Inclusion Criteria:

* Undergone bariatric surgery within SGH lIfe centre and must have completed the intake questionnaire.

Exclusion Criteria:

-
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects

This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test).


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and between 18 and 55 years of age at Screening.
* Subject is in good physical and mental health status determined on the basis of the medical history and a general clinical examination.
* Subject has no evidence of active or inactive Tuberculosis (TB).
* Female subjects of childbearing potential should have a negative pregnancy test at study entry and should be using a medically accepted method of contraception during the entire duration of the study and for 10 weeks after the final dose of CZP.

Female subjects who are postmenopausal for at least 2 years and have a serum follicle stimulating hormone (FSH) level \>40mIU/mL at the Screening Visit, or have undergone a hysterectomy, bilateral tubal ligation, and/or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential.

Exclusion Criteria:

* Subject receiving any live (includes attenuated) vaccination or immunoglobulins within 56 days preceding the CZP injection.
* Subject has taken any drugs (including over-the-counter medications) within 56 days preceding the CZP injection (with the exception of those noted in Section 7.8.1.).
* Subject is known to be intolerant to pegol.
* Subject has previously received CZP.
* Subject has received TNFα-inhibitors within 12 months or other biologic within 6 months before randomization into the study.
* Subject has an active or chronic/latent infection including TB, hepatitis C virus (HCV), hepatitis B core antigen (HBc), or human immunodeficiency virus (HIV).-- Subject has symptomatic herpes zoster infection (shingles) within 6 months prior to Screening.
* Subject has chronic, serious, opportunistic recurring infection or condition within 6 months prior to Screening.
A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel

To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative metastatic breast cancer (MBC).

This is a prospective, randomized, 2-arm, open-label, single-center, phase II trial. A total of 30 patients will be included during a period of 2 years.

The study will be initiated with a non-randomized, feasibility stage including ten patients who will be treated with bevacizumab and paclitaxel, in order to determine the safety of metastatic tumor biopsies during therapy with bevacizumab.

In the second phase, patients will be randomized (1:1) between two treatment arms: A. Bevacizumab + paclitaxel and B. Paclitaxel

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years.
2. Performance status ECOG 0-2.
3. Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.
4. At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.
5. Clinically and/or radiographically documented measurable disease according to RECIST v1.1 criteria. At least one site of disease must be unidimensionally measurable as follows:

   1. CT-scan, physical exam ≥ 10 mm} Chest X-ray ≥ 20 mm }see Eisenhauer et al. for more details
   2. Lymph node short axis ≥ 15 mm }
   3. All radiology studies must be performed within 28 days prior to registration (35 days if negative).
6. Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:

   1. Haematology: Absolute granulocytes \> 1.5 x 109/L Platelets \> 100 x 109/L
   2. Biochemistry:Bilirubin within normal limits Serum creatinine within normal limits
7. APTT and INR within normal limits within 7 days prior to enrollment.
8. Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) within normal limits determined by echocardiogram or MUGA within 28 days prior to inclusion.
9. Written informed consent must be given.

Exclusion Criteria:

1. Previous systemic treatment for MBC.
2. Major surgery less than 28 days prior to enrollment.
3. Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
4. Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
5. Major cardiac comorbidity.
6. Previous treatment with bevacizumab.
7. Previous allergic reaction to taxane analogs.
8. Ongoing pregnancy or lactation.
9. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.