cyrilzakka/clinical-trials huggingface dataset:
Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study

This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial.

This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. The P1-CaLL study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques. Caregivers will receive 4 weeks of stress-management sessions (over the phone). Then, they will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy or Metta-Meditation (over the phone). Participants will receive tasks to complete each week.

Eligibility Criteria:
Inclusion Criteria:

1. Informal caregiver of a patient screening for a phase 1 clinical trial
2. Self-identifies as a caregiver as consistent with the National Study Of Caregiving (NSOC) definition13- individuals who help a patient with self-care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to the patient (paid or and non-paid) or are unrelated non-paid helpers.
3. Provision to sign and date the consent form.
4. Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of \>3.
5. Stated willingness to comply with all study procedures and be available for the duration of the study.
6. Age \>18
7. Has consistent access to a telephone
8. Able to read and understand English

Exclusion Criteria:

1. Has a cognitive or psychiatric condition prohibiting participation.
2. Current enrollment in another psychosocial intervention trial.
Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness

Not all patients with the Obstructive Sleep Apnea Syndrome (OSAS), mostly mild, have excessive daytime sleepiness. Sleep fragmentation provides the performance decrease with increasing reaction time to external stimuli and correlates with excessive sleepiness. So, the study aims at assessing the effect of sleep fragmentation on the Reaction Time and it's maintenance in patients with OSAS compared with healthy, to better clarify were patients with and without somnolence differ. For that, will be recruited 30 male volunteers aged between 20 and 50 year old to participate in the study. They will be distributed in three groups: "CONTROL" (without symptoms of sleepiness and apnea and hypopnea index (AHI) less than 5), "SS" (with AHI between 5 and 15 without symptoms of somnolence) and group "CS" (with AHI between 5 and 15 with symptoms of somnolence). The groups will undergo a polysomnography and subsequently, the Test and Maintenance of Wakefulness and PVT Battery Tests. The reaction time will be compared, as well as the ability to keep the reaction time over time between groups to see whether there is a difference between the motor performance throughout the day and the perception of sleepiness.


Eligibility Criteria:
Inclusion Criteria:

* Man
* Aged between 20 and 45 years old
* BMI between 20-30

Exclusion Criteria:

* Cigarette Smoke
* Drug intake
* Other sleep disturbances
Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer

CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient 18 years of age or older
* Cytology or biopsy-proven squamous cell head and neck cancer scheduled to be treated with standard of care surgery. Patients who are not surgical candidates should have adequate tissue from tumor biopsy for analysis of CCR2
* Lesion size of at least 1.5 cm (treatment naïve)
* Able to give informed consent
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 14 hour period immediately prior to administration of 64Cu-DOTA-ECL1i is negative

Exclusion Criteria:

* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years
* Unable to tolerate approximately 90 minutes (total time) of PET/CT imaging
Jodkids: a Study of Iodine Intake Among Children Aged 2-10 Years

The overall aim of the study is to monitor the effects of the increased iodine fortification level implemented in 2019 on iodine intake from the diet (incl. dietary supplements) and the excretion of iodine in urine in children aged 2-10 years.

All children in Denmark receive iodine fortification through the iodine fortification program of salt, bread, and baked goods. As DANSDA's results demonstrate a risk of increased iodine intake among the youngest children, it is necessary to carry out the study in these age groups, as this can have harmful effects on children's thyroid health as well as neural development. Children are the group in society that most easily exceeds the intake of iodine, whereas many pregnant women still find it difficult to achieve a sufficient intake with the current level of fortification. Through this study, it is possible to detect and deal with a potentially too high intake in children in time. If, on the other hand, the study shows that the children have a satisfactory intake of iodine, the iodine fortification level can potentially be increased, so that the iodine intake is increased in the groups that still have an iodine intake below the recommended level.

The study consists of two sub-studies. The specific objectives of the sub-studies are to:

* Iodine status (1): Estimate the iodine intake and food sources of iodine among children after the increased iodine fortification and assess whether some children are at risk of an increased iodine intake (2-10 years old).
* Diet validation (2): Validate the estimated iodine intake based on dietary records against the actual iodine intake measured in spot urines (4-10-year-olds).

A total of 600 participants are recruited, divided into 200 participants in each of three age groups: 1) 2-3 years, 2) 4-6 years and 3) 7-10 years. A short, electronic questionnaire is completed for all participants. In the iodine status study (1), the child's parents/guardians collect one urine spot sample from each participant to measure the population's iodine intake. The diet validation study (2) is carried out in a subsample of 100 participants divided into 50 participants in each of the age groups 2) 4-6 years and 3) 7-10 years. From here, the child's parents/guardian register data for the dietary intake every day for 7 consecutive days and collect one spot urine per day on the same 7 days when the dietary registration takes place.

All examinations are considered harmless.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-10 years

Exclusion Criteria:

* Chronic diseases that can influence iodine metabolism (metabolic diseases, kidney or liver diseases or diabetes)
* Parents/guardians do not have the opportunity to fill in the basic questionnaire or the diet questionnaire electronically
Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.

Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Understand and sign an Informed Consent document;
* Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
* Agree not to wear contact lenses for the duration of the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

* History of eye surgery, as specified in the protocol;
* Eye infection or inflammation, as specified in the protocol;
* Eyelid abnormalities; eyelid tattoos;
* Treated with LipiFlow or iLux in either eye in the last 12 months;
* Contact lens wear within the 1 month prior to Screening;
* Other protocol-specified exclusion criteria may apply.
Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical outcome is wellknown. This catabolism is especially pronounced in patients with acute or chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into both these categories.

To prevent this undesirable catabolism, we will investigate the effects of intravenous administration of predominantly anabolic amino acids (with an amino acid content equal to breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and intracellular signalling pathways.

Twenty-four patients will be block-randomized by gender in this parallel-group, randomized, assessor-blinded, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or saline. Metabolism before and after the intervention will be assessed by palmitate- and amino acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a measure of cellular activity.

With this study we hope to find evidence for anabolic effects of intravenous amino acids in j-pouch surgery for ulcerative colitis. The perspective is a potential for primary prophylaxis of surgical complications, reduction in the length of hospitalization, and subsequently optimized long-term functional outcome of the pouch.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ulcerative colitis who are having an ileal pouch-anal anastomosis performed, 18 \< age \< 50, written informed consent.

Exclusion Criteria:

* Inability to understand written Danish, postmenopause, severe asthma, diabetes mellitus, severe rheumatologic disease, severe comorbidity (ASA group III-IV) in general. Acute or progressing liver failure, uremia without possibility for dialysis, phenylketonuria, defects in amino acid metabolism. Participation in scientific studies in the preceding year, where ionizing radiation has been used, including significant x-ray investigations.
Deep Neuromuscular Blockade on Postoperative Pain

This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia.
* American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.

Exclusion Criteria:

* Patients undergoing emergency surgery.
* Patients with chronic pain or currently taking analgesics for chronic pain.
* Known hypersensitivity to general anesthetic agents or analgesics.
* Patients with underlying cardiovascular disease.
* Patients with neuromuscular disorders.
* Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
Variation in Serum Prolactin Levels During IntraCytoplasmic Sperm Injection

The purpose of the study is to determine whether or not stressful conditions such as ovum pick and awaiting Embryo Transfer is associated with significant increase in serum Prolactin (PRL) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm injection (ICSI) \& possible effect on implantation \& pregnancy rate.

Methodology in details:

After applying inclusion and exclusion criteria to infertile patients scheduled for start of ICSI cycle at kasr alainy assisted reproduction unit, and taking the patient's informed consent for all blood samples that will be drawn from her.

The baseline serum prolactin level is recorded and the first blood sample is scheduled to be taken in operating room just before induction of anesthesia for ovum pickup. A Second blood sample will be taken two hours after aspiration of the last follicle in recovery room post-operatively.

A third final blood sample will be taken before Embryo transfer .The blood samples will be sent immediately to central laboratory in Kasr Alainy Cairo University Hospital after being obtained on every occasion, and Serum prolactin will be analyzed by immunoassay in each time.

Descriptive data such as age, type of infertility \& cause will be recorded. Also result of every serum prolactin level will be recorded as well as type of protocol used for ovulation induction, number of oocytes retrieved at ovum pick up, embryo grading and day of transfer.

Serum beta human chorionic gonadotropin (B-hCG) will be drawn from the patient 2 weeks after the date of embryo transfer to determine pregnancy and recorded.

Statistical analysis will be done for the laboratory results, All statistical calculations were performed using the computer program SPSS (Statistical Package for the Social Science; SPSS Inc.) version 15 for Microsoft Windows

.

Eligibility Criteria:
Inclusion Criteria:

* Age: adult female \>20 years old.
* Complaining of infertility 1ry or 2ry \& scheduled for ICSI.

Exclusion Criteria:

* Hyperprolactinemia patients.
* Severe Male factor infertility
* Frozen embryo transfer cycles
* Uterine Anomalies.
* Repeated implantation failure in ICSI.
* Any contraindications for Pregnancy as(serious uncontrolled medical diseases such as Diabetes, heart disease, hypertension), mental illnesses, ovarian tumors,cancer of any location and Acute inflammatory disease).
* On medication that is known to alter prolactin levels e.g antipsychotics, Atypical agents and risperidone
* Thyroid dysfunction.
* Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and hypothyroidism.
Endoscopic Characteristics of Duodenal and Ampullary Lesions

The purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. It has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, Duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. It is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined.

This knowledge would be important in furthering our understanding of the development of cancer. There is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. Additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. Genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

Eligibility Criteria:
Inclusion Criteria:

* Intention to perform Endoscopic Mucosal Resection
* Adenoma equal to or greater than 20mm
* over 18 years of age
* Able to give informed consent to involvement in trial

Exclusion Criteria:

* Pregnancy
* Lactation: currently breastfeeding
* Taken clopidogrel within 7 days
* Taken warfarin within 5 days
* Had full therapeutic dose unfractionated heparin within 6 hours
* Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
* Known clotting disorder
Monitoring Adherence Using Mobile Technology

This study plans to learn more about how children use their asthma medicines. The investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma


Eligibility Criteria:
Inclusion Criteria:

* age 6-17 years and their parents
* either 2 emergency department visits/prednisone bursts in the last 12 months or at least 1 asthma related hospitalization in the last 12 months
* requiring daily controller therapy with either inhaled corticosteroids or combination corticosteroids/long acting beta agonist (LABA).
* Patients using metered dose inhaler therapy would be eligible. Patients may also be on leukotriene antagonists,
* Must be made aware that they will have to read and accept to the terms of the User Agreement prior to enrollment in the study. If they do not agree they will not be able to continue participation. The User agreement will be read agreed to electronically when they begin using the device, however a paper version will be provided at the time of consent upon request.

Exclusion Criteria:

* Primary language other than English or Spanish
* Presence of other significant chronic lung disease including cystic fibrosis, interstitial lung disease, tracheostomy status.
* Patients using diskus therapy.
* Patients only on leukotriene antagonists.
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects

Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* healthy male/female aged 19 to 45 with body mass index(BMI) between 18 and 25kg/m2
* Subject who has no congenital, chronic disease and disease symptoms in medical examination result
* Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead ECG etc)
* Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

* Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
* Subject who is hypersensitive to components contained in YH12852 or prucalopride or aspirin/antibiotics like drugs
* Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
* Clinically significant abnormal values in diagnostic check within 28 days before the treatment(\>1.25 fold of normal upper limit in the levels of AST or ALT, \>1.5 fold of normal upper limit in the levels of Total bilirubin, \< 80ml/min of Cockcroft-Gault used creatinine clearance
* Subject has over QTc interval of 550 ms or PR interval of 210 ms or QRS interval of 120 ms or QT interval of 500 ms on baseline 12-lead ECG, as determined by the Investigator
* Subject who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment
* Subject who participated in another clinical trail within 2 months before enrolling in this study
* subject who donated whole blood within 2 months or component blood within 1 month before the treatment
* Medically unacceptable contraception used during the clinical trial
* Subject who drank over 30g/day or were detected alcohol positive on test
* Subject who stopped smoking within 3 months before the treatment or weren't able to stop smoking during the hospitalization
* Subject who had a beverage containing caffeine during the hospitalization
* Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Responsible Behavior With Younger Children Pilot Study

The purpose of this study was to develop and pilot test a universal school-based prevention curriculum to prevent the onset of child sexual abuse (CSA) perpetration by early adolescents against younger children.

The proposed Responsible Behavior with Younger Children (RBYC) curriculum was developed and pilot tested in 6th and 7th grade classes in Baltimore City Public Schools. This study had three aims: 1) to develop and refine a new classroom-based universal curriculum to prevent the onset of CSA perpetration, 2) to evaluate the immediate effects (pre-post design) of RBYC on targeted constructs, and 3) to determine the feasibility and acceptability of RBYC to youth, parents, and school personnel.

Eligibility Criteria:
Inclusion Criteria:

* Student Assessments: 1) are in a 6th or 7th grade class within one of the four participating schools, 2) are fluent in English, and 3) have a "yes" consent form completed by their parent/legal guardian; students will also be asked to complete an electronic assent form at the beginning of each of the three student assessments.
* Educator Interviews: 1) have witnessed at least one session of the RBYC curriculum, 2) are fluent in English, and 3) have completed a consent form

Exclusion Criteria:

* Children residing in foster care will not be eligible for participation because of challenges associated with obtaining written parental consent from the legal guardian and other clinical concerns regarding this potentially vulnerable population that may arise with either students or parents. It is not feasible to address these challenges in the study.