cyrilzakka/clinical-trials huggingface dataset:
Salivary dysfuncTion After Radioiodine Treatment

Aim/Introduction:

The treatment of differentiated thyroid cancer includes generally a total thyroidectomy, followed by a radioiodine (131I)-therapy. Due to their ability to concentrate iodine, the salivary glands may present inflammation after administration of 131I, which may be symptomatic, may lead to longer-term chronic abnormalities, resulting in alterations in patients' nutrition and quality of life. The incidence of salivary dysfunctions after 131I-therapy varies considerably between studies due to methodological limitations. Also, the occurrence of these dysfunctions may be linked to increased uptake and/or retention of 131I in the salivary glands and/or individual radiosensitivity. However, no clinical or genetic factors have been identified to date to define patients at risk, allowing the delivered activity to be adapted to the expected risk of salivary dysfunctions. The aims of this study are to estimate the incidence of salivary dysfunctions after 131I-therapy, to characterize patients at risk of developing post-treatment dysfunctions using clinical, biomolecular and biochemical factors, and to validate a dosimetric method to calculate the dose received at the salivary gland level in order to analyse the dose response relationship between exposure of salivary glands to 131I and salivary dysfunctions.

Materials and Methods:

This prospective cohort aims to include 120 patients, candidates for a 131I-therapy in the context of their differentiated thyroid cancer, treated in the Nuclear Medicine department of the Pitié-Salpêtrière hospital (40 and 80 patients in a 1.1GBq and a 3.7GBq dose groups respectively). The follow-up is based on 3 scheduled visits: at inclusion (immediately before 131I therapy), 6months and 18months after treatment. For each visit, questionnaires on salivary disorders (validated French tool), quality of life (HAD-scale, MOS-SF-36), and nutritional status are administered. At inclusion and at T6, saliva samples and individual measurement of the salivary flow, without and with salivary glands stimulation, are performed.

External thermoluminescent dosimeters are placed opposite the salivary glands and at the sternal fork on the treatment's day before radioiodine administration and removed 5days after treatment. From dosimeters, a reconstitution of the dose received at the salivary glands will be established using physical and computational phantoms.

Genetic and epigenetic analyses will be performed to find biomarkers of predisposition to develop salivary disorders after 131I-therapy.

Expected results Inclusion of patients started in September 2020 and are still ongoing. Statistical analyses will study the links between salivary dysfunctions and the 131I dose received by the salivary glands, taking into account associated factors. In addition, impacts on the patients' quality of life will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* treated for differencied thyroid cancer
* aged of 18 and more

Exclusion Criteria:

* having been treated by chemiotherapy or radiotherapy
* no French language
* can't be follow at 6 months after treatment
Verticality Perception Assessed by the Haptic Vertical

The investigators previously shown that a rotating optokinetic stimulus results in shifts of the subjective visual vertical in healthy human subjects. However, the origin of these shifts is still poorly understood. Both torsional displacement of the eyes and a shift in the internal estimate of direction of gravity have been proposed as potential explanations. Here the investigators use a vision-independent setup to differentiate between these two hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if torsion triggers the shift.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-65 years
* informed consent
* absence of exclusion criteria

Exclusion Criteria:

* peripheral-vestibular deficit
* disturbed consciousness
* history of sensory deficits
* visual field deficits
* other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* intake of antidepressants, sedatives, or neuroleptics
* pregnancy, unless excluded by a negative pregnancy test
* known neck pain or status post neck trauma
A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021

This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity to better understand the natural course of eosinophilic esophagitis and define the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic maintenance or intermittent treatment.

All subjects who complete PR-021 will be offered the opportunity to participate in this study. The duration of this follow-up study is six months, during which subjects will visit the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8, Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week 20.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed full participation in Study PR-021 (Subjects discontinued prematurely from PR-021 due to HPA axis suppression will be eligible for study PR-022)
* Written informed consent (parent or legal guardian must sign when applicable) and assent form, if required
* Willing and able to adhere to all study procedures

Exclusion Criteria:

* Subjects already requiring medications or procedures for the treatment of EoE at the time of enrollment into the follow-up study, such as systemic (oral or parenteral) or inhaled corticosteroids, esophageal dilation, Proton Pump Inhibitors (PPIs) and/or dietary restrictions; in the case of subjects already on PPIs and /or dietary restrictions during Study PR-021, only subjects requiring an increase in dosage of PPIs and/or new dietary restrictions because of worsening of symptoms will be excluded
* Any physical, mental, or social condition, history or concurrent illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study
* Contraindication to esophagogastroduodenoscopy (EGD) or esophageal biopsy or narrowing of the esophagus precluding EGD
* Female subjects who are pregnant or breastfeeding
* Participation in a clinical study involving an investigational drug or investigational device
Recovery Kinetics Following a Soccer Training in Middle-aged Males

This study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. The participants will perform a soccer training session \[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training.

Eleven male middle-aged participants will be included in this study. Participants will be initially informed about the main goals of study as well as the associated risks and benefits and then will provide their signed consent form. At baseline, they will undergo assessment of their anthropometrics (body mass, height, BMI, WHR), body compotition (using DXA), physical contition level (peak oxygen consumption, VO2peak), haemodynamic profile (diastolic and diastolic blood pressure) and daily dietary intake.Thereafter, they will participate in two experimental trials (Control trial and Soccer trial) in a randomized, crossover, repeated measure design: 1) ST (Soccer Trial): Participants in this trial will perform a soccer training session (60 min) consisted of warm-up, technical exercises and small-sided game, CT (Control Trial): Participants in this trial will only execute the evaluations daily in the dependent variables (they will not receive any intervention). Before each trial, the participants will provide a resting blood sample (for the determination of white blood cells, granulocyte cells, monocyte cells, lymphocyte cells, Hemeatocrit, Hemoglobin, red blood cells and platelets, total antioxidant capacity, glutathione and creatine kinase activity) and undergo assessments of their delay onset muscle soreness (DOMS), maximal voluntary isometric contraction (MVIC) of knee extensors and flexors (by isokinetic dynamometer), height and power of countermovement jump (CMJ-using force platform), 10m and 30m sprint time (will be evaluated using light cells). A 7-day wash-out period will apllied between ST and CT. The blood sample will be collected before and 24, 48 and 72 hours post-taining. Also, the evaluation of DOMS, MVIC, sprinting performance, power and jump height (by CMJ) will be evaluated before and 24, 48, 72 and 96 hours post training.

Eligibility Criteria:
Inclusion Criteria:

* Free of musculoskeletal injuries
* No use of ergogenic supplements or medication
* Free of chronic diseases
* age of 40-60 years

Exclusion Criteria:

* Musculoskeletal injury
* Use of alcohol, caffeine and any type of ergogenic supplements or medication during the course of the study
Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors

The study seeks to determine the impact of assessing risk for osteoporosis in women on patient and physician behaviors through a pharmacist directed osteoporosis screening program. Women will be offered a heel ultrasound to screen for their bone density and may or may not be asked questions about their risk for bone fracture. Pharmacists will counsel and educate all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months after the screening and asked a series of 10 questions to follow up on decisions made by their physicians or changes made to their health behaviors related to bone health.

A maximum of 90 participants will be recruited and randomized to the FRAX® assessment intervention group or the control group to a total of 45 participants in each group. The number of participants was chosen based on the simple randomized design of the study and use of basic statistics (versus regression analysis). Subjects will be recruited from the employee population of Duquesne University, clients visiting the Spirit of Health mobile health unit, and the downtown Pittsburgh community and surrounding neighborhoods of Duquesne University. Participants will be recruited through posted flyers at these various screening venues. Data collected will be the T-score at baseline screening in both groups. The percent risk for fracture as determined by the FRAX® tool will be determined for the intervention group. After 3 months have elapsed, a questionnaire will be administered via telephone to both the intervention and control groups, a series of 12 yes/no questions. Fisher's exact test will be used to analyze the data. Data collected will be nominal data with n in each group at 45 for a total of 90 participants. Descriptive statistics will also be employed.

Eligibility Criteria:
Inclusion Criteria: Inclusion Criteria:

1. Postmenopausal female participants over the age of 45 years up to and including 65 years of age. The participant will be required to have a medical doctor and covered by an insurance plan in case a DXA-scan is ordered by the physician.
2. Ability to be screened at the Center for Pharmacy Care or at other community screenings on the Achilles® heel ultrasound bone densitometer.
3. After heel ultrasound is conducted, include those individuals as participants in the study who present with a T-score equal to or less than -1.0.

Exclusion Criteria:

1. Unable to participate in the follow-up survey conducted over the telephone.
2. Age less than 45 years or over 65 years.
3. Any individual currently taking biphosphonates for osteoporosis treatment.
4. After heel ultrasound is conducted, if T-score is greater than -1.0.
5. Males
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.

This is a double-blind, placebo controlled, randomized multicenter global phase 2 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in participants with advanced gastric cancer who have responded to first line platinum based chemotherapy. Participants are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status.

Participants will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met.

After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those participants without disease progression, survival status, and new anticancer therapy.

Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥ 18 years.
2. Signed informed consent.
3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
4. Received platinum based first line chemotherapy for ≤ 28 weeks.
5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
6. Able to be randomized to study ≤ 8 weeks after last platinum dose.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
8. Adequate hematologic, renal and hepatic function.
9. Must be able to provide archival tumor tissue for central biomarker assessment.
10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.

Key Exclusion Criteria:

1. Unresolved acute effects of prior therapy ≥ Grade 2.
2. Prior treatment with PARP inhibitor.
3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
5. Diagnosis of myelodysplastic syndrome (MDS)
6. Other diagnoses of significant malignancy
7. Leptomeningeal disease or brain metastasis
8. Inability to swallow capsules or disease affecting gastrointestinal function.
9. Active infections requiring systemic treatment.
10. Clinically significant cardiovascular disease
11. Pregnant or nursing females.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Program Development Study for Emotional Intelligence

For qualified nursing care, emotional intelligence skills of nurses should be developed during their vocational training. This research was carried out in order to develop and evaluate the Emotional Intelligence Training Program based on the Bar-On Emotional Intelligence Model for nursing students in line with Demirel's program development model.

The experiment was planned in a randomized controlled experimental design with placebo, control group (pretest-posttest control pattern), blind technique. It is a research with a mixed pattern, since the individual in-depth interview method, one of the qualitative research methods, is also used in the research together with quantitative methods. The research was carried out with first-year nursing faculty students (N: 250) of a university.

The Emotional Intelligence training program created and was applied to the experimental group in the specified period. In order to minimize the risk of interaction, a different training program was simultaneously applied to the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* The average score of the students on the emotional intelligence scale is in the range of 1-4 points.
* Willingness to participate in the study

Exclusion Criteria:

* Have received or receiving professional psychological or psychiatric support
Oral Health in Children With Inflammatory Bowel Disease

In adults with inflammatory bowel disease (IBD), a higher prevalence of dental caries and periodontal disease has been reported compared with healthy control subjects, but similar data on children are missing in the literature.We aimed to evaluate the prevalence of dental erosion, dental caries and periodontal disease in children with IBD.

In this age- and gender-matched prospective case-control study, detailed questionnaires including nutritional habits and oral examinations were completed for 32 IBD patients aged 11 to 18 (15,53±2,00 yr) and 32 healthy controls based on the established criteria of the World Health Organization by the same pediatric dentist.

Eligibility Criteria:
Inclusion Criteria:

* 11-18 years of age
* Study population with IBD in the remission period of disease
* Permanent dentition stage

Exclusion Criteria:

* Those who refused or whose families refused participation in this study
* Study population with IBD in the active period of disease
* Primary or mix dentition stage
* Systemic conditions, or medications with impact on periodontal tissues and previous orthodontic or periodontal treatment within the last year.
* Smoking
Does Sourdough Fermentation Improve Iron Uptake From Whole Grain Rye Bread?

Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major source of iron, but much of this is not bioavailability due to it being bound by the high amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can release iron and increase its bioavailability. In a human cell model of iron uptake, sourdough fermentation, which included activation of phytase, the enzyme that breaks down phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate that this concept also works in humans


Eligibility Criteria:
Inclusion Criteria:

* Healthy women under 50 years old

Exclusion Criteria:

* Pregnancy or breast feeding
* Use of mineral or other dietary supplements
* Use of medical or recreational drugs
* Donation of blood within the previous 3 months
Diabetes Homeless Medication Support

This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.

This study has an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). The investigators' central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH.

This study will involve addition of a randomization schema to compare D-Homes to brief diabetes education. The study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. This includes an assessment of sustained impact of the program at 24-weeks post-treatment. These will complement 12-week post-treatment primary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 yrs. or older
2. English-speaking
3. Homelessness by federal definition (HEARTH ACT) in the past 24 mos.
4. Self-reported diagnosis of type 2 diabetes with A1c \>7.5%, later verified in medical record and study point-of-care lab test.
5. Plan to stay in local area or be reachable by phone for the next 24 weeks
6. Willingness to work on medication adherence and diabetes self-care

Exclusion Criteria:

1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
2. Active psychosis or intoxication precluding ability to give informed consent
3. Pregnant or lactating people
Senior Adult Hepatobiliary Prehab Study

The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks
* ECOG 0-2
* Able to sign consent

Exclusion Criteria:

* Does not meet inclusion criteria
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ITP
* platelet counts \< 25 x10\*9/L or \< 50 x10\*9/L with bleeding symptoms
* meets criteria for treatment with TPO-ra
* Females must use contraceptives when applicable for at least three months before inclusion

Exclusion Criteria:

* Pregnancy or nursing
* Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation
* Liver insufficiency (for eltrombopag only)
* TPO-ra contraindications (e.g. allergy)
* TPO-ra treatments less than 6 months prior to inclusion
A Single-Dose Pharmacokinetics Study of Tapimycin Injection

The purpose of this study is to examine the pharmacokinetic properties of Tapimycin injection (piperacillin 4 g + tazobactam 0.5 g powder for injection) in healthy volunteers under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index (BMI) between 18.5 and 25.
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry.
6. No significant deviation from normal hematology.
7. No significant deviation from normal urinalysis.

Exclusion Criteria:

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Acute or chronic diseases or having undergone surgery from 4 weeks prior to PeriodI dosing.
4. Any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical study drug from 3 months prior to Period I dosing.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody.
11. A positive test for HIV antibody.