cyrilzakka/clinical-trials huggingface dataset:
Effect of a Nutritional Supplement with Phytoglycogen on Gut-brain Axis with Focus to Perceived Stress, Mood and Sleep

Aim of the study is to investigate the effects of a 8-week supplementation of a phytoglycogen on perceived stress, sleep, mood and emotional wellbeing. Additionally, stress-related biomarker will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Women and men
* BMI ≥ 19 and ≤ 30 kg/m²
* Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology
* PSQ20 total score ≥33
* Capable and willing to give written informed consent

Exclusion Criteria:

* Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases (colitis ulcerosa, Crohn's IBS, peptic ulcers, celiac disease), depression, diabetes, heavy liver disease, immunodeficiency, pancreas insufficiency, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
* A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
* Regular intake of drugs possibly interfering with this study (e.g. antidepressants, soporifics) within 3 months prior to study start or during study (stable and controlled L-Thyroxin intake would be allowed)
* Regular intake of supplements possibly interfering with this study (e.g. cannabidiol, St. John's wort, melatonin, dietary fiber supplements, probiotics etc.) within 4 weeks prior to study start or during the study (stable vitamin D intake would be allowed)
* Vegan nutrition
* Smoker \&gt; 10 cigarettes / day
* Blood donation 4 weeks prior to screening visit and during the study
* Known pregnancy, breast feeding or intention to become pregnant during the study
* Alcohol or drug abuse
* Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
* Relevant allergy or known hypersensitivity against compounds of the study products
* Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Safety and Immunogenicity of Live Attenuated Influenza H5N2

The purpose of this study is to evaluate immune response and safety of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, Thailand in healthy Thais.

It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as being tested in phase I.

150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. All will be separated in 4 batches; Batch 1: 36 participants (24 vaccinees and 12 placebos) Batch 2: 38 participants (25 vaccinees and 13 placebos) Batch 3: 38 participants (25 vaccinees and 13 placebos) Batch 4: 38 participants (26 vaccinees and 12 placebos)

Each batch will be admitted in the isolation ward for 5 days after each immunization mainly for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 28 days apart. Total follow up is 60 day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 18-49 years old
* Having Thai ID card or equivalent
* Are seronegative to the specific H5 influenza virus determined by antibody titer less than 1:40 by HAI test to the corresponding antigen.
* Anti HIV - Negative
* All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value)
* Able to read and write and sign written informed consent.

Exclusion Criteria:

* Known history of egg allergy
* Having had recently influenza infection confirmed as H5
* History of bronchial asthma
* History of chronic lung diseases
* History of chronic rhinitis
* History of immunodeficiency state
* History of immunosuppression
* History of heavy smoking (more than 5 rolls per day)
* History of alcoholic (pure drink 200 ml per day)
* Acute infectious and noninfectious diseases (within 2 weeks)
* Exacerbation of chronic diseases or cancer or HIV positives
* Anamnestic leukocytosis, hepatitis B and C positives
* The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
* Participation in other research study or stop participant less than 1 month
* Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
* Any concomitant medication with Aspirin
* Poultry workers
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and Dapagliflozin tablets administered orally together in the fasted and fed state

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (PE), vital signs, 12-lead ECG, and clinical laboratory determinations
* Body mass index (BMI) of 18.5 to 30 kg/m(2)
* Men and women, ages 18 to 50 years
* Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of chronic or recurrent urinary tract infection for females
* History of glucose intolerance or diabetes mellitus
* History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose cotransporter (SGLT) inhibitors
* Prior exposure to Saxagliptin or Dapagliflozin or related drugs
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)

This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of \>600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for Pegetron® will be applied to participants.


Eligibility Criteria:
Inclusion Criteria:

* Must demonstrate willingness to participate in the study.
* Diagnosed with chronic HCV.
* Between 18 and 65 years of age of either gender and of any race.
* a. HCV positive, \>600,000 IU/mL at baseline AND b. Genotype 1.
* Suitable for treatment with Pegetron® per the Canadian product monograph.
* Investigator has already decided to treat with PEGETRON REDIPEN®

1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.

* HCV-RNA negative at treatment week 4.
* Meet certain minimum laboratory values at the week 4 screening visit.
* Women of childbearing potential and male partners must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g. hysterectomy or tubal ligation).

Exclusion Criteria:

* Had previous interferon-based therapy for Chronic Hepatitis C.
* Active Hepatitis B virus (HBV) infection.
* Human Immunodeficiency Virus (HIV) antibody positive.
* Cirrhotic (Stage 4 on Metavir system).
* Uncontrolled history or current severe depression or psychoses.
* Uncontrolled epilepsy.
* Use of illicit drugs.
* History of non-compliance to medical regimens.
* Liver disease other than from chronic hepatitis C.
* Participating in any other clinical study.
* Used any investigational drugs within 30 days of screening.
* Participants weighing \< 40 kg or \> 125 kg.
* Pregnant women or women who plan to become pregnant or sexual partners of women who want to become pregnant.
LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.

This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Age ≥ 50
3. Diagnosis of active CNV secondary to neovascular AMD
4. BCVA ETDRS letters between 5 and 63
5. Subjects must have received a minimum of 2 injections within 6 months prior to screening
6. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
5. Uncontrolled diabetes defined as HbA1c \>7.5%
Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors

Increasing number of ovarian cancer patients are receiving PARP inhibitor as maintenance therapy. Predictive factors to PARP inhibitor other than BRCA mutation or HRD status are unknown. Previous study, we analyzed the dynamic immunological changes in peripheral T cells during PARP inhibitor maintenance therapy and found predictive biomarkers. The purpose of this study is to prospectively validate the biomarkers for predicting response to PAPR inhibitors in ovarian cancer. We collect serial blood samples (before initiation of therapy and after 1, 3, and 6 months) in ovarian cancer patients who receive PARP inhibitor and analyze immunological characteristics of peripheral CD8 and regulatory T cells. Through assessment of the baseline properties and dynamic changes in T cells, we aim to validate the predictive biomarker and develope promising novel targets to enhancing survival outcomes of high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of epithelial ovarian cancer, 2. Presence of germline or somatic BRCA mutational status result, 3. Advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start PARPi (olaparib or niraparib) maintenance therapy.

Exclusion Criteria:

1. Patients who refuse to participate, 2. Patients having difficulty understanding the protocol due to language barrier
A Brief Acceptance Intervention for Stress to Improve Students' Well-Being

The goal of this randomized controlled trial is to test a brief psychological intervention that focusses on acceptance of stress in a student population. The main questions it aims to answer are:

* Does this brief acceptance intervention increase the well-being of students in the short term?
* By which mechanisms does this effect occur?
* What are moderating factors of this effect?

Half of the participants follow a one-hour intervention, which includes

* psychoeducation and metaphors about stress and how acceptance can help to deal with it
* experiential exercises
* mindfulness meditation
* mindfulness homework practice

Students that receive the intervention will be compared to students that merely received psychoeducation about stress and acceptance to see if the intervention lead to larger increases in well-being.


Eligibility Criteria:
Inclusion Criteria:

* Student at the University of Amsterdam in the Bachelor's programme psychology or communication science

Exclusion Criteria:

* Panic Disorder as measured with the Rapid Measurement Toolkit-20 (Batterham et al., 2020; cutoff at 9)
* Asthma, Chronic Obstructive Pulmonary Disease (COPD), another lung disease (including covid-related lung complaints), or tightness of chest
* Pregnancy
* Physical disability that limits ability to move and jump
Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19

This study aimed to assess the cytokine profile in COVID 19 patients and its relation with disease progression \& severity using COVID reporting and data system (CORADS) score.

Study Participants This was a prospective case control study done from February to December 2021, 50 COVID19 patients and 50 control participants after taking their written consents were recruited from the emergency department and outpatient clinic to the Medical microbiology and immunology department and infection control unit in Benha university hospital, Benha, Egypt.

Blood samples were taken at admission from each patient and repeated during the convalescence period for severe pneumonic cases. Serum C-reaction protein (CRP), D-dimer, lipids and glucose were determined by conventional laboratory methods. Blood samples of the control group were also collected and tested. The obtained blood samples were placed in tubes containing EDTA and blank tubes then immediately centrifuged at 1500g and stored at -80°C.

Enzyme-Linked Immunosorbent Assay Quantitative detection for tumor necrosis factor alfa (TNF-α) \& intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.

Statistical analysis Data were analysed using SPSS software, version 25.0 (IBM, Armonk, NY, USA) for Windows. Quantitative data were tested for normality using Kolomograph test assuming normality at P\>0.05. they were proved to be non parametric, so they were presented as median and inter-quartile range (IQR), and analyzed by Man Whitney U test and Kruskal Wallis (KW) test for independent groups. P ≤0.05 was considered significant

P value \>0.05 insignificant P≤0.05 significant P\<0.001 highly significant

Eligibility Criteria:
Inclusion Criteria:All patients confirmed by RT-PCR, as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who visited the emergency room and the outpatient clinic in the study period. The control group included 50 healthy volunteers.

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Exclusion Criteria:

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Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

This is a multicenter, randomized, open-Label , non-inferiority phase III study . All premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio. Furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study. The efficacy of maintaining serum E2 levels ≤30 pg/mL at 4-48 weeks post-treatment will be assessed in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal female subjects aged 18 to 55 years old.
* Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer.
* Subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery.
* Life expectancy is not less than 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate function of major organs.

Exclusion Criteria:

* History of evidence of distant metastatic lesions;
* Subjects have the history of new adjuvant or adjuvant endocrine treatment for breast cancer ( Excluding subjects receiving tamoxifen citrate tablets treatment for less than 12 weeks before informing).
* Active hepatitis B, hepatitis C or HIV in screening.
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia

Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

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Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids

This study will aid in the development of a research instrument for rapid and highly sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of 25 participants.The standard clinical protocols for administering oxytocin to human subjects at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed and dosed as per standard of care with no change due to study enrollment. The study will only involve sampling of saliva and blood.

The general hypothesis to be tested is that 1) the sensor will accurately report the levels of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor yields rapid (\<20 minutes) oxytocin results with minimal discomfort to subjects. Overall, this will allow to optimize the administration of oxytocin, and for a better understanding of the blood concentration and effects of oxytocin on mother and child.

Oxytocin, a neuropeptide hormone, plays an important role in the dynamic function of the brain and a variety of complex social behaviors including affiliation, sexual behavior, social recognition, and aggression. Oxytocin is best known for its role to facilitate the birth process through induction of uterine smooth muscle contractions. Oxytocin is primarily used to induce labor, and contract the uterus after delivery. Oxytocin is considered the first line uterotonic to prevent and treat uterine atony and manage postpartum hemorrhage. Currently, there is no instrument that is capable of point-of-care oxytocin detection. A practical research tool to monitor peripheral levels of both endogenous and exogenous oxytocin is therefore needed to better understanding the pharmacokinetics and pharmacodynamics of oxytocin in the mother, fetus and newborn. A better understanding of drug concentration and effect may lead to optimal dosing and better management of induction of labor and/or uterine atony after delivery.

With increased research on the importance of oxytocin monitoring, a bedside oxytocin monitor is envisioned that would allow healthcare professionals to improve our pharmacokinetic/dynamic understanding of oxytocin and to monitor and adjust the dose of oxytocin administered during childbirth. Currently, there is no instrument that is capable of point-of-care oxytocin detection.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, pregnant woman (37-41 weeks)
* Scheduled for induction of labor (not already in active labor) or cesarean section
* Ages 18-45 years old
* ASA physical status 1 or 2
* Singleton pregnancy
* Able and willing to sign consent

Exclusion Criteria:

* Women with any significant medical or obstetric condition (such as gestational hypertension, diabetes,coagulopathy, and renal impairment)
* Morbid obesity (BMI greater than/equal to 40)
* In active labor upon arrival to L\&D
Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.

The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs.

Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.

Eligibility Criteria:
Inclusion Criteria:

* Differentiated thyroid cancer
* treated by thyroidectomy and at least 1 ablation with 131-I \> 5 months ago
* TSH \< 4 imU/L

Exclusion Criteria:

* Pregnancy
* Known metastasis
Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention

Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Thus far, treatment satisfaction has not yet been assessed, while this may play an important role in treatment adherence and persistence. Moreover, there is no data on the long-term safety of IAI, e.g. regarding the development of (pre)malignant bladder lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment

Exclusion Criteria:

* Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes
* Receiving IAI as suppressive therapy for chronic prostatitis
* Presence of a chronic indwelling catheter
* Patient has objected to the use of his/her data
* Inability to provide informed consent