cyrilzakka/clinical-trials huggingface dataset:
The Pacing (Guided Vs Unguided) Strategies Study

The objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise.

This experiment aims to accomplish two goals: collect additional metabolic flexibility data with young fit adults in response to exercise; and demonstrate that automated pace guidance generated from real-time thermal-work strain monitoring and an optimized pacing policy will allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The two exercise sessions will be conducted as part of a \~24 hour stay in an indirect calorimetry chamber.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Ages 18 to 29 at the beginning of the study
* Relatively fit can run 2 miles in under 16 minutes

Exclusion Criteria:

* History of Skin Sensitivity to Nickel
* Hypertension
* Alcoholism
* Diabetes
* Pregnant
* Age \>29
* Cannot run 2 miles in less than 16 minutes
* No regular weekly exercise
* Difficulty Swallowing Food or Large Pills
* Diverticulitis
* Inflammatory Bowel Disease
* Peptic Ulcer Disease
* Crohn's Disease
* Ulcerative Colitis
* Previous Gastrointestinal Surgery
* Possible Nuclear Magnetic Resonance Scan
* Women who have given birth during the previous 12 months
* Pregnant women or women who plan to become pregnant or become pregnant during the study
* Lactating women
* History or presence of kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (for at least 6 months prior to the start of the study)
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
* Unable or unwilling to give informed consent or communicate with study staff.
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Blood donation within the previous month
Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment

The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.

This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.

Exclusion Criteria:

* history of cancer.
* gestational carrier.
Efficacy of Eco-guided PENS on Handgrip Strength

Low-frequency percutaneous electrical stimulation is the application of an electrical current of \<1000Hz through acupuncture needles located on the epineurium of the peripheral nervous system.

The hypothesis is that by placing the electrode, needle, closer to the nerve, a greater stimulation of the same will be achieved, thus being able to obtain greater effects. The goal is to determine if this technique has any effect on grip strength in the short term.

Single-blind randomized clinical trial of n = 12 healthy subjects. 4 assessments of the grip strength of the non-dominant hand will be made using a digital dynamometer, by a blinded investigator. A V0-pre-intervention, a V1-post-intervention, a V2 at 24 hours and a V3 at 10 days after the intervention. Subjects will be randomly assigned by EPIDAT 3.1, to an experimental group or a control group, with n = 6 each group. In the experimental group, an ultrasound-guided percutaneous electrical stimulation will be performed. With a pointer, a symmetrical biphasic low-frequency current of 10 Hz and 240 microseconds will be applied to the median nerve and ulnar nerve, until reaching the excitomotor threshold, with applications of 10 seconds and rests of 5 seconds until reaching a stimulation of 1 minute. total over each nerve. In the control group, the same invasive procedure will be performed, but no type of electrical stimulation will be applied.

Statistical analysis will be performed by another blinded assessor, using IBM SPSS Statistics 24. A two-factor ANOVA (intervention-time) with Bonferroni correction will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
* Tolerance to the application of electrotherapy.
* That they have not diagnosed any pathology.
* They do not present a contraindication to puncture and / or the application of electric currents.

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb.
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

The objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss.

In the Netherlands all neonates are routinely screened for hearing during the first weeks after birth with the Otoacoustic Emissions (OAE) procedure. After the second refer an Automated Auditory Brainstem Response (AABR) is performed. The parents of all newborns, born at ≥ 37 weeks gestational age, that fail this AABR in the Netherlands (about 550 yearly) will be asked for consent for CMV-testing on the dried blood spots. Newborns diagnosed with congenital CMV and with confirmed SNHL (≥ 20 dB) are eligible for inclusion. After informed consent infants will be randomized before the age of 13 weeks to a treatment group (6 weeks valganciclovir 32 mg/kg daily dose; oral solution) or control group (no antiviral treatment). Infants will be monitored for leucopenia and liver- and kidney function. Inclusion will continue for at least 1.5 years, or until 25 infants in each treatment arm have been randomized.

At 1 year follow-up hearing and child development are assessed. Hearing will be assessed with Brainstem Evoked Response Audiometry at an audiological center. Child development will be assessed during a home visit with the Bayley Scales of Infant Development III and parents will fill in the Dutch Child Development Inventory (NCDI) which will give more detailed information on communicative development of their child. Viral loads in blood and urine will be monitored during antiviral treatment as well as twice in the control group.

This study will provide information on the percentage of infants with a congenital CMV infection who fail the neonatal hearing screening . The RCT will show whether early treatment of congenital CMV infected children with hearing impairment prevents deterioration of hearing loss and to what extent. The outcome may lead to implementation of congenital CMV testing in the neonatal hearing screening program or possibly into the newborn blood screening.

Eligibility Criteria:
Inclusion Criteria:

* Infants with congenital CMV infection and hearing loss (≥ 20 dB, in one or both ears).
* Age at time of inclusion is \< 13 weeks after birth.
* ≥ 37 weeks gestational age.
* Birth weight ≥ 2500 gram.
* Parental signed informed consent.

Exclusion Criteria:

* Indications for symptomatic congenital CMV infection based on diagnostics carried out prior to the inclusion of the child in the trial.
* In case during the house visit the presence of a symptomatic CMV infection is doubted, inclusion will be discussed. Depending on the medical history taking, physical examination and laboratory tests inclusion will be decided upon.
* Treatment with other antiviral agents or immunoglobulins.
* Leucopenia \< 0,5 x 10\*9/L (blood sample tested at t=0).
Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

This clinical trial will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age, have a singleton pregnancy, score less than 10 on the Edinburgh Postnatal Depression Scale (EPDS; (Cox et al., 1987b), willing to participate in the eight-week intervention or be randomized to the TAUM condition, have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance use disorder, etc.), have no chronic pain condition (e.g., fibromyalgia), and proficient in English or Spanish

Exclusion Criteria:

* Women who screen 10 or higher on the EPDS
Impact of Anxiety and Depression on Implicit and Explicit Memory Performance

This study examines the effect of anxiety and depression on memory processes, focusing on implicit and explicit memory. Implicit memory involves unconscious recall, such as recognizing familiar words without effort, while explicit memory requires conscious recollection of specific information. The study aims to investigate whether individuals with depression and anxiety show differences in these types of memory, which may contribute to biases related to their emotional states.

Participants were divided into three groups: individuals with depressive disorder, individuals with generalized anxiety disorder, and a control group with no emotional disorders. Each group was assessed using tasks designed to measure both implicit and explicit memory performance. The goal is to enhance understanding of memory biases in individuals with depression and anxiety, potentially supporting more targeted interventions.

This cohort study is designed to explore potential memory biases in individuals with depressive and anxiety disorders compared to a control group. The study includes 27 participants divided into three groups: nine individuals diagnosed with major depressive disorder, nine with generalized anxiety disorder, and nine control subjects with no history of emotional disorders. All participants were matched by age and education level.

Participants completed standardized tasks and assessments, including the Spielberger State-Trait Anxiety Inventory and various memory tasks such as word decoding and recognition memory tasks. These tasks aim to evaluate mood-congruent biases in memory recall. Data collection will focus on analyzing any distinct memory processing patterns in depression and anxiety to improve psychological treatment approaches.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* Individuals diagnosed with major depressive disorder (Group 1)
* Individuals diagnosed with generalized anxiety disorder (Group 2)
* Healthy individuals with no history of emotional disorders (Group 3)

Exclusion Criteria:

* History of neurological disorders
* Visual impairments
* Substance abuse or drug addiction
* Psychiatric hospitalizations unrelated to primary diagnosis (for Groups 1 and 2)
Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy

The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while \> 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.


Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years
2. Stage IIIB/IIIC/IV/IVA/IVB NSCLC patients treated with first-line afatinib for EGFR sensitizing mutations (Del19, L858R, G719X, S768I, or L861Q etc.)
3. Afatinib treatment was started 13 month prior to data collection date to reduce premature censoring of patients. Data cutoff date will be determined before data entry starts.

Exclusion Criteria:

1. Patients who received drug(s) other than afatinib (Giotrif®) as the first-line treatment
2. Patients who received drug(s) other than 3rd-generation EGFR TKI osimertinib as the second-line in "Cohort A'
Breast Cancer PSMA PET

The purpose of this research is to determine the expression of Prostate Specific Membrane Antigen(PSMA) in metastatic Triple Negative Breast Cancer (TNBC) patients using Fludeoxyglucose F18 (FDG) PET/CT as the gold standard. The investigators hypothesize that most lesions in metastatic TNBC are PSMA-avid; and thus PSMA-based radionuclide therapy can be a valid treatment option for TNBC, and clinical trials can be designed for this purpose. Thirty metastatic TNBC patients will be enrolled and will be on the study for maximum of 4 weeks.

Prostate Specific Membrane Antigen (PSMA) is not only expressed in prostate cancer and its metastases, but also it is expressed on the neovasculature of many other solid tumors including gastric, lung, adrenal, bladder and renal cell carcinomas. Also, there is evidence that breast carcinomas express PSMA, although this has not been specifically studied in the metastatic TNBC.

The study involves a total of 2 visits and on each visit, patients will undergo a PET imaging. Each patient will first undergo an (FDG) PET/CT and then in few days will undergo an 18F-DCFPyL-PET/CT. The PET scanner is a large machine with a hollow tube that will be used to see how F18 FDG is taken up into the tumor and other tissues. The patients will be asked to lie on the back on a special table that slides into the tube. The sides of the tube will be close to the body. At the first visit patients will be in this scanner for approximately 20 minutes.

The study will evaluate the expression of PSMA via 18 F-DCFPyL-PET/CT in metastatic TNBC patients and compare it with lesion detection rate of FDG PET/CT. PSMA-avid lesions will be detected using the novel agent 18 F-DCFPyL and concordance rate with FDG-avid lesions will be calculated. The standardized uptake values (SUV) of each lesion on both FDG PET/CT and 18F-DCFPyL-PET/CT will be compared to find a correlation between tumor aggressiveness (lesion SUV on FDG PET/CT) and tumor angiogenesis (lesion SUV on 18 F-DCFPyL-PET/CT).

Eligibility Criteria:
Inclusion Criteria:

* Female \>= 18 years of age
* Patients in distantly metastatic TNBC based on the initial diagnosis biopsy.
* Patient should have FDG positive metastatic lesions on the initial PET/CT scan performed in this study to be further included.

Exclusion Criteria:

* Patients with known active other malignancy.
* Unable to tolerate PET/CT procedure.
* Pregnant or breastfeeding.
* Patients with any medical condition that might compromise the safety of subject during PET acquisitions.
A Retrospective, Blinded Validation of a Host-response Based Diagnostics

This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.


Eligibility Criteria:
Inclusion Criteria:

The infectious disease samples should also fulfill the following criteria:

* The patient had a peak temperature ≥38°C (AND)
* Symptoms initiated ≤ 7 days before sampling

The non-infectious disease control group will include:

* Patients with a non-infectious disease

Exclusion Criteria:

* Another infection episode during the last 3 weeks before sampling
* Congenital immune deficiency (CID)
* A proven or suspected HIV-1, HBV, HCV infection
* Active hematological malignancy
* Current treatment with immune-suppressive or immune-modulating
* Other illnesses that affect life expectancy and/or quality of life
A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer

Objective: To investigate the efficacy and safety of radiotherapy combined with EGFR-KI in the treatment of stage III EGFR mutant lung cancer. Methods: Stage III EGFR mutant lung cancer cases who underwent radiotherapy combined with EGFR-TKI from December 2014 to December 2022 at the People's Hospital of Laibin, the First People's Hospital of Yulin, the Affiliated Hospital of Guilin Medical College, and the Park East Hospital of Guangxi Medical University Kaiyuan were collected, and the primary index of the study was progression-free survival (PFS), and the secondary indexes were objective remission rate, overall survival, recurrence pattern, and adverse events. Survival analysis was performed using the Kaplan-Meier method with Log rank test for univariate analysis and Cox proportional risk model for multifactorial analysis of prognosis.


Eligibility Criteria:
Inclusion Criteria:

* ①patients diagnosed with lung cancer by pathology; ②genetic testing for EGFR mutation type; ③compliance with the international eighth edition of lung cancer TNM stage IIIA-IIIC; ④treatment modality of radiotherapy + targeted therapy. ⑤Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2

Exclusion Criteria:

* (1) those who underwent surgery; (2) those who received chemotherapy. (3) Combination of other serious diseases that affect survival.
Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

* To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction
* To evaluate the safety and tolerability of oral omecamtiv mecarbil

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Japanese male or female ≥ 20 years and ≤ 85 years of age
* History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
* Treated for HF with optimal pharmacological therapy
* Left ventricular ejection fraction ≤ 40% at screening

Exclusion Criteria:

* Severe uncorrected valvular heart disease
* Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
* Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization
* Systolic blood pressure (BP) \> 160 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg, or heart rate (HR) \> 110 beats per minute (bpm) or HR \< 50 bpm
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
* Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Documented history of perennial allergic rhinitis
* A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
* Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
* Other criteria apply

Exclusion Criteria:

* History of physical findings of nasal pathology (within 60 days prior to screening visit)
* Participation in any investigational drug study 30 days preceding screening visit
* History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
* Use of any prohibited concomitant medications
Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations

Background. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress.

Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* all patients who undergo ambulatory surgical operations and sign informed consent

Exclusion Criteria:

* death or blind patients