cyrilzakka/clinical-trials huggingface dataset:
Fetal and Neonatal Thyroid in Pregnancies With Severe Acute Respiratory Syndrome Coronavirus 2 ( SARS- COV2 ) COVID-19

The thyroid gland has been shown to be a common target for COVID 19 virus. Babies born to mothers positive for COVID 19 infections were noticed to have elevated thyroid stimulating hormone ( TSH ) levels on screening. Thyroid function tests were monitored in these babies to determine presence of temporary or permanent thyroid disorders following COVID 19 infections during pregnancy.

TSH estimation is carried out in all newborn babies in Saudi Arabia as a screening test for hypothyroidism. The first babies who were born to COVID 19 positive mothers were noticed to have significantly abnormal high TSH values. All the data and studies on the effect of COVID 19 on thyroid gland are from adult literature. Hence with these results of TSH in the the newborns we designed this observational study to monitor the thyroid functions in infants of COVID 19 positive mothers born in our hospital. The study confirmed presence of abnormal TSH and free thyroxine in these babies at birth and these babies were followed further after that for evidence of thyroid disorders.Results of thyroid functions in the babies who born in the same period of the study to mothers without COVID 19 infection were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* All newborns

Exclusion Criteria:

* Babies with congenital malformations
Is Ultrasonography Comparable to MRI for the Detection of Morton Neuroma of the Foot?

Patients with Morton neuroma of the foot will undergo either ultrasonography or MRI. The results will be compared.

In case of surgery, the pathology report will be compared with the ultrasonographic or MRI findings.

Which is the most reliable and specific: ultrasonography or MRI?


Eligibility Criteria:
Inclusion Criteria:

* Morton neuroma of the foot

Exclusion Criteria:

-
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control). Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).

Eligibility Criteria:
Inclusion Criteria:

* Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial fibrillation, and other arrhythmias)
* Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7
* Age 18 or older.
* Individuals must be in the post-acute phase of their CVD; this is operationalized as \> 2 months post an acute cardiac event.

Exclusion Criteria:

* Non-English speaker/literate
* No access to a digital device
* Severely vision impaired
* Severe cognitive impairment
* Pending acute surgery or with a life prognosis of fewer than 6 months
* The presence \[by self-report\] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
* Initiation or change of psychotropic medication dosage within the past 4 weeks
* Received CBT for anxiety in last 3 months
GT201 Injection in Combination with Teraplizumab Injection for Treatment of Patients with Non-small Cell Lung Cancer

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 4. Expected survival time of ≥ 12 weeks;
* 5. Good function of vital organs;
* 6. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 7. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.
The GEOLynch Cohort Study

The GEOLynch cohort study has been established to investigate the influence of genetic, environmental and other factors on tumour risk in persons with Lynch syndrome.

The GEOLynch cohort study includes persons with Lynch syndrome (LS) only. Persons with LS carry an inherited mutation in one of the DNA mismatch repair genes MLH1, MSH2, MSH6 or PMS2 which increases their risk of several types of cancer, especially colorectal and endometrial cancer. Additionally, mutations in the EPCAM gene that result in epigenetic silencing of the MSH2 gene cause LS. Since 2006, persons with LS are invited to participate in the GEOLynch cohort study via the Netherlands Foundation for the Detection of Hereditary Tumours, the Radboud University Medical Center Nijmegen or the University Medical Centre Groningen. Moreover, persons with LS can participate in the study after contacting the researcher themselves. Participants are asked to complete a food frequency questionnaire and questionnaires about dietary supplement use, physical activity, weight, height and medication use. A buccal swab was asked of every participant recruited between 2006 and 2008. From 2012 on, newly recruited participants are asked to donate a blood sample instead of a buccal swab. Furthermore, participants who had been recruited between 2006 and 2008 were asked to complete the questionnaires again and to donate a blood sample too. Hence, follow-up measurements are available for a subset of participants. DNA has been subtracted from the buccal swabs to genotype SNPs of the IGF gene axis and polymorphisms of MTHFR C377T. Blood samples are biobanked to facilitate future analyses of biomarkers, nutrients, DNA etc. Clinical characteristics regarding performed colonoscopies and tumour diagnoses of all participants is gathered from medical records and a linkage to the nationwide network and registry of histo- and cytopathology in the Netherlands (PALGA Foundation ). Hazard ratios will be calculated to investigate the influence of genetic, environmental and other factor on tumour risk. Repeated measures analyses will be used if follow-up measurements are taken into account.

Eligibility Criteria:
Inclusion Criteria:

* Persons with a known mutation in a gene that causes Lynch syndrome, i.e. with an inherited monoallelic pathogenic germline mutation in either the MLH1, MSH2, MSH6, PMS2 or EPCAM gene.
* Aged between 18 and 80 years at inclusion.

Exclusion Criteria:

* Additional carrier of another hereditary colon cancer predisposition syndrome (e.g. FAP)
* (Chronic) Inflammatory bowel disease
* Non-Dutch speaking
* Dementia or another mental condition that makes it impossible to fill out questionnaires
* Terminally ill persons
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

A one arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient is currently receiving Prograf ® based immunosuppressive therapy for liver transplantation.
* Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

Exclusion Criteria:

* Patient has previously received an organ transplant other than a liver
* Patient is currently receiving sirolimus immunosuppression therapy.
Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

Sleep disordered breathing, especially central sleep apnea, is common in patients with chronic heart failure. Heart valve replacement could have some effect on central sleep apnea. The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes respiration in patients with rheumatic heart disease.

Sleep apnea, especially central sleep apnea, has a high prevalence in patients with chronic heart failure. Although sleep disordered breathing (SDB) have been described in patients with heart disease, the prevalence is not known because: ①There are various forms of SDBs, including obstructive sleep apnea(OSA), central sleep apnea (CSA), and mixed forms of sleep apnea syndromes that have variable prevalence; ②Patients suffering from rheumatic valve disease usually have varying degrees of heart failure, and this variability affects estimates of prevalence; ③There are no international patient registries and SDB is underdiagnosed in many parts of the world.

The previous studies are most focusing on nonvalvular disease. We ①investigate the prevalence and the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases, ②compare the changes of parameters of Cheyne-Stokes Respiration and heart function (like apnea hypopnea index, pulse oxygen saturation, blood pressure, echocardiogram, electrocardiogram, 6-minute walk test) before heart valve replacement and 3, 6, and 12 months after the surgery.

With nocturnal polysomnography (PSG) examination 30 patients typical CSR are going to be screened out from 300 patients with heart valve disease and waiting for cardiac surgery. The Comparison of 30 patients undergoing heart valve replacement will be performed before and 3, 6, and 12 months following heart valve replacement. We shall analyze the changes of CSR before and after valve replacement as well as the correlation among cardiac function and PSG parameters.

Eligibility Criteria:
Inclusion Criteria:

* heart valve disease with any ejection fraction
* clinical diagnosis of Cheyne-Stokes respiration

Exclusion Criteria:

* unstable heart failure
* stroke
* transient ischemic attack in last 6 months
* pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
* severe chronic obstructive pulmonary disease
Vortioxetine to Prevent Return of Symptoms in Children With Depression

The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.

The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.

The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.

Eligibility Criteria:
Inclusion Criteria:

De novo participants

* The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).
* The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
* The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit

Exclusion Criteria:

* The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
* The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.
* The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.
* The participant has attempted suicide or is at significant risk of suicide

Other inclusion and exclusion criteria may apply.
Factors That Affect the Development of COPD Symptoms

Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the United States. There is no cure and the disease gets worse over time. Although it usually occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and without COPD to determine why some COPD symptoms occur in some people and not others.

COPD is a chronic lung disease in which the lungs' airways and balloon-like air sacs, called alveoli, are damaged, lose their shape, and become floppy. As a result, they cannot fully inflate to allow the maximum amount of air through. COPD is usually the result of many years of cigarette smoking. Breathing in other kinds of lung irritants, such as pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD. Some people with COPD have an excess of mucus in their lungs, possibly caused by an overactive immune response, which can lead to coughing and shortness of breath. Although cigarette smoking seems to make this symptom worse, researchers are not sure why it occurs in some people and not others. This study will examine and compare blood and lung tissue samples from smokers and nonsmokers with and without COPD to determine what physiological differences, environmental factors, genes, and biomarkers contribute to the development of and symptoms associated with COPD.

Before their scheduled lung resection surgery, participants in this study will attend one study visit. It will last approximately 1 to 2 hours and will consist of answering questions about medical history, filling out health questionnaires, and providing a blood sample. After the surgery, study researchers will take the lung tissue that was removed and examine it in a laboratory. Participants will be contacted by study staff if, when examining the lung tissue, researchers discover that a participant has a medical disorder that current treatment can stop or improve. Also, participants will be contacted at the end of the study to answer brief questions about their health.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write in English
* Able to participate in the informed consent process
* Planned lung resection at BJH
* Acceptable pulmonary function tests done at BJH within 1 month of enrollment
* Acceptable chest CT scan done at BJH within 3 years of enrollment

Exclusion Criteria:

* Pregnant
* Prisoner
* Vulnerable populations
* Clinically significant lung disease other than COPD and the indication for resection (e.g., cystic fibrosis, bronchiectasis, obliterative bronchiolitis, airway lesion)
* Coexisting active chronic inflammatory or collagen vascular disease, immune deficiency of any kind, or previous organ transplant
* Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
* Systemic chemotherapy within past 1 month (30 days)
* Hematologic malignancy or thoracic radiation within past year
A Randomized Controlled Trial of the Treatment of Mallet Fractures

Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as Mallet fractures. Treatment of Mallet fractures remains controversial. Although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. There are many different operative techniques, all with specific disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet splint.


Eligibility Criteria:
Inclusion Criteria:

* avulsion fracture involving more than 30% of articular surface

Exclusion Criteria:

* (sub)luxation of the distal phalanx
* patients with a Mallet fracture developed 3 weeks or more prior to presentation
* patients with a Mallet fracture with failure of conservative treatment
The Effect of Puzzle Activity on Nursing Students' Willingness to Work With Older Adults and Gerontological Nursing Competence

The study will be conducted using a parallel-group randomized controlled experimental design to determine the effect of a puzzle activity on nursing students' willingness to work with older adults and their competence in gerontological nursing. The study population will consist of second-year students (N=243) enrolled in the Faculty of Nursing at a university. The sample of the study will include at least 86 nursing students, with 43 students in the puzzle group and 43 students in the control group. The research will be carried out between March 2025 and June 2025. In this study, data will be collected using the "Descriptive Information Form," the "Willingness to Work with Older People Scale," and the "Gerontological Nursing Competence Scale."

The study will be conducted using a parallel-group randomized controlled experimental design to determine the effect of a puzzle activity on nursing students' willingness to work with older adults and their gerontological nursing competence. The study group will consist of second-year students (N=243) enrolled in the Faculty of Nursing at a university. The G\*Power program was used to calculate the sample size. In the reference study (Kaynak, S., Ergün, S., \& Karadaş, A. (2023). The effect of crossword puzzle activity used in distance education on nursing students' problem-solving and clinical decision-making skills: A comparative study. Nurse Education in Practice, 69, 103618), it was determined that at least 86 students (43+43) were needed, with α = 0.05, 80% power, and an effect size of 0.615.

After assigning the students to the intervention and control groups, a puzzle activity will be conducted with the intervention group following a lecture. In preparing the puzzles, the researchers will use free online puzzle-making tools (e.g., https://crosswordlabs.com/). The puzzles will include questions related to basic knowledge and concepts concerning gerontological nursing competence. During the puzzle-solving process, the researcher will be present in the classroom and provide guidance to students when needed. After students complete the puzzles, the researcher will project the puzzle on the presentation screen and evaluate the answers through interactive discussion with the students. Upon completion of each puzzle, the researcher will collect the puzzles from the students to prevent contamination between the intervention and control groups. A post-test will be administered to students at the end of the puzzle activity.

Eligibility Criteria:
Inclusion Criteria:

* • Being a second-year nursing student

  * Volunteering to participate in the study

Exclusion Criteria:

Not taking the Geriatric Health Nursing course

* Having difficulty in understanding and speaking Turkish
* Incomplete or incorrectly answered data collection tools
* Willingness to withdraw from the study voluntarily
Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older

The purpose of the study is to evaluate the safety and effectiveness of conservative treatment in treatment of patients over 75 years with impacted femoral neck fracture.

The study is to compare clinical outcomes between conservative treatment, internal fixation, and hemiarthroplasty in patients over 75 years with impacted femoral neck fracture. All the 3 groups were evaluated by hip pain(visual analogue scale,VAS), hip function(Harris hip score,HHS), health related quality of life(European Quality of Life-5 Dimensions index scores, Eq-5d). All thses parameters were assessed at admission and 1-, 3-, 6- 12-, 24- and 36 months after intervention. Operation duration and blood loss were recorded. Mortality, union rate, complications and re-operation were also monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

Patients \>75 years old who were diagnosed with impacted femoral neck fracture with confirmation of mutual embedding and close combination of the fracture ends by CT or MRI scanning(including Garden 1 and 2 and varus impacted FNF) were eligible for the inclusion.

Exclusion Criteria:

Patients \<75 years old, pathological fracture, nonimpacted or displaced fracture, unable to walk previously, avascular necrosis of femoral head, previous symptomatic hip pathology (such as arthritis), infection, a history of fracture in the studied hip, deformity of lower limb.