cyrilzakka/clinical-trials huggingface dataset:
Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis

Clinical research study that evaluates the effect of Turkish Beam-Selective UV developed by RD GLOBAL ARAŞTIRMA GELİŞTİRME SAĞLIK İLAÇ İNŞAAT YATIRIMLARI A.Ş. use into Intravascular, Intrapulmonary, Intratracial, Intrarespiratory area. Bacteria, Fungal and Virus-based pathogens systematically to collect and evaluate specific clinical performance and safety data.

This Clinical Research aims to investigate the effectiveness of the treatment group and control group mortality rates, intensive care hospitalization times, monitoring the virus load by PCR, and the treatment effectiveness of UVC application.

This Clinical Research covers determining the treatment effectiveness and reliability of UVC application to patient groups, the details of which are determined in the protocol.

DESIGN

Prospective, parallel, multicentre, randomized controlled study Ages between 40 and 75 years of age and positive symptoms such as fever, malaise, cough, and shortness of breath, or positive atypical pneumonia in CT findings or COVID-19 (SARS-CoV-2) test In the intensive care unit, which is accepted as COVID 19 infection and has been treated, patients will be treated with UVC radiation and laser beam treatment according to IKU principles in addition to Antimalarial therapy + Antiviral therapy + Anitibiotic therapy. Standard treatment consisting of Antimalarial therapy + Antiviral therapy + Antibiotic therapy will be applied to the control group. The dosage of the standard treatment consisting of antimalarial therapy + Antiviral therapy + Anitibiotic therapy, the number of days of treatment, and its active ingredient are indicated in the table.

Eligibility Criteria:
Inclusion Criteria:

* Respiratory rate ≥ 30
* Dyspnea and breathing difficulties findings
* Cases with oxygen saturation below 90% despite nasal oxygen support of 5 liters / minute and above
* Cases with partial oxygen pressure below 70 mmHg despite nasal oxygen support of 5 liters / minute and above
* PaO2 / FiO2 \<300 Lactate\> 4 mmol / L Bilateral infiltrations or multi-lobar involvement on chest x-ray or tomography
* Hypotension (systolic blood pressure \<90 mmHg,\> 40 mmHg drop from usual SKB, mean arterial pressure \<65 mmHg)
* Skin perfusion disorder Organ dysfunction such as kidney function test, liver function test disorder, thrombocytopenia, confusion Presence of immunosuppressive disease- Presence of uncontrolled comorbidity with more than one feature
* Troponin height, arrhythmia
* COVID 19 Test positivity

Exclusion Criteria:

* Under 40 years old
* Pregnant women and those with suspected pregnancy
* Those with a history of anaphylaxis
* Those with known DNA repair deficiencies:
* Those diagnosed with mental disorder,
* puerperant women and lactating women
The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level

Emotional freedom technique will be applied to menopausal women. Emotional freedom technique group, sham emotional freedom technique group and control groups each consisted of 35 menopausal women.

Objective: The aim of the study was to determine the effect of emotional freedom technique (EFT) on menopausal symptoms, quality of life and depression level.

Materials and Methods: This randomized controlled trial will be conducted with a total of 105 menopausal women at Fırat Family Health Center and Göztepe Family Health Center between January 2024 and June 2024 (35 EFT, 35 sham, 35 control). EFT and Sham EFT will be applied in the study. Women in the EFT group will receive EFT four times at one week intervals. Women in the Sham EFT group will receive Sham EFT four times with one week intervals. Before the applications, pre-test data will be obtained by filling out the Personal Information Form, Perimenopausal Depression Scale, Menopause Specific Quality of Life Scale and Menopause Symptom Assessment Scale before the application of Emotional Freedom Technique. After the applications, post-test data will be obtained by filling out the Perimenopausal Depression Scale, Menopause Specific Quality of Life Scale and Menopause Symptom Assessment Scale. In addition, the Subjective Units of Experience (SUE) scale will be applied before and after each EFT intervention.

Eligibility Criteria:
Inclusion Criteria:

* A person who has gone through menopause naturally,
* No menstruation for the last one year,
* Literate,
* Not taking Hormone Replacement Therapy,
* No oncologic disease,
* No infection, wound, scar in the tapping areas,
* Women who are able to communicate will be included in the study.

Exclusion Criteria:

* One who has not gone through menopause naturally,
* Illiterate,
* Receiving Hormone Replacement Therapy,
* Women with conditions such as infections, wounds, scars in the tapping areas.
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients at least 20 years of age
* Patients with diagnosed primary cancer
* Patients with metastatic lesions by CT/MRI

Exclusion Criteria:

* Patients who have contraindication to the MRI examinations
* Patients who have severe renal disorder
* Patients in extremely serious general condition
68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19

The goal of this observational study is to investigate the role fibroblasts play in the persistent respiratory complaints after a COVID-19 infection. Fibroblasts are involved in tissue remodeling and repair by creating scar-tissue (fibrosis) after tissue damage has occurred. The hypothesis is that this process of fibrosis is ongoing in patients with persistent complaints. To evaluate the roll of fibroblasts a new type of scan is used that is capable of imaging active fibroblasts, a 68Ga-FAPI PET/CT scan.

Rationale: The pathogenesis of post-acute COVID-19 with respiratory complaints remains unknown. We aim to explore the pulmonary pattern and fibrosis activity in patients with post-acute COVID-19 with respiratory complaints using 68Ga-FAPI Positron Emission Tomography-Computed Tomography (PET/CT) imaging.

Objective: To relate pulmonary fibroblast activity, measured by FAPI-PET/CT at least 3 months after hospital discharge, to interstitial lung abnormalities on high resolution CT (HRCT) at the same time point in post-acute COVID-19 patients with respiratory complaints.

Study design: This is a ZonMw funded single center prospective observational cohort study of post-acute COVID-19 patients with respiratory complaints.

Study population: We will recruit 20 adult patients, all post-ICU or post High-Flow Nasal Oxygen therapy due to there COVID-19 infection, with post-acute COVID-19 and respiratory complaints that will undergo 68Ga-FAPI PET/CT imaging to establish pulmonary fibrosis activity.

Main study parameters/endpoints: To assess the degree of Fibroblast Activation Protein expression on 68Ga-FAPI PET/CT at least 3 months after hospital discharge and to relate this to interstitial lung abnormalities on HRCT at the same time point.

Eligibility Criteria:
Inclusion Criteria:

* Male patients \>18 years and female patients \>20 years discharged from hospital after PCR-confirmed COVID-19 infection.
* Previous ICU or ward admission with high flow nasal oxygen (HFNO) or mechanical ventilation.
* Persistent respiratory complaints (shortness of breath) at least 3 months after hospital discharge.

Exclusion Criteria:

* Inability or unwilling to give informed consent.
* History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
* Severe or significant comorbidity, defined as COPD GOLD stage II or higher and/or known interstitial lung disease.
* Women who are pregnant or breastfeeding.
Real-time Amino Acid Profiling

This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 and ≤80
* BMI ≥20 and ≤32 kg/m2
* Non-smoking
* Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.
* Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
* Veins suitable for cannulation (blood sampling)
* Voluntary participation
* Having given written informed consent
* Willing to comply with study procedures
* Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
* Accept disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

* Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study
* Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
* Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
* Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (\> 7 mmol/l in finger prick blood) as assessed during screening visit
* For men: Hb \<8,5 mmol/l as assessed during screening visit; for women: Hb \<7,5 mmol/l.
* Use of protein supplements
* Mental status that is incompatible with the proper conduct of the study
* A self-reported reported food allergy or sensitivity to dairy ingredients
* Alcohol consumption for men \> 28 units/week and \>4/day; for women: \>21 units/week and \>3/day
* Reported unexpected weight loss or weight gain of \> 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period
* Reported slimming or medically prescribed diet
* Recent blood donation (\<1 month prior to Day 01 of the study)
* Not willing to give up blood donation during the study
* Personnel of NIZO food research and FrieslandCampina, their partner and their first and second degree relatives
* Not having a general practitioner
* Not willing to accept information-transfer concerning participation in the study, or information regarding his or her health, like laboratory results and eventual adverse events to and from his general practitioner
Neonatal Seizure Registry - Developmental Functional EValuation

The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.

Neonatal seizures due to brain injury (acute symptomatic seizures) are associated with high risk of neurodevelopmental disability in infancy. Although prognosis in early childhood is a critical question for parents and providers, outcomes beyond infancy are largely unknown. Further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development.

The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants enrolled at one of nine sites across the USA. Participants will be evaluated using developmental questionnaires and in-person neurodevelopmental testing. Parent well-being will be assessed at each time point.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in NSR-II
* Alive at the start of the NSR-DEV study period
* Parent(s) who are English or Spanish literate (with assistance of interpreter)

Exclusion Criteria:

* Neonates who were found to have exclusion criteria after NSR-II enrollment
* Risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to: inborn errors of metabolism, fetal infection, brain malformation)
* Transient cause for seizures (e.g., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging)
* Neonatal-onset epilepsy syndromes
Cognitive, Psychological, and Physical Functioning in Long-COVID Patients With Different Levels of Fatigue.

Post COVID-19 usually occurs 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Patients report a range of disabling symptoms such as fatigue, shortness of breath, cognitive impairment, memory loss and mental health and employment issues. This clinical heterogeneity complicates the identification of the appropriate needs and care.

The aim of this cross-sectional study is to identify subgroups (clusters) of post COVID patients based on clinical symptoms, demographic characteristics, levels of fatigue and physical, cognitive and psychological functioning of the individuals.


Eligibility Criteria:
Inclusion Criteria:

The participant must report current persisting symptoms (such as brain fog, anxiety, shortness of breath, headaches but also others) and indicate on the Post COVID-19 Functional Status Scale that these have an impact on everyday functioning (grade 2, 3, and 4). These symptoms need to be present for more than two months.

Further inclusion criteria are:

* Fatigue Severity Scale (FSS) score \> 4
* Aged over 18 years old
* Willing to sign the digital informed consent
* Dutch speaking and Dutch understanding
* Be tested positive for COVID-19, i.e. by reverse transcription polymerase chain reaction (RT-PCR), computed tomography (CT) of the lungs, or symptom-based diagnosis by the general practitioner.

Exclusion Criteria:

* Pregnant women
* Pacemaker, defibrillator
* Brain or nerve disorders
* Epilepsy
* A copper spiral or recent bone fracture
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1

The investigators propose to evaluate Suicide Assessment and Follow-up Engagement: Veteran Emergency Treatment (SAFE VET) which is currently being implemented in 4 VA ED/Urgent Care Units across the United States (Portland VA Medical Center (VAMC), Denver VAMC, Manhattan VAMC, and Philadelphia VAMC).

Background: In 2009, a novel clinical demonstration project entitled Suicide Assessment and Follow-up Engagement: Veteran Emergency Treatment (SAFE VET) was initiated as a potential standard of care for suicidal Veterans who receive treatment at Veterans Affairs (VA) emergency departments (ED). SAFE VET is designed to attenuate suicide risk by helping Veterans manage suicidal thoughts and behaviors, and adhere to prescribed clinical care; thereby promoting resiliency and increased capacity to cope with suicidal states.

Objectives: Using a quasi-experimental design, the aim of this study is to compare the effectiveness of the SAFE VET intervention versus enhanced usual care (E-CARE)on the following: 1) the proportion of patients who attempt suicide within 6 months of index emergency department (ED) visit; 2) the severity of suicide ideation within 6 months after index ED visit; 3) the proportion of patients who attend \> 1 outpatient mental health or substance abuse treatment appointments within 30 days following index ED visit; and 4) the degree of suicide-related coping for attending treatment during the 6 month period.

Methodology: Six hundred Veterans, up to 300 per condition (SAFE VET or E-CARE), who meet inclusion/exclusion criteria will be enrolled. E-CARE sites are as follows: Long Beach VAMC, Bronx VAMC, Milwaukee VAMC, and San Diego VAMC. All subjects will participate in an approximately 1-hour long baseline assessment battery (index ED visit) by phone, and will be contacted by phone at approximately 1, 3, and 6 months after the index ED visit to complete follow-up measures. Medical records will also be reviewed to determine VA health service usage in the six-month period after study enrollment.

Eligibility Criteria:
Inclusion Criteria:

Veterans will be enrolled who:

1. have received the SAFE VET intervention in VA SAFE VET EDs or treatment-as-usual in E-CARE EDs;
2. aged 18 years or older;
3. identified as being at risk for suicide based upon presenting complaints and/or the assessment of an ED clinician;
4. able to provide 2 contacts with telephone numbers for tracking purposes; and
5. able to provide a home/residential/shelter address where the participant resides and either a home, cellular, or other telephone number where the participant can be reached.

Exclusion Criteria:

Veterans will not be enrolled if they are:

1. unable to read and understand English;
2. unable or unwilling to give informed consent as determined either by the referring VA ED clinical staff or research personnel (see Mini Quiz below); and/or
3. admitted to the VA inpatient psychiatric unit from the ED.
From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.

With the risen popularity of low-dose computed tomography (LDCT) for lung cancer screening, many patients present with peripheral pulmonary ground-glass nodules (GGNs) with a suspicious solid part. The appropriate diagnostic and management strategy for those lesions can be questionable. If malignancy is suspected, a surgical biopsy with the guidance of various localization methods available is recommended.

Each localization method has its advantages and disadvantages. Therefore, it may not be possible to establish a gold standard for localizing indeterminate lung nodules since comparative clinical trials are lacking.

The management of pulmonary ground-glass nodules (GGNs) may be different. If GGN is an incidental finding through LDCT, the lesion should be followed according to the current guidelines. It is recommend a multidisciplinary team discussion to be initiated if a new solid component develops or the solid portion size grows on follow-up CT as the risk of malignancy is high. Attempts to preoperatively biopsy solid components in part-solid GGNs are often not feasible and not helpful in clinical settings. Currently, if malignancy is suspected, a surgical biopsy with the guidance of various localization methods is recommended. If malignancy is confirmed, sub-lobar resection may provide an excellent oncologic outcome.

The LungVision system is a novel augmented-fluoroscopy-based real-time navigation and guidance technology for bronchoscopy that can enable real-time visualization and localization of pulmonary nodules.

In this study, all patients over the age of 18 will be enrolled in case of finding of lung GGNs with the presence of a solid part inside\> = 6 mm or with a solid part even less than 6 mm but with an increase in size. These must be subject to surgical treatment for both diagnostic or therapeutic purposes. These nodules must have a bronchus sign inside. In these patients, a bronchoscopy under general anesthesia with oro-tracheal intubation with LungVision system and r-EBUS will be performed to select the area to mark with fiducial marker. After fiducial marker placement, a CT scan will be performed to control the position of fiducial marker compared to the lesion. Patients will subsequently undergo surgical treatment by using intraoperative ultrasonography to detect the position of fiducial marker in the completely deflated lung. The correct positioning of the fiducial marker compared to the lesion and the complete surgical excision of the target lesion will be evaluated on the surgical specimen.

Eligibility Criteria:
Inclusion Criteria:

* all patients over the age of 18;
* lung GGNs with the presence of a solid part inside \> = 6 mm or with a solid part even less than 6 mm but with an increase in size;
* subjects evaluated for surgical treatment during multidisciplinary tumor board.

Exclusion Criteria:

* Patients not eligible for surgery
N-Acetyl Cysteine After Cervical Cerclage

The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy outcome in women undergoing cervical cerclage for cervical insufficiency.

A randomized controlled clinical trial to be carried out in a university-affiliated tertiary center.Participating women will be randomized into two groups: Group A will be given an oral daily dose of 0.6 g of NAC in effervescent form; group B, serving as controls, will not receive NAC.The two groups will then be compared according to pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

* women with history suggestive of cervical insufficiency together with ultrasound findings suggestive of cervical insufficiency undergoing elective cervical cerclage between the 11th and 12th gestational week.
* singelton viable fetus

Exclusion Criteria:

* women tested positive for bacterial vaginosis
* women currently with threatened abortion (vaginal bleeding or uterinecramps)
* age older than 35 years or younger than 20 years
* unwillingness to participate
* irregular and/or uncertain menstrual dates
* rupture of membranes
* previous cesarean delivery
* possible risks for preterm birth in the current or previous pregnancy such as twin pregnancy, IUFD, malpresentation, known fetal anomaly, progesterone or heparin treatment during the current pregnancy, hypertension, and/or seizure disorders.
* women with contra indications for cervical cerclage or anesthesia.
High Flux Hemodialysis Thrice Versus Once

To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.

This study will be conducted in the HD center at NTUH. Patients undergoing chronic HD for at least 6 months will be evaluated for eligibility. Patients with previous adverse reactions to FX series dialyzer will not be included in this study. Detailed demographic physical characteristics of the participants will be recorded, including age, gender, underlying diseases, blood pressure, intradialytic complications, as well as indices of nutrition, inflammation, and dialysis adequacy. Eligible patients will first undergo a 4-week run-in HD with conventional-flux dialyzer twice weekly plus high-flux dialyzer once weekly (i.e., basic formula), followed by random allocation into two separate groups. Patients in group A will continue HD with the basic formula, while those in group B will receive HD using high-flux membranes thrice weekly. Three months later, all participants will be put back on HD with basic formula for 1 month (wash-out period). Group A patients will then be switched to receive HD with high-flux membranes thrice weekly, and group B patients will be changed to undergo HD with basic formula for another 3 months. Laboratory tests will include monthly biochemistry and hemogram, plus blood and urine specimens taken on 4 occasions before and during the study (baseline, end of the first 3 months, end of wash-out, and end of the second 3 months) to investigate selective markers and indices for nutrition, inflammation, and dialysis adequacy.

Eligibility Criteria:
Inclusion Criteria:

1. ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
2. Age: 18\~80 years old.
3. Blood flow during dialysis ≧ 250ml/min

Exclusion Criteria:

1. Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
2. Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
3. Bacteremia, myocardial infarction or stroke in previous 3 months.
4. Known diagnosis with dialysis related amyloidosis