cyrilzakka/clinical-trials huggingface dataset:
The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Antidepressant-like effects of tadalafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with tadalafil was shown to be PKG-dependent and lead to increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Low-dose tadalafil improved both depressive symptoms in patients with erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).

Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse Patients with concurrent active medical condition Patients with history of seizures Patients with history of receiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Cardiovascular disorders Severe renal impairment: creatinine clearance of ≤ 25 ml/min Moderate or severe hepatic impairment
A Study of Lung Cancer Screening in People with Unexplained Weight Loss

The researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for American Cancer Society lung cancer screening, as follows:

  * Age 50-80 years old
  * At least 20-pack year history of smoking
* Weight loss of 3-10%, defined as UWL, within any timeframe over the past in the 18 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator

  * Note that patients who have 3-10% weight may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts.
  * Documented weight loss can be self-reported or extracted from weights obtained during physician visits. However, if self-reported weight loss is contradicted by weight loss documented in the medical record (e.g. a patients states that (s)he lost 10 lbs in the past 6 months, but a weight documented in the medical record does not support that history), the measured and quantified weight change will be used to ascertain eligibility
* Life expectancy greater than 1 year, per assessment of the treating clinician.

Exclusion Criteria:

* Currently pregnant or trying to become pregnant via self-report
* Prior history of recent CT scan of the chest either through LDCT screening or with a scan of the chest (standard, not LDCT) performed within the past 12 months
* Prior history of NSCLC

  ○ Note that patients with a history of diagnosis of non-lung cancers are eligible for the study.
* Currently undergoing or referred for diagnostic evaluation due to clinical suspicion for malignancy (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
* Patients with a germline pathogenic genetic variant who have undergone whole body MRI within the past 12 months
* Unable to comply with study procedures
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI), (done before, during, and after treatment) may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II trial is studying how well MRI and MRSI evaluate patients who are undergoing treatment for gliomas.

OBJECTIVES:

* Determine the magnetic resonance spectroscopic imaging (MRSI) characteristics of patients who are undergoing treatment for supratentorial glioma.
* Determine the survival of patients who undergo magnetic resonance imaging and MRSI.
* Determine the clinical outcome of patients who undergo these imaging procedures.
* Correlate measures of metabolic tumor burden (i.e., CNI, CCCrI, CrNI, and LLI) with survival and clinical outcome in patients who undergo these imaging procedures.
* Determine the time to clinical progression in patients who undergo these imaging procedures.

OUTLINE: Patients are assigned to 1 of 2 treatment groups based on grade of disease.

* Group 1 (patients with grade II glioma): Patients undergo magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI). Patients then receive chemotherapy. Patients undergo repeat MRI/MRSI after courses 2 and 4 of chemotherapy.
* Group 2 (patients with grade III-IV glioma): Patients undergo MRI/MRSI and then undergo surgical resection of the tumor. Patients then receive chemoradiotherapy. Patients undergo repeat MRI/MRSI within 2 weeks and at 2 months after completion of radiotherapy.

Patients are followed for recurrence, disease progression, and survival.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed supratentorial glioma

  * Grade II-IV disease
  * Previously untreated disease
* Eligible for surgical resection and/or chemotherapy with or without radiotherapy
* Tumor accessible by magnetic resonance spectroscopic imaging

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Life expectancy ≥ 8 weeks
* Not pregnant
* No contraindication for magnetic resonance examinations, including any of the following:

  * Cardiac pacemaker or fibrillator
  * Aneurysm clip
  * Insulin or infusion pump
  * Any implant held in place by a magnet
  * Metal contamination anywhere in the body

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No prior radiotherapy
* No prior treatment for the malignancy
Carotid Artery Analysis During an LPEC Manoeuvre

Verify in ultrasound the impact of a Sellick and LPEC manoeuvre in terms of compression of the carotid artery and decrease in vascular flow.


Eligibility Criteria:
Inclusion Criteria:

* Adults Volunteers

Exclusion Criteria:

* pregnant women
* people with carotid artery defects
* people with an anomaly in the oropharyngeal massif
Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software

Chang Gung Atrial Fibrillation Detection Software is an artificial intelligence electrocardiogram signal analysis software that detects whether a patient has atrial fibrillation by static 12-lead ECG signals. This study is a non-inferiority test based on the control group. The main purpose is to verify whether Chang Gung atrial fibrillation detection software can correctly identify atrial fibrillation in patients with atrial fibrillation, and can be used to provide a reference for doctors to detect atrial fibrillation.

This study is a retrospective study, and the data is from the six hospitals of Chang Gung Medical Research Database (CGRD). We collected de-identified static 12-lead electrocardiogram (ECG) data from the database during the period of January 1, 2006, to December 31, 2019.

We created a training set and a testing set of ECG data from the CGRD. Then, we stratified and sampled ECG signals from the testing set according to the actual proportion to obtain the experimental sample.

The computer first preliminarily screened and selected ECG data that met the inclusion and exclusion criteria, and then numbered them sequentially. A cardiologist confirmed that the sampled ECG data did not include exclusion criteria.

The ECG data were converted into images and interpreted for the presence or absence of atrial fibrillation by three cardiologists. Their results were used as the gold standard (reference) for this study.

After determining the experimental standards, the ECG signals were inputted into the Chang Gung Atrial Fibrillation Detection software for analysis and interpretation of each ECG data.

After the software interpretation was completed, the results were compared with the interpretations of the physicians, and the primary and secondary evaluation indicators were analyzed accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Equal or greater than twenty years old
* Static 12-lead electrocardiogram of General Electric MUSE XML format file.
* The data comes from the static 12-lead electrocardiogram device of General Electric (model MAC5500).
* The electrocardiogram signal is 500 Hz.
* The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz.

Exclusion Criteria:

* Cases used in the model development process.
* Lacks any electrode.
* Contain any electrode lacks a segment.
* Misplaced leads
Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia

the aim of this study is to evaluate the effect of Nursing care Bundle on Oral Intake among Critically Ill Children with Post-Extubation Dysphagia

The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the children provided an informed consent. children's baseline data was collected from their records prior to intervention in order to identify children who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group, and so on, distributed the participants into two equivalent groups as fellow:

Control Group: Consisted of 30 children who will receive conventional hospital care with no additional interventions.

Study Group: Consisted of 30 children who will receive a nursing care bundle on oral intake starting the day after their successful extubation and extend for 14th days. Additionally, the participants were provided with a brief education on safe swallowing.

Eligibility Criteria:
Inclusion Criteria:

* undergoing emergency oral endotracheal intubation for at least 48 hours
* able to communicate and having no sensory deficit and accepted to participate in the research

Exclusion Criteria:

* children who had a history of neuromuscular disease, preexisting swallowing problems and agitated children were excluded.
Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients

The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.

Multiple sclerosis (MS) is one of the most common autoimmune diseases in the world. One of the complications of MS, is cognitive disorder.

In some studies on rats, stimulation of somatosensory neurons has improved the hippocampus activity by increasing the amount of acetylcholine. Hippocampus has a major role in cognition and behavior.

TENS is a non-invasive method in which the electrical pulses are sent to the body trough skin by electrodes. This device can stimulate the somatosensory neurons by electrical impulses. In several studies, the effect of TENS has been proved on short term memory and verbal fluency in patients with mild stages of Alzheimer disease. Also it has been effective on some aspects of cognition on old people suffering from forgetfulness.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed multiple sclerosis by McDonald criteria;
* score 25 or less in mini mental state examination (MMSE)

Exclusion Criteria:

* MMSE score greater than 25;
* the history of psychiatric problems;
* addiction to alcohol; head trauma; cerebrovascular disease; hydrocephalus; neoplasm; epilepsy; renal or respiratory diseases; impaired consciousness
Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.

To address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft

Exclusion Criteria:

* Non-functioning kidneys
Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.

Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.

Eligibility Criteria:
Inclusion Criteria:

1. patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
2. No prior chemotherapy was allowed.
3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
4. 18 to 60 years of age
5. Karnofsky performance status (KPS) of 60-100 points
6. Unidimensionally measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
7. Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤2 upper limit of normal \[ULN\],AST ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.
8. life expectancy of at least 12 weeks.
9. All patients provided written informed consent according to federal and institutional guidelines.

Exclusion Criteria:

1. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
2. another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix.
3. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
4. radiation therapy have not been completed 4 weeks before enrollment.
5. major surgery within the prior 4 weeks;
6. participating any clinical trial within the prior 4 weeks;
7. Pregnant or lactating women.
8. tumor involvement of major blood vessels
9. uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 6 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
10. chronic renal disease.
11. urine protein ≥ 500 mg in 24 hours;
12. prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis.
13. pulmonary embolus, or deep venous thrombosis
14. ECG: QTC ≥ 480 ms
15. Patients on therapeutic doses of heparin or antiplatelet agents.
16. Patients who received thrombolytic agents or who required full-dose anticoagulation
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant melanoma or renal cell carcinoma
* At stage IV or relapse
* At least one prior chemotherapy including targeted agents
* At least one haploidential or partially matched-HLA donor
* ECOG performance status 0-1
* Age 18-75 years
* Measurable lesion
* Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

* Chemotherapy within 4 weeks
* Stem cell transplantation
* Active CNS metastasis
* Hypersensitivity to IL-2
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe submental fat
* Dissatisfaction with submental area
* History of stable body weight
* Signed informed consent

Exclusion Criteria:

* Any medical or other condition that would affect subject safety or evaluation of efficacy
* Previous intervention in the submental area
Renal Sympathetic Denervation in Mild Refractory Hypertension

The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension


Eligibility Criteria:
Inclusion Criteria:

* Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization
* Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values)
* No change in blood pressure medication within 6 months after randomization
* Age 18 to 75 years
* Informed consent

Exclusion Criteria:

* Blood pressure outside range mentioned above
* Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
* Estimated glomerular filtration rate \<45 mL/min/1.73 m² (modification of diet in renal disease formula)
* Unstable angina pectoris
* Myocardial infarction within 6 months prior to randomization
* Planned surgery or cardiovascular intervention within 6 months after randomization
* Severe heart valve disease
* Severe comorbidities with limited life expectancy
* Pregnancy
* Participation in another trial
Helping Ease Anxiety and Depression Following Stroke

The aim of this mixed methods research is to conduct feasibility pilot testing of an existing mindfulness intervention called HEADS: UP. The intervention is designed to help people affected by stroke self-manage symptoms of anxiety and depression.

Mindfulness-based interventions are thought to help people affected by stroke (Lawrence et al., 2013). Helping Ease Anxiety and Depression (HEADS: UP) is an adapted mindfulness-based intervention for people affected by stroke (Lawrence, 2019). This study aligns with the feasibility/piloting stage of the Medical Research Council framework (Craig et al., 2008) and will optimise intervention delivery and study processes, ensuring all elements are working together, ready for testing at a later stage.

The aim of this mixed methods research is to conduct feasibility pilot testing of HEADS: UP to help people affected by stroke self-manage symptoms of anxiety and depression prior to Phase III testing in future work.

This stage is a non-randomised pilot study based in Glasgow, United Kingdom. The purpose of the pilot is to assess feasibility and acceptability of delivering HEADS: UP, and recruitment and questionnaire data collection processes; identify any additional HEADS: UP adaptions.

Eligibility Criteria:
Inclusion Criteria:

* Have had ≥1 stroke 3-60 months previously (reflects incidence of anxiety/depression)
* Interested in learning skills to help them cope with self-reported anxiety and/or depression
* Able to speak and understand conversational English
* Able to identify a family member/peer who would: like to take part, can speak and understand conversational English; not participating in another trial.

Exclusion Criteria:

* Prior MBSR attendance in the last three years (as this may confound results)
* Current participant in another trial
* Cannot follow a 2-stage command
* ≥28 on Behavioural Assessment of Dysexecutive Syndrome (BADS) scale; assesses the cognitive skills required to engage with group-based interventions (goo.gl/uumeFw)
* Hospital Anxiety and Depression Scale (HADS); screens for anxiety and depression; used extensively in Primary Care research (goo.gl/TtdDDW). A score of 8-10 suggests mood disorder; ≥11 indicates 'probable presence'. A total cut-off score of 11 achieves optimal balance between sensitivity and specificity, and will be used for family/peer participants who have not had a stroke. A lower cut-off score is recommended for stroke survivors i.e. 4 on each sub-scale.

NOTE: A current prescription for anxiolytics or antidepressants is not an exclusion criterion. If screening identifies a potential participant who requires GP referral, that individual may subsequently be prescribed medication; this is a feature of the pilot work. In a future trial, where participants are randomised to two arms and there is equal probability of people being on medication in each arm, it will not be an issue.