cyrilzakka/clinical-trials huggingface dataset:
A Study of Outcomes in Patients With Fractured Neck of Femur During the COVID-19 Pandemic

In early 2020 the evolving COVID-19 Pandemic provided the world and medical community with a generational challenge. As a novel disease, countries were left with strategic decisions and many went into social lockdown. Initial resources and research were directed at upscaling internal medicine and intensive care services, understanding the disease pathophysiology, and testing treatments. It soon became evident that COVID-19 had multi-system effects at it's worst. In orthopaedics one of the most vulnerable groups to COVID-19 were the elderly, specifically those who suffered fractured neck of femur at this time. More literature is needed urgently if we are to understand and mitigate the negative impacts in this group of patients. This observational study assesses the early morbidity and mortality of patients with this diagnosis during the evolving COVID-19 Pandemic.

Many elderly patients admitted to hospitals during the evolving COVID-19 pandemic after falls or being generally unwell, were considered to have a possible diagnosis of COVID-19. This was extremely relevant to the subgroup of patients who suffered from fractured neck of femurs during this time, with most of them elderly, frail, and more likely to have multiple co-morbidities. COVID-19 was considered a precipitating factor for falls, but also anecdotally, an indicator of potentially poor recovery and rehabilitation.

With regards to orthopaedic and trauma surgery, a limited amount of literature is available pertaining to COVID-19 and specifically it's potential effects on patient outcomes in patients requiring surgery.

We performed a multi centre observational study across London, United Kingdom, looking at the demographics and details of patients admitted with fractured neck of femur during the evolving pandemic. All data collected was non identifiable. Data was also collected as to the COVID-19 status of these patients, either positive or negative. Data was analysed to assess the morbidity and mortality of this patient group and search for any prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Fractured neck of femur
* Received operative intervention for fractured neck of femur

Exclusion Criteria:

* open fracture
* fracture of femoral shaft
* periprosthetic fracture
* revision surgery
Ultra Sound Guided Genicular Nerves Cooled Radiofrequency Ablation in Total Knee Replacement Surgeries

Total Knee Replacement surgery is common procedure that is usually done for patients suffering from persistent pain with limitation of movement. Unfortunately, they do suffer after the operation as it is associated still with significant pain that affect the rehabilitation plan, hospital length of stay, life style and patient satisfaction. New approaches are rising every day to add to the multimodal management plan. Genicular nerves cooled radiofrequency ablation is a new approach that can be simply done U.S. guided with little side effects, if any, and great results.

the study measures the efficacy of genicular nerves cooled radiofrequency ablation in enhancing quality of rehabilitation in patients undergoing total knee replacement

Eligibility Criteria:
Inclusion Criteria:• Undergoing a scheduled unilateral total knee replacement surgery

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Exclusion Criteria:

* • Allergy to any of the drugs used in the study

  * Alcohol or drug abuse
  * Psychiatric disease
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease

Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.

The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.

Eligibility Criteria:
Inclusion Criteria:

* . Patients undergo spinal anesthesia
* . Over 20 years of age

  * Patients who are competent to understand the study and provide written informed consent.

Exclusion Criteria:

* Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis)
* Refuse participated in this study or pre-existent neurological disease.
* Patients with advanced tumor staging (stage 3 or 4).
Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing

The hypothesis was that a one-year experience of choir singing once a week is more beneficial than group discussions to saliva concentration of testosterone.

The project aimed to study the health effects of regular choir singing for persons who are in a psychosomatic condition (Irritable Bowel syndrome - IBS). A group of IBS patients were randomized to choir singing or an information group were followed during one year with biological and psychosocial assessments. The choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material "To live with IBS" for home studies. At the same time a comparison group with IBS patients meet in groups, studying and discussing on the same materials under the direction of a group leader. Both groups meet once per week.

Eligibility Criteria:
Inclusion Criteria:

* IBS according to physician certificates.
* Wish to start choir singing but no such experience during past ten years.
* Acceptance of randomisation condition.

Exclusion Criteria:

* No serious somatic diseases.
* No abuse of alcohol or drugs.
* No ongoing acute psychiatric condition.
Augmentation in Tx-resistant OCD: an Open Label Trial

This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.

A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 19-55 years of age
* have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
* SSRI resistant patients with OCD
* Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
* Signed written informed consent prior to entering any study procedures.
* Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit

Exclusion Criteria:

* Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
* Patients with concurrent DSM-IV diagnosis of mental retardation
* Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
* Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
* Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
* Patients with score of less than 16 on Y-BCOS during screening.
* Patients with history of intolerance or hypersensitivity to acamprosate.
* Patients based on history or mental status exam have significant risk fo committing suicide.
* Patients who are homicidal or violent.
* Patients with severe renal impairment
* Female patients who are pregnant or lactating
* Subjects with history of psychosurgery for OCD
Vitrous Analysis in Proliferative Diabetic Retinopathy

Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy

To analyse and compare vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* proliferative diabetic retinopathy with vitreous hemorrhage

Exclusion Criteria:

* vitreous hemorrhage of other cause than proliferative diabetic retinopathy
* previous vitrectomy
Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma

The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and to reveal the best diagnostic imaging time of 68Ga-FAPI-46 PET/CT.

Participants with breast carcinoma will undergo contemporaneous 18F-FDG and 68Ga-FAPI PET/CT. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT will be calculated and compared to evaluate the diagnostic efficacy. In addition, best diagnostic imaging time of 68Ga-FAPI-46 PET/CT will be evaluated at 10th, 30th and 60th minute scan time.

Eligibility Criteria:
Inclusion Criteria:

* adult participants (aged 18 years or order);
* participants with newly diagnosed breast carcinoma;
* pathology confirmed by lesion tru-cut biopsy;
* participants who were able to provide informed consent.

Exclusion Criteria:

* participants with non-malignant lesions;
* participants with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
ASPIrin in Reducing Events in Dialysis ( ASPIRED )

People with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (CV) disease compared with the general population. A cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (ESKD). At the same time, this population has increased risks of clotting as well as bleeding episodes. While aspirin is known to reduce cardiovascular complications in the general population, evidence to support the use of aspirin in people with ESKD receiving dialysis therapy is currently lacking. The ASPIrin to Reduce Event in Dialysis (ASPIRED) trial will test whether aspirin use in dialysis patients safely improves outcomes compared with no aspirin use.

ASPIRED is an investigator-initiated, multi-center, double-blind, parallel group, event-driven, pragmatic, registry-based randomized controlled trial that will define the value of low dose aspirin (100 mg daily) on cardiovascular events in people with ESKD receiving dialysis.

The study will be conducted using the existing platform of the Chinese peritoneal dialysis (PD) and hemodialysis (HD) Dialysis Registry to screen, recruit and to collect study data as part of patient's routine clinical care during dialysis to improve efficiency and to minimize cost of a clinical trial.

ASPIRED is an event driven trial with an anticipated duration of approximately 5 years.

Randomization will be performed using a web-based system via a pass word protected encrypted website interface.

The study procedure utilizes routine six-monthly clinic visits for study follow-up to increase efficiency and minimize the burden on participants.

The analysis will be based on intention-to-treat principles. An independent Data Safety and Monitoring Board (DSMB) will established to monitor the study for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry.
* An expectation of ongoing maintenance dialysis requirement.
* Willing and able to provide informed consent for this study.

Exclusion Criteria:

* Requirement for any form of antiplatelet agent (aspirin, glycoprotein IIb/IIIa inhibitors etc), or oral anticoagulation (warfarin, NOACs), in the view of the treating physician.
* Contraindication to aspirin, in the view of the treating physician.
* Dialysis requirement due to acute kidney injure with expectation of kidney function recovery.
* History of haemorrhagic stroke or intracranial bleed within 12 months of screening.
* Coagulopathy from any cause.
* Unable to provide informed consent.
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 32 weeks
* birth weight \< 1500 grams
* mother is English speaking
* mother is \> 18 years of age.

Exclusion Criteria:

* Congenital anomalies of the face, lungs, or gastrointestinal system
* not expected to survive
Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects

This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.


Eligibility Criteria:
Selected Inclusion Criteria:

* Age 21 years or older at randomization
* Heart failure with at least one of the following signs of current fluid overload:

  1. Peripheral (or sacral) edema \>1+ or ascites during screening or on day of randomization
  2. Pulmonary congestion as determined by chest X-ray during the screening period
* Ambulatory and able to perform the 6-minute walk test

Selected Exclusion Criteria:

* Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening
* Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening
* Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation
* Heart transplant recipient, or anticipated need for transplant or LVAD during study participation
* Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator
Role of the Kallikrein-kinin System in Septic Cardiomyopathy

The purpose of this study is to investigate whether there are differential expressions of molecules in the kallikrein-kinin system (KKS) pathway in septic cardiomyopathy, and to analyze their regulatory mechanisms and gene expression changes.

This study is designed as a prospective, single-center, prospective case-control study. The research plan mainly aims to collect clinical data and blood samples from patients with septic cardiomyopathy and the control group within the next 3 years (October 2023 to October 2025). Diagnostic criteria are as follows: (1) Diagnosis of sepsis is based on the SEPSIS 3.0 criteria, which is defined as a rapid increase in SOFA score by ≥2 points after infection as a clinical criterion for sepsis-related organ dysfunction. (2) Diagnostic criteria for septic cardiomyopathy include: diagnosis of sepsis and elevation of cardiac markers \[cardiac troponin I (cTnI) or BNP\]; systolic dysfunction: echocardiography shows LVEF \< 50%; diastolic dysfunction: Doppler ultrasound shows an E/A ratio (rapid filling phase/atrial contraction phase) ≤1 at the mitral valve; BNP \> 200 pg/mL; left ventricular fractional shortening (FS) \> 25%; normal or increased wall thickness, decreased left ventricular filling rate.

Eligibility Criteria:
Inclusion Criteria:

(1) Age range greater than 18 years. (2) Patients diagnosed with septic cardiomyopathy. (3) Clear determination of the cause of myocardial injury, such as the source of infection, bacterial culture results, etc. (4) Patients who are capable of cooperating and completing the necessary examinations and treatments.

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Exclusion Criteria:

(1) Presence of other significant underlying cardiovascular diseases, such as coronary heart disease, heart failure, etc. (2) Presence of other organ dysfunction that poses a significant threat to life, such as respiratory failure, liver failure, etc. (3) Presence of severe infections or inflammatory diseases unrelated to myocardial injury, such as severe acute pancreatitis. (4) History of receiving interventional treatments, such as immunomodulatory agents, anti-inflammatory drugs, etc. (5) Pregnant or lactating women. (6) Pediatric patients who are under the age of majority.

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Distal Venous Arterialisation of Ischemic Limb

Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.

The aim of this study was to estimate validity of distal venous arterialisation (DVA) as a limb salvage procedure. This prospective randomized study reported early results of 30 unreconstructible patients with critical limb ischemia (CLI) treated during 2009 year at Clinic for vascular surgery, Clinical Center of Serbia in Belgrade. Patients were divided in two groups, 10 treated with DVA and 20 conservatively (CT) using antiplatelet drugs.

Eligibility Criteria:
Inclusion Criteria:

* Absence of any possibility for direct revascularisation due to extensive occlusive disease of crural and pedal arteries
* Sufficient deep venous system and usable great saphenous vein as a graft for in situ bypass surgery according duplex scanning
* localized infective of necrotic process up to the metatarsal level
* Satisfactory general patient condition

Exclusion Criteria:

* advanced lower limb ischemia
* venous insufficiency of lower limb
A Self-Help Method for Nightmares

The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from Nightmares
* Access to internet
* A valid e-mail address
* Be able to understand Dutch

Exclusion Criteria:

* Severe posttraumatic complaints
* Severe depression
* High anxiety ratings
* In therapy for post traumatic stress disorder
* Being suicidal
* Schizophrenic or having a psychosis episode
Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.


Eligibility Criteria:
Inclusion criteria

1. patient is over 18 years
2. ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy
3. Karnofsky score \> 60
4. Life expectancy \> 4 months

Exclusion criteria

1. Any of following conditions (mentally incapacitated or emotional or psychiatric disorder, user of any illicit drugs, has an active infection, hypersensitivity to ramosetron or aprepitant)
2. Patients have received a nonapproved drug within last 4 weeks
3. abnormal laboratory values (AST \> 2.5 normal, ALT \> 2.5 normal, Bilirubin \> 1.5 normal, Creatinine \> 1.5 normal)
4. Antiemetic drugs within 48 hours of study
5. Benzodiazepine or opiate within 48 hours
6. CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
7. CYP3A4 inhibitors (clarithromycin, ketoconazole)
8. CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)
Association of Psychological Distress in Patients With Lung Cancer

Psychological distress is a multi-factorial experience of a psychological, social, spiritual, and/or physical nature that may interfere with one's ability to cope effectively with cancer, physical symptoms and treatment. Psychological distress is common and affects the efficacy and prognosis of patients with lung cancer. The systematic anti-tumor therapy may effectively relieve psychological distress including anxiety, depression, and fatigue in patients with advanced lung cancer, the relief of the psychological distress can in turn improve the therapeutic effect.

In summary, this study is to explore the associations of (dynamic) psychological stress with the efficacy and survival of anti-tumor therapy including immunotherapy and targeted therapy for advanced lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of lung cancer
* 18 years of age or older
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Not willing to participate in this clinical trial