cyrilzakka/clinical-trials huggingface dataset:
The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients

This is a prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in nasopharyngeal carcinoma patients.

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Radiotherapy (RT) and chemotherapy are the mainstays of therapy for NPC because these tumors are biologically highly radiosensitive and chemosensitive. Anxiety and depression symptoms were common psychological symptoms around the time of cancer diagnosis and were often persistent during cancer treatment. Psychological symptoms are associated with prolonged hospital stays, lower quality of life, and worse treatment adherence among patients with cancer. Depressive symptoms have been demonstrated to predict early mortality among patients with some kinds of cancer. But among NPC patients, the influence of anxiety and depression symptoms to long term survival have not be explored. Therefore, this prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in NPC patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* Age between 18-70
* Male and no pregnant female
* Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Pregnancy or lactation
* Patient with severe medical condition
Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries

To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia.

Hypothesis:

1. NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery.
2. Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks.
3. Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.

Optimal perioperative pain management is important not only for patient satisfaction but also for hemodynamic stability and effective restitution. Despite being the principal element of anaesthesia, analgesia delivery has long been based on non-objective surrogate parameters such as blood pressure and heart rate. This may lead to hemodynamic inconsistency, poor restitution and patient dissatisfaction, which are some of the observed challenges. In that context, there has long been a search for a monitor which can guide the meticulous administration of analgesics. Recently, a nociception level monitor (NOL) based on an advanced software algorithm was developed using multiple physiological parameters. It offers an objective number (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. With the availability of NOL monitors, a meticulous adjustment in the administration of opioids became a possibility. Therefore, the investigators are planning a randomised study to investigate if opioid consumption can be reduced and if immediate and long-term postoperative complications can be minimised.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection

Exclusion Criteria:

* Inability to give consent,
* atrial fibrillation,
* local anesthetic allergy,
* lumpectomy converted to Mastectomy.
Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?

The study was to evaluate the long term effects, over one year, of five airway clearance techniques used by people with cystic fibrosis (active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one second (FEV1)and the null hypothesis was that there are no differences among the regimens.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis (genotype or sweat sodium concentration greater than 70 mmol/litre)
* Forced expiratory volume in one second greater than or equal to 25% predicted, on assessment for entry to the study.

Exclusion Criteria:

* Evidence of a current respiratory exacerbation (Thornton et al 2004)
* Current severe haemoptysis
* Past history of pneumothorax
* Awaiting lung / heart-lung transplantation
* Pregnancy
* Recent (within 3 months) acquisition of Burkholderia cepacia
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

This study is a multi-center, open-label, dose escalation and expansion study of RLY-1971 in subjects with advanced or metastatic solid tumors.

Dose escalation/dose expansion study to assess the MTD, safety, tolerability, PK and preliminary anti-tumor activity of RLY-1971. Approximately 70 patients

Eligibility Criteria:
Inclusion Criteria:

Subject is willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures Subject is a male or female subject ≥18 years of age at the time of consent Subject must have an ECOG PS ≤ 1 Subject must have histologically or cytologically confirmed advanced or metastatic solid tumor Subjects who are refractory to FDA-approved, standard therapy or for which standard or curative therapy does not exist or is not considered sufficient or appropriate by the patient or Investigator Subject must have radiographically measurable or evaluable disease Subject must have recovered from the reversible effects of prior anti-neoplastic therapy, except for alopecia and ≤ grade 2 neuropathy.

Subject has adequate end organ function Subject is willing to comply with all protocol-required visits, assessments, and procedures Male and female subjects of child-bearing potential are willing to use medically acceptable methods of birth control from the screening visit through 30 days after the last dose of study medication

Exclusion Criteria:

Subjects with documented history of tumor mutations that may not be amenable to treatment with RLY-1971, including:

KRAS mutations: G12D, G12V, G13X, and Q61X BRAF V600E mutation MEK mutations Subjects with prior antineoplastic therapy within 3 weeks of Study Day 1, or 5 half-lives, whichever is shorter Subjects with prior palliative radiotherapy within 1 week of Study Day 1 Subjects who have had major surgery or trauma, or incomplete recovery from surgery or trauma, within 4 weeks of Study Day 1 Subjects with known central nervous system (CNS) metastases or primary CNS tumor that is associated with progressive neurologic symptoms or requires increasing doses of corticosteroids to control the CNS disease. If patient requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks preceding C1D1, or subject has new lesions appearing on follow up brain MRI that require CNS-directed intervention.

Subjects with a history or evidence of ophthalmic disease Subjects with a history or evidence of significant cardiac dysfunction Subjects with a history or evidence of significant gastrointestinal disease Subjects with other serious concurrent medical conditions Subject is pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy obtained within 7 days before the first dose of study treatment
Patient Outcomes in Unattended and In- Lab Polysomnography

This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.

Individuals referred to the Sleep Disorder Centre with a major complaint of snoring or, apneas or hypersomnia, with at least one additional minor concern of snoring, apneas, restless leg syndrome or insomnia, will be considered for entry into the study. Using a randomized controlled trial design, study participants will be randomly assigned to either the intervention group who will undergo a full unattended polysomnography (level 2 home sleep study) using the Prodigy portable wireless sleep monitor or in-lab polysomnography (level 1 sleep study). Other aspects of care including the clinical assessment will be equivalent between groups. A randomly assigned sleep specialist physician will make treatment recommendations to the patient based on the sleep study results and determine the need for a subsequent testing (including repeat sleep studies) as part of each patient encounter. Physicians participating in the study will receive an introduction to the Odds Ratio Product (ORP) and training on its diagnostic potential. Diagnostic confidence using a 5 point Likert scale from 10% (very unsure) to 90% (very confident) will be assessed after each sleep study review.

Eligibility Criteria:
Inclusion Criteria:

* referral for major concern of "snoring" or "apnea" or "hypersomnia" with additional minor concerns of "snoring", "apneas" "restless leg syndrome" or "insomnia"
* willing to undergo a sleep study

Exclusion Criteria:

* referrals where parasomnias, respiratory failure, narcolepsy listed as concerns
* comorbid congestive heart failure, ischemic heart disease, arrhythmia, stroke, chronic obstructive pulmonary disease/respiratory failure, patients with a BMI 50 kg/m2
* undergone a previous sleep study
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent.
* Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
* History of disabling migraine for at least 1 year.
* MIDAS score ≥11.
* Migraine onset before the age of 50 years.
* History of 3 - 8 migraine attacks per month (\< 15 headache days per month).
* Male or female, aged 18 years or above.
* Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
* Able and willing to complete an electronic diary.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Women of child-bearing potential not using or not willing to use highly effective contraception.
* Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
* History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
* History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
* History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
* History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
* History of orthostatic hypotension with syncope.
* Significant renal or hepatic impairment.
* Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.
* Known Hepatitis B or C or HIV infection.
* History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.
* Use of more than 3 doses per month of either opiates or barbiturates.
* Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)

The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple sclerosis (MS) participants.

This is a cross-sectional, multi-center, multi-national, epidemiological study to estimate the prevalence of anti-JCV antibody in MS participants. This study will provide an estimate of the prevalence of anti-JCV antibody in the MS population and will investigate inter-country differences.

Eligibility Criteria:
Key Inclusion Criteria:

* All candidates for this study must have the ability to understand the purpose of the study and provide signed and dated informed consent.
* All patients with a diagnosis of Multiple Sclerosis (MS) of any type, irrespective of their treatment, are eligible to participate once.

Key Exclusion Criteria:

* None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Impact of Physical Activity on the Postoperative Symptoms, Complications, and Quality of Life Among Lung Cancer

The purpose of this study is to examine the impact of physical activity on the postoperative symptoms, complication, and quality of life.

Non-small cell lung cancer (NSCLC) survivor is increasing as developing early diagnosis and perioperative management. Despite multidisciplinary treatment, Surgery is the primary treatment option for cure in NSCLC. The patients with lung cancer who underwent surgery have limitation of pulmonary function and high risk of co-morbidities. Perioperative physical activity has been shown to reduce symptoms and prevent complications, improve long term quality of life after surgery. But validated exercise regimen has not been established for lung cancer patients. Therefore, Evidence-based guideline focusing on lung cancer after surgery is needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with lung cancer
* Patients who are able to walk with ECOG (Eastern Cooperative Oncology Group) performance status \< 1
* Patients who understand the purpose of this study and provide the written informed consent

Exclusion Criteria:

* Patients who have difficulty for walking
* Patients with history of other cancer in the last 3 years
* Patients with neoadjuvant chemotherapy and/or radiation therapy
* Patients who are diagnosed with recurrent lung cancer or multiple cancer
* Foreigner of patients from overseas who are not able regularly participate in this study
Ureteric Jet Doppler Waveforms in Patients With Spinal Cord Injury

Urinary dysfunction is very common in individuals with spinal cord injury. The urine flowing from the collecting ducts to the renal calyx stretches the calyces. ANS controlled peristaltic contractions originate in the proximal renal pelvis and travel down the ureters, pushing urine from the renal pelvis towards the bladder. The urine bolus delivered from the kidneys through the peristaltic contraction of the ureter creates an image called ureteric jet. Using the Doppler analysis of ureteral jets, previous studies have examined the changes in the ureteric jet pattern in pathological conditions such as the diagnosis of normal ureteral physiology.

This cross-sectional study was conducted at a tertiary rehabilitation center. Eighteen spinal cord injury patients who met the inclusion criteria and 24 healthy volunteers were included in the study. The appearance of üreteric jet form and bladder wall thicknesses were obtained by urinary Doppler ultrasound both in patient and control groups. Detrusor pressure and bladder volume were measured only in patient group during urodynamic assessment.

Eligibility Criteria:
The case group

Inclusion Criteria:

* With signs of upper motor neuron lesion,
* Suprasacral spinal cord injury,
* Normal urinary ultrasound findings
* Planned urodynamics

Exclusion Criteria:

* Neurological disease other than spinal cord injury
* Urinary tract infection
* Urinary obstruction
* History of urinary tract Stones
* Diabetes, hypertension
* History of urinary surgery,
* Sacral injury
* Second motor neuron lesions (such as cauda equina, or cauda conus)

The control group

Inclusion Criteria:

• Normal urinary ultrasonography

Exclusion Criteria:

* Neurological disease
* Urinary tract infection
* Urinary obstruction
* History of urinary tract Stones
* Diabetes, hypertension
A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management

This is a randomized, double blind, placebo-controlled, single dose study to assess the safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \>= 20 years of age at Screening
* Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
* American Society of Anesthesiology Physical Class 1 - 3
* Adequate clinical lab values (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator.
* Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires

Exclusion Criteria:

* Body weight less than 40 kg.
* Concurrent fissurectomy.
* Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
* Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
* History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
* Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg.
* Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery.
* Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week before screening visit.
* Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery.
* Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period.
* Contraindication to epinephrine or any of the pain-control agents planned for postoperative use.
* Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration.
* Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance.
* Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial.
* Any clinically significant event or condition may be uncovered during surgery.
* History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years.
* Known history of anti-HIV antibody positive
* Failure to pass drug and alcohol screen.
Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Total Knee Arthroplasty

To compare the adequacy of exsanguination in the surgical field between the use of the Esmarch bandages elevation and the simple leg elevation.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee

Exclusion Criteria:

* There are deep vein thrombosis and pulmonary embolism
* There are bleeding disorder,hypercoagulability,peripheral arterial disease and chronic venous insufficiency
* Take blood clotting pills
* Have had total knee arthroplasty
* BMI \> 30
Characteristics of TraceTogether Users

In this protocol, we seek the understand the demographics of individuals who have used the TraceTogether mobile application. Little is known about the group of individuals who are more likely to utilise the application. Hence, this study hopes to: (1) Understand the demographics of Singaporeans who use and do not use TraceTogether, (2) Identify other behavioural habits of people who do use TraceTogether, (3) Determine if confidence in government would have any effect on TraceTogether usage


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years
* Has stayed in Singapore for at least 2 years

Exclusion Criteria:

* Below 21 years
* Has stayed in Singapore for less than 2 years
Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes

This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.

This study tests the effects of a 12-week mindful self-compassion (MSC) program in people with type 1 diabetes. Eighty participants will be randomized to the MSC program or be in a wait-list control group. Measures of primary outcome are self-compassion and diabetes- distress. Secondary outcomes are hemoglobin A1C, diabetes self-efficacy, stress and depression symptoms, and sleep quality. Outcomes will be measured at baseline, 12 weeks (end of the program) and 24 weeks (post program).

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes, age 18-30
* own computer or tablet with access to internet for meetings
* willingness to complete all 6 sessions

Exclusion criteria:

* history of self-harm or suicide attempt in the pat one year
* severe diabetic complications such as dialysis or blindness
* unstable depression, requiring ongoing medication adjustment within the last 3 months
* A1C \> 11%
* Severe hypoglycemia requiring emergency room visit or hospitalization in the past 6 months
* History of Diabetic Ketoacidosis requiring hospitalization in the past 3 months
* pregnant or intend to get pregnant during the study timeframe
Food Effect Study of VHX-896 in Healthy Volunteers

A single center, two-period, randomized study to evaluate the food effect of VHX-896 tablets in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female participants between 18 to 55 years (inclusive).
* Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2).
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations.
* No clinically significant medical, psychiatric or sleep disorders.

Exclusion Criteria:

* Participants with history of drug or alcohol abuse in last 12 months.
* Participants who suffered from significant physical illness in the 4-week period preceding baseline.
* Pregnant or nursing (lactating) women.