cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
Ribose and Sport Performance

Investigate the acute effect of ribose supplementation on performance and recovery in athletes.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Training volume \> 7hrs/week
* VO2 max \> 40 and 45 mg/kg/min (for women and men respectively)
* Otherwise healthy individuals

Exclusion Criteria:

* Pregnant or breastfeeding women
* Individuals with endocrine disorders, hypercholesterolemia, cardiovascular diseases, gut diseases, cancer, anemia, hypoglycemia
* Medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood disorders
* Excessive alcohol consumption (more than two drinks by day for men, one for women), smoking, drug use, supplements or natural products consumption during the study
Role of Endocrine Disruptors in Thyroid Cancer

the relationship between human exposure to EDCS and TC is poorly investigated and still unclear. The aim of this study is to evaluate the possible role of old and new generation endocrine disruptors in thyroid cancer. The primary aim is to evaluate the difference in the average levels of the main endocrine disruptors (PFAS, including: PFOA, PFOS, PFDA, PFUnA, PFHpS and possibly subsequently other categories, such as bisphenols, phthalates, parabens, PCBs, flame retardants) between patients with and without a diagnosis of thyroid cancer through highly sensitive, selective and precise mass spectrometry methods, such as liquid chromatography combined with tandem mass spectrometry (LC-MS / MS).

The secondary aim is to evaluate the relationship between the concentrations of endocrine disruptors and some anamnestic variables studied (for example the type of diet, the use of personal care products).


Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of thyroid cancer in the last 5 years (arm A)
* patients without a diagnosis of thyroid cancer will match patients included in arm A

Exclusion Criteria:

* subjects under 18 years old
* patients unable to sign the informed consent or questionnaires
Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)

The aim of this study is to evaluate a new and innovative educational application based on targeted education on the adherence level for NOACs (non-vitamin K antagonist oral anticoagulants) in AF patients, compared with standard care, online targeted education and in-person targeted education.

Several other parameters (knowledge level, quality of life, symptom burden, self-care capabilities, evaluation of educational efforts) will be studied. If resources allow, cardiovascular outcomes, cost-effectiveness and cost-utility will also be investigated.

This substudy is part of the AF-EduCare study (NCT03707873): an extra study arm will be added to the main trial in which eligible AF patients (= in possession of a smartphone and capable working with their smartphone) will test this new educational application. Not eligible patients randomized to this group, will receive standard care.

This extra study arm will additionally include an anticipated 221 patients (eligible plus not eligible patients).

\[An anticipated total of 1259 AF patients will be included for the AF-EduCare study (1038 AF patients) plus the AF-EduApp substudy (221 AF patients).\]

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,...).
3. Patients who are capable to sign the informed consent.

Exclusion Criteria:

1. Not able to speak and read Dutch.
2. Cognitive impaired (e.g. severe dementia).
3. Life expectancy is estimated to be less than 1 year.
4. Ongoing participation in another clinical trial.
5. Pregnant women
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC

This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)

Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA potential clinical application in the near future. In the early stage of NSCLC, ctDNA has been indicated to identify those at high risk of recurrence after radical surgery. And this study will focus on those patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months). 10ml plasma will be collected every three months until disease progression to interrogate ctDNA by high-depth panel sequencing, exploring its prediction value about the risk of progression. Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
* General condition: ECOG score 0 or 1
* First-line monotherapy or combination immunotherapy
* The long-term benefit of immunotherapy was defined as PFS=12months
* Tumor tissue samples can be obtained at the time of enrollment, and at least 5 \~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available.
* At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard.
* Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form
* Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.

Exclusion Criteria:

* Serious primary diseases of the heart, liver and kidney
* Other malignant tumors within 3 years prior to diagnosis of NSCLC
* Women in pregnancy and lactation
* The active stage of human immunodeficiency virus (HIV) infection
* Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
* Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.
Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC)

Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a brief, theory-based, video intervention prior to standard contraceptive counseling and women exposed to standard counseling alone.

Secondary: To identify predictors of immediate postabortal LARC uptake among all participants including the role of:

* Demographic and reproductive health history variables
* Baseline decisional balance, self-efficacy and stage of change for contraceptive initiation

This is a randomized controlled trial evaluating the effect of a brief video intervention on postabortal uptake of long acting reversible contraception.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 29 Surgical abortion being performed the day of the study English speaking

Exclusion Criteria:

* Nonviable pregnancy Sexual assault Administered sedative medication Non English speaking
Patients Perspectives on Discontinuation of Their Fertility Treatment Due to the COVID-19 Pandemic

The COVID-19 pandemic brought new challenges to our nationwide healthcare system, with rapid escalation of the number of affected individuals over a handful of weeks. From March 13, a first set of measures was taken to minimise the spread of the virus, which largely impacted societal and economical daily life. A view days later, on March 17, the country was put in "lockdown" and all non-urgent medical treatments were cancelled or postponed. As recommended by the major scientific fertility societies, all non-ivf fertility treatments were discontinued abruptly, whereas started ivf stimulations were continued until oocyte aspiration, where after a freeze-all strategy was applied.

There is little information available for women aiming for pregnancy or embarking on assisted conception. Given the modelling of the pandemic, including the time to peak and subsequent tail, considerable delays in conception to substantially attenuate risk may be required, which will inevitably impact patients wellbeing and overall success rates.

A questionnaire was developed to explore patients perspectives on different aspects of their fertility treatment during the COVID-19 pandemic.

The questionnaire contains the following sections:

* demographic variables;
* questions regarding the fertility history of the respondent;
* questions regarding the impact of fertility treatment cancellation / postponing fertility treatment during COVID-19 on their life, psychological wellbeing and relationship;
* questions regarding continuing medical treatment on their own, or seeking treatment elsewhere;
* questions regarding the satisfaction of measures taken by their fertility center regarding the COVID-19 pandemic;
* questions regarding expectations of further treatments, with focus on safety issues related to the COVID-19 pandemic.

Eligible patients will be selected electronically from our database and digital agenda. After selection, patients will be contacted via email to participate. Two reminders will be send in case the questionnaire is not filled out: a first reminder after one week, a second reminder after two weeks.


Eligibility Criteria:
Inclusion Criteria:

* patients that did not start a fertility treatment yet ("intake group") OR;
* patients for which a treatment plan was made, but treatment was postponed ("before treatment") OR;
* patients who were undergoing a non-inf treatment cycle (ovulation-induction (OI), intra-uterine insemination (IUI)) and whose cycle was cancelled after starting the treatment cycle ("non-ivf treatment group") OR;
* patients who were undergoing a cryo cycle and whose cycle was cancelled after starting the treatment cycle ("cryo treatment group") OR;
* patients who were undergoing an IVF treatment cycle and for whom fresh embryo transfer was cancelled (freeze-all group).

Exclusion Criteria:

* Language other than Dutch
The Impact of a Virtual Reality Environment on Phantom Limb Pain

Phantom limb pain occurs in the majority of people who lose a limb. It significantly affects quality of life and is hard to manage. Recent evidence suggests that mirror therapy and similar techniques that create a visual representation of the missing limb under the control of the patient may reduce phantom limb pain.

The investigators previously explored the use of a virtual reality environment for this purpose with people with upper limb loss but found that using it within the clinical setting limited its potential efficacy. Phantom limb pain is highly variable and assessing the effects of the activity during a hospital appointment when the phantom pain may not be present, or may not be problematic, made it difficult to judge the effects adequately.

This study involves training the patient in the clinic to use a portable, self-contained virtual reality system which they will then use at home, unsupervised, for 2 months. The aim is to discover whether phantom limb pain intensity decreases by performing an activity in a virtual reality environment in which a visual representation of the missing limb is controlled by the patient. Participants will be directed to use the system every day, and whenever their phantom limb pain is present and problematic.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Unilateral upper limb amputee (transradial and transhumeral).
* Amputation occurred at least 6 months ago.
* Stump has fully healed and has no ulcerations present.

Exclusion Criteria:

* Amputation of digit(s) only.
* The presence of a wound, ulcer or broken skin on the residual limb.
* The presence of a psychiatric disorder.
* Have pre-existing binocular vision abnormalities.
* A history of seizures or epilepsy.
* A pacemaker or other implanted medical device that could be affected by magnets or components that emit radio waves.
* Lacking the capacity to understand the instructions on how to use the virtual reality equipment.
* Lacking the capacity to consent.
* Unable to comply with the requirements of the study.
Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.


Eligibility Criteria:
Inclusion Criteria:

* Single level osteoporotic compression fracture of thoracic and lumbar spine

Exclusion Criteria:

* Can't tolerate the postural reduction by pillow
* Pathological spine fracture caused by tumor, infection.
* Multiple spine fractures
* Patient presented with neurological. deficits
Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration of analgesia continues to be under debate. The investigators performed a prospective randomized study to evaluate the effect of perineural dexamethasone in different concentrations in postoperative analgesia in femoral nerve block for anterior cruciate ligament reconstruction.

After Ethics committee approval, 75 patients American Society of Anesthesiologists score (ASA) I-III were randomized at the end of surgery into 3 groups of 25 patients each who underwent femoral nerve block: group A with 20 ml ropivacaine 0,5% and 20 ml lidocaine 1%; group B with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 4 mg dexamethasone; group C with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 8 mg dexamethasone.

All groups received postoperative analgesia when visual analog scale (VAS) over 3 (by request), with IV Perfalgan 1 g and morphine (loading dose 0.1 mg/kg and titration until VAS under 3, followed by subcutaneous (SC) administration of 1/2 of total loading dose on demand for the following 24 hours (h) .

Efficacy was evaluated by the time interval from performing the block until the first analgesic dose required, the total amount of morphine in the first 24 h postoperative, the patient satisfaction and the neurological side effects.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* BMI\<40

Exclusion Criteria:

* High risk grade hypertension
* Chronic renal failure
* Known allergy to drugs used
* Chronic treatment with steroids
* Drugs dependency
* History of diabetes mellitus
* Ulcer or chronic gastritis
* Infection on the puncture site
* Neuropathy at the surgical level
* Coagulopathy
* Requesting another type of anesthesia
* Fear to sign informed consent
* By-pass aorto-femoral
Diagnostic Study of Temporal Arteritis

Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. It seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases.

With this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery.

Exclusion Criteria:

* Pregnancy; age \> 80 or \< 18; unable to answer study questions
Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel

The purpose of this study is to determine the effectiveness of acupuncture as a treatment for Posttraumatic Stress Disorder (PTSD) among military personnel.

Untreated Posttraumatic Stress Disorder (PTSD) leads to decreased force readiness and increased health care utilization. Yet, service members with the disorder may be resistant to traditional treatments or find them undesirable because of side-effects, stigma, and long-term commitment. Acupuncture, which has few known side effects, holds promise as an effective treatment option for PTSD. Acupuncture has been shown to improve well-being and has been successfully used to treat stress, anxiety and pain conditions. In order to test the efficacy of acupuncture for treating the symptoms of PTSD-measured by the PTSD Checklist (PCL)-a 12-week, randomized, waitlist-controlled trial will be conducted using a sample of 75 active duty military personnel. Participants will receive an eight-session acupuncture treatment, and will be evaluated throughout the study by way of clinical assessments and an independent assessing acupuncturist.

Eligibility Criteria:
Inclusion Criteria:

* Active duty military personnel
* Criteria met for PTSD based on Clinician-Administered PTSD Scale (CAPS) interview
* A stable medication dosing regimen or therapeutic treatment schedule for at least eight (8) weeks prior to beginning the study.

Exclusion Criteria:

* Acupuncture treatment within the previous 6 months
* Pain greater than or equal to level 8 on the Numeric Rating Scale for Pain
* Significant head injury with loss of consciousness greater than 1 hour
* Uncontrolled diabetes mellitus: fasting blood glucose \>180 mg/dl
* Unstable or uncontrolled endocrine disorders, thyroid disease, renal failure, anemia, hemorrhagic diathesis, renovascular disease, Cushing's disease, or hyperaldosteronism
* Unwillingness on the part of participants to complete all study visits and/or the daily Life Chart
* Pregnancy
* Scheduled surgery during the treatment phase of the study
* Medical instability sufficient to warrant inpatient treatment in the medical or intensive care units
* Psychiatric symptoms sufficient to warrant inpatient treatment by the clinical care team
* Psychosis within the past two years
* A traumatic experience, as defined by the DSM-IV criterion A for ASD/PTSD, within the past 30 days
Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis

The Connect-MS is multicentre real-world observational cohort study wherin the outcomes of standard care digital monitoring of 700 patients with multiple sclerosis (including all subtypes) are recorded over a follow-up period of two years. Patients use the MS sherpa and NeuroKeys applications. Outcomes are related to the utilisation of digital biomarkers including the adherence to digital monitoring and the impact digital outcomes have on clinical decision making, the effect of digital monitoring on healthcare consumption, and the ability of these technological biomarkers to detect clinical outcomes on the short and long term. Most recorded variables are part of the standard care, however participants of this study are also subject to additional questionnaires regarding the consumption of healthcare and the influence of digital monitoring on decision making during clinical consultation.


Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Have signed non-WMO informed consent
* Be able to comply with the study protocol, as judged by the investigator.
* Have a minimum age of 18 years.
* Have a definite diagnosis multiple sclerosis (either RRMS, SPMS or PPMS) according to the revised 2017 McDonald criteria. (Thompson et al., 2018)
* Willing and able to install and use MS Sherpa and NeuroKeys on a privately-owned cell phone.

Since this is an observational cohort study, concomitant participation in any intervention trial is allowed.
Opioid Sparing Anaesthesia for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery

In spite of multimodal analgesic strategies, which consist of opioids, dexamethasone, non-steroidal anti-inflammatory drugs, and local anesthetics applied into the surgical wound, postoperative pain and postoperative nausea and vomiting (PONV) are still common complaints reported after laparoscopic gynecological surgery.

So, it is hypothesized that the infusion consisting of lidocaine, dexmedetomidine and ketamine, as an opioid substitute was a feasible technique for laparoscopic gynecological surgery and would be associated with less incidence of PONV and lower opioid requirements in the early postoperative period.

The aim of this study was to evaluate the effect of opioid sparing technique via infusion of Dexmedetomidine, Ketamine and Lidocaine on post-operative nausea and vomiting in laparoscopic gynecological surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic gynaecological surgery, who:

  * had the American Society of Anesthesiologists (ASA) I or II physical status,
  * were 21-60 years of age

Exclusion Criteria:

* A body mass index \>35 kg/ m2
* Pregnant, breast feeding women
* Hepatic, renal or cardiac insufficiency
* Diabetes mellitus
* History of chronic pain
* Alcohol or drug abuse
* Psychiatric disease
* Allergy or contraindication to any of the study drugs
Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Macular edema secondary to BRVO
* Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
* Duration no shorter than 3 months
* Duration no longer than 12 months

Exclusion Criteria:

* Proliferations in study eye
* Blod in vitreous cavity
* Previous fundus laser treatment
* BRVO with over 180˚ of ischemia on FA
* Age under 18
* Other eye condition which contribute to relevant loss of visual acuity