cyrilzakka/clinical-trials huggingface dataset:
Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics.

The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.

This is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia. The trial will entail 6 weeks of total involvement for each participant including 3 weeks of active participation, with 4 weeks follow up: the irrigation happens at the beginning of week 2, so 4 weeks later is week 6.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old with ability to comprehend and consent to protocol.
* Diagnosis of fibromyalgia by American College of Rheumatology (ACR) criteria (questionnaire).
* At least a 4/10 baseline on the visual analogue pain scale (VAS).
* Stable fibromyalgia medications for at least 4 weeks.
* Owns or has access to a smart phone or computer to complete outcome measures.

Exclusion Criteria:

* Use of opioids
* Otitis externa or media within the past six months.
* Current ear pain with or without other symptoms of otitis externa.
* History of tympanic membrane rupture or surgery.
* Current pregnancy.
* Inability to lay supine for 30 minutes.
* Limited decision making capacity.
* Engaged in litigation, currently or prior, related to FMS.
* Inability to commute to clinic once.
* Primary language not English.
* Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study
* Treatment with the medication meclizine for vertigo
* History of seizures
* Diagnosis of bipolar disorder (treated or untreated)
Framingham Nutrition Studies

To examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based Framingham Offspring Studies.

DESIGN NARRATIVE:

Longitudinal analyses were conducted on the associations between diet and cardiovascular and cardiopulmonary disease risk in approximately 3,800 Offspring men and women over eight years of follow-up (from 1984 to present). These analyses considered key nutrients as well as newly defined dietary patterns in Framingham men and women. Cross sectional analyses of diet and plasma lipoprotein relationships in Offspring men and women at two examinations (Exam 3, 1984-88; and Exam 5, 1991-94) were also conducted. All analyses evaluated the total (direct and indirect) and joint effects of dietary nutrients. Where appropriate, analyses controlled for plasma nutrient levels (folacin, vitamins B6 and B12 and homocysteine). The influence of potential confounding variables, effect modifiers, and intervening variables that lie in the causal pathway were examined, as appropriate to the statistical model, including traditional cardiovascular disease risk factors and apoE isoform status.

Several existing Framingham data sets were utilized, including comprehensive data sets on nutrient intake, cardiovascular disease risk factors, clinically verified cardiovascular and cardiopulmonary endpoints and other covariates. The Offspring Exam 3 and 5 nutrition data sets included multiple day assessments of dietary intake which improved the ability to detect relationships of interest. The investigators completed the Framingham Food Habit Questionnaire data set for Exam 5; this instrument included important covariates for the analyses (including vitamin supplement use).

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Adjuvant Chemotherapy With or Without Intercalated Icotinib

Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study aims to assess the efficacy and safety of adjuvant chemotherapy with or without Intercalated combination of icotinib in patients undergoing resection of stage IIB to IIIA (N1-2) EGFR-mutated NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging IIB to ⅢA, N1-2; PS = 0 or 1; Adequate hematological, biochemical and organ functions

Exclusion Criteria:

* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
The Clinical Carbetocin Myocardium Trial

Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.

Carbetocin has been in clinical use in EU for some years and the efficacy is documented in several RCTs. Circulatory adverse events leading to death has been reported after intravenous injection of oxytocin. Some studies indicate that oxytocin may lead to dose dependent ischemic ECG changes, prolongation of QT time and liberation of biomarkers of myocardial cell death. Previously we have demonstrated comparable vasodilatory effects of oxytocin and carbetocin. There is no clinical study comparing the specific myocardial effects of oxytocin with carbetocin. It may have great impact on the choice of standard medication if the cardiotoxicity of carbetocin is lower compared with oxytocin. The study of potential cardiotoxicity has to be performed in healthy women. Knowing that millions of laboring women have had uneventful injections of oxytocin and carbetocin after delivery, there is probably no reason to fear long lasting negative effects of either drug. If there are differences in cardiotoxicity, this new information should be taken into consideration when planning delivery in pregnant women with heart disease.

The aims of this study are to compare 0h (before C-section), 4h, 12h, 24h, and 48h plasma concentrations of Troponin I, Troponin T, proBNP, CK, and other relevant myocardial markers in elective healthy C-section patients randomized to oxytocin 2.5 U or carbetocin 100 µg, 1 minute injection immediately after delivery.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy pregnant women age 18 to 50
2. Singleton pregnancy at gestational age 36 weeks or more
3. Able to read and understand Norwegian.

Exclusion Criteria:

1. Patients with placenta pathology such as praevia, acreta, pre-eclampsia
2. Patients with bleeding disorders including vonWillebrand disease type I.
3. Known intolerance to one of the two drugs.
4. Patients with prolonged QT-time or other serious cardiac diseases.
5. Liver or kidney failure.
6. Epilepsy.
7. Any medical reason why, in the opinion of the investigator, the patient should not participate
Emotion, Aging, and Forgiveness: Protocol for a Feasibility of Randomized Controlled Trial

Over recent decades, Emotion-Focused Therapy, aging, and forgiveness have garnered significant attention in the field of psychology. However, there is a lack of studies on Emotion-Focused Therapy and forgiveness specifically tailored for older adults. This article describes a protocol to assess the feasibility and acceptability of a Randomized Controlled Trial of Emotion-Focused Therapy for the resolution of emotional injury in individuals over the age of 65 in the context of interpersonal offenses. The study is structured as a two-arm, parallel-group randomized trial with a waiting list control. We propose recruiting a sample of 70 participants, randomly assigned to either an immediate intervention group, which will receive Emotion-Focused Therapy over twelve weekly sessions, or a control group that will receive the same therapy after a twelve-week waiting period. Data will be collected in the beginning, middle, and at the end of therapy, and in two planned follow-ups (three and six months after therapy). Once this protocol is implemented, if the therapy proves to be feasible, acceptable, and shows promising results, the findings will inform a large-scale randomized clinical trial to advance the understanding of psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Our eligibility criteria include being 65 years or older, having experienced an interpersonal offense, residing at home or in a senior residence, stable prescribed medication use, scoring ≥ 26 on the MoCA (Montreal Cognitive Assessment), and fluency in Portuguese or English.

Exclusion Criteria:

* Exclusion criteria include reporting an offense which is less than a year old, severe emotional injuries (such as being a victim of domestic violence or abuse), psychiatric disorders, suicidal ideation, parasuicidal behavior, recent loss of a loved one, involvement in other therapies or clinical studies, current alcohol or drug abuse, living with another participant, and frequent hospitalizations.
Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

To evaluate the efficacy and safety of Jing Fang Wu Mei Wan Jiawei Fang in the treatment of idiopathic blepharospasm using a clinical randomized controlled trial method.

Idiopathic blepharospasm is an idiopathic dysfunction characterized by involuntary spasms of the eyelids bilaterally that interfere with visual function and cause ocular discomfort. The incidence has increased each year in recent years, and the disease may present with persistent eye closure or even functional blindness in advanced stages. In some patients, the disease may be associated with submandibular dystonia, known as Meige's syndrome. Currently, the disease is treated symptomatically. Such as oral.These treatments not only have large side effects, but also make it difficult to relieve the patient of multiple lesions in the eyes, face and tongue. Chinese medicine has unique advantages in treating this disease, highlighting the overall diagnosis and solving different parts of the disease in an integrated manner. Wu Mei Wan is a traditional Chinese medicine prescription, and our team has been using Wu Mei Wan Jia Wei Fang for the treatment of Meige syndrome since 2009 under the leadership of Gao Jiansheng, a famous Chinese medicine teacher in the capital, and found significant therapeutic effects in preliminary clinical observation, but there is a lack of large sample of randomized controlled clinical studies. In this study, we propose to systematically observe the efficacy of traditional Chinese medicine in the treatment of idiopathic blepharospasm by using the traditional sutra formula for idiopathic blepharospasm as a test group and local botulinum toxin A injection as a control group, and to scientifically evaluate the efficacy of the Wu Mei Wan Jia Wei Fang in the treatment of idiopathic blepharospasm.The results were evaluated in order to provide new treatment options for the clinical management of idiopathic blepharospasm (including Meige syndrome) and to benefit more patients.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic blepharospasm met the diagnostic criteria.
2. The age ranges from 18 to 80 years.
3. Liver Yang deficiency,mixed syndrome of cold and heat.
4. Signed Informed consent

Exclusion Criteria:

1. Secondary blepharospasm due to keratoconjunctivitis, trichiasis, and blepharitis.
2. Open eyelid disuse.
3. hemifacial spasm.
4. The patient had undergone eye surgery in the previous 6 months.
5. Allergic to the ingredients in the medicine.
6. Corneal lenses were worn during the study.
7. A woman who is pregnant or breastfeeding.
8. Combined with cardiovascular, cerebrovascular,Liver and kidney function, hematopoietic system serious primary disease, mental patients, combined with stroke patients.
9. At the same time, use drugs that interfere with the evaluation of drug efficacy.
10. Idiopathic blepharospasm is treated with other drugs.
Study Of Lybrel In Relation To Venous Thromboembolism

Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones for as long as the drug is used. Lybrel was marketed in the US in July of 2007. The objective of this database case-control study is to estimate the risk of idiopathic VTE (deep vein thrombosis and pulmonary embolism) in current users of Lybrel (ethinyl estradiol 20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing 20μg of ethinyl estradiol.

The base population consists of all currently available data on current users (15-49 years old) of Lybrel and other oral contraceptives (OC) containing 20 µg ethinyl estradiol in the PharMetrics/IMS and MarketScan databases. From among the base population, the databases are then searched for any diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) \[referred to collectively as venous thromboembolism or VTE\] that occurred after receipt of Lybrel or other oral contraceptives containing 20 µg ethinyl estradiol. The intent is to include newly diagnosed cases of VTE.

Eligibility Criteria:
Inclusion Criteria:

* New users of the study drugs (i.e., Lybrel and the comparison OCs)

Exclusion Criteria:

* No specific exclusion criteria for the base study cohort.
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.


Eligibility Criteria:
Inclusion Criteria:

* A treatment field (TF) on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that: a) is a contiguous area measuring 25 cm\^2, b) contains 2 to 8 clinically typical, visible, and discrete actinic keratosis (AK) lesions, and c) has an overall clinical picture that is consistent with Olsen grade 1
* If a women of child-bearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to Screening), she must: a) Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration. b) Be using effective methods of birth control. c) Agree to have pregnancy tests while in the study and at the end of the study
* Participants should be willing to avoid sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
* Participants should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines

Exclusion Criteria:

* The location of the TF is: a) on any location other than the face or scalp. b) within 5 centimeters (cm) of an incompletely healed wound. c) Within 10 cm of a suspected basal cell carcinoma (BCC) or other neoplasm. d) on the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils
* Presence in the TF of: a) clinically atypical and/or rapidly changing AK lesions b) hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions), and/or cutaneous horn. c) confluent AK lesions (that is, non-discrete lesions, as per inclusion criterion 2). d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3 percent (%) gel
* History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely
* History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study
* Immunocompromised participants, including participants with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients
STEP Trial for Heel Fat Pad Syndrome

The primary objectives of this study are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). For mechanistic understanding of the effect of the loop taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness.

The study objectives are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). We hypothesize that the fat pad loop taping is superior to control taping in immediate and short-term pain reduction and short-term function and mobility improvement. To understand potential mechanisms underlying the benefits of the looping taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness. We hypothesize that applying fat pad loop taping will increase the pressure pain threshold (i.e., diminished pain sensitivity) recorded by a mechanical pressure algometer and increase fat pad thickness quantified by ultrasound. Despite being the second leading cause of plantar heel pain, RCTs for conservative management do not exist. Findings of this proposed project will provide much-needed evidence on effective non-pharmacological managements of HFPS.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 79 years of age
* History of plantar heel pain in either foot for at least one week and less than 3 years before enrollment
* Tenderness on palpation of the heel fat pad
* Self-reported worst unilateral or bilateral central heel pain of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS) during the past week
* Pain ≥ 3 on NPRS during at least one of two pain-aggravating activities of 30-sec static single leg standing OR barefoot 20-meter walking assessed during the enrollment screening and before the tape application

Exclusion Criteria:

* Primary diagnoses of plantar heel pain (e.g., plantar fasciopathy, posterior tibialis tendinopathy, or tarsal tunnel syndrome) other than HFPS
* Ultrasound-measured plantar fascia thickness ≥ 4mm, combined with clinical presentations of plantar fasciopathy
* BMI ≥ 35
* Systemic inflammatory arthritis
* Diabetes
* Lumbar radiculopathy
* Neurological conditions affecting gait and mobility
* Having received taping for HFPS within the last month
* Prior heel surgery
A Study to Test a New Pelvic Examination Assessment Tool

The purpose of this study is to show that a new assessment tool for pelvic examination is valid and reliable.

Physical examination of the pelvis is an important core skill that medical students need to acquire. However, due to its intimate nature some students are graduating unable to perform competent pelvic examinations. At present, evaluation of the medical students competence at pelvic examination is done by subjective faculty assessment. This assessment is typically performed at the end of the teaching block and is based on the assessors' recollection of the students' performance. This kind of assessment has been shown to have poor validity and reliability. This is in contrast to objective structured assessments of technical skill (OSATS), which use task specific and global rating scales and have been used to evaluate a wide range of clinical and surgical skills. However, no studies to date have evaluated an assessment tool for pelvic examination. In this study the investigators aim to determine the validity and reliability of an OSATS for pelvic examination. In addition, the investigators aim to identify factors that influence the scores in OSATS.

Eligibility Criteria:
Inclusion Criteria:

* Final year medical students starting their Obstetrics and Gynaecology placement
* Final year medical students finishing their Obstetrics and Gynaecology placement
* Pre Royal College of Obstetrics and Gynaecology registered junior doctors doing a Obstetrics and Gynaecology placement.
* Signed Consent Form

Exclusion Criteria:

• None