cyrilzakka/clinical-trials huggingface dataset:
Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study

This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years of age and over
2. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
3. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.
4. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
5. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Are requiring hip revision surgery
2. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
3. Evidence of asymptomatic DVT by Duplex Ultrasound
4. Peripheral arterial disease (ABPI \< 0.8), varicose veins or lower limb ulceration or ischemia.
5. Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
6. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
7. Recent trauma to lower limb.
8. Chronic Obesity (BMI Index \>40kg/m2).
9. Pregnancy.
10. Significant history of following diseases I. Cardiovascular: Recent MI (\< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (\< 3 months for Bare Metal Stent (BMS) and \< 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.

    VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders
11. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
12. Long term steroid with dermatological changes
13. A pulse rate of less than 40 beats/minute
14. A sitting systolic blood pressure \>180 and \<100 mmHg and/or a sitting diastolic pressure of \>100 mmHg.
15. Any significant illness during the four (4) weeks preceding the hip replacement surgery.
16. Participation in any clinical study during the eight (8) weeks preceding the screening period
Effect of Fibre Products on Appetite and Weight

This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.

This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers aged between 21 and 65 years

Exclusion Criteria:

* Weight change of more than 3kg in the preceding 2 months
* Current smokers
* Substance abuse
* Excess alcohol intake
* Pregnancy
* Diabetes
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* Use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.
Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

This study examines the prognostic properties of immune parameters, clinical scores, electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of functional outcome one year after treatment on a neurological intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* severe neurological disease making treatment on a neurological intensive care unit necessary
* age ≥ 18
* consent by the patient or the legal representative

Exclusion Criteria:

* participation in an interventional trial
Improving Knowledge in Heart Failure Inpatient With Therapeutic Education

The objective is to evaluate the impact of a pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients. The knowledge score on heart failure disease and medications will be compared between two groups one month after hospitalization. The intervention group will receive a therapeutic education intervention and usual hospital care and the control group will receive only usual hospital care.

Heart failure patients are at risk of decompensation of their disease and frequent hospitalizations. Poor adherence to their treatment may be the cause. By improving the knowledge of hospitalized heart failure patients about their disease and their medications, it is expected that these patients will adhere better to their heart failure drug therapy and benefit from a better effectiveness of their treatment. This could promote an improvement in their quality of life, a decrease in their risk of disease complications and even an increase in their life expectancy.

The objective of this research project is to deploy a therapeutic teaching intervention at the bedside of decompensated and hospitalized heart failure patients, associated with follow-up by the pharmacist at discharge from the hospital, and to measure its impact on knowledge change (primary endpoint), on their beliefs about medications, on their therapeutic adherence, and on the consumption of unplanned care such as rehospitalizations and emergency room visits (secondary endpoints).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in the Department of General Internal Medicine or Cardiology for decompensated heart failure with lowered left ventricular ejection fraction (LVEF) (≤40%) from any cause or mildly lowered LVEF (41-49%) with the presence of heart failure-specific drug therapy
* Stability of the patient's clinical condition
* ≥ 2 heart failure medications
* ≥18 years
* Full capacity of discernment
* Absence of cognitive impairment
* Ability to speak, understand and read in French
* Get a personal telephone
* Consent form signed by the participant

Exclusion Criteria:

* Inability to follow study procedures
* Institutionalized persons
* Asylum seekers, homeless people, prisoners
* Incapacity of judgment and discernment
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis \[ERA\] including JPsA).
* Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).

Exclusion Criteria:

* Participants must not have systemic JIA, with or without active systemic features.
* Participants must not have persistent oligoarticular arthritis.
* Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.
Chest Dysphoria in Transmasculine Spectrum Adolescents

The investigators hypothesize that masculinizing top surgery (e.g., mastectomy and chest masculinization) leads to an improvement in self-report chest dysphoria, gender dysphoria, and gender congruence in assigned-female-at-birth, transgender and non-binary youth and young adults. This is a prospective, observational study that will enroll assigned-female-at-birth, transmasculine spectrum individuals age 13 to 25 years old who are or are not undergoing top surgery. Participants will complete a set of standard of care questionnaires regarding their chest dysphoria (e.g., distress about the chest), gender dysphoria (e.g., distress about a gender identity that does not match assigned sex), and gender congruence (e.g., degree to which an individual feels they are living in their authentic appearance and gender identity). They will complete this same set of questionnaires either three months after their top surgery or three months after the initial set of surveys.


Eligibility Criteria:
Inclusion Criteria:

* Assigned the female sex at birth
* Affirmed gender identity of male, non-binary, or gender other than female
* English-speaking
* Undergoing top surgery or matches a top surgery participant on age and number of months on testosterone

Exclusion Criteria:

* Non English speaking
* Unable to complete self-report questionnaires
Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia

Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months.

This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure.

This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years
* Manometric diagnosis of achalasia
* Eckardt score more than 3
* Informed consent

Exclusion Criteria:

* Increased surgical risk for important comorbidities,
* Pseudoachalasia
* Mega-esophagus (more than 7 cm) and or sigmoid esophagus,
* Previous esophageal or gastric surgery (with the exception of gastric perforation)
* Inability of completing the questionnarie
* Inability to keep a commitment for follow-up
* Esophageal diverticulum
Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial

The purpose of this study is to evaluate the efficacy of Durvalumab plus Regorafenib versus observation for patients with stage IV colorectal cancer achieving the no evidence of disease state.

The NED state can be achieved in any line of treatment and it is defined as:

1. R0 resection for surgery,
2. the complete ablation defect covering the lesion on CT scan for radiofrequency,
3. the erogation of ≥ 60 Gy for stereotactic radiotherapy,
4. complete response to antineoplastic treatments on CT scan. In all these cases CEA and CA 19.9 must be within normal limits at the time of randomization.

Participants in this study will receive:

Experimental arm:

Regorafenib 90 mg d1-21 every 28 days plus Durvalumab 1500 mg every 28 days for 1 year

Control arm:

Observation (crossover to Experimental arm is allowed in case of relapse)

Tumor assessment will be performed every 12 weeks.

The safety run-in phase is planned for the first 4 patients randomized to the experimental arm using a starting dose of 60 mg/die of Regorafenib (and fixed 1500 mg of Durvalumab), to be escalated after 2 months to 90 mg/die if \< 2 patients report serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years; ECOG PS 0-1;
2. Body weight \>30 kg;
3. Histologically confirmed diagnosis of colorectal adenocarcinoma;
4. Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy;
5. Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle;
6. NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;
7. Life expectancy of at least 12 weeks;
8. CEA within normal limits;
9. No residual toxicity from previous chemotherapy;
10. Adequate organ function;

Exclusion criteria:

1. MSI/dMMR patients;
2. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo;
3. Active or prior documented autoimmune or inflammatory disorders;
4. Relevant concomitant comorbidities;
Apolipoprotein A-I Gene Polymorphism and Atherosclerosis

To further define the linkage of the Apo A-I gene polymorphism to genetic high density lipoprotein (HDL) deficiency and premature coronary artery disease. Also, to utilize this gene marker to define the prevalence of genetic HDL deficiency in patients with premature coronary disease and to determine the relative risk of premature coronary disease associated with the Apo A-I gene polymorphism.

BACKGROUND:

Apolipoprotein (apo) A-I is the major protein constituent of plasma high density lipoproteins (HDL). HDL has been shown to promote cholesterol efflux from cells in vitro. Decreased plasma concentrations of HDL cholesterol and Apo A-I have been associated with premature coronary artery disease due to atherosclerosis in our society. A genetic HDL deficiency, familial hypoalphalipoproteinemia, appears to be fairly common in patients with premature coronary artery disease. The gene for Apo A-I has been isolated and characterized. Preliminary studies indicate that a specific Apo A-I gene polymorphism, detected following Pst I restriction enzyme digestion utilizing a specific probe, is significantly more common in subjects with premature coronary artery disease than in normal control subjects, and in some kindreds is associated with genetic HDL deficiency. This Apo A-I gene polymorphism is due to an alteration in the Apo A-I, Apo C-III intergenic region, near the 3' end of the coding region for Apo A-I. These observations have important implications for the detection of individuals genetically predisposed to premature coronary disease, as well as for providing insights into the mechanism leading to atherosclerosis.

DESIGN NARRATIVE:

Questionnaires were used to obtain information from each patient on known risk factors and diet. Fasting blood samples were obtained for lipoprotein analysis. Standard clinical and cardiological information and fasting blood samples were also collected for the cases. Blood was drawn for the DNA studies. A determination was made as to whether the Pst I Apo A-I gene polymorphism was associated with diminished levels of plasma Apo A-I or HDL cholesterol, by analysis of the distribution of these variables in cases and controls, after controlling for other known risk factors. Linkage analysis was used to determine whether the Pst I Apo A-I gene polymorphism co-segregates with premature coronary disease, or with diminished levels of plasma Apo A-I, or HDL cholesterol in 50 kindreds. A characterization was made of the abnormality in the Apo A-I, Apo C-III, Apo A-IV gene complex in patients with HDL deficiency, premature coronary disease, and the Pst I Apo A-I gene polymorphism.

Eligibility Criteria:
No eligibility criteria
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions

The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.

A total of 224 adult patients (18 years or older) undergoing spinal fusion surgery at Duke University Hospital, will be recruited from the Duke Department of Neurosurgery and the Duke Department of Orthopedics. Participants will be consented and will complete standard of care outcomes questionnaires (Visual Analogue Scale, Oswestry Disability Index and Euro-Quol 5D) at the pre-operative clinic visit for baseline comparison. Participants will be randomized, through REDCap, with equal probability to either: A) the control group, with standard post-surgery handouts, or B) the experimental group, which will receive text messages for a period of 2 weeks after surgery (daily for the first week, and every other day for the second week). Text messages were designed to be standardized and automated, with an embedded link to a video regarding at-home, post-surgery-care instructions. Patients will be directed not to respond to the text messages, but to call for any questions or concerns. The primary outcome will be a reduction in 30-days post-surgery readmission rates. The secondary outcomes will be a reduction in 30-days post-surgery ED visits rates, back and leg pain scores, and anxiety levels. These outcomes will be assessed via a phone interview at 30-days (up to max of 37 days) post-discharge for both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Primary lumbar fusion 1-4 levels
2. 18 years or older
3. Degenerative spine diagnosis
4. Answers YES to all the following screening questions:

   * Do you own a mobile phone that is capable of sending and receiving text messages?
   * Do you know how to text and feel comfortable texting?
   * Are you a regular (at least once a day) text-message user?
   * Are you agreeable to regular contact?

Exclusion Criteria:

1. Prior lumbar fusions
2. Tumors/infection/trauma
3. Prisoners or institutionalized patients
4. Non-English speaking patients
5. Patients who smokes or with uncontrolled diabetes
6. Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting \~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
* Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

* Pregnant or nursing females.
* Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
* Use of any antibiotic within 72 hours of treatment.
* Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
* Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
Moxibustion for Primary Dysmenorrhea

Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized controlled trial. 152 participants will be included. Two arms: moxibustion treatment group and ibuprofen control group.

There is no convincing evidence for the efficacy of moxibustion for primary dysmenorrhea, due to low methodologic quality and small sample size. The investigators designed the random clinical trial to investigates the effectiveness of moxibustion in treating primary dysmenorrhea, the purpose of this study is to provide the research base of moxibustion efficacy. The investigators also examined the acceptability and any adverse effects associated with the use of moxibustion.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Guidelines of Primary dysmenorrhea clinical by the Society of Obstetricians and Gynaecologists of Canada
* Menstrual cycle is regular (28±7) days
* Syndrome differentiation of Traditional Chinese Medicine: Congealing cold-damp and Qi-stagnation and blood stasis
* Mean value of ≥40mm during last 3 months
* Informed consent form must be signed by patient or lineal relative

Exclusion Criteria:

* Patients with secondary dysmenorrhea, which is caused by endometriosis, pelvic inflammation, myoma of uterus and so on
* Patients who are unconscious and psychotic
* Patients with serious primary illness or diseases of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on
* Patients take prostaglandin synthetase inhibitors (PGSI) 2 weeks before inclusion
* Pregnant women or women in lactation
Early Feasibility Study of the "Easy Light" Fluorecence Imaging System

This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.

This study was designed to clinically evaluate the functionality of an prototype of our near-infrared fluorescence device named Easy Light. In brief, this device is an open-field handheld wireless fluorecence imaging system that allows real-time visualization of fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld is a rechargeable device responsible for excitation of the operative field with infra-red lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized via wi-fi in the smartphones and tablets using a pre-installed application software. Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes after lymphatic mapping by interstitial indocyanine green injection in the cervix was feasible with the use of our device named Easy Light.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with biopsy-proven cervical or uterine cancers;
2. Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics;
3. Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant;
4. Performance status of 0-2;
5. No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery;
6. Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding;
7. Appropriated cardio-respiratory, hepato-renal and hematological reserves;
8. Signing of the Consent Form.

Exclusion Criteria:

1. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.