cyrilzakka/clinical-trials huggingface dataset:
Investigating the Impact of Self-monitoring Feedback for Health Behaviors

Investigating the impact of self-monitoring feedback for health behaviors

Obesity is highly prevalent in Samoa, where a 2010 study estimated that 64.6% of adult females were obese, according to Polynesian BMI cut offs (BMI ≥32.0 kg/m2).1,2 Interventions designed to increase physical activity or facilitate weight loss often include a self-monitoring component, but these intervention programs have not yet been tested in the Samoan setting. The goal of this project is to pilot test such an approach.

The specific aims of this study are:

1. To investigate the acceptability and feasibility of self-monitoring of physical activity and weight through the introduction of step counting devices (FitBit Zips) and scales (BodyTrace).
2. To measure any changes that occur in participants' health, health behaviors related to diet and physical activity, or conceptions of health (including self-efficacy and perceptions of weight) over the study period.

Eligibility Criteria:
Inclusion Criteria:

* Samoan ethnicity (measured by their having four Samoan grandparents)
* 31.5 - 40 years of age
* Physically inactive - defined using the World Health Organization (WHO) definition of inactivity and the WHO Global Physical Activity Questionnaire
* Motivated and ready to make behavior changes - defined using the Physical Activity Stages of Change framework (contemplation or preparation phase)18
* Not pregnant or planning to become pregnant during the 5-week study period - self-reported at baseline
* Weigh less than 180 kg - based on measured weight at baseline. This restriction is due to the maximum weight of the BodyTrace scales used in the intervention.
* No medical condition preventing physical activity or making participation inadvisable. These conditions will be measured based on self-report of doctor diagnoses and include: hypertension, heart attack, heart disease, stroke, uncontrolled Type 2 diabetes, non-skin cancer diagnosis, dialysis, or a diagnosed eating disorder. Participants will also be excluded if they have had significant (\>10 kg) self-reported weight loss in the last 6 months.

Exclusion Criteria:

* If participant does not fit the requirements above
Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis in patients with AIDS and as a second line therapy for HCMV infections not responding to ganciclovir or foscarnet.

In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established extracorporal renal replacement therapy with a high clearance rate.

Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used.

Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir during CVVH in critically ill patients. It is suspected that Hemofiltration will influence cidofovir plasma levels.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years
* Suspected of proven HCMV infection
* Suspected or proven resistancy of HCMV to the first line therapy (ganciclovir / foscarnet).
* Continuous venovenous hemodiafiltration (CVVHDF) due to acute or chronic renal failure.

Exclusion Criteria:

* Known history of hypersensitivity to cidofovir or probenecid.
* An expected survival of less than three days.
* Known alcohol dependency, epilepsy, pregnancy or liver failure.
* Infection with a ganciclovir or foscarnet susceptible HCMV strain
Pilot Study Testing Professional, Peer, and Mentor Health Coaches for Weight Loss

Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or Professionals. The aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* age 40-60

Exclusion Criteria:

* Participants will be excluded if they:

  1. Are unwilling to participate in a weight control program that includes weight coaches.
  2. Report not being able to walk 2 blocks (1/4 mile) without stopping.
  3. Are participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months.
  4. Are pregnant, lactating, less than 6 months post-partum or plan to become pregnant during the time of the intervention.
  5. Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Participants reporting joint problems, medication use, or other medical conditions that may limit their ability to exercise will be required to obtain written permission from their physician to participate in the intervention.
  6. Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, bulimia nervosa, dementia, or severe psychiatric condition).
Therapeutic Oncolytic Monitoring as a Tool for Effective Exposure to 5-FU in Patients With Locally Advanced, Resectable Gastric or Gastro-oesophageal Junction Cancer Treated With Perioperative FLOT

Traditional dosing of 5-FU is based on body surface area and DPD enzyme activity. However, BSA-based dosing is associated with wide inter-individual variations in 5-FU systemic exposure, and also 5-FU-induced toxicity. The international association for therapeutic drug monitoring and clinical toxicology (IATDMCT) state in there clinical guideline, in which all previous clinical pharmacokinetic studies of 5-FU were reviewed, that only 25% of the patients are within the therapeutic range. In the traditional treatment regimens a bolus of 400 mg/ m2 5-FU is given, followed by a dose of 2400 mg/m2 as a 46-hour infusion. The therapeutic range of 5-FU in these older regimens is defined by a target AUC of 20-30 mg\*h/L. In contrast, 5-FU in FLOT regimen is given without a bolus, and in a high dose of 2600 mg/m2 as a 24-hour infusion. This means that a comparable absolute dose of 5-FU is given with FLOT and the older regimens, however, the manner and duration of administration differ. Based on this administration, it is expected that the FLOT regimen will result in an approximately two-fold higher steady state concentration (Css), as it is given in an approximately two-fold shorter period of time (t). As a result of this pharmacokinetic predictions, the exposure to 5-FU (AUC = Css x t) will be comparable between these different 5-FU regimens. Therefore, we hypothesise that the therapeutic range of 5-FU in FLOT will be comparable to the target AUC of 20-30 mg\*h/L in the older regimens. Similar to the older treatment regimens, we expect that a significant part of patients will be outside this therapeutic window. To test these hypotheses, the aim of this study is to establish the population exposure of 5-FU in FLOT treatment regimen, and to determine the percentage of patients that achieves this therapeutic range.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed malignancy for which treatment with 5-FU is indicated in the FLOT regimen.
2. Age ≥ 18 years
3. Patient is able and willing to give written informed consent
4. WHO performance status 0-2
5. Patient fulfills the general treatment criteria for treatment with FLOT including appropriate liver and renal function and other standard applicable laboratory values
6. Patient is able and willing to undergo extra blood sampling for 5-FU analysis

Exclusion Criteria:

1. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety.
2. Inability to undergo additional blood sampling.
Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush

The objective of the present study was to compare the effects of reduction of extrinsic stains between a commercially available Oclean electric toothbrush and Oral B manual toothbrush.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-70 years old
* Good general health
* Could attend the clinical examinations during the 4 week study period
* Possessing \>20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars
* Having a whole-mouth mean tooth stain score of more than 1.5 according to the Lobene index.

Exclusion Criteria:

* Severe oral diseases, chronic disease or allergic to the trial products
* Advanced periodontal diseases
* Females who are pregnant or lactating
* Taking part in other clinical trials
* Taking part in orthodontic treatment or wearing removable denture
* Fluorosis or tetracycline teeth
* Receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.
Haut-Tief Patient Education on Psoriasis and Eczema

'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with psoriasis or atopic dermatitis. A range of support activities will be offered in order to learn effective self-management strategies and attitude to one's chronic skin disease and consequently improving quality of life.

The educational program consists of 2-hours of educational (dermatology, specialized nurse, psychologist) and stress-reduction sessions (yoga, meditation, physiotherapy) twice a week during 9 weeks.

A multidisciplinary team of trainers is involved. Primary endpoint is the general and skin dependent quality of life measured by questionnaires. HRQoL (Health-Related Quality of Life) is measured at baseline, after 3 months, 6 months and 9 months follow up. Patients are recruited from the out-patient clinic at the Department of Dermatology of the University Hospital Zurich. Patients are randomized in an intervention and control group. Intervention group receives the education program additionally to follow-up visits whereas the control group receives follow-up visits. Several runs are planned.

Eligibility Criteria:
Inclusion Criteria:

* Chronic psoriasis (disease for more than 3 months)
* Chronic eczema (disease for more than 3) months)
* Age ≥ 18 years
* Oral and written informed consent

Exclusion Criteria:

* systemic antiinflammatory therapy
* treatment with other investigational products
* other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
* known or suspected non-compliance, drug or alcohol abuse,
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject
* participation in another study within the 30 days preceding and during the present study, (viii) previous enrollment into the current study,
* enrolment of the investigator, his/her family members, employees and other dependent persons.
The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.

The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.

Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception

Exclusion Criteria:

* A history of serious somatic disease
* Migraine or any other type of headache (except episodic tension-type headache less than once a month)
* Daily intake of any medication except contraceptives
A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .

Background \& Aims: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death in the world. The 5-year recurrent rate of HCC after first curative resection is 77%\~100%. Laparoscopic repeat liver resection (LRLR) has been shown in small retrospective studies to be a safe and effective treatment for recurrent hepatocellular carcinoma (rHCC) in selected patients, and radiofrequency ablation (RFA) has been increasingly performed for treating recurrent tumors involving the liver after hepatectomy. The aim of this study was to compare the short-term and long-term outcome of laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) in the treatment of rHCC.

Eligibility Criteria:
Inclusion Criteria:

* Any gender,18 to 70 years old;
* Preoperative diagnosis of recurrent HCC clear,liver resection was done previously;
* No active hepatitis and decompensated cirrhosis;
* Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
* No tumor rupture or bleeding;
* Child-Pugh class A or B grade,ICG-R15 \<20%;
* No coagulation disorders,platelet count \> 50 × 109 / L and prolonged prothrombin time \< 5 seconds;
* After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
* Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts;
* Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
* Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent.

Exclusion Criteria:

* Opposite of the above inclusion criteria;
* Severe upper abdominal adhesions;
* Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
* Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up;
* Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.
Venous Drainage of the Craniocervical Junction: a Retrospective Anatomical Study (SVCR MR1)

This study aims to examine the feasibility of distinctly visualizing the different cervical venous networks (subcutaneous, muscular, extra-canalicular, and intra-canalicular) using dedicated magnetic resonance imaging (MRI) sequences. Theoretically, these venous networks contribute to the complex distribution of blood drainage in the cervical region, but their precise identification on imaging remains challenging.The objectives of this research are twofold: first, to assess the ability of MRI to differentiate each venous network, thereby enhancing the anatomical and functional understanding of this region; and second, to explore the possibility of grouping patients according to the predominant venous network, which could reveal significant physiological variations and specific anatomical profiles.The results could not only refine the diagnosis of cervical vascular pathologies but also guide targeted therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated with a social security system
* Age \>18 years
* Patient who underwent a T1 Angio-MRI with gradient echo and contrast agent of the cranio-cervical region, regardless of the indication, at the Brest University Hospital between 01/01/2019 and 01/11/2024

Exclusion Criteria:

* Patients under judicial protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of venous occlusive pathology OR vascular pathology such as cerebral or spinal AVM/FAV History of posterior cranial fossa surgery OR surgical approach to the posterior cervical spine History of radiotherapy/chemotherapy/any known vein-toxic therapies
Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules

This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age.
2. Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.

   * Score 3 and \> 20 mm in size.
   * Score 4 and \>15 mm in size.
   * Score 5 and \>10 mm in size.
3. Clinical suspicion of thyroid cancer:

   * PET-positive thyroid tumor.
   * Thyroid tumor and palsy of the recurrent laryngeal nerve.
   * Rapidly growing thyroid tumor.
   * Hard and/or immobile thyroid tumor.
   * Tumor in the thyroid with suspicious lymph nodes.

Exclusion Criteria:

* Previous participation in the study.
* Language or other barriers not allowing adequate information.
Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients

Evaluation of the glycemic efficacy of cabergoline on diabetic patients

Type 2 diabetes mellitus (DM) is a progressive metabolic disorder that is associated with basal hyperinsulinemia, insulin resistance and impaired insulin release. Glycemic control is a fundamental part of the management of type 2 DM and difficult to achieve. Different antidiabetic agents can handle diabetic metabolic abnormalities. The development of antidiabetic agentswith novel mechanisms of action is highly desirable. Cabergoline, a long acting D2 agonist, is expected to play a role in the glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients.

Exclusion Criteria:

* Other drugs administration
Gellan Contact Study

The primary objective of this study will be to establish the safety of the two different Gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. This will be compared to a control dressing-- Mepitel One (Polyurethane net with soft Silicone).

This contact study is part of the Wellcome trust Anti-scarring Dressing project to develop a carrier dressing that will be used to deliver therapeutic agents to the skin. A polysaccharide, Gellan, has been chosen as the main component of this dressing (the biomembrane)and it can be produced in either a sheet or fluid gel forms. Gellan is a widely used material in both the food and medical industry e.g. as a lubricant in eye-drops (e.g. Timoptol XE, Merck Sharp \& Dohme, USA).

As part of the development of the dressing, the epidermal (skin) response to Gellan needs to be evaluated to check its safety.

The main objective of this study is to establish the safety of the two different Gellan formulations (2% Gellan sheet and 2% Gellan fluid gel) following application to the epidermis (skin).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥ 18 years old
* Subjects who can provide informed consent

Exclusion Criteria:

* Subject with existing skin conditions/diseases which may interfere with the aim(s) of the study. Examples include pathological fibrosis e.g. scleroderma; pathological thinning e.g. epidermolysis bullosa and collagen disorders e.g. Marfan's syndrome
* Chronic steroid use, history of skin malignancy or chronic papulo-squamous disease (e.g. eczema, pemphigus) and history of Steven Johnson or TENS disease
* Blemishes, marks (e.g. tattoos, scars or burns,) on the test site(s) which may interfere with assessment on the test site
* Use of medication which may affect may affect skin response
* Known allergy to the materials used in the study
* Known allergy to adhesive plasters or tapes
* Fitzpatrick skin type VI (due to the difficulty of identifying erythema)
* Irritated skin on the test site
* Known pregnancy (confirmed by urine pregnancy test) or lactating
* Inability to commit to attending all sessions.
* Participation in another study which may affect the results of this contact study.
* Any other reason that clinician considers will interfere with the objectives of the study
Intrathecal Hydromorphone for Pain Control After Cesarean Section

The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.

Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.

Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.

In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.


Eligibility Criteria:
Inclusion Criteria:

* Elective primary cesarean section
* Females age 18-40

Exclusion Criteria:

* Emergency cesarean section
* Anesthetic other than spinal
* History of chronic pain or pre-op opioid use
* Allergy to morphine or hydromorphone
* BMI\>40