cyrilzakka/clinical-trials huggingface dataset:
Sensory Perception of Sweet Flavors in E-Cigarette

Despite the explosive popularity of sweet flavored electronic cigarettes, there is little empirical evidence regarding how "sweet" flavors interact with different levels of nicotine to reduce its perceived bitterness and harshness, and thereby increase its appeal and additive potential. This study will serve to fill this knowledge gap through empirical psychophysical data that will determine the association between sweet flavor and nicotine and its link to the acceptance and rejection of vaped nicotine.

We will recruit current, healthy e-cigarette users between the ages of 18-35.This study will require 1 visit to the Oregon State University campus to partake in a 1 hour (approximate) testing session. During the testing session, participants will be asked to puff commercial e-cigarettes containing 9 commercially available e-liquid preparations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18-35 years of age; have been vaping for at least 1 month; currently use an e-cigarette that contains nicotine; have used an e-cigarette with medium (9-12 mg/mL) or high (18 to 36 mg/mL) nicotine strength at some point in their e-cigarette using history.

Exclusion Criteria:

* Do not have mouth or throat problems that would keep subject from vaping comfortably; do not have health problems that would keep subject from tasting or smelling normally; do not have any food ingredient allergies and have never had an allergic reaction to propylene glycol or vegetable glycerin; do not have any respiratory allergies (i.e., frequent sneezing, nasal congestion, nasal discharge); do not have a history of pulmonary disease or asthma; are not in the process of trying to quit vaping; are not pregnant, breast feeding, or trying to become pregnant.
Clinical Decision Support for Patient Migraine Management

Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. The proposed project will pilot the first patient level intervention designed to improve adherence to preventive and acute migraine management strategies. The study will identify people most at risk for non-adherence to migraine management strategies. Participants will be randomly assigned to receive a tailored clinical decision support tool or education intervention.

Participants with a diagnosis with migraine who currently meet criteria for episodic migraine (migraine with headaches that occur on fewer than 15 days per month) will be recruited from local providers. After an initial screening, eligible participants will complete 30 days of monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study eligibility. Participants whose eligibility is confirmed will complete an additional 2 months (60 days) of monitoring headache activity and adherence to acute and preventive (medication and behavioral) strategies recommended for people with migraine. Participants who show suboptimal adherence during the first 3 months of monitoring (\<50% of eligible days) will be eligible to continue to the intervention component of the study. Participants who choose to continue in the study will be randomized to receive a tailored clinical decision support tool or education intervention, both delivered through the smartphone app. Participants will continue to self-monitor, with the intervention components active, for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Have an International Classification of Headache Disorders - 3 beta diagnosis of migraine
* Self-report and diary-confirmed 6 to 14 headache days per month
* Are currently prescribed a triptan for acute migraine management
* Are stable on current preventive and acute treatment regimen for migraine
* Are between the ages of 18 and 65
* Reads and understands English
* Has capacity to consent
* Completes 80% of diary recordings in the first 30 days of monitoring

Exclusion Criteria:

* Probable or confirmed medication overuse headache
* A plan to change, or changing preventive or acute migraine medication during study participation
* Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications)
* Psychiatric illness or cognitive difficulties that would interfere with participation in the study
* Participated in the pilot development of the intervention evaluated by this research protocol.
Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
* Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

* Have any ocular/systemic health problems
* Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.
Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees

This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.

This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention

Eligibility Criteria:
Inclusion Criteria:

1. Patients above the age of 40
2. Patients with opposing full natural dentition or completely or partially edentulous arches
3. Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants
4. Cooperative patients that are willing to attend all follow-up periods.
5. Patients with healthy attached mucosa of appropriate thickness free from any inflammation.

6- Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes

Exclusion Criteria:

1. Patients with any temporomandibular joint disorder or parafunctional habits
2. Patients with flabby or flat ridges
3. Patients with extreme anatomical limitations such as a large torus that requires surgical excision.
4. Patients with a history of allergy to dentures made of resins.
5. Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
6. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Maternal Reflective Functioning During the Transition to Motherhood

The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are:

Does MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship.

Participants will:

Answer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth).

intervention group will participate in an online short intervention to enhance MRF.

Using this trial, the investigators will be able to better understand rather MRF moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. Using RCT design we will be able to understand mechanism of change.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women in 27-30 weeks pregnant in enrollment
* speak read and understand Hebrew
* Has a connection to internet and ZOOM platform.
* Ready to participate in a group workshop

Exclusion Criteria:

* Women who can\&#39;t participate in a online workshop due to physical or mental health difficulties.
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension

The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).


Eligibility Criteria:
Inclusion Criteria:

Study Parts A and B:

-Cirrhosis of alcohol aetiology according to physician's assessment prior to screening.

Part A:

-Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices).

Part B:

* Cirrhosis with TIPSS in situ and PPG\>5mmHg.
* Fully functioning TIPSS without variceal filling as confirmed by portography.

Exclusion Criteria:

Study Parts A and B:

* Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening.
* Decompensated cirrhosis (Child-Pugh score \>9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at visit 1.
* Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.

Part A:

* BMI (weight\[kg\] / height\[m\^2\]) \> 40 kg/m\^2.
* Any contraindication to having an MRI scan

Part B:

-Contraindication to catheterization
Study to Evaluate the Care Process and the Quality of STEMI Care

Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction are globally responsible for a large number of hospitalizations and deaths. Monitoring the quality of care for these patients is very relevant topic. Investigators developed indicators from the scientific literature on the quality of care for patients with STEMI at both the patient level and hospital level. The indicators were subsequently validated by a RAND modified Delphi - study of multidisciplinary experts in the care of patients with STEMI.

In this study, the following objectives are set:

1. ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with cardiology department by retrospective and prospective audit of 20 patient records per participating hospital .
2. ) Study of the interdisciplinary relationships and communication within teams involved in the care of patients with STEMI in the participating hospitals 3) Study of perceived organization of care for patients with STEMI in the participating hospitals

In accordance with the objectives of the research, the study consists of three phases:

1. ) A retrospective observational audit of 20 patient records of patients with STEMI each participating hospital.
2. ) A prospective observational audit of 20 patient records of patients with STEMI each participating hospital.
3. ) A survey using validated instruments of interdisciplinary relationships and communication on the one hand and on the other by the teams involved in the care of patients with STEMI perceived organization of care .

Data collection is performed by local researchers and remains their property. The data is coded and kept confidential. Only the local researcher has access to the encryption key. The data are protected by the Belgian law on privacy and medical confidentiality, only to be used in the context of this study. The results are published anonymously.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted with STEMI within 24 hours after symptom onset and
* eligible for reperfusion according to ESC STEMI guidelines

Exclusion Criteria:

-
Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale

This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema Assessment Scale. There is no treatment (intervention) associated with this study.


Eligibility Criteria:
Inclusion Criteria:

* Rosacea

Exclusion Criteria:

* Unwilling to remove all facial make-up
Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer

An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.

This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.

Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.

The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.

All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.

Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.

The study expected to last six and a half years, of which one and a half years for recruiting 416 patients, 208 each arm, with five years of follow-up. Patients will be followed up at 1, 4, 12, 24, 36, and 60 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists(ASA) grade I-III.
* Right colon cancer (\*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
* Informed consent

Exclusion Criteria:

* Age \> 85 years old.
* T1, N0
* T4b, any N
* BMI \> 30.
* Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
* American Society of Anesthesiologists(ASA) grade IV.
* History of cancer in recent 5 years.
* Need for Emergency surgery.
* Infectious disease requiring treatment.
* Pregnancy.
* Use of systemic steroids.
* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Low vs. Standard Dose CT for Appendicitis Trial

To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).

* Acute appendicitis is a very common disease. Many patients are adolescents or young adults.
* CT is the current standard imaging test for the diagnosis of appendicitis.
* In recent years, the awareness of carcinogenic risk associated with CT radiation has increased.
* According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis.
* However, LD CT is not yet widely accepted.
* To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.

Eligibility Criteria:
Inclusion Criteria:

* Emergency department visit with suspected symptoms and signs of acute appendicitis
* Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
* Willing to provide telephone or cell phone numbers for follow-up
* Signed informed consent provided prior to study entry

Exclusion Criteria:

* Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
* Prior history of surgical removal of the appendix
Treg Cell Therapy in Liver and Kidney Transplantation - Preclinical Validation of Batches of Treg Cells Amplified in Vitro

Kidney and liver transplantation requires a fine tuning of immune responses in order to achieve long term operational tolerance with immunosuppressants or immune modulators. Numerous experimental findings indicate that CD4+ FOXP3 expressing regulatory T (Treg) cells play a central role in the induction of tolerance to the grafts indicating that the use of Treg cells may be an innovative therapeutic strategy in kidney transplantation that would enable the diminution of immunosuppressive drugs or even their discontinuation, thus decreasing their risk of adverse events.

As human Treg cells represent less than 10% of CD4+ T cells, and because it has been shown in mice that a dose of 2\*104 polyclonal Tregs/g was necessary to induce tolerance in animal models of solid organ transplantation, it is mandatory to expand human Treg cells ex vivo, after isolating them from peripheral blood. The investigators previously defined a protocol for Treg cell isolation and expansion in clinical grade conditions (cGMP) that enabled us to obtain the expected number of expanded cells maintaining high levels of FOXP3 (3).

The investigators therefore hypothesize in humans, as it has been already shown in mice, that the infusion of autologous expanded polyclonal Treg cells would lead to the obtaining of operational tolerance in kidney and liver graft in association with classical immunosuppressants and an expectable diminution of those.

To this end, it is necessary to have pre-clinical batches of expanded Treg cells validated by the National Agency for Medicines and Health Products Safety validate (ANSM). The investigators therefore plan to have 4 batches from 2 liver transplant patients and 2 kidney transplant patients validated.


Eligibility Criteria:
Inclusion Criteria:

For liver transplant patients:

* Liver transplantation carried out for 1 to 3 months for alcoholic cirrhosis;
* Normal liver biological test;
* Normal hepatic morphological assessment;

For kidney transplant patients:

* Renal transplantation carried out for 3 to 6 months for any disease requiring renal transplantation;
* Normal renal biological assessment;
* Normal renal morphological assessment;
* DSA \<1500 MFI at inclusion

Common criteria:

* Age ≥ 18 years and ≤ 70 years
* GB ≥1500 / mm3
* Hemoglobin level\> 10g / 100ml
* Platelets\> 50,000 / μl
* Weight\> 40Kg
* Informed and signed consent;
* Patient affiliated to a social security scheme

Exclusion Criteria:

For liver transplant patients:

- Hepatocellular carcinoma or history of another cancer;

For kidney transplant patients:

- Kidney cancer or a history of another cancer

Common criteria:

* Active infectious diseases: positive serology for hepatitis A, B or C, HIV, HTLV, CMV and EBV;
* Associated autoimmune disease, including type 1 diabetes;
* GB \<1500 / mm3;
* Any contraindication to citrate and calcium gluconate.
* Pregnancy or lactating woman
* Patient under guardianship or curatorship
* Patient deprived of liberty or under administrative security measure
Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain

The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP.

The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years
2. NERD, or GERD LA Class A-B (endoscopy)
3. Subjects with positive pH testing
4. At least one episode of chest pain a week in the past month
5. Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
6. Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)

Exclusion Criteria:

1. Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
2. Subjects with previous upper gastrointestinal surgery
3. Pregnancy
4. Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
5. (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
6. Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
7. Medications such as baclofen, and prokinetic agents.
8. History of substance abuse