cyrilzakka/clinical-trials huggingface dataset:
Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)

The purpose of this research study is to:

1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).

The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of smokers: those with genotypes associated with less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with higher levels of novelty-seeking, depression, and attention deficit symptoms.

Eligibility Criteria:
Inclusion Criteria:

* The subjects will be male and female smokers age 18-75.
* Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

* Planning a pregnancy, pregnant, or lactating
* Current addiction to opiates, cocaine, or stimulants
* Skin allergies or chronic dermatitis (based on medical history/self-report)
* An Axis 1 major psychiatric disorder
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma

This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
* Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.
* Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria
* There are measurable lesions present
* The function of main organs is normal.
* Subjects need to adopt effective methods of contraception.

Exclusion Criteria:

* Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
* Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication
* Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
* Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication
* Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment
* Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication
* Subjects who have experienced arterial/venous thrombotic event occurred within 6 months prior to the first administration
* Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders;
* Subjects with any severe and/or uncontrolled disease
* According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
Use of Probiotics in Oral Health of Patients With Dental Implants

The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri Prodentis upon the peri-implant health of edentulous patients with dental implants and peri-implant mucositis, establishing comparisons versus implants without peri-implant disease. The hypothesis of the study is that using these probiotics are going to improve the periimplant health.

A double-blind, placebo-controlled, prospective cross-over study was made. All the patients were edentulous and were divided into two groups: A) with no peri-implant disease; B) with peri-implant mucositis affecting one or more implants. Patients with peri-implantitis were excluded. All patients in both groups initially received the oral probiotic Lactobacillus reuteri Prodentis, followed by placebo. Only the supervisor of the study knew this information; clinical examiner and patients were blind. Were studied: crevicular fluid volume, modified plaque index, probing depth, modified gingival index, and concentrations of interleukin 1β, interleukin 6 and interleukin 8, and Bacterial load.

Eligibility Criteria:
Inclusion Criteria:

* Totally edentulous patients subjected to dental implant rehabilitation in one or both arches
* Prosthetic restoration in function for at least 24 months
* Healthy individuals without known disease

Exclusion Criteria:

* Patients receiving any kind of local or systemic decontamination treatment of the oral cavity (e.g., antibiotics or rinses) in the last 3 months, or periodontal treatment in the last 6 months
* Uncontrolled periodontal disease
* Patients with immune deficiencies, diabetes, rheumatoid disease, head and neck radiotherapy, bisphosphonate treatment, chemotherapy or anticoagulation
* Patients with dental implants presenting intraoral exposure of the rough portion of any implant
* Smokers
* Incomplete protocols due to a lack of patient cooperation: a) failure to follow the treatment instructions; b) failure to report to the visit after one month of follow-up
* Failure to provide informed consent to participation the study
* Patients presenting at least one implant with peri-implantitis
The Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Health and the Skin Microbiome in Photoaged Skin

This study is a double-blind randomized vehicle-controlled study assessing how Zinc Di-(dibutyryl lisinate) (Z-DBL) influences skin biophysical measures such as skin hydration, transepidermal water loss, and elasticity, as well as its effects on the skin microbiome of photoaged skin.


Eligibility Criteria:
Inclusion Criteria:

* Females between the ages of 40 years of age until 60 years of age
* Participants must have facial fine lines and wrinkles
* Subjects must minimize sun exposure
* Subjects must avoid professional or facial spa procedures during the study

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* Those who are unwilling to discontinue topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
* Those who are unwilling to discontinue topical antibiotics and benzoyl peroxide for two weeks to meet the washout criteria prior to enrolling.
* Those who have been on an oral antibiotic within 1 month prior to enrolling.
* Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
* Those who are unwilling to discontinue all facial topical products except the product provided in the study.
* Individuals who have changed any of their hormonal based contraception within 3. months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Efficacy of a Desensitizing Agent During At-home Bleaching

The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching.

1. Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient. A positioning guide tray will be fabricated for color measurement.
2. Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products) and one syringe of desensitizing agent (UltraEZ, Ultradent Products) or placebo (glycerin), according to their study group. Both the desensitizing agent and placebo will be dispensed in identical syringes, coded as A and B, to ensure the blinding of the study; only the clinician responsible for randomization knows the coding. Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record the degree of dental sensitivity .
3. Visit 3: First-week bleaching review. Data collection (color + sensitivity).
4. Visit 4: Second-week bleaching review. Data collection (color + sensitivity).
5. Visit 5: Third-week bleaching review and end of the study. Data collection (color + sensitivity).

Eligibility Criteria:
Inclusion Criteria:

* No oral or systemic pathology
* Periodontally healthy
* No cavities
* Tooth shade of the upper and lower canines A2 or darker

Exclusion Criteria:

* Adhesive restorations or prostheses in the anterior region
* Enamel or dentin alterations
* Smoking
* Pregnant women
* Undergone prior bleaching treatment
A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

This Phase 1 study is planned to establish the clinical safety and pharmacokinetics profile of multiple dose of LT3001 drug product and to investigate drug interactions of LT3001 with potential concomitant medications in healthy subjects.

This study is a two-part study. Part A is double-blind, placebo-controlled, and will examine the safety and PK profiles of multiple doses of LT3001 drug product in healthy subjects. Part B is open-label and will assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban or dabigatran.

Eligibility Criteria:
Inclusion Criteria:

* Subject's body weight is ≥50 kg and BMI is within the range of 18 to 32
* Subject is a healthy volunteer.
* Subject's PT, aPTT, and TT are within the normal laboratory range.
* Subject is a nonsmoker

Exclusion Criteria:

* Subject has a current or recent history of regular alcohol consumption.
* Subjects who are enrolled in Part B and allergic to acetylsalicylic acid, other salicylates, clopidogrel, thienopyridines (eg, ticlopidine, prasugrel), apixaban or dabigatran.
* Part B Cohort 2 only: subjects who are poor metabolizers of clopidogrel (CYP2C19\*2/\*2, \*2/\*3, or \*3/\*3 genotype)
* Subject has a presence or history of coagulation abnormality.
* Subjects need to receive a surgery or clinical procedures associated with high bleeding risk.
* Subject has a history of minor bleeding episodes, eg, epistaxis, rectal bleeding, gingival bleeding.
* Subject has a history of peptic ulcer or gastrointestinal bleeding.
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite

The objective of this study is to determine the satiety value of different bran fibers on appetite \& subsequent food intake with acute consumption. Satiety will be measured subjectively by visual analogue scales (VAS).

Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes

Eligibility Criteria:
Inclusion Criteria:

* healthy women between the ages of 18-40
* body mass index between 18.5-29.9kg/m2
* eat breakfast regularly
* nonsmoking
* not taking weight loss medications
* non-dieting (weight stable over the past 3 months)
* spoken and written English literacy.

Exclusion Criteria:

* antibiotic use within the past 6 months
* cardiovascular disease
* diabetes mellitus
* cancer in the past 5 years
* renal or hepatic disease
* recent bacterial infection
* gastrointestinal conditions affecting digestion or absorption
* weight loss\>5kg in prior 3 months (intentional or unintentional)
* history of drug or alcohol abuse in prior 6 months
* food allergies
* high fiber intake(3 or more servings of high fiber foods per day)
* lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
* restrained eater(score\>10 on the dietary restraint factor of the Three Factor Eating Questionnaire)
* concurrent or recent (within 30 days) participation in an intervention study.
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).


Eligibility Criteria:
Inclusion Criteria:

* Aged 3 to \< 12 months
* Diagnosis of AD fulfilling the diagnostic criteria of Seymour
* AD affecting at least 5% total body surface area
* Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
* Informed consent

Exclusion Criteria:

* Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
* Topical tacrolimus or pimecrolimus within 2 weeks
* Topical therapy (e.g., tar, topical corticosteroids) within 3 days
* Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
* Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
* Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
* Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
* Clinical conditions other than AD that according to investigator can interfere with the evaluation
Fluid Overload Quantification in Septic Shock

Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies.

Several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients.

The Body Composition Monitor (BCM) allow for measurement of total body water (TBW), extracellular water (ECW) and intracellular water (ICW) volumes using bioimpedancemetry. The BCW is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. The BCM has never been validated in septic shock patients.

The aim of the study is to investigate the accuracy of the BCM to measure the variation of the TBW during a fluid challenge of 500 ml of saline during the early phase of septic shock.

Patients suffering from septic shock admitted in our critical care unit for less than 24 hours will be eligible. TBW, ECW and ICW volumes will be measured using the BCM just before (T0), just at the end (T1) and 1 h after the end (T2) of a fluid challenge of 500 ml of saline. Fluid responsiveness will be assessed using trans thoracic echocardiography (TTE). TTE will be performed at T0, T1 and T2. Blood samples will be obtained at T0, T1 and T2 to dose biomarkers of endothelial dysfunction and of capillary leak. The effectiveness of fluid challenge on microcirculation will be investigated by measuring the tissue perfusion index of the urethral mucosa using the IKORUS UP device.

Patients will be followed until Day 28 after admission in the critical care unit.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged from 18 to 80 years old
* Admitted to ICU for septic shock for less than 24 h
* Fluid resuscitation decided by intensivist
* Patient affiliated to a social security system or recipient of a such system
* Patient/proxy not opposed to the study

Exclusion Criteria:

* Subject with amputation of 1 or more limbs
* Body mass index \> 35 kg.m-2 ou \< 18 kg.m-2
* Impossibility of setting up an arterial catheter for invasive blood pressure monitoring and / or a central venous catheter in the upper cava territory
* Patient with pacemaker and / or implantable cardioverter defibrillator
* Quality of cardio echo image insufficient to allow studied parameters measurement
* Moribund subject ( life expectancy expected less than 48 hours)
* Uncontrolled intracranial hypertension (intracranial pressure ≥ 20 mm Hg by ICP monitoring or by a pulsatility index ≥ 1.30 in the transcranial Doppler)
* Patient under ECMO/ECLS
* Legal incapacity or limited legal capacity
* Subject without health insurance
* Pregnant woman
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
Double-blind Comparative Study of SYR-472

The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Epidemiology of Venous Disease

To conduct several studies on the epidemiology of venous disease.

BACKGROUND:

Venous disease is commonplace, more prevalent in women, increases with age, and is a major cause of morbidity. Between 6 and 30 percent of all medical expenditures for cardiovascular disease are for venous disease. Despite these facts, the basic epidemiology of venous disease has received limited attention. Even the definition of peripheral venous disease varies widely, often confusing symptoms and signs with demonstrable pathophysiologic abnormalities.

This study provided estimates of the extent of peripheral venous disease, contributed to more efficient diagnosis, allowed insight on how to prevent or ameliorate this condition through risk factor modification, and provided quantitative estimates of the daily burden this disease imposes on patients.

DESIGN NARRATIVE:

The overall, and age, sex, and ethnic-specific, prevalence of peripheral venous disease was determined in a stratified multiethnic random sample of 2,408 men and women aged 29 to 91 years. Three specific categories of venous disease were defined including: telangiectasias and flat reticular veins; superficial venous disease without deep valvular incompetence or obstruction; deep venous disease, with valvular incompetence or obstruction. Varicose veins were typically but not invariably present in the latter two categories. These three categories were diagnosed by an ordered non-invasive evaluation, including visual inspection, with photographic documentation of abnormal findings, and duplex color sonography to diagnose valvular incompetence and venous obstruction.

An evaluation was made of the sensitivity, specificity, and predictive value of each of the traditional signs and symptoms of venous disease for each of the three categories of venous disease. Signs and symptoms evaluated included aching, itching, swelling and edema, heaviness, cramps, nocturnal restless legs, pigmentation, induration, ulcers, and the Trendelenburg test. Risk factors were evaluated for each of the above three categories-of venous disease. Risk factors assessed included age; sex; ethnicity; socioeconomic status; height; weight; obesity; exercise; blood pressure; standing versus sitting in daily activities; family history of venous disease; cigarette smoking; alcohol consumption; diet; constipation; constrictive clothing; aspirin use; use of selected other medications; history of hernia, flat feet, or other conditions associated with connective tissue laxity; parity; use of estrogens or progestins; age at menarche; age at menopause; and concomitant arterial disease. Finally, an evaluation was made of the degree of morbidity and interference with daily activities resulting from venous disease, using the Quality of Well Being (QWB) scale developed at University of California at San Diego.

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