cyrilzakka/clinical-trials huggingface dataset:
Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin

The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults (ages 18 years or older)
* Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
* Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Women,
* aged from 18 to 50 years old the day of their surgery,
* had a bariatric surgery in Poitiers university hospital center (France),
* are under french social security system.

Exclusion Criteria:

* to be under guardianship or tutelage measures
* to express opposition to participate to this study.
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer


Eligibility Criteria:
Inclusion Criteria:

* Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months.

Exclusion Criteria:

* Known or documented brain metastases prior to Cetuximab therapy.
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations

This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI \> 40 kg/m2 will have even greater clearance than those who are leaner.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.
* We are recruiting 6 normal weight (BMI \<25 kg/m2), 6 obese (BMI 25-40 kg/m2), and 6 extremely obese (BMI \> 40 kg/m2) for this study. Half of each group will be male, the other half will be female.

Exclusion Criteria:

* Creatinine clearance \< 70 ml/min as estimated by the Cockcroft-Gault equation.
* Pregnant or nursing or unwilling to use a reliable contraception method during the study period. The effects of ethambutol on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ethambutol, so that the pregnancy and post-partum state would be a confounding variable.
* Abnormal liver function tests: transaminases \>10 time the upper limit of normal, alkaline phosphatase \> 5 time the upper limit of normal, total bilirubin \>5 time the upper limit of normal.
* History of allergy to ethambutol.
* Ethambutol is contraindicated for any reason.
* Suspected or documented mycobacterial infection.
* History of gout.
Culture-Based Multicomponent Cognitive Training Program

To provide care without exacerbating behavioral and psychological problems and preventing functional decline, a multi-component, cognitive training program was designed. The purpose of this study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods.

The purpose of the study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods. This study was a 4-month cluster-randomized controlled trail. Participants who met sample selection criteria were recruited and assigned to either the experimental group or the comparison group, depending on the day-care center they attended. Subjects in the experimental group were received with the multi-component, cognitive training program (MCCTP) via research assistants (RAs) and caregivers of day care center for 8 weeks, then provide by caregivers of day care center for 8 weeks, as well as RAs provided assistance for activity process.

Eligibility Criteria:
Inclusion Criteria:

1. persons aged 60 years and over, (2) living in their own home, (3) with or without a hearing device and able to speak Mandarin or Taiwanese, (4) attending a day care centre at least three days per week, (5) cognitively impaired as determined by a score of 22 or lower on the Mini-Mental State Examination (MMSE), and (6) self or legal proxy agreed to participate in the study.

Exclusion Criteria:

- Persons were excluded if they were bedridden and unable to sit in a wheelchair or had one or more acute illnesses during the data collection period causing them to be unable to return to the day care centre.
Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs

Dose Escalation study

Eligibility Criteria:
Inclusion Criteria:

* Patients with CF aged 18 years and above colonized with P. aeruginosa
* Normal subjects ages 18 and above without CF or p. aeruginosa

Exclusion Criteria:

* for patients and volunteers will include the presence of asthma, allergic rhinitis, pregnancy, a history of gastric or duodenal ulcer, smoking, and a baseline FEV1 less than 60% of predicted normal value and a pulmonary exacerbation within the last 2 weeks as defined by use of systemic antibiotic
DPBRN Longitudinal Study of Repaired or Replaced Dental Restorations

The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN "Reasons for replacement and repair of dental restorations" study, and the factors affecting how long the fillings last.

The study is an observational follow-up of previously placed dental restorations (fillings)and is conducted during routing dental care visits.

Eligibility Criteria:
Inclusion Criteria:

* participant in the DPBRN "Reasons for replacement or repair of dental restorations" study
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
* Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

* Not applicable
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
* Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
* Part 1: Subjects with advanced or metastatic solid tumors.
* Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
* Presence of measureable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group performance status 0 or 1.

Exclusion Criteria:

* Laboratory and medical history parameters not within the protocol-defined range.
* Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
* Receipt of a live vaccine within 30 days of planned start of study drug.
* Active autoimmune disease that required systemic treatment in the past.
A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy

Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social phobia.

To the investigator´s knowledge, no study has yet directly compared live-CBT to Internet therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered via the Internet. The study is considered to be an equivalence trial. 128 patients will be randomly assigned to one of the two treatment conditions. The primary outcome measure is Liebowitz Social Anxiety Scale (LSAS).


Eligibility Criteria:
Inclusion Criteria:

* Must have a primary diagnosis of social phobia

Exclusion Criteria:

* Substance abuse during the last 6 months
* Other dominating diagnosis (not phobic personality disorder)
* A history of bipolar disorder or psychosis
* Major depression according to DSM-IV and \>20 on madrs-s
* Risk of suicide
* Start of medication or change of dosis during the last 2 months
* Other parallel psychological treatment
* Previous CBT (last 3 years) for social phobia
Tailored Versus Traditional Resistance Exercise

Preserving functional ability is crucial for healthy aging. Unfortunately, age-related decreases in muscle power often lead to declines in functional ability. As power is the product of force and velocity, decreases in power can originate from changes in muscle force, contraction velocity, or both, varying between individuals. The primary method to prevent functional disability is power-based resistance training. Although training interventions are effective for most older adults, they do not induce substantial improvements in a subset of the population. These inconsistent outcomes may arise from neglecting the observed differences in the force-velocity (F-v) profiles between individuals. Therefore, this study provides a novel approach to resistance exercise, in which exercise dose is tailored according to the individual's F-v profile. The effectiveness of the tailored method will be assessed in a randomized control trial, comparing the effects of an individualized and a non-individualized 12-week training intervention on muscle power parameters and functional ability.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults
* 65-80 years old

Exclusion Criteria:

* Systematic engagement in resistance exercise during the past year
* Unstable cardiovascular disease, neuromuscular disease, acute infection or fever
* Recent surgery
* Lower-extremity injuries
* Low levels of functional ability (i.e., SPPB score ≤ 9)
* Cognitive malfunctioning (i.e., Mini-Mental State Examination \< 24)
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies

This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies


Eligibility Criteria:
Inclusion criteria:

* Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
* World Health Organization (WHO) performance status ≤ 2
* Patients who met protocol-specified hematologic and non-hematologic laboratory values
* Patients with adequate liver and renal function

Exclusion criteria:

* Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
* Peripheral neuropathy ≥ CTCAE grade 2
* Unresolved diarrhea ≥ CTCAE grade 2
* Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
* Female patients who were pregnant or breast feeding
* Patients who were unwilling to use an effective method of birth control
* Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
* Patients with another primary malignancy that required active intervention or were clinically significant
Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood

Prospective study comparing hemodynamic and respiratory changes and exercise capacity during Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of premature infants and term controls

The study population included 4 groups of infants; preterm infants born \< 300 weeks' gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born \< 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks' gestation) and term controls.

Pulmonary function testing and spirometry were measured Participants performed CPET on an electronically braked cycle ergometer. During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained.

The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study.

Eligibility Criteria:
Inclusion Criteria:

* 7-10 years of age
* The ability to ride stationary bicycles as assessed by the parents.

Exclusion Criteria:

* Immobility
* An acute febrile or upper respiratory illness in the last 2 weeks
* The use systemic or inhaled steroids or antiepileptic drugs in the previous month
* Inhaled bronchodilator use in the previous 24 hours
* A chronic lung illness (with the exception of BPD and asthma)
* Congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale).
Soft Tissue Augmentation Around Immediate Implants In The Esthetic Zone

Following tooth loss, a considerable reduction in hard- and soft-tissue volume can be expected (Tan WL, et al., 2012), (AraujoMG, et al., 2015). In the anterior maxilla, tissue loss can make future implant restorations more challenging and less predictable in terms of achieving and maintaining favorable soft-tissue-emergence profiles. Even with careful implant planning and placement, marginal gingival recession of 0.5-1 mm has been a common finding with single-tooth implants (Nisapakultorn K, et al., 2010), (Suphanantachat S, et al., 2012). This is partly attributed to bone remodeling after implant surgery, and occurs regardless of implant-placement protocol used (Hof M, et al., 2015).

The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome. The advantage of the dome CT technique is that it allows for both buccal and coronal augmentation of local soft tissue, while maximizing blood supply to the area by using tunneling-technique principles. It enhances and augments the peri-implant tissue foundation for a favorable facial and interproximal restorative emergence profile. As this technique does not involve raising an independent buccal flap, the gingival tissue of the adjacent teeth is not compromised, and thus the risk of recession and formation of black triangles on the adjacent teeth is minimized.

Eligibility Criteria:
Inclusion Criteria:

* Patients with healthy systemic condition
* Patients aged from 20 to 45 years old Availability of bone apical and palatal to the socket to provide primary stability.
* Presence of adequate gingival architecture with the surrounding dentition
* Patient provides an informed consent
* Adequate Inter-arch space for implant placement
* Favorable occlusion (no traumatic occlusion)
* Good oral hygiene
* Accepts 6-month follow-up period

Exclusion Criteria:

* Patients with signs of acute infection related to the area of interest
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as para-functional habits
* Current and former smokers
* Pregnant females
* HIV or Hepatitis; 5/Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Alcoholism or chronic drug abuse; 7/ Heavy smokers \>10/cigarettes per day
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

Mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. Several forms of psychotherapy have been found to be effective in the treatment of depression. Among these, behavioral activation has a strong empirical base. The efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades.

Moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. It may also be possible to reduce the number of sessions.

Since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. Instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face CBT sessions and a smartphone app as a complement and support to the four sessions. As a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.

Eligibility Criteria:
Inclusion Criteria:

* depressive symptoms according to DSM-IV
* have access to a smartphone and to the Internet
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation
Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy

This study is a prospective randomised trial where a computer will randomly allocate

patients to one of two possible methods of delivering oxygen during the procedure of

bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in

delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-

bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.

HFNC uses humidified higher gas flow rates than conventional low flow systems such as

nasal prongs which are limited by the respiratory rate and effort.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air
* Age ≥ 18 years
* Able to breathe spontaneously throughout the procedure

Exclusion Criteria:

* Respiratory or cardiac failure
* Recent myocardial infarction \< 6 weeks ago
* On long term oxygen therapy, those with tracheostomy and/ or non-invasive or invasive mechanical ventilation
* Nasal and/ or nasopharyngeal disease
* Inability to give informed consent
* Dementia
* Hepatic or end stage renal disease
* Pregnancy
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life

The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).

Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Teeth and implants with keratinized gingiva width \<1 mm
* A healthy periodontal and peri-implant condition
* Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
* Patients who underwent implant surgery for the first oral surgery experience
* Maximum two teeth/implants on recipient area

Exclusion Criteria:

* Patients receiving any medication to disrupt wound healing
* Lactation or pregnancy
* Caries or defects on the tooth root surface
* Periapical lesion in the recipient area active periodontal disease
* Patients who have previously had periodontal or oral surgery experiences