cyrilzakka/clinical-trials huggingface dataset:
Cosmetic Products and Facial Skin Microbiome

The skin microbiome diversity in female healthy volunteers will be studied along with cosmetic products application in 1 month period. This study is also aimed to investigate the efficacy of cosmetic products on skin rejuvenation. .

The study is conducted in COVID-19 pandemic era, thus every person involved in this study must follow health protocol for COVID-19.

The study procedure, consist of screening visit (D -7), 7-day wash out, baseline visit (D 0), first follow up ( D 14), and second follow up (D 28).

1. Screening visit: obtained Informed Consent, COVID-19 detection by swab RT-PCR, and inclusion and exclusion criteria, wash out product dispensing, and subject's diary dispensing.
2. Baseline visit: Investigator will check vital signs, facial skin value by Cutometer, Mexameter, Sebumeter, Corneometer, Colorimeter, Tewameter, dan pH meter, and kin taping by Corneofix tape. Investigational Products will dispensed in this visit for 2 weeks usage.
3. First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.
4. Second follow up: Investigator will check vital signs, facial skin value, and skin taping by Corneofix tape.

All adverse events (AEs) occurred during study will be recorded in Case Report Form.

Eligibility Criteria:
Inclusion Criteria:

1. female 18-35 years old
2. signed the informed consent

Exclusion Criteria:

1. infected by COVID-19
2. females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy
3. females with ongoing skin treatments.
The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.

A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Overweight to obese men and women (BMI ≥ 25 kg/m2 \<35 kg/m2)
* Aged 20-50 years
* Caucasian
* Normal fasting glucose (\<6.1 mmol/L.)
* Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
* Weight stable in last 3 months (±2 kg)
* A low defecation frequency, \<4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
* A slow whole gut transit (\>35h)

Exclusion Criteria:

* Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
* Regular smokers
* People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
* Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
* Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
* Following a hypocaloric diet
* Gluten intolerance
* Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
* More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as

  1. Straining in \>1/4 defecations;
  2. Lumpy or hard stools in \>1/4 defecations;
  3. Sensation of incomplete evacuation in \>1/4 defecations;
  4. Sensation of anorectal obstruction/blockade in \>1/4 defecations
  5. Manual maneuvers to facilitate \>1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
  6. \<3 defecations/week
* Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
* Not to be able to understand the study information
* Blood donation 2 months prior to the study and during the study
* Participation in other studies
The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector

The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

Eligibility Criteria:
Inclusion Criteria:

* currently on sick leave for burnout
* employed in the Swedish healthcare services as a nurse or as a physician

Exclusion Criteria:

-
Development of a New Method for Liver Stiffness Measurement Using FibroScan

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
* Adult patient able to give his written consent
* Patient affiliated to the French Social Security system

Exclusion Criteria:

* Vulnerable patients
* Patients with liver ascites
* Patients with heart failure
The Impact of Implementing NIDCAP on the Developmental Sensitivity of Nurses Caring for Preterm Infants

The purpose of this study is to determine whether implementing the Newborn Individualized Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the developmental care needs of preterm infants.

Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU (Neonatal Intensive Care Unit) care that seeks to optimize the developmental course and outcomes for preterm infants. In controlled trials, implementation of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been associated with with positive medical and neurobehavioral outcomes. The purpose of this study is to examine the impact of implementing the NIDCAP on the developmental sensitivity of nurses caring for preterm infants in a tertiary level NICU in a children's hospital in the midwest. The NIDCAP program consists of 1) structured behavioral observations which are conducted at regular intervals during the preterm infant's hospitalization, 2) written plans which outline specific, individualized interventions to address the infant's unique developmental needs which are updated following each observation, and 3) consultations with the infant's caregivers to articulate the infant's current needs and plan. A convenience sample of 32 NICU nurses will be observed during a routine caregiving episode with one preterm infant before and another preterm infant after the implementation of the NIDCAP program with preterm infants in the NICU. Following the observations, the nurse's developmental sensitivity will be scored using a standardized tool. The nurses' developmental sensitivity before the implementation of the NIDCAP program will be compared with their developmental sensitivity following NIDCAP implementation. Informed consent will be obtained from the nurses participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* be an RN,
* be an employee of the NICU at the study site,
* have completed the NICU nursing orientation at the study site,
* work at least 0.4 FTE in the NICU at the study site, and
* be observed while caring for a preterm infant born at less than or equal to 36 weeks gestation and at less than or equal to 1500 grams

Exclusion Criteria:

* Nurses will not be observed while caring for fullterm infants or preterm infants receiving heavy sedation or paralyzing medications.
Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.

This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.


Eligibility Criteria:
Inclusion Criteria:

* Age range ≥ 18 or ≤60.
* Both sexes.
* American Society of Anesthesiologists (ASA) II-III.
* Body mass index:18.5 to 30 kg/m2.
* Hemimandibulectomy patients with an anticipated difficult airway \[El-Ganzouri Risk Index (EGRI)\>3\].

Exclusion Criteria:

* Patient's refusal.
* Known allergy to drugs used in the study.
* Neurological disorders.
* Advanced liver or kidney disease.
* Patient with psychiatric disorders.
* Patient who needs postoperative ICU.
* Airway distortion and cervical spine movement.
Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.

Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. In clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ILD could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location.

Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore, immediate validation of optical measurements during a biopsy is possible. Optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant.

Hypothesis: Novel optical techniques (pCLE and pOCT) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ILD.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

  * Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy

Exclusion Criteria:

* Smoked in the last 6 months
* Inability and willingness to provide informed consent
* Inability to comply with the study protocol
A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age

This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.

This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling children and adolescents 2 to 17 years of age.
* Written Informed Consent or Assent.
* Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)
* Symptom onset less than 5 days prior to study visit.
* Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.

Exclusion Criteria:

* Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment
* Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results
* Concurrent enrollment in another clinical study

Patient already enrolled during this influenza season

* Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
Services Mapping Among Older Adults With Hip Fracture

Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public health issue in China. The British Orthopedic Association and the British Geriatric Society have published the UK Blue Book, which summarizes current evidence and best practice in the hip fracture care and secondary prevention, but this kind of standardized practice in hip fracture care is not yet existed in China. The Blue Book standards will be used as the most contemporary evidence-based guidelines for management of hip fracture.This study is to prospectively examine the barriers and facilitators in the current management of hospital in China by comparing the Blue Book standards.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 years old or over;
* Hip fracture with X-ray-confirmed femoral neck, trochanteric or sub-trochanteric fracture;
* Within 21 days of a hip fracture;
* Willingness to sign informed consent form;

Exclusion Criteria:

* Patients with pathological fractures;
* With terminal malignancies.
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.


Eligibility Criteria:
Inclusion Criteria:

* New and existing allograft recipients
* All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers

Exclusion Criteria:

* Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).
Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study

A comparison of caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. The secondary objective is to assess participants experience with the s-IOT device.

The primary purpose of this study is to compare caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. Patient experience with the s-IOT device will be assess using a short questionnaire.

Fifty adult patients who have been referred to the Section of Oral and Maxillofacial Radiology (OMR) at the University of North Carolina (UNC) School of Dentistry (SOD) for horizontal bitewing (BW) radiographs or a Full Mouth Series (FMX) with horizontal bitewing radiographs will be recruited for the study.

Participants will receive an experimental s-IOT bitewing radiograph on each side of their mouth and a visual exam to look for caries. Experienced observers will assess the presence or absence of caries using the two imaging modalities. The results of their analysis will be evaluated to determine statistical difference. Participants completed questionnaires will be tabulated and the data will be analyzed using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Scheduled for horizontal BW or Full (FMX) with horizontal BWs
* Patients who have in the right and left maxilla and mandible at least a canine and two posterior teeth that are in contact
* At least one proximal caries lesion in a surface of a posterior tooth (premolar or molar) that is in contact with another tooth. Lesion depth can be incipient (outer half enamel), moderate (inner half enamel) or advanced (outer half dentin) as determined by conventional BW radiography.
* At least one non-carious proximal surface of a posterior tooth (premolar or molar) that is in contact with another tooth.
* Patients should be able to provide informed consent

Exclusion Criteria:

* Institutionalized subject (prisoners, nursing home, etc.) (identified by medical record)
* Critically ill or mentally unstable patients (identified by medical record)
* Patients with no radiographic caries of the posterior teeth as determined by conventional BW radiographs
* Patients with only severe caries lesions as determined by conventional BW radiographs
Duration of Antibiotic Treatment of Erythema Migrans

The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.


Eligibility Criteria:
Inclusion Criteria:

* solitary erythema migrans in patients \> 15 years

Exclusion Criteria:

* a history of Lyme borreliosis in the past
* pregnancy or lactation
* immunocompromised status
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis
Is Inpatient Rehabilitation Effective for Very Old Patients?

The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders.

The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? Data from about 2000 patients will be retrospectively analyzed. Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) were recorded on admission and discharge.

Researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve.

Inpatient rehabilitation has been shown to improve exercise capacity and quality of life in patients with neurological and musculoskeletal disorders.

Rehabilitation in Valens includes intensive strength and endurance training. Expectedly improvements in physical and mental performance measured by Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) is recognized after inpatient rehabilitation. But is this clinical effect in the same way represented in very old patients?

To the knowledge of the investigators only few studies evaluated changes after rehabilitation in patients with neurological and musculoskeletal disorders in very old patients.

Therefore, the primary goal of this study is to evaluate changes in physical and mental performance in patients with neurological and musculoskeletal disorders after inpatient rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* german speaking
* age \>74
* patients with neurological and musculoskeletal disorders

Exclusion Criteria:

* age \<75
* patients with pulmonological and internal disorders
Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients

The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent
* Age≥ 17 and \<80 years,
* Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)
* Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic medication therapy before, or having received anti-diabetic medication ≤ 14 days but not received any antidiabetic medication within the last 1 month prior to enrollment)
* HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

* Women of child bearing potential
* body mass index (BMI)≥35 Kg/m2 or BMI \<18.5 Kg/m2
* Hemoglobin A1c (HbA1c)\>10.0% or \<7.0%
* Active liver disease and/or significant abnormal liver function
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
* Congestive heart failure defined as New York Heart Association (NYHA) class III or IV and /or left ventricular ejection fraction ≤40%
* Significant cardiovascular history with the past 6 months
* Severe retinopathy, persistent uncontrolled hypertension (SBP≥180mmHg, or DBP≥105mmHg)
* Severe chronic gastrointestinal disease
* History of alcohol abuse or illegal drug abuse within the past 12 months
* Diagnosed anemia
* Creatine kinase ≥3 X ULN
* Serum creatinine ≥1.5 mg/dL(133μmol/L) \[males\], ≥1.4 mg/dL(124 μmol/L)\[females\]
* Alanine amino transferase (ALT) and/or aspartate amino transferase (AST)\> 1.5 X ULN and/or total bilirubin \> 2 X ULN
* Hemoglobin \<12g/dL \[males\], \<11g/dL \[females\]
* Allergies and Adverse Drug Reactions
* Prohibited Treatments and/or Therapies
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
* Subjects decline to participate