louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04224246: Impact of Gamma-OH on Sleep in ICU Patients
Official title: Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean from Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Weaning from Mechanical Ventilation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.


Eligibility criteria: Inclusion Criteria:

* intubated at least 24 hours
* difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
* Patients will be included after to obtain inform consent.

Exclusion Criteria:

* neuromuscular disease
* central nervous disease
* psychiatric disease
* severe obesity

Primary outcomes:
measure: Proportion of patients having poor sleep with Gamma-OH
timeFrame: Hour24
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT04128046: The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation
Official title: The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation: A Split Face Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Rejuvenation
Skin Quality
Wrinkle
Nasolabial Fold
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10
* Agreed to continue any contraceptive hormonal therapy for duration of the study
* Agreed to not initiate the use of hormonal therapy during the study
* Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study
* Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day
* Agreed to refrain from excessive sun exposure/tanning

Exclusion Criteria:

* History of skin/connective tissue disorders
* History of immunosuppressive therapy or radiotherapy
* Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months
* Use of topical/prescription acne medications in the last three months
* Current smokers or prior smokers who quit fewer than 10 years ago

Primary outcomes:
measure: Change in VISIA skin score
timeFrame: Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Secondary outcomes:
measure: Change in Wrinkle Severity Rating Scale
timeFrame: Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment
measure: Skin Rejuvenation Outcomes Evaluation (SROE)
timeFrame: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
measure: VISIA Outcomes Questionnaire
timeFrame: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
References:
Clinical trial NCT03643146: Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in CVD
Official title: Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the proposed project is to evaluate the usability, acceptability, and adherence of a lifestyle and behavioral self-tracking and ePersuasive tool aimed at improving: 1) adherence to diet/nutrition (\<1500 mg of sodium/day and less than 10% daily free sugar intake), physical activity (PA) (150 minutes of moderate PA/week), and sleep guidelines (7-8 hours of sleep/day)-- and 2) control 3% reduction in systolic BP and glucose from baseline to end of study follow-up after 2 months (exploratory objective) in a sample of 20 patients with Hypertension or Diabetes. The study will utilize a Step-Wedge Design where the 20 patients will be divided into 4 wedges (5 patients in each wedge).


Eligibility criteria: Inclusion Criteria:

* NYU and/or Bellevue patient
* Diagnosed with HTN and pre-diabetes/diabetes
* Must be English speakers
* Ownership of a smart phone and are willing to use it to download app built in TrialX which will be free for participants
* Must be ambulatory

Exclusion Criteria:

* are unable or unwilling to provide informed consent;
* are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
* are pregnant, are currently trying to become pregnant, or who become pregnant during the study
* are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
* have had or are planning to have bariatric surgery during the study
* have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)

Primary outcomes:
measure: User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey
timeFrame: 12 Months
measure: Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Azizi Seixas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687046: A Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults Using Real-World Evidence
Official title: A Real-World Evidence Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chin Retrusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants receive VOLUX treatment at Hainan Boao Super Hospital, with screening and follow-up visits at Hainan Boao Super Hospital or another hospital.

Brief summary: This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.

Detailed description: There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.

Eligibility criteria: Inclusion Criteria:

-Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.

Exclusion Criteria:

* History of hypersensitivity to lidocaine,HA, or Streptococcal protein
* History of tendency to develop hypertrophic scarring
* Untreated epilepsy or porphyria
* Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area
* Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
* Permanent filler, semi-permanent filler, or fat injected in the treatment area
* Temporary filler, other than VOLUX, injected in the treatment area within 12 months before enrollment
* Females who self-report current pregnancy or breastfeeding

Primary outcomes:
measure: Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 3
measure: Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
timeFrame: Month 3
measure: The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits
timeFrame: Month 1, 3, 6, and 12
measure: The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits
timeFrame: Month 1, 3, 6, and 12
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Hainan Boao Super Hospital /ID# 235968
state: Hainan
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03247946: The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Official title: The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding and Eating Disorders
Keywords: infant
feeding position
respiratory
ear
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 163
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 month old infants were recruited from 2 Mother-Child-Health clinics and followed for 12 months. Mothers from intervention group were instructed to feed their babies (88 infants) with their head in upright position. Mothers from control group (75 infants) fed their infant regularly without any instructions . Respiratory and ear morbidity were evaluated during the following 12 month period.
Primary purpose: PREVENTION

Brief summary: Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year?

Detailed description: The investigators examined the influence of teaching mothers to feed infants with their head in an upright position and evaluated the infant ear and respiratory morbidity during a one-year follow-up. Mothers of 88 infants born during 2011 were instructed by trained nurses at Maternal-Child-Health clinics to feed their infants with their head in upright position (intervention group). The control group consisted of 75 mothers of infants of similar socioeconomic background who fed their infant regularly without any instructions and were followed at another Maternal-Child-Health clinic. Feeding position was evaluated at the beginning and the end of the study, and morbidity data of both groups were evaluated at every 3-month follow-up meeting. The study was part of the PhD thesis of Efrat Danino, Head Nurse of Pediatric Department at Hadassah Medical Organization.

Eligibility criteria: Inclusion Criteria:

* healthy 3 month old infants, bottle fed at least once a day, parent agreeing to participate

Exclusion Criteria:

* Prematurity, need of supplemental oxygen, broncho-pulmonary dysplasia, cystic fibrosis, familial dysautonomia, cleft lip or cleft palate, any ear-throat-lung or airway congenital anomaly, congenital heart disease, any other chronic disease of childhood or malignancy

Primary outcomes:
measure: Infant morbidity
timeFrame: every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up
Secondary outcomes:
measure: Feeding position angle
timeFrame: at beginning and end of study (1 year follow up)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
citation: Tully SB, Bar-Haim Y, Bradley RL. Abnormal tympanography after supine bottle feeding. J Pediatr. 1995 Jun;126(6):S105-11. doi: 10.1016/s0022-3476(95)90249-x.
Clinical trial NCT01123746: Utility of Laboratory Testing for Children With Seizure in Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizure
Keywords: Seizure
electrolyte
risk factor
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients who come to wanfang hospital due to seizure

Brief summary: Objective: To evaluate the predisposing factors associated with abnormal laboratory findings in patients who came to the emergency room due to a first seizure.

Methods: Patients were divided into separate groups based on normal and abnormal laboratory results for sodium, potassium, calcium, and glucose. The difference in age, gender, whether this was the first attack, whether there was fever, whether there were gastrointestinal symptoms, the duration and pattern of the seizure, and whether there was a seizure at the emergency department, were evaluated.


Eligibility criteria: Inclusion Criteria:

* Age: less than 18 years old
* The patient came to emergency department due to seizure
* The patient received blood sampling including serum sodium, potassium, calcium and glucose.

Exclusion Criteria:

* The patient came to the outpatient department.
* The patient did not received blood sampling at emergency room.
* The seizure occurred after admission.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-WanFang Hospital
Study officials:
affiliation: Pediatrics department, Wanfang hospital
name: Hsiao-Feng Chou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01438346: Behavioral Treatment for Substance Abuse
Official title: A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Substance Abuse
Substance Addiction
Substance Dependence
Treatment program
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.

Detailed description: This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse. Both groups will run concurrently over the course of a 10-week period, twice per week.

Eligibility criteria: Inclusion Criteria:

* Substance abuse or dependence
* Resident/day client in the House of Hope substance abuse treatment program
* Minimum stay in treatment at House of Hope for 3.5 months
* Fluent in English

Exclusion Criteria:

* Psychosis
* Suicide risk
* Dementia
* Significant withdrawal risk
* Severe, unstable depression
* Requires intensive mental health treatment
* Cognitive impairment

Primary outcomes:
measure: Change from baseline in the measure of the Penn Alcohol and Craving Scale
timeFrame: Week 5 and Week 11
measure: Change from baseline in Alcohol and Drug Use Consequences Scale
timeFrame: Week 5 and Week 11
Secondary outcomes:
measure: Subjective distress
timeFrame: Pre (Baseline) Mid (Week 5), Post (Week 11)
measure: Depression
timeFrame: Pre (Baseline) Mid (Week 5), Post (Week 11)
measure: Sleep
timeFrame: Pre (Baseline) Mid (Week 5), Post (Week 11)
measure: Mindfulness
timeFrame: Pre (Baseline) Mid (Week 5), Post (Week 11)
measure: Self-Compassion
timeFrame: Pre (Baseline) Mid (Week 5), Post (Week 11)
measure: Well-being
timeFrame: Weekly for 11 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: House of Hope
state: Utah
city: Salt Lake City
country: United States
facility: Pain Research Center, Anesthesiology, University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshi Nakamura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00615446: A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
Official title: A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: solid tumor malignancy, SU011248, sunitinib, neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
* Patient has good performance status (ECOG 0 or 1)

Exclusion Criteria:

* Prior treatment with either gemcitabine or SU011248
* Hypertension that cannot be controlled by medications

Primary outcomes:
measure: To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
timeFrame: From screening until at least 28 days beyond discontinuation of study treatment
Secondary outcomes:
measure: To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered
timeFrame: From screening until at least 28 days beyond discontinuation of study treatment
measure: To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease
timeFrame: From screening until at least 28 days beyond discontinuation of study treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Michaelson MD, Zhu AX, Ryan DP, McDermott DF, Shapiro GI, Tye L, Chen I, Stephenson P, Patyna S, Ruiz-Garcia A, Schwarzberg AB. Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study. Br J Cancer. 2013 Apr 16;108(7):1393-401. doi: 10.1038/bjc.2013.96. Epub 2013 Mar 19.
Clinical trial NCT00508846: Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients
Official title: Screening for Gynecologic Cancers Among Women With Hereditary Non-Polyposis Colon Cancer (HNPCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Hereditary Non-Polyposis Colon Cancer
Gynecologic Cancers
Genetic Counseling
Questionnaire
Survey
HNPCC
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-30
Enrollment: 93
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, age 25 years of age or older, diagnosed with Hereditary Non-Polyposis Colon Cancer (HNPCC).

Brief summary: Among women with HNPCC, this study will assess:

1. Knowledge of screening recommendations for endometrial and ovarian cancers.
2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.
4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
5. Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
6. Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.

Detailed description: Women who are at risk for HNPCC will be recruited to participate in this pilot study.

Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.

Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.

Eligibility criteria: Inclusion Criteria:

1. Being female
2. Being 25 years of age or older
3. Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC

Exclusion Criteria:

1. Persons who have tested negative for a known HNPCC-predisposing mutation in their family
2. Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
3. Being younger than 25 years old
4. Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.

Primary outcomes:
measure: Patient Responses to Questionnaire
timeFrame: 7 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References: