louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03966924: The PREFORM Study: Rotational Fractional Resection for Submental Contouring
Official title: The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lipodystrophy
Keywords: submental
laxity
lipodystrophy
Lead sponsor: Recros Medica, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-29
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.

Detailed description: This is a prospective, single-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female
* At least 30 years old
* Moderate to severe submental laxity
* Up to moderate submental lipodystrophy
* Agree to maintain weight (±5%) for the duration of the study

Exclusion Criteria:

* Previous intervention to treat submental fat or skin laxity
* Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
* Severe acne, cystic acne or acne scars on neck
* Trauma of chin or neck area
* Skin infection or rash on neck
* Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo
* History of scarring
* Body mass index (BMI) \>30
* Clinically significant bleeding disorder
* Anemia, kidney disease, or liver disease

Primary outcomes:
measure: Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
timeFrame: 90 days post treatment
Secondary outcomes:
measure: Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
timeFrame: 90 days post treatment
measure: Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale
timeFrame: 90 days post treatment
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Steve Yoelin, MD Medical Associates, Inc.
state: California
Study officials:
affiliation: Recros Medica
name: Robin McIntosh
role: STUDY_DIRECTOR
References:
Clinical trial NCT02305524: Intubation During Adult Intubation
Official title: Evaluation of Chest Compression Effect on Airway Management With he Visualized Tracheoscopic Ventilation Tube and the Macintosh Laryngoscopy by Novice Paramedics: a Randomized Crossover Simulation Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: endotracheal intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Time to intubation
timeFrame: 1 day
measure: Cormack-Lehan scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
References:
Clinical trial NCT05448924: Isolated Growth Hormone Deficiency and Amennorrhea
Official title: Isolated Growth Hormone Deficiency and Amennorrhea: Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Keywords: ISOLATED GROWTH HORMONE DEFICIENCY
AMENORRHEA
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This 14-year old female came to the gynaecology clinic with a chief complaint of amenorrhea

Brief summary: This is a case report of a 14-year old female with no menstruation history.

Detailed description: This is a case report of a 14-year-old with a chief complaint of inability to menstruate. Lab tests were done.

Eligibility criteria: Inclusion Criteria:

* A single female participant with amenorrhea

Exclusion Criteria:

* The study only included the above subject

Primary outcomes:
measure: Growth hormone levels
timeFrame: 1 month after testing
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Department of Obstetrics and Gynecology, Universitas Padjadjaran
state: West Java
Study officials:
References:
citation: Crottaz B, Uske A, Reymond MJ, Rey F, Temler E, Germond M, Gomez F. Normogonadotropic primary amenorrhea in a growth hormone-deficient woman with ectopic posterior pituitary: gonadotropin pulsatility and follicle-stimulating hormone bioactivity. J Endocrinol Invest. 1996 Jan;19(1):48-53. doi: 10.1007/BF03347858.
Clinical trial NCT01673724: Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
Official title: Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 121
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

Detailed description: PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

SECONDARY OBJECTIVE

* Evaluate the improvement for Depression which is one of the Nonmotor symptoms
* Evaluate the improvement of clinical symptoms between two groups
* Evaluate the improvement of Quality of Life between two groups

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease patients in accordance with UK Queensquare Brain Bank
* modified Hoehn \& Yahr stage \<3
* Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.

Exclusion Criteria:

* K-MMSE\<24
* History of drug-induced Parkinsonism
* secondary parkinsonism
* History of schizophrenia or hallucination
* Requirement of treatment with anti-depressants due to depressive disorder
* Pregnant and/or breeding women
* Renal inadequacy

Primary outcomes:
measure: K-NMSS
timeFrame: 24 weeks
Secondary outcomes:
measure: K-MADRS
timeFrame: 24 weeks
measure: UPDRS I/II/III
timeFrame: 24 weeks
measure: K-PDQ39
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Youngnam University Hospital
city: Kangwon
country: Korea, Republic of
facility: Kangwon Nat'l University Hospital
city: Seoul
country: Korea, Republic of
facility: Inje university Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Seongbeom Koh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931224: Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D660 Monotherapy in Essential Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 346
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy


Eligibility criteria: Inclusion Criteria:

* Subjects who are 19 years old or older.
* Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

1. Subjects with a history of secondary hypertension or suspected secondary hypertension
2. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
3. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
4. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
5. Subjects who received other clinical trial drugs within 4 weeks of screening visit.
6. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
7. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Primary outcomes:
measure: Change from baseline in MSSBP
timeFrame: 8 weeks after drug administrations
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Inho Chae, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04666324: Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies
Official title: Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infantile Colic
Lead sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic.

Detailed description: Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Multilac Baby). Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries. Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland), a quantitative immunoassay.

Eligibility criteria: Inclusion Criteria:

* diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria:

* previous treatment with probiotic or synbiotic
* previous treatment with antibiotics

Primary outcomes:
measure: Change of days of crying
timeFrame: Three weeks
measure: Change of average duration of evening crying
timeFrame: Three weeks
measure: Change of fecal calprotectin values
timeFrame: 1-30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brody
country: Poland
facility: GP Clinic "Panaceum"
city: Koziegłowy
country: Poland
facility: GP Clinic "Pro Familia"
Study officials:
affiliation: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
name: Hanna Krauss, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.
citation: Sommermeyer H, Bernatek M, Pszczola M, Krauss H, Piatek J. Supporting the diagnosis of infantile colic by a point of care measurement of fecal calprotectin. Front Pediatr. 2022 Sep 29;10:978545. doi: 10.3389/fped.2022.978545. eCollection 2022.
citation: Bernatek M, Piatek J, Pszczola M, Krauss H, Antczak J, Maciukajc P, Sommermeyer H. Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study. Microorganisms. 2022 Feb 12;10(2):430. doi: 10.3390/microorganisms10020430.
Clinical trial NCT05129124: Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Official title: Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch and Lomb Site 01
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00888524: Plus Deep Water Running on Low Back Pain
Official title: Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: head out water immersion,
high intensity exercise,
evidence-based physiotherapy;
aquatics;
hydrotherapy
aquatics therapy
exercise therapy
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state.

Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a week. Each group received EBP (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of DWR at the individualized aerobic threshold. Measurements were made pre and post intervention for pain, disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.


Eligibility criteria: Inclusion Criteria:

* Participants were diagnosed with non-specific CLBP, with no radiation to the legs, and lasting at least three months

Exclusion Criteria:

* Low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome
* Patients not able to follow instructions
* Patients with any digressive condition

Primary outcomes:
measure: pain in VAS
timeFrame: scale 0 -100, pre and post intervention and follow up 6 and 12 month
Secondary outcomes:
measure: disability RMQ
timeFrame: scale 0-24, pre and post intervention and follow up 6 and 12 month
measure: general (mental and physical) health state with SF-12
timeFrame: scale 0 -100, pre and post intervention and follow up 6 and 12 month
measure: functional Measurements: range on motion in degrees with inclinometer dual, strength with lineal dynamometer (newton) and endurance muscular with soerensen test (seconds)
timeFrame: scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: School Medicine University of Malaga
Study officials:
affiliation: University of Malaga
name: Antonio Cuesta-Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01117324: Bone Density of Large Newborn Infants and Infants of Diabetic Mothers
Official title: Bone Density of Large Newborn Infants and Infants of Diabetic Mothers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Density
Keywords: Bone density
infant of diabetic mother
large birth weight
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy term infants of birth weight 4 kg and above and infants of diabetic mothers

Brief summary: Bone density was found to be impaired among lage babies and infants of diabetic mothers as found in small group studies. The assumption is that large weight decreases fetal movements and causes decreased bone mineralization.The aim of the study is to compare 2 study groups - of large infants and infants of diabetic mothers to each other and to controls.


Eligibility criteria: Inclusion Criteria:

* Term infants of birth weight 4 kg and above, and
* Infants of diabetic mothers.

Exclusion Criteria:

* Preterms,
* Major congenital malformations,
* Sick babies.

Primary outcomes:
measure: Bone density
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01764724: Attitudes and Understanding of Sodium Claims on Food Labels
Official title: Consumer Attitudes and Understanding of Low Sodium Claims on Food: An Analysis of Healthy and Hypertensive Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Attitudes and understanding of sodium claims
General canadian population
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Advance Foods and Materials Network
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Stroke Network
First posted: 2013-01-10
Enrollment: 987
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A subsection of the Canadian Consumer Monitor Panel - a national representative online consumer panel comprised of 30,000 Canadians

Brief summary: Sodium-related claims on food labels should help people find lower sodium food choices; however consumer attitudes and understanding of such claims are unknown.

The objective of this study was to evaluate: 1) the attitudes and understanding to different types of permitted sodium claims and 2) the effect of hypertension on responses to such claims.


Eligibility criteria: Inclusion Criteria:

* Primary grocery shoppers
* Canadian adults between the ages 20 to 69 years

Exclusion Criteria:

* Did not have an email address or have access to internet

Primary outcomes:
measure: Response to survey questions measuring attitudes towards sodium claims using 5 point likert rating scales
timeFrame: On average the survey took 25 minutes to complete
measure: Response to survey questions evaluating participants understanding of sodium claims
timeFrame: On average the survey took 25 minutes to complete
Secondary outcomes:
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Toronto
name: Mary R L'Abbé, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong CL, Arcand J, Mendoza J, Henson SJ, Qi Y, Lou W, L'Abbe MR. Consumer attitudes and understanding of low-sodium claims on food: an analysis of healthy and hypertensive individuals. Am J Clin Nutr. 2013 Jun;97(6):1288-98. doi: 10.3945/ajcn.112.052910. Epub 2013 Apr 10.