louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02363465: Echographic Measurement of Skin Thickness
Official title: Echographic Measurement of Skin Thickness at the Deltoid and Proximal Forearm in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Thickness
Keywords: skin thickness
high-frequency ultrasound
Lead sponsor: Novosanis NV
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited in the vicinity of the university and its university hospital of Antwerp, in the period of January 2015 until April 2015.

Brief summary: To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI.

Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Age: 18-65 years
* Dutch-speaking
* Caucasian

Exclusion Criteria:

* Pregnancy or lactating
* Using ointment, crème, or gels based on corticoids
* Suffering from skin diseases (psoriasis, burning wounds)

Primary outcomes:
measure: skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)
timeFrame: 10 minutes
measure: skin thickness (in milimeters) of the proximal forearm ventral (both left and right)
timeFrame: 10 minutes
measure: skin thickness (in milimeters) of the deltoid region (both left and right)
timeFrame: 10 minutes
Secondary outcomes:
measure: Body Mass Index
timeFrame: at the moment of entering the study
measure: Age
timeFrame: at the moment of entering the study
measure: sex
timeFrame: at the moment of entering the study
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken
state: Antwerp
Study officials:
affiliation: CEO
name: Vanessa Vankerckhoven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Mulder TJ, de Koeijer M, Theeten H, Willems D, Van Damme P, Demolder M, De Meyer G, Beyers KC, Vankerckhoven V. High frequency ultrasound to assess skin thickness in healthy adults. Vaccine. 2017 Mar 27;35(14):1810-1815. doi: 10.1016/j.vaccine.2016.07.039. Epub 2016 Aug 3.
Clinical trial NCT01007565: Postoperative Pain After Volar Plating for Distal Radius Fractures
Official title: Postoperative Pain After Volar Plating for Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Distal Radius Fractures
Keywords: periarticular injection
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2009-11-04
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators undertook to evaluate early postoperative pain levels after the volar plating of distal radius fractures performed under regional anesthesia, and to determine whether periarticular multimodal drug injections into the joint, ligament, periosteum, subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an additional sensory nerve block) provide additional pain management benefits.

Detailed description: To evaluate whether periarticular injections (PI) had additional pain management benefits, patients were randomly allocated to two groups, that is, the PI and No-PI groups, using a randomization table. Members in the PI group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure. For the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve.

A volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve. The anterior interosseous nerve was blocked in the course of the pronator quadratus and posterior interosseous nerve in the 4th dorsal extensor compartment.

The mixture of anesthetics consisted of 2 ampules of ropivacaine HCl (Naropin®, 0.75%, 7.5mg/ml, 20ml/ⓐ), 1 ampule of morphine sulfate (5mg/ⓐ), 1 ampule of epinephrine HCL (1mg/ml, 1ml/ⓐ) and normal saline 20cc.

Eligibility criteria: Inclusion Criteria:

* distal radius fracture with or without a styloid fracture not requiring surgery

Exclusion Criteria:

* multiple trauma
* a combined distal radio-ulnar joint instability or a large ulnar styloid fragment requiring fixation
* regularly narcotics user
* those with a psychiatric illness, a major systemic illness or a known allergy or contraindication to opiates or local anesthetics.

Primary outcomes:
measure: postoperative pain level
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of orthopedic surgery, Seoul national university bundang hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyun Sik Gong, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01574365: A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
Official title: A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Type 2 Diabetes
Keywords: CKD patients with type 2 diabetes
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Detailed description: To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus.

To evaluate the safety and tolerability of RTA 402.

Eligibility criteria: Inclusion Criteria:

* CKD patients with type 2 diabetes mellitus
* Patients whose eGFR levels are eligible for this study
* Patients being treated with stable dose of ACE inhibitors and/or ARB etc.

Exclusion Criteria:

* Patients with Type 1 diabetes
* Patients with known non-diabetic renal disease
* Patients with a history of renal transplantation
* Patients with mean SBP \> 160 mmHg or mean DBP \> 90 mmHg
* Patients with HbA1C \> 10%
* Patients with cardiovascular disease specified in the study protocol etc.

Primary outcomes:
measure: Efficacy:Changes in eGFR
timeFrame: Up to 16 weeks
measure: Adverse event collection and assessment
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: Baseline, week 4, 8 and 12.
Other outcomes:
Locations:
city: Toride City
country: Japan
state: Ibaraki
Study officials:
References:
Clinical trial NCT03900065: Flap Preconditioning by Intermittent Negative Pressure
Official title: Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Surgical Procedure
Flap Ischemia
Keywords: flap preconditioning
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial comparing no preconditioning to preconditioning.
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.

Detailed description: Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.

Eligibility criteria: Inclusion Criteria:

* All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.

Exclusion Criteria:

* Infection of skin of planned flap.

Primary outcomes:
measure: Percentage of hypoperfused skin island
timeFrame: up to 7 days postoperatively
measure: Skin oxygen saturation of distal flap
timeFrame: 1 day postoperative
Secondary outcomes:
measure: Wound complications
timeFrame: up to 12 weeks postoperatively
measure: VEGF expression in skin and muscle of flap
timeFrame: once during surgery
measure: Density of flap dermal vessels
timeFrame: once during surgery
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
state: NRW
Study officials:
affiliation: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
name: Björn Behr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
name: Mehran Dadras, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00653965: Treatment of Hypercholesterolaemia in Hispanic Subjects (STARSHIP)
Official title: A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in Hispanic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidaemia
Keywords: Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Atorvastatin
Lipitor
Hispanic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 3000
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 purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in Hispanic subjects with hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* Fasting low density lipoprotein \& triglyceride levels as defined by the protocol.
* Self described Hispanic race
* Subjects with coronary heart disease or at high risk of coronary heart disease.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Primary outcomes:
measure: Low density lipoproteins cholesterol levels
timeFrame: 6 weeks
Secondary outcomes:
measure: Other blood lipid level changes
timeFrame: 6 weeks
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: San Antonio, USA
name: Steve Haffner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT04305574: Social Media Use During COVID-19
Official title: Getting it Right: Towards Responsible Social Media Use During a Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Depression
Anxiety
Stress
Keywords: COVID-19
Social media
Communication
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 1145
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative sample of the Singapore population

Brief summary: The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.


Eligibility criteria: Inclusion Criteria:

* At least 21 years
* Has stayed in Singapore for at least 2 years

Exclusion Criteria:

* Below 21 years
* Has stayed in Singapore for less than 2 years

Primary outcomes:
measure: Depression, Anxiety and Stress Scale
timeFrame: Single measurement (upon study enrolment)
Secondary outcomes:
Other outcomes:
measure: Assessment of COVID-19 situation
timeFrame: Single measurement (upon study enrolment)
measure: Familiarity and trust in COVID-related rumours
timeFrame: Single measurement (upon study enrolment)
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
affiliation: Yale-NUS College
name: Jean Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu JCJ, Tong EMW. The Relation Between Official WhatsApp-Distributed COVID-19 News Exposure and Psychological Symptoms: Cross-Sectional Survey Study. J Med Internet Res. 2020 Sep 25;22(9):e22142. doi: 10.2196/22142.
Clinical trial NCT04642274: The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis
Official title: The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERAS
Keywords: ERAS
Cardiac surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.

Detailed description: The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery, thereby improving the overall prognosis of cardiac surgery patients, reducing the incidence of complications, and shortening the length of hospital stay.

Eligibility criteria: Inclusion Criteria:

* ASA II/III
* BMI 16.5-31 kg/㎡
* Elective cardiac surgery under CPB
* Volunteer to participate and sign informed consent

Exclusion Criteria:

* Redo cardiac surgery
* Patients who do not cooperate or cannot communicate
* Abusers of alcohol, drugs or narcotics
* Pregnant or Breastfeeding

Primary outcomes:
measure: Length of hospital stay
timeFrame: Within 1 month after surgery
Secondary outcomes:
measure: Duration of mechanical ventilation after surgery
timeFrame: Within 1 week after surgery
measure: Length of ICU stay
timeFrame: Within 1 month after surgery
measure: Mortality
timeFrame: Within 1 month after surgery
measure: Overall hospitalization costs
timeFrame: Within 3 months after surgery
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of AnHui Medical University
state: Anhui
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05894174: The Effect of Board Game-Based Nutrition Education on Primary School Children
Official title: The Effect of Board Game-Based Nutrition Education on Primary School Children's Nutrition Behaviors, Self-Efficacy and Attitudes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Assessment
Education
Child Behavior
Keywords: Dietary Intake
Behavior
Self Efficacy
Attitude
Lead sponsor: Istanbul Kent University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with the intervention group in which the game was applied and the control group
Primary purpose: TREATMENT

Brief summary: The purpose of this study to design a board game that will enable primary school children to recognize foods by enabling them to distinguish between healthy and unhealthy foods by going beyond the traditional education patterns and to compare the effects of this board game-based nutrition education intervention on children's behaviors, self-efficacy, and attitudes with the control group in which no intervention was made.

Detailed description: Nutrition is an important part of health and development. In particular, the gaining of healthy eating habits in early childhood promotes growth and development and reduces the risk of many non-communicable diseases, especially obesity. In order to create healthy societies in the future, nutrition education is one of the effective methods for developing healthy eating behaviors and raising awareness starting from childhood. Game-based education approaches provide motivation for learning information that is made a part of the game by going beyond traditional education methods. Board games are used in nutrition education by giving children the opportunity to think interactively and make different choices with their immersive stories and designs.

Eligibility criteria: Inclusion Criteria:

* In the 3 schools where the study will be carried out
* 4th grade student
* Does not have any physical disability related to vision, hearing and speech
* Without any chronic or metabolic disease

Exclusion Criteria:

* Having any chronic or metabolic disease
* Can't read and write

Primary outcomes:
measure: Change in Food Behavior Scale (FBS)
timeFrame: Baseline and four weeks
measure: Change in Children's Dietary Self- Efficacy Scale (CDSS)
timeFrame: Baseline and four weeks
measure: Change in Nutrition Attitude Subscale (NAS)
timeFrame: Baseline and four weeks
Secondary outcomes:
measure: Change in The Food Frequency Questionnaire (FFQ)
timeFrame: Baseline and four weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beyzanur Çamlıbel
state: Gaziosmanpaşa
Study officials:
affiliation: Istanbul Kent University
name: Beyzanur Çamlıbel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023774: Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure
Official title: Effects of Granulocyte Colony-stimulating Factor (GCSF)-Neupogen on Cases With Thin Endometrium or Previous Implantation Failure in ICSI Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Disorders
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 20
Sex: FEMALE
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment of thin endometrium or in women with recurrent implantation failure in ICSI cycles

Detailed description: Prospective analytical study which will be conducted at a private IVF center starting from june 2016.

the study will be recruited from both the fertility clinics and centers by fulfilling inclusion and exclusion criteria , all patient will be subjected to complete history taking medical and fertility history including previous induction or implantation failure.

patients will be randomized into two groups, group A will be treated with neupogen 30 international unit (IU) and group B will be treated with clexane 40mg and estrogen.

study procedure: ovaries were stimulated with standard protocol (long GnRH Agonist) or gonadotrophic releasing hormone (GnRH Antagonist, when at least 3 follicles achieved 18 mm diameter, Human chorionic gonadotrophic (hCG) (10000 IU) was administered for ovulation triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hCG . the oocytes were fertilized by intracytoplasmic sperm injection (ICSI) method. the thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which containing (300 mcg/1 ml) GCSF (neupogen) was infused slowly in the uterine cavity and after 5 days (before embryo transfer) endometrial thickness was evaluated again. all patients received oral and parenteral progesterone for luteal phase support.

Eligibility criteria: Inclusion Criteria:

* male partner with normal semen analysis according to world health organization (WHO) 2010.
* female partner under the age of 36 presented with: a-thin endometrium (less 7 mm on transvaginal ultrasound) or b- previous history multiple unexplained
* female with no history of Asherman's syndrome , fibroids, and polyps in diagnostic hysteroscopy

Exclusion Criteria:

* women with sickle cell disease, renal insufficiency, upper respiratory infection or pneumonia, chronic neutropenia, known past or present malignancy

Primary outcomes:
measure: increase in endometrial thickness (above 7 mm)
timeFrame: one week
Secondary outcomes:
measure: chemical pregnancy (serum beta hCG titre more than (25 mili liter international unit (mIU)/ml) and clinical pregnancy defined as the presence of an intrauterine gestational sac on transvaginal ultrasound (TVS)as 6 weeks.
timeFrame: 6 week
Other outcomes:
Locations:
Study officials:
References: