louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04245007: Effect of Intermittent Fasting on Fat Mass
Official title: Effect of 8 Weeks 5:2 Intermittent Fasting on Fat Mass Among Obese Male Students Aged 18-25 in Indonesia University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obese
intermittent fasting
fat mass
body fat reduction
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to assess the different effect on fat mass between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male student aged 18-25. Female students are excluded because if they do any restriction intake during their menstruation period which is a lot of blood lost, it will be a risk for them.

This study is designed as non-blinding randomized control trial. Subject who adhere with less than 85 percent fasting (14 out of 16) will be dropped out from this study. Total sample in this study is 62 students which are 31 students for each group.

Detailed description: 5:2 intermittent fasting (IF) is eating pattern in which no or few calories are consumed for 13 hours (for 5 am to 6 pm) done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, without any requirement of water restriction.

Subjects will be distributed to each group by using randomization block of four.

This study will use 8 forms consist of; informed consent, subject selection form, re-anthropometric measurement form, questionnaire, semi quantitative food frequency questionnaire (SQ-FFQ), international physical activity questionnaire (IPAQ), food record book, and control and evaluation form. While the tolls are consist of food photograph book (to help in filling the food record book), body height scale, and bio-electrical impedance analysis (BIA) Seca medical body composition analyzer (mBCA) 515/514 (to measure body composition).

Eligibility criteria: Inclusion Criteria:

* obese male student age 18-25
* do not have experience on amputation
* willingness to participate in the whole study by signing informed consent

Exclusion Criteria:

* hypertrophy muscle students identified from body composition measurement
* in a certain diet at the moment
* consuming lipid-lowering drug at the moment
* doing regular fasting (2 days a week) for 2 months before the study begin
* suffer from chronic illness (confirmed by disease history form
* using electronic implants, for example pacemaker or pane
* using prostheses (artificial body part)

Primary outcomes:
measure: Fat mass
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Depok
country: Indonesia
facility: Indonesia University
state: West Java
Study officials:
affiliation: Indonesia University
name: Hadiyati HF Fudla
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03388307: Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis
Official title: Unilateral Decompression Approach for Lumbar Canal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.

Detailed description: Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord.

Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal .

The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes.

The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS.

Eligibility criteria: Inclusion Criteria:

1. age:40-80 years
2. sex:both sexes
3. symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
4. radiologically confirmed LSS , caused by degenerative changes
5. canal stenosis at a maximum of 2 levels

Exclusion Criteria:

1. were to undergo a concomitant fusion or instrumentation placement;
2. had had previous lumbar surgeries at the same level;
3. had spondylolisthesis of any grade or degenerative scoliosis;
4. had evidence of instability on dynamic radiographs.

Primary outcomes:
measure: back pain
timeFrame: one year
Secondary outcomes:
measure: neurogenic claudication pain
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00324207: Molecular Quantification of Insulin mRNA
Official title: Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Insulin mRNA
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital and clinic patients and their siblings.

Brief summary: The objectives of this study are to:

1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects,
2. determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects,
3. determine the identity of the white cell responsible for expression of insulin mRNA and
4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.

Detailed description: Indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. Currently there are no reliable indicators readily available.

Insulin mRNA in the white cell fraction of blood has been detected or elevated under several circumstances including:

1. normal animals
2. after islet cell transplantation
3. hyperglycemic induced expression and
4. during induction of diabetes with streptozotocin

The investigators propose that quantitative measurement of insulin mRNA may be an accurate, innovative and minimally invasive indicator of beta cell destruction.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects ages 1 to 17 years of age
2. Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity
3. Subjects with new onset type 1 diabetes
4. Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes
5. Unrelated nondiabetic controls with no family history of type 1 diabetes
6. Of sufficient size to donate 10ml of blood

Exclusion Criteria:

None if subjects meet above inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Wayne Moore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04203407: Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults
Official title: Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game on Self-efficacy and ACP Behaviors Among Chinese Older Adults: a Mixed Method Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Game
Older Adults
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Xihu community healthcare service centre
name: Guanshaling community healthcare service centre
First posted: 2019-12-18
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults. This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt focus group interviews for data collection. Recruited subjects from the community centres will be randomly allocated to the intervention and control group. The older adults in the experimental group will receive an ACP board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle. The outcome measures of the older adults will include the ACP Engagement scale, the Life-Support Preferences Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month (T3). The qualitative arm of this study will contribute to the understanding of issues and effects of ACP game as an intervention. Its finding will complement the results obtained from the RCT.


Eligibility criteria: Inclusion Criteria:

* aged 60 years or over;
* speak Chinese.

Exclusion Criteria:

* uncommunicable because of language barrier or sensory impairment;
* have been referred to the palliative care service at the time of recruitment.

Primary outcomes:
measure: Advance Care Planning Engagement Scale
timeFrame: 3 months
Secondary outcomes:
measure: Certainty rate of end-of-life preferences toward medical care
timeFrame: 3 months
measure: Self-develped ACP knowledge questionnaire
timeFrame: 3 months
Other outcomes:
measure: Change of emotional status
timeFrame: Immediate post-intervention
measure: Experience of playing ACP game
timeFrame: Immediate post-intervention
Locations:
city: Changsha
country: China
facility: Xihu community, guanshaling community
state: Hunan
Study officials:
affiliation: Chinese University of Hong Kong
name: Li LIU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316107: A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients
Official title: Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With Nateglinide in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Nateglinide Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: ASP1941
long-term safety
nateglinide
Diabetes mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed description: This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: change from baseline in hemoglobin A1c (HbA1c)
timeFrame: baseline and for 24 weeks
Secondary outcomes:
measure: change from baseline in fasting plasma glucose
timeFrame: baseline and for 24 weeks
measure: change from baseline in fasting serum insulin
timeFrame: baseline and for 24 weeks
measure: Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
timeFrame: for 52 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04628507: Cell Free Preimplantation Genetic Testing
Official title: Evaluation of Cell Free Preimplantation Genetic Testing
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infertility, Female
Infertility, Male
Keywords: PGT
Noninvasive
Lead sponsor: Genomic Prediction Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing IVF electing to utilize LifeView testing who consented for embryo spent media collection and analysis.

Brief summary: This study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). Genetic testing of culture media will be compared to conventional methods based on embryo biopsies.

Detailed description: Consenting patients will receive standard clinical IVF and PGT. Culture media from embryos will be collected for analysis. Collection of media will include laser assisted collapse of the blastocyst on day 5, 6, or 7 in order to release blastocoel fluid into the culture media. Embryos diagnosed as aneuploid or monogenic disorder affected (abnormal embryos) will be donated for additional analysis with patient consent.

Results obtained from culture media will not be provided to the patients. The information obtained from cf-PGT will be compared to results obtained from embryo biopsies obtained as part of routine PGT and evaluated for concordance and reliability. Abnormal embryos will be rebiopsied (\~3 to 4 times) to evaluate concordance with cf-PGT and the original clinical trophectoderm biopsy PGT results.

All cases will be labelled using a 5-digit barcode and embryo number or saliva source code. Because PGT will be conducted under clinical regulatory approval (CAP and CLIA), patient information will be protected under HIPAA guidelines, including sending reports in encrypted secure email per standard operating procedures. All publications and presentations will maintain de-identification of any patient data used.

Patients may withdraw from the study at any time by contacting the principal investigator of their respective recruiting site. They will continue to receive standard of care through their treating IVF center. A recruitment target of 200 patients is intended for this study.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF electing to utilize LifeView testing (PGT) will be offered participation in this study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Concordance with PGT
timeFrame: 14 dyas
Secondary outcomes:
Other outcomes:
Locations:
city: North Brunswick
country: United States
facility: Genomic Prediction Clinical Laboratory
state: New Jersey
Study officials:
References:
Clinical trial NCT04927507: Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing
Official title: Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Injuries
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 140
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: Rotator cuff injury patients treated with ERAS were included. The control group was given routine nursing. The observation group was given the Internet plus nursing home rehabilitation mode.

Relying on mobile app and wechat, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.


Eligibility criteria: Inclusion Criteria:

* Rotator cuff injury
* ERAS surgery treatment
* Full thickness tear of rotator cuff, The range of tear is 1cm-3cm

Exclusion Criteria:

* Surgery not applicable
* Combined with other injuries, malignant tumor, disabilities, mental illness, critically ill patients, pregnant women, illiteracy, minors, cognitive impairment

Primary outcomes:
measure: The Constant-Murley score
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Ping Qian
Study officials:
References:
Clinical trial NCT02001207: Salivary Cortisol in Intensive Care Unit
Official title: Association of Salivary Cortisol Levels and Outcome of Critically Ill Patients in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit in Seoul National University Hospital

Brief summary: In critical illness, patients are highly stressed and should have elevated cortisol (stress hormone) secretion to adapt to stress. Dysfunction of this system is referred to as critical illness-related corticosteroid insufficiency. Free cortisol (unbound form) which is mainly responsible for its physiologic function is difficult to measure. We hypothesized that the salivary cortisol, which can be obtained by noninvasive methods, can more accurately evaluate adrenal function of critically ill patients.


Eligibility criteria: Inclusion Criteria:

* patients who agreed to participate

Exclusion Criteria:

* Known adrenal or pituitary disease
* oral bleeding
* currently on systemic or inhaled corticosteroids

Primary outcomes:
measure: Overall mortality
timeFrame: 28 days
Secondary outcomes:
measure: ICU days
timeFrame: 28 days
measure: ventilator-free days
timeFrame: 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Sang-Min Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244007: Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy
Official title: Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Disease
Keywords: macular hole
lamellar macular hole
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eyes with macular hole or lamellar macular hole

Brief summary: We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Detailed description: We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Eligibility criteria: Inclusion Criteria: Eyes with macular hole or lamellar macular hole -

Exclusion Criteria: Eyes with retinal detachment, retinal vascular disease, glaucoma

-

Primary outcomes:
measure: Recovery of microstructure
timeFrame: 6 months
Secondary outcomes:
measure: Visual improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Mitaka-shi
country: Japan
facility: Makoto Inoue
state: Tokyo
Study officials:
affiliation: Korin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References: