louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05001646: Electromagnetic Field Protection Device Use Impact in Healthy Volunteers
Official title: Clinical and Molecular Impact of In-home Resonance-based Electromagnetic Field Protection Device Usage in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aging
Aging Well
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
Collaborators: name: Blushield USA
First posted: 2021-08-12
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single group, self-controlled study to evaluate the clinical and molecular impact of continuous in-home resonance-based electromagnetic field (EMF) protection device usage in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Any sex, gender orientation, and ethnicity
* Between ages 30 and 70
* Must be willing and able to participate in venipuncture, health history and clinical assessments, passive monitoring (Oura ring), and continuous in-home Blushield device usage

Exclusion Criteria:

* Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition 2. Any ongoing immune system concerns or immunodeficiency disease
* History of any viral illness in preceding year
* Body mass index (BMI) \> 35 kg/m2
* Presence of active infection
* Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable
* Unable or unwilling to provide required biological sample
* Unable or unwilling to avoid pregnancy during study period

Primary outcomes:
measure: Epigenetic Testing
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hernandez-Segura A, Nehme J, Demaria M. Hallmarks of Cellular Senescence. Trends Cell Biol. 2018 Jun;28(6):436-453. doi: 10.1016/j.tcb.2018.02.001. Epub 2018 Feb 21.
citation: Karipidis K, Mate R, Urban D, Tinker R, Wood A. 5G mobile networks and health-a state-of-the-science review of the research into low-level RF fields above 6 GHz. J Expo Sci Environ Epidemiol. 2021 Jul;31(4):585-605. doi: 10.1038/s41370-021-00297-6. Epub 2021 Mar 16.
citation: Kohli J, Wang B, Brandenburg SM, Basisty N, Evangelou K, Varela-Eirin M, Campisi J, Schilling B, Gorgoulis V, Demaria M. Algorithmic assessment of cellular senescence in experimental and clinical specimens. Nat Protoc. 2021 May;16(5):2471-2498. doi: 10.1038/s41596-021-00505-5. Epub 2021 Apr 28.
Clinical trial NCT04732546: Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
Official title: Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mullerian Anomaly of Vagina
Mullerian Anomaly of Uterus, Nec
Mullerian Anomaly of Cervix
Keywords: Mullerian anomaly
Diagnostic tools
Surgical treatment
Reproductive function
Obstetric complications
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 1000
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed and/or treated in the Ghent University Hospital

Brief summary: The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Detailed description: Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Eligibility criteria: Inclusion Criteria:

* women with a uterus
* presence of a mullerian variation
* Maximum age 45y

Exclusion Criteria:

* women without a uterus
* aged \>45y

Primary outcomes:
measure: Fertility
timeFrame: 10 years after trying to conceive
measure: Fertility
timeFrame: 18 weeks after conception
measure: Surgical approach
timeFrame: during surgery
measure: Surgical success
timeFrame: 15 years after surgery
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: at the time of diagnostic workup
measure: Obstetric complications
timeFrame: 1 year after conception
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Ghent
state: East Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Tjalina Hamerlynck
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03436446: Role of Social Incentives in PRO Collection
Official title: Using Social Incentives to Increase Response Rate to Routine Patient Reported Outcome Measurement After Episodic Healthcare Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Keywords: Patient Reported Outcomes (PRO)
Social Incentives
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include post-operative orthopedic patients.

Brief summary: Value-based healthcare is heavily dependent on the accurate measurement of patient outcomes, both immediately after treatment and at long-term intervals. Patient reported outcomes (PROs) are often the central component of any quality improvement process as they are patient centered, reflect the ultimate objective of the intervention and are endorsed by many professional societies as the preferred physician performance metric. Although high response rates are critical to producing reliable data to support value-based payment models, quality improvement, and stakeholder transparency - especially in arthroscopy in which patients often fare well over time and may be less likely to continue with follow-up - response rates to outcome surveys after initial recovery from treatment are consistently below 50%. Monetary incentives offer only minor improvements in response rates against large increases in already rising costs. Individually tailored social incentives - as grounded in current behavioral economic practice - offer a potential cost-effective solution to this problem in Sports Medicine and arthroscopy.

The investigators predict that well-constructed, personal social incentives will increase response rates for long-term follow-up of episodic care compared to control. The investigators predict these rates will vary depending on the patient demographics and other characteristics.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Orthopedic patient
* 6-24 months post-operative

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Interview feedback
timeFrame: End of discussion with patient, 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard C Mather III, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981769: POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Official title: POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Anavasi Diagnostics
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 125
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible subjects presenting to clinical site for Covid-19 testing

Brief summary: Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.

Detailed description: Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.

Eligibility criteria: Inclusion Criteria:

* Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.

Exclusion Criteria:

* Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing

Primary outcomes:
measure: Covid-19 PCR test result
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06237569: Dose Low Dose Ketamine in Casesarian
Official title: Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Pain
Postpartum Depression
Keywords: midazolam with low dose ketamine
low dose ketamine
postoperatıve analgesıc need
postpartum depression
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cesarean section under spinal anesthesia

Brief summary: The results of ketamine, ketamine and midazolom and placebo can be copied after birth in cesareans subjected to spinal anesthesia.

Detailed description: Postpartum depression will be evaluated by dividing the patients into 3 groups: group 1 as ketamine, group 2 as ketamine and midasom, and group 3 as placebo group.

Eligibility criteria: Inclusion Criteria:

American Society of Anesthesiologists 2-.3 18 -45years old Patients planned to be born by cesarean section The patient requests a cesarean section with spinal anesthesia

ExclusionCriteria:

Pathological obstetric complications

Hypertension

Contraindication for ketamine Contraindication for spinal

Primary outcomes:
measure: postpartum depression
timeFrame: 4 weeks
measure: intraoperative complications
timeFrame: 1 day
measure: postoperative pain
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu universitesi
Study officials:
affiliation: Inonu University
name: DUYGU DEMIROZ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912769: Knee Muscle Force Recovery After Minimally Invasive Surgery (MIS) Total Knee Replacement (TKR)
Official title: Outcome and Benefit After Total Knee Arthroplasty: Natural History of Muscle Power Recovery and Difference Between Different Surgical Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement Approach
Muscle Torque
Keywords: Total knee replacement
Subvastus
Midvastus
Isokinetic
Quadriceps
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after total knee replacement without severe systemic disorders

Brief summary: To compare muscle torque recovery between patients under subvastus approach and those under midvastus approach after total knee replacement

Detailed description: Total knee Arthroplasty is a common operated surgery in each hospitals, and a lots of patients benefit from this surgery. Traditionally the frequently used surgical approach is parapatellar approach. However, recently the subvastus and midvastus approach has gained a world-wide population. These two methods had less damage to the quadriceps tendon and theoretically should have better post-operative muscle power recovery, less lateral retinaculum release because of better patellar tracking. The only differences between these two approaches are that the midvastus approach will split the vastus medialis muscle and denervation may occur. In this study we will use HSS or KSS functional score and Cybex dynamometer to evaluate the functional recovery, and use Merchant's view radiography to evaluate the result of patellar tracking. The follow-up period will not be limited and we will use mixed-model statistic's random effect to gain the natural history of muscle power recovery, which will become the base of other study. We can also compare the difference of results between PS type and CR type and different surgical approach. The natural history of the knee score will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Patients after subvastus approach or midvastus approach total knee replacement

Exclusion Criteria:

* patients with severe hypertension, heart disease or other problems which negatively influence the security of muscle test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Ciao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei
Study officials:
References:
Clinical trial NCT01090869: Physical Training Per se
Official title: Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.

Detailed description: At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests:

* Cardio respiratory fitness
* blood pressure
* anthropometric measures

At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity.

Tissue and blood samples were also collected for further analysis:

* Total-protein analysis of selected proteins
* Fasting plasma glucose, insulin and free fatty acids

Eligibility criteria: Inclusion Criteria:

* Overweight (body mass index 25-30 kg/m2)
* Weight stable (±2 kg during the past 6 months)
* Body fat% \>25%,
* Maximal oxygen uptake \<45 mL/min/kg
* Sedentary and healthy according to interview
* Fasting glucose \<6.1 mmol/L
* Blood pressure \<140/90 mmHg
* No first degree relatives with type-2-diabetes

Exclusion Criteria:

* Resistance training
* Inability to meet intervention criteria

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: week 0 and 13
Secondary outcomes:
measure: Changes in body composition
timeFrame: DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences
Study officials:
affiliation: University of Copenhagen
name: Pernille Nordby, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825669: Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
Official title: A Randomized Controlled Trial of Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Portal vein tumor thrombus
laser ablation
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 100
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: Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.

Detailed description: Hepatectomy is still the treatment of choice for hepatocellular carcinoma, but the prognosis is not agreeable. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might further increase the pressure of portal vein and lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment available now for PVTT yet. TACE is mostly often used to treat the PVTT. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.

Eligibility criteria: Inclusion Criteria:

1. PVTT after liver resection was diagnosed with at least two types of imaging findings, such as CT, MRI or color doplor findings.
2. The functions of the kidney, heart and lung and the routine test of the blood are in good condition.
3. The liver function is of grade A or B in Child-Pugh classification.
4. The patient is eligible of the trial and will show consent to the test.

Exclusion Criteria:

1. any of the parameters. WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml.
2. disfunction of the heart, lung, kidney, or brain.
3. any other disease might affect the trial .
4. the patients would not sign the consent to the trial.

Primary outcomes:
measure: overall survival
timeFrame: 2010
Secondary outcomes:
measure: the changes of the PVTT
timeFrame: 2010
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University
name: shen feng, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT04011969: The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer
Official title: The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer: Next-generation Sequencing (NGS) as a Screening Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: chronic inflammation
young-onset colorectal cancer
gut microbiome
NGS
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected with colorectal cancer who come to our hospital to conduct colonoscopy procedure will be recruited for this study and will undergo a series of examinations. Since this is a pilot study to obtain gut microbiome pattern on colorectal cancer patients, the number of samples is determined by the researchers: 100 subjects for neoplasm and 50 subjects for non-neoplasm (according to histopathology report)

Brief summary: This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 35 years old
2. Suspected with colorectal cancer and undergoing a colonoscopy procedure
3. No history of colorectal cancer treatment

Exclusion Criteria:

1. Unwilling to provide fecal and blood sample
2. Incomplete colonoscopy procedure due to any reasons

Primary outcomes:
measure: Gut microbiome
timeFrame: pre-colonoscopy, approximately 1 day before colonoscopy
measure: Asia Pacific Colorectal Screening (APCS) score
timeFrame: pre-colonoscopy, approximately 1 day before colonoscopy
measure: Carcinoembryonic antigen (CEA) serum level
timeFrame: pre-colonoscopy, approximately 1 day before colonoscopy
measure: Presence of NF-ҡB
timeFrame: pre-colonoscopy, approximately 1 day before colonoscopy
measure: Fecal immunochemical test (FIT)
timeFrame: pre-colonoscopy, approximately 1 day before colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Murdani Abdullah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366769: Evaluation of Outcomes Following LASIK Surgery Using CustomVue
Official title: Evaluation of Visual Outcomes, Contrast Sensitivity, Glare, and Induction of High Order Aberrations Following LASIK Surgery Using CustomVue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Myopic Astigmatism
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.


Eligibility criteria: Inclusion Criteria:

* Myopia 0.00 to -6.00 D
* Astigmatism 0.00 up to -3.00 D
* Manifest refraction spherical equivalent (MRSE) up to -6.00 D.

Exclusion Criteria:

* History of ocular pathology
* Previous ocular surgery
* Large pupils (greater than 8mm diameter, infrared measurement)
* Thin corneas (preoperatively calculated minimal residual bed \< 250 um)
* Irregular astigmatism
* Asymmetric astigmatism
* Unstable refraction
* Any other condition that precludes the patient from undergoing LASIK

Primary outcomes:
measure: Visual acuity
measure: Induction of high order aberrations
Secondary outcomes:
measure: Contrast sensitivity & glare
measure: Patient satisfaction
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Kerry D. Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: