louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03161743: Calculation of Platelet-rich Plasma Preparation Yield
Official title: Calculation of Platelet-rich Plasma Preparation Yield From Baseline CBC Platelet Count
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet-rich Plasma Production
Keywords: platelet-rich plasma
platelet
Lead sponsor: Harrison, Theodore, M.D.
Sponsor class: INDIV
First posted: 2017-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal adults

Brief summary: This is a study to determine 1) the consistency of platelet-rich plasma produced by several methods, and 2) whether the platelet content of platelet-rich plasma can be accurately estimated from a baseline CBC platelet count.

Detailed description: In the first phase of this study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The platelet count will be measured in each PRP preparation and compared to the CBC platelet count to determine the platelet yield for each method.

In the second phase of the study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The CBC platelet count will be used to calculate the estimated platelet content of each sample/method based on the platelet yields determined in the first phase. The platelet count will be measured in each PRP preparation and compared to the estimated platelet content to determine the predictive accuracy for each method.

Eligibility criteria: Inclusion Criteria:

* English speaking

Exclusion Criteria:

* platelet count \< 150,000
* platelet count \> 350,000
* History of blood disorder
* History of altered platelet function
* History of chemotherapy or radiation therapy

Primary outcomes:
measure: Platelet yield
timeFrame: within 8 hours of blood draw
measure: Platelet yield estimate accuracy
timeFrame: within one month of final data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Sidney
country: Canada
facility: Theodore E Harrison
state: British Columbia
Study officials:
affiliation: Theodore Harrison
name: Theodore E Harrison
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03975543: Retrospective Natural History Study of Retinitis Pigmentosa
Official title: Natural History Study of Retinitis Pigmentosa in Patient Carrying Pathogenic Mutations in RHO, PDE6A or PDE6B.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinitis Pigmentosa (RP)
Keywords: Retinitis Pigmentosa
RHO
PDE6A
PDE6B
Pathogenic mutation
Retrospective
Natural History
Retinal Disease
Eye Diseases
Blindness
Inherited Eye Diseases
Vision Disorders
Inherited Retinal Disorders
Rod-Cone Dystrophy
Lead sponsor: SparingVision
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with RP caused by pathogenic mutations in RHO, PDE6A or PDE6B gene mutations.

Brief summary: This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6A or PDE6B gene mutations.

Detailed description: This is a retrospective, longitudinal, observational case history study to determine the natural history of rods and cones degeneration in patients diagnosed with RP caused by pathogenic mutations in genes with selective expression in rods: rhodopsin (RHO), phosphodiesterase 6A (PDE6A) or phosphodiesterase 6B (PDE6B).

113 participants will be enrolled in this study at the single center: CHNO-CIC Quinze-Vingt Paris in France.

Eligibility criteria: Inclusion Criteria:

* Patients with RP caused by pathogenic mutations in RHO, PDE6A or PDE6B genes.

Exclusion Criteria:

* Patients with a pathogenic mutation in any other gene known to be involved in RP.
* Patients with any ocular disorder other than RP, likely to impact the retinal function.

Primary outcomes:
measure: Visual acuity
timeFrame: 2 years
measure: Visual field
timeFrame: 2 years
measure: Spectral Domain Optical Coherence tomography (SD-OCT)
timeFrame: 2 years
measure: Fundus Autofluorescence (FAF)
timeFrame: 2 years
Secondary outcomes:
measure: Patients characteristics
timeFrame: 2 years
measure: Clinical diagnosis
timeFrame: baseline (At diagnosis)
measure: Genetic diagnosis
timeFrame: baseline (At diagnosis)
measure: Electroretinogram (ERG)
timeFrame: baseline (At diagnosis)
measure: Color vision
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: CHNO XV-XX Paris - CIC 1423
Study officials:
References:
Clinical trial NCT01190943: DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma
Official title: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Osteosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Osteosarcoma
Metastatic Osteosarcoma
Recurrent Osteosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-08-30
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PATIENTS WITH OSTEOSARCOMA WITH SPECIMENS COLLECTED AND BANKED ON THE OS BIOLOGY PROTOCOL (P9851) OR THE REPLACEMENT AOST06B1

Brief summary: This research study is studying DNA biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.

Detailed description: OBJECTIVES:

I. To comprehensively detect genomic, epigenomic, and transcriptomic aberrations in tissue samples from patients with osteosarcoma that may play a role in chemoresistance and metastasis using high-resolution genome-wide technologies.

II. To identify recurrent genetic mutations involved in the pathogenesis of osteosarcoma, especially for the development of chemoresistance and metastatic tumors.

III. To identify and validate these biomarkers for new therapeutic targets for patients with osteosarcoma, especially those with metastatic disease and whose tumors are resistant to standard chemotherapy.

OUTLINE: This is a multicenter study. Archived tumor tissue and peripheral blood DNA specimens are analyzed for DNA copy number profiling, gene expression profiling, DNA methylation profiling, microRNA profiling, and genomic resequencing. Clinical data including demographics; date of diagnosis, surgery, chemotherapy, recurrence, progression, and death; imaging; toxicity; and pathologic data elements associated with the specimens are also collected and analyzed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of osteosarcoma
* Fresh-frozen samples collected at the time of diagnosis with matchedblood DNA (preferred) from patients enrolled on the following osteosarcoma biology protocols:

  * COG-P9851
  * COG-AOST06B1
* Available clinical outcome data
* Not specified
* Not specified

Primary outcomes:
measure: Expression of genes
timeFrame: Baseline
measure: Incidence of copy number abberations
timeFrame: Baseline
measure: Incidence of mutations that occur at a clinically significant frequency
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Ching C Lau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756843: Early Orthodontic Treatment of Dental Crowding
Official title: Early Versus Late Orthodontic Treatment of Dental Crowding - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Crowding
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: City of Vantaa
First posted: 2021-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. The randomized controlled trial study will be conducted in a public health care center.


Eligibility criteria: Inclusion Criteria:

* Dental developmental stage of mixed dentition
* Crowding on both dental arches
* Skeletal discrepancy not suspected

Exclusion Criteria:

* National criteria for publicly funded treatment not met by the severity of the malocclusion
* Other malocclusions
* Angle Class III relationship of the molars
* Malocclusion related to a syndrome
* Non-compliance to orthodontic treatment

Primary outcomes:
measure: Treatment time
timeFrame: Up to 36 months
Secondary outcomes:
measure: Treatment burden
timeFrame: Up to 48 months
measure: Alignment of dental arches
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Heidi Arponen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06961643: Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function
Official title: Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.


Eligibility criteria: Inclusion Criteria:

1. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
2. Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18\~32 kg/m2 (including the threshold).

Exclusion Criteria:

1. In the judgment of the investigator, may be allergic to the study drug or its components.
2. Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
3. Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
4. History of drug or substance abuse, or a positive urine drug test at screening.
5. Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
6. Individuals with a history of severe hypoglycemia.
7. Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.

Primary outcomes:
measure: The maximum plasma concentration of HRS-7535 (Cmax)
timeFrame: Post-dose at day 1 to day 4.
measure: Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)
timeFrame: Post-dose at day 1 to day 4.
measure: Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
timeFrame: Post-dose at day 1 to day 4.
Secondary outcomes:
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Post-dose at day 1 to day 4.
measure: Terminal half-life (t1/2)
timeFrame: Post-dose at day 1 to day 4.
measure: Apparent clearance (CL/F)
timeFrame: Post-dose at day 1 to day 4.
measure: Apparent volume of distribution (Vz/F)
timeFrame: Post-dose at day 1 to day 4.
measure: Adverse events (AEs)
timeFrame: Screening period up to Day 7.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial Infectious Disease Hospital
state: Henan
Study officials:
References:
Clinical trial NCT00265343: 6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
Official title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 306
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 is an extension study to further test

the efficacy and safety of asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Continue to meet all demographic and procedural

inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

this extension trial.

* Have demonstrated an acceptable

degree of compliance and completed the 25543

trial, and would benefit from continued treatment

according to the investigator.

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant

medical condition.

* Have been judged to be medically

noncompliant in the management of their disease.

Primary outcomes:
measure: Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
timeFrame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Secondary outcomes:
measure: Change in Quality of Life Measured by Quality of Life Scale (QLS)
timeFrame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Other outcomes:
Locations:
Study officials:
References:
citation: Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
Clinical trial NCT03007043: Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response
Official title: Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes as a Causative Factor of Suboptimal Response Following Ovarian Stimulation for IVF/ICSI. A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Disorders
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women undergoing ovarian stimulation

Brief summary: To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation


Eligibility criteria: Inclusion Criteria:

1. Age between 18-38 years old
2. BMI 18-28
3. Antral follicle count (AFC) \> 9 or Anti-mullerian hormone (AMH) \>1.1 ng/ml
4. 1st or 2nd ovarian stimulation cycle for IVF/ICSI
5. Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol

Exclusion Criteria:

1. Antral follicle count (AFC) \<9 and AMH\<1.1 ng/ml
2. PCOS patients according to the Rotterdam criteria
3. Patients undergoing in vitro maturation (IVM)
4. Untreated endocrine abnormalities

Primary outcomes:
measure: prevalence of the main FSH receptor polymorphism
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dexeus Salud de la Mujer
city: Ho Chi Minh City
country: Vietnam
facility: Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam and Research Center for Genetics and Reproductive Health (CGRH), School of Medicine, Vietnam National University HCMC
Study officials:
References:
citation: Neves AR, Vuong NL, Blockeel C, Garcia S, Alviggi C, Spits C, Ma PQM, Ho MT, Tournaye H, Polyzos NP. The effect of polymorphisms in FSHR gene on late follicular phase progesterone and estradiol serum levels in predicted normoresponders. Hum Reprod. 2022 Oct 31;37(11):2646-2654. doi: 10.1093/humrep/deac193.
citation: Polyzos NP, Neves AR, Drakopoulos P, Spits C, Alvaro Mercadal B, Garcia S, Ma PQM, Le LH, Ho MT, Mertens J, Stoop D, Tournaye H, Vuong NL. The effect of polymorphisms in FSHR and FSHB genes on ovarian response: a prospective multicenter multinational study in Europe and Asia. Hum Reprod. 2021 May 17;36(6):1711-1721. doi: 10.1093/humrep/deab068.
Clinical trial NCT02158143: A Single High-dose Oral Supplement of Vitamin D in Young Chinese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2014-06-06
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.


Eligibility criteria: Inclusion Criteria:

* Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years;
* haven't taken vitamin D supplement for the past 6 months;
* with a normal BMI (18-25 kg/m2);
* with baseline serum 25(OH)D \< 30 ng/ml;
* be willing to follow the instruction and complete the study.

Exclusion Criteria:

* clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness;
* self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment;
* Severe anemia (hemoglobin concentration \< 70 g/L);
* Serum 25(OH)D ≥ 30 ng/mL at enrollment;
* participating in other research studies within the 3 months before enrollment;
* history of drug dependence or drug abuse;
* History of heavy drinking (drinking 14 cups or more per week, equivalent to 360 mL beer or 150 mL white wine or 45 mL liquor per cup) and smokers (more than 10 cigarette per day);
* clinical abnormal of blood biochemistry, hematology or urine laboratory values;
* current pregnancy or lactation.

Primary outcomes:
measure: Effect of vitamin D3 supplementation on serum 25(OH)D changes
timeFrame: within 140 day after supplementation
measure: Effect of vitamin D3 supplementation on serum PTH
timeFrame: within 140 day after supplementation
measure: Effect of vitamin D3 supplementation on serum calcium
timeFrame: within 140 day after supplementation
measure: Effect of vitamin D3 supplementation on serum creatinine
timeFrame: within 140 day of supplementation
measure: Effect of vitamin D3 supplementation on urinary calcium / creatinine
timeFrame: within 140 day after supplementation
Secondary outcomes:
measure: Effect of vitamin D3 supplementation on fasting blood glucose
timeFrame: within 140 day after supplementation
measure: Effect of vitamin D3 supplementation on serum lipids
timeFrame: within 140 day after supplementation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute for Nutrition Sciences, Chinese Academy of Sciences
state: Shanghai
Study officials:
References:
Clinical trial NCT03616743: Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain
Official title: Effects of a Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment.

Detailed description: The primary aim of this randomized controlled trial was to investigate the effects of a brief pain and smoking (BPS) cessation intervention on the willingness to consider quitting smoking in adults with chronic pain seeking treatment in a pain specialty outpatient clinic. The investigators hypothesized that participants randomized to the BPS intervention, relative to a brief non-tailored control smoking (BCS) intervention, would be more likely to self-report willingness to consider quitting smoking. Secondary aims included examining the effects of group allocation on the (1) interest in learning about smoking cessation programs; (2) willingness to consider scheduling a smoking cessation program; (3) scheduling a smoking cessation program; and (4) change scores of the Thoughts About Abstinence Scale (TAAS).

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* chronic pain of greater than 3 months duration
* smoke at least 10 cigarettes daily

Exclusion Criteria:

* cancer-related pain
* current participation in a smoking abstinence program
* current self-guided attempt to reduce or abstain from smoking
* use of other forms of tobacco including pipe, cigar or chew
* history of schizophrenia or other chronic psychotic disorder
* history of a dementing illness

Primary outcomes:
measure: Self-report willingness to consider quitting smoking.
timeFrame: Immediate post-intervention assessment
Secondary outcomes:
measure: Thoughts About Abstinence Scale
timeFrame: Pre-intervention and immediately post-intervention assessments
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Anesthesiology
name: William M Hooten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooten WM, Townsend CO, Hays JT, Ebnet KL, Gauvin TR, Gehin JM, Laures HJ, Patten CA, Warner DO. A cognitive behavioral smoking abstinence intervention for adults with chronic pain: a randomized controlled pilot trial. Addict Behav. 2014 Mar;39(3):593-9. doi: 10.1016/j.addbeh.2013.11.010. Epub 2013 Nov 21.
citation: Hooten WM, LaRowe LR, Zale EL, Ditre JW, Warner DO. Effects of a brief pain and smoking cessation intervention in adults with chronic pain: A randomized controlled trial. Addict Behav. 2019 May;92:173-179. doi: 10.1016/j.addbeh.2018.11.040. Epub 2018 Nov 28.