louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05815615: Plasmapheresis: a Multi-modal Approach
Official title: Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasmapheresis
Haematology
Sport Performance
Body Composition
Inflammation
Immunology
Adverse Events
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of donations. The repetition effect of the donations, whether whole blood or plasma, can be different from the effects measured after one single donation. It is therefore critical to test and document this repetitive effect to build trustable and valid guidelines concerning repetitive plasma donation.


Eligibility criteria: Inclusion criteria:

* male,
* age between 18-50 years
* BMI between 20-28 kg/m2
* aptitude to perform maximal physical efforts assessed by the physical activity readiness questionnaire (PAR-Q)

Exclusion criteria:

* The specific exclusion criteria of the Rode Kruis Vlaanderen for blood donation will not be systematically applied to the present study to increase the pool of recruitment.

  * In case the subjects do not comply with the criteria of the Rode Kruis Vlaanderen, their plasma donations will be thrown away.
  * In case the subjects comply, their plasma donations will be handled as usually.
* The criteria will be assessed before each plasma donation by a questionnaire as usually done in the Center of the Rode Kruis.

Primary outcomes:
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Sport performance
timeFrame: 3 months
measure: Sport performance
timeFrame: 3 months
Secondary outcomes:
measure: Body composition
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Blood markers
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: UCLouvain
state: Brabant Wallon
Study officials:
References:
Clinical trial NCT00172952: The Role of SNP of ECM and MMP on the Development of Pathological High Myopia
Official title: National Taiwan University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: high myopia, genomic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: To study the clinical characteristics and inheritance of pathological myopia in Taiwanese patients.

Detailed description: High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Pathological myopia often accompanied by glaucoma, cataracts, macular degeneration, and retinal detachment, leading to blindness when the damage to the retina is extremely severe. Population and family studies in Chinese have provided evidence for a geneticcomponent to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia. The retina receives the signal from the retina-RPE complexes and affects the growth of scleral coats. The changes of scleral components, collagen fibrils and proteoglycans, are noted in experimental and human myopia and induce the pathology of high myopia. It is interesting to know that individual difference of SNP in the components of scleral coat affects the response to the signal from retina-RPE complexes. The most important effectors in scleral coats are collagens, proteoglycans, MMPs and TIMPs. Therefore, the difference of SNPs in different genes might contribute the formation of scleral thinning during myopia development. In this project, we will focus on this subject by using GenomeLab SNPstream Genotyping System which is powerful and helpful for identify some specific SNPs in the regard.

Eligibility criteria: Inclusion Criteria:

* They are unrelated Chinese subjects with high myopia ≦-6.00D. The diagnosis of myopia is determined by the refractive error. Anisometropic individuals, with a refractive error of ≦-6.00 D for one eye and ≦-6.00 D for the other eye, with at least a 2-D difference between the two eyes, are considered unaffected

Exclusion Criteria:

* Individuals are excluded if there is known ocular disease or insult that could predispose to myopia, such as retinopathy of prematurity or early-age media opacification, or if they had a known genetic disease associated with myopia, such as Stickler or Marfan syndrome.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yung-Feng Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193232: Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer
Official title: A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: Millennium Pharmaceuticals, Inc.
First posted: 2005-09-19
Enrollment: 50
Sex: MALE
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: Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.

Detailed description: Upon determination of eligibility, patients will be receive:

* Docetaxel + Bortezomib

Patients with objective responses or stable disease will continue treatment for eight courses or until disease progression is documented.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer, and objective evidence of metastatic disease
* Progression while receiving androgen ablation therapy
* No previous chemotherapy
* Measurable or evaluable disease in conjunction with elevated serum PSA levels
* ECOG performance status 0, 1, or 2
* Adequate bone marrow, liver and kidney function
* Voluntarily provide written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Moderate or severe peripheral neuropathy
* Age \< 18 years
* Other serious medical conditions that may interfere with protocol therapy
* Other active malignancies
* history of treatment for other invasive cancers within 3 years

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: objective response rate
Secondary outcomes:
measure: progression-free survival
measure: overall survival
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hainsworth JD, Meluch AA, Spigel DR, Barton J Jr, Simons L, Meng C, Gould B, Greco FA. Weekly docetaxel and bortezomib as first-line treatment for patients with hormone-refractory prostate cancer: a Minnie Pearl Cancer Research Network phase II trial. Clin Genitourin Cancer. 2007 Mar;5(4):278-83. doi: 10.3816/CGC.2007.n.004.
Clinical trial NCT00003832: Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Official title: Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-09-30
Enrollment: 75
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment

Detailed description: OBJECTIVES:

I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.

II. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times.

OUTLINE:

Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I or II (T1-2) carcinoma of the prostate

  * PSA greater than 8 ng/mL
  * Abnormal findings on digital rectal examination
* Eligible for radical prostatectomy
* Performance status - ECOG 0 or 1
* No prior biologic therapy
* No prior chemotherapy
* No prior neoadjuvant hormonal therapy
* No prior radiotherapy
* See Disease Characteristics
* No prior therapy that would affect tumor growth rates or volume

Primary outcomes:
measure: Average doubling time between low and high volume tumors
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leonard Glode
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02673632: The Influence of AMH on Ovarian Responsiveness to Ovulation Induction With GnRH in Women With PCOS
Official title: The Influence of Anti-Müllerian Hormone on Ovarian Responsiveness to Ovulation Induction With Gonadotrophins in Women With Polycystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Anti-Müllerian hormone
Ovarian stimulation
Polycystic ovary syndrome
Intracytoplasmic sperm injection
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises women with PCOS, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, assisted reproductive technology (ART) Unit, during the study period, who are planning for Intracytoplasmic sperm injection (ICSI).

Brief summary: The investigator suggests that PCOS women with high AMH levels are resistant to ovarian stimulation and may need adjustment of the dose of gonadotrophin.

Detailed description: There is a correlation between high levels of AMH and the severity of PCOS. Excessive AMH may have a negative effect on the sensitivity of the resting follicles to gonadotropins.

This is an observational prospective study to investigate the impact of circulating AMH on gonadotrophin induction in women with PCOS.

Eligibility criteria: Inclusion Criteria:

* Women of age 18 - 35 years
* BMI 20 - 30 kg/m2
* Anovulatory infertility
* Diagnosis of PCOS based on Rotterdam consensus criteria (two of three criteria: Oligo/anovulation, hyperandrogenaemia and sonographic appearance of polycystic ovaries)

Exclusion Criteria:

* Women Above 35 years or under 18 years
* Women with BMI above 30 kg/m2 or under 20 kg/m2
* Normally ovulating women
* Patients with marked hyperandrogenaemia were screened for congenital adrenal hyperplasia (by measuring serum concentration of 17alpha hydroxyl-progesterone) or Patients with Cushing syndrome (by measuring urinary free cortisol)

Primary outcomes:
measure: Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Amer SA, Mahran A, Abdelmaged A, El-Adawy AR, Eissa MK, Shaw RW. The influence of circulating anti-Mullerian hormone on ovarian responsiveness to ovulation induction with gonadotrophins in women with polycystic ovarian syndrome: a pilot study. Reprod Biol Endocrinol. 2013 Dec 17;11:115. doi: 10.1186/1477-7827-11-115.
Clinical trial NCT05203432: Red Light Intervention on Myopic Progression
Official title: The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.


Eligibility criteria: Inclusion Criteria:

1. Age at enrolment: 6-12 years;
2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
3. Anisometropia of 1.5 D or less;
4. The BCVA of distant vision is at least 0.8;
5. Myopia progressed more than 0.5D in the past year;
6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
7. Written informed consent of guardian and child.

Exclusion Criteria:

1. Strabismus, amblyopia or other ocular abnormalities;
2. Other systemic abnormalities;
3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
4. Atropine allergy;
5. Other situations that not suitable for participating in the trial as judged by the researcher.

Primary outcomes:
measure: Changes of axial length
timeFrame: at least 1 year
Secondary outcomes:
measure: Change of spherical equivalent
timeFrame: at least 1 year
measure: Change of choroidal thickness
timeFrame: at least 1 year
measure: Change of uncorrected visual acuity
timeFrame: at least 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: Jiannan Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952432: Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test
Official title: A Single-center, Prospective, Randomized, Positive Controlled, Parallel Design Trial to Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Multiple Excitability Test
Keywords: Carpal Tunnel Syndrome
Multiple Excitability Test
Nerve Conduction Study
QtracW
carbamazepine
Acupuncture
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal Tunnel Syndrome.


Eligibility criteria: Inclusion Criteria:

* Age greater than 20 years old
* outpatient or inpatient subject with numbness of arm, clinically met diagnostic criteria of AAEM(American association of Electrodiagnostic Medicine CTS task force), and proven to have distal motor neurological disorder through nerve Conduction Study (distal motor latency \>4.6 msec, decreased SNAP \< 12uV or prolonged median sensory distal latency (palm to wrist) \> 2.5msec)。
* Willing to sign the Informed Consent form

Exclusion Criteria:

* subject with external hand injury or disformation
* subject with Polyneuritis or Cervical nerve root lesions
* Subject with peripheral hypertrophy, hypothyroidism, multiple myeloma, or amyloidosis
* Allergic to Carbamazepine or similar type of medicine
* inability to act independently, or in the opinion of the investigator, not suitable for the study
* In the opinion of the investigator, the subject requires surgical repair of the Carpal Tunnel Syndrome, or the symptoms will be worsen result in irreversible damage to the subject if not treated with surgical repair within 3 months.

Primary outcomes:
measure: Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
timeFrame: 12 weeks
Secondary outcomes:
measure: use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.
timeFrame: 12 weeks
measure: use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.
timeFrame: 12 weeks
measure: Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.
timeFrame: 12 weeks
measure: Evaluate the safety of 2 arms during the study period
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Jia-Ying Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604732: Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
Official title: Randomized Controlled Trial on Pre-operative Withdrawal Versus no Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal Hernia
Laparoscopic Inguinal Hernia Repair
Aspirin
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery.

Detailed description: This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery. Simple randomization will be performed and allocation is via closed envelope method. The surgeon will be blinded regarding the usage of Aspirin. The primary outcome is the incidence of post-operative hematoma formation within the first 24 hours after surgery. The secondary outcomes are the incidence of post-operative seroma formation within 24 hours, the incidence of post-operative hematoma requiring intervention (including blood transfusion, percutaneous drainage and surgical hemostasis) within 30 days, pain at regular intervals and the incidence of other post-operative complications.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair
* Age 21-80 years
* Patients taking Aspirin
* BMI 18-30

Exclusion Criteria:

* Age \<21 and \>80years
* Recurrent inguinal hernia
* Coagulopathy
* Patients who can't stop Aspirin
* BMI \<18 and \>30

Primary outcomes:
measure: Incidence of hematoma
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of seroma
timeFrame: 24 hours
measure: Incidence of hematoma requiring intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Davide Lomanto, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04929132: Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules
Official title: Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules Graded With the Breast Imaging Reporting and Data System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasound
Breast Cancer
Pathology
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
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 with nodules which were sonographically classified as BI-RADS 4 A breast lesion

Brief summary: The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

Detailed description: The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed to evaluated the added value in BI-RADS 4A nodules

Eligibility criteria: Inclusion Criteria:

patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion

Exclusion Criteria:

(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

Primary outcomes:
measure: CEUS
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: SAHZJU
state: Zhejiang
Study officials:
References: