louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03835143: Outcome of Sub-inguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchilagia With Normal Semen
Official title: the Effect of Sub-inguinal Varicocelectomy in Patients Complaining of Orchialgia With Normal Semen Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varices; Cord
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: there is no description

Brief summary: varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not.

Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen.

This study will focus on the effect of operation on the semen postoperatively .


Eligibility criteria: Inclusion Criteria:

1. Primary varicocele.
2. Patient's age more than 20 years.
3. Scrotal pain (after exclusion of other causes).
4. Normal semen analysis

Exclusion Criteria:

1. Secondary varicocele.
2. Recurrent varicocele.

Primary outcomes:
measure: Grades of Motility of sperm in semen analysis
timeFrame: 3 months after the operation
Secondary outcomes:
measure: Count of sperms in semen analysis
timeFrame: 3 months after the operation
Other outcomes:
measure: Pain improvement using Numeric Pain Rating Scale
timeFrame: 3 months after the operation
measure: duppler
timeFrame: 3 months after the operation
Locations:
city: Assiut
country: Egypt
facility: Assuit Medical School
state: Assuit
Study officials:
References:
citation: Cayan S, Shavakhabov S, Kadioglu A. Treatment of palpable varicocele in infertile men: a meta-analysis to define the best technique. J Androl. 2009 Jan-Feb;30(1):33-40. doi: 10.2164/jandrol.108.005967. Epub 2008 Sep 4.
citation: Kupis L, Dobronski PA, Radziszewski P. Varicocele as a source of male infertility - current treatment techniques. Cent European J Urol. 2015;68(3):365-70. doi: 10.5173/ceju.2015.642. Epub 2015 Oct 15.
citation: Shabana W, Teleb M, Dawod T, Elsayed E, Desoky E, Shahin A, Eladl M, Sorour W. Predictors of improvement in semen parameters after varicocelectomy for male subfertility: A prospective study. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):E579-82. doi: 10.5489/cuaj.2808. Epub 2015 Sep 9.
citation: Paick S, Choi WS. Varicocele and Testicular Pain: A Review. World J Mens Health. 2019 Jan;37(1):4-11. doi: 10.5534/wjmh.170010. Epub 2018 May 16.
citation: Cho CL, Esteves SC, Agarwal A. Novel insights into the pathophysiology of varicocele and its association with reactive oxygen species and sperm DNA fragmentation. Asian J Androl. 2016 Mar-Apr;18(2):186-93. doi: 10.4103/1008-682X.170441.
Clinical trial NCT01102543: Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
Official title: Observational Study in Neonatal Intensive Care Units (NICU) on the Real Life Use of Curosurf in Prophylaxis of RDS in Premature Babies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: pulmonary surfactant
Respiratory distress syndrome
Newborn
prophylaxis
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 972
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 900 premature babies in 2 groups/cohorts : group 1 - babies born before 28 weeks GA ; groupe 2 - babies born at 28 - 32 weeks GA

Brief summary: The aim of Alizé is to describe a population of premature babies (gestational age (GA) \< 32 weeks) in real life situation and the management of RDS.

Detailed description: Description includes gestational age, birth clinical characteristics in particular the respiratory function, evaluation of the mother prenatal corticosteroids treatment in prophylaxis of RDS, mother medical and obstetric history, premature babies care in the delivery room with a special focus on the Curosurf use: prophylactic or curative use / other surfactant / no surfactant. A special focus is on the Prophylactic use.

Eligibility criteria: Inclusion Criteria:

* during the study, each neonatologist will have to include all the babies born with a gestational age \< 32 GA

Exclusion Criteria:

* gestational age \> 32 GA
* No consent to the data collection by one of the parents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Courbevoie
country: France
facility: Laboratoire Chiesi S.A.
Study officials:
affiliation: Chiesi S.A.
name: Capucine de Meynard, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05076643: Biomarkers, TCM Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression
Official title: Biomarkers, Traditional Chinese Medicine Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students in UTAR, Malaysia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: University students

Brief summary: This study aims to determine the predictors of depression among university students in Universiti Tunku Abdul Rahman (UTAR) Sungai Long Campus.

Detailed description: University students are a high at risk group for development of depression. Identifying the determinants of depression could help in the diagnosis and treatment of this disorder. This study will incorporate questionnaire and blood sample data collection procedures on 397 subjects. Written consent will be obtained from the subjects. Eligible subjects will be given self-administered questionnaires which include Patient health questionnaire (PHQ-9), Constitution in Chinese medicine questionnaire (CCMQ), Dysfunctional Attitude Scale (DAS), Depression Anxiety Stress Scales (DASS-21) - stress and anxiety subscales, Perceived stress scale-10 (PSS-10), Rosenberg self-esteem scale (RSES), and Food frequency questionnaire (FFQ). Once the subjects completed the questionnaires, blood samples will be collected from them by a trained phlebotomist. In addition, 10 most high at risk of depression subjects (with PHQ-9 scores 10 and above) and 10 healthy subjects (with PHQ-9 scores lower than 10) will be selected randomly for protein expression to further identify the proteins that significantly expressed among them.

Eligibility criteria: Inclusion Criteria:

* Malaysian citizen
* Able to read and communicate in English

Exclusion Criteria:

* Special education disability (deaf and blind)
* Physical support
* History of infectious diseases

Primary outcomes:
measure: Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students.
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of depression among university students.
timeFrame: Baseline
measure: Protein significantly expressed between depressed and non-depressed students.
timeFrame: Baseline
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Selangor
Study officials:
affiliation: Universiti Tunku Abdul Rahman
name: Chai Nien Foo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03822143: Fetus Anemia Diagnosis by Ultrasound Data Collection
Official title: Fetus Anemia Diagnosis by Ultrasound Data Collection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia in Fetus
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-01-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to diagnose anemia in fetuses through the use of ultrasound.


Eligibility criteria: Inclusion Criteria:

* Pregnant women from 16th week to 41st week +6 days
* Singleton fetus

Exclusion Criteria:

* All others

Primary outcomes:
measure: Anemia diagnosis in fetus
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Alon Shrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04932343: Comparison of Genomic and Transcriptomic Patterns Between CTC and Metastatic Tumormetastatic Tumor
Official title: Comparison of Genomic and Transcriptomic Patterns Between the Circulating Tumor Cells and Metastatic Tumor Cells, and Their Specific Relevance to Circulating Tumor DNAs: Quest for Any Distinct or Complementary Roles of CTCs and ctDNAs to Understand the Metastasis in Advanced NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC Stage IV
NSCLC Stage IIIB
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: CytoGen, Inc.
name: UNIST (Ulsan National Institute of Science and Technology)
First posted: 2021-06-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naïve stage III-IV non-small cell lung cancer who undergoing surgery for any intent

Brief summary: This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.


Eligibility criteria: Inclusion Criteria:

* All subjects need to sign the informed consent form
* All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively
* Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV)
* Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing

Exclusion Criteria:

* Patients with previous history of lung cancer
* Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
* Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment

Primary outcomes:
measure: The gene expression and the cell population
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jhingook Kim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01473043: Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
Official title: Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Renal Cell Carcinoma
Keywords: Axitinib
metastatic renal cell carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.


Eligibility criteria: Inclusion Criteria:

* Metastatic renal cell carcinoma with a component of clear cell subtype.
* Prior first line systemic therapy
* At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors \[RECIST 1.1\].
* Adequate hematology, liver and kidney functions
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1.
* Life expectancy of ≥12 weeks.
* Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)
* Negative pregnancy test
* Adequate recovery time from prior systemic therapy, surgery or radiation
* Willing and able subjects who have signed consent

Exclusion Criteria:

* More than one prior systemic therapy regimen
* Major bowel-penetrating surgery \<4 weeks
* Active gastro intestinal bleed in past 3 months
* Active peptic ulcer disease in the past 6 months
* Current or anticipated use of potent CYP3A4/5 inhibitors
* Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers
* Requirement for therapeutic warfarin or high dose steroids
* Symptomatic or untreated brain metastases
* A serious uncontrolled medical disorder or active infection
* Pregnant or breastfeeding females
* History of another active malignancy
* Dementia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Douglas
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Hobart
country: Australia
facility: Pfizer Investigational Site
state: Tasmania
city: Wendouree
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04806243: Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）
Official title: A Phase II, Second-line, Single-arm Clinical Trial of Carelizumab Combined With Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-03-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

Detailed description: Currently, there is little experience in the application of targeted drugs combined with immunotherapy. Through this study, we hope to explore the optimal population for the use of carelizumab combined with regorafenib in the second-line treatment of hepatocellular carcinoma (HCC), as well as the efficacy and safety.

This research is a single-center trials phase II second-line, single arm, explore the clinical outcome of treatment.

Eligibility criteria: Inclusion Criteria:

* Not convenient to disclose

Exclusion Criteria:

* Not convenient to disclose

Primary outcomes:
measure: os（overall survival）
timeFrame: 21 days
Secondary outcomes:
measure: PFS（progression-free survival）
timeFrame: 21 days
measure: TTP（Time-To-Progression）
timeFrame: 21 days
measure: ORR（Overall Response Rate）
timeFrame: 21 days
measure: DCR（disease control rate）
timeFrame: 21 days
measure: DoR
timeFrame: 21 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00998543: A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
Official title: A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smallpox
Keywords: Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947)

Brief summary: The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

Detailed description: None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).

Eligibility criteria: Inclusion Criteria :

* Subject vaccinated and who completed the Phase II VVL04 trial.
* Informed consent form signed.
* Subject able to comply with all trial procedures.
* Subject entitled to national social security.

Exclusion Criteria :

* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Primary outcomes:
measure: To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
timeFrame: 1 to 5 years post-vaccination
measure: To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).
timeFrame: 1 to 5 years post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Gières
country: France
city: Lagord
country: France
city: Montpellier Cedex 5
country: France
city: Paris
country: France
city: Poitiers
country: France
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01240343: Creation of the Biobank Related to Eye Disease
Official title: Creation of the Biobank Related to Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Keywords: Biobank
Genetics
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Vision Research Foundation
First posted: 2010-11-15
Enrollment: 669
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric and adult patients (age 0-99)who are being seen in the eye Dr. office and or having eye surgery

Brief summary: The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases.

Detailed description: The purpose of the Biobank related to eye disease at Beaumont Hospital is to help connect specialties and Specialists with each other, outside traditional limits of hospital or laboratory departments. The specimens (blood, fluids, and/or tissue samples) that will be collected from men, women and children will assist the researchers in a variety of studies on human eye diseases.

Research utilizing these specimens will allow for an increased understanding of the etiology, disease process, and response to treatments for various eye diseases, and will provide opportunities to subsequently improve our management decisions. Furthermore, projects that cross over between subspecialties are sparse and that is a limiting factor for the development of research that takes a more comprehensive approach.

Eligibility criteria: Inclusion Criteria: All pediatric and adult patients age 0-99 years -

Exclusion Criteria: All patients who do not agree to consent for collection of blood, fluids, tissue.

Patients who are cognitively impaired and are not able to verbalize understanding of the risks/benefits.

-

Primary outcomes:
measure: To build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: Associated Retinal Consultants, P.C.
name: Kimberly Drenser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06496243: Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels
Official title: A Phase 2 Study to Evaluate the Effect of Obicetrapib Alone and in Combination With Evolocumab (Repatha®) on Lipoprotein (a) in Patients With Mild Dyslipidemia: The VINCENT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dyslipidemias
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 8 weeks on 10 mg daily obicetrapid followed by 8 weeks on obicetrapib 10 mg daily/Repatha 140 mg SC every 2 weeks combination therapy
Primary purpose: TREATMENT

Brief summary: The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab

Patients will:

Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16


Eligibility criteria: Inclusion Criteria:

* Lp(a) \>50 mg/dL
* LDL-C \>70 mg/dL
* TG \< 400mg/dL

Exclusion Criteria:

* HbA1c\>=10 or FPG \>=270 mg/dL
* CV events within 3 months of screen

Primary outcomes:
measure: To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).
timeFrame: 16 weeks from baseline; 8 weeks on combination therapy
Secondary outcomes:
measure: To evaluate the effect of obicetrapib alone on Lp(a).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
Study officials:
References: