louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02040545: Salivary Diagnostic Testing for IVF
Official title: Venopuncture-Free IVF: Can "Patient-friendly" Salivary Hormone Measurements Replace Serum Monitoring of IVF Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
In Vitro Fertilization (IVF)
Venopuncture-free treatment
Needle-free treatment
Lead sponsor: Boston IVF
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 335
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

Brief summary: This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.

Detailed description: The goal of this study is to determine the performance of a salivary hormone competitive immunoassay for monitoring patient estrogen and progesterone levels during treatment for infertility using controlled ovarian stimulation (COH) and in vitro fertilization (IVF). Specifically, inter- and intra-assay precision, correlation with serum measurements (the gold-standard), and user satisfaction will be determined. Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center

Primary outcomes:
measure: Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: HRC Fertility
state: California
city: Atlanta
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Chicago
country: United States
facility: Fertility Center of Illinois
state: Illinois
city: South Portland
country: United States
facility: Boston IVF
state: Maine
city: Rockville
country: United States
facility: Shady Grove Fertility Reproductive Science Center
state: Maryland
city: Quincy
country: United States
facility: Boston IVF
state: Massachusetts
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
city: New York
country: United States
facility: Reproductive Medicine Associates of New York, LLP
state: New York
Study officials:
affiliation: Boston IVF
name: Alison Zimon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06925945: Modified Thoracoabdominal Plane Block and Rectus Block Combination
Official title: Comparison of Pain Between Modified Thoracoabdominal Plane Block and Rectus Block Combination and Intraperitoneal Local Infiltration Analgesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Analogue Scale
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* ASA1-2
* Laparoscopic cholecystectomy cases

Exclusion Criteria:

* Bleeding disorders
* Anticoagulant use
* Patients with previous nerve damage
* Lack of patient consent
* Patients with liver and kidney failure
* Patients allergic to local anesthetics used
* Patients with BMI \> 35

Primary outcomes:
measure: visual analogue scale
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.
citation: Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.
Clinical trial NCT00965445: The Comparison of Oxidative Stress Between Inhalation Anesthetics
Official title: The Comparison of Oxidative Stress Between Inhalation Anesthetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Cardiac Surgery
Keywords: isoprostanes
mass spectrometry
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving cardiac valve surgery in Taipei Change Gung Memorial Hospital will be invited to participate this study

Brief summary: Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to investigate the effect of different anesthetics on isoprostanes.

Detailed description: Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue.

Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.

Eligibility criteria: Inclusion Criteria:

* patients receiving cardiac valve surgery in ASA II-III physical status

Exclusion Criteria:

* trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery

Primary outcomes:
measure: isoprostanes isomer as marker of oxidative stress
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dept. of Anesthesiology, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yun-Hui Teng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04992845: Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
Official title: Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Juvenile Idiopathic Scoliosis
Lead sponsor: Spinologics Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 44
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of juvenile or adolescent idiopathic scoliosis
2. Male and female subjects greater than 8 years of age with significant growth remaining
3. Risser Stage 0 or 1
4. Subjects should have at least three years of estimated growth remaining based on Risser staging
5. Major thoracic scoliosis with Cobb Angle \> 40° and \< 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure
6. Thoracic kyphosis (T5-T12) \< 50°
7. Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)
8. Menses \< 4 months
9. Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
10. Subject assent and parent/legal guardian consent obtained and documented.

Exclusion Criteria:

1. Scoliosis curve is less than 30° or more than 70°
2. Thoracic kyphosis is greater than or equal to 50° (T5-T12)
3. The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
4. One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length)
5. One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length)
6. Non-idiopathic scoliosis
7. Non-ambulatory
8. Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease
9. Prior thoracic surgery
10. Abnormal neurological status at baseline
11. Any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant's best interest

Primary outcomes:
measure: Rate of device- &/or procedure-related SAEs
timeFrame: 12 months
measure: Change in Cobb angle measurement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: CHEO
Study officials:
affiliation: BC Children's
name: Firoz Miyanji
role: PRINCIPAL_INVESTIGATOR
affiliation: CHEO
name: Kevin Smit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022645: Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes
Official title: Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Glucose Intolerance
Type 2 Diabetes
Intrauterine Contraception
Keywords: Intrauterine device
Gestational diabetes
Postpartum contraception
Postpartum birth control
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2009-12-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postpartum women with gestational diabetes in the last pregnancy

Brief summary: The study is being done in order to gain information on the most suitable types of birth control in women who recently had gestational diabetes, or diabetes diagnosed during pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and releases a hormone called a progestin into the uterus. The copper IUD contains no hormones and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).


Eligibility criteria: Inclusion Criteria:

1. Age 18-45 years at the time of enrollment
2. Single gestation in the current pregnancy
3. GDM in the current pregnancy, diagnosed by 2- or 3-hour oral glucose tolerance test (OGTT) performed at 24-32 weeks gestation
4. Desires intrauterine contraception or tubal ligation postpartum
5. Willing and able to read and sign an informed consent form in English
6. Willing to comply with the study protocol

Exclusion Criteria:

1. History of pre-gestational DM, type 1 or 2
2. Pregnancy conceived with assisted reproductive technologies
3. Positive for human immunodeficiency virus (HIV) infection
4. Desires repeat pregnancy within the first 12 months following delivery

Primary outcomes:
measure: Glucose tolerance at 12 months postpartum.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern Universeity
name: Jessica W Kiley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00130845: Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Official title: A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Diabetic retinopathy, Octreotide Acetate in Microspheres
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-16
Enrollment: 312
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: The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Males and females with type 1 and type 2 diabetes mellitus
* Moderately severe or severe NPDR or mild PDR in at least one eye:

  * with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of \> 35 letters; and
  * not previously treated with scatter photocoagulation.
* HbA1c \< 13% at study entry

Exclusion Criteria:

* Condition which could interfere with the assessment of retinopathy progression
* History of symptomatic gallstones without cholecystectomy
* Brittle diabetes or history of severe hypoglycemia unawareness
* Previous treatment with a somatostatin analogue

Primary outcomes:
measure: time to progression of diabetic retinopathy
Secondary outcomes:
measure: time to development or progression of macular edema,
measure: time to moderate vision loss
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis
name: Customer Information
role: STUDY_CHAIR
References:
Clinical trial NCT00730145: A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
Official title: A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Dialysis
Pharmacokinetics
Keywords: pharmacokinetics, PD-0332334, hemodialysis, renal dialysis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 1. Quantify how much PD-0332334 is removed from the blood with hemodialysis
2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Detailed description: Assess the elimination of PD-0332334 from the blood with hemodialysis

Eligibility criteria: Inclusion Criteria:

* Patients receiving regular hemodialysis
* Male or female patients 18 to 65 years

Exclusion Criteria:

* Severe heart failure
* Renal transplant or renal allograft
* Illicit drug use (with the exception of prescribed sedatives)

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis
timeFrame: 0 to 8 days
measure: Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis
timeFrame: 0 to 8 days
measure: Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast).
timeFrame: 0 to 8 days
Secondary outcomes:
measure: Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.
timeFrame: 0 to 8 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04965545: Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson Disease
Official title: Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wilson Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with wilson disease

Brief summary: The investigators aimed to identify factors associated with symptoms and features of Wilson disease from a large cohort during long-term follow-up

Detailed description: Wilson disease is an autosomal recessive disorder that impairs copper homeostasis and is caused by homozygous or compound heterozygous mutations in ATP7B, which encodes a copper-transporting P-type ATPase. Patients have variable clinical manifestations and laboratory test results, resulting in diagnostic dilemmas. Therefore, the investigators aimed to identify factors associated with symptoms and features of Wilson disease, thereby give timely diagnosis for patients.

Eligibility criteria: Inclusion Criteria:

* genetically diagnosed patients with wilson disease

Exclusion Criteria:

* Deny follow-up

Primary outcomes:
measure: Serum ceruloplasmin
timeFrame: From 2004 through 2030
measure: Urinary Copper Excretion
timeFrame: From 2004 through 2030
measure: Kayser-Fleischer Rings
timeFrame: From 2004 through 2030
measure: Brain Magnetic Resonance Imaging
timeFrame: From 2004 through 2030
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
name: Zhi-Ying Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01614145: Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples
Official title: Diagnostic Study Evaluating the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Immunocompromised patients at risk for invasive aspergillosis

Brief summary: Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.


Eligibility criteria: Inclusion Criteria:

* Host factors
* Informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Test sensitivity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Freiburg University Hospital
state: Baden-Würrtemberg
city: Mannheim
country: Germany
facility: Mannheim University Hospital
state: Baden-Würrtemberg
city: Frankfurt (Oder)
country: Germany
facility: Frankfurt (Oder) General Hospital
state: Brandenburg
Study officials:
affiliation: Germany: Mannheim University Hospital, University of Heidelberg
name: Dieter Buchheidt, MD
role: PRINCIPAL_INVESTIGATOR
References: