louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01074424: Studying Biomarkers in Blood Samples From Patients With Invasive Cervical Cancer
Official title: Development of a Serum Proteomic Profile for Cervical Cancer With Potential Prognostic Value
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-24
Enrollment: 84
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in blood samples from patients with invasive cervical cancer.

Detailed description: OBJECTIVES:

Primary

* To develop a serum proteomic profile for cervical cancer using banked pre-treatment serum specimens from patients with invasive cervical cancer and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis.

Secondary

* To develop a serum proteomic profile for cervical cancer using banked post-treatment serum specimens from these patients and to determine if this serum proteomic profile has possible utility in cervical cancer prognosis.

OUTLINE: This is a multicenter study.

Banked serum specimens are used to generate proteomic profiles.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed invasive adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix

  * Stage IIB, III, or IVA disease
* Eligible and evaluable for GOG-0191
* Pre- and/or post-treatment serum specimens available for proteomic analysis

PATIENT CHARACTERISTICS:

* Patient has given consent to allow their specimen(s) to be used for future cancer research

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Generation of a serum proteomic profile using banked pre-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and progression-free survival [PFS])
Secondary outcomes:
measure: Generation of a serum proteomic profile using banked post-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and PFS)
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: Samir N. Khleif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261324: Is the 4MGS a Useful Outcome Measure Post-PPCI
Official title: Is the Four Metre Gait Speed a Useful Outcome Measure in Patients With Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Percutaneous coronary intervention
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2014-10-10
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient hospitalised for primary percutaneous coronary intervention for acute myocardial infarction. The cohort will be recruited from Harefield hospital

Brief summary: This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to assess whether this can predict future cardiovascular events and death.


Eligibility criteria: Inclusion Criteria:

* Any patient hospitalised with an acute myocardial infarction who has undergone primary percutaneous coronary intervention
* Capacity to consent
* Able to walk
* Age over 18 years

Exclusion Criteria:

* Significant co-morbidities that would limit exercise capacity or make exercise unsafe (e.g. neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)

Primary outcomes:
measure: Mortality rate
timeFrame: 1 year
Secondary outcomes:
measure: Occurrence of cardiovascular events
timeFrame: 1 and 5 years
measure: Need for repeat revascularisation
timeFrame: 1 and 5 years
measure: Health resource usage
timeFrame: 1 and 5 years
measure: All-cause mortality
timeFrame: 5 years
measure: Cardiovascular death
timeFrame: 1 and 5 years
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield Hospital
state: Middlesex
Study officials:
affiliation: NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust
name: William DC Man, FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00596024: Lutein and Alzheimer's Disease Study
Official title: Lutein and Oxidative Stress in Alzheimer's Disease - A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon Partnership for Alzheimer's Research
First posted: 2008-01-16
Enrollment: 3
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants may suppress this free radical damage associated with AD. Carotenoids are a family of naturally occurring antioxidants that have important functions for human health. Carotenoids are known to reduce oxidative damage, but their effects have not been studied in AD patients.

The objective of the study is to examine whether lutein supplementation helps to reduce oxidative damage from free radicals in AD patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with moderately severe Alzheimer's disease

Primary outcomes:
measure: oxidative damage markers
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Wei Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149924: Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
Official title: A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 354
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Aged 20 \~ 39 years(inclusive)
3. Body mass index (BMI) between 18\~30 kg/m2(inclusive)
4. Regular menstrual cycle (25\~35 days)
5. Basal FSH \< 10 IU/L (menstrual cycle day 2\~5)

Exclusion Criteria:

1. History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
2. History of ≥3 recurrent spontaneous miscarriages
3. Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
4. Primary ovarian failure or poor responders to ovarian stimulation
5. Presence of pregnancy in previous 3 months
6. Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
7. History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 36-38 hours after hCG administration
Secondary outcomes:
measure: Total dose of r-hFSH administered
timeFrame: From date of randomization up to 16 days
measure: Number of days of r-hFSH stimulation
timeFrame: From date of randomization up to 16 days
measure: Serum estradiol concentration
timeFrame: From date of randomization up to 16 days
measure: Endometrial thickness
timeFrame: From date of randomization up to 16 days
measure: Fertilization Rate of Oocytes
timeFrame: Day 1 of IVF/ICSI
measure: Rate of high-quality embryos
timeFrame: 3 days after oocyte retrieval
measure: Implantation rate
timeFrame: five to six weeks after oocyte retrieval
measure: clinical pregnancy rate
timeFrame: 35 ± 4 days after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: Ten weeks after embryo transfer
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT00923624: Patient Portal to Support Treatment Adherence
Official title: Patient Portal to Support Treatment Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiretroviral Medication Adherence
Keywords: electronic medical record
antiretroviral medication adherence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by nurses via an electronic medical record (EMR) patient web portal to determine if this is an efficacious method for supporting medication adherence.

Detailed description: 300 adult HIV+ patients will be randomized to one of two arms. 150 will be assigned to receive secure messages focused on antiretroviral adherence from a nurse through the health plan EMR patient website. 150 will be assigned to an attention control comparison arm, and will receive electronic messages from a study staff member that provide information about the various features of the health plan patient website. Patients will be invited by mail to be telephone screened for enrollment in the study. Patients will be provided the opportunity to opt out of being contacted by the study. Eligible and interested patients will be mailed an access code and separately emailed a link to a secure study website where they will complete a web consent form and a baseline web survey before being randomized to an intervention arm. This trial will allow us to evaluate the effectiveness of using health information technology as an intervention delivery vehicle to improve patient disease management behaviors such as treatment adherence.

Eligibility criteria: Inclusion Criteria:

* enrollment in GHC or KP health plans for at least 6 months
* expect to stay enrolled for 1 year in health plan
* HIV+
* currently prescribed antiretroviral medication
* regular access to a computer with internet capabilities and working email address and meet one of the following:
* gap in antiretroviral prescription refills based on 6 month refill records
* referral to study by provider team for adherence problems

Exclusion Criteria:

* dementia or psychosis diagnosis documented in medical record

Primary outcomes:
measure: Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records).
timeFrame: 12 months
Secondary outcomes:
measure: Web service utilization.
timeFrame: 12 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Sheryl L. Catz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625024: Quality Assurance of Cognitive-behavioral Therapy
Official title: Quality Assurance of Cognitive-behavioral Therapy: Adherence and Competence in Therapists and Treatment Outcome in Patients With Depression and Anxiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Anxiety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients in psychiatric outpatient care with depression or anxiety disorder.

Brief summary: The study examines associations between competence in cognitive-behavioral therapy (CBT) and adherence to evidence-based generic CBT in therapists and treatment outcome in patients with depression or an anxiety disorder in psychiatric outpatient care.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of major depression or an anxiety disorder (panic disorder, agoraphobia, social anxiety, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder)

Exclusion Criteria:

* Psychosis, bipolar disorder, eating disorder, substance use disorder, high risk of suicide, any simultaneous psychological treatment

Primary outcomes:
measure: Disorder-specific self-reported symptoms change instruments
timeFrame: Change from baseline symptoms at 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: WeMind Psykiatri
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03534024: The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome
Official title: The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this study is planned to determine the effects of supplementation of nanomicelle curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* 25\<body mass index \>40
* waist circumference \>102 cm in men or \>88 cm in women
* Fasting blood glucose \>100 mg/dL
* Triglycerides (TG) \> 150 mg/dL
* High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men
* Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria:

* insulin administration for diabetes control
* hypo- or hyperthyroidism,
* renal failure or other chronic diseases
* pregnancy and breastfeeding
* taking weight loss supplements and obeying unusual weight loss plans

Primary outcomes:
measure: hemoglobin A1c (HbA1c)
timeFrame: 12 weeks
measure: serum glucose
timeFrame: 12weeks
measure: serum insulin
timeFrame: 12weeks
measure: homeostatic model assessment of insulin resistance(HOMA-IR)
timeFrame: 12weeks
measure: homeostatic model assessment of beta cell(HOMA-B)
timeFrame: 12weeks
measure: serum triglyceride (TG)
timeFrame: 12 weeks
measure: serum total Cholesterol
timeFrame: 12 weeks
measure: serum LDL-C
timeFrame: 12 weeks
measure: serum HDL-C
timeFrame: 12 weeks
measure: systolic blood pressure
timeFrame: 12 weeks
measure: diastolic blood pressure
timeFrame: 12 weeks
measure: serum curcumin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Golbon Sohrab
state: National Nutrition And Food Technology Research Institute
Study officials:
References:
Clinical trial NCT00330824: Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery
Official title: Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Lasik Surgery Inflammation
Keywords: prevention of post inflammation in LASIK surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2006-05-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

Detailed description: antibiotic/steroid combination compared to individuals components 15 days of treatment

Eligibility criteria: Inclusion Criteria:

* patients having LASIK surgery;
* men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems

Exclusion Criteria:

* Uncontrolled glaucoma or intraocular hypertension;
* Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
* A history of chronic or recurrent ocular inflammatory disease;
* Uncontrolled diabetes mellitus and diabetic retinopathy ;
* Patients with sight in a single eye;
* Iris atrophy in the eye to be operated;
* Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
* Known or suspected allergy or hypersensitivity to any component of study medication;
* A history or any other evidence of severe systemic disease

Primary outcomes:
measure: day 15 evaluation of anterior chamber
timeFrame: 15 days pos-op
Secondary outcomes:
measure: day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
timeFrame: 15 days pos-op
Other outcomes:
Locations:
city: São paulo
country: Brazil
facility: Dept. of Ophthalmology - Rua Botucatu 824
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Rubens Belfort Jr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04028024: Protective Effect in Cardiac Surgery Patients
Official title: Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* subject needs to have valve surgery
* subject needs to have coronary artery bypass grafting surgery
* subject needs to have artificial blood vessel replacement surgery
* ASA(American Society of Anesthesiologists) score II\~III
* NYHA(New York Heart Association) II\~III

Exclusion Criteria:

* LVEF(left ventricular ejection fraction) \<40% measured by echocardiogram
* history of myocardial infarction within 1 month
* history of serious pulmonary infection or endocarditis within 3 months
* history of important surgery within 6 months

Primary outcomes:
measure: postoperative delirium
timeFrame: 7 days postoperatively or discharge, whichever came first
measure: postoperative renal insufficiency
timeFrame: 7 days postoperatively or discharge, whichever came first
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Hui-lin Wang, Phd
role: PRINCIPAL_INVESTIGATOR
References: