louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06373744: Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients
Official title: Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
metronomic chemotherapy
capecitabine
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 597
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced breast cancer taking metronomic chemotherapy

Brief summary: The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:

How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Females, \>18 years old;
2. Diagnosed with advanced breast cancer when using metronomic chemotherapy;
3. At least one clinical evaluation, including physical examination and imaging, according to the instructions of the supervising physician during the use of metronomic chemotherapy. Examinations include ultrasound, computed tomography, and magnetic resonance imaging;
4. Metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included;
5. The clinical pathological information that needs to be collected is complete.

Exclusion Criteria:

1. Taking the drug for less than 2 weeks;
2. losing follow-up after taking the therapy;
3. The patient's breast cancer was still in the early stage when taking the therapy.

Primary outcomes:
measure: Progression free survival
timeFrame: Baseline up to approximately 20 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline until death (up to approximately 40 months)
measure: Objective Response Rate
timeFrame: Baseline up to approximately 20 months
measure: Disease Control Rate
timeFrame: Baseline up to approximately 20 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Shusen Wang
state: Gangdong
Study officials:
affiliation: Sun Yat-sen University
name: Shusen Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01795144: Incretin Regulation of Insulin Secretion in Monogenic Diabetes
Official title: Incretin Regulation of Insulin Secretion in Monogenic Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Monogenic Diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.

Detailed description: Monogenic diabetes patients and healthy matched controls will be admitted to the University of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on separate days:

1. Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points
2. Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points
3. OGTT during GLP-1 infusion
4. IGI during Exendin-9 infusion

Eligibility criteria: Monogenic Diabetes Subjects:

Inclusion Criteria:

* Diagnosis of monogenic diabetes
* Previously participated in US Neonatal Diabetes Registry (IRB 15617B) or Genetics of diabetes mellitus (IRB 6858)
* Age: 18 years +

Exclusion Criteria:

* Pregnancy
* Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate \<50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct \< 36%), or uncontrolled hypertension

Healthy Controls:

Inclusion Criteria:

* Good general health
* Stable weight for 6 months
* Age: 18 years +

Exclusion Criteria:

* Pregnancy
* Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate \<50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct \< 36%), or uncontrolled hypertension

Primary outcomes:
measure: Incretin Effect
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Siri Atma W Greeley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086444: Tranexamic Acid in Abdominoplasty.
Official title: The Effectiveness of Tranexamic Acid in Abdominoplasty Plastic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Abdominal Wall Defect
Hemorrhage
Bleeding
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing abdominoplasty surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in patients undergoing abdominoplasty surgery.

Detailed description: Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for abdominoplasty. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Eligibility criteria: Inclusion Criteria:

* Scheduled abdominoplasty
* ASA 1 or 2
* age \>18 and \<75 years

Exclusion Criteria:

* BMI \<20 or \>35 kg/m2
* ASA 3 or \> 3
* medical history of thromboembolism
* history of hematological disease
* treatment with aspirin 14 days before the procedure
* treatment with anticoagulants 5 days before the procedure
* epilepsy
* allergy to tranexamic acid
* coagulation disorders

Primary outcomes:
measure: Blood loss volume
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: HBG
timeFrame: 24 hours after surgery
measure: D-dimer
timeFrame: 24 hours after surgery
measure: Fibrinogen
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Sciences
name: Małgorzata Domagalska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01953744: High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus
Official title: Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cutaneous Leishmaniasis
Keywords: Fluconazole; Meglumine antimoniate;L.Braziliensis;
L.Guyanensis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Federal University of Bahia
First posted: 2013-10-01
Enrollment: 53
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

  * Lack of suitability for the trial:
* Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures

  * Administrative reasons:
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures

Primary outcomes:
measure: Cure rate or complete cicatrization of the ulcer.
timeFrame: 6 months
Secondary outcomes:
measure: Initial cure rate or complete cicatrization of the ulcer
timeFrame: 2 months
Other outcomes:
Locations:
city: Presidente Tancredo Neves
country: Brazil
facility: Posto de Saúde de Corte de Pedra
state: Bahia
Study officials:
affiliation: University of Bahia
name: Paulo Roberto Lima Machado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prates FV, Dourado ME, Silva SC, Schriefer A, Guimaraes LH, Brito MD, Almeida J, Carvalho EM, Machado PR. Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial. Clin Infect Dis. 2017 Jan 1;64(1):67-71. doi: 10.1093/cid/ciw662. Epub 2016 Nov 1.
Clinical trial NCT00954044: Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
Official title: Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: randomized clinical trial
prostate cancer
partnered exercise
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the benefits of "Exercising Together"-a partnered strength training program for married couples coping with prostate cancer- on the physical and emotional health of prostate cancer survivors and their spouse and on marital quality.


Eligibility criteria: Inclusion Criteria For PCS:

* Received treatment for histologically confirmed prostate cancer
* Not currently undergoing radiation therapy or chemotherapy for prostate cancer
* Currently residing with an identifiable spouse willing to participate
* 60 years and older at enrollment

Inclusion Criteria for Spouses:

* Currently residing with prostate cancer survivor

Exclusion Criteria for prostate cancer survivor and Spouses:

* Current participation in moderate/vigorous intensity resistance training 2 or more hours per week
* Cognitive difficulties that preclude answering the survey questions, participating in performance tests, or giving informed consent
* Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise
* Unwillingness to be randomized

Primary outcomes:
measure: Physical function
timeFrame: baseline, 3, 6 months
Secondary outcomes:
measure: Marital quality
timeFrame: 0,3,6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health & Science University-School of Nursing
name: Kerri Winters-Stone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health & Science University-School of Nursing
name: Jessica Dobek, MS
role: STUDY_DIRECTOR
References:
citation: Winters-Stone KM, Lyons KS, Bennett JA, Beer TM. Patterns and predictors of symptom incongruence in older couples coping with prostate cancer. Support Care Cancer. 2014 May;22(5):1341-8. doi: 10.1007/s00520-013-2092-0. Epub 2013 Dec 17.
citation: Winters-Stone KM, Lyons KS, Dobek J, Dieckmann NF, Bennett JA, Nail L, Beer TM. Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project. J Cancer Surviv. 2016 Aug;10(4):633-44. doi: 10.1007/s11764-015-0509-0. Epub 2015 Dec 29.
Clinical trial NCT04217044: Histopathology Images Based Prediction of Molecular Pathology in Glioma Using Artificial Intelligence
Official title: Histopathology Images Based Prediction of Molecular Pathology in Glioma Using Deep Learning or Machine Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Keywords: Molecular
Histopathology image
Deep Learning
Machine Learning
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2020-01-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed glioma that receive tumor resection

Brief summary: This registry aims to collect clinical, molecular and radiologic data including detailed clinical parameters, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and images of HE slices in primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine histopathology image based algorithms that are able to predict molecular pathology or subgroups of gliomas.

Detailed description: Non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations is challenging. With the development of artificial intelligence, much more potential lies in the histopathology images of HE slices in primary gliomas could be excavated to aid prediction of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed molecular pathology, histopathology image data and with sufficient sample size for deep learning (\>1000) provide considerable opportunities for personalized prediction of molecular pathology with non-invasiveness and precision.

Eligibility criteria: Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfunctions

Primary outcomes:
measure: AUC of prediction performance
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT03360344: Non-surgical Intervention for Carpal Tunnel Syndrome
Official title: Effects on Occupational Performance Through Dorsal Application of Kinesio Tape for Musculoskeletal Disorder - Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome, Susceptibility to
Keywords: carpal tunnel syndrome, pain, numbness, kinesio tape
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled trial
Primary purpose: OTHER

Brief summary: This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain.

Detailed description: This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain. Little evidence exists for an effective non-surgical intervention. Semi-structured interviews will be conducted to explore changes in occupational performance and compliance in order to understand if Kinesio Tape contributed to results and if so, how the participants perceived the interventions.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years of age
* Fluent in English
* Report signs and symptoms of carpal tunnel syndrome
* Pain, numbness, and tingling of the forearm, wrist, or hand, which worsen at night
* Demonstrate positive Phalen's Test or Tinel's Test of the affected extremity

Exclusion Criteria:

* Currently receiving treatment for carpal tunnel syndrome
* History of surgical carpal tunnel release
* Pregnant
* Diabetes not controlled by medication
* Radiculopathy ie: cervical radiculopathy, diabetic radiculopathy
* Thoracic outlet syndrome
* Allergy to adhesives or compromised skin integrity
* Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Primary outcomes:
measure: Numerical Pain Rating Scale (NRS Pain)
timeFrame: change between baseline and 3 weeks
measure: Visual Analog Scale for Pain (VAS Pain)
timeFrame: 3 weeks
Secondary outcomes:
measure: Grip Strength and Pinch Strength
timeFrame: change between baseline and 3 weeks
measure: Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS)
timeFrame: change between baseline and 3 weeks
measure: Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS)
timeFrame: 3-weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Grenith Zimmerman, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01671644: Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study
Official title: Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: In vitro fertilization
Assisted reproductive therapy
Time-lapse image recording
Image analysis software
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 104
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.

Brief summary: The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

Detailed description: The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

Eligibility criteria: Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
* IVF cycle attempts ≤ 3.
* Egg age ≤ 40 years.
* Planned Day 3 embryo transfer.
* At least 5 normally fertilized eggs (2PN).
* All 2PN embryos must be imaged by Eeva.
* Normal uterine cavity as evaluated by standard methods.
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
* Willing to comply with study protocol and procedures.
* Willing to provide written informed consent.

Exclusion Criteria:

* Planned preimplantation genetic diagnosis.
* Planned "freeze all" cycle (oocytes or embryos).
* Concurrent participation in another clinical study.

Primary outcomes:
measure: Rate of clinical pregnancy
timeFrame: 5-8 weeks gestational age
Secondary outcomes:
measure: Implantation rate (# of implanted embryos out of # of total embryos transferred)
timeFrame: 5-8 weeks gestational age.
measure: Ongoing Pregnancy Rate (gestational week 10-12)
timeFrame: Gestational age week 10-12
measure: Multiple pregnancy rate
timeFrame: Gestational weeks 5-8 and 10-12
measure: Spontaneous miscarriage rate
timeFrame: Gestational age week 10-12
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Gent University Hospital
state: East Flanders
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: South Holland
Study officials:
affiliation: Progyny, Inc.
name: Shehua Shen, MD, ELD
role: STUDY_DIRECTOR
References:
citation: Kieslinger DC, De Gheselle S, Lambalk CB, De Sutter P, Kostelijk EH, Twisk JW, van Rijswijk J, Van den Abbeel E, Vergouw CG. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study. Hum Reprod. 2016 Nov;31(11):2450-2457. doi: 10.1093/humrep/dew207. Epub 2016 Sep 12.