louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02762695: Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile
Official title: Evaluation of a Model of Care for People With Hypertension and Type II Diabetes Based on Case Management and Risk Adjustment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Diabetes Mellitus, Type 2
Keywords: Hypertension
Diabetes Mellitus, Type 2
Case Management
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2016-05-05
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
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 whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.


Eligibility criteria: Inclusion Criteria:

* Adults diagnosed with Hypertension and/ or Type 2 Diabetes

Exclusion Criteria:

* Severe mental illness and / or deterioration of cognitive abilities.
* Severe hearing loss.
* Diagnosed with cancer
* Stage 4 or 5 of chronic kidney disease

Primary outcomes:
measure: Glycated Hemoglobin
timeFrame: One year
measure: Systolic and Diastolic Blood Pressure
timeFrame: One year
Secondary outcomes:
measure: Quality of Care
timeFrame: one year
measure: Patient satisfaction
timeFrame: one year
measure: Medication adherence
timeFrame: one year
Other outcomes:
Locations:
city: Peñalolén
country: Chile
facility: CESFAM La Faena
state: RM
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Fernando C Poblete, Master
role: STUDY_CHAIR
References:
Clinical trial NCT01207895: Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Official title: Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rectal Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if positron emission tomography (PET) imaging with an imaging agent called 18F-fluorodeoxythymidine(\[18F\]-FLT) will allow investigators to measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy). Additionally, the investigators want to determine if it is possible to predict how well tumor(s) might respond to treatment with \[18F\]-FLT PET imaging.


Eligibility criteria: Inclusion Criteria:

* Subjects with known rectal cancer.
* Subjects must have signed an approved consent form.
* Subjects must be 18 years of age or older.

Exclusion Criteria:

* Children less than 18 are excluded.
* Pregnant women and women who are breast feeding will be excluded from this study. A serum beta HCG will also be performed for each pre-menopausal female subject.
* Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study

Primary outcomes:
measure: Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
timeFrame: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
Secondary outcomes:
measure: Correlative biology
timeFrame: at study entry before treatment, at week 3 of treatment, and at week 11 after treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Henry Manning, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00657995: Tight Glycemic Control by Artificial Pancreas
Official title: Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasm
Keywords: pancreatogenic
diabetes
artificial
pancreas
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Detailed description: This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Eligibility criteria: Inclusion Criteria:

* This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Exclusion Criteria:

* weight loss greater than 10% during the previous 6 months
* signs of distant metastasis
* respiratory, renal,or heart disease
* Patients provided written informed consent prior to enrollment

Primary outcomes:
measure: the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
timeFrame: the first postoperative 18 hours in the surgical intensive care unit
Secondary outcomes:
measure: the total amount of insulin required for glycemic control after pancreatic resection
timeFrame: the first postoperative 18 hours in the surgical intensive care unit
Other outcomes:
Locations:
city: Nankoku-City
country: Japan
facility: Kochi Medical School, Kochi University
state: Kohasu-Okocho
Study officials:
affiliation: Kochi Medical School, Kochi University
name: Takehiro Okabayashi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02035995: EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
Official title: EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Evaluation in Patients With GDM.
Keywords: gestational diabetes mellitus; optical coherence tomography; pregnancy; retinal nerve fiber layer.
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-01-14
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes and it is responsible for the morbidity of both mother and child. The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).

Detailed description: We have three groups; the first group consisted of pregnant volunteers with GDM. The second group consisted of healthy pregnant participants. The third group consisted of healthy, non-pregnant women at the reproductive age. Macular, choroid and retinal nerve fiber layer (RNFL) thicknesses were evaluated in patients with GDM and comparisons were made among GDM, healthy pregnant and healthy non-pregnant subjects for these parameters by using optic cohorence tomography.

Eligibility criteria: Inclusion Criteria:

Singleton pregnancies Pregnancies between 26-28 weeks of gestation Gestational Diabetes

Exclusion Criteria:

* ocular surgery ocular trauma glaucoma cystoid macular edema macular degeneration optic atrophy

Primary outcomes:
measure: Retinal evaluation
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Education and Research Hospital
Study officials:
References:
Clinical trial NCT00001295: Continuing Care and Treatment for Patients With Cancer/AIDS/Skin Disease
Official title: Continuing Treatment for Children and Adults in the Center for Cancer Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
HIV
Keywords: Follow-Up
Treatment
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 2145
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: This protocol is to provide continuing medical/surgical/radio-therapeutic care, treatment and follow-up for NCI patients not currently entered on an active research protocol. No investigational treatments will be administered on this protocol.

Detailed description: Background:

It may be in the interest of the CCR to continue to follow and treat certain subjects after they have completed their treatment and participation on a research protocol.

Objective:

To provide continuing treatment and medical follow-up for CCR subjects who have completed their treatment and participation on a research protocol and who are not currently entered on or eligible for another active research protocol.

Eligibility:

Subjects who have been previously enrolled on and received treatment according to an approved CCR research protocol. (clinical trial)

It is in the best interest of the subject and the CCR for the subject to continue to receive standard care and follow-up at the NIH.

Design:

Medical/surgical/radiotherapeutic care, treatment and follow-up is provided for CCR subjects who have completed their treatment and participation on a research protocol and who are not currently entered on an active research protocol.

No investigational treatments will be administered. This protocol is not be used as a platform to perform pilot studies of off-label uses for standard agents.

Eligibility criteria: * INCLUSION CRITERIA:

Subjects of any age who have been previously enrolled and treated on an approved CCR research treatment protocol.

It is in the best interests of the subject and the CCR for the subject to continue to receive treatment and follow-up at the NIH.

The subject or guardian signs the informed consent and agrees to the proposed treatment regimen.

EXCLUSION CRITERIA:

Subjects who have not been previously treated on a CCR research treatment protocol.

Subjects who are receiving an investigational therapy.

Primary outcomes:
measure: To provide continuing treatment and medical follow-up for CCR subjects who have completed their treatment and participation on a research protocol and who are not currently entered on or eligible for an active research protocol.
timeFrame: Open-ended
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Caryn Steakley, R.N.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802295: Aneuploidies and Different Stimulation Protocols
Official title: Influence of Ovarian Stimulation and Embryo Aneuploidy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneuploidy
Keywords: Ovarian
hyperstimulation
Embryo
Aneuploidy
Ovarian hyperstimulation and Embryo Aneuploidy Rates
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (\>20 oocytes and/or E2 levels the day of the hCG injection \>3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).


Eligibility criteria: Inclusion Criteria:

* Healthy women between 18 - 29
* with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (\> 20 oocytes)
* No symptom of OHSS

Exclusion Criteria:

* donors with 2 previous miscarriages
* PCO
* Severe Male Factor

Primary outcomes:
measure: Aneuploidy rate with two different stimulation protocols.
timeFrame: three months
Secondary outcomes:
measure: Normal blastocyst rate
timeFrame: three months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
affiliation: IVI Valencia
name: Jose Remohi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rubio C, Mercader A, Alama P, Lizan C, Rodrigo L, Labarta E, Melo M, Pellicer A, Remohi J. Prospective cohort study in high responder oocyte donors using two hormonal stimulation protocols: impact on embryo aneuploidy and development. Hum Reprod. 2010 Sep;25(9):2290-7. doi: 10.1093/humrep/deq174. Epub 2010 Jul 13.
Clinical trial NCT05991895: Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
Official title: Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ALK-positive non-small cell lung cancer

Brief summary: This study is a national multicenter real-world investigation aimed at evaluating the real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in China.

The study aims to enroll ALK-positive NSCLC patients who have undergone treatment with Iruplinalkib prior to enrollment. Demographic information, medical history, Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related data will be collected for all enrolled patients.

As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. The primary sources of data for this study will mainly consist of patients' routine medical records or healthcare documentation.


Eligibility criteria: Inclusion Criteria:

* Patients willingly contribute their clinical data for this study
* Patients with ALK-positive non-small cell lung cancer
* Age ≥ 18 years
* Patients who have undergone treatment with Iruplinalkib.

Exclusion Criteria:

* Known pregnant or lactating females
* Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: JinMing Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366595: Zinc Supplementation in Pediatric Sepsis
Official title: Zinc Supplementation in Pediatric Sepsis; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Zinc in Pediatric Sepsis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

Detailed description: a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

The study included 72 cases that were randomly divided into 2 groups

A- Group A (Zinc treated group):

Included 36 cases who received oral zinc sulfate supplementation at doses ranging from 10 mg (infants) to 20 mg (under-five children) of elemental zinc per day, a dosage that is safe in these children.

B- Group B:

Included 36 cases who didn't receive zinc sulfate supplementation.

Method of randomization:

The cases were randomly divided into two groups using the closed envelope technique. The numbers from 1 to 72 were written in flat pieces of papers and put in closed envelopes that were randomly distributed to the participants.

The cases with the odds number were allocated to the zinc treated group while the cases with the even numbers were allocated to the other group.

Eligibility criteria: Inclusion Criteria:

* 2- Pediatric patients who fulfill Pediatric Consensus criteria for definition of severe sepsis as 1) greater than or equal to 2 age-based systemic inflammatory response syndrome criteria, 2) confirmed or suspected invasive infection, and 3) cardiovascular dysfunction, acute respiratory distress syndrome, or greater than or equal to 2 organ system dysfunctions

Exclusion Criteria:

* Infants and children with history of prematurity (\< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, surgical conditions and any other chronic medical condition.
* Those who are regularly taking vitamin or mineral supplementations

Primary outcomes:
measure: Mortality rate
timeFrame: through study completion an average of one year
Secondary outcomes:
measure: Zinc level
timeFrame: after 10 days of treatment
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children's Hospital
Study officials:
affiliation: Mansoura University
name: Angi A Al Wakil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519895: Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers
Official title: Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychological Stress
Keywords: quality of life
anxiety
stress
carers
colorectal or colon cancer
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2012-01-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.

Detailed description: telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone

Eligibility criteria: Inclusion Criteria:

* Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
* Self identified as formal or informal family caregivers
* Over 18 years old
* Chinese
* Cantonese speaking

Exclusion Criteria:

* Cognitive disability
* Domestic helpers or maids
* Non Chinese

Primary outcomes:
measure: Distress level
timeFrame: Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Secondary outcomes:
measure: Burden of care
timeFrame: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
measure: Quality of life
timeFrame: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: N F Shum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06592495: Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315
Official title: Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

Detailed description: The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

Eligibility criteria: Inclusion Criteria:

* Over 19 year old
* Healthy adult volunteers

Exclusion Criteria:

* with a history of mental disorder
* For female volunteers, those who are suspected of being pregnant or lactating

Primary outcomes:
measure: The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
timeFrame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
measure: The Area under the curve(AUC)last of DWJ1589 and DWC202315
timeFrame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: H Plus Yangji Hospital
name: KANG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: