louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05852626: Structuring of Diabetes Care in Primary Health Care
Official title: Structuring Diabetes Care in Primary Health Care With Individualized Goals and Multidisciplinary Integration: A Cluster-randomized Clinical Trial for
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2023-05-10
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the effectiveness of reorganization in Primary Health Care teams and individualized glycemic targets for type 2 diabetes.

Detailed description: The prevalence of diabetes is increasing in parallel with the obesity epidemic. Diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. Also, it has significant social cost related to reduction of productivity. This study will evaluate the effectiveness of a multimodal intervention for Primary Health Care (PHC) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in Porto Alegre, Brazil. Two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in PHC.

Eligibility criteria: Health care unit:

Inclusion criteria

* Health unit has registered at least 50 users diagnosed with type 2 diabetes

Exclusion criteria:

* Health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study.

Individuals:

Inclusion criteria

* Individuals with type 2 diabetes for at least one year
* In person diabetes consultation in the last six months

Exclusion criteria:

* Expected survival \< one year

Primary outcomes:
measure: Number of patients who achieved individualized target HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of clinical consultations carried out by nurses
timeFrame: 12 months
measure: Foot evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Ana Maria Frölich Matzenbacher
state: Rio Grande Do Sul
Study officials:
affiliation: UFRGS e HCPA
name: Beatriz Schaan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01544426: Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome
Official title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Office hysteroscopy,
intrauterine insemination
endometrial scrap
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 332
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.

Detailed description: The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.

Eligibility criteria: Inclusion Criteria:

* 18- 38 years old
* at least one patent tube
* unexplained infertility, anovulation, mild to moderate male factor infertility
* previous failed IUI

Exclusion Criteria:

* indicated for ICSI

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 10 month
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-AINY hospital
Study officials:
affiliation: Cairo University
name: Waleed El-khayat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Khayat W, Elsadek M, Saber W. RETRACTED: Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:96-100. doi: 10.1016/j.ejogrb.2015.08.025. Epub 2015 Aug 28.
Clinical trial NCT00912626: Family Functioning and Child Behavior When a Sibling is Critically Ill
Official title: Family Functioning and Child Behavior When a Sibling is Critically Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Keywords: siblings
family
child behavior
critical illness
social support
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to determine if there is a correlation between an efficacious family environment and sibling behavior in families with children who are critically ill.

Detailed description: Families of critically ill children can face many emotional challenges during the course of a child's illness. While some research has looked at the impact on parents, there has been little focused on siblings. We want to better understand how social support may have a protective effect on siblings' quality of life. The goal of this study is to determine if there is a correlation between an efficacious family environment and sibling behavior in families with children who are critically ill. Our hypothesis is that a cohesive, emotionally rich and open family environment provides social support so that siblings can explore and express the difficult emotions that accompany illness, and is therefore a protective factor for a sibling's behavior.

Eligibility criteria: Inclusion Criteria:

* adult (age 18 and older) who has decision making authority for CHOP patient who has been referred to the Pediatric Advanced Care Team (PACT) for palliative care services, and with a child(ren) age 6-11 years who is a sibling of the patient
* any race/ethnicity

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: To compare behavioral assessment scores of siblings of children who are critically ill to scores of the general population
timeFrame: baseline and 6 months
Secondary outcomes:
measure: To assess if parents who receive results of sibling behavior scores and a brief intervention, compared to parents who do not receive this information or intervention, have a different perception of the sibling's strengths and difficulties.
timeFrame: baseline and 1 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Chris Feudtner, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04959526: Shear-wave Elastography Compared to Respiratory Function Testing
Official title: Comparison of Shear-wave Elastography to State-of-the-art Respiratory Function Testing to Measure the Range of Forces Generated by the Diaphragm Muscle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Function Loss
Respiratory Complication
Keywords: Elastography
Ultrasound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the relationship between transdiaphragmatic pressure (Pdi) and diaphragm shear-wave elastography (SWE) during state-of-the-art respiratory muscle testing including volitional efforts (e.g., maximal inspiratory pressure, maximal expiratory pressure, Valsalva maneuver), as well as maximal phrenic nerve stimulation.


Eligibility criteria: Inclusion Criteria:

- Adult male and female healthy volunteers.

Exclusion Criteria:

* Volunteers who are pregnant.
* Volunteers with known pulmonary pathology (COPD, asthma requiring routine treatment).

Primary outcomes:
measure: Shear wave speed
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carlos Matilla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01881126: An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 93
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: This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or glaucoma that requires treatment with medication
* Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria:

* History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
* History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
* Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

Primary outcomes:
measure: Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
timeFrame: Week 12 at 8 AM, 12 PM, and 4 PM
Secondary outcomes:
Other outcomes:
Locations:
city: Barrie
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01012726: Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Official title: FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 20
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
Primary purpose: TREATMENT

Brief summary: The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.


Eligibility criteria: Inclusion criteria:

* fistulizing CD
* CD \< 6 months
* at least one insufficient fistula closure try

Exclusion criteria:

* CDAI \> 200
* Abscesses
* CRP \> 100

Primary outcomes:
measure: Fistula closure
timeFrame: 01.08.2009 - 31.07.2012
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT01667926: Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Official title: Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 37
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: Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.


Eligibility criteria: Inclusion Criteria:

* Outpatient with sever treatment resistant depression
* Currently depressed
* Currently under regular psychiatric care
* On an aggressive antidepressant regimen, stable for 4 weeks.

Exclusion Criteria:

* No history of other major psychiatric illness, including bipolar
* No history of psychosis
* No history of drug abuse
* No major medical illness or unstable medical problem

Primary outcomes:
measure: Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
timeFrame: up to 4 months
Secondary outcomes:
measure: HDRS-28 Total
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical and Reseach Program - MGH
state: Massachusetts
Study officials:
affiliation: MGH Department of Psychiatry
name: Cristina Cusin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02723526: Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer
Official title: Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Metastatic Hormone-Sensitive Prostate Cancer；circulating tumor cells；Prognosis；Liquid biopsy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer

Brief summary: As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.


Eligibility criteria: Inclusion Criteria:

1. Male patients;
2. 18 yrs and older, and 80 yrs and younger;
3. Histologically or cytologically proven prostate adenocarcinoma;
4. Imaging examinations including Emission Computed Tomography (ECT),Positron Emission Tomography (PET),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
5. Not yet receiving hormonal therapy;
6. Not yet receiving chemotherapy previously;
7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
8. Patients are willing to participate and can be followed up regularly；

Exclusion Criteria:

1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
3. Patients received chemotherapy previously;
4. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);

Primary outcomes:
measure: time to castration-resistant prostate cancer
timeFrame: 3 years
Secondary outcomes:
measure: time to radiographic progression
timeFrame: 3 years
measure: time to prostate specific antigen (PSA) progression
timeFrame: 3 years
measure: time to prostate specific antigen (PSA) nadir
timeFrame: 2 years
measure: complete serologic response rate at 6 month and 12 month
timeFrame: 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Bo Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02333526: Syndecan 1 as Biomarker for Inflammation
Official title: Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colitis
Keywords: ulcerative colitis
Clostidium difficile-associated colitis
Syndecan-1
biomarker
Lead sponsor: Helios Albert-Schweitzer-Klinik Northeim
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with inflammatoy bowel disease, infectious colitis and healthy volunteers

Brief summary: The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from venous blood of patients with infectious intestinal diseases such as Clostridium difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients with active inflammation and with disease in remission. Secondary objectives were the assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be volunteers. Blood will be taken as part of the routine clinical work-up after the written agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In addition, the subjects are asked to answer a short questionnaire. The study is designed as a prospective, comparative cohort study.


Eligibility criteria: Inclusion Criteria:

* Subject with at least 18 years of age
* able to give informed consent
* healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)

Exclusion Criteria:

* not able to give informed consent

Primary outcomes:
measure: Soluble serum Syndecan-1 in ng/ml
timeFrame: 6 months
Secondary outcomes:
measure: Underlying disease
timeFrame: 6 months
measure: Patient age
timeFrame: 6 Months
measure: Disease activity in Inflammatory bowel disease
timeFrame: 6 Months
measure: Calprotectin in stool
timeFrame: 6 Months
measure: Leucocyte blood count
timeFrame: 6 Months
measure: CRP in serum
timeFrame: 6 Months
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
state: Lower Saxony
city: Northeim
country: Germany
facility: Helios Albert-Schweitzer-Klinik Northeim
state: Lower Saxony
Study officials:
affiliation: Helios Albert-Schweitzer-Klinik Northeim
name: Tobias Meister, PD Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floer M, Clausen M, Meister T, Vollenberg R, Bettenworth D, Tepasse PR. Soluble syndecan-1 as marker of intestinal inflammation: A preliminary study and evaluation of a new panel of biomarkers for non-invasive prediction of active ulcerative colitis. Adv Clin Exp Med. 2021 Jul;30(7):655-660. doi: 10.17219/acem/139040.
Clinical trial NCT06290726: Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients
Official title: Long-term Outcomes of Active Vaccination Against de Novo Hepatitis B Among Pediatric Recipients of Living Donor Liver Transplantations With Anti-HBc (+) Grafts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Living Donor Liver Transplantations With Anti-HBc (+) Grafts
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 204
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The consecutive pediatric LDLT recipients enrolled at a tertiary medical center from February 2002 to February 2016, with follow-up to December 2023.

Brief summary: The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts. The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated. Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival.

Detailed description: A particular strength of the present study is in the inclusion of a consecutive cohort of pediatric LDLT recipients with long-term details of follow-up, although there are several limitations. First, this was a retrospective study conducted at a single medical center. Second, the HBV prophylaxis changed from lamivudine to entecavir in 2008, therefore investigators were unable to evaluate the risk of developing lamivudine resistance. In addition, the DNA level data for the donor and graft tissues were lacking. Lastly, this study was conducted in an area with a high prevalence of anti-HBc positivity.

Eligibility criteria: Inclusion Criteria:

- consecutive pediatric LDLT recipients.

Exclusion Criteria:

* Adult LDLT recipients

Primary outcomes:
measure: Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts
timeFrame: Feb. 2002-Feb.2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: