louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01336855: Collection of Blood for Multiple Collaborative Studies
Official title: Collection and Preservation of Blood and Serum Specimens From HIV Positive or HIV Negative Patients for Multiple Collaborative Studies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: HIV
Observational
Pathogenesis
Immunology
Virology
Control
Healthy control
Men who have sex with men
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected based on positive or negative HIV antibody, depending on the study for which blood is being collected. Patients will be chosen from the Positive Health Practice populations at SFGH and UCSF, the General Medicine Clinic at the San Francisco Veterans Affairs Medical Center. HIV uninfected healthy volunteers with comparable risk factors to the HIV positive subjects will be recruited from the community.

Brief summary: This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies.

Detailed description: HIV positive patients are currently the focus of multiple collaborative research studies, both at UCSF and other institutions. The aims of these research projects include improving the understanding of etiology, immunology, epidemiology and treatment of HIV. There are numerous requests from basic scientists at UCSF for collaborative studies on specimens, especially for blood, saliva and urine samples. Specimens may be used to test such things as virus characteristics, genotyping and/or phenotyping resistance, plasma drug concentrations, immune function or evidence of complications of HIV disease. The samples may also be tested for genetic factors that may be related to the course of HIV disease

Eligibility criteria: Inclusion Criteria:

* HIV-1 antibody negative with similar characteristics to HIV-1 positive cohort
* HIV-positive subjects naive to antiretroviral therapy
* HIV-positive subjects stable on or off antiretroviral therapy for a minimum of 6 months
* Good venous access
* Able to provide informed consent

Exclusion Criteria:

* Hemoglobin \< 9g/dl
* Hematocrit \< 27%
* Active treatment for cancer
* Hospitalization or IV antibiotic use within the last 4 months
* Immunosuppressive therapy within the last 4 months

Primary outcomes:
measure: Plasma HIV RNA level
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of Californa, San Francisco
name: Steven Deeks, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03705455: Immunization Schedule Alert Platform
Official title: Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunization
Lead sponsor: Lifespan Healthcare Resource Limited
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 1800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.

Detailed description: The ISAP - Immunization Schedule Alert Platform study is investigating the efficacy of ISAP SMS exposure to Caregivers with children( who have fulfilled our inclusion criteria) due for routine childhood Immunisation in influencing decision for timely and complete Immunization uptake. ISAP SMS messages contains information on the Immunization appointment schedule, time ,vaccine to be administered and the address of the Immunization centre.

Eligibility criteria: Inclusion Criteria:

Caregiver with child due for birth dose vaccination or at 6weeks-OPV1,Penta1,PCV1,Rota1.

Exclusion Criteria: Caregiver with child who have already had OPV1,Penta1,PCV1and Rota1.

-

Primary outcomes:
measure: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Enugu
country: Nigeria
facility: Nkanu East Health centre Immunization clinic
Study officials:
affiliation: Lifespan Healthcare Resource
name: Emmanuel Ihedioha, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
Clinical trial NCT01570855: Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
Official title: Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
chemosensitivity
Lead sponsor: Marshall University
Sponsor class: OTHER
Collaborators: name: Cabell Huntington Hospital
First posted: 2012-04-04
Enrollment: 45
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: Patients who have a suspected or confirmed diagnosis of lung cancer, and who are scheduled to have a diagnostic fine needle aspiration, core needle biopsy, or excisional biopsy of the lung lesion.

Brief summary: The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment.

Detailed description: The chemosensitivity assay will be performed on tissue obtained during the diagnostic fine needle aspiration, core biopsy, or excisional biopsy of the lung lesion. Cancer cells (Bulk of tumor) and Cancer Stem Cells (CSCs) will be isolated and expanded in the laboratory.

The drug screening assay will be used to evaluate the response of the CSCs and of the cancer cells to the various chemotherapy regimens.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed diagnosis of lung cancer

  * undergoing a fine needle aspiration, core biopsy, or excisional biopsy for diagnosis.
* Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
* Patient must be at least 18 years of age
* Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.

Exclusion Criteria:

* Patient pathology shows benign pathology for sample submitted
* Patient is not indicated to receive chemotherapy for their disease

Primary outcomes:
measure: Tumor size
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Cabell Huntington Hospital
state: West Virginia
Study officials:
affiliation: Marshall University School of Medicine
name: Pier P. Claudio, M.D., Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645055: Biologics for Stricturing Crohn's Diseases
Official title: The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: The Efficacy of Biologics for Stricturing Crohn's Diseases
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200

Brief summary: Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.


Eligibility criteria: Inclusion Criteria:

* patients with stricturing Crohn's diseases
* no surgical indication
* patients with asymptomatic penetrating diseases
* written consent acquired

Exclusion Criteria:

* patients with surgical indication
* patients with symptomatic penetrating diseases
* contraindication of biologics
* anticipating other trial

Primary outcomes:
measure: clinical remission rate at 1 year
timeFrame: clinical remission rate at 1 year
Secondary outcomes:
measure: clinical remission rate at 5 year
timeFrame: clinical remission rate at 5 year
measure: surgical recurrence rate at 1 and 5 year
timeFrame: at 1 and 5 year
measure: endoscopic recurrence rate at 1 and 5 year
timeFrame: at 1 and 5 year
measure: quality of life of patients assessed by IBDQ
timeFrame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
measure: quality of life of patients assessed by Short form 12
timeFrame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
measure: score of obstructive
timeFrame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Weiming wm Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01895114: Assessment of Renal Function in Cirrhotic Patients
Official title: Assessment of Renal Function in Cirrhotic Patients -A Comparison of Cystatin C and Creatinine Based Calculations to 125I-iothalamate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Failure
Renal Failure
Keywords: Renal function
cirrhotic patients
transplant evaluation
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from Baylor All Saints Medical Center and Baylor University Medical Center who have cirrhosis and a stable urine creatinine

Brief summary: The purpose of this study is to help determine whether cystatin C is a more sensitive laboratory measurement for renal function in cirrhotic patients.

Detailed description: Serum cystatin C, creatinine clearance based calculations, and 125I-Iothalamate clearance (Glofil) will be obtained in 220 patients with cirrhosis. Utilizing this information, the correlation between cystatin C and 125I-Iothalamate clearance will be obtained. In addition, the current serum creatinine based calculations and true creatinine clearance will also be correlated with 125I-Iothalamate clearance. The results of this study should help to determine whether serum cystatin C is a more sensitive laboratory measurement of renal function in patients with cirrhosis.

Eligibility criteria: Inclusion Criteria:

* over 18 undergoing evaluation for a liver transplant

Exclusion Criteria:

* known allergy or sensitivity to 125I-Iothalamate

Primary outcomes:
measure: Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Baylor All Saint's Medical Center in Fort Worth
state: Texas
Study officials:
affiliation: Baylor All Saints
name: Bernard Fischbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03527914: Patient Generated Goals in Mental Health: Better Outcomes?
Official title: Patient Generated Goals in Mental Health: Better Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Depression
Psychosis
Personality Disorder
Substance Abuse
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 152
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers believe that clinical care can be improved by engaging patients and families directly in planning the care process. Engagement efforts have included asking patients/families to provide information about whether they are getting better. But what does "getting better" mean? The merits of surveys, questionnaires, or rating scales have been widely discussed. Should they be disorder-specific or global? What should the investigators do if patients have difficulty reading or understanding these instruments? Investigators in the United Kingdom have proposed a simple solution: ask the patients and families what their primary goal treatment goal is and track progress together on that goal (Goal-Based Outcomes or GBO). Although there has been some work to suggest that this is helpful, it has never been tested in a controlled way. This study will do a randomized controlled trial to test whether GBO improves clinical care in child and youth mental health. Although the study will use this in child and youth mental health care, if it is successful, it can be tested and applied in any care setting with any type of medical problem. This could change practice at the Children's Hospital of Eastern Ontario (CHEO) and throughout Canada.


Eligibility criteria: Inclusion Criteria:

* Children and youth
* Attending outpatient mental health services at CHEO

Exclusion Criteria:

-Child and youth attending group therapy at CHEO Outpatient Mental Health Services

Primary outcomes:
measure: Patient/Family Satisfaction
timeFrame: Administered at study completion (up to 52 weeks)
measure: Change in Symptoms
timeFrame: Administered at the first appointment and at study completion (up to 52 weeks)
measure: Change in Function
timeFrame: Administered at the first appointment and at study completion (up to 52 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Kathleen Pajer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02656914: Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
Official title: Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold

Detailed description: Double blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation

Eligibility criteria: Inclusion Criteria:

* Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
* Signed consent.

Exclusion Criteria:

* Patients with any clinically significant disease that, in the investigator opinion, can´t participate in the study;
* Patients with any laboratory finding or image finding that, in the investigator opinion, can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Patients with vaccine reaction;
* Patients who have uncontrolled asthma. However, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
* Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
* Patients with diabetes mellitus type I and II;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients in use of drugs that can interfere with flu symptoms evaluation.

Primary outcomes:
measure: Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms.
timeFrame: 7 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 7 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References:
Clinical trial NCT01936714: Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm
Official title: Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Efficacy and Safety
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution
* LOCS 2-5

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* previous corneal pathology
* previous endothelial cell count \<1200
* glaucoma
* uveitis
* PEX
* diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
* intraocular complication like posterior capsular
* postoperative comlpications (e.g. postoperative uveitis)

Primary outcomes:
measure: phacoemulsification time
timeFrame: intraoperative
measure: effective phacoemulsification time
timeFrame: intraoperative
measure: fluid volume
timeFrame: intraoperative
Secondary outcomes:
measure: postoperative corneal oedema
timeFrame: 1 day, 1 week, 6 months
measure: postoperative endotheial cell loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry of the Medical University Vienna
Study officials:
References:
Clinical trial NCT02828514: Nasal Resonance Change After Endoscopic Endonasal Transsphenoidal Skull Base Surgery: Analysis of Quality of Voice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Voice Quality
Endoscopic Pituitary Surgery
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

Brief summary: The purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

Exclusion Criteria:

* Patients under 18 year
* Patients cannot following command including loss of conscious
* Patients cannot speak including patient on tracheostomy tube
* Patients who has nasal tumor, nasal polyp, sinusitis
* Patients who has cleft lip cleft palate or submucosal cleft
* Patients who underwent adenotonsillectomy or palatoplasty in same setting with endoscopic pituitary surgery

Primary outcomes:
measure: Nasal resonance change after endoscopic endonasal transsphenoidal surgery which was assessed by computer speech lab
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
state: Khon Kean
Study officials:
affiliation: Khon Kaen University
name: Pornthep Kasemsiri, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasemsiri P, Duangthongphon P, Prathanee B, Thongrong C. Nasal resonance changes after endoscopic endonasal transsphenoidal skull base surgery: Analysis of voice quality. Laryngoscope Investig Otolaryngol. 2021 Nov 19;6(6):1275-1282. doi: 10.1002/lio2.701. eCollection 2021 Dec.
Clinical trial NCT06095414: Prospective Radiomics Study for Breast Cancer
Official title: Prospective Study of MRI-based Radiomics in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Korea University Ansan Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 121
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population should fulfill the following criteria as follows:(a) histologically confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before treatment

Brief summary: The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer.

The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.

Detailed description: The written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images are extracted from the results of MRI of participants. The tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. Radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. The investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (AUC) and the DeLong test.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with invaseiv breast cancer

Exclusion Criteria:

* Diagnosed with other cancers

Primary outcomes:
measure: The signal intensity of Magnetic Resonance Images for tumor microenvironment
timeFrame: Baseline, pre-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Bo Kyoung Seo
Study officials:
affiliation: Korea University Ansan Hospital
name: Bo Kyoung Seo, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: