louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04695015: Research of Pathological Imaging Diagnosis of Ocular Tumors Based on New Artificial Intelligence Algorithm
Official title: Research of Pathological Imaging Diagnosis of Ocular Tumors Based on New Artificial Intelligence Algorithm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma (Skin)
Melanoma in Situ
Nevus Eye
Sebaceous Gland Carcinoma of the Eyelid
Basal Cell Carcinoma
Squamous Cell Carcinoma in Situ
Ocular Tumor
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from the Department of Ophthalmology, Peking University Third Hospital who has an eye tumor and undergoes surgery.

Brief summary: The purpose of this study is to establish a standardized process for obtaining digital pathological image information of ocular tumors; use modern pathological techniques to obtain the co-expression information of multiple biomarkers in the pathological tissues of ocular tumors, and finally construct standardized digital ocular tumors with biomarkers Pathology image database.

Detailed description: This study is a prospective study. Patients with common and representative ocular tumors in the Department of Ophthalmology, Peking University Third Hospital, will be selected and enrolled after informed consent to collect basic clinical information, preoperative blood samples, and ocular tumors Obtain pathological image annotation data and genomics-related data from ocular tumor tissue specimens, use blood samples for genomics information analysis, provide multi-dimensional data for the development of artificial intelligence algorithms, and establish artificial intelligence-assisted image data for eye tumors Standardize the process and establish a multi-modal ocular tumor standardized database of "clinical information-tissue samples-pathological images-genomics data". The database and the diagnosis system are correlated with each other to provide optimal image data for later machine learning and related algorithm establishment, and finally the investigators will be completed the design of a new artificial intelligence-assisted diagnosis system for eye tumors.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with eye tumors and undergoing eye tumor surgery.
2. Patients sign informed consent for sample collection and sample transfer agreement, and can cooperate with long-term regular follow-up requirements.

Exclusion Criteria:

1. Patients who are unable to undergo tumor surgery or retain samples due to various reasons .
2. Patients who are positive for hepatitis B, HIV, and syphilis.
3. Patient compliance is poor.

Primary outcomes:
measure: To compare the diagnostic accuracy of OPAL and IHC for melanoma and other tumors.
timeFrame: Up to 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Chun Zhang, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06560515: Dinoprostone Versus Vaginal Misoprostol for Induction of Labour
Official title: Vaginal Dinoprostone Versus Vaginal Misoprostol for Induction of Labour in Post-dated Pregnancy; a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Vaginal Delivery
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility \& enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.


Eligibility criteria: Inclusion Criteria:

* pregnant women at 40 weeks or beyond
* singleton pregnancy
* Bishop score 4 or more
* fetus in a cephalic presentation
* Adequate fetal biophysical profile

Exclusion Criteria:

* Any signs of labour (Prelabor rupture of membranes)
* Grand Multiparous women (parity of 4 or more)
* IUFD
* fetal weight \> 4 kg
* BMI \> 35

Primary outcomes:
measure: Sucess of induction
timeFrame: number of women who delivered vaginally after induction
measure: Induction to delivery time
timeFrame: time from start of induction till delivery of the fetus
Secondary outcomes:
measure: Postpartum hemorrhage
timeFrame: after delivery of the placenta
measure: neonatal outcomes
timeFrame: at 1 and 5 minutes of delivery
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: ElShatby University Maternal Hospital
Study officials:
References:
Clinical trial NCT05098015: Randomized Controlled Trial of Game Changers
Official title: Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Institute, Uganda
name: Makerere University
name: Indiana University
First posted: 2021-10-28
Enrollment: 885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group.
Primary purpose: PREVENTION

Brief summary: The study is a randomized controlled trial (RCT) of Game Changers, an 8-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks.

Detailed description: This RCT of Game Changers, a peer-led group intervention for persons living with HIV (PLWH) in Uganda, will test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit up to 4 social network members to complete assessments (736 total, 368/arm). All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline.

Eligibility criteria: Inclusion Criteria:

* age 18 years and older
* HIV-positive
* in HIV care at The Infectious DIseases Institute for at least one year

Exclusion Criteria:

* Participated in the prior pilot study of the intervention.
* Has significant cognitive impairment
* Health status is not sufficiently stable to reliably complete 18 month study.
* Does not speak Luganda fluently (index participant); English or Luganda fluently (social network participant)
* spouse/partner or household member are enrolled as index participant in the study

Primary outcomes:
measure: HIV testing
timeFrame: Past 6 months
measure: Condom use
timeFrame: Past 6 months
Secondary outcomes:
measure: Internalized HIV stigma
timeFrame: Past 6 months
measure: HIV prevention advocacy
timeFrame: Past 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
Study officials:
affiliation: RAND
name: Glenn Wagner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagner GJ, Bogart LM, Green HD, Storholm ED, Klein DJ, McBain RK, Serunkuuma R, Mubiru K, Matovu JKB, Okoboi S. Social network-based group intervention to promote HIV prevention in Uganda: study protocol for a cluster randomized controlled trial of Game Changers. Trials. 2022 Mar 28;23(1):233. doi: 10.1186/s13063-022-06186-z.
Clinical trial NCT00752115: Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
Official title: Randomized Phase II Study of Combination Chemotherapy With Sildenafil Plus Carboplatin and Weekly Paclitaxel in Patients With Previously Untreated Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
previously untreated
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2008-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. The study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.

Detailed description: Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
* Good performance status (ECOG 0-1)
* No previous treatment
* Adequate bone marrow, liver and renal functions
* Must be able to swallow tablets
* Provided written informed consent

Exclusion Criteria:

* Severe complications or a concomitant malignancy
* Contraindicated sildenafil, carboplatin or taxol
* Inappropriate patients for entry to this study, judged by the physicians

Primary outcomes:
measure: progression free survival
timeFrame: three-year
Secondary outcomes:
measure: overall response rate
timeFrame: three-year
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
affiliation: Hamamatsu University School of Medicien Institution Review Board
name: Kingo Chida, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02921815: A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid Treatment
Official title: Revlimid 5 mg Capsules Special Use-results Surveillance of Transformation to Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Keywords: Leukemia
Acute Myeloid Leukemia
Revlimid
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 84
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: All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as Acute Myelogenous Leukemia (AML)) has not been documented at the end of the observation period of the all-case surveillance.

Brief summary: To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and who are continuing or no longer continuing Revlimid treatment.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qMDS) patients in the all-case surveillance.
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.


Eligibility criteria: Inclusion Criteria:

* All del(5q)MDS patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as AML) has not been documented at the end of the observation period of the all-case surveillance.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Shinko Hospital
state: Hyogo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01025115: Diamel in the Treatment of Metabolic Syndrome
Official title: Efficacy of Diamel in the Treatment of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Keywords: Dietary supplement
Diamel
Metabolic Syndrome
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
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 assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.


Eligibility criteria: Inclusion Criteria:

* Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
* Signed informed consent

Exclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
* Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
* Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
* Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
* Sepsis or any other condition that could potentially interfere with treatment
* Any other treatment that could potentially interfere with treatment
* Pregnancy

Primary outcomes:
measure: Blood concentrations of glucose at months 0,3,6,9,12.
timeFrame: 12 months
measure: Blood concentrations of insulin at months 0,3,6,9,12.
timeFrame: 12 months
measure: Blood concentrations of cholesterol at months 0,3,6,9,12.
timeFrame: 12 months
measure: Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
timeFrame: 12 months
measure: Blood concentrations of triglycerides at months 0,3,6,9,12.
timeFrame: 12 months
measure: Blood concentrations of creatinine at months 0,3,6,9,12.
timeFrame: 12 months
measure: Blood concentrations of uric acid at months 0,3,6,9,12.
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure at months 0,3,6,9,12.
timeFrame: 12 months
measure: BMI index at months 0,3,6,9,12.
timeFrame: 12 months
measure: Waist-to-hip index at months 0,3,6,9,12.
timeFrame: 12 months
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: National Institute of Endocrinology
state: Havana
Study officials:
affiliation: National Institute of Endocrinology
name: Eduardo Cabrera-Rode, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554015: Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Official title: Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outside this investigation, stoma patients eligible for the Heylo™ device prescription, will be onboarded to Heylo™ by stoma care nurses.

Subjects for this study will be identified through their Heylo™ app activation. A minimum of 100 subjects will be enrolled.

Brief summary: This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.


Eligibility criteria: Inclusion Criteria:

1. Are you at least 18 years old? \[Yes/No\]
2. Do you have an ileostomy or a colostomy? \[Yes/No\]
3. Have you used Heylo™ for less than seven days? \[Yes/No\]

Exclusion Criteria:

1) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]

Primary outcomes:
measure: Primary endpoint
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT01270815: An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Official title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes As Compared To The Immediate Release Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
timeFrame: 3 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
Clinical trial NCT06487585: ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
Official title: Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery (ANG-First Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hypotension After Cardiac Surgery
Lead sponsor: University of Maryland St. Joseph Medical Center
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.


Eligibility criteria: Inclusion Criteria:

* 1. Adult patients ≥ 18 years of age. 2. Patients must have clinical features of vasodilation, as determined by a MAP \< 65 mmHg requiring any dose of vasopressors intra/post-operatively 3. Patients must be adequately volume resuscitated in the opinion of the treating physician.

Exclusion Criteria:

-1. Patients with active bleeding as the primary reason for hypotension AND an anticipated need for transfusion of \> 4 units packed red blood cells within the next 48 hours.

2. History of atrial fibrillation 3. Patients already on renal replacement therapy or creatinine of \> 4 mg/dl within 2 weeks of surgery

Primary outcomes:
measure: Incidence of postoperative acute kidney injury, atrial fibrillation
timeFrame: 28 days
Secondary outcomes:
measure: Hours on Vasopressors
timeFrame: 28 days
measure: Total IVF
timeFrame: 28 days
measure: ICU LOS
timeFrame: 28 days
measure: Postoperative LOS
timeFrame: 28 days
measure: Any major STS complication
timeFrame: 28 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: