louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06939400: Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence
Official title: Study on Precision Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma Multiforme (GBM)
Keywords: Glioblastoma Multiforme
photodynamic therapy
metaverse
yellow fluorescence
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
First posted: 2025-04-22
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: NON_PROBABILITY_SAMPLE
Study population: GBM patients recevied traditional treatment options (including surgery combined with radiotherapy and chemotherapy) or PDT treatment

Brief summary: GBM patients receiving PDT treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. The prognosis was analyzed by comparing with the control group from multiple perspectives such as image evaluation, imaging effect, Karnofsky score, median survival time and survival rate.


Eligibility criteria: Inclusion Criteria:

Pathologically confirmed primary focal GBM; Recurrent GBM(single or satellite lesions); Multiple (multiple germinal centers)GBM.

Exclusion Criteria:

* Photosensitizer allergy.

  * Severe coagulation disorder.

    * Patients with severe cardiovascular and cerebrovascular diseases, especially patients in the acute stage.

      * Multiple organ failure, end-stage patients. ⑤ Pregnant women: Photofrin is considered a class C pregnancy risk (toxic, non-teratogenic) drug with non-dialysis properties.

Non-gbm diagnosis: Patients with other types of brain tumors or diseases. 7 Do not agree to informed consent: patients who are unwilling to sign informed consent or do not agree to participate in the study.

Primary outcomes:
measure: Number of Participants with Treatment of Surgical combination Photodyanmic therapy
timeFrame: From June 2025 to June 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05058300: Prospective Registry for Patients With Chest Pain in Emergency Department
Official title: Prospective Registry for Patients With Chest Pain in Emergency Department
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chest Pain
Keywords: Chest Pain
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Zentrum für Klinische Studien Jena
name: GE Healthcare
First posted: 2021-09-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An unselected patient-population with chest pain in emergency department

Brief summary: monocentric, prospective registry collection of clinical data of all patients with chest pain in emergency department and follow-up after 30 days

Detailed description: An unselected patient-population with chest pain entering through the emergency department participate in a diagnostic survey where a chest pain algorithm based mainly on risk scores (Grace, TIMI, Heart) verifying the diagnostic forecasting power (sensitivity, specificity, negative and positive predictive value) of biomarkers, risk scores and imaging methods for diagnosing of potential life-threatening disease.

Eligibility criteria: Inclusion Criteria:

* age \>18 years old chest pain written confirmation of participants or legal representative

Exclusion Criteria:

* thorax trauma

Primary outcomes:
measure: Diagnostic forecast of biomarkers, risk scores and computer tomography
timeFrame: From admission to emergency unit discharge
Secondary outcomes:
measure: Sensitivity
timeFrame: During diagnostic procedure
measure: Specificity
timeFrame: During diagnostic procedure
measure: Positive predictive value
timeFrame: During diagnostic procedure
measure: Negative predictive value
timeFrame: During diagnostic procedure
measure: Major adverse cardiac events (MACE)
timeFrame: From admission to emergency unit until 30 days after or death
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Emergency
state: Thuringia
Study officials:
affiliation: Emergency Unit, University hospital Jena
name: Wilhelm Behringer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206400: Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study
Official title: Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Keywords: eugonadal, testosterone
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2010-09-21
Enrollment: 45
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 eugonadal men with type 2 diabetes mellitus

Brief summary: To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Detailed description: Several clinical studies demonstrated that pioglitazone not only improves insulin sensitivity but also decreases plasma androgen concentrations (DHEAS and androstenedione) in women with polycystic ovary syndrome (PCOS) . However the reduction in the androgen levels in PCOS is whether secondary to increase in the insulin sensitivity or due to direct effect of thiazolidinediones on steroidogenesis is not known.So far, two human studies have been conducted regarding the effects of rosiglitazone (a thiazolidinedione group of drug) on testosterone level, one in healthy individuals and another was in patients of type 2 diabetes with hypogonadism . But these studies gave equivocal results as the study population were different. Hence we plan to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* HbA1c level of 7.5% or less on stable dosages of sulphonylurea (glimepiride 1-6mg/day) and metformin (1-2g/day) for at least six weeks and BMI of 20-30 kg/m2.

Exclusion Criteria:

* hepatic impairment, coronary artery disease and or heart failure, renal failure, those who requires insulin therapy or HbA1c \>7.5%, presence of macular edema and serum albumin \<3gm/dL.

Primary outcomes:
measure: pioglitazone effect on testosterone level
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: PGIMER,Chandigarh
name: Dr. Anil Bhansoli, MD.DM
role: STUDY_CHAIR
References:
citation: Kapoor D, Channer KS, Jones TH. Rosiglitazone increases bioactive testosterone and reduces waist circumference in hypogonadal men with type 2 diabetes. Diab Vasc Dis Res. 2008 Jun;5(2):135-7. doi: 10.3132/dvdr.2008.022.
Clinical trial NCT00273000: The Importance of Glucagon-Like Peptide-2 (GLP-2)in Mesenteric Bloodflow in Humans
Official title: The Importance of Glucagon-Like Peptide-2 (GLP-2)in Mesenteric Bloodflow in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University of Copenhagen
First posted: 2006-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to study the effect of GLP-2 on mesenteric bloodflow in healthy adults by the use of ultrasound., it is the hypothesis that GLP-2 vil increase the bloodflow.

Detailed description: The investigation will include 10 testpersons.

It will be a 2 fase study over 2 days.

day 1: The testperson will meet fasting, and take in a standard liquid meal, after this the bloodflow in a mesenteric artery will be measured by use of ultrasonic technique. Bloodsamples will be taken regular in a total wolumne of 200 ml.

day 2:The testperson will meet fasting, there wil be administered intraveneous GLP-2 in 3 increasing doses over 3 x 45 min.and one subcutaneous dose. During this the bloodflow in a mesenteric artery will be measured by use of ultrasonic technique. Bloodsamples will be taken regular in a total wolumne of 200 ml.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* use of drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Copenhagen City
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Mads Hornum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00131300: A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Musculoskeletal Diseases
Keywords: Osteoarthritis of the shoulder
Musculoskeletal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic OA pain of shoulder (gleno-humeral)

Exclusion Criteria:

* Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety

Primary outcomes:
measure: Pain relief
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hopital Ambroise Pare
city: Lyon
country: France
facility: Clinique Saint Anne Lumiere
city: Merignac
country: France
facility: Centre de Medecine et Traumatologie du Sport Clinique du Sport
city: Tours
country: France
facility: CHRU Hopital Trousseau
city: Bad Oeynhausen
country: Germany
facility: August-Viktoria-Klinik
city: Halle/Saale
country: Germany
facility: Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05691400: Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype
Official title: Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: CYP3A4*22
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: arms are designated based off of genotype; however, treatment is the same for each arm
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to estimate the effect of CYP3A4\*22 on the clearance and area under the plasma concentration-time curve of Palbociclib, Ribociclib, and Abemaciclib


Eligibility criteria: Inclusion Criteria:

1. MGI participant with genotype of interest (e.g., CYP3A4\*1/\*1, CYP3A4\*1/\*22, or CYP3A4\*22/\*22) and consented to recontact for future research
2. Age≥18
3. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Concurrent use of a moderate or strong inhibitor or inducer of CYP3A4, based on the current version of the Drug Interactions Flockhart Table™, available at this link or by google search: https://drug-interactions.medicine.iu.edu/MainTable.aspx
2. Carriers another variant known to affect CYP3A4 activity, particularly CYP3A4\*20.
3. Active malignancy or other disease state that would affect the pharmacokinetics of CDK4/6 inhibitors or place the participant at particular risk of toxicity from a single dose of a CDK4/6 inhibitor, in the opinion of the study team
4. History of allergic reaction to CDK4/6 inhibitor
5. Pregnancy or nursing female

Primary outcomes:
measure: Effect of CYP3A4*22 on the Clearance of Palbociclib
timeFrame: 2 days after initiation of Palbocicblib treatment
measure: Effect of CYP3A4*22 on the Clearance of Ribociclib
timeFrame: up to 32 days after initiation of Study drug
measure: Effect of CYP3A4*22 on the CL of Abemaciclib
timeFrame: up to 62 days after initiation of Study drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Daniel L Hertz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01411800: An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Official title: A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-08
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: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Adult subjects age 18 to 55 years
* Vital signs acceptable at Screening
* Body mass index (BMI) between 18 and 35 kg/m\^2 at Screening
* Considered to be in good health, as determined by the Investigator
* Normal ECG findings
* Negative urine screen for drugs of abuse and negative breath test for alcohol
* Negative hepatitis B surface antigen, hepatitis C antibody, and HIV1 and HIV2 antibody tests within the last 28 days
* Ability to provide written informed consent

Exclusion Criteria:

* Use of any medication (including acetaminophen) within 5 days of dosing
* Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
* Administration of any protein or antibodies within 90 days of study start
* Donation or loss of greater than 450 mL of blood within 45 days of study start
* Known history of hepatic disease or significantly abnormal liver function tests
* History of alcoholism or substance abuse within 3 years prior to study start
* Participation in any other clinical study within 30 days preceding the first dose of study drug
* Positive serum pregnancy test

Primary outcomes:
measure: Urinary 5-HIAA levels
timeFrame: 34 days
measure: Plasma 5-HIAA levels
timeFrame: 30 days
Secondary outcomes:
measure: Maximum observed plasma concentration
timeFrame: 32 days
measure: Time at which maximum observed plasma concentration occurs
timeFrame: 32 days
measure: Half-life of the drug in plasma
timeFrame: 32 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Lexicon Investigational Site
state: Kansas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Ikenna Ogbaa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02823600: Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers
Official title: A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand- Held (Non-mydriatic) Camera in Outpatient Dialysis Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Eye Diseases
Diabetic Retinopathy
Keywords: retinal screening
outpatient dialysis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Welch Allyn
First posted: 2016-07-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.

Detailed description: There are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient population (\~300,000 Americans). Approximately 50% of this population has End-stage Retinal Disease (ESRD) due to diabetes. Dialysis patients are among the most debilitated patients, and thus, have even more barriers to receiving their recommended annual retinal evaluation. The advent of the RetinaVue hand-held retinal camera holds great promise in this population, as dialysis patients access medical care 3 times a week, for several hours at a time at their dialysis clinic.

Eligibility criteria: Inclusion Criteria:

* The subject must currently be seeking treatment for end-stage renal disease (ESRD) at one of the specified dialysis clinics.
* The subject must be ≥ 18 years of age.

Exclusion Criteria:

* The subject is \<18 years of age.
* No exclusions will be made on the basis of gender, ethnicity, or race.

Primary outcomes:
measure: Usability of the RetinaVue Hand-Held 100 Camera
timeFrame: baseline visit
Secondary outcomes:
measure: Overall Retinopathy in a Dialysis Population
timeFrame: Post retinal eye exam
measure: Participant Satisfaction
timeFrame: Post retinal eye exam
measure: Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population
timeFrame: Baseline and post retinal eye exam
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Ophthalmology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Seema Garg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07009600: Conversion Surgery After Target Therapy or Immunotherapy in Stage IV Gastric Cancer
Official title: Impact of Targeted Therapy and Immune Checkpoint Inhibitors on Prognosis and Surgical Outcomes in Conversion Surgery for Stage IV Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer Stage IV
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically diagnosed and histologically confirmed stage IV gastric cancer between January 2010 and August 2024 and received systemic palliative-intent chemotherapy as initial treatment and underwent conversion surgery at Samsung Medical Center.

Brief summary: In this retrospective study, investigators conducted a comprehensive investigation of the factors influencing postoperative prognosis in patients with stage IV gastric cancer undergoing conversion surgery. Specifically, investigators examined the impact of targeted therapy or immune check point inhibitors (ICIs) in combination with preoperative chemotherapy on (1) prognostic differences based on initial progression (invading adjacent organs) and metastatic site (peritoneum, distant lymph node \[LN\]) at the time of stage IV gastric cancer diagnosis and (2) conversion surgery outcomes and pathological complete response (pCR).


Eligibility criteria: Inclusion Criteria:

* Stage IV gastric cancer patients who underwent conversion surgery

Exclusion Criteria:

* Patients who did not undergo gastrectomy
* Patients who underwent emergent surgery due to cancer perforation
* Patients with missing medical records or information

Primary outcomes:
measure: overall survival and disease free survival
timeFrame: from date of surgery until the date of first documented cancer recurrence or date of death from cancer progression, whichever came first, assessed up to 160 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05131100: Korean Regulatory Post Marketing Surveillance for Somavert
Official title: Korean Post-marketing Surveillance for Somavert
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acromegaly
Keywords: acromegaly, Somavert, Post-Marketing Surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 100
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: Adult acromegaly patients who have had an inadequate response to surgery and/or radiation therapy and in whom appropriate medical treatment with somatostatin analogues did not normalize IGF-1 concentrations or was not tolerated

Brief summary: Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)


Eligibility criteria: Inclusion Criteria:

All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.

Exclusion Criteria:

Patients who are contraindicated for Somavert

Primary outcomes:
measure: Number of participants who experience adverse events
timeFrame: Baseline through 28 days after last dose (approximately 52 weeks)
Secondary outcomes:
measure: Number of participants who experience Clinical Improvement as assessed by investigator
timeFrame: Baseline through approximately 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: