louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06344871: Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF
Official title: Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Diseases
Lead sponsor: Positrigo AG
Sponsor class: INDUSTRY
Collaborators: name: University of Zurich
name: University of Leipzig
First posted: 2024-04-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.

The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype.


Eligibility criteria: Inclusion Criteria:

* Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form).
* Ability to sit still in the head-only PET scanner for 15 minutes.
* Are scheduled to receive a regular brain PET scan as part of clinical routine.
* Male and Female patients 18 years to 80 years of age.

Exclusion Criteria:

* Contraindications to PET examination,
* Patient height smaller than 160 cm or taller than 200 cm,
* Patient weight more than 120 kg,
* Patient cannot sit upright for at least 15 minutes,
* Metal implants in the head,
* Pregnant or Breastfeeding women,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.

Primary outcomes:
measure: PET Image of the Brain
timeFrame: 1 day
Secondary outcomes:
measure: Ease of Placement (Usability)
timeFrame: 1 day
measure: Usage of accessories for patient placement (Usability)
timeFrame: 1 day
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT03261271: Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
Official title: Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Prostate Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-08-24
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.


Eligibility criteria: Inclusion Criteria:

* Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)
* Body Mass Index (BMI) 25-45 kg/m2
* Has internet access

Exclusion Criteria:

* History of 5 alpha reductase inhibitors prior 3 months
* History of radiation therapy for cancer treatment
* Taking active cancer treatment
* Undergoing salvage therapy
* Castration-resistant PCa
* Evidence of metastasis
* Evidence of biochemical recurrence
* High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)

Primary outcomes:
measure: Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
timeFrame: Change from Baseline to Month 6
measure: Change in Weight
timeFrame: Change from Baseline to Month 6
measure: Change in Body Composition
timeFrame: Change from Baseline to Study End
measure: Change in Quality of Life
timeFrame: Change from Baseline to Month 6
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill Hamilton-Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01049971: REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
Official title: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Wound Infections
Keywords: colorectal surgery
wound infection
wound protector
laparoscopy
surgical site infection after laparoscopic colorectal surgery with minilaparotomy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 109
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: Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery.

Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections.

This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.


Eligibility criteria: Inclusion Criteria:

* elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria:

* emergency operation
* patients under 18 years of age

Primary outcomes:
measure: percentage of wound infections
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: colonialization of abdominal wall with bacteria
timeFrame: 6 months postoperatively
measure: postoperative costs
timeFrame: 6 months postoperatively
measure: length of hospital stay
timeFrame: 6 months postoperatively
measure: cosmetic result
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin; Hindenburgdamm 30
Study officials:
References:
Clinical trial NCT05428371: Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features
Official title: A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thyroid Nodule
Thyroid Cancer
Keywords: Thyroid carcinoma
Indeterminate thyroid nodule
Genomics
Proteomics
Metabolomics
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Prof. Pietro Giorgio Calò
name: Dott. Gian Luigi Canu
First posted: 2022-06-23
Enrollment: 256
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: We plan to include in our study patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda classification) who have a mild risk of thyroid cancer (15-30%)

Brief summary: Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.


Eligibility criteria: Inclusion Criteria:

* Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)

Exclusion Criteria:

* Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
* Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
* Patients with distant metastases

Primary outcomes:
measure: Identification of biomarkers of thyroid carcinoma
timeFrame: 50 months
Secondary outcomes:
measure: Elaboration of diagnostic algorithm
timeFrame: 60 months
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
Clinical trial NCT00523471: Blood Test to Measure DNA Damage in Blood
Official title: Gamma-H2AX as a Molecular Predictor of Prostate Cancer Radiosensitivity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: prostate cancer
gamma H2AX
radiosensitivity
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2007-08-31
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: To check the radiosensitivity level in individual patients based on their DNA damage level.


Eligibility criteria: Inclusion Criteria:

* prostate cancer diagnosis
* undergoing radiotherapy
* agree to participate in study

Exclusion Criteria:

* not willing to participate
* not undergoing radiotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Nadeem Pervez, MBBS, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03226171: Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Official title: Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.


Eligibility criteria: Inclusion Criteria:

* Average serum PTH\>240 pg/mL during 2 weeks at the screening
* Serum corrected Ca≧8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion Criteria:

* Primary hyperparathyroidism
* Severe liver disease
* Severe Cardiac disease
* History or family history of Long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* A history of severe drug allergy

Primary outcomes:
measure: Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
timeFrame: 18 weeks
Secondary outcomes:
measure: Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
timeFrame: 18 weeks
measure: Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Investigational site (there may be other sites in this country)
Study officials:
References:
Clinical trial NCT06485271: A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer
Official title: A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
RWS
PD-1 Immunotherapy
Lead sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced gastric cancer confirmed by pathology or histology

Brief summary: The purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.Patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, both male and female;
2. patients with advanced gastric cancer diagnosed by pathology or histology and progressed or recurred after 6 months of adjuvant therapy can also be considered for enrollment;
3. Have at least one measurable lesion on imaging (RECIST 1.1 criteria), the spiral CT or MR target lesion should be ≥10 mm and lymph node ≥15 mm;
4. The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;
5. Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA4 monoclonal antibody, etc.);
3. Prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.);
4. Patients who, in the judgment of the investigator, are not suitable for inclusion.

Primary outcomes:
measure: Objective response rate
timeFrame: 24 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: Disease control rate
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Changzhi
country: China
facility: Changzhi People's Hospital Affiliated to Changzhi Medical College
state: Shanxi
Study officials:
References:
Clinical trial NCT03001271: Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects
Official title: Acute Effect of Agiotensin-(1-7) on Bood Pressure and Heart Rate in Healthy and Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hypertension
Keywords: Angiotensin-(1-7)
Renin-angiotensin System
Autonomic Nervous System
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and demonstrates promising therapeutic potential due to it is generally opposite effects to Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and hypertensive subjects.


Eligibility criteria: Healthy Group Inclusion Criteria:

* arterial pressure \<140/90 mmHg
* body mass index (BMI) between 18,5 and 29 Kg/m2

Hypertensive Group Inclusion Criteria:

* anti-hypertensive drug treatment
* ambulatory blood pressure monitoring (ABMP) \>130/85 mmHg
* body mass index between 18,5 and 29 Kg/m2

Healthy Group Exclusion Criteria:

* drug treatment
* recent surgeries
* pregnancy
* previous cardiovascular events
* high performance athletes
* dislipidemia
* diabetes
* renal injury
* obesity (BMI above 30 kg/m2)
* alcoholism
* smoking.

Hypertensive Group Exclusion Criteria:

* recent surgeries
* pregnancy
* beta-blockers drug treatment
* previous cardiovascular events
* high performance athletes
* dislipidemia
* diabetes
* renal injury
* obesity (BMI above 30 kg/m2)
* alcoholism
* smoking

Primary outcomes:
measure: Absence of adverse effects after Ang-(1-7) acute administration
timeFrame: Along 25 hours
Secondary outcomes:
measure: Blood Pressure Changes after Ang-(1-7) administration
timeFrame: Recording along 24 hours
measure: Ang-(1-7) effects on Blood Pressure Variability
timeFrame: Along 1 hours after Ang-(1-7) acute administration
measure: Heart Rate Changes after Ang-(1-7) administration
timeFrame: Recording along 24 hours
measure: Ang-(1-7) effects on Heart Rate Variability
timeFrame: Along 1 hours after Ang-(1-7) acute administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03376971: Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy
Official title: Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lesion
Lung Cancer
Diagnoses Disease
Keywords: Lesion
Lung
Cancer
Diagnosis
Optical Biopsy
Biopsy
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.

Detailed description: PRIMARY OBJECTIVES:

I. Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.

II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples.

OUTLINE:

Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.

Eligibility criteria: Inclusion Criteria:

* Participants will be drawn from the pool of patients who have suspicious lesions identified on CT and who are already scheduled for a lung biopsy procedure with Dr. Woodhead or one of his colleagues
* Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project

Exclusion Criteria:

- Excluded from this study will be minors below age 18, prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)

Primary outcomes:
measure: Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy
timeFrame: At the time of biopsy
measure: Imaging of ex vivo tissue samples using an endoscopic instrument
timeFrame: At the time of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
Study officials:
affiliation: The University of Arizona
name: Andrew Rouse, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Arizona
name: Gregory Woodhead, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06507878: Global Real World Data in Patients With Advanced Thyroid Cancer on Standard of Care and Specialized Interventions- Registry of Oncologic Outcomes With Testing and Treatment.
Official title: Global Real World Data in Patients With Advanced Thyroid Cancer on Standard of Care and Specialized Interventions- Registry of Oncologic Outcomes With Testing and Treatment.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 459
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: MD Anderson Cancer Center

Brief summary: The goal of this clinical research study is to learn about the barriers in the real world to accessing treatments for ATC. And to learn about how patients with ATC tolerate and respond to the commercially available medications for treatment of this disease, outside of a clinical study.

Detailed description: Primary Objectives:

The primary objective of this study is to compare overall survival (OS) between ATC patients treated at MDA versus outside of MDA using treatment regimens offered at MDA based on BRAF status and stage of the disease. We will gather prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status.

Secondary Objectives:

1. To evaluate effect of chemotherapy, immunotherapy, and radiation therapy on the quality of life for ATC survivors
2. To evaluate how factors such as health insurance and lack of coverage, adherence, and other sociodemographic characteristics influences patient outcomes.

Eligibility criteria: Inclusion Criteria:

All adult patients aged 18 years or older with anaplastic thyroid cancer or poorly differentiated thyroid cancer as their clinical and/ or histological diagnosis will be included.

Exclusion Criteria:

Patients who do not have anaplastic thyroid cancer or poorly differentiated thyroid cancer on their tumor tissue would be excluded.

Primary outcomes:
measure: Overall Survival
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priyanka C Iyer, MBBS
role: PRINCIPAL_INVESTIGATOR
References: