louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06188468: ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors
Official title: ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors and Compared with 18F-FDG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor
Solid Tumor
Positron-Emission Tomography
Keywords: Tumor
Solid
Positron-Emission Tomography
Trop-2
Diagnosis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to construct a noninvasive approach 68Ga-MY6349 PET/CT to detect the Trop-2 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.

Detailed description: As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-MY6349 is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with various types of tumors underwent contemporaneous 68Ga-MY6349 and standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-MY6349 PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-MY6349 was calculated and compared to standard-of-care imaging.

Eligibility criteria: Inclusion Criteria:

1. adult patients (aged 18 years or older);
2. patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
3. patients who had scheduled both standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) and 68Ga-MY6349 PET/CT scans;
4. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

1. patients with pregnancy;
2. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in various cancer types.
timeFrame: 1 week
Secondary outcomes:
measure: To investigate the superiority of 68Ga-MY6349 PET/CT over 18F-FDG PET/CT in some tumors through comparative analysis
timeFrame: 2 weeks
measure: Description of 68Ga-MY6349 uptake by measuring standardized uptake value (SUV) in various types of tumors
timeFrame: 1 week
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References:
Clinical trial NCT04452968: Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome
Official title: Intermittent Fasting and Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Weight Loss
Intermittent Fasting
Lead sponsor: Karachi Medical and Dental College
Sponsor class: OTHER
Collaborators: name: Aziz Medical Center
First posted: 2020-07-01
Enrollment: 96
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.


Eligibility criteria: Inclusion Criteria:

* PCOS as described by Rotterdam's criteria

Exclusion Criteria:

* endocrine disorders
* diabetic
* hypertensive
* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
* The body weight fluctuated more than 5% in recent 3 months.
* Liver and kidney dysfunction: renal impairment, creatinine clearance rate \< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
* History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
* History of thyroid diseases;
* pregnant
* Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight)
* Patients who cannot be followed for 16 months (due to a health situation or migration)
* Patients who are unwilling or unable to give informed consent

Primary outcomes:
measure: weight loss in kg
timeFrame: in 3 months
Secondary outcomes:
measure: decrease in body fat percentage
timeFrame: in 3 months
measure: fasting plasma insulin
timeFrame: in 3 months
measure: blood pressure in mm Hg
timeFrame: in 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aziz Medical Center
state: Sindh
Study officials:
affiliation: Aziz Medical Center
name: Rubina Izhar
role: STUDY_CHAIR
References:
Clinical trial NCT00944268: Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
Official title: Clinical Study Phase III, Multicenter, Prospective, Open to Evaluate the Efficacy and Tolerability of the Combination Use of Passiflora Incarnata L, Crataegus Oxyacantha and Salix Alba L in Mild and Moderate Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anxiety
Efficacy
Tolerability
Keywords: Passiflora, Crataegus and Salix
Mild and Moderate anxiety
Tablet
To evaluate the efficacy and tolerability of the combination
Lead sponsor: Ativus Farmaceutica Ltda
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.

Clinical study phase III, multicenter, prospective, open.

Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.


Eligibility criteria: Inclusion Criteria:

* Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;
* Individuals of any ethnic group male and female, aged above 18 years;
* Consent of the subject of research (a consent form signed).

Exclusion Criteria:

* Patients with known hypersensitivity to any components of the formula;
* Pregnant women and nursing mothers;
* Patients with endogenous depression, schizophrenia, suicidal tendency;
* Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;
* Addiction to drugs, including alcohol, at the discretion of the investigator;
* Patients who are using any medication that could interfere with the effect of the drug under study;
* Impossibility of compliance to the protocol

Primary outcomes:
measure: Hamilton Scales
timeFrame: 30 days
Secondary outcomes:
measure: Safety evaluation by adverse events relate.
timeFrame: 30 days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Elie Fiss
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532168: Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
Official title: Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: advanced HIV-infected patients
late presenters
antiretroviral therapy
immune reconstitution
Treatment Naive
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2007-09-20
Enrollment: 108
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: There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.


Eligibility criteria: Inclusion Criteria:

* Chronic HIV-1 infection
* Age 18 or more
* Antiretroviral-naive
* Baseline CD4+ count \<100 cels/mcL.
* No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
* Written informed consent

Exclusion Criteria:

* Hypersensibility to study drugs.
* Pregnancy or breastfeeding
* Active OI requiring admission
* Active lymphoma or malignancy (Kaposi sarcoma included)
* Cl creatinine below 30 ml/min.
* Liver failure
* Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.

Primary outcomes:
measure: Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose M Miró, MD
role: STUDY_CHAIR
References:
citation: Miro JM, Manzardo C, Ferrer E, Lonca M, Guardo AC, Podzamczer D, Domingo P, Curran A, Clotet B, Cruceta A, Lozano F, Perez I, Plana M, Gatell JM; Advanz-3 Study Group. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):206-15. doi: 10.1097/QAI.0000000000000567.
Clinical trial NCT01169168: Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome (SIRS), Sepsis or Chronicle Liver Disease on Intensive Care Units (ICU)
Official title: Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome, Sepsis, Chronicle Liver Disease or After Lysis on Intensive Care Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SIRS
Sepsis
Liver Disease
Keywords: fibrinogen
SIRS
sepsis
liver disease
chronic liver disease
septic shock
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in intensive care units of the university hospital

Brief summary: In this study patients with

1. chronicle liver diseases

   * primary biliary cirrhosis
   * primary sclerosing cholangitis
   * alcoholic liver cirrhosis
   * hepatitis b or C
   * Wilson's disease
   * cryptogenic cirrhosis
2. Septic Inflammatory Response Syndrome (SIRS)

   * sepsis
   * septic shock
3. patients after lysis

should be included

Blood samples will be gathered from the patients to measure fibrinogen with 5 different methods.

The methods are:

* Clauss fibrinogen
* PT-Derived fibrinogen
* immunoturbidimetric method
* heat-precipitated fibrinogen
* Schulz fibrinogen

The result of these tests will be correlated with laboratory values which are gathered in routine and the clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* SIRS
* sepsis
* septic shock
* chronicle liver disease (MELD-Score \>10)
* patient after lysis
* patient agrees

Exclusion Criteria:

* no agreement

Primary outcomes:
measure: Fibrinogen levels from 5 test methods
Secondary outcomes:
measure: Number of bleedings
measure: Number of administered fresh frozen plasma
measure: Number of administered erythrocyte concentrates
measure: Number of administered thrombocyte concentrates
measure: mortality
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University Hospital
state: Hessen
Study officials:
References:
Clinical trial NCT03182868: Vestibular Testing: Consistency and Effects Over Time
Official title: Vestibular Testing: Consistency and Effects Over Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to test the consistency and repeatability of a portable goggle system for testing optokinetic, ocular, and reaction time. The study examines the day to day consistency, time of day and learning effects as well as any secondary motion sickness.

Detailed description: The goal of this study was to test the constancy and repeatability of this test by testing it in different individuals and different times of day, after a variety of tasks and after repeated performance

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* Both Females and males
* Staff and students at all levels at the University of Miami or first-degree - relatives/significant others of those individuals.

Exclusion Criteria:

* History of vestibular disorder/dysfunction
* Central processing disorder
* Impaired vision without corrective lenses (max 20/60 uncorrected)
* Moderate to severe hearing loss \[\>55 decibel (dB) Pure Tone Average (PTA), \<50% word identification\]

Primary outcomes:
measure: Vestibular Reaction Times
timeFrame: 2 Days
measure: Vestibular Subjective Visual Vertical
timeFrame: 2 Days
measure: Vestibular Smooth Pursuit Horizontal
timeFrame: 2 Days
measure: Vestibular Percentage of Saccade
timeFrame: 2 Days
measure: Vestibular Anti-Saccade
timeFrame: 2 Days
measure: Vestibular Gain
timeFrame: 2 Days
measure: Vestibular Saccade Horizontal
timeFrame: 2 Days
measure: Vestibular Predictive Saccade
timeFrame: 2 Days
measure: Motion Sickness as Measured by the MSAQ
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Michael Hoffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02019368: Antioxidant Effect of Aged Garlic Extract
Official title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Smoker or Non-smoker
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Wakunaga Pharmaceutical Co., Ltd.
First posted: 2013-12-24
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.


Eligibility criteria: Inclusion Criteria:

* Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)

Exclusion Criteria:

* Under medication for chronic disease
* Garlic allergy
* Engaging in vigorous exercise
* Taking drugs or functional food that may possess antioxidant property
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease

Primary outcomes:
measure: Urinary 8-hydroxydeoxyguanosine (8-OHdG)
timeFrame: Every 4 weeks (Overall 12 weeks)
Secondary outcomes:
measure: High sensitive CRP
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Blood pressure
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Indices of the second derivative of photoplethysmogram (SDPTG)
timeFrame: Every 4 weeks (Overall 12 weeks)
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00620568: Study Evaluating Multiple Ascending Dose in Schizophrenia Patients
Official title: An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2008-02-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, inpatient, ascending multiple dose study to assess safety and tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and schizoaffective disorder.


Eligibility criteria: Inclusion Criteria:

* Men, aged 18-50 years old
* Women, aged 18-50 years old

Exclusion Criteria:

* Non-lactating women, aged 18-50 years old
* Non-pregnant women, aged 18-50 years old

Primary outcomes:
measure: Observe safety and tolerability
timeFrame: 25 days
Secondary outcomes:
measure: PK and PD profile
timeFrame: 25 days
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02248168: Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease
Official title: Mirapex PMS Study Final Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 1449
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic Parkinson's disease

Brief summary: The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.

* Unexpected adverse events (especially, serious adverse events (SAEs))
* To find out the status of incidence of adverse events under actual practice
* Factors on the safety profile
* Factors on the efficacy profile


Eligibility criteria: Inclusion Criteria:

* Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping

Exclusion Criteria:

* Following patients are contraindicated.

  1. Patients who are hypersensitive to MIRAPEX or its ingredients
  2. Refer to the insert paper for other contraindication.
* Following patients should be carefully administered.

  1. Patient with renal impairment
  2. Refer to the insert paper for other precaution.

Primary outcomes:
measure: Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 4 weeks
measure: Global Assessment of efficacy by investigator on 3-point scale
timeFrame: after 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01228968: Toward an Automated Method of Abdominal Fat Segmentation of MR Images
Official title: Toward an Automated Method of Abdominal Fat Segmentation of MR Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will have a wide range of body mass index and other physical characteristics.

Brief summary: Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be used to compare two abdominal fat segmentation techniques. The first technique is already validated and in use. The second technique was recently developed and has not been validated. The hypothesis is that the second technique will be the faster and more reliable of the two.


Eligibility criteria: Inclusion Criteria:

* ambulatory
* cognitively sound

Exclusion Criteria:

* body mass index less than 18 or greater than 45 kilograms per square meter

Primary outcomes:
measure: Visceral Fat Volume With Automated Analysis
timeFrame: five minutes
measure: Visceral Fat Volume With Manual Segmentation
timeFrame: five minutes
Secondary outcomes:
measure: Subcutaneous Fat Volume With Automated Analysis
timeFrame: five minutes
measure: Subcutaneous Fat Volume With Manual Segmentation
timeFrame: five minutes
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: