louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01297582: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Official title: A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-6950
Healthy Adult Subjects
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35kg/m2 (inclusive)
* For females, postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

* History or presence of clinical significant disease

Primary outcomes:
measure: Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations
timeFrame: up to 7 days
Secondary outcomes:
measure: Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects
timeFrame: up to 7 days
measure: Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Miramar Clinical Site
state: Florida
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06461182: Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
Official title: Ga-68-CXCR4 PET/CT in Detecting, Evaluating Response to Treatment, and Monitoring Risk of Aggressiveness of Indolent B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Indolent B-Cell Non-Hodgkin Lymphoma
Keywords: Ga-68-CXCR4 PET/CT
indolent B-cell lymphoma
Lead sponsor: Koo Foundation Sun Yat-Sen Cancer Center
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing treatment response, and monitoring the risk of aggressiveness in indolent B-cell lymphoma. The background introduces CXCR4 and discusses its role in cancer research. Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising detection capabilities across various lymphomas, suggesting its potential as a superior imaging modality for low-grade lymphomas.


Eligibility criteria: Inclusion Criteria:

* The pathological diagnosis is slow-growing lymphoma, such as: marginal-zone B-cell lymphoma, Waldenstrom macroglobulinemia lymphocytic lymphoma, CLL/SLL, mantle cell lymphoma.
* Have undergone or planned to undergo FDG PET scan for indications including initial staging, therapeutic response evaluation, or follow-up examinations within 3 to 6 months in the clinical observation group.
* Able to lie flat for at least 30 minutes.
* Signing the subject consent form.
* ECOG grade 0-2.
* The timing of F-18-FDG usage in this trial follows the "Lymphoma Treatment Principles" of our institution.

Exclusion Criteria:

* Pregnant woman
* Severe renal impairment (eGRF\< 30ml/min)
* Known or suspected allergy to radiopharmaceuticals
* Concurrent or previous diagnosis of malignancies other than lymphoma
* Inability to undergo the necessary PET scan procedure
* Refusal or unwillingness to sign the informed consent form
* Severe medical conditions (severe disabilities, mental disorders)

Primary outcomes:
measure: Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma
timeFrame: up to 24 months
Secondary outcomes:
measure: Ga-68-CXCR4 compared to F-18-FDG PET/CT
timeFrame: up to 24 months
measure: Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT
timeFrame: up to 24 months
measure: Prognostic value of Ga-68-CXCR4 PET/CT scan
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
state: Beitou
Study officials:
References:
Clinical trial NCT06056882: Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
Official title: Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for bronchoscopy and biopsy for suspicious pulmonary lesions

Brief summary: It is planned to use the CLE probe and cryoprobe simultaneously after detection of the round focus.

It is planned to include 5 patients with suspected central airway invading lung carcinoma and 15 patients with suspected peripheral lung carcinoma who have an indication for bronchoscopic histologic confirmation.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Suspicion of lung carcinoma

Exclusion Criteria:

* Known allergy to fluorescin
* Pregnancy and/or lactation
* No discontinuation of ß-blocker 12 hours before intervention possible

Primary outcomes:
measure: Safety and feasibility
timeFrame: during bronchoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Daniela Gompelmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529082: The Attitudes and Beliefs of Hispanic/Latino Individuals Toward Prescription Opioids and Non-Medical Opioid Use
Official title: The Attitudes and Beliefs of Hispanic/Latino Individuals Toward Prescription Opioids and Non-Medical Opioid Use
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Opioids
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutional of Health
name: UT Health Science Center
First posted: 2022-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To better understand how people think and feel about prescribed pain medication, including opioids.

Detailed description: OBJECTIVES:

Primary Objectives:

1. To examine the general attitudes and beliefs of Hispanic/Latino individuals about the use of prescription opioids. The primary outcomes include the responses to questions 13-28 from the Opioid Attitudes and Beliefs survey.

Secondary

1. To evaluate Hispanic/Latino individuals' reports of personal experiences with the use of opioids. The corresponding outcomes are the responses to questions 1-12 from the Opioid Attitudes and Beliefs survey.
2. To find out any potential reasons why some Hispanic/Latino individuals may refuse to use clinically indicated opioid prescriptions. These outcomes are the responses to questions 14-15 from the Opioid Attitudes and Beliefs survey.
3. To explore factors associated with participant's comfort with the use opioid analgesics for their pain. The outcome will be the association between participants' responses to question 2 and their characteristics such as age, gender, race, level of education, extent of acculturation, knowledge of opioids, or previous opioid use.

Eligibility criteria: Inclusion criteria:

1. Aged 18 years or older.
2. Ability to understand, read, write, or speak English and/or Spanish.
3. Ability to give informed consent.
4. Willingness to participate in the survey.

Exclusion criteria:

1. Refusal to participate in the study

Primary outcomes:
measure: Opioid Attitudes and Beliefs Survey
timeFrame: through completion of study an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Joseph Arthur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180882: LMBA02 Protocol for Patients With a Burkitt Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Burkitt Lymphoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.


Eligibility criteria: Inclusion Criteria:

* Age : 18 years or older
* Histologically or cytologically proven Burkitt lymphoma according to the WHO classification
* WHO performance \< 3
* Informed consent

Exclusion Criteria:

* Known HIV positive infection
* Positive serology for HCV and HBV (except after vaccination)
* Patients previously treated for lymphoma
* cardiac disease that contradict anthracycline chemotherapy
* Psychological or psychiatric condition who contradict steroids therapy
* Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L)
* Cirrhosis or severe hepatic failure unrelated to the lymphoma
* Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Primary organ transplant or other immunosuppressive conditions Pregnancy

Primary outcomes:
measure: Event free survival from date of first randomization
Secondary outcomes:
measure: Complete and partial response rate, overall survival, toxicity
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Vincent RIBRAG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. doi: 10.1016/S0140-6736(15)01317-3. Epub 2016 Apr 11.
Clinical trial NCT00741182: Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Official title: Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Shoulder Fractures
Trochanteric Fractures
Keywords: Fracture
Osteoporosis
Forsteo
Teriparatide
Fracture healing
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2008-08-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.


Eligibility criteria: Inclusion Criteria:

* Acute new osteoporotic trochanteric or collum chirurgicum fracture
* Postmenopause

Exclusion Criteria:

* Calcium metabolic disease other than osteoporosis
* Diseases known to affect calcium homeostasis
* Dementia
* Hypersensitivity to drug or other components of medication
* pre-existing hypercalcemia
* Decreased kidney function
* Increased alkaline phosphatase
* Prior external radiation therapy or brachytherapy of the skeleton
* Skeletal malignancies or bone metastases
* Alcohol and/or drug abuse
* Systemic treatment with corticosteroids within the last four weeks
* Non-cooperating patients
* Patients who do not speak and understand the danish language

Primary outcomes:
measure: Radiological evaluation of healing
timeFrame: 0, 4, 8, 12, (16) weeks after fracture
Secondary outcomes:
measure: Biochemical bone markers
timeFrame: 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
measure: SF-36 questionnaire
timeFrame: 0, 4, 8, 12, (16) weeks after fracture
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Center for Ageing and Osteoporosis, Glostrup University Hospital
Study officials:
affiliation: Glostrup University Hospital
name: Peter Schwarz, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704482: N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement
Official title: N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Surgery for Rheumatic Valvular Heart Disease
Renal Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement.


Eligibility criteria: Inclusion Criteria:

* patients with rheumatic heart disease undergoing single valve replacement

Exclusion Criteria:

* End stage renal disease (plasma creatinine concentration ≥ 300 µmol/L)
* Emergency cardiac surgery
* Planned off-pump cardiac surgery
* Chronic inflammatory disease on immunosuppression
* Chronic moderate to high dose corticosteroid therapy (≥ 10 mg/day prednisone or equivalent)
* Age ≤ 18 years.

Primary outcomes:
measure: Absolute change in serum creatinine from baseline to peak level
timeFrame: within 5 days after surgery
Secondary outcomes:
measure: the relative change in serum creatinine.
timeFrame: the first five postoperative days
Other outcomes:
measure: the urinary output
timeFrame: the first five postoperative days
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
Study officials:
affiliation: Assiut university hosiptal
name: Laila H Mohamed, Prof
role: STUDY_CHAIR
affiliation: Assiut university hosiptal
name: Nawal A Gad El-rab, Prof
role: STUDY_DIRECTOR
affiliation: Assiut university hosiptal
name: Fatma A Abd El-Aal, Ass Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04473482: Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
Official title: Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol-Related Disorders
Liver Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-07-16
Enrollment: 60
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: The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.


Eligibility criteria: Inclusion Criteria:

* Enrolled at University of Michigan general hepatology clinics or inpatient wards
* Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
* Drinking of any amount of alcohol within the 6 months prior to recruitment
* No alcohol use treatment within the past 1 month
* Access to a phone for purposes of follow-up

Exclusion Criteria:

* Active alcohol use treatment
* Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
* Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine

Primary outcomes:
measure: Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
timeFrame: Up to 6 months
measure: Feasibility of MAIN-ART Tool as Measured by Retention Rates
timeFrame: Up to 6 months
measure: Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview
timeFrame: Baseline and 6 months
measure: Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jessica Mellinger, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05647382: Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
Official title: Soluble Vascular Endothelial-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
ARDS
Lung Injury, Acute
Cardiopulmonary Bypass
Keywords: Hypoxemia
acute lung injury
Cardiopulmonary Bypass
FiO2/PaO2
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: More than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. However, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. According to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. On the basis of traditional detection, the investigators found a new indicator, serum soluble vascular endothelial-cadherin, which are easy to obtain and have certain specificity. Importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Underwent cardiac surgery using CPB technology.

Exclusion Criteria:

* Patient's lack of consent to participate;
* Presence of abnormal liver, kidney or other organ function;
* Pulmonary inflammation, chronic obstructive pulmonary disease or tumors;
* Underwent cardiac surgery without CPB technology;
* Postoperative need for extracorporeal membrane oxygenation support.

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: Day 1 after CPB, Day 2 after CPB
measure: lung-injury scores
timeFrame: Day 1 after CPB, Day 2 after CPB
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04057482: Treatment of BV With Donaxyl and a Molecular Test of Cure
Official title: Treatment of Bacterial Vaginosis With Dequalinium Chloride Vaginal Tablets and a Test of Cure Using a New Molecular Diagnostic Test for the Diagnosis of Bacterial Vaginosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginoses
Keywords: Bacterial vaginosis, polymerase chain reaction, molecular diagnostic
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-15
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: local maternity and youth clinics in Skaraborg county

Brief summary: . Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Detailed description: This is the first study to utilize a molecular diagnostic test as a test of cure for bacterial vaginosis. The Nugent score is a reliable method for diagnosing bacterial vaginosis, but similar to traditional clinical diagnostic methods, it is not equally reliable when utilized as a test of cure. This study demonstrated that molecular diagnostic testing can be used as a test of cure and this is the first molecular test that can do that. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Eligibility criteria: Inclusion Criteria:

BV

Exclusion Criteria:

No other infection (Gc, clhlamydia, trihomonas)

Primary outcomes:
measure: cure rate of BV
timeFrame: 1 year
Secondary outcomes:
measure: Diagnosis of BV using molecular test
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: överläkare
name: P-G Larsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: