louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00404820: Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Official title: A Multi-center, Randomized, Open-label, Controlled, One-year Trial to Measure the Effect of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteopenia and Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: osteoporosis
bisphosphonate
biomarker
zoledronic acid
alendronate
postmenopausal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 604
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.


Eligibility criteria: Inclusion Criteria:

- Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women

Exclusion Criteria:

- Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population
timeFrame: Screening to end of study (Month 12)
measure: Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population
timeFrame: Screening to end of study (Month 12)
Secondary outcomes:
measure: Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12
timeFrame: Screening to end of study (Month 12)
measure: Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12
timeFrame: Baseline to end of study (Month 12)
measure: Number of Patients With a Clinical Fracture From Baseline to Month 12
timeFrame: Baseline to end of study (Month 12)
measure: Change in Body Height From Baseline to Month 12
timeFrame: Baseline to end of study (Month 12)
measure: Therapy Preference at End of Study (Month 12)
timeFrame: Month 12
Other outcomes:
Locations:
city: Multiple Cities
country: Germany
facility: For site information contact Novartis Pharmaceuticals
Study officials:
affiliation: Novartis
name: Novartis Pharma GmbH, Germany +49 911 273-0
role: STUDY_DIRECTOR
References:
Clinical trial NCT02131220: Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
Official title: A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Percutaneous Coronary Intervention
Thrombolytic Therapy
Keywords: No-Reflow Phenomenon
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* ST-segment elevation AMI within 12 hours of symptom onset

Exclusion Criteria:

* Contraindications to thrombolysis or PCI
* Patients administered a fibrinolytic agent before PCI
* Patients enrolled in clinical trials

Primary outcomes:
measure: Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
timeFrame: At the end of Percutaneous Coronary Intervention procedure
Secondary outcomes:
measure: ST segment resolution in ECG
timeFrame: 3 hours post PCI procedure
measure: peak troponin T level
timeFrame: in the 7 days post PCI procedure
measure: plasma N terminal-proBNP levels
timeFrame: 1 and 30 days post PCI procedure
measure: infarction area confirmed by SPECT
timeFrame: 30 days post PCI
measure: incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization
timeFrame: 30 days post PCI
Other outcomes:
measure: TIMI defined total major bleeding
timeFrame: 30 days post PCI
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Zhongshan Hospital, Fudan University
name: Junbo Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04030520: Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
Official title: Improving Uptake and Adherence to HIV Prevention Services With PrEP, HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: MRC/UVRI and LSHTM Uganda Research Unit
name: Medical Research Council
name: London School of Hygiene and Tropical Medicine
name: National Institute of Mental Health (NIMH)
First posted: 2019-07-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.


Eligibility criteria: Inclusion Criteria:

* Female age 15- to 24-years old
* Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative
* Agree to participate in a minimum of four interviews over a 12-month period; including baseline
* Willing to receive services at Good Health for Women Project (GHWP)
* For those initiating PrEP (Truvada):
* Participants should have immunity to Hepatitis B infection and serum creatinine before
* Contra-indications for starting Truvada to be considered include Creatinine \> 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.

Exclusion Criteria:

* Inability to consent to participation in the study
* Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.

Primary outcomes:
measure: Initiation of PrEP
timeFrame: 12 months
measure: Adherence to PrEP
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Entebbe
country: Uganda
facility: Uganda Virus Research Institute
Study officials:
affiliation: University of California, San Francisco
name: Rachel King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01918020: Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs
Official title: Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Child
Keywords: Fruit
Vegetables
Motor Activity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 796
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with the goal of improving the health and wellbeing of low income families. University of Minnesota Extension every year offers nearly 4000 educational events, serving approximately 70,000 Minnesotans through the program. Extension is conducting an impact study to determine program effectiveness and assess sustained changes of participants and their families that can be directly attributed to programming on a larger and methodically sound scale.


Eligibility criteria: Inclusion Criteria:

* Third grade elementary students
* Schools that are eligible for SNAP ED funding (have more than 50% students received free/reduced lunch)

Exclusion Criteria:

* Other grade elementary students
* Schools that are not eligible for SNAP ED funding

Primary outcomes:
measure: To assess changes in adiposity level among the program participants indicated by BMI measurements.
timeFrame: We will assess BMI in the 1st, 3rd, 5th and 12th month
Secondary outcomes:
measure: To assess changes of fruit and vegetable intake and among program participants.
timeFrame: We will measure the changes of fruits and vegetable intakes in the 1st month (baseline), 3rd month, 7th month, and 12th month
measure: To assess changes of physical activity levels among program participants.
timeFrame: We will measure the changes of physical activity level in the 1st month (baseline), 3rd month, 7th month, and 12th month
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota Extension Center for Family Development
state: Minnesota
Study officials:
affiliation: University of Minnesota Extension Center for Family Development
name: G. Ali Hurtado, Doctorate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05139420: Risk of Metabolic Adaptation After Weight Loss
Official title: Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Weight Loss
Obesity
Keywords: resting metabolic rate
metabolic adaptation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.


Eligibility criteria: Inclusion Criteria:

BMI \> or = 30 any ethnicity

Exclusion Criteria:

weight \> or = 400 lbs.

diabetes (type 2 or type 1)

hypertension

heart disease

kidney disease

liver disease

active cancer

post solid organ or bone marrow transplant

HIV/AIDS

pregnancy

breastfeeding

current smoker

current recreational drug use

Primary outcomes:
measure: change in measured and predicted resting metabolic rate during and after weight loss
timeFrame: 18 months
Secondary outcomes:
measure: change in circulating leptin during and after weight loss
timeFrame: 18 months
measure: change in circulating thyroid hormones during and after weight loss
timeFrame: 18 months
measure: change in circulating GLP-1 during and after weight loss
timeFrame: 18 months
measure: change in circulating PYY during and after weight loss
timeFrame: 18 months
measure: change in circulating AgRP during and after weight loss
timeFrame: 18 months
measure: change in 24h urine catecholamines during and after weight loss
timeFrame: 18 months
measure: change in heart rate variability during and after weight loss
timeFrame: 18 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Lisa L Morselli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946720: Aggression From the Perspective of Patients and Nurses
Official title: Aggression From the Perspective of Patients and Nurses: An Integrated Study on the Evaluation of Aggression in Psychiatric Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Keywords: aggression
aggression in psychiatry clinics
perception of aggression
risk level of violence
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre- post test, training and control group, randomise controlled trial
Primary purpose: OTHER

Brief summary: The research, was planned in a randomized controlled design, aiming to evaluate the effect of the training given to nurses working in psychiatric clinics on the use of aggression and BVC (Broset Violence Checklist) on the nurses' perceptions of aggression and the compliance of the use of BVC, which they evaluated for the patients watched in the videos, with the BVC determined by expert opinion.

The study was conducted in Adana Doctor Ekrem Tok Mental Health and Diseases Hospital between July 2021 and April 2022. A total of 97 nurses working in psychiatric clinics, 47 in the training group and 50 in the comparison group, participated in the study. A pre-test was administered to the nurses and nurses in the training group were randomized and given training including aggression and BVC use. After the training, a post-test was administered to all nurses.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research,
* To have been working in the hospital where the research was conducted for at least 1 year,
* To have no vision, hearing and speech problems.

Exclusion Criteria:

* To want to withdraw from the research at any stage of the research,
* Not completing or not being able to complete the research for any reason,
* To work in the filiation team during the research process.

Primary outcomes:
measure: Perception of Aggression Scale
timeFrame: Procedure (one week before the training)
measure: Broset Violence Checklist
timeFrame: Procedure (one week before the training and one day after the training)
measure: Perception of Aggression Scale
timeFrame: Procedure (one day after the training)
measure: Broset Violence Checklist
timeFrame: Procedure (one day after the training)
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova Üniversitesi
Study officials:
References:
Clinical trial NCT05867420: A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
Official title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: AskGene Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First posted: 2023-05-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

Detailed description: A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
2. ECOG performance status of ≤ 2.
3. Life expectancy of ≥ 3 months.
4. The results of the laboratory tests must meet all criteria.

Exclusion Criteria:

1. Patients have received antitumor therapy during the first 4 weeks before study drug use.
2. Received a live attenuated vaccine within 4 weeks prior to C1D1.
3. Known cerebral parenchymal metastasis or meningeal metastasis.
4. History of serious cardiovascular or cerebrovascular diseases.
5. Active or recurrent autoimmune diseases.
6. History of ascites or pleural effusion requiring drainage.
7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

Primary outcomes:
measure: Dose limiting toxicities (DLTs)
timeFrame: 21days
measure: Adverse events(AEs)
timeFrame: 21days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 21days
measure: Area under the concentration time curve (AUC)
timeFrame: 21days
measure: Plasma clearance rate (CL)
timeFrame: 21days
measure: Evaluation of immunogenicity
timeFrame: Up to 2 years from date of treatment start until data cut-off
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: Ask-Gene Pharma, Inc.
name: Barbara Hickingbottom, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00520520: Influence of Mild Therapeutic Hypothermia on Leukocyte Count
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventricular Fibrillation
Keywords: post resuscitation
post ventricular fibrillation
patients receiving mild therapeutic hypothermia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-08-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Survivors in out of hospital cardiac arrest

Brief summary: Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac arrest due to ventricular fibrillation. Potential immunologic responses are unknown.


Eligibility criteria: Inclusion Criteria:

* Survivors of cardiac arrest due to VF
* Age 18-90

Exclusion Criteria:

* Suspected / proven pregnancy
* Immunodeficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Hospital
Study officials:
affiliation: Charite University, Berlin, Germany
name: Joerg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Christian Storm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409120: Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Official title: Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia-Parkinsonism, Adult-Onset
Parkinson Disease
Keywords: Dystonia
Parkinson's Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2018-01-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To measure the effects of directional DBS on dystonia, we will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline
Primary purpose: BASIC_SCIENCE

Brief summary: This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688). If participants have dystonia associated with Parkinson's disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.

Detailed description: To measure the effects of DBS on dystonia, the investigators will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline. This will allow them to contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.

Eligibility criteria: Inclusion Criteria:

* Enrollment in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
* Diagnosis of Parkinson's disease with and without dystonia

Exclusion Criteria:

* Not enrolled in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)

Primary outcomes:
measure: Burke-Fahn-Marsden Dystonia Rating Scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Associate Professor of Neurology
name: Harrison C Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olson JW, Nakhmani A, Irwin ZT, Edwards LJ, Gonzalez CL, Wade MH, Black SD, Awad MZ, Kuhman DJ, Hurt CP, Guthrie BL, Walker HC. Cortical and Subthalamic Nucleus Spectral Changes During Limb Movements in Parkinson's Disease Patients with and Without Dystonia. Mov Disord. 2022 Aug;37(8):1683-1692. doi: 10.1002/mds.29057. Epub 2022 Jun 14.