louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645372: A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients
Official title: A Six Week, Multicenter, Double Blind, Double-Dummy, Parallel, Comparative Study To Compare The Efficacy, Safety And Tolerability Of Ziprasidone With Risperidone In The Treatment Of Chinese Subjects With Acute Exacerbation Of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with schizophrenia
* Miminum PANSS score of 60 when randomized

Exclusion Criteria:

* Planned, regular use of antipsyhotics within 1 week of randomization
* Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Week 6
Secondary outcomes:
measure: Adverse events, laboratory test changes, movement disorder scale scores
timeFrame: Weeks 1, 2, 4, and 6
measure: Change from baseline in PANSS negative subscale score
timeFrame: Weeks 1, 2, 4, and 6
measure: Change from baseline in PANSS general psychopathology subscale score
timeFrame: Weeks 1, 2, 4, and 6
measure: PANSS responder rate
timeFrame: Weeks 1, 2, 4 and 6
measure: Clinical Global Impression-Severity (CGI-S) score
timeFrame: Baseline and Weeks 1, 2, 4, and 6
measure: Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
timeFrame: Weeks 1, 2, 4, and 6
measure: Change from baseline in PANSS positive subscale score
timeFrame: Weeks 1, 2, 4, and 6
measure: Clinical Global Impression-Improement (CGI-I) score
timeFrame: Weeks 1, 2, 4, and 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
city: Nanjing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00014872: Genetic Epidemiology and Energy Metabolism in Black Girls
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiovascular Diseases
Obesity
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2001-04-12
Enrollment: 600
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 12-15 years old black girl with Cardiovascular Diseases Obesity

Brief summary: To investigate the role of genes and energy metabolism in the pathogenesis of obesity in adolescent Black girls.

Detailed description: BACKGROUND:

The high prevalence of obesity in African-American (AA) women is of public health importance since AA women suffer higher mortality from cardiovascular and renal diseases than do white women. The reason for their marked susceptibility to obesity remains poorly understood though it is now known that AA women manifest lower resting energy expenditure than white women.

DESIGN NARRATIVE:

This is a multi-pronged metabolic and genetic epidemiologic study to examine two candidate genes (UCP3 and b3AR) implicated in energy metabolism. A total of 600 African American girls, aged 12-15 years, will be screened using buccal swabs as a non-invasive method of obtaining DNA, to determine their UCP3 genotypes as well as b3AR genotypes. An estimated 211 girls will be recruited, selected based on their UCP3 genotype, for measurements of resting energy expenditure and body composition (using dual energy X-ray absorptiometry \[DEXA\]) in a controlled setting of the Clinical Research Center at the Cincinnati Children's Hospital. Variation in resting energy expenditure will be examined across the genotypes of UCP3 with a large sample. The 2x3 design will allow the investigators to examine whether the effects associated with UCP3 variation are due to the UCP3 locus alone or due to the additive effect or interaction between UCP3 and b3AR. The study will help to elucidate the relationship between variation in two important candidate genes for energy metabolism, UCP3 and b3AR, and inter-individual variation in the levels of resting energy expenditure in this very high risk (for obesity) population.

Eligibility criteria: No eligibility criteria

Primary outcomes:
measure: UCP3 genotype correlation to obesity
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico
name: Sue Kimm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06734572: 18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study
Official title: 18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As a new dual targeting PET radiotracer, 18F-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 18F-FAPI-Biotin in patients with various types of cancer and compared them with the results of 18F-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 18F-FAPI.

Detailed description: Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Biotin is overexpressed in various tumor cells and underexpressed in normal cells. We assume that expanding molecular probes targeting FAPI and biotin with dual targets to enhance the targeting ability of the tracer, improve the sensitivity and specificity of tumor lesion detection. 18F-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 18F-FAPI-Biotin, and performed a head-to-head comparison with 18F-FAPI or 18F-FDG PET/CT scans in patients with various cancers.

Eligibility criteria: Inclusion Criteria:

* Various solid tumors with available histopathological findings • Signed informed consent

Exclusion Criteria:

* pregnant or lactational women • who suffered from severe hepatic and renal insufficiency

Primary outcomes:
measure: Dosimetry of normal organs and tumors
timeFrame: From right after tracer injection to 120 minutes at post-injection
Secondary outcomes:
measure: Incidence of Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06136572: Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome
Official title: Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tourette Syndrome
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 350
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: The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...).


Eligibility criteria: Inclusion Criteria:

* Tourette syndrome
* Participants aged 18 years or over

Exclusion Criteria:

* Participants under legal protection
* Inability to complete questionnaires alone

Primary outcomes:
measure: Rathus assertiveness questionnaire
timeFrame: 5 minutes at inclusion
Secondary outcomes:
measure: MOVES
timeFrame: less than 5 minutes at inclusion
measure: HADS
timeFrame: 3 minutes at inclusion
measure: ASRS-5
timeFrame: 2 minutes at inclusion
measure: Rosenberg Self-Esteem Scale
timeFrame: 2-3 minutes at inclusion
measure: DERS
timeFrame: 5 minutes at inclusion
measure: GTS-QoL
timeFrame: 5 minutes at inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Isabelle JALENQUES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04219072: Clinical Classification of Pain in Breast Cancer Survivors
Official title: Clinical Classification of Pain in Breast Cancer Survivors: Nociceptive, Neuropathic or Nociplastic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Cancer Pain
Breast Cancer
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2020-01-06
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The convenience sampling will implement for this cross-sectional study. Breast cancer survivors experiencing chronic pain who presented at the Department of Oncology of Kutahya Health Sciences University Evliya Celebi Hospital will screen for eligibility by their physician and were subsequently requested to participate in this study.

Brief summary: Breast cancer is the most common malignancy in women worldwide according to International Agency for Research on Cancer. Unfortunately, cancer survivors often face long-term symptoms that occur or persist after completion of treatment. In addition to fatigue, pain is the most common persistent symptom after cancer and cancer treatment. The diagnosis and treatment of pain in cancer survivors is not clear for many physicians. A mechanism-based classification of pain in cancer survivors might be a critical step for clinical reasoning, especially for discrimination of different pain types. The primary aim of this study is to determine the prevalence of the predominant type of pain in Turkish breast cancer survivors using a recent published clinical algorithm.


Eligibility criteria: Inclusion Criteria:

* diagnosed with histologically confirmed invasive or non-invasive primary breast cancer
* completed remission and their primary treatment at least 3 months prior to study participation
* experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale

Exclusion Criteria:

* patients affected by other chronic disease,
* severe psychological disorders
* active metastases

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 1 minute
measure: Margolis Pain Diagram
timeFrame: 5 minute
measure: Central Sensitization Inventory
timeFrame: 10 minute
measure: Short Form 36
timeFrame: 10 minute
Secondary outcomes:
measure: Quantitative sensory test
timeFrame: 10 minute
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: KutahyaMSU
state: Kutahya Health Sciences University
Study officials:
References:
Clinical trial NCT04915872: Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.
Official title: Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparotomy
Critical Illness
Piperacillin, Tazobactam Drug Combination
Keywords: Open Abdomen
Negative Pressure Therapy
Antibiotics
Piperacillin - Tazobactam
Pharmacokinetics
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 46
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: Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy

Brief summary: For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions.

According to current practice, piperacillin-tazobactam (PTZ) is widely used as part of empirical combined antibiotic therapy to treat severe abdominal infections in the critically ill patients. On the other hand, little is known about the impact of OA/NPT on antibiotics pharmacokinetics and pharmacodynamics (PK/PD) and the optimal dosing regimens in this population remain unclear.

As PTZ is a small hydrophilic molecule with a very low level of protein binding, invesitigators hypothesized that OA/NPT should lead to significant changes in volume of distribution (Vd) and/or drug clearance (CL

The main objective of this study was to assess the incidence of underdosing and the pharmacokinetics of piperacillin in critically ill patients with OA/NPT.

The secondary objective was to assess the appropriateness of recommended regimens for empirical minimum inhibitory concentration (MIC) coverage.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Admitted in surgical ICU for a suspected length of stay \> 3 days
* Receiving an antimicrobial therapy by PTZ
* For an intra-abdominal infection
* Under OA/NPT during antimicrobial therapy
* With urinary and arterial catheters

Exclusion Criteria:

* Severe renal failure (CLCR \< 30 ml/min) without indication for continuous renal replacement therapy (CRRT)
* Known allergy to PTZ
* Patient's refusal for participation to the research
* Patient unable to consent (dementia or severe psychiatric disorders, people under legal protection, people deprived of their liberty...)
* Pregnancy or breast-feeding

Primary outcomes:
measure: Rate of piperacillin
timeFrame: T1 (Day of the first surgical revision, up to 72 hours after inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References:
Clinical trial NCT01403272: Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Official title: Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Keywords: pressure ulcers
stage 1
stage 2
stage 3
stage 4
wounds
sores
infection
bioburden
bacterial contamination
bed linen
sheets
underpad
skin assessment
microclimate
shear
friction
moisture
fabrics
long term care
nursing home
decubitus ulcer
bed ridden
anti-microbial
Lead sponsor: Precision Fabrics Group, Inc.
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2011-07-27
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.

Detailed description: Additional objectives of this research study are:

* To evaluate healing of pressure ulcers already present or pressure ulcers that develop during the study.
* To evaluate the effectiveness of DermaTherapy® bedding and alternative diapers to reduce the potential for bacterial contamination associated with patients' bed linens, underpads, gowns and pajamas, and thereby help reduce the incidence of facility-acquired infections.

Study nurses will assess the skin of the subjects once or twice a week for the presence of pressure ulcers and measure the size of the pressure ulcers if they are present. Study nurses will also obtain bacterial culture swabs of the bedding weekly for the first eight weeks of the study from five participants in each group.

Eligibility criteria: Inclusion Criteria:

* Residents admitted for long term care.
* Residents admitted for Hospice Care with an expected length of stay greater than one week.
* Residents with an expected length of stay equal to or greater than 90 days.

Primary outcomes:
measure: Prevention and reduction in the incidence of pressure ulcers
timeFrame: Weekly assessments for 1 year
Secondary outcomes:
measure: Reduction of bacterial contamination
timeFrame: Weekly for 8 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Duke University Medical Center
name: Jack I Twersky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA medical Center, Duke University Medical Center
name: Kenneth E Schmader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03283072: Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
Official title: Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensitivity
Keywords: thermal threshold
pressure pain threshold
temporal summation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
Primary purpose: OTHER

Brief summary: Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported.

Detailed description: Despite the strong results of motor studies, the affects of AIH on sensory function has not been established. We will use a commercially-available hypoxicator that can be programmed to achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously published protocols that have generated motor facilitation (and a sham condition) to characterize and effects on sensory function in healthy adults.

Eligibility criteria: Inclusion Criteria:

* 18 to 40 years of age

Exclusion Criteria:

* Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery disease, congenital and valvar heart diseases)
* Diagnosis of neuromuscular disease
* Diagnosis of any neurological disease
* Presence of concurrent medical illness including infection, fractures
* Diagnosis of obstructive sleep apnea
* Diagnosis of obstructive/restrictive lung disease
* Diagnosis of exercise induced asthma
* FEV1/FVC\<80% and/or FVC\<80% of predicted value indicating airway obstruction
* Subjects on prednisolone therapy or selective serotonin reuptake inhibitor (SSRI) therapy will be excluded from the study as these pharmacological agents are known to amplify the effects of IH\[22, 23\]
* Diagnosis of epilepsy or history of seizures and attention deficit disorders
* Pregnancy
* Diabetes
* History of coagulation disorders
* History of chronic pain
* Body mass index(BMI)\> 35kg/m2
* Subjects on prescription medicines such as beta blockers and other drugs that are prescribed in any of the exclusionary disorders listed above.

Primary outcomes:
measure: Sensory Function
timeFrame: Every 10 minutes for 60 minutes post intervention, average reported
measure: Temporal Sensory Summation
timeFrame: Every 10 minutes for 60 minutes post intervention, average reported
measure: Sensory Function - Pressure
timeFrame: Every 10 minutes for 60 minutes post intervention, average reported
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Unversity of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Mark D Bishop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04193072: Imagery Ability in Obstetric Brachial Plexus Palsy
Official title: Assessment of Imagery Ability in Children With Obstetric Brachial Plexus Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Palsy
Image, Body
Keywords: brachial plexus
imagery
body image
sensation
questionnaires
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with obstetric brachial plexus palsy and healthy children.

Brief summary: Obstetric brachial plexus palsy (OBPP) is the paralysis of the ipsilateral upper extremity after a brachial plexus injury that occurs during labor. Imagery is to rehearse sensorial experiences in the mind such as auditory, visual, tactile, olfactory, gustatory or kinesthetic sensation. Imagery is used as a new technique in rehabilitation recently. Various studies have reported the importance of imagery and using imagery as a rehabilitation technique in different neurologic and orthopedic conditions. This study aimed to evaluate imagery ability in children with OBPP.


Eligibility criteria: Inclusion Criteria:

* Ages between 8-18 years
* Children with OBPP Narakas's classification system rating of Type 1, Type 2a, Type 2b, or Type 3
* Standardized mini-mental state examination score \>24
* With no physical or neurological condition affecting motor development

Exclusion Criteria:

* Narakas's classification system rating of Type 4
* Standardized mini-mental state examination score \<24
* Surgical operation in last 6 months
* Physical or neurological conditions
* Refuse to attend to the study

Primary outcomes:
measure: Movement Imagery Questionnaire-3
timeFrame: 2 weeks
measure: Kinesthetic and Visual Imagery Questionnaire-20
timeFrame: 2 weeks
measure: Active Movement Scale
timeFrame: 1 week
measure: Narakas's Sensory Grading System
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
Study officials:
affiliation: Medipol University
name: Nursena Şengün, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: