louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006059: Genetic Study of Familial Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
neurologic and psychiatric disorders
rare disease
seizures
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Columbia University
First posted: 2000-07-06
Enrollment: 898
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Determine the chromosomal regions that contain genes that raise the risk of epilepsy in families by performing genetic linkage analysis of idiopathic/cryptogenic epilepsy.

Detailed description: PROTOCOL OUTLINE: Family histories are obtained, then the patients undergo an interview, a neurological examination, and EEG. Blood specimens are also collected.

Linkage analysis is performed on specimens and analysis of shared marker alleles are used to identify genomic regions likely or unlikely to contain the epilepsy genes. Genotypes in family members are determined at microsatellite markers throughout the genome. Markers tested include chromosomes linked to human epilepsy syndromes (6p, 8p, 8q, 20q, 21q) and chromosome 3 (similar to mouse "epilepsy" genes). Linkage to markers on chromosome 10q are also tested.

Patients do not receive the results of the testing and the results do not influence the type and duration of any treatment.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Male or female members of families with at least 1 close relative pair (sibling, half sibling, avuncular, grandparent-grandchild, or first cousin) affected with idiopathic/cryptogenic epilepsy that developed before age 25

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Ruth Ottman
role: STUDY_CHAIR
References:
Clinical trial NCT03684759: Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections in Cystic Fibrosis
Official title: Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Respiratory Infection
Keywords: Expectoration
Cystic Fibrosis
Nasopharyngeal
Viral molecular diagnosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participant living with cystic fibrosis disease cared in french pediatric or adult CRCM

Brief summary: The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

Detailed description: In cystic fibrosis (CF), patients face polymicrobial airway infections. Besides bacteria, viruses are now also considered as important agents in lung function deterioration. No strategy has been established on the optimal sampling for respiratory viral molecular diagnostic in CF. Nasopharyngeal swabs (NP) are recommended for respiratory viral screening in non-CF patients but are invasive and sometimes painful for patients. As sputa are non invasive and collected for bacterial monitoring in CF patients they could represent a convenient alternative to NP swabs.

This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.

Eligibility criteria: Inclusion Criteria:

* Participant with Cystic Fibrosis
* Participant able to expectorate
* Participant with sign of acute respiratory infection

Exclusion Criteria:

* participant not able to expectorate
* patient refusing to participate

Primary outcomes:
measure: Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Roscoff
country: France
facility: Centre de Perharidy
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References:
Clinical trial NCT00497159: A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
Official title: A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington's Disease
Keywords: Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Huntington Study Group
First posted: 2007-07-06
Enrollment: 91
Sex: ALL
Minimum age (years): 29
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.


Eligibility criteria: Inclusion Criteria:

* Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
* Able to take medication (capsules) by mouth.

Exclusion Criteria:

* Clinical evidence of unstable medical illness;
* Females who are pregnant or lactating or who intend to become pregnant during the study period.

Primary outcomes:
measure: To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
timeFrame: 90 days
Secondary outcomes:
measure: To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
timeFrame: 90 days
measure: To assess the pharmacokinetics of Dimebon.
timeFrame: 90 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Huntington Study Group
state: New York
Study officials:
affiliation: Huntington Study Group, University of Rochester
name: Karl Kieburtz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kieburtz K, McDermott MP, Voss TS, Corey-Bloom J, Deuel LM, Dorsey ER, Factor S, Geschwind MD, Hodgeman K, Kayson E, Noonberg S, Pourfar M, Rabinowitz K, Ravina B, Sanchez-Ramos J, Seely L, Walker F, Feigin A; Huntington Disease Study Group DIMOND Investigators. A randomized, placebo-controlled trial of latrepirdine in Huntington disease. Arch Neurol. 2010 Feb;67(2):154-60. doi: 10.1001/archneurol.2009.334.
Clinical trial NCT00190359: Growth Hormone and Heart Failure
Official title: Modifications of the Growth Hormone/IGF1 Axis in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure, Congestive
Keywords: heart failure
hormones
growth substances
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Heart failure induces modification in several neurohormonal systems. The aim of this study is to determine if the growth hormone/IGF1 axis is modified in heart failure patients compared to healthy volunteers.

Detailed description: One hundred and sixty three heart failure patients were evaluated by clinical examination, echocardiography, exercise test and measurement of blood BNP. Growth hormone and IGF-1 plasma levels were determined in each patient. The same biological measurements were performed in a group of 148 healthy controls. Comparisons were performed between groups for Growth hormone plasma level, IGF-1 plasma level and Growth hormone/IGF-1 index. A correlation between the severity of heart failure and the different biological parameters was searched.

Eligibility criteria: Inclusion Criteria:

* Heart failure patients in stable condition

Exclusion Criteria:

* cancer
* pituitary disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: APHP
name: Patrick Maison, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06731959: A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD
Official title: A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER-01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: COPD
Lead sponsor: Aer Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.

Study will compare active drug to placebo.


Eligibility criteria: Main Inclusion Criteria

Each participant must meet all the following criteria to be enrolled in this study:

* Participant is male or female ≥40 to ≤80 years of age.
* Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is \>25% and \<60% of predicted normal at Visit 1.
* Participant meets the following spirometry performance criteria:

  * Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2.
  * Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2.
* Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
* Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.

Main Exclusion Criteria

Participants meeting any of the following criteria will be excluded from the study:

* Participant has an active uncontrolled medical condition
* Participant has a diagnosis of current asthma
* Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
* Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1
* Participant has active lung infection
* Participant has received any vaccine within 7 days prior to Day 1.
* Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.

Primary outcomes:
measure: FEV1
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence of AEs (including SAEs and AESIs) throughout the study
timeFrame: 4 weeks
measure: Change from baseline in CT mucus plug segment score at Week 4
timeFrame: 4 weeks
measure: Change from baseline in E-RS:COPD score at Week 4
timeFrame: 4 weeks
measure: Change from baseline in prebronchodilator FVC at Week 4
timeFrame: 4 weeks
measure: Change from baseline in SpO2 at Week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05656859: Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments
Official title: Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorders
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the Department of Health Promotion

Brief summary: The Department of Health Promotion at Aalborg University Hospital gets patients referred from all the hospital's departments. The Department of Health Promotion offers lifestyle courses to aid preventing disease relapses and further comorbidities to patients referred to other ambulatory treatments at the hospital. For most patients this also includes weight loss, but the primary goal is lifestyle change regarding eating and exercise habits to improve overall health state. Since it is known that eating disorders commonly occurs in individuals seeking help for weight loss, and that the prevalence is larger than in the background population, we also suspect that eating disorders would commonly occur among patients referred to the Department of Health Promotion. Therefore, we aim to investigate the prevalence of eating disorders among patients referred to lifestyle courses at the Department of Health Promotion.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the Department of Health Promotion at Aalborg University Hospital, Denmark

Exclusion Criteria:

* Under age 18
* Not able to read and understand Danish
* Not able to recieve mail in the danish digital postbox, e-Boks

Primary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: 10 minutes
Secondary outcomes:
measure: Binge Eating Disorder Questionnaire (BED-Q)
timeFrame: 5 minutes
measure: Grazing Questionnaire (GQ)
timeFrame: 5 minutes
Other outcomes:
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 5 minutes
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North of Jutland
Study officials:
References:
Clinical trial NCT04924959: Construction and Validation of Risk Prediction Model for PICC Catheter Displacement
Official title: Construction and Validation of Risk Prediction Model for PICC Catheter Displacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Patients With PICC
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Zhejiang Provincial People's Hospital
First posted: 2021-06-14
Enrollment: 663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients with PICC

Brief summary: The occurrence of PICC catheter displacement is caused by many factors. In order to predict the risk of PICC and early warn high-risk patients, this study prospectively included patients with PICC catheter in a three Grade-A hospitals in June 2019, analyzed a variety of related factors, built a scientific and effective risk prediction model of PICC catheter displacement, and verified the goodness of fit and differential validity of the model.


Eligibility criteria: Inclusion Criteria:

* Patients with PICC

Exclusion Criteria:

* Patients with primary ectopia during PICC catheterization
* Patients with secondary ectopic adjusting length of catheter exposure
* Patients with mental illness and cognitive impairment
* Patients with incomplete clinical data

Primary outcomes:
measure: Prediction Model of PICC catheter displacement
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affilicated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01626859: A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
Official title: A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Central Nervous System Agents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 24 weeks
measure: Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
timeFrame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
measure: Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
timeFrame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
timeFrame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Sakai
country: Japan
state: Osaka
Study officials:
References:
Clinical trial NCT01232270: The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl
Official title: The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conscious Sedation Under Spinal Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 43
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in lowering propofol requirement for conscious sedation under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion Criteria:

* patients with any co-morbidity

Primary outcomes:
measure: Cerebral state index
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital, Department of Anesthesia and Pain Medicine
name: Tae-Dong Kwon, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646670: Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema
Official title: Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Diseases
Keywords: diabetic macular edema
aflibercept
ranibizumab
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study in to compare the efficacy of treatment of diabetic macular edema (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus Ranibizumab (Lucentis®).

It is a randomized clinical trial that will evaluate the efficacy of the combination of two substances currently used in the treatment of DME. Will be allocated in different four groups randomly pacients who receive treatment with intravitreal injections of ranibizumab, aflibercept or a combination of aflibercept and ranibizumab.

Detailed description: Interventions will be carried out with intravitreal injections in patients with formal indications of diabetic macular edema treatment previously assessed with complete eye examination in Goiania Eye Institute(Instituto de Olhos de Goiânia)

Patients will be divided into four groups:

* In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 following the application.
* In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 subsequent
* The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.
* In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.

Eligibility criteria: Inclusion Criteria:

* patients with Diabetic macular edema

Exclusion Criteria:

* patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose

Primary outcomes:
measure: Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: