louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01990300: Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus
Official title: Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 3281
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus who have been examined at a medical institution

Brief summary: The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

Detailed description: This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus

Exclusion Criteria:

* Patients meeting any of the following criteria will be excluded:

  1. Patients with current cardiac failure or a past history of cardiac failure
  2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
  3. Patients with serious hepatic dysfunction
  4. Patients with serious renal dysfunction
  5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
  6. Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
  7. Pregnant or possibly pregnant women

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Events
timeFrame: Up to 12 Months
measure: Changes From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)
Secondary outcomes:
measure: Changes From Baseline in Fasting Blood Glucose (FBG)
timeFrame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)
Other outcomes:
Locations:
city: Someplace
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06043700: A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology
Official title: A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alzheimer's Disease
Keywords: Alzheimers Disease
Blood-based biomarkers
Community-based screening
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with or without symptoms of AD will be screened in this study.

Brief summary: The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age 50 to 80 years inclusive, at the time of informed consent

   - Those 50 to 64 years of age must have 1 of the following risk factors confirmed prior to blood sample collection:
   * First degree relative with dementia onset before age 75,
   * Known before screening to have at least 1 Apolipoprotein E4 (APOE4) allele, or
   * Known before screening to have elevated brain amyloid according to previous positron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing
2. Provide written informed consent
3. Willing and able to comply with all aspects of the protocol
4. Willing to be referred to a clinical site if the assessment results meet the criteria

Exclusion Criteria:

1. Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
2. Participation in an interventional clinical trial study at the time of consent

Primary outcomes:
measure: Number of Participants With Low, Medium, and High Amyloid Pathology
timeFrame: At Screening on Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont
country: United States
facility: Eisai Site #3
state: Florida
city: Lady Lake
country: United States
facility: Eisai Site #1
state: Florida
city: District Heights
country: United States
facility: Eisai Site #2
state: Maryland
Study officials:
References:
Clinical trial NCT00731900: Pharmacogenetic Study for Topiramate-Induced Cognitive Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Dysfunction
Keywords: pharmacogenetic
study
Topirmate
induced
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with epilepsy or patients with migraine treated by topiramate

Brief summary: Topiramate (TPM) is an antiepileptic drug with a unique mode of action that is often useful in patients refractory to other drugs. However its use is restricted by the high incidence of cognitive adverse drug reactions (ADRs) that are associated with TPM exposure. TPM has been shown to cause particular cognitive ADRs, characterized by verbal fluency, attention, working memory and language deficits, at a much higher rate than other antiepileptic drugs. There do not appear to be obvious differences between patients that do or do not experience cognitive ADRs when on TPM (e.g. age, sex, concomitant medications, diagnosis), which suggests a genetic contributor.


Eligibility criteria: Inclusion Criteria:

* adult (\>17 years old) patients with epilepsy or patients with migraine treated by topiramate

Exclusion Criteria:

* allergy to topiramate
* abnormal liver or renal function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Horng-Huei Liou, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01186900: Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses
Official title: Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage in the Management of Cutaneous Abscesses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abscess
Keywords: skin abscess
needle aspiration
incision and drainage
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 20
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 investigators propose to conduct a, two armed, randomized, controlled pilot study to assess the clinical effects of a) open incision, drainage with daily packing changes, compared to b) Ultrasound guided needle aspiration, in drainage of uncomplicated cutaneous abscesses below the skin surface of adult emergency department patients using concealed allocation in evaluating patient satisfaction.


Eligibility criteria: Inclusion Criteria:

Patients presenting to the Civic Campus emergency department of The Ottawa Hospital with an abscess less than 5 cm diameter, as judged by the attending emergency physician (measurement with tape measure for diameter) between the hours of 7 am and 10 pm will be approached for possible enrollment. Ultrasound will be used to assess the appropriate exclusion criteria.

Exclusion Criteria:

* Patients under the age of 18 years,
* Patients with a Glasgow coma scale score of \<15 (i.e. not completely alert and oriented),
* Patients suspected of having necrotising fascitis,
* Patients with hemodynamic instability (defined as SBP \<90, and/or HR \>110),
* Patients admitted to hospital,
* Patients who are neither French nor English speaking,
* Patients who are not available for telephone follow-up (i.e. homeless).
* Ultrasound image demonstrates that the abscess is not compressible (generally indicates that the contents of the cyst includes solids, which would not be amenable to aspiration)
* Ultrasound demonstrates that there is no abscess to manage,
* Patients with perianal abscesses who have either Crohn's disease or ulcerative colitis or known perirectal fistula,
* Patients with recurrent abscesses in the same location or abscesses present for more than 2 weeks
* Patients with complex abscesses including deep tissue, sensitive body part involvement which includes: ears, eyes, lacrimal, orbital, submandibular, mouth, peritonsillar, and Bartholin's gland.
* Patients with renal impairment, diabetes, immunocompromised (as these patients are at risk of becoming more ill if an abscess were able to grow).

Primary outcomes:
measure: Patient satisfaction
timeFrame: 7 days
Secondary outcomes:
measure: Failure rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Michael Woo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00793000: Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
Official title: A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Tract Infections
Keywords: Safety tolerability pharmacokinetics PK first in human FIH
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.
* Japanese subjects muct have 4 Japanese grandparents who were born in Japan.

Exclusion Criteria:

* Previous antibiotic use within 14 days prior to dosing.
* Use of antibiotics during hospitalization within 90 days prior to dosing.
* History of sensitivity to macrolides or ketolides.
* Presence of clinically significant eye conditions (other than corrective lenses).

Primary outcomes:
measure: Evaluation of safety and tolerability of PF-04287881 after single oral dose.
timeFrame: Daily up to discharge, follow-up 7-10 days after dosing
Secondary outcomes:
measure: Pharmacokinetics of PF-04287881 after a single oral dose.
timeFrame: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06259500: Patient-derived Stem Cell Models of Anorexia Nervosa
Official title: Generation and Analysis of Patient-derived Stem Cell Models of Hypothalamic Neurons and Microglia in Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anorexia Nervosa
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from specialised care unit Controls from community

Brief summary: Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. This attributed to the obvious lack of valid tissue and non-invasive imaging techniques of high enough resolution. Stem cell models have evolved as a useful tool for the exploration of other neuropsychiatric disorders with a comparably high genetic contribution as AN. The investigators will here use patient-derived induced pluripotent stem cells (iPSCs) to profile Arc neurons and peripheral blood mononuclear cell (PBMC) derived microglia in AN, thus defining molecules to explore as drug targets.


Eligibility criteria: Inclusion Criteria anorexia nervosa:

* female
* 18-45 years of age
* AN restrictive diagnosis as main diagnosis
* more than 5 years duration

Exclusion Criteria anorexia nervosa:

-

Inclusion Criteria healthy control:

* female
* 18-45 years of age
* BMI 18,5 - 25

Exclusion Criteria healthy control:

* own or family member with eating disorder diagnosis
* own or family member with autism diagnosis

Primary outcomes:
measure: Microglia function and transcriptomic profiling
timeFrame: 2025
measure: Arcuate neuron function and transcriptomic profiling
timeFrame: 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT06237400: A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
Official title: A Phase I/II Dose Escalation and Expansion Study to Evaluating the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: KRAS G12C Mutant Advanced Solid Tumors
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Subjects who fully understood this trial and voluntarily signed the informed consent form;
* Men or women ≥ 18 years old;
* ECOG Performance Status (PS) 0 or 1;
* Life expectancy \> 3 months.

Exclusion Criteria:

* Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.;
* Patients requiring medications that can potentially prolong QTc interval;
* Other conditions that the investigator considers to be unsuitable for participation in this study.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: Up to 21Days
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT00635700: Ziprasidone in the Psychosis Prodrome
Official title: Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychosis Prodrome
Keywords: psychosis
schizophrenia
prodrome
ziprasidone
placebo
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.


Eligibility criteria: Inclusion Criteria:

* Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis
* clinically referred

Exclusion Criteria:

* prolonged corrected QT interval
* history of syncope

Primary outcomes:
measure: Conversion to Psychosis
timeFrame: 6 months
Secondary outcomes:
measure: Change in Scale of Psychosis-risk Symptoms Total Score
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California at San Diego
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University School of Medicine
state: Michigan
city: Glen Oaks
country: United States
facility: North Shore, Long Island Jewish Health System
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353300: Gene Mutation in Samples From Young Patients With Pleuropulmonary Blastoma Syndrome at Risk for Developing Cancer
Official title: Investigation of DICER1 in Cystic Nephroma and Cystic Partially Differentiated Nephroblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain and Central Nervous System Tumors
Hereditary Wilms Tumor
Kidney Cancer
Liver Cancer
Neuroblastoma
Pleuropulmonary Blastoma
Sarcoma
Keywords: embryonal childhood rhabdomyosarcoma
cystic nephroma
neuroblastoma
childhood medulloblastoma
childhood hepatoblastoma
stromal predominant Wilms tumor
hereditary Wilms tumor
pleuropulmonary blastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-13
Enrollment: 31
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of pleuropulmonary blastoma syndrome.

Brief summary: RATIONALE: The identification of gene mutations in young patients with pleuropulmonary blastoma syndrome may allow doctors to better understand the genetic processes involved in the development of some types of cancer, and may also help doctors identify patients who are at risk for cancer.

PURPOSE: This research study studies gene mutations in samples from young patients with pleuropulmonary blastoma syndrome at risk for developing cancer.

Detailed description: OBJECTIVES:

* To determine if DICER1 mutations contribute to tumor pathogenesis in cystic nephromas and cystic partially differentiated nephroblastomas outside of families with pleuropulmonary blastoma (PPB) syndrome.

OUTLINE: Archived DNA samples are analyzed for DICER1 mutation by qPCR and directly sequenced using BigDye Terminator chemistry. Results are then compared against the single nucleotide polymorphism (SNP) database.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of pleuropulmonary blastoma syndrome
* Normal tissue samples, if available
* Parental and sibling DNA samples, if available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Relationship between DICER1 mutations and tumor pathogenesis in cystic nephromas and cystic partially differentiated nephroblastomas outside of families with PPB nephroblastomas
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's National Research Institute
name: Dana A. Hill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632800: Sensory Effects of Rapidly-Changing Magnetic Fields
Official title: Sensory Effects of Rapidly-Changing Magnetic Fields
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Disorders
Keywords: Magnetic fields discomfort
Lead sponsor: Weinberg Medical Physics LLC
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-07-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing the time required for imaging. Experience has shown that unpleasant side-effects from magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when the magnetic pulses are shortened. In this study, we will explore whether this effect holds true when very short magnetic pulses are applied.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Adults over 18, capable of informed consent

Exclusion Criteria:

* History of arrhythmia. Has implanted pacemaker or defibrillator, right wrist-to-sternum distance of less than 60 centimeters, visible tattoos of the right hand or wrist, or with any metallic objects that cannot be removed from the right hand or wrist. Irregular or imperceptible pulse. Heart rate less than 50 beats per minute or more than 100 per minute, resting respiratory rate greater than 25 per minute, diastolic blood pressure less than 50. Solid meal ingested within 2 hours prior to the study.

Primary outcomes:
measure: Degree of Discomfort Under Applied Pulsed Magnetic Fields
timeFrame: Bioeffects will be assessed within the five-minute application of each pulse sequence
Secondary outcomes:
Other outcomes:
Locations:
city: Freeville
country: United States
facility: Applied Pulsed Power
state: New York
Study officials:
affiliation: Children's National Research Institute
name: Stanley Fricke, PhD
role: PRINCIPAL_INVESTIGATOR
References: