louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00392002: Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response
Official title: A Cluster-Randomized Study to Examine National Characteristics and Outcome Measures of GERD Patients Utilizing the PPI Acid Suppression Symptom (PASS) Test for Response [EncomPASS].
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: GERD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 2000
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: To characterize the burden of disease in GERD patients of prescription therapy'


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, 18 years or older, diagnosis of GERD

Exclusion Criteria:

* Peptic ulcer disease, upper gastrointestinal surgery, malignancy

Primary outcomes:
measure: To compare the improvement in burden of overall GERD symptoms after 4 weeks of treatment with Esomeprazole verses maintenance of current therapy in subjects with persistent GERD symptoms.
Secondary outcomes:
measure: To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels.
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Canada Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Moayyedi P, Hunt R, Armstrong D, Lei Y, Bukoski M, White R. The impact of intensifying acid suppression on sleep disturbance related to gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2013 Apr;37(7):730-7. doi: 10.1111/apt.12254. Epub 2013 Feb 21.
Clinical trial NCT04246502: Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Official title: A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 200
Sex: FEMALE
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: This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.


Eligibility criteria: Inclusion Criteria:

* HER2 positive recurrent or metastasis breast cancer.
* Patients with measurable disease are eligible.
* Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
* Adequate organ function.
* Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

* History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
* History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
* Assessed by the investigator to be unable receive systemic chemotherapy.
* History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
* Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Approximately 42 months
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: From the first drug administration to within 28 days for the last treatment
measure: Overall Survival
timeFrame: Up to 2 years
measure: Objective Response Rate
timeFrame: Approximately 42 months
measure: Duration of Objective Response
timeFrame: Approximately 42 months
measure: Clinical Benefit rate
timeFrame: From the start of randomization to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00043602: Clinician Managed Interpersonal Psychotherapy
Official title: Clinician Managed Interpersonal Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Depression
Depression, Postpartum
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-08-13
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.

Detailed description: CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.

Eligibility criteria: Inclusion criteria:

* Women between 8 and 24 weeks postpartum
* Meet DSM-IV criteria for Major Depression
* Hamilton Rating Scale for Depression score of 12 or more

Exclusion criteria:

* Active substance abuse
* Psychotic disorders

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: Measured at Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Scott P. Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05419102: Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
Official title: Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment
Keywords: dental implant
peri-implantitis
enamel matrix derivative
Lead sponsor: North Dallas Dental Health
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Routine adult patients in a private periodontal practice.

Brief summary: The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.

Detailed description: See brief summary.

Eligibility criteria: Inclusion Criteria:

* all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)

Exclusion Criteria:

* none except for routine medical contraindications for periodontal surgery

Primary outcomes:
measure: retention of the implant
timeFrame: 0.71 to 6.4 years
Secondary outcomes:
measure: record the clinical condition of the implant at the time of reevaluation
timeFrame: 0.71 to 6.4 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: North Dallas Dental Health
state: Texas
Study officials:
name: Thomas G Wilson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04124302: The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.
Official title: The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes type 1
insulin bolus
prandial insulin requirement
postprandial glycemia
insulin pump therapy
mixed meal
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* duration of type 1 diabetes longer than 12 months
* insulin pump therapy longer than 3 months
* treated by the same type of insulin longer than 3 months
* written informed consent by patients and parents

Exclusion Criteria:

* celiac disease
* diabetes related complications (e.g. nephropathy)
* any disease judged by the investigator to affect the trial
* withdrawal of consent to participate in the study

Primary outcomes:
measure: Postprandial glycemia
timeFrame: 60 minutes after meal
measure: Postprandial glycemia
timeFrame: 120 minutes after meal
measure: Postprandial glycemia
timeFrame: 180 minutes after meal
measure: Postprandial glycemia
timeFrame: 210 minutes after meal
measure: Postprandial glycemia
timeFrame: 240 minutes after meal
measure: Postprandial glycemia
timeFrame: 270 minutes after meal
measure: Postprandial glycemia
timeFrame: 300 minutes after meal
Secondary outcomes:
measure: Glucose Area Under the Curve (AUC)
timeFrame: 5 hours study period
measure: The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)
timeFrame: 5 hours study period
measure: Hypoglycemia Episodes
timeFrame: 5 hours study period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02507102: A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Official title: A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Lead sponsor: Nativis, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 11
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: This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Subject has histologically confirmed diagnosis of GBM.
2. Subject has failed or intolerant to radiotherapy.
3. Subjects has failed or intolerant to temozolomide therapy.
4. Subject has progressive disease with at least one measureable lesion on MRI or CT.
5. Subject is at least 18 years of age.
6. Subject has a KPS ≥ 60.
7. Subject has adequate organ and marrow function.
8. Subject has provided signed informed consent.

Exclusion Criteria:

1. Subject has life expectancy less than eight weeks
2. Subject has received other investigational therapy within the last 28 days.
3. Subject has received surgery within the last two weeks or not fully from prior surgery.
4. Subject has a clinically significant electrolyte abnormality.
5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
7. Subject is known to be HIV positive.
8. Subject is pregnant, nursing or intends to become pregnant during the study period.
9. Subject is participating in other investigational research.
10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.
11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.

Primary outcomes:
measure: Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
timeFrame: 6 months
measure: Tumor Response
timeFrame: 2 months
Secondary outcomes:
measure: Overall survival at six months compared with historical response
timeFrame: 6 months
measure: Progression free survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
Study officials:
affiliation: Nativis, Inc.
name: Donna Morgan Murray, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01031602: Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients
Official title: Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Keywords: Cancer
Gynecology
Sexual Dysfunction
Depression
Anxiety
Underserved
Minority
Psychological distress
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson (LBJ) General Hospital and able to read and write either English or Spanish.

Brief summary: Objectives:

* Assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.
* Assess the prevalence and severity of sexual dysfunction in this patient population.

Detailed description: The instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. The questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. No patient names or medical record numbers will be documented.

When a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the Female Sexual Function Index, the Hospital Anxiety and Depression Scale, and a demographic questionnaire. The tools used in this study will be available in both English and Spanish.

Eligibility criteria: Inclusion Criteria:

- Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson General Hospital. The women must be able to read and write either English or Spanish.

Exclusion Criteria:

- Women who are unable to complete the questionnaires.

Primary outcomes:
measure: Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed
timeFrame: Survey perfomed at single point in time
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson (LBJ) General Hosptial
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Lois M. Ramondetta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05129202: Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases
Official title: Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases：A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain metastasis received immunotherapy

Brief summary: Non-small cell lung cancer patients may have brain metastases at diagnosis. Patients with brain metastasis may contribute as poor prognosis factors. This trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.


Eligibility criteria: Inclusion Criteria:

* 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs

Exclusion Criteria:

* 1.Patients with a clear driver mutation that can be targeted for first-line treatment

Primary outcomes:
measure: ORR
timeFrame: November 2017- October 2021
measure: PFS
timeFrame: November 2017- October 2021
Secondary outcomes:
measure: OS
timeFrame: November 2017- October 2021
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang C Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02273921: EEG Classification System for Dementia
Official title: EEG Classification System for Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Dementia, Diagnosis, Electroencephalography
Lead sponsor: Mentis Cura
Sponsor class: INDUSTRY
Collaborators: name: Landspitali University Hospital
First posted: 2014-10-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups.

In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis.

The groups in the data analysis will initially be based on the following:

1. Healthy controls
2. Mild Cognitive Impairment
3. Alzheimers Disease (AD)
4. Lewy-body Dementia
5. Parkinsons Disease Dementia
6. Vascular Dementia (VaD)
7. Frontotemporal Dementia (FTD)
8. Depression

Other groups will be added if needed.


Eligibility criteria: Inclusion Criteria:

* Age of participant in the range of 50-90 years

Exclusion Criteria:

* Outside required age range

Primary outcomes:
measure: Classification system for dementia based on EEG
timeFrame: The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Landspitali University Hospital
name: Jón Snædal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12.
citation: Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
citation: Snaedal J, Johannesson GH, Gudmundsson TE, Blin NP, Emilsdottir AL, Einarsson B, Johnsen K. Diagnostic accuracy of statistical pattern recognition of electroencephalogram registration in evaluation of cognitive impairment and dementia. Dement Geriatr Cogn Disord. 2012;34(1):51-60. doi: 10.1159/000339996. Epub 2012 Aug 23.
Clinical trial NCT01097421: Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
Official title: Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 329
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: specialist care

Brief summary: This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.


Eligibility criteria: Inclusion criteria:

1. Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study
2. Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
3. Male or female PD patients aged at least 30
4. Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
5. Written informed consent by the patient for study participation.

Exclusion criteria:

1. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement.
2. Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).

Primary outcomes:
measure: Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment
timeFrame: 8-12 weeks
measure: Level of Adherence
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Patient Preference
timeFrame: 8-12 weeks
measure: Adverse Events (AE) Considered Related to Observed Medication
timeFrame: 8-12 weeks
measure: Pramipexole (PPX) Dose
timeFrame: pre-treatment and after 8-12 weeks
measure: Clinical Global Impressions (CGI)
timeFrame: 8-12 weeks
measure: Patients Global Impressions (PGI)
timeFrame: 8-12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: