louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01467414: A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female Japanese subject aged 20-70 years (both inclusive)
* Japanese passport holder
* Japanese-born parents
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with insulin for at least 3 months
* Body Mass Index (BMI) maximum 33.0 kg/m\^2
* Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
* Fasting C-peptide below 1.0 nmol/L

Exclusion Criteria:

* Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
* Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic

Primary outcomes:
measure: Area under the glucose infusion rate curve during one dosing interval at steady state
timeFrame: Within 0-24 hours after last dosing
Secondary outcomes:
measure: Maximum glucose infusion rate at steady state
timeFrame: Within 0-24 hours after last dosing
measure: Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state
timeFrame: Within 0-24 hours after last dosing
measure: Maximum observed serum insulin degludec concentration at steady state
timeFrame: Within 0-24 hours after last dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05449314: Reliability and Validity Study of Urdu Version of Modified Barthel Index in Stroke Patients
Official title: Cultural Adaptation and Validation of Urdu Version of Modified Barthel Index to Assess the Independence of Pakistani Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Modified Barthel index
Urdu Version
Reliability
Validity
Cerebrovascular Disease
Stroke
Activities of Daily Living
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urdu speaking population with Activities of Daily Living, balance, or gait impairments effected with Stroke

Brief summary: Aim of the study is to translate and culturally adapt the modified Barthel index into Urdu language and to investigate the reliability and validity of this scale in Urdu speaking Stroke population for performance evaluation. Also check its correlation with Functional independence measure and Katz index of Activities of Daily Living.

Detailed description: The English version of the Barthel index will be translated and traditionally adapted as prior endorsement. In Activities of Daily Livings disabled stroke population, Urdu Version of Modified Barthel Index will distributed among sixty participants choose by convenience sampling technique based on pre-distinct inclusion and exclusion standards. To test inter and intra-observer reliability of the final Urdu Version of Modified Barthel Index will be completed on the same day, by two observers, and for the inter-observers evaluation, with an interval of 30 minute between the first and the second submission. Third evaluation will be carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Core steadiness will be analyzed with Cronbach alpha value. Test-retest reliability will be evaluated using an intra-class correlation coefficient.The Urdu Version of Modified Barthel Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria: Inclusion Criteria:

* Male and female both genders
* Adults between the ages of 18 and above
* Patient suffering from Stroke
* Ability to provide informed consent

Exclusion Criteria:

* Suffering from any cardiovascular pathologies
* Any disorder of contagious infections
* Any history of neurological disorders
* Having any spinal deformity

Primary outcomes:
measure: Modified Barthel Index
timeFrame: 1st day
measure: Functional Independence Measure
timeFrame: 1st day
measure: Katz index of Activities of Daily Living
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT06281314: The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment
Official title: VESPA 2.0 - Virtual Environment for a Superior Neuropsychiatry Second Generation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodegenerative Diseases
Cognitive Decline
Parkinson Disease Dementia
Alzheimer Disease
Multiple Sclerosis
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders.

Detailed description: The goal of this study is to verify the effectiveness of the intensive-individual cognitive participation intervention (SCI-i) on the general cognitive functioning and specific cognitive functions of patients with mild or moderate cognitive decline affected by Alzheimer's dementia, Parkinson's and Multiple Sclerosis.

Participants will be subjected to cognitive training (tasks on attention, memory, language, executive functions, and visual-spatial functions) through software. They will take place using virtual cameras and virtual reality (VR) viewers. All subjects will undergo follow-up evaluation.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
* Severity of mild to moderate cognitive impairment
* Sign informed consent

Exclusion Criteria:

* Important comorbidities with psychiatric syndromes
* Failure to sign the informed consent
* Atypical parkinsonisms
* Clinical conditions that involve vision-related problems.

Primary outcomes:
measure: Montreal cognitive assessment (MoCA)
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
state: Sicily
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Francesco Corallo, PSY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04463914: Evaluation of a Mobile Therapy for Elevated Depressive Symptoms
Official title: Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-07-09
Enrollment: 649
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 purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Elevated depressive symptoms, defined as a score of \> 10 on the Patient Health Questionnaire-9 (PHQ-9)57
* Age 18+
* Currently own an iOS- or Android-compatible smartphone
* Report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
* Have a current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
* Enrolled in Epic's MyChart program
* English fluency

Exclusion Criteria:

- Current suicidal ideation at study screening, defined as a response \>1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")

Primary outcomes:
measure: Mean Score of Depressive Symptoms
timeFrame: Between baseline and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jennifer Dahne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202614: Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma
Official title: Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage I Pulmonary Adenocarcinoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 58
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 suffering from pulmonary adenocarcinoma in stage I

Brief summary: The clinical and derived data from the preoperative computed axial tomography (CT) and Positron Emission Tomography (PET) of patients with pathological stage I pulmonary adenocarcinoma will be analyzed retrospectively, classified according to the current pathological classification IASLC / ATS / ERS of pulmonary adenocarcinoma, subjected to surgical treatment in our Operating Unit between August 2006 and July 2011. A follow-up will be performed on the patients enrolled in the study up to the date of death, and in any case no later than October 31, 2019


Eligibility criteria: Inclusion Criteria:

* patients suffering from pulmonary adenocarcinoma in stage I underwent CT, PET and surgical treatment with radical intent, at San Raffale Hospital (thoracic surgery) between August 2006 and July 2011

Exclusion Criteria:

* primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.

Primary outcomes:
measure: Stratification of stage I adenocarcinoma patients, using clinical data derived from preoperative CT and PET
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
References:
citation: Khullar OV, Liu Y, Gillespie T, Higgins KA, Ramalingam S, Lipscomb J, Fernandez FG. Survival After Sublobar Resection versus Lobectomy for Clinical Stage IA Lung Cancer: An Analysis from the National Cancer Data Base. J Thorac Oncol. 2015 Nov;10(11):1625-33. doi: 10.1097/JTO.0000000000000664.
citation: Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.
citation: Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094.
Clinical trial NCT00419614: Outcome of Pancreatic Stump Closure Following Resection of Tumors of the Head of the Pancreas.
Official title: Retrospective Chart Review on the Association of Pancreaticoduodenectomy Without Pancreatic-Gastrointestinal Anastomosis to Perioperative Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Chart review evaluating outcome of patients in whom following resection of a tumor involving the head of the pancreas no anastomosis of the pancreatic stump was done to the gastrointestinal tract.


Eligibility criteria: Inclusion Criteria:

* Pathologically proven carcinoma of the head of pancreas or other periampullary carcinoma treated by pancreaticoduodenectomy.

Exclusion Criteria:

* Patients undergoing pancreaticoduodenectomy for other indications (i.e. trauma)
* Charts not available for review.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Itamar Ashkenazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02698514: The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
Official title: The Ratio of Hypnotic to Analgesic Potency of Sevoflurane and Desflurane : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.

Detailed description: Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there is no study that demonstrate the difference between analgesic potency of volatile anesthetics. The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.

Eligibility criteria: Inclusion Criteria:

* patients undergoing general anesthesia using volatile anesthetics and supraglottic airway (I-gel™)
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing tracheal intubation for airway management
* pregnant women

Primary outcomes:
measure: Surgical pleth index
timeFrame: the 10 min at steady-state anesthesia after endotracheal intubation
Secondary outcomes:
measure: Bispectral index
timeFrame: the 10 min at steady-state anesthesia after endotracheal intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoungho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826014: TREC@TAMU Cancer Prevention Registry and Repository
Official title: Texas Regional Excellence in Cancer (TREC) @Texas A&M University Cancer Prevention Registry and Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Genetics
Disease
Diet
Lifestyle Factors
Keywords: cancer
genetics
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TREC@TAMU Registry will recruit as many participants as possible. The estimated enrollment in five years is expected to be 2500, but investigators will not limit recruitment if that number is exceeded.

Brief summary: This study collects health and genetic information to implement cancer prevention and treatment strategies.

Detailed description: This research will explore how genetics, diet, exercise, and jobs influence the risk of developing cancers that can be treated early. The goal is to find out if this knowledge can help doctors and health insurers improve their methods for preventing cancers that cannot be treated.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older, and,
* People participating in the Cancer Prevention and Research Institute of Texas (CPRIT) A coordinated cancer screening research program in Bryan and Navasota Family Medicine Clinics and,
* People with COPD, liver disease, cervical intraepithelial neoplasia (CIN) lesions, having had a colonoscopy or a low dose computed tomography (LDCT) lung scan or cervical exam in the last 12 months or scheduled for one, and,
* Able to give and comprehend the consent process, and,
* Able to consent to donate blood and urine samples, genetic material through buccal swabs for future research, and,
* Able to understand that their specimens, health record, and changes in health status will be followed for a five-year period and shared in deidentified form with the research community, and,
* All sexes and gender identities.

Exclusion Criteria:

* Declines to participate or interact with staff/share their medical status.
* A diagnosis of Alzheimer's disease or related dementias in a medical record indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning Individuals who are unable or unwilling to provide consent will be excluded

Primary outcomes:
measure: Frequency and nature of ADRs on the Naranjo Scale Questionnaire
timeFrame: 5 years
Secondary outcomes:
measure: Self-reported Health status and any significant changes
timeFrame: 5 years
Other outcomes:
Locations:
city: Bryan
country: United States
facility: Texas A&M Family Care
state: Texas
Study officials:
References:
Clinical trial NCT05153395: Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation
Official title: Novel Treatment for Brain Insulin Resistance and Hypoperfusion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy
Vasodilation
Insulin Resistance
Autonomic Dysfunction
Obesity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to examine the impact of increases in brain insulin on sympathetic nervous system activity, as well as peripheral and cerebral blood flow in humans.


Eligibility criteria: Inclusion Criteria:

* healthy adult men and women;
* 18-45 years of age;
* BMI \>18 kg/m2;
* non-pregnant/non-breastfeeding;
* non-nicotine users;

Exclusion Criteria:

* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Self-reported history of:

* hepatic, renal, pulmonary, cardiovascular, or neurological disease;
* stroke or neurovascular disease;
* bleeding/clotting disorders;
* sleep apnea or other sleep disorders;
* diabetes;
* smoking;
* history of alcoholism or substance abuse;
* hypertension;
* respiratory disease;
* active cancer;
* autoimmune disease.

Primary outcomes:
measure: Amount of cerebral blood flow
timeFrame: Change from baseline at minute 15
Secondary outcomes:
measure: Amount of muscle sympathetic nerve activity (MSNA)
timeFrame: Change from baseline at minute 15
measure: Amount of leg blood flow
timeFrame: Change from baseline at minute 15
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline K Limberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: