louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01325831: Changes of Functional Connectivity After rTMS in Depression
Official title: Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

Detailed description: Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache.

We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS.

All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.

Eligibility criteria: Inclusion Criteria:

* DSM-IV major depressive episode
* Failure of at least 3 different kind of antidepressant

Exclusion Criteria:

* Organic brain disorder
* Other diagnosis of DMS-IV except nicotine dependence
* History of seizure disorder

Primary outcomes:
measure: change of functional connectivity between pre/post rTMS
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Department of Psychiatry, Severance Hospital
Study officials:
affiliation: Yonsei University College of Medicine, Severance Hospital
name: EUN LEE, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang JI, Lee H, Jhung K, Kim KR, An SK, Yoon KJ, Kim SI, Namkoong K, Lee E. Frontostriatal Connectivity Changes in Major Depressive Disorder After Repetitive Transcranial Magnetic Stimulation: A Randomized Sham-Controlled Study. J Clin Psychiatry. 2016 Sep;77(9):e1137-e1143. doi: 10.4088/JCP.15m10110.
Clinical trial NCT01238731: Persistent Pulmonary Artery Hypertension After Valve Replacement
Official title: Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent Severe PH After Valve Therapy
Keywords: Valve replacement
pulmonary hypertension
long term follow up
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Actelion Pharmaceuticals Deutschland GmbH
First posted: 2010-11-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with proven PH before valve replacement by right heart catherterization will be screened for study entry.

Brief summary: Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.

Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to identify factors predicting persistent PH.

Methods: All patients which underwent valve replacement at our institution between the years 2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by means of right-heart catheterization will receive prospective follow-up with echocardiography. Diagnosis of persistent PH will be confirmed with right heart catheterization.


Eligibility criteria: Inclusion Criteria:

* Proven pulmonary hypertension before valve replacement and informed consent for data acquisition

Exclusion Criteria:

* patients do not meet inclusion criteria

Primary outcomes:
measure: Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease
timeFrame: > 6 months after valve therapy
Secondary outcomes:
measure: MACCE, all cause mortality during FU
timeFrame: Within 24 months after valve therapy
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Medizinische Klinik II, University of Bonn
Study officials:
References:
Clinical trial NCT02295631: ETI During Spinal Trauma
Official title: A Comparison of Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Intubation time
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
measure: Preferred ETI device
timeFrame: 1day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
References:
Clinical trial NCT00829231: Hepatic Impairment Study
Official title: Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Disease
Keywords: Liver disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.

Primary outcomes:
measure: PK measurements
timeFrame: Day 1-6
Secondary outcomes:
measure: Physical Exam
timeFrame: Screening, Day 6
measure: Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
timeFrame: Screening Day 1, Day 6
measure: ECG
timeFrame: Screening Day 1, Day 6
measure: Vital Signs
timeFrame: Screening Day 1, Day 6
measure: Follow up phone call
timeFrame: Day 14
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Knoxville
country: United States
state: Tennessee
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05769231: CBT-I Chatbot for Youth
Official title: Efficacy of a Chatbot to Deliver Cognitive-behavioral Therapy for Insomnia in Youth: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Insomnia
Keywords: Chatbot
Youth
Insomnia
CBT-I
RCT
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is prevalent in youth, and it associates with depression and other psychiatric disorders, leading to increased mental health burden. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line treatment for insomnia. Digital tools have been employed to automate mental health interventions, in order to address deterrents such as clinician shortage, limited appointment availability, high cost, and stigma of seeking help. Digital CBT-I is shown to be effective in treating insomnia. Future digital intervention will incorporate patient-centered design, input from key stakeholders, and new understandings of behavior change. Artificial Intelligence (AI)-powered chatbots are utilized in different industries for better customer experience. AI chatbot is also utilized in the mental health industry to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. Some famous AI mental health chatbots in Western societies were developed to give tailored feedback, respond to emotions that a user expresses, and encourage users to complete an intervention. This study will investigate the effect of a CBT-I chatbot on insomnia to provide further evidence on mental health chatbot.


Eligibility criteria: Inclusion Criteria:

* score 8 or higher on the Insomnia Severity Index (ISI)
* between 18 and 35 years old
* read and type Chinese
* own a smartphone
* have consistent internet access to their smartphone

Exclusion Criteria:

* have a self-reported diagnosis of any psychiatric disorder(s)
* have been on regular medication(s) in the past month
* do not have instant messaging app(s) will be excluded.

Primary outcomes:
measure: The Insomnia Severity Index (ISI)
timeFrame: 10-20 minutes
Secondary outcomes:
measure: The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ)
timeFrame: 10-20 minutes
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 10-20 minutes
measure: Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16)
timeFrame: 10-20 minutes
measure: Sleep Hygiene Index (SHI)
timeFrame: 10-20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06477731: Waiting Time in the Premedication Room on Anxiety
Official title: The Effect of Waiting Time in the Premedication Room on Anxiety and Intraoperative Anesthetic Need
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Anesthetic Consumption
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 patients over the age of 18 who will receive general anesthesia and undergo surgical procedures will be included in the study.

Brief summary: The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.


Eligibility criteria: Inclusion Criteria:

* Being in the age group of 18 and over
* Being literate and able to communicate
* Individuals will have surgery in ENT, Urology, Brain Surgery, Orthopedics, General Surgery, Plastic Surgery, CVS and gynecology and obstetrics departments.
* Agreeing to participate in the research voluntarily

Exclusion Criteria:

* alcohol or drug use
* history of psychiatric illness
* central nervous system disease
* use of psychotropic medication
* pregnancy
* lack of vision, hearing

Primary outcomes:
measure: total anesthetic consumption
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Bayrak A, Sagiroglu G, Copuroglu E. Effects of Preoperative Anxiety on Intraoperative Hemodynamics and Postoperative Pain. J Coll Physicians Surg Pak. 2019 Sep;29(9):868-873. doi: 10.29271/jcpsp.2019.09.868.
citation: Ahmetovic-Djug J, Hasukic S, Djug H, Hasukic B, Jahic A. Impact of Preoperative Anxiety in Patients on Hemodynamic Changes and a Dose of Anesthetic During Induction of Anesthesia. Med Arch. 2017 Oct;71(5):330-333. doi: 10.5455/medarh.2017.71.330-333.
citation: Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
Clinical trial NCT03964831: Study Comparing the P200TxE and P200DTx
Official title: Visualization Study of the UWF (Ultra Wide-field) SLO (Scanning Laser Ophthalmoscope) RG (Red Green), AF (Autofluorescence), FA (Fluorescein Angiography) and ICG ( Indocyanine Green Fluorescence) Images Using the P200TxE (Indy) and P200DTx (California)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates image quality between two devices.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site,
3. Subjects who agree to participate in the study;
4. Subjects diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable images;

Primary outcomes:
measure: Qualitative Image assessment
timeFrame: 6 months
measure: Safety Assessment from Adverse Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
References:
Clinical trial NCT00099931: Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of insulin as defined by the protocol
* Body mass inde (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Adverse event profile after 24 weeks of treatment
measure: Change from baseline in mean daily insulin dose at 24 weeks
measure: Change from baseline in mean daily number of insulin injections at 24 weeks
measure: Patients with endpoint <7% after 24 weeks
Other outcomes:
Locations:
city: Investigative Sites
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.
Clinical trial NCT01169831: Regulation of Endothelial Progenitor Cells by Short-Term Exercise
Official title: Regulation of Endothelial Progenitor Cells by Short-Term Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Exercise
Cardiovascular Disease
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
Collaborators: name: University of Maryland, Baltimore
name: University of Maryland, College Park
First posted: 2010-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. young individuals, and endurance exercise training increases EPC number and function in young adults. Oxidative stress adversely affects endothelial cells and preliminary evidence indicates that oxidative stress negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative stress and may enhance EPC function in older adults. The investigators hypothesize that older endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC function and that altering the physical activity levels of both groups will move them to intermediate points between these two extremes. The investigators also propose that the investigators can "mimic" the effect of exercise training on EPC function in cell culture by altering intracellular levels of a key enzyme and a signaling molecule which the investigators have shown to regulate EPC function with respect to exercise training in young individuals.


Eligibility criteria: Inclusion Criteria:

* 50-80 years of age, BMI = 18-35 kg/m2, non-smoking, women must be postmenopausal

Exclusion Criteria:

* history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension

Primary outcomes:
measure: Baseline Endothelial progenitor cell number
timeFrame: Day 1
measure: Final Endothelial Progenitor Cell Number
timeFrame: Day 15
Secondary outcomes:
measure: Baseline Endothelial Reactivity
timeFrame: Day 1
measure: Final Endothelial Reactivity
timeFrame: Day 15
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore & Baltimore VA Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Steven J Prior, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05640531: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771
Official title: Phase-I, Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771 in Adult Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.


Eligibility criteria: Inclusion Criteria:

* Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg/height in m2
* Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings

Exclusion Criteria:

* Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs
* Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
* Use of any prescription drug within 14 days prior to start of the study (check-in) and nonprescription drug within 7 days prior to start of study (check-in)

Primary outcomes:
measure: To evaluate the safety & tolerability of multiple doses of WCK 771
timeFrame: Day 12
measure: To evaluate the pharmacokinetics of multiple doses of WCK 771
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200
state: Texas
Study officials:
affiliation: Wockhardt Ltd
name: Ashima Bhatia, MD
role: STUDY_DIRECTOR
References: