louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06782763: Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder
Official title: A Randomized Controlled Study on the Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 82
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder.
2. To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation mechanism of cognitive neural circuits.


Eligibility criteria: Inclusion Criteria:

1. Aged 14 to 45 years, right-handed;
2. Meet the diagnostic criteria for bipolar disorder in the stable remission period of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
3. Stable medication treatment;
4. Clinical remission for more than three months, Young Mania Rating Scale (YMRS) ≤ 6 points Hamilton Depression Rating Scale 17 (HDRS 17) score ≤ 7 points;
5. Cognitive impairment on the Cognitive Deficit Questionnaire (PDQ) ≥ 17 points;
6. Fully understand the transcranial magnetic stimulation treatment, be willing to actively cooperate with the treatment, and sign the informed consent.

Exclusion Criteria:

1. Those with a history of severe physical illness or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);
2. Those with neurological diseases or risk of epileptic seizures, such as previous craniocerebral diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or a family history of epilepsy;
3. Those with contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as those with metal or electronic devices in the body (metal foreign bodies in the brain, cochlear implants, pacemakers and stents);
4. Those at high risk of suicide, or those who have already committed suicide or serious self-harm and need emergency intervention;
5. Those who are pregnant, breastfeeding, or planning to become pregnant during the trial;
6. Those with color blindness or hearing impairment;
7. Those with a history of substance or alcohol abuse;
8. Other situations that the researcher determines are not suitable as research subjects.

Primary outcomes:
measure: PDQ-21
timeFrame: 0-5 days
Secondary outcomes:
measure: brain imaging (MRI)
timeFrame: 0-5 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00434863: Comparative Study of the Effect of Dysport and Botox
Official title: A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aging
Keywords: botulinum toxin type A
Dysport®
Botox®
hyperfunctional forehead lines
randomized controlled trial
double-blinded trial
electromyogram (EMG)
Lead sponsor: Laserklinik Karlsruhe
Sponsor class: OTHER
First posted: 2007-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.


Eligibility criteria: Inclusion Criteria:

* age between 30 and 70 years
* moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest

Exclusion Criteria:

* application of botulinum toxin products for a period of 12 months prior to the study
* any significant health disturbances
* facial nerve palsy, and any facial conditions that could confound safety or efficacy results
* pregnancy and breast-feeding
* neuromuscular diseases
* drugs interfering with neuromuscular function (e.g. aminoglycosides)

Primary outcomes:
measure: EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
measure: Frown Wrinkle Severity (photographs and questionnaire) at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
Secondary outcomes:
measure: Side Effects upon completion of the study (20 weeks after injection)
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Laserklinik Karlsruhe
state: BW
Study officials:
affiliation: Laserklinik Karlsruhe
name: Syrus Karsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210963: Central Corneal Thickness With SENSIMED Triggerfish
Official title: Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Glaucoma and ocular hypertension patients, at least 18 years old and with stable IOP-lowering treatment (if any).

Brief summary: Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.


Eligibility criteria: Inclusion Criteria:

* glaucoma and ocular hypertension scheduled for overnight hospitalisation
* stable IOP-lowering treatment since at least 4 weeks before study
* at least 18 years
* having provided informed consent

Exclusion Criteria:

* contact lens wear within the last 2 years
* contraindication for silicone lean wear
* corneal abnormality in either eye
* ocular infection or inflammation
* history of ocular surgery within the last 3 months
* full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
* pregnancy and lactation
* patients not able to understand the nature of the research
* patients under tutelage
* patients committed to an institution by virtue of an order issued either by the courts or by an authority
* simultaneous participation in other clinical research

Primary outcomes:
measure: Pachymetry (central corneal thickness)
timeFrame: after 8 hours nocturnal continuous IOP monitoring
Secondary outcomes:
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Augen- und Poliklinik, Universitätsklinikum Würzburg
Study officials:
affiliation: Wuerzburg University Hospital
name: Thomas Klink, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00365963: Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers
Official title: Clinician Integration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: lung cancer, caregivers, support, resources, education
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-08-18
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to find out if patients with lung cancer and their main informal caregiver (person providing physical, emotional, or financial support) are helped by getting information, support, and decision making tools through a computer system called CHESS(the Comprehensive Health Enhancement Support System)

Detailed description: Many patients and their family/friends use the internet for obtaining information regarding the cancer diagnosis and treatment. In this study, the main caregiver of patients with advance (stage III or IV) non-small cell lung cancer is provided with a computer and internet access. Approximately one-half of the participants will also receive CHESS.

Eligibility criteria: Inclusion Criteria:

* Advanced Non-Small Cell Lung Cancer (Stage III or Stage IV)
* Needs to have a "caregiver" - a spouse, partner, family member, or friend providing emotional, physical, and/or financial support - to participate with the patient.

Primary outcomes:
measure: Caregiver affect and adjustment
timeFrame: 1 year post patient death
Secondary outcomes:
measure: Clinician-Patient-Caregiver Communication
timeFrame: throughout study
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin- Madison 610 Walnut St, WARF 1109A
state: Wisconsin
Study officials:
affiliation: Center for Health Systems Research and Analysis
name: David H Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustafson DH, DuBenske LL, Atwood AK, Chih MY, Johnson RA, McTavish F, Quanbeck A, Brown RL, Cleary JF, Shah D. Reducing Symptom Distress in Patients With Advanced Cancer Using an e-Alert System for Caregivers: Pooled Analysis of Two Randomized Clinical Trials. J Med Internet Res. 2017 Nov 14;19(11):e354. doi: 10.2196/jmir.7466.
citation: DuBenske LL, Gustafson DH, Namkoong K, Hawkins RP, Atwood AK, Brown RL, Chih MY, McTavish F, Carmack CL, Buss MK, Govindan R, Cleary JF. CHESS improves cancer caregivers' burden and mood: results of an eHealth RCT. Health Psychol. 2014 Oct;33(10):1261-72. doi: 10.1037/a0034216. Epub 2013 Nov 18.
citation: Chih MY, DuBenske LL, Hawkins RP, Brown RL, Dinauer SK, Cleary JF, Gustafson DH. Communicating advanced cancer patients' symptoms via the Internet: a pooled analysis of two randomized trials examining caregiver preparedness, physical burden, and negative mood. Palliat Med. 2013 Jun;27(6):533-43. doi: 10.1177/0269216312457213. Epub 2012 Sep 17.
Clinical trial NCT01205763: Evaluation of Effects of Clavicular Hook Plate on Subacromial Space
Official title: Evaluation of Effects of Clavicular Hook Plate on Subacromial Space
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AC Joint Dislocation
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient received surgical treatment for AC joint dislocation of unstable distal clavicle fracture

Brief summary: In this study, the investigators intend to demonstrate that the hook plate may have adverse effects on subacromial structures even with a short period of hardware retention. The investigators also sought to determine if musculoskeletal sonography could be used as a tool to demonstrate shoulder pathology such as subacromial impingement or rotator cuff tear in patients receiving hook plate fixation. The clinical results of patients receiving hook plate fixation, specifically bony union, pain relief, shoulder function and range of motion (ROM), were also evaluated.


Eligibility criteria: Inclusion Criteria:

* The patient received surgical treatment for AC joint dislocation of unstable distal clavicle fracture in our hospital from December 2007 to January 2009.

Exclusion Criteria:

* The patient who was expired or the injured limb has preexisting injury or neurological deficit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Wei-Pin Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05513963: Clairity in a University Mental Health Clinic
Official title: Feasibility and Effectiveness of the Clairity Tool in a University Mental Health Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Suicide
Mental Health Issue
Lead sponsor: Clarigent Health
Sponsor class: INDUSTRY
Collaborators: name: Xavier University of Louisiana.
First posted: 2022-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-Control Trial
Primary purpose: SCREENING

Brief summary: This is a clinical trial to evaluate the effectiveness of the Clairity tool within the university setting for students who are being seen by a mental health provider.

Detailed description: In this study, the investigators plan to evaluate the effect of the Clairity process in a university setting. The Clairity process will be implemented as a 15-20 minute "between-the-visit" mental health check-in between a patient and clinical staff. Clairity will record and analyze patient speech using artificial intelligence algorithms developed for early detection and monitoring of mental health and suicidal risk. This study will be the first to return Clairity results real time to the clinician. The study employs a mixed-methods design, using rolling recruitment of clients of the Xavier University Psychological services clinic (XUPS) during the 2022-2023 school year. Study-trained clinical research coordinators will begin enrolling participants after completing the online protocol training and brief human subject's protection training.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Currently a client receiving services from XUPS
* Able to provide informed consent
* Speaks and understands English fluently
* Willing to abide by all research procedures

Exclusion Criteria:

* Participants with communication disorders (linguistic or articulation) or who cannot articulate clearly in English.
* Participants with an intellectual and/or neurocognitive disability that the study staff deems a barrier to participation.
* History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll.
* Any participant, who at the discretion of the study staff, should not be enrolled.

Primary outcomes:
measure: Clairity Dashboard
timeFrame: 12 month
measure: Identify Mental States with Area Under the AUC metric
timeFrame: 12 month
measure: Outcome Measure Comparison
timeFrame: 12 month
measure: Clinical Utility Treatment Outcomes
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Xavier University Psychological Services Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT00384163: Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique
Official title: Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: cardiac
adult
PVR
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: Pulmonary valve replacement in the adult population is an uncommon operation. The majority of native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or pulmonary stenosis created by previous childhood operations. Without the valve size constraints present at prior operations, these patients can be well-served by the placement of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac literature of the actual technique of pulmonary valve replacement. We present our current technique and the pitfalls encountered when performing pulmonary valve replacement in adults.

Detailed description: This will be primarily a technique paper. The only clinical data points I am interested in are the presence of pulmonary stenosis, pulmonary insufficiency or perivalvular leak on the initial post-operative echocardiogram. I estimate reviewing 50 patients' charts dated March 22.2003 through and including March 22.2006 at Emory Hospital .

Primary Aim: Present an effective technique for pulmonary valve replacement

Secondary Aim: Present our excellent technical results of PVR in our adult congenital patients

Eligibility criteria: Inclusion Criteria:

* Adults undergoing pulmonary valve replacement
* at Emory Hospital
* between 3.22.03 amd 3.22.06

Exclusion Criteria:

* those charts that do not fall under inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University SOM
name: Brian E Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06214663: Investigation of the Analgesic Effects of Intradermal and Subdermal Sterile Water Injection on Active Labor Pain
Official title: Investigation of the Analgesic Effects of Intradermal and Subdermal Sterile Water Injection on Active Labor Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor Pain and to Reduce Pain
Keywords: Delivery
Pain
Analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients in active labor (6 cm cervical dilatation) will be randomly divided into 3 groups. For each patient, first, VAS score (visual analogue scale: patients were asked to evaluate their own pain on a vertical, unnumbered scale. Then, the patient's evaluation was graded with the help of a scale divided into 1/10 sections of the same length as the scale: "0: no pain and 10: "unbearable pain") will be measured for labor pain and repeated at 10, 30, 60 and 90 minutes after injection. Injections will be administered over the sacral area (both posterior iliac spines and 2 cm downward and medial), and this technique was described by Lytzen et al in 1989 and later standardized. The results will be compared between the three groups.
Primary purpose: SCREENING

Brief summary: Labour pain has different locations, intensity, quality and meaning for each woman, and the experience of pain changes throughout the delivery process. This pain is often associated with varying degrees of fetal malposition, particularly occipito-posterior position, which may apply pressure on pain-sensitive structures within the pelvis. Administration of Injections into the sacral area (both posterior iliac spines and 2 cm downward and medial) is used and have been shown to relieve the pain of labor. Controlling pain with simple methods can reduce the desire of mothers to give birth by cesarean section and make them more diligent for normal birth.

The benefit we expect from the research; Since sterile water injection is a safe, effective and low-cost method, it is important to understand the effectiveness of its use to reduce labor pain. It also aims to increase the knowledge of gynecologists about this method.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnant women with cephalic presentation who are admitted to the delivery room clinic for delivery, who do not have an additional chronic disease, who have not given birth before, and who are in the second stage of labor (active cervical dilatation of 6 cm and above) will be included in the study.

Exclusion Criteria:

* Patients who do not volunteer to participate in the study will be excluded.

Primary outcomes:
measure: Investigation of the analgesic effects of intradermal and subdermal sterile water injection on active labor pain.
timeFrame: 10, 30, 60 and 90 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00780286: Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2
Official title: Retention of an Orally Administered Investigational Device vs Commerical Device in the Oral Cavity and Oropharynx of Healthy Human Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-10-27
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single usage, open label study in up to 40 adult healthy males. Eligible subjects will receive a single usage of the investigational or commercial device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.


Eligibility criteria: Inclusion Criteria:

* Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test
* Are able to tolerate the procedure and
* Be generally healthy

Exclusion Criteria:

* Have history of allergy or hypersensitivity to the study ingredients
* Major diseases
* Taking medication regularly
* Radiation exposure recently

Primary outcomes:
measure: Area under the curve for volume of investigational device retained in the oral cavity.
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Walter J Doll, PhD, RPh
state: Kentucky
Study officials:
affiliation: Scintipharma, Inc
name: Walter J Doll, PhD, RPh
role: PRINCIPAL_INVESTIGATOR
References: