louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02176473: Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy
Official title: Evaluating the Feasibility and Efficacy of Computerized Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In an open-label feasibility study, fifteen will be recruited to participate in the study from among those who have already chosen of their own accord to undergo ECT (standard of care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients will receive computer-assisted cognitive behavior therapy (CCBT).


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* meet DSM-5 criteria for depressive episodes
* able to use a computer

Exclusion Criteria:

* diagnosis of an axis II (personality disorder)
* active suicidal thoughts with a plan
* current substance use disorder
* non-affective psychosis
* prior treatment with ECT in the past 6 months
* CBT treatment in the past 12 months
* dementia
* delirium or another other neurological or mental disease that might affect cognition or the ability to meaningfully participate in computerized CBT

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: week 2
measure: Beck Depression Inventory
timeFrame: Week 5 through week 15
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomology (QIDS)
timeFrame: Baseline, Week 2, week 5, week 10, week 15
measure: Montgomery-Åsberg Depression Rating Scale ( MADRS)
timeFrame: Baseline, Week 2, week 5, week 10, week 15
measure: Clinical Global Impression (CGI)
timeFrame: Baseline, Week 2, week 5, week 10, week 15
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, Week 2, week 5, week 10, week 15
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Samule Wilkonson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803127: VS-Sense Result Reading Clarity
Official title: VS-Sense Result Reading Clarity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginitis
Keywords: vaginal infection, color appearance
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
Collaborators: name: Lin Medical Center, Haifa
name: Common Sense
First posted: 2008-12-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic and asymptomatic women, ages 18 and above.

Brief summary: This study is designed to demonstrate the result reading clarity of the VS-SENSE is substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for vaginal secretions.

Detailed description: Once informed consent has been signed, the clinician will perform the following:

Record baseline variables in the CRF. The 1st clinician will obtain a vaginal secretion sample by using the VS-SENSE swab. The 1st clinician will obtain the specimen by separating the labia to expose the vagina. The yellow tip of the VS-SENSE swab will be inserted into the vagina approximately 5 cm/ 2". The 1st clinician will use the VS-SENSE according the instructions for use - attachment 1 to the protocol.

The 1st clinician will read the VS-SENSE results and record them on the designated form (Clinician Report - VS-SENSE Result form), and fill out the table regarding the VS-SENSE reading clarity on the same form.Vaginal examination (including speculum examination) - will be performed by a 2nd clinician, masked from the results of the 1st clinician test.

The 2nd clinician will use a vaginal swab for pH measurement by Nitrazine pH Paper test. The Nitrazine pH Paper test will be performed according to strict manufacturer's instruction.

The 2nd clinician will read the results of the Nitrazine pH Paper test result, document it on the Clinician Report - pH Test Result form, and fill out the table regarding the pH test reading clarity on the same form.

Eligibility criteria: Inclusion Criteria:

1. Symptomatic women, ages 18 and above.
2. Subjects willing and able to sign the informed consent form.

Exclusion Criteria:

1. Subjects are unable or unwilling to cooperate with study procedures.
2. Subjects are currently participating in other clinical study that may directly or indirectly affect the results of this study.
3. Women with blood present in their vaginal secretion.
4. Subjects that have had sexual relations or applied vaginal douched within the previous 12 hours.
5. Subjects that applied vaginal medications within the last 3 days.
6. Subjects with symptoms and signs of pelvic inflammatory disease.

Primary outcomes:
measure: The clinician reports of the VS-SENSE test results, the pH measurement by Nitrazine Paper test records, and the results reading clarity grade from the clinician.
timeFrame: 5 minuts
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Lin Medical center
state: West Galil
Study officials:
References:
Clinical trial NCT05293327: IMP3 and PCNA Expression in Laryngeal Squamous Cell Carcinoma in Sohag Governorate
Official title: Immunohistochemical IMP3 and PCNA Expression as Diagnostic and Prognostic Markers in Laryngeal Squamous Cell Carcinoma in Sohag Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Squamous Cell Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Blocks obtained from laryngeal squamous cell carcinoma tissue previously extracted from patients treated in Sohag University Hospital

Brief summary: Laryngeal cancer is responsible for 2-5% of all new cancer cases worldwide. Squamous cell carcinoma of the larynx (LSCC) is the most common malignant tumor of the larynx, accounting for 85-90% of all laryngeal malignancies.

Despite significant therapeutic developments in recent decades, increases in patients' 5-year survival rates are still minimal , which is likely due to late-stage diagnosis and other complex factors. Therefore, to improve the outcome, timely diagnosis, selection of the most appropriate therapy, and an adequate follow-up approach is needed.

The insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a new biomarker that may be implicated in the carcinogenesis of various malignancies, including head and neck squamous cell carcinoma. IMP3 normally expressed in embryonic tissue but decreases after birth and is no longer detectable in adult tissue With the exception of a few tissues. As a result, IMP3 is expressed only in tumors and not in neighboring normal tissues.

Proliferating Cell Nuclear Antigen (PCNA) is a nuclear protein that acts as a cell proliferation marker. In most forms of solid malignancies, such as colorectal cancer and breast cancer, PCNA is closely linked to prognosis and survival.

In this study, hoping to improve diagnosis of LSCC and assess prognosis better by using both IMP3 and PCNA biomarkers. As IMP3 may have a role in cell growth and proliferation and PCNA is a marker of cell proliferation; studying the association between both markers in laryngeal carcinoma is recommended.


Eligibility criteria: Inclusion Criteria:

1. Laryngeal resection (total or partial laryngectomy) and biopsies.
2. Complete clinical data.

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.

Primary outcomes:
measure: Diagnosis and prognosis of Laryngeal Squamous Cell Carcinoma
timeFrame: One or two days after staining sections with the markers
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
affiliation: Faculty of Medicine,Sohag University
name: Asmaa AM Abd El-latif
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03761927: Physiological, Behavioural and Subjective Measures of Listening Effort
Official title: Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) listening to short radio excerpts and answering subsequent comprehension questions. At the same time participants are required to perform a manual target-tracking task on a touch screen. During this study, continuous, non-invasive physiological measurements (heart rate, skin conductance and hemoencephalography) will be made from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a three factor (listening task x algorithm x signal-to-noise ratio), within-subjects design. Each participant performs each listening task (about 4min long each) with each algorithm (reference, noise reduction I, noise reduction II), at two signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Heart rate variability data
timeFrame: 6 weeks
measure: Skin conductance data
timeFrame: 6 weeks
Secondary outcomes:
measure: Hemoencephalography data
timeFrame: 6 weeks
measure: Dual-task performance test 1
timeFrame: 6 weeks
measure: Dual-task performance test 2
timeFrame: 6 weeks
measure: Subjective Listening Effort rating
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
affiliation: Sonova AG
name: Juliane Raether
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178227: Smokerface Mirroring in Brazil RCT
Official title: Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil - Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Before February 2018 the baseline survey is conducted in about 60 class in Brazilian secondary schools. These classes are randomized to control and intervention group in a 1/1 manner. A few weeks thereafter medical students from the local medical school visit the schools and perform a smoking prevention intervention called "photoaging mirroring intervention" which takes about 45 minutes. One month and six months after the intervention the intervention group receives another anonymous questionnaire monitoring smoking status. The primary endpoint is the difference in the chance of smoking prevalence between the two groups.

Detailed description: Before February 2018 the baseline survey is conducted in about 60 class in Brazilian secondary schools. These classes are randomized to control and intervention group in a 1/1 manner. A few weeks thereafter medical students from the local medical school visit the schools and perform a smoking prevention intervention called "photoaging mirroring intervention" which takes about 45 minutes. One month and six months after the intervention the intervention group receives another anonymous questionnaire monitoring smoking status. The primary endpoint is the difference in the chance of smoking prevalence between the two groups.

Eligibility criteria: Inclusion Criteria:

Visiting a Brazilian secondary school

Exclusion Criteria:

Not visiting a Brazilian secondary school

Primary outcomes:
measure: The difference of prevalences after six months
timeFrame: six months
Secondary outcomes:
measure: The difference of prevalences after one month
timeFrame: 1 month
Other outcomes:
Locations:
city: Itauna
country: Brazil
facility: University of Itauna
city: Bünde
country: Germany
facility: Titus Brinker
Study officials:
References:
citation: Faria BL, Brieske CM, Cosgarea I, Omlor AJ, Fries FN, de Faria COM, Lino HA, Oliveira ACC, Lisboa OC, Klode J, Schadendorf D, Bernardes-Souza B, Brinker TJ. A smoking prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised trial. BMJ Open. 2017 Dec 10;7(12):e018589. doi: 10.1136/bmjopen-2017-018589.
Clinical trial NCT06442527: Using Virtual Reality Before Transcranial Magnetic Stimulation for the Treatment of OCD
Official title: Using Virtual Reality Before Transcranial Magnetic Stimulation for the Treatment of OCD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: TMS
Transcranial Magnetic Stimulation
Virtual Reality
VR
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 5
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 study will focus on the use of Virtual Reality (VR) technology in patients receiving treatment using Transcranial Magnetic Stimulation (TMS) for Obsessive-Compulsive Disorder (OCD)


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years old
* Patients must have been clinically evaluated by a Yale Interventional Psychiatry Service physician who has deemed them appropriate to receive TMS for the treatment of OCD
* Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

Exclusion Criteria:

* Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
* Difficulty in understanding spoken or written English
* Pregnancy
* History of seizure disorder
* Unable to provide informed consent
* Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
* Any implanted medical device, risk of interference with which by the VR device in the investigator's judgment can put patient at additional undue risk.
* Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
* Was previously enrolled/randomized into the study

Primary outcomes:
measure: Tolerability of VR treatment by qualitative assessment
timeFrame: Within 1 hour after each treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
state: Connecticut
Study officials:
affiliation: Assistant Professor, Departement of Psychiatry, Yale University
name: Sina Nikayin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03028727: Diode Laser Therapy As An Adjunct To Scaling And Root Planing
Official title: Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: KLE Society's Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).

Detailed description: Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.

The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.

Eligibility criteria: Inclusion Criteria:

* 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
* Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm

Exclusion Criteria:

* Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
* Subjects on antibiotics or immunosuppressants.
* Chronic smokers, alcoholics, smokeless tobacco users.
* Subjects with acute illnesses/acute intraoral lesions.
* Pregnant women
* Subjects who had undergone extensive restorative dental treatment.

Primary outcomes:
measure: Change in levels of P.gingivalis
timeFrame: 14 weeks
Secondary outcomes:
measure: Change in gingival index
timeFrame: 14 weeks
measure: Change in plaque index
timeFrame: 14 weeks
measure: Change in probing pocket depth
timeFrame: 14 weeks
measure: Change in clinical attachment level
timeFrame: 14 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05210127: Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure
Official title: Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hallux Valgus
Keywords: hallux valgus
core foot system
rehabilitation protocol
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to identify the impact of CFS foot muscle training on time-space parameters, anthropometric parameters and bioelectrical activity (EMG) of the foot muscles during walking and to develop an algorithm for an effective therapeutic method in patients after hallux valgus correction. Achieving the purpose of the research will contribute to the answer to the following research questions:

* Does the CFS therapy used significantly change the arch of the foot in HV patients compared to the control group?
* Does the CFS therapy used significantly improve gait characteristics after HV surgery in relation to the control group?
* Does muscle stimulation and the moment of their activation differ in groups in which different therapies have been used?
* Will the results of the questionnaires and scale be significantly different in both groups?


Eligibility criteria: Inclusion Criteria:

* hallux valgus deformity
* surgical procedure
* voluntary consent to the study

Exclusion Criteria:

* lack of consent to research
* other deformation and operations of the foot
* pain after the surgery which prevents experimental procedure

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint
timeFrame: 8 weeks
measure: The 36-Item Short Form Survey (SF-36)
timeFrame: 8 weeks
measure: Zebris Medical System
timeFrame: 8 weeks
measure: EMG test
timeFrame: 8 weeks
measure: Podoscope test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01776827: Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital
Official title: Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Hiatal Hernia
Paraesophageal Hernia
Keywords: GERD
Hiatal Hernia
Paraesophageal Hernia
Biologic Mesh
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: LifeCell
First posted: 2013-01-28
Enrollment: 69
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent paraesophageal hernia repair at the University of Nebraska Medical Center.

Brief summary: To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh.

Detailed description: To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh. A barium swallow test with x-rays will be performed to look for recurrence of hiatal hernia. If the participants are symptomatic, additional medical therapy will be provided as deemed appropriate.

Eligibility criteria: Inclusion Criteria:

* Subjects who underwent paraesophageal hernia repair at UNMC.
* Greater than 19 years of age
* Not pregnant

Exclusion Criteria:

* Children and adolescents
* Pregnant and breast-feeding patients
* Vulnerable subjects such as decisionally impaired persons

Primary outcomes:
measure: Recurrence of hiatal hernia or GERD symptoms
timeFrame: 3+ years after initial surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Dmitry Oleynikov, MD
role: PRINCIPAL_INVESTIGATOR
References: