louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03902795: Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy
Official title: Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Vitrectomy
Keywords: Rhegmatogenous retinal detachment
Vitrectomy
Metamorphopsia
M-charts
Microperimetry
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 62 eyes that underwent successful vitrectomy with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively.

Brief summary: To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Detailed description: Background:

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Methods:

The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.

Exclusion Criteria:

* history of uveitis,
* diabetic retinopathy,
* previous vitreoretinal surgery,
* glaucoma or eye trauma,
* retinal detachment combined with macular hole or proliferative vitreoretinopathy

Primary outcomes:
measure: The best-corrected visual acuity (BCVA)
timeFrame: 1 to 6 months
measure: Amsler test
timeFrame: 1 to 6 months
measure: M-charts
timeFrame: 1 to 6 months
measure: Central retinal thickness
timeFrame: 1 to 6 months
measure: Microperimetry
timeFrame: 1 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: General Department of Ophthalmology in Lublin
Study officials:
References:
citation: Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.
Clinical trial NCT03398395: Endocrown and 90° Shoulder Endocrown
Official title: Comparison of Long Term Clinical Efficacy of Different Computer-Aided Design & Computer-Aided Manufacturing(CAD/CAM) Materials for the Restoration of Teeth With Root Canal Therapy With Endocrown or 90° Shoulder Endocrown
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endocrown Restoration
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use chairside Computer-Aided Design \& Computer-Aided Manufacturing(CAD/CAM) system (computer aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and durability between two kinds of root canal restoration methods:endocrown and 90° shoulder endocrown. Objective to establish the optimal method and material for the restoration of the teeth with root canal therapy.


Eligibility criteria: Inclusion Criteria:

1. 18-60 year old patients with healthy body, the tooth is molar, root tip no obvious damage, no root fracture by X-ray;
2. after complete root canal therapy, the remaining 4 wall intact tooth tissue;
3. after complete root canal therapy, the remaining 3 wall intact tooth tissue;
4. have good oral hygiene habits;
5. agreed to participate in the trial and signed the informed consent form;
6. patients who are not participating in other clinical trials;
7. after completion of the repair, compliance with the USPHS evaluation criteria of marginal density class A cases

Exclusion Criteria:

1. obvious destruction of the apical tissue and large cysts;
2. severe periodontitis patients;
3. oral malignant tumor patients;
4. radiotherapy patients;
5. pregnant women;
6. patients with mental illness or systemic diseases;
7. people who can not take care of themselves;
8. the researchers believe that is not suitable for the test.

Primary outcomes:
measure: USPHS criteria for dental restorations assessment
timeFrame: 2 Years
Secondary outcomes:
measure: Marginal Adaptation
timeFrame: 2 Years
measure: Marginal discoloration
timeFrame: 2 Years
measure: Integrity of restoration
timeFrame: 2 Years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: BuLing Wu, PHD
role: STUDY_DIRECTOR
References:
citation: Sun J, Ruan W, He J, Lin X, Ci B, Yin S, Yan W. Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial. Trials. 2019 Jul 24;20(1):454. doi: 10.1186/s13063-019-3530-1.
Clinical trial NCT00000195: Neurobiology of Opioid Dependence: 4 - 4
Official title: Neurobiology of Opioid Dependence: 4
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Behavioral, physiological, neuroendocrine response to yohimine
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037595: Effect of Turmeric on Pruritus in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: End Stage Renal Failure
Keywords: hemodialysis
turmeric
pruritus
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether turmeric can be effective in treatment of pruritus in hemodialysis patients.

Detailed description: pruritus is a common in hemodialysis patients and many treatment recommended for it . as turmeric has anti-inflammatory , anti-cytokine and anti-oxidant effect it may effective in treatment of uremic pruritus. thus we compared turmeric with placebo in this study

Eligibility criteria: Inclusion Criteria:

* Hemodialysis for more than 3 months
* More than 18 years old
* Pruritus

Exclusion Criteria:

* Use other treatment for pruritus

Primary outcomes:
measure: improvement in pruritus
timeFrame: 6 mo
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University Hemodialysis Center
state: Fars
Study officials:
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT01799395: Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer
Official title: Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Lead sponsor: Maggiore Bellaria Hospital, Bologna
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced lung cancer undergoing treatment and follow-up at the Oncology Units of the Azienda USL di Bologna (government structure that manages several public hospitals that "cover" a 800.000 inhabitants area)

Brief summary: Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).

The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy

Exclusion Criteria:

* Age \< 18 year
* Pregnancy
* Refusal to sign informed consent

Primary outcomes:
measure: Incidence of central airway obstruction
timeFrame: 12 months
Secondary outcomes:
measure: Predictor variables associated with the presence/occurrence of central airway obstruction
timeFrame: 12 months
measure: Prevalence of central airway obstruction
timeFrame: 1 day
Other outcomes:
Locations:
city: Bentivoglio
country: Italy
facility: Bentivoglio Hospital
state: Emilia Romagna
city: Bologna
country: Italy
facility: Bellaria Hospital
state: Emilia Romagna
city: Bologna
country: Italy
facility: Maggiore Hospital
state: Emilia Romagna
city: Budrio
country: Italy
facility: Budrio Hospital
state: Emilia Romagna
city: San Giovanni in Persiceto
country: Italy
facility: SS Salvatore Hospital
state: Emilia Romagna
Study officials:
affiliation: Maggiore Bellaria Hospital, Bologna, Italy
name: Rocco Trisolini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686695: Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniere Disease
Keywords: Transcutaneous auricular vagus nerve stimulation
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.

Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.

Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.

A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 and Age \<=70.
2. Clinical diagnosis of meniere disease.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.

Primary outcomes:
measure: Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
timeFrame: Day 0 and postintervention at Week 12
measure: Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
timeFrame: Day 0 and postintervention at Week 12
measure: Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
timeFrame: Day 0 and postintervention at Week 12
Secondary outcomes:
measure: Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
timeFrame: Day 0 and postintervention at Week 12
measure: Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks
timeFrame: Day 0 and postintervention at Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References:
Clinical trial NCT03299595: Oral Mucosal Lesions Among Smokers in an Egyptian Population.
Official title: Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smokers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 824
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Brief summary: This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

Detailed description: The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Eligibility criteria: Inclusion Criteria:

* Gender: males and females.
* Age: all age groups.
* Smokers.
* Individuals who agreed to sign the informed consent.

Exclusion Criteria:

* Individuals suffering from any systemic disease.
* Individuals on medications.
* Non-Egyptians.

Primary outcomes:
measure: oral mucosal lesions
timeFrame: one year
Secondary outcomes:
measure: Oral health-related quality of life (OH-QoL) evaluation
timeFrame: one year
measure: histopathological evaluation
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT05087095: Managing Distress in Malignant Brain Cancer
Official title: Managing Distress in Malignant Brain Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Metastatic to Brain
Brain Metastases, Adult
Keywords: bMET
CALM
Service Members
Veterans
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-10-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.

Detailed description: Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology
* At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
* Score \> 20 on the TICS
* Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
* Ability to read, speak, and understand English
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Major communication difficulties, which would prohibit psychotherapeutic interaction
* Inability to meet with interventionist via an electronic device for telehealth intervention sessions
* Inability to understand and provide informed consent
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk

Primary outcomes:
measure: Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains
timeFrame: 4 Months
measure: Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.
timeFrame: 12 months
measure: Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions
timeFrame: 3 Months
measure: Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion
timeFrame: 3 Months
measure: Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion
timeFrame: 3 Months
measure: Benefit of Intervention in the Proof of Concept Project
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee Loughan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977495: Take Charge of Your Diabetes
Official title: Testing Enrollment Methods on Participation in Behavioral Economic Interventions for Diabetes Care: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Keywords: Diabetes
Enrollment methods
Behavioral Economic Intervention
Opt-in Enrollment
Opt-out Enrollment
lottery
financial incentives
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-11-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.


Eligibility criteria: Inclusion Criteria:

1. Adults between 18 and 80 years of age
2. Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania
3. Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years
4. A confirmed diabetes diagnosis
5. Planning to stay in area for study duration (6 months)
6. Can understand and communicate fluently in English

Exclusion Criteria:

1. Unable to read and give consent
2. Suffer from an uncontrolled psychiatric disease

Primary outcomes:
measure: Enrollment and participation rates
timeFrame: End of study- 6 months after enrollment
Secondary outcomes:
measure: Uptake of Device Usage
timeFrame: End of study- 6 months after enrollment
Other outcomes:
measure: Change in Hemoglobin A1c
timeFrame: End of study- 6 months after enrollment
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jaya Aysola, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637714: The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
Official title: The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* willing to consent/undergo necessary procedures
* between the age of 19 and 75 years
* diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)

Exclusion Criteria:

* uncontrolled hypertension (Blood pressure \> 180/110 mmHg)
* uncontrolled diabetes mellitus (FBS \> 200 mg/dL)
* malignancy, cerebrovascular disease, cardiovascular disease
* history of abdominal surgery except appendectomy and hernia repair
* inflammatory bowel disease
* clinically or laboratory-confirmed gastroenteritis
* the use of motility drug or dietary fiber supplement in 2 weeks
* serum Cr \> 2 x Upper normal limit
* AST or ALT \> 2 x Upper normal limit
* Pregnancy, Lactating woman

Primary outcomes:
measure: change of Irritable bowel syndrome symptom severity score (IBS-SSS)
timeFrame: after 8 weeks
Secondary outcomes:
measure: Stool frequency and form
timeFrame: after 4 weeks and 8 weeks
measure: Symptom control of irritable bowel syndrome
timeFrame: after 4 weeks and 8 weeks
measure: Improvement of overall symptom in patient with irritable bowel syndrome
timeFrame: after 4 weeks and 8 weeks
measure: Assessment for quality of life related with irritable bowel syndrome
timeFrame: after 4 weeks and 8 weeks
measure: Assessment for patient satisfaction after administration completion
timeFrame: after 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joo Sung Kim, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References: