louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01267877: Patient Perception of Mammogram Guidelines
Official title: Patient Perception of Mammogram Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitude
Practice Guideline
Breast Cancer
Keywords: U.S. Preventive Services Task Force
Patient attitude
Mammogram
Guideline
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 247
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. The population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group.

Detailed description: Subjects completed a baseline questionnaire listing demographics, previous experience with mammograms, and acquaintances with breast cancer. They then were randomly assigned one of two articles (one favorable and one unfavorable) that had been published in the newspaper regarding the USPSTF breast cancer screening guidelines. Their attitudes towards the safety of the guidelines and their willingness to comply with them was then measured.

Eligibility criteria: Inclusion Criteria:

* women aged 39-49 seeing their gynecologist for routine preventive care

Exclusion Criteria:

* women not aged 39-49
* women with breast cancer
* women not able to read English

Primary outcomes:
measure: Willingness to forgo mammograms from age 40-49
timeFrame: within 15 minutes of completion of reading assigned article
Secondary outcomes:
measure: Do you feel that the mammogram recommendations safe?
timeFrame: within 15 minutes of completion of reading assigned article
measure: Do attitudes regarding the breast cancer screening guidelines differ by acquaintance with breast cancer?
timeFrame: within 15 minutes of completion of reading assigned article
measure: Does willingness to forgo mammograms in their 40's differ by previous "false alarms" with mammography?
timeFrame: within 15 minutes of completion of reading assigned article
Other outcomes:
Locations:
city: Auburn
country: United States
facility: UMassMemorial Medical Group- Auburn Gyn
state: Massachusetts
city: Shrewsbury
country: United States
facility: Shrewsbury Ob-Gyn
state: Massachusetts
city: Shrewsbury
country: United States
facility: UMassMemorial Medical Group- OB-GYN
state: Massachusetts
city: Worcester
country: United States
facility: Women's Health of Central Mass
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Dale Magee, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: AuTumn Davidson, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02320877: Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea
Official title: Evaluation of the Overall Effectiveness Including Cardiovascular Effects of the Custom-made, Titratable Duoblock Flex SomnoDent® MAS in the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 100
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: In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI \> 15/h sleep) will be included and treated with mandibular advancement devices (MAD). These patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients. These cardiovascular examinations will take place before and during MAD therapy.


Eligibility criteria: Inclusion Criteria:

* AHI \> 15 events/hour
* No other active OSA therapy in the 3 months preceding inclusion
* Willing to participate after informed consent
* Positive advice on OAT after DISE

Exclusion Criteria:

* Insufficient teeth to support the device
* Periodontal problems including tooth mobility
* Active temporomandibular joint dysfunction
* Limited maximum protrusive capacity (\< 6 mm)

Primary outcomes:
measure: cardiovascular outcome - interventricular septum thickness
timeFrame: 1 year
measure: cardiovascular outcome - ventricular dilatation
timeFrame: 1 year
measure: cardiovascular outcome - cardiac strain
timeFrame: 1 year
measure: cardiovascular outcome - stroke volume
timeFrame: 1 year
Secondary outcomes:
measure: OSA efficacy: apnea-hypopnea index
timeFrame: 1 year
measure: Therapy compliance
timeFrame: 1 year
measure: efficacy on subjective complaints: epworth sleepiness scale
timeFrame: 1 year
measure: efficacy on subjective complaints: visual analogue scale for snoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Olivier Vanderveken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dieltjens M, Vanderveken OM, Shivalkar B, Van Haesendonck G, Kastoer C, Heidbuchel H, Braem MJ, Van De Heyning CM. Mandibular advancement device treatment and reverse left ventricular hypertrophic remodeling in patients with obstructive sleep apnea. J Clin Sleep Med. 2022 Mar 1;18(3):903-909. doi: 10.5664/jcsm.9766.
Clinical trial NCT01962077: Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.
Official title: Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpotomies Primary Teeth
Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth
Keywords: pulpotomy
MTA
primary teeth
formocresol
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.


Eligibility criteria: Inclusion Criteria:

1. healthy children
2. with Asymptomatic primary molars with a deep carious lesion;
3. Exposure of a vital pulp by caries;
4. No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
5. Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.

Primary outcomes:
measure: Success of MedCem MTA pulpotomy in primary molar
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT03807453: Comparison of Scalp Microbiota of the Psoriasis and Seborrheic Dermatitis Patients
Official title: Comparison of Scalp Microbiota of the Patients With Psoriasis Vulgaris and Seborrheic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Seborrheic Dermatitis
Microbial Colonization
Keywords: Psoriasis Vulgaris
Seborrheic Dermatitis
Scalp
Microbiome
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Turkish Dermatology Association
First posted: 2019-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic and community sample

Brief summary: A sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or seborrheic dermatitis and the volunteer control group will be examined in our study. The examples of the microbiota of the patients will be taken both the lesional scalp and the lesion-free part of the scalp. Then, the microbiota differences between the lesioned scalp and the lesion-free scalp of both groups, and the microbiome differences between the two groups and the control group will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Patients with scalp psoriasis
2. Patients with seborrheic dermatitis
3. Agree to participate in research 4 - Do not use any drugs for their disease topically or systemically for two months

Exclusion Criteria:

1. Patients who do not want to participate in the study
2. Patients with psoriasis vulgaris or seborrheic dermatitis that does not effect scalp.
3. Those with chronic diseases that may affect skin microbiome
4. Patients using antibiotics, antifungal or antiviral therapy for any reason for the last one month.
5. Patients who are using topical or systemic drugs for their illness

Primary outcomes:
measure: The scalp microbiota of the patients with psoriasis and seborrheic dermatitis
timeFrame: 6 months
Secondary outcomes:
measure: The differences between the scalp microbiota of different countries
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Melek Aslan Kayıran
Study officials:
References:
Clinical trial NCT00519753: Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav
Official title: Safety and Efficacy of Switching to the Travoprost/Timolol Maleate Fixed Combination (DUOTRAV®) From Prior Mono or Two-Drug Therapy in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 522
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: The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.


Eligibility criteria: Inclusion Criteria:

* Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Age related.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in intraocular pressure at 12 weeks from other prior therapies (baseline)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Mainz
Study officials:
affiliation: Alcon Research
name: Mark C Jasek
role: STUDY_DIRECTOR
References:
citation: Pfeiffer N, Scherzer ML, Maier H, Schoelzel S, Jasek MC, Stewart JA, Stewart WC. Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy. Clin Ophthalmol. 2010 May 14;4:459-66. doi: 10.2147/opth.s10694.
Clinical trial NCT06086353: A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India
Official title: A Prospective, Single-arm, Multicenter, Observational Safety Surveillance Study of VyndaMx® (Tafamidis Capsule 61 mg) in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transthyretin Amyloid Cardiomyopathy
Keywords: Safety surveillance
Tafamidis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 15
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: All patients diagnosed with ATTR-CM and prescribed with VyndaMx® Capsule 61 mg according to routine clinical practice at 3 centers in India and willing to participate will be included in the study

Brief summary: The purpose of this study is to learn about the safety of Tafamidis for the treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM) in India.

ATTR-CM is a condition that affects people's hearts. Transthyretin is a protein that is made in the liver. In some people this protein stops working and forms clumps called as amyloid. Transthyretin amyloid builds up in heart and stops the heart from pumping properly.

This study is seeking for participants who are:

* confirmed with ATTR-CM.
* given Tafamidis capsules to be taken by mouth.

The safety of Tafamidis capsules will be checked based on side effects. These side effects can happen within 6 months after taking Tafamidis. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.

Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.

This study will help to see if Tafamidis is safe.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥18 years) with diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
* Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild or hereditary ATTR-CM.

Exclusion Criteria:

* Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product.
* Patients with rare hereditary problems of fructose intolerance.
* Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.

Primary outcomes:
measure: Number of Adverse events with Tafamidis
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences and Research
state: Karnataka
city: Hyderabad
country: India
facility: AIG Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00747253: Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
Official title: AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Tumor
Brain Tumor, Recurrent
Brain Neoplasm
Brain Cancer
Glioblastoma Multiforme
Recurrent Glioblastoma Multiforme
Keywords: laser interstitial thermal therapy
laser therapy
thermal therapy
brain tumors
recurrent brain tumor
progressive brain tumor
glioblastoma multiforme tumor
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 10
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: The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).


Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
* Clinical/radiographic suspicion of tumor recurrence/progression

Exclusion Criteria:

* Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).

Primary outcomes:
measure: Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
timeFrame: 14 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, 9500 Euclid Ave
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Gene Barnett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Andrew Sloan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sloan AE, Ahluwalia MS, Valerio-Pascua J, Manjila S, Torchia MG, Jones SE, Sunshine JL, Phillips M, Griswold MA, Clampitt M, Brewer C, Jochum J, McGraw MV, Diorio D, Ditz G, Barnett GH. Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. J Neurosurg. 2013 Jun;118(6):1202-19. doi: 10.3171/2013.1.JNS1291. Epub 2013 Apr 5.
Clinical trial NCT01134653: A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
Official title: Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain
Keywords: Acute ankle sprain in children and young adults
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an estimated 2 million injuries per year and 20% of all sports injuries in the United States. Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work or play time. Current best practice guidelines for treatment of an acute ankle sprain are protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews for ankle sprains call into question this treatment. Two critical components; immobilization and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal injuries including ankle sprains. Historically the limitation to early mobilization has been pain. Recently developed stretch bands have been introduced to the therapy market as a tool that allows pain-free active and resisted ankle movement after acute ankle sprain.

The investigators propose a double blind randomized controlled study to compare 2 ankle sprain treatments on their ability to speed recovery and reduce morbidities such as pain, swelling and weakness.


Eligibility criteria: Inclusion Criteria:

* 3 day post injury

Exclusion Criteria:

* fracture
* chronic sprain

Primary outcomes:
measure: days until return to activities
timeFrame: discharge
Secondary outcomes:
measure: VAS scale
timeFrame: 1 week
measure: strength
timeFrame: 1 week
measure: Figure of Eight Measurement
timeFrame: 1 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: columbus cri
name: Linda p Lowes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04834453: Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema
Official title: Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Edema
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with isolated blunt TBI from (age 18-60 years) of both sex, will be included in the study and followed prospectively. Severity of trauma is evaluated by GCS, Rotterdam computed tomography score (CTS) care system with the help of our radiodiagnosis colleagues

Brief summary: The most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation.

Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns


Eligibility criteria: Inclusion Criteria:

* isolated blunt Traumatic Brain Injury
* age 18-60 years

Exclusion Criteria:

* Pregnancy
* Intracerebral hemorrhage
* Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows.

Primary outcomes:
measure: the correlation between CCT scans score and Pulsatility Index of each patient
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: