louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00166348: Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?
Official title: Efficacy of Group Based Cognitive Rehabilitation Following Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: Cognitive Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Nicloe Holzworth, OTR/L
name: Bergequist, Thomas, Ph.D.
name: Brown, Allen, M.D.
name: Sue Lepore, OTR/L
name: Walter Stobaugh. LICSW
First posted: 2005-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
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 determine whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.

Detailed description: This research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. Criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. The assessments used: Three Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence Scale. The group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. Techniques such as the problem solving format and a calendar system. Analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting.

Of the 20 participants, 3 chose not to be included.

Eligibility criteria: Inclusion Criteria:

* All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.

Primary outcomes:
measure: provide evidence which supports cognitive therapy in a group setting
measure: less labor intensive
measure: cost effectiveness
measure: peer feedback is effective
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Merri L Vitse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463148: Validation of a Sensor for Non-Invasive Measurements
Official title: Validation of a Sensor for Non-Invasive Measurement of Vital Signs, Hemodynamic Parameters and Time-Dependent Physiological Waveforms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CHF
Renal Disease
Hypertension
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-13
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women over 22 years of age

Brief summary: Subjects will be measured with both a sensor and a reference device

Detailed description: Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 (eighteen) years of age at screening.
2. Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
3. Subject selection will not be based on age, height, or weight.
4. Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study.

Exclusion Criteria:

1. Subject is participating in another clinical study that may affect the results of either study.
2. Subjects that are pregnant will not be included in the study.
3. Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours.
4. Subject is considered by the Principal Investigator to be medically unsuitable for study participation.

Primary outcomes:
measure: Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure.
timeFrame: 3-36 Months
measure: Fluids
timeFrame: 3-36 Months
measure: Heart Rate
timeFrame: 3-36 Months
measure: Heart Rate Variability
timeFrame: 3-36 Months
measure: Respiration Rate
timeFrame: 3-36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: toSense, Inc. Headquarters
state: California
Study officials:
affiliation: Baxter Healthcare Corporation
name: Matthew Banet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983448: Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
Official title: Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Diastolic
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).


Eligibility criteria: Inclusion Criteria:

1. Male and female patients older than 18 year old
2. Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment

Exclusion Criteria:

1. Left ventricular dysfunction (Left ventricular ejection fraction \<40%)
2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
3. Recent (\<6 months) stroke or myocardial infarction
4. Severe heart failure (NYHA class III or IV)
5. Recurrent vaso-vagal syncopal episodes
6. Unilateral or bilateral vagotomy
7. Pregnancy or breast feeding
8. Sick sinus syndrome (without a pacemaker), 2nd or 3rd degree AV block, bifascicular block or prolonged (PR\>300ms) 1st degree AV block

Primary outcomes:
measure: Echocardiographic Markers of Diastolic Dysfunction
timeFrame: after 1 hour of stimulation
Secondary outcomes:
measure: Heart Rate Variability Measures
timeFrame: after 1 hour of stimulation
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
References:
citation: Tran N, Asad Z, Elkholey K, Scherlag BJ, Po SS, Stavrakis S. Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. J Cardiovasc Transl Res. 2019 Jun;12(3):221-230. doi: 10.1007/s12265-018-9853-6. Epub 2018 Dec 17.
Clinical trial NCT03314948: Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30
Official title: Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing an elective hand or forearm surgery

Brief summary: The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.


Eligibility criteria: Inclusion Criteria:

18 to 80 years old, with American Society of Anesthesiologists physical status I to IV, undergoing elective hand or forearm surgery under a BPB will be enrolled for this study.

Exclusion Criteria:

Patient's refusal, American Society of Anesthesiologist physical status greater than IV, pregnancy, neuromuscular disease, prior surgery on the intraclavicular fossa, nerve injury or neurological disorders, bleeding tendency or evidence of coagulopathy, history of allergy to local anesthetic drugs, skin infection at the site of needle insertion, or contraindication to regional anesthesia.

Primary outcomes:
measure: Success rate of costoclavicular brachial plexus block
timeFrame: Within 45 minutes of completion of block placement
Secondary outcomes:
measure: Identification of costoclavicular space
timeFrame: during placement of the block
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Christopher Robards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420248: Comparison of Pain of Two Different Methods in Uterine Artery Embolization
Official title: Comparison of Pain After Uterine Artery Embolization Using Non-spherical Polyvinyl Alcohol Particles or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leiomyoma
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Detailed description: Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The non-spherical polyvinyl alcohol particle and tri-acryl gelatin microsphere are two embolic materials used for UAE.Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Eligibility criteria: Inclusion Criteria:

* Uterine artery embolization due to multiple fibroids

Exclusion Criteria:

* Severe liver or kidney dysfunction
* Drug allergy
* Bradycardia (\<45 bpm) or heart block
* Uncontrolled hypertension

Primary outcomes:
measure: Pain intensity by numerical rating scale
timeFrame: 0-24 h after UAE
Secondary outcomes:
measure: C-reactive protein
timeFrame: 24 h after UAE
measure: White blood cell count
timeFrame: 24 h after UAE
measure: Neutrophil percentage
timeFrame: 24 h after UAE
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 24 h after UAE
measure: Platelet-to-lymphocyte ratio
timeFrame: 24 h after UAE
measure: Mean platelet volume
timeFrame: 24 h after UAE
measure: Sucessful rate at 3 month after UAE measured by MRI
timeFrame: 3 month after UAE
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sesverance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
name: So Yeon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
name: Man Deuk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510848: Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament
Official title: Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.


Eligibility criteria: Inclusion Criteria:

* isolated rupture of the anterior cruciate ligament with instability of the knee joint
* meniscal tear possible to suture
* partial meniscectomies

Exclusion Criteria:

* chronic laxity (more than 9 months)
* associated collateral laxity (grade III)
* subtotal or total meniscectomy
* infection or inflammatory disease of the knee joint
* large cartilage lesion

Primary outcomes:
measure: X-ray, CT-scan, KT1000
timeFrame: 12 months
Secondary outcomes:
measure: X-rays, CT-scan, KT1000
timeFrame: 24 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Peter Verdonk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robbrecht C, Claes S, Cromheecke M, Mahieu P, Kakavelakis K, Victor J, Bellemans J, Verdonk P. Reliability of a semi-automated 3D-CT measuring method for tunnel diameters after anterior cruciate ligament reconstruction: A comparison between soft-tissue single-bundle allograft vs. autograft. Knee. 2014 Oct;21(5):926-31. doi: 10.1016/j.knee.2014.05.003. Epub 2014 May 20.
Clinical trial NCT01972048: Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening
Official title: Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
breast cancer screening
mammogram
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.

Detailed description: Specific aims over the three-year period include the following: (1) The first year will be devoted to intervention and protocol development. A major emphasis in year 1 will be developing the community advisory board (CAB), conducting a series of pre-intervention focus groups, and working with pertinent persuasive technology consultants to develop and pilot-test the intervention. (2) The second year and the first half of the third year will focus on delivery of the intervention. (3) the second half of the third year will be devoted to data analysis and dissemination.

Eligibility criteria: Inclusion Criteria:

* Korean American immigrant women
* Aged 40-79
* Residence in Minnesota
* Possession of mobile phone with text-message function
* Possession of active email account

Exclusion Criteria:

* Mammogram receipt within the past 2 years

Primary outcomes:
measure: Mammogram receipt
timeFrame: 1 week
Secondary outcomes:
measure: Breast cancer knowledge
timeFrame: 1 week
measure: Breast cancer health beliefs
timeFrame: 1 week
measure: Culture specific attitudes toward breast cancer
timeFrame: 1 week
measure: Participant intent to undergo screening
timeFrame: 1 week
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Hee Y Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee H, Ghebre R, Le C, Jang YJ, Sharratt M, Yee D. Mobile Phone Multilevel and Multimedia Messaging Intervention for Breast Cancer Screening: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Nov 7;5(11):e154. doi: 10.2196/mhealth.7091.
Clinical trial NCT01472848: A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects
Official title: A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389


Eligibility criteria: Inclusion Criteria:

Obesity

Exclusion Criteria:

Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis

Primary outcomes:
measure: - Incidence, severity and duration of nausea and vomiting collected as adverse events.
timeFrame: Day 1 to day 28
Secondary outcomes:
measure: - Change in body weight from baseline
timeFrame: Day 1 to day 28
measure: - Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline
timeFrame: Day 1 to day 28
measure: - Multiple dose PK parameters of PF 05212389
timeFrame: Day 1 to day 28
measure: - Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason
timeFrame: Day 1 to day 28
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03590548: Clinical Audit of Managment of Gausher Disease in Children
Official title: Assiut University Children 's Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gaucher Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include 42 diagnosed Gaucher disease patient under enzyme replacement therapy attend the hematology unit in Assuit University Children's Hospital in one year

Brief summary: clinical audit on managment of gausher disease in children

Detailed description: The main aim of study is to evaluate the management of Gausher disease patient under enzyme replacement therapy in Assuit University Children's Hospital and compare our policy for management with International guideline of management of Gausher disease in children (8)

* Type of study : clinical audit
* Inclusion criteria: All cases with confirmed diagnosis of Gaucher disease type 1 and type 3 receiving enzyme replacement therapy at Assuit University Children's Hospital.
* Site of study :Assuit University children's Hospital Methodiological
* Exclusion criteria 3-New diagnosed cases not on ERT. 2-other lipid storage disease.
* Patient\& method The study will include 42 diagnosed Gaucher disease patient under enzyme replacement therapy attend the hematology unit in Assuit University Children's Hospital in one year Reviewing the proposal will be carried out before starting via the ethical committee of Assuit Faculty of Medicine.
* Ethical consideration The aim of the study will be explained to each patient before beginning of the process.

We will compare our policy in management of Gausher disease with International guideline of management of gausher disease

1-cases of Gaucher type 2.

Eligibility criteria: Inclusion Criteria:

* All cases with confirmed diagnosis of Gaucher disease type 1 and type 3 receiving enzyme replacement therapy at Assuit University Children's Hospital.

Exclusion Criteria:

* 1-cases of Gaucher type 2. 2-other lipid storage disease. 3-New diagnosed cases not on ERT.

Primary outcomes:
measure: evaluate the management of Gausher disease patient under enzyme replacement therapy in Assuit University Children's Hospital and compare our policy for management with International guideline of management of Gausher disease in children (8)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut unversity
name: Mervit Amin, doctora
role: PRINCIPAL_INVESTIGATOR
References: