louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01442844: Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
Official title: Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Impaired Wound Healing
Keywords: Mohs
Scalp
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Momelan Technologies
First posted: 2011-09-29
Enrollment: 3
Sex: ALL
Minimum age (years): 40
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 evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.

Detailed description: Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.

Eligibility criteria: Inclusion Criteria:

1. Between 40-75 years old
2. Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention
3. Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle
4. Area is less then 6 cm2 (wound diameter less than 2cm)

Exclusion Criteria:

1. Female patients who are breastfeeding, pregnant, or planning to become pregnant
2. Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
3. Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
4. Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance

Primary outcomes:
measure: Percentage of Wound Re-epithelialization
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mgh Curtis
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alexandra B Kimball, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948844: Automatic Detection of Falls and Near Falls
Official title: Automatic Detection of Falls and Near Falls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Falls
Missteps
Keywords: falls
Missteps
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Healthy Older Adults
* Parkinson's Disease Patients
* Idiopathic Fallers

Brief summary: The aim of this study is to develop an algorithm to automatically detect falls and near falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.

Detailed description: The aim of this study is to develop a detailed algorithm which will automatically detect falls and near falls, in the elderly as a general population prone to falls. The algorithm will be used as well in patients with Parkinson's Disease representing neurodegenerative diseases. All participants will arrive at the investigators' gait laboratory for an inhanced assessment, including neurological examination, various questionnaires. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.

Eligibility criteria: Inclusion Criteria:

* Healthy Older Adults
* Parkinson's Disease Patients
* Idiopathic Fallers

Exclusion Criteria:

* Walking Aid
* Other Neurological Diseases than PD
* Significant Disturbance in Vision/Hearing
* History of CVA
* Significant Orthopedic Problem
* Dementia

Primary outcomes:
measure: 3 D acceleration
timeFrame: during assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC
state: IL
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Jeffrey M Hausdorff, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05617144: Aromatherapy Protocol for Pain Reduction in Hospice Patients
Official title: Aromatherapy Protocol for Pain Reduction in Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: hospice care
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to introduce aromatherapy with current pain medication protocols to see if it improves patient satisfaction and reduces pain in hospice care patients.


Eligibility criteria: Inclusion Criteria:

* currently on hospice at Seasons Assisted Living

Exclusion Criteria:

* pain level not 3/10 or higher

Primary outcomes:
measure: Patient satisfaction as assessed by the score on the Patient Satisfaction survey
timeFrame: end of study (7 days after baseline)
Secondary outcomes:
measure: Change in pain as assessed by the score on the Wong Baker Face Scale (WBFPS) scale
timeFrame: Baseline, 2 hours after every aromatherapy administration
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Tamara Blanton, MS,RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05827744: The Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles
Official title: The Evaluation of the Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles in Patients With Unilateral Traumatic Transfemoral Amputation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation, Traumatic
Keywords: amputation
hip flexors
hip extensors
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 27 patients with unilateral transfemoral amputation

Brief summary: The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

Detailed description: The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

This study will be useful in understanding whether ultrasonography is an appropriate imaging method in the follow-up of changes in functional strength in the hip girdle in patients with unilateral traumatic transfemoral amputation.

Eligibility criteria: Inclusion Criteria:

* Aged between 18-65
* The time elapsed after amputation \> 6 months
* Using prosthesis for at least 3 months
* Being able to walk without an assistive device

Exclusion Criteria:

* Bilateral lower extremity amputation
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

Primary outcomes:
measure: 6-minute walking test (6MWT)
timeFrame: through study completion, an average of one month
measure: 10-meter walking test
timeFrame: through study completion, an average of one month
measure: Timed up and go test
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: assistant professor
name: Merve Örücü Atar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03659344: Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study
Official title: Vicryl Plus and Vicryl Sutures in Reduce of Infection in Dental Implant Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection, Surgical Site
Keywords: sutures
Surgical Wound Infection
Polyglactin 910
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2018-09-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In group1, vicryl plus suture was used to close flaps. In group2,vicryl was used to close flaps
Primary purpose: PREVENTION

Brief summary: Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.

Detailed description: Patients were divided randomly based on computer randomization list in two groups: In group1, vicryl plus 4-0 (Vicryl Plus Ethicon,Johnson \& Johnson Company, Sommerville, NJ) suture was used to close surgical site and Vicryl 4-0 (Vicryl Ethicon,Johnson \& Johnson Company, Sommerville, NJ) in group II.

All dental implants were placed through creating subperiosteal flaps. In each group, fresh socket placed dental implants were documented. Patients were visited in 1, 2, 3 and 4 weeks after dental implant surgeries.

Postoperative infection was defined as local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site. If wound dehiscence occurred, it was documented.

Patients were blind about what suture was used.

Eligibility criteria: Inclusion Criteria:

* Need 3 dental implants at the posterior of the mandible

Exclusion Criteria:

* Diabetic patients
* smoker
* poor oral hygiene

Primary outcomes:
measure: The prevalence of post-operative infection
timeFrame: In one month
measure: The prevalence of post-operative dehiscence
timeFrame: In one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04764344: Haloperidol for the Treatment of Nausea and Vomiting in the ED
Official title: A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vomiting
Nausea
Abdominal Pain
Cannabis Use
Lead sponsor: Western Michigan University School of Medicine
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ondansetron for the treatment of nausea and vomiting.
Primary purpose: TREATMENT

Brief summary: Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.


Eligibility criteria: Inclusion Criteria:

* presenting to the emergency department with chief complaint of nausea or vomiting

Exclusion Criteria:

* abnormal blood pressure (\>200/100mmHg or \<90/40mmHg),
* fever (\>100.4F),
* acute trauma,
* QT \> 450ms on cardiac monitor,
* altered mental status (GCS \< 15),
* chest pain,
* known allergy to haloperidol or ondansetron,
* Parkinson's disease,
* pregnancy or lactation,
* use of any antiemetic in the previous 8 hours,
* nausea and vomiting associated with vertigo,
* prisoners or any wards of the state.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: from enrollment to 30, 60, and 90 minutes after drug administration
Secondary outcomes:
measure: Analgesia
timeFrame: 0, 30, 60, 90 minutes
measure: Efficacy in marijuana users
timeFrame: Baseline (time 0)
measure: QT prolongation
timeFrame: Baseline (time 0) and 90 minutes
measure: Incidence of side-effects
timeFrame: 0, 30, 60, 90 minutes and 24 hours
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
Study officials:
affiliation: Western Michigan University School of Medicine
name: Jessica McCoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00683644: Zinc to Treat Tinnitus in the Elderly
Official title: Zinc to Treat Tinnitus in the Elderly: A Randomized Placebo Controlled Crossover Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Keywords: tinnitus, zinc
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Tinnitus Research Initiative
First posted: 2008-05-23
Enrollment: 116
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group.

Detailed description: There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group. 116 patients were tested. Tinnitus loudness and the Tinnitus Handicap Questionnaire are the outcome measures.

Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* Tinnitus for 6 months or more
* Normal copper levels
* Be generally healthy

Exclusion Criteria:

* Have a treatable otological disorder
* Involved in litigation
* Have or are suspected of having a serious psychiatric problem
* Involved in other treatments for tinnitus
* Are taking drugs which might interact with zinc and result in tinnitus
* Have copper deficiency
* Have Zinc levels above normal
* Are cognitively impaired.

Primary outcomes:
measure: Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months
timeFrame: baseline - 4 months
Secondary outcomes:
measure: Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment
timeFrame: baseline and 4 months
measure: Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment
timeFrame: baseline and 4 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Richard S. Tyler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coelho C, Witt SA, Ji H, Hansen MR, Gantz B, Tyler R. Zinc to treat tinnitus in the elderly: a randomized placebo controlled crossover trial. Otol Neurotol. 2013 Aug;34(6):1146-54. doi: 10.1097/MAO.0b013e31827e609e.
Clinical trial NCT04406844: Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic
Official title: An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology Patients
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 98
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise all the cancer patients who are registered in the Max Superspeciality hospital, Patparganj between Nov 1st 2019 to Jan 31st 2020

Brief summary: In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.

Detailed description: Protocol No: Onco_Covid-19

Version no:1.0

Objectives: Firstly the patients recently diagnosed with cancer will be selected for enrollment who are on active treatment during lockdown based on the date of their registration in the hospital. This is followed by a telephonic interview with patients or their attendant to carry out a prospective, cross-sectional, observational study in order to address the issues and challenges faced by them during Lockdown.

Collection of data will be done through telephonic communication. Participation in this study will be entirely voluntary. Telephonic verbal consent will be taken from the patients or their attendants before collection of their response on the study questionnaire and then will be asked questions accordingly based on the questionnaire which is available in English and Hindi both. Data and general information regarding participants will only be collected in questionnaire. No personal data of the participants will be taken which will also be conveyed to the participant or attendant during telephonic verbal consent.

Eligibility criteria: Inclusion Criteria:

* Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020
* Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020

Exclusion Criteria:

-

Primary outcomes:
measure: Oncology patients
timeFrame: 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Superspeciality hospital, A Unit of Balaji Medical and Diagnostic Centre
Study officials:
affiliation: Max Hospital, Patparganj
name: Geeta Kadayaprath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04977544: Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
Official title: A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phobia
Keywords: phobia
VR
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for phobias in DSM-IV.
* Age from 18 to 45 years old.
* Graduated from junior high school or above.
* No serious physical disease, no serious visual impairment, and no family history of mental illness.

Exclusion Criteria:

* Exclude other psychiatric diagnosis and treatment history.

Primary outcomes:
measure: the level of anxiety
timeFrame: 3 months
measure: heart rate of the patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
References: