louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04889833: Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy
Official title: Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Opioid Use
Keywords: hypnosis
shoulder arthroplasty
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.


Eligibility criteria: Inclusion Criteria:

* diagnosis of primary shoulder osteoarthritis, massive cuff tear arthropathy, and rotator cuff arthropathy requiring a primary total or reverse shoulder replacement,
* the ability to read, speak, and understand English
* the ability and willingness to use a web-based application (OBERD) on a smartphone, pad, or computer, and
* 18 years of age or older.

Exclusion Criteria:

* shoulder replacement for the treatment of acute proximal humerus fractures
* hemiarthroplasty
* revision shoulder replacement
* patients with active cancer or receiving palliative care
* Less than 18 years of age

Primary outcomes:
measure: Change in Perioperative Anxiety
timeFrame: 7 days before surgery, day of surgery, 7 days after surgery
measure: Change in Perioperative Pain
timeFrame: 7 days before surgery, day of surgery, 7 days after surgery
measure: Change in Opioid Consumption
timeFrame: 7 days after surgery, postoperative day 10, postoperative day 49
Secondary outcomes:
measure: Change in Anxiolytic Consumption
timeFrame: 7 days after surgery, postoperative day 10, postoperative day 49
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Mark A Frankle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410033: Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
Official title: Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 74
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Any subjects at onset of Type 1 Diabetes
* Treatment with either Insulin Aspart and Soluble Human Insulin or Soluble Human Insulin and Isophane Human Insulin / Mixtard® for at least 9 months from the time of diagnosis of diabetes

Exclusion Criteria:

* Treatment with immunosuppressive agents
* For the Insulin Aspart + Isophane Human Insulin: Treatment with insulin analogues other than Insulin Aspart or treatment with fast acting human insulin for a period of 7 days or more during the treatment period
* For the Soluble Human Insulin and Isophane Human Insulin group: Treatment with insulin analogues
* Other diseases influencing immune response
* Unable or unwilling to provide consent

Primary outcomes:
measure: Insulin aspart specific, human insulin specific and cross reacting antibodies
timeFrame: measured up to at most 2.5 years after diagnosis
Secondary outcomes:
measure: HbA1c
measure: Insulin requirements
measure: Incidence of hypoglycaemic episodes
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Holmberg H, Mersebach H, Kanc K, Ludvigsson J; Insulin Aspart Study Group on Immunogenicity. Antibody response to insulin in children and adolescents with newly diagnosed Type 1 diabetes. Diabet Med. 2008 Jul;25(7):792-7. doi: 10.1111/j.1464-5491.2008.02468.x.
Clinical trial NCT00701233: Botulinum Toxin for Carpal Tunnel Syndrome
Official title: Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 0
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: To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study.

Detailed description: To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study. The goal is to investigate if Botulinum toxin A injections are effective for Carpal Tunnel Syndrome compared to steroid injections in terms of pain relief and length of symptom alleviation.

Eligibility criteria: Inclusion Criteria:

* Any individual with symptoms of carpal tunnel syndrome and a diagnosis of CTS either clinically or via EMG will be included into this study. There will be a total of 20 subjects displaying symptoms of CTS. The gender of the subjects will not determine enrollment. There is no requirement of male to female ratio for this study. There is no age cut-off or minimal age requirement to enroll in the study. No specific Racial or ethnic restrictions will be present for this study. Female subjects of childbearing potential (not surgically sterile or postmenopausal for at least 2 years) must have a negative pregnancy test at screening.

Exclusion Criteria:

1. Any individual who has a diagnosis of CTS (by EMG or other means) but no symptoms of CTS will be excluded from this study.
2. Vulnerable subjects as defined as children, pregnant women, those with limited autonomy, decisional incapacity and prisoners will not be enrolled in this study.
3. Individuals with any history of carpal tunnel release surgery and recurrent or persistent symptoms will be excluded form this study.
4. Subject is pregnant or lactating.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: one week, one month, three months, six month, nine months, and twelve months
Secondary outcomes:
measure: Carpal Tunnel Syndrome Assessment Questionnaire
timeFrame: one week, one month, three months, six month, nine months, and twelve months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota PM&R Department
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dennis Dykstra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755333: Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation
Official title: Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic Stem Cell Transplantation
Dental Prophylaxis
Oral Hygiene
Motivation
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing autologous hematopoietic stem cell transplantation (HSCT) for hematologic diseases. The study included patients treated at the Hematology Unit of Pisa University Hospital. Participants were selected based on their eligibility for HSCT and their consent to participate in the study

Brief summary: This study assessed the effectiveness of a preventive protocol that included oral hygiene measures, patient education, and motivational strategies in individuals eligible for hematopoietic stem cell transplantation (HSCT).

Detailed description: At baseline (T0), the patient underwent a professional oral hygiene session prior to initiating chemotherapy, as part of the routine pre-transplant protocol. During this session, periodontal charting was completed, and patients were provided with oral hygiene instructions.

Following admission, patients received pre-transplant conditioning chemotherapy. Once engraftment of the transplant was confirmed by the Hematology Unit (9 days after engraftment), clinical parameters were reassessed (T1).

Eligibility criteria: Inclusion Criteria:

* male or female patients
* aged 18-75 years
* patients scheduled for HSCT
* acceptance of study participation
* compliance to follow-up

Exclusion Criteria:

- denial of the consent to participate in the study

Primary outcomes:
measure: PPD
timeFrame: measured at enrolment (T0) and 9 days after engraftment (T1)
measure: FMBS
timeFrame: measured at enrolment (T0) and 9 days after engraftment (T1)
measure: FMPS
timeFrame: measured at enrolment (T0) and 9 days after engraftment (T1)
measure: CI
timeFrame: measured at enrolment (T0) and 9 days after engraftment (T1)
measure: PRESENCE OF MUCOSITIS
timeFrame: measured 9 days after engraftment (T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa
Study officials:
References:
Clinical trial NCT01352533: Closure Techniques and Scar Appearance
Official title: A Randomized Prospective Trial of 2-Octyl Cyanoacrylate (Derma-Bond) Tissue Adhesive Versus Running Subcuticular Suture Combined With Tissue Adhesive Versus Epidermal Sutures in Dermatologic Surgery Procedures of the Head and Neck
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound Closure Techniques
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control of running stitches within each wound. The investigators plan to measure outcomes by assessing for scar appearance, the incidence of wound opening, scar elasticity and subject satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Linear closures on the head and neck, at least 3cm in length
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
* Defects on the scalp

Primary outcomes:
measure: Wound Healing
timeFrame: 10 day/3 weeks and 3 months
Secondary outcomes:
measure: Dehiscence
timeFrame: 10 days/3 weeks and 3 months
measure: Subject Satisfaction
timeFrame: 10 days/3 weeks and 3 months
measure: Adverse Events
timeFrame: 10 days/3 weeks and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386433: Paxlovid in the Treatment of COVID-19 Patients With Uremia
Official title: The Effect of Paxlovid in the Treatment of COVID-19 Patients With Uremia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: COVID-19
Uremia
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-23
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: This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants).

This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants).

After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent. Age ≥ 18 years old. COVID-19 (nucleic acid test positive) was diagnosed before randomization. At least 1 symptom or sign of COVID-19 at the time of being enrolled into the study(symptoms and signs related to COVID-19 including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, stuffy nose, runny nose, etc.).

Exclusion Criteria:

* History of active liver disease, including chronic or active hepatitis B or C, primary biliary cirrhosis, Child-Pugh B or C, or acute liver failure.

HIV infection and the viral load is greater than 400 copies/ml. Suspected or confirmed active systemic infections that may have an impact on the study evaluation except for COVID-19.

Acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications.

Allergic to any ingredients of Paxlovid.

Primary outcomes:
measure: time of negative conversion of SARS-CoV-2 nucleic acid
timeFrame: up to 60 days
measure: Proportion of ICU transfer or disease progression to severe or critical illness
timeFrame: up to 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02447133: TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Official title: TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects Presenting With Normal Eyes
Keywords: no known ocular pathology
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with no known eye disease

Brief summary: The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.

Detailed description: Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Eligibility criteria: Inclusion Criteria

1. Participants must be at least 18 years of age
2. They must be able to complete all testing (all OCT scans)
3. They must volunteer to be in the study and sign the consent form

Exclusion Criteria

1. Subject with history of ocular disease or ocular pathology
2. TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.

Primary outcomes:
measure: TopQ Cut Off
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems, Inc.
state: New Jersey
Study officials:
affiliation: Topcon Corporation
name: Randy Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00075933: ARQ 501 in Subjects With Cancer
Official title: A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2004-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).

ARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy.


Eligibility criteria: Inclusion Criteria

* Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective.
* ECOG performance status greater than or equal to 1
* Life expectancy greater than three months
* Acceptable pretreatment clinical laboratory results

Exclusion Criteria

* Subjects who have had chemotherapy or radiotherapy within 4 weeks
* Subjects receiving any other investigational agents
* Subjects with known untreated brain metastases
* Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")
* Subjects with uncontrolled intercurrent illnesses
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber/Partners CancerCare Inc
state: Massachusetts
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Geoffrey I Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mary Crowley Medical Research Center
name: C. Casey Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04754633: Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines
Official title: Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines: Correlation Between Radiologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Infection Viral
CT Scan
Keywords: Coronavirus
Computed Thomography
PCR
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
First posted: 2021-02-15
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who applied to the emergency department with the diagnosis of COVID-19 and had chest CT examination between 07.01.2020 and 07.20.2020.

Brief summary: To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.

Detailed description: A total of 764 adult patients who were diagnosed with COVID-19 inpatient of researchers' hospital 2020 were included in this study. The findings were recorded as typical, indeterminate, and atypical by the RSNA guidelines and as classical COVID-19, possible COVID-19, indeterminate, and non-COVID-19 by the BSTI classification. The data obtained according to both classification systems were compared with each other.

Eligibility criteria: Inclusion Criteria:

1. Who had single negative RT-PCR
2. Non-optimal chest CT , insufficient data
3. \<18 age of year
4. Thoracic trauma
5. Chest CT Negative

Exclusion Criteria:

1. RT-PCR positive and chest CT positive findings
2. At least two RT-PCR negative and chest CT positive findings
3. \>18 age of year

Primary outcomes:
measure: Current study evaluating the success of the guidelines recommended by RSNA and BSTI in detecting COVID-19 disease
timeFrame: 1st week from the moment of first admission
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Sağlik Bilimleri Üniversitesi Training and Research Hospital
Study officials:
References:
Clinical trial NCT02197533: Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
Official title: Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Overactive bladder (OAB) is a common condition among postmenopausal women, requiring a multifaceted treatment approach that requires patient retention of information given to them in clinic. Recall of recommendations is a key component of compliance. Supplemental educational tools such as handouts and audiovisual information have been investigated for their ability to improve patients' recall of information and increase satisfaction with the clinical encounter.

Objective: To determine if a written list of seven management strategies for overactive bladder leads to improved immediate and delayed recall of these recommendations in postmenopausal women presenting with OAB compared to a traditional verbal discussion.

Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed (2-week) recall of seven OAB management strategies will be compared between two groups. The intervention group will receive a handwritten list during their verbal discussion of OAB treatment while the control group will receive standard care (verbal discussion only). Immediate and delayed recall will be assessed by a member of the study team who has been blinded to participants' group assignments.

Results: The results of this study may guide clinicians in the most effective mode of providing treatment recommendations to post-menopausal patients with OAB.


Eligibility criteria: Inclusion Criteria:

* New diagnosis of overactive bladder
* post-menopausal

Exclusion Criteria:

* Pre-existing diagnosis of dementia or other cognitive disorders
* Patients with mixed incontinence
* Non-English speaking
* Patients with contraindications to taking vaginal estrogen or anticholinergic medications

Primary outcomes:
measure: Recall
timeFrame: 0 and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Colleen McDermott, MD, MSc, FRSCS
role: PRINCIPAL_INVESTIGATOR
References: