louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00233389: Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
Official title: A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stomach Ulcer
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 301
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study


Eligibility criteria: Inclusion Criteria:

1. Patients aged 20 years or older at time of consent
2. H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent
3. Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal diameter: -\>5 mm
4. Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy

Exclusion Criteria:

1. Patients who have previously received H. pylori eradication therapy
2. Patients with acute gastric ulcer
3. Patients with linear ulcer
4. Patients with complication of duodenal ulcer (excluding cicatrix)
5. Patients who have undergone upper-GI tract or vagal nerve resection
6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
8. Patients with a history of amoxicillin shock
9. Patients with infectious mononucleosis
10. Patients with severe renal disorders
11. Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
12. Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
14. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Primary outcomes:
measure: Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Otsuka Pharmaceutical Co., Ltd.
Study officials:
affiliation: Division of New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References:
Clinical trial NCT00596089: Use of Jumping Mechanography as a Method to Assess Musculoskeletal Status in Older Adults
Official title: Use of Jumping Mechanography as a Method to Assess Musculoskeletal Status in Older Adults: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Status
Muscle Weakness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women 60 years and older and men and women 20-30 years of age

Brief summary: Decline in muscle function may increase risk of hip fracture and decrease quality of life. Different tests are currently used to measure muscle function but they do not work for all individuals. A test called "jumping mechanography," which measures jumping power, may be useful in more people and obtain better information. This study will help us determine whether this test is able to detect differences between muscle function in younger and older adults, as well as whether it is a safe method to use in all ages.


Eligibility criteria: Inclusion Criteria:

1. Women and men aged 20 to 30 or ≥ 60 years
2. Able and willing to sign informed consent.
3. Ability to stand without assistance.

Exclusion Criteria:

1. Acute pain different and/or worse than the individuals chronic baseline pain
2. History of recent trauma to musculoskeletal system
3. Neuromuscular disease impairing balance to the degree of not being able to stand without assistance.
4. History of fragility fracture within the last year
5. Patients with a BMD T-score of less than -3.5 at any measured site and a vertebral fracture.
6. History of severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.
7. Recent history of malignancy with metastasis to the musculoskeletal system.

Primary outcomes:
measure: The primary outcome is the instantaneous weight corrected peak power taken from the maximal countermovement jump
timeFrame: single session
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Osteoporosis Clinical and Research Program
state: Wisconsin
Study officials:
affiliation: University of Wisconsin - Institute on Aging
name: Neil C Binkley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503489: Risk Factors for AD-Associated Switch to Mania
Official title: Risk for Antidepressant-associated Switch From Depression to Hypomania, Mania, or Mixed Episode During the 8 Weeks After the Introduction of an Antidepressant or After Increasing the Dosage of Baseline Antidepressant.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Switch
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bipolar I and II disorder patients.

Brief summary: The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage.

Detailed description: Treatment of bipolar depression with antidepressants is strongly debated for the methodologically poor and insufficient data supporting their use and the widely held belief that antidepressants can induce new episodes of abnormal mood elevation or accelerate the rate of cycling. The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage, in a prospective, longitudinal design.

Eligibility criteria: Inclusion Criteria:

* Bipolar I and II disorder.

Exclusion Criteria:

* Major medical comorbidities.

Primary outcomes:
measure: Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.
timeFrame: 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
state: Catalonia
Study officials:
affiliation: Bipolar Disorders Program, Hospital Clinic Barcelona.
name: Marc Valenti, MD
role: STUDY_DIRECTOR
References:
citation: Valenti M, Pacchiarotti I, Undurraga J, Bonnin CM, Popovic D, Goikolea JM, Torrent C, Hidalgo-Mazzei D, Colom F, Vieta E. Risk factors for rapid cycling in bipolar disorder. Bipolar Disord. 2015 Aug;17(5):549-59. doi: 10.1111/bdi.12288. Epub 2015 Feb 12.
citation: Valenti M, Pacchiarotti I, Bonnin CM, Rosa AR, Popovic D, Nivoli AM, Goikolea JM, Murru A, Undurraga J, Colom F, Vieta E. Risk factors for antidepressant-related switch to mania. J Clin Psychiatry. 2012 Feb;73(2):e271-6. doi: 10.4088/JCP.11m07166.
Clinical trial NCT02297789: Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Official title: Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.

The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.


Eligibility criteria: Inclusion Criteria:

* AHI ≥ 5 from the diagnostic night
* ≥ 18 years of age
* Either prescribed APAP or CPAP or Bi level for OSA
* Existing full face users

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerance to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be pregnant

Primary outcomes:
measure: The mask is comfortable and is effective for the participant during in-home use
timeFrame: 1 week for each mask prototype in-home
Secondary outcomes:
measure: Acceptability of the Full Face mask prototypes
timeFrame: 1 week for each mask prototype in-home
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare Ltd.
state: East Tamaki
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Bhavi Ogra, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071689: Radiographic Evaluation of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
Official title: Radiographic Evaluation of the Peri-implant Circumferential Bone Level and Bone Changes in the Posterior Mandible of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Keywords: All-on-Four implant
PEEK framework
Soft metal
Selective laser melting
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eighteen patients will be selected from the outpatient clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation.

patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.

Detailed description: All patients will receive conventional maxillary and mandibular complete dentures.

2. The mandibular denture will be modified by shortening the flanges and cutting the posterior part till the 1st molar then 3D scanned for recording the correct dimension of each tooth to be concerned during the construction of the superstructure and the final prosthesis.

3. Abutment level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of superstructure with abutments.

4. patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.

5. The fit of the framework will be verified intraorally, and the final prosthesis will be digitally constructed; according to the dimensions of the scanned denture; to fit over the framework.

Evaluation Radiographic evaluation of circumferential bone level around implants and bone changes in the posterior mandible will be done using CBCT at one, two, three, and five years after insertion of the final prosthesis.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous maxillary ridges and mandibular arch with four implants placed according to the All-on-4 distribution. All patients were recruited from the previous study.
* All selected patients will be with sufficient inter-arch space and restorative space.
* All selected patients will have healthy ridges covered by the compressible oral mucosa and free from any ridge flabbiness.

Exclusion Criteria:

* History of para-functional habits (Bruxism, clenching), smoking, and alcoholism.
* History of radiation therapy in the head and neck region.

Primary outcomes:
measure: bone changes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Khloud Ezzat
Study officials:
affiliation: Lecturer
name: Khloud Ezzat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04334889: Measurement of Spinal Kinematics During Various Movements
Official title: Differences in Spinal Kinematics During Various Activities Between Asymptomatic Subjects and Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Low Back Pain
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
name: Clinique Romande de Readaptation
First posted: 2020-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLBP patients will be recruited through a multimodal rehabilitation program at Lausanne University Hospital, medical doctors or physiotherapists' consultations.

Healthy controls will be a convenience sample recruited using flyers and emails, notably posted at the Lausanne University Hospital, the University of Health Professions in Lausanne (HESAV) and at the University of Lausanne.

Brief summary: Participants will perform movements while receiving different visual cues. Spinal kinematics will be measured during these movements and compared between asymptomatic and CLBP participants. Participants will come for a unique session.


Eligibility criteria: Inclusion Criteria:

- sufficient French level to understand the instructions for the tests, the information sheet, the consent form.

For CLBP patients:

- diagnosis of non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.

For asymptomatic participants:

* no history of LBP requiring medical attention during the last two years
* no other concomitant pain or condition that could compromise the evaluation of lumbar kinematics.

Exclusion Criteria:

* pregnancy
* skin allergy to tape
* body mass index (BMI) above 32

For patients with CLBP only:

* specific low back pain (such as the presence of infection, rheumatological or neurological diseases, spinal fractures, tumours)
* any known important spinal deformities
* previous back surgery that limits spinal mobility
* high level of pain at the time of experiment that prevents repeated movements (severity and irritability)
* other concomitant pain or condition that could compromise the evaluation of spinal kinematics.

Primary outcomes:
measure: Spinal kinematics
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05195489: Examining the Impact of Family Connectors
Official title: Examining the Impact of Family Connectors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Stress Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-01-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.

Detailed description: The study objectives are to examine the association between involvement in Family Connectors, a manualized peer-to-peer support and education program for family members of adolescents or young adults with symptoms of first episode psychosis, and feelings of empowerment, self-efficacy and social support.

Eligibility criteria: Inclusion Criteria:

* English speaking, due to the study materials not being validated in other languages.
* 18 years of age or older,
* Family member of adolescents/young adults with first episode psychosis who participated in OnTrackNY.

Exclusion Criteria:

* Does not provide informed consent.

Primary outcomes:
measure: Change in perceived social support
timeFrame: Month 1, Month 7
measure: Change in caregiver strain
timeFrame: Month 1, Month 7
measure: Change in perceived self-efficacy
timeFrame: Month 1, Month 7
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kimberly Hoagwood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867489: A Qualitative Study Into How Patients Deal With Chemotherapy-related Side Effects at Home
Official title: A Qualitative Study Into How Patients With Cancer Deal With Chemotherapy-Related Side Effects at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exploration of How Patients Deal With Side Effects From Chemotherapy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 28
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: Adult patients treated with chemotherapy

Brief summary: This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays
* Dutch speaking
* Able to provide informed consent and to participate in an interview

Exclusion Criteria:

* Patients who were in the first 2 cycles of treatment
* Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome.
* Patients who had reported not to experience any side effect from treatment at all

Primary outcomes:
measure: patient's experience
timeFrame: one interview during the course of treatment, i.e. one timepoint between 2 months after the start of chemotherapy and the end of the patient's treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT05857189: Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses
Official title: Assessment of the Quality-of-life Impact of Newly Formed Digitalized Printed Paper Inserted Into Eyeglasses for Unilateral Eye Defect Patient Rehabilitation (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Deformity
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover between experimental and traditional groups after 2 weeks of lapse time. both groups will be compared to healthy control
Primary purpose: TREATMENT

Brief summary: A straightforward, user-friendly removable orbital prosthesis is a practical choice for effective rehabilitation in such patients with defective eyes. One of the essential elements for a good recovery is the retention of the prosthesis. The prosthesis can be retained by using a spectacle frame, conformers, adhesives, osseointegrated implants, magnets, or buttons. Only osseointegrated prostheses in the maxillofacial region can use semi-precision attachments.

Detailed description: Aim: Using of eyeglasses with newly formed digitalized printed paper of mirrored photograph of an intact eye for orbital defected patients to restore the esthetic appearance. An evaluation of the quality of life for patients using temporalized eyeglasses with digitalized printed paper of mirrored photographs of a healthy eye.

Eligibility criteria: Inclusion Criteria:

* Patients with an orbital defective eye (type I).
* Patients age more than 6 years.
* Patients with a unilateral enucleated eye.
* Skin-grafted orbital defects with a lack of natural retentive means either natural undercuts or retaining implants.
* Patients who are not prone to be received any prosthetic rehabilitation either for financial, age, or transportation problems of material that are needed for fabrication of prosthetic eye.

Exclusion Criteria:

* Patients with the bilateral enucleated eye.
* Patients with primary signs of skin inflammation, infection, or untreated local disease
* Patients refusing to wear any eyeglasses.
* Patients with ocular defects.

Primary outcomes:
measure: Change in quality of life score
timeFrame: Through study completion, average 6 months
measure: Patient behaviour toward using the newly designed eye glasses
timeFrame: Through study completion, average 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References: