louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02358447: SPECT-CT for Assessment of Total Knee Arthroplasty in Navigated and Non-navigated Total Knee Arthroplasty
Official title: SPECT-CT for Assessment of Patients Before and After Navigated and Conventional Total Knee Arthroplasty.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
X-rays; Effects
Keywords: total knee arthroplasty
total knee prothesis
Spectrometry, X-Ray Emission
SPECT/CT
measurement of TKA component position
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paitents before and after total knee replacement surgery

Brief summary: By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we want to show wich method has the better outcome.

Detailed description: With SPECT/CT we want to controll the clinical outcome of patients who underwent a navigated or a non-navigated TKR.

Eligibility criteria: Inclusion Criteria:

* Total Knee prosthesis (primary)
* \>18 years

Exclusion Criteria:

* pregnancy
* lactating women
* endocrine diseases
* tumour diseases
* posttraumatic osteoarthritis of the knee
* previous infection of the knee
* medicaments which influence the metabolism of the bone

Primary outcomes:
measure: which operation method is the best in terms of outcome and SPECT/CT imaging
timeFrame: five years
Secondary outcomes:
measure: Improvement in the post-treatment
timeFrame: five years
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland, Bruderholz
state: Baselland
Study officials:
affiliation: Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
name: MIchael T. Hirschmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06002347: Middle School Parent Module for a Brief Bullying Intervention Program
Official title: Development, Acceptability, and Short-Term Outcomes of a Parent Module for a Brief, Bullying Bystander Intervention for Middle School Students in Rural, Low-Income Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bullying
Lead sponsor: Boise State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-08-21
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the feasibility and short-term outcomes of a parent training designed as a companion module to a bullying bystander intervention (STAC) for middle school students in rural communities. The aim of this project is to provide a brief, low-cost intervention that can be easily disseminated as part of a school-based bullying prevention program to address this important public health problem.


Eligibility criteria: Inclusion Criteria:

1. Being a parent of an adolescent enrolled in grades 6, 7, or 8 in a participating middle school in Idaho.
2. Speaks and reads English.
3. Consents to participate.

Exclusion Criteria:

1. Speaks and reads only a language other than English.
2. Does not consent for participation.

Primary outcomes:
measure: Knowledge and Confidence to Support Defenders
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Confidence Managing Bullying
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Comfort Managing Bullying
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Parental Role
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Bullying Self-Efficacy
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Communication Self-Efficacy
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Attitudes About Bullying
timeFrame: pre-training (baseline); immediate post-training (30 minutes)
measure: Intention to Use Parent STAC Strategies
timeFrame: immediate post-training (30 minutes)
Secondary outcomes:
measure: Acceptability of the Parent STAC Training
timeFrame: immediate post-training (30 minutes)
measure: Interest in Receiving Bullying Prevention
timeFrame: immediate post-training (30 minutes)
measure: Features of a Technology-Based Program
timeFrame: immediate post-training (30 minutes)
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise State Univerity
state: Idaho
Study officials:
References:
Clinical trial NCT05405647: Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome
Official title: Extra Corporeal Shock Wave Versus Kinesio Tape in the Treatment of Carpal Tunnel Syndrome for Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: shock wave
kinesio tape
carpal tunnel syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 50
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty menopausal women with mild to moderate CTS will be selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Shobra to participate in this study,Group A: Represented the study group, it consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B: Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days .
Primary purpose: TREATMENT

Brief summary: This study would be conducted to answer the following question: was there any difference between the effects of Shock wave versus Kinesio Tape in the treatment of carpal tunnel syndrome for post-menopausal women.

Detailed description: Fifty menopausal women with mild to moderate CTS were selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Age was ranged from 45 - 55 years old.

Group A, consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days.

Eligibility criteria: Inclusion Criteria:

* -Age was ranged from 45 - 55 years old
* All subjects would not take analgesics by another route during the study.

Exclusion Criteria:

* Patients had previous carpal tunnel release.
* Skin over sensitivity of some patients to the tape.

Primary outcomes:
measure: Computerized electromyography
timeFrame: 6 weeks
Secondary outcomes:
measure: Boston carpal tunnel questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ghada Ebrahim Elrefaye
Study officials:
References:
Clinical trial NCT03424447: Stimulation of the Efferent Loop Before Loop Ileostomy Closure
Official title: Stimulation of the Efferent Loop Before Loop Ileostomy Closure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ileostomy - Stoma
Ileostomy; Complications
Stoma Ileostomy
Ileus Paralytic
Lead sponsor: Hospital de Basurto
Sponsor class: OTHER
Collaborators: name: Alberto Loizate Totoricaguena
name: Pedro García Alonso
First posted: 2018-02-07
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Ambispective cohort study
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay

Detailed description: Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.

Eligibility criteria: Inclusion Criteria:

* Patients with loop ileostomy
* Barium transit throught the efferent limb without leaks

Exclusion Criteria:

* Chemotherapy at the moment
* Ileostomy closure at the same admission than the ileostomy creation

Primary outcomes:
measure: postoperative ileus
timeFrame: during the admission for the ileostomy closure
measure: bowel movement
timeFrame: during the admission for the ileostomy closure
Secondary outcomes:
measure: hospital stay
timeFrame: during the admission for the ileostomy closure
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
Study officials:
affiliation: general surgeon
name: Alba Vázquez-Melero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04117347: Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
Official title: Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Circadian timing
Mood
Light
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-10-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.

Detailed description: Brain emotional processing was determined with the Emotional Faces Assessment Task (EFAT). In this task, participants view a trio of faces and match one of the two faces (bottom) that expresses the same emotion as the target face (top). The faces display one of five expressions (angry, happy, fearful, sad, neutral) and the other (incongruent) probe face always displays a neutral (or happy if the target is neutral) expression. The paradigm consists of 20 face trials per expression and 20 shape trials, presented in pseudorandomized order, separated by a 3-7 sec intertrial blank screen with fixation cross.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for traumatic stress
* Normal or corrected to normal vision
* Right-handed
* Fluency in English
* Physically able to travel for study visit attendance

Exclusion Criteria:

* Significant chronic uncontrolled disease (e.g. uncontrolled diabetes, advanced liver disease, cancer, etc.)
* Severe hearing problem
* Intellectual disability or serious cognitive impairment
* Inability to tolerate enclosed spaces (e.g. the MRI machine)
* Ferrous-containing metals within the body
* Pregnant, trying to get pregnant, or breastfeeding
* Epilepsy
* Other research participation
* Frequent number of special events during study period (weddings, concerts, exams, etc.)

Primary outcomes:
measure: Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
timeFrame: Baseline and treatment week 2 and treatment week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Helen Burgess
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burgess HJ, Rizvydeen M, Huizenga B, Prasad M, Bahl S, Duval ER, Kim HM, Phan KL, Liberzon I, Abelson J, Klumpp H, Horwitz A, Mooney A, Raglan GB, Zalta AK. A 4-week morning light treatment reduces amygdala reactivity and clinical symptoms in adults with traumatic stress. Psychiatry Res. 2024 Dec;342:116209. doi: 10.1016/j.psychres.2024.116209. Epub 2024 Sep 21.
Clinical trial NCT02926547: New Approaches for the Identification and Characterization of Functional Markers of the Risk of Extension of Breast Cancer Without Lymph Node Involvement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: proteomics
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 108
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CCIS and invasive breats cancer in women

Brief summary: 1. Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement .
2. Consider their role in the invasion and the risk of tumor spread .


Eligibility criteria: Inclusion Criteria:

* Breast cancer
* CCIS
* Invasive tumors
* Breast cancer tissues available in the biobank

Exclusion Criteria:

* non availability of cancer tissue specimen

Primary outcomes:
measure: A list of the ten proteins most associated with early breast cancer invasion phases without lymph node involvement .
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01625247: Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Cholecystitis
Empyema
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.


Eligibility criteria: Inclusion Criteria:

* Acute cholecystis
* Laparoscopic cholecystectomy
* KAROFSKY PERFORMANCE SCALE \> 70
* No history of major operation

Exclusion Criteria:

* NYHA class \> 3
* Open cholecystectomy
* No- compliance
* Intraoperative injuries
* Inadequate hemostasis

Primary outcomes:
measure: frequency of postoperative complication occurrence
timeFrame: whinin 1 week and 8 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance hospital
Study officials:
References:
Clinical trial NCT02522247: RCT Between UPP and Controls in Adult OSA
Official title: Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.

Detailed description: Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery .

The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.

Eligibility criteria: Inclusion Criteria:

* AHI of 15 or more
* Friedmans stage I+II
* Tonsil size 0-1
* BMI\<34
* ESS värde \>7
* Failed treatment with CPAP and mandibular device

Exclusion Criteria:

* Severe cardiovascular or neurological disease
* ASA IV
* Not interested in surgical treatment

Primary outcomes:
measure: Polysomnography: group differences in changes of apnea-hypopnea index (AHI)
timeFrame: 6 months
Secondary outcomes:
measure: Questionnaire: group differences in changes of daytime sleepiness
timeFrame: 6 months
measure: Questionnaire: group differences in changes of general health
timeFrame: 6 months
measure: Blood pressure: group differences in changes of blood pressure
timeFrame: 6 months
Other outcomes:
measure: Polysomnography: changes of AHI between baseline and 4 years postoperatively
timeFrame: 4 years
measure: Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively
timeFrame: 4 years
measure: Questionnaire: changes of general health between baseline and after 4 years postoperatively
timeFrame: 4 years
measure: Postoperative bleeding complications
timeFrame: 6 months
measure: Postoperative days at hospital
timeFrame: 6 months
Locations:
city: Stockholm
country: Sweden
facility: Orl dep, Karolinska University Hospital
Study officials:
affiliation: ORL-dep, Karolinska University Hospital
name: Bo Tideholm, Md, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05530447: Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy
Official title: An Intermediate-size, Expanded Access to SUVN-G3031 for the Treatment of Subjects With Narcolepsy Who Have Completed the CTP2S13031H3 Protocol
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Narcolepsy
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2022-09-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well as the subject believe that the benefits outweigh the risks to continue the treatment with SUVN-G3031.

Detailed description: The qualified subjects will be given 2mg of SUVN-G3031 expanded access treatment for 30 days. At the end of 30 days if the subject wishes to continue the treatment, he/she will be provided with adequate investigational drug for next 30 days. This cycle will be repeated up to a maximum of 2 times (total duration of expanded access treatment up to 90 days).

Eligibility criteria: Inclusion Criteria:

1. Subjects who have completed the 2-week treatment phase and follow-up period of study CTP2S13031H3 (NCT04072380) as planned and wish to continue unblinded treatment with SUVN-G3031 (2 mg, qd).
2. Subject must sign the ICF to participate in the study.
3. The investigator after review of relevant information and in consultation with the subject believes that continued treatment following study CTP2S13031H3 could be beneficial to the subject.

Exclusion Criteria:

1. Any clinically relevant concomitant disease or AEs/SAEs during the Phase 2 study (CTP2S13031H3), which in the opinion of the investigator, makes the subject unsuitable for inclusion in the protocol.
2. Has participated or is participating in any other clinical (investigational) study after completion of CTP2S13031H3 protocol (NCT04072380).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01219647: Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
Official title: Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Exercise
Cognition
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: California State University, Northridge
First posted: 2010-10-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise has been shown to improve memory and thinking in persons with diseases such as Alzheimer's. This study will investigate whether a program of aerobic exercise can improve memory and thinking in persons with MS

Detailed description: Persons with Multiple Sclerosis(MS)will be screened for eligibility and randomized to a protocol with two intervention arms. One group will have aerobic training on a recumbent cross trainer three times a week for 20-30 minutes/session. The other group will participate in stretching exercises at the same frequency and intensity.Total training time will be six months.Outcome measures will include tests of memory and thinking, and fitness measures.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of MS Complaints of cognitive problems Able to ride a recumbent cross trainer

Exclusion Criteria:

* Cardiopulmonary or structural disease that would limit ability to participate in exercise training On treatment with chemotherapy or natalizumab Screening score of \>50 on PASAT

Primary outcomes:
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: 36 weeks
Secondary outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 36 weeks
measure: VO2 max
timeFrame: 36 weeks
measure: Long latency cognitive event related potentials ( LLCERP)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCalifornia at Los Angeles
state: California
city: Northridge
country: United States
facility: CAl State University at Northridge
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Barbara Giesser, MD
role: PRINCIPAL_INVESTIGATOR
References: