louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05666648: Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment
Official title: Comparison of Sitz Bath and no Sitz Bath Treatments in Patients With Acute Anal Fissure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Keywords: Acute anal fissure, pain, sitz bath
Lead sponsor: Combined Military Hospital Quetta
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of acute anal fissure of both genders between 18 to 60 years

Brief summary: To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure.

Detailed description: ABSTRACT Objective To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure.

Study Design Randomized Controlled Trial Place and Duration of Study Department of Surgery Combined Military Hospital, Quetta, from15 January 2019 to 15 August 2021.

Patients and Methods Individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. Patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. Main outcome measures were validated.

Keywords Acute anal fissure, pain, sitz bath

Eligibility criteria: Inclusion Criteria:

* Patients of acute anal fissure of both genders between 18 to 60 years

Exclusion Criteria:

* While the patients with history of recurrent fissure, chronic anal fissure, pregnant woman and patients who were operated previously for any anorectal pathology were excluded from the study.

Primary outcomes:
measure: healing of fissure
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Khalid Pervaiz
Study officials:
affiliation: CMH Quetta
name: Zeeshan Ayub, FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04978948: Study of STIM1 Membrane Expression
Official title: Study of STIM1 Membrane Expression During Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Diseases
Keywords: autoimmune diseases
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 18 years old. Diagnosis of one of the autoimmune diseases of interest according to the commonly accepted classification criteria for each disease, regardless of the level of disease activity.

Brief summary: The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.

This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of one of the autoimmune diseases

Exclusion Criteria:

* Treatment with rituximab in the previous 12 months

Primary outcomes:
measure: level of STIM1-PM
timeFrame: Day 0
Secondary outcomes:
measure: correlation between STIM1 expression and Clinical Score
timeFrame: Day 0
Other outcomes:
Locations:
city: Morlaix
country: France
facility: Centre Hospitalier des Pays de Morlaix
state: Brittany
city: Quimper
country: France
facility: Centre Hospitalier de Quimper
state: Brittany
city: Fort-de-France
country: France
facility: CHU de Martinique
state: Martinique
city: Brest
country: France
facility: CHRU de Brest - Service de rhumatologie
Study officials:
References:
Clinical trial NCT01140230: Outcomes After Repair of Acute Rotator Cuff Tears
Official title: Structural and Clinical Outcomes After Repair of Acute Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
rotator cuff repair
age
timing to surgery
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 42
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective review of our computerized database identified 49 patients repaired at our institution between May 2004 until May 2009 due to acute traumatic rotator cuff tears. 42 patients who fulfilled the inclusion criteria, were willing to participate in a follow-up evaluation after written and oral informed consent.

Brief summary: Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. The purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* significant trauma to the shoulder
* sudden onset of symptoms
* asymptomatic in the shoulder before trauma
* pseudoparalysis in the shoulder after trauma
* full thickness rotator cuff tear of at least one tendon

Exclusion Criteria:

* patients with previous or gradual onset of symptoms in the traumatised shoulder
* partial rotator cuff tear
* displaced fracture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopeadic, Linkoeping University Hospital
name: Lars Adolfsson, Associate Professor
role: STUDY_DIRECTOR
References:
citation: Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
citation: Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.
Clinical trial NCT06012630: Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients
Official title: Ultrasound Evaluation of the Median Nerve in Patients With Rheumatoid Arthritis and Its Relationship With Disease Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Median Nerve Entrapment
Keywords: Rheumatoid arthritis
Ultrasound
Carpal Tunnel Syndrome
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria healthy controls (HC) with no history of rheumatic diseases and CTS.

Brief summary: In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made based on clinical findings and physical examinations. Then, the cross-sectional areas of the participants' median nerves from different levels were measured. Meidolateral and anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated. The obtained data were compared between RA with CTS, RA without CTS and healthy control.


Eligibility criteria: Inclusion Criteria:

* RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria
* healthy controls (HC) with no history of rheumatic diseases and CTS.
* Individuals aged 18-65 years.

Exclusion Criteria:

* thoese with hypothyroidism,
* gout,
* diabetes mellitus,
* history of CTS surgery,
* upper extremity plexopathy,
* polinöropathy,
* uncontrollable fibromyalgia,
* steroid injection for CTS
* For the HC group, those with phalen or tinnel detected in at least one wrist and those with bifid median nerve detected during US evaluation were not included in the study.

Primary outcomes:
measure: Comparison of US findings among participants
timeFrame: 6 months
Secondary outcomes:
measure: Relationship between US findings and disease activity in the patient group
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Resarch Hospital
Study officials:
References:
Clinical trial NCT06591130: Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism
Official title: A Pilot Trial of a Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Self Harm
Keywords: Autism
Self harm
Youth suicidality
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this feasibility randomized controlled trial is to assess the feasibility and acceptability of Youth Culturally Adapted Manually Assisted brief psychological intervention (YCMAP) in young people with autism in Pakistan. In a rater-blind, 2-arm, multi-site, feasibility randomized controlled trial (RCT), participants will be randomized either to 1) YCMAP added to the Treatment as Usual (TAU) or 2) TAU alone. Participants in the Y-CMAP arm will receive 8-10 sessions delivered individually over 3 months (weekly for 1 month then fortnightly), lasting for 60 minutes. Assessments will be conducted at baseline and at 3 months.


Eligibility criteria: Inclusion Criteria:

* Aged 18-24 years
* History of self-harm and/or possible suicidal behavior
* Able to engage in assessment and intervention
* Ability to provide informed consent

Exclusion Criteria:

* Young people with autism with limited receptive and expressive language skills that would prevent engagement
* With any chronic medical disorder or physical condition (including communicable diseases such as Tuberculosis) that would prevent participation in assessments and or intervention.
* Not willing to participate.

Primary outcomes:
measure: Intervention feasibility
timeFrame: Baseline to 12 weeks
measure: Intervention acceptability
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Suicide Attempt and Self-Harm
timeFrame: Baseline to 12 weeks
measure: Beck Scale for Suicide Ideation
timeFrame: Baseline to 12 weeks
measure: Card sort Task for Self-harm Behavior
timeFrame: Baseline to 12 weeks
measure: Beck Hopelessness Scale
timeFrame: Baseline to 12 weeks
measure: Autistic Depression Assessment Tool - Adult
timeFrame: Baseline to 12 weeks
measure: Kessler Psychological Distress Scale
timeFrame: Baseline to 12 weeks
measure: Euro-Qol-5 Dimensions scale
timeFrame: Baseline to 12 weeks
measure: Autism Diagnostic Observation Schedule
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, FRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06212830: Pain Relief After Corneal Collagen Cross-Linking
Official title: Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-01-19
Enrollment: 51
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery.

Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient.

In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.


Eligibility criteria: Inclusion Criteria:

* Patients above the age of 15 years
* Patients who are undergoing CXL treatment

Exclusion Criteria:

* Renal and/or hepatic failure
* Patients under the age of 15

Primary outcomes:
measure: Pain questionnaires
timeFrame: The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
Study officials:
References:
Clinical trial NCT02684630: Trima Accel® System Post Count Algorithm Study
Official title: A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of \>100,000/µL.

Detailed description: This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.

Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:

1. a single platelet product is collected
2. a double platelet product is collected, with or without other components.

Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.

Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
* Appears to have adequate venous access to obtain a postprocedure platelet count.
* Has given written informed consent.

Exclusion Criteria:

* Has undergone a splenectomy.

Primary outcomes:
measure: Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
timeFrame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis
measure: Donor Postprocedure Platelet Count Following Donation of Double Platelet Product
timeFrame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Blood Bank
state: California
city: Denver
country: United States
facility: Bonfils Blood Center
state: Colorado
Study officials:
affiliation: Terumo BCT, Inc
name: Heather Pidcoke, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01944930: Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastrointestinal and Gynecologic Malignancies
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI. The order of white-light and NBI laparoscopy will be randomized for each patient (crossover design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. The number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. To gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.


Eligibility criteria: Inclusion Criteria:

* adult patients
* diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract

Exclusion Criteria:

* clinical contraindication to diagnostic laparoscopy

Primary outcomes:
measure: Rate of Detectable Peritoneal Metastases
timeFrame: After each Laparoscopy, at time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Thomas Schnelldorfer, MD
role: STUDY_DIRECTOR
References:
citation: Schnelldorfer T, Jenkins RL, Birkett DH, Wright VJ, Price LL, Georgakoudi I. Laparoscopic narrow band imaging for detection of occult cancer metastases: a randomized feasibility trial. Surg Endosc. 2016 Apr;30(4):1656-61. doi: 10.1007/s00464-015-4401-9. Epub 2015 Jul 21.
Clinical trial NCT01148030: Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgical Site Infection
Lead sponsor: 3M
Sponsor class: INDUSTRY
Collaborators: name: Sharp HealthCare
First posted: 2010-06-22
Enrollment: 333
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Emergent Hip Fractures

Brief summary: Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. After surgery, the subjects will be observed for any surgical site infections.

Detailed description: Infection rate study.

Eligibility criteria: Inclusion Criteria:

* Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will be enrolled in the study.

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
References:
Clinical trial NCT06786130: Societal Burden Associated with Type 1 Diabetes in Canada
Official title: Burden and (dis)utility of Caregivers of Children with T1D
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes Mellitus
Quality of Life (QOL)
Work Productivity
Caregiver Subjective Burden
Keywords: observational
quality of life
caregiver
work productivity
real-world
Lead sponsor: PeriPharm
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2025-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parental caregivers of a child with T1D

Brief summary: The purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life.


Eligibility criteria: Inclusion Criteria:

1. Parental caregiver of a child recently diagnosed (\<= 2 years) with T1D before study inclusion;
2. Age ≥18 ;
3. Residence in the Canada;
4. Willingess to complete a 20-minute survey
5. Ability to read and understand French or English;
6. Signature of informed consent form (ICF)

Exclusion Criteria:

1. Participation in a clinical trial.

Primary outcomes:
measure: To estimate work productivity impairment of caregivers of a T1D child.
timeFrame: At recruitment
Secondary outcomes:
measure: To estimate healthcare resource utilization in caregivers of T1D child
timeFrame: At recruitment
measure: To estimate health-related quality of life in caregivers of a T1D child
timeFrame: At recruitment
measure: To estimate the caregiver burden in caregivers of a T1D child
timeFrame: At recruitment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: PROxy Network, an initiative of PeriPharm Inc.
state: Quebec
Study officials:
References: