louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01955343: Immune Response in Lung Cancer
Official title: Immune Response in Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Immune response
Cancer
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lithuanian residents who are investigated ant treated in Hospital of Lithuanian University of Health Sciences Kaunas Clinics Department of Pulmonology and Immunology and Department of Heart, thoracic and vascular surgery

Brief summary: This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of 0-1
* Patients with histologically documented non-small cell lung cancer
* Control group - patients without non-small cell lung cancer
* Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

* Any other malignancies within 5 years
* Any unstable systemic disease (including active infections, significant cardiovascular disease)
* Prior chemotherapy or radiotherapy
* Autoimmune disease
* Nursing or pregnant women

Primary outcomes:
measure: progression-free survival
timeFrame: one year after enrolment to the study
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Marius Zemaitis, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackute J, Zemaitis M, Pranys D, Sitkauskiene B, Miliauskas S, Vaitkiene S, Sakalauskas R. Distribution of M1 and M2 macrophages in tumor islets and stroma in relation to prognosis of non-small cell lung cancer. BMC Immunol. 2018 Jan 24;19(1):3. doi: 10.1186/s12865-018-0241-4.
Clinical trial NCT03768843: Surgical Outcome of Type II Odontoid Fracture, Harms Technique
Official title: Surgical Outcome of Type II Odontoid Fracture, Harms Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tramatic Odontoid Fracture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cervical trauma is a common cause of disability following spinal cord injury, especially in athletic populations. The biomechanics in the atlantoaxial joint carry more than 50% of the rotational movement which can be affected in transverse ligament tear associated with odontoid fracture type II. Odontoid fracture type II considered an unstable fracture with a high rate of non-union in conservative treatment. Limitation of the odontoid screws in some cases gives the chance of posterior cervical fixation to have the superior role. Use of polyaxial screws in Harms technique gives the best results in maintaining the majority of the biomechanics.

Purpose: our aim in this study to evaluate Harms technique in those patients regarding pain improvement and restoration of the motor power and to report the complications.

Study design: A retrospective case series study. We Used the Frankel grading system to evaluate the postoperative neurological state.

Detailed description: After approval of Research Ethics Committee, twelve patients with post-traumatic odontoid fracture type II were scheduled in our Neurosurgery department at Sohag University Hospital for atlantoaxial fusion using polyaxial C1 lateral mass and C2 pedicle screws between January 2015 and January 2018.

Eligibility criteria: Inclusion Criteria:

1. C1-C2 displacement that needs intra-operative reduction
2. Short neck not suitable for anterior odontoid screw
3. Osteoporotic patients
4. Odontoid fracture associated with transverse ligament tear suspected.
5. Oblique line of fracture
6. Failure of union after conservative treatment.

Exclusion Criteria:

* Associated spinal fractures
* Other comorbidities

Primary outcomes:
measure: evaluation neurological deficit using Frankel grading system within 3 years
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ahmed Salaheldin Mohammed Saro
Study officials:
affiliation: Sohag faculty of medicine
name: Hisham A Elsharkawy, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06145243: Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer
Official title: Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 60
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to compare the effects of video-based application method of resistance exercise training and supervised exercise training on mobility, body composition, quality of life, fatigue, muscle strength and physical performance in patients with prostate cancer receiving androgen deprivation therapy treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with prostate cancer with at least 1 year of Androgen deprivation therapy treatment
* 65 years of age or older
* No speech and hearing problems

Exclusion Criteria:

* Presence of metastatic cancer focus
* Carrying a pacemaker
* Mental and coordination problems
* Patients with neurological or orthopedic pathology that would prevent participation in exercise

Primary outcomes:
measure: Muscle strength
timeFrame: 8 weeks
measure: Body composition- fat percentage
timeFrame: 8 weeks
measure: Body composition- Body mass index( BMI in kg/m^2)
timeFrame: 8 weeks
measure: Short Physical Performance Battery
timeFrame: 8 weeks
measure: Quality of Life- Functional Assessment of Cancer Therapy - Prostate cancer (FACT-P)
timeFrame: 8 weeks
Secondary outcomes:
measure: Grip strength
timeFrame: 8 weeks
measure: Fatigue -Functional assessment of chronic illness therapy - fatigue
timeFrame: 8 weeks
measure: Sarcopenia Risk Survey
timeFrame: 8 weeks
measure: Anxiety - The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Professor Cemil Taşcıoğlu Training and Research Hospital
Study officials:
References:
Clinical trial NCT06617143: Effect of MBCT Applied to Asthma Patients on Anxiety, Depressıon and Dyspnea
Official title: Effects of Short-Term Conscious Awareness-Based Cognitıve Therapy Applied to Asthma Patients on Anxiety, Depression and Dyspnea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Mindfulness
Keywords: asthma
mindfulness-based cognitive therapy
anxiety
depression
dyspnea
Lead sponsor: Ardahan University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre-test post-test quasi-experimental design
Primary purpose: OTHER

Brief summary: In this study, short-term MBCT will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. A quasi-experimental study was planned for this purpose.

Detailed description: In the study, cognitive behavioral therapy will be applied to the intervention group, which is determined as the experimental group, and a group of asthma patients who did not receive any application during the same periods will be included and the dyspnea, anxiety and depression levels of the patients in these two groups will be compared.

Eligibility criteria: Inclusion Criteria:

Over 18 years old, Inpatient treatment in the chest ward volunteer participants with no communication problems

Exclusion Criteria:

Under 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma

Primary outcomes:
measure: Anxiety
timeFrame: Average of 1 week after completion of the intervention
measure: Depression
timeFrame: Average of 1 week after completion of the intervention
measure: Dyspnea
timeFrame: Average of 1 week after completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ardahan
country: Turkey
facility: Ardahan University
Study officials:
affiliation: Ardahan University
name: Derya ŞİMŞEKLİ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
citation: Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Clinical trial NCT02130843: Tiemann Mounted Urodynamic Catheter Technique for Difficult Bladder Catheterization
Official title: RETROSPECTIVE STUDY ABOUT A TECHNIQUE OF INSERTION OF TIEMANN MOUNTED URODYNAMIC CATHETER FOR DIFFICULT BLADDER CATHETERIZATION IN MALES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: URINATION DISORDERS
Keywords: URINARY INCONTINENCE
URODYNAMICS
URINARY RETENTION
URINARY CATHETERIZATION
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-05-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MALE PATIENTS 18-80 Y/O WHO UNDERWENT URODYNAMIC STUDY, AND HAD DIFFICULT CATHETERIZATION

Brief summary: A report of a technique for insertion a soft urodynamic catheter into the bladder, when urethral obstruction causes the catheter to bend and fold over itself at the resistance site.

Detailed description: The urodynamic catheter is mounted on a 12F Coudé tip Tiemann catheter, which then carries the tip of the urodynamic catheter beyond the obstruction site into the bladder.

The Tiemann catheter-mounted urodynamic catheter technique can serve as a suitable option to insert a urodynamic catheter into the bladder in all male patients in whom it fails due to kinking.

Eligibility criteria: Inclusion Criteria:

- MEN THAT UNDERWENT URODYNAMIC STUDY EVALUATION BETWEEN 6/2011 TO 9/2013

Exclusion Criteria:

NONE

-

Primary outcomes:
measure: Successful Catheterization
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-gan
country: Israel
facility: Sheba Medical Center
state: IL
Study officials:
References:
Clinical trial NCT04908943: RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
Official title: RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Keywords: Systemic Sclerosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2021-06-01
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of Systemic Sclerosis (SSc), any subtype
* Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
* Have access to a computer and an internet connection
* Are able to speak and read English.

Exclusion Criteria:

* Currently undergoing structured rehabilitation or psychological treatment.
* Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)

Primary outcomes:
measure: Change in Fatigue
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in Pain Interference
timeFrame: Up to 12 weeks
measure: Change in Resilience
timeFrame: Up to 12 weeks
measure: Change in Depressive symptoms
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Susan Murphy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452343: A Study of CM310 in Subjects With Chronic Pruritus
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Chronic Pruritus of Unknown Origin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Pruritus of Unknown Origin
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 50
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 is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM310 in subjects with chronic pruritus of unknown origin.

Detailed description: The study consists of a Screening Period (up to 4 weeks), Treatment Period (16 weeks) and Safety Follow-up Period (8 weeks).

50 subjects who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All subjects will receive mometasone furoate nasal spray (MFNS) on a daily basis as a background treatment throughout the study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* With chronic pruritus of unknown origin.
* With the worst pruritus numerical rating scale (WI-NRS) ≥7.
* Contraception.

Exclusion Criteria:

* Heavy drinking in the 3 months prior to screening.
* With severe hepatic and renal impairment.
* Previous history of autosensitivity dermatitis.
* Allergic to CM310/placebo.
* Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.

Primary outcomes:
measure: Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)
timeFrame: at week 16
Secondary outcomes:
measure: Safety parameters
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01525043: Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
Official title: Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epicondylitis of the Elbow
Keywords: Epicondylitis
Lead sponsor: International Clinical Research Institute
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.

Detailed description: The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:

1. Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow
2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
3. Naproxen Sodium: 500mg bid

Eligibility criteria: Inclusion Criteria:

* Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
* Age 18 or higher
* Minimum of 4 on Question 5 of BPI

Exclusion Criteria:

* Peripheral neuropathy of any origin in the index limb
* Cubital tunnel syndrome in patients with medial epicondylitis
* Cortisone injection in the last 4 weeks into the index limb
* Surgical intervention in the past for the epicondiitis
* Participants in any other clinical trial in the last 30 days
* Known allergy to lidocaine, tetracaine, NSAIDs or PABA
* Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator
* Patient who is deemed to be medically unstable by the principal investigator including but not limited to Liver disease or Cardiac arrhythmias
* Patients who are pregnant, lactating or breast feeding
* Vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.

Primary outcomes:
measure: Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily
timeFrame: Day 1 and Day 14
Secondary outcomes:
measure: Pain quality assessment scale
timeFrame: Every visit from the entry
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: International Clinical Research Institute
state: Kansas
Study officials:
affiliation: International Clinical Research Institute, Inc.
name: Srinivas Nalamachu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02861443: Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life
Official title: Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colostomy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The target population is composed of adults with end colostomy. The sample is drawn from adult members of "la Federation des stomisés de France" who have a terminal colostomy.

Brief summary: The main objective of this study was to determine the frequency of the practice of colonic irrigation (CI) among patients with a colostomy,.

Other objectives are:

* To compare the quality of life between a group of patients with a colostomy and practicing CI versus a group of patients with a colostomy without CI.
* To determine the causes of non-realization of the CI or failure.
* To determine the conditions of realization of colonic irrigation by the return of user experience (time of day when the CI is practiced, amount and type of fluid used, time spent in the bathroom, time to recurrence of stool, media used between two irrigations).


Eligibility criteria: Inclusion Criteria:

* The subject was informed about the implementation of the study's objectives, constraints and the rights of the subject
* The subject is aged at least 18 years
* The subject is a member of the Ostomy Federation of France
* The subject has had a terminal colostomy for more than 6 months

Exclusion Criteria:

* The subject is under guardianship or curatorship
* The subject is under judicial protection
* The subject formalizes his/her opposition
* It is not possible to inform the subject

Primary outcomes:
measure: Practice of large bowel irrigation (yes/no)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04759443: Detection of Small Fiber Neuropathy Using Skin Properties
Official title: Detection of Small Fiber Neuropathy Using Skin Properties
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Fiber Neuropathy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 400
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: Patients with small fiber neuropathy

Brief summary: Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

Detailed description: Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.

The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.

This approach can improve the availability of diagnosis of small fiber neuropathy.

Eligibility criteria: Inclusion Criteria:

* Patients with age 18 year or older
* Patients that sign the informed consent form to participate in this study
* Patients completed the autonomic testing with skin biopsies

Exclusion Criteria:

* Patients with significant hairs at the legs that will cover the skin
* Any dermatological disorder that can affect the skin composition
* The use of skin lotion

Primary outcomes:
measure: Diagnostic accuracy of image processing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
References: