louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02600143: Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.
Official title: Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Colitis
Keywords: Melanoma
Colitis
Ipilimumab
Nivolumab
Pembrolizumab
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 123
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: 300

Brief summary: The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.

Detailed description: Immunotherapy with immune checkpoint-inhibitors is standard treatment for patients with melanoma. However, in about 15% of patients treated with Ipilimumab a grade 3-4 colitis will occur. In programmed cell death protein 1 (PD1) inhibitors colitis is also seen as adverse event, although less prominent. We want to find a good predictive biomarker to select patients that are prone to colitis.So far no test is available that might be predictive whether a patient will develop a grade 3-4 colitis.

The study will consists of four parts: 1.) to identify a genetic profile associated with ipilimumab-induced colitis, 2.) to identify predictive (serum or fecal) biomarkers for ipilimumab-induced colitis, 3.) to study the tissue of ipilimumab-induced colitis and 4) to study the role of the gut microbiome in the development of colitis. Patients are able to participate in one, or more parts of the study.

Eligibility criteria: Inclusion Criteria:

1. Patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)
2. Signed written informed consent.
3. Able to comply with the protocol.

Exclusion Criteria:

1. Patients with a pre-existing colitis (e.g. Crohn's disease, ulcerative colitis).

Primary outcomes:
measure: Genetic predisposition for immunotherapy-induced colitis
timeFrame: 1 week
Secondary outcomes:
measure: Predictive biomarkers for immunotherapy-induced colitis in stool and serum
timeFrame: Day 0, 21, 42, 63
measure: Clinical scoring system of colitis
timeFrame: Day -7 to 85
measure: Histological assessment of colon biopsies in patients that develop colitis
timeFrame: 1 day
measure: Analysis of the gut microbiome in stool samples
timeFrame: Day 0, 21, 42, 63
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: UMCG
name: G. A.P. Hospers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194543: High-Definition 3D Visualization System for Ophthalmic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Cataract
HD 3D
Microscope
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cataract

Brief summary: To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract surgery


Eligibility criteria: Inclusion Criteria:

* The patients are scheduled to cataract surgery on both eyes.

Exclusion Criteria:

* The patients who have other complicating ophthalmic diseases or previous history of ophthalmic surgeries were excluded

Primary outcomes:
measure: the best corrected visual acuity
timeFrame: 1 month after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06188143: Study of Pain Control in Diagnostic Hysteroscopy
Official title: The Efficacy of Combination of Ibuprofen and Paracetamol for Pain Control in Diagnostic Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 58
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial study is to learn about how to decrease the pain during the diagnostic hysteroscopy. The main question it aims to answer is "Do the Paracetamol and Ibuprofen taken before the procedure can lower the pain during the diagnostic hysteroscopy".

Detailed description: After the participants those are indicated for diagnostic hysteroscopy and eligible for the study undergo informed consent, then they were divided to two groups for control group those get no medication and study group those get Paracetamol 500mg and Ibuprofen40mg per oral before the hysteroscopy, and both group needs to evaluate the pain score in VAS before, during hysteroscopy and after hysteroscopy for 30 minutes to compare the pain level in two groups.

Eligibility criteria: Inclusion Criteria:

* Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old

Exclusion Criteria:

* Women with contraindication for undergoing diagnostic hysteroscopy includes women with pregnancy, uterine infection, diagnosed with cervical cancer or endometrium cancer and women who is undergoing with active vaginal bleeding
* Women with history of allergy to Paracetamol or Ibuprofen medicine
* Women with currently or pre-existing medical conditions that contraindicate the use of ibuprofen includes kidney disease, heart disease, cirrhosis, gastritis or individuals with a history of peptic ulcer or gastrointestinal bleeding
* Women with currently taking anticoagulant or antiplatelet medications
* Women with history of psychiatric disorders

Primary outcomes:
measure: The pain score comparing between study and control group
timeFrame: During and 30minutes after the hysteroscopic procedure
Secondary outcomes:
measure: The associated factors effecting the pain of the procedure
timeFrame: During and 30minutes after the hysteroscopic procedure
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao College of Medicine and Hospital
Study officials:
References:
Clinical trial NCT04833543: Verticalization Robotic Exoskeleton DoC
Official title: Verticalization With Vestibular Stimulation for Patients With Severe Disorders of Consciousness: A Novel Application of a Robotic Exoskeleton
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries
Disorder of Consciousness
Lead sponsor: Memorial Hermann Health System
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mobilization, specifically verticalization, has been shown to play a role in enhancing consciousness. Vestibular stimulation has the potential to influence the neural substrate of consciousness, but this modality has not been thoroughly explored. The primary aim of this study is to compare the influence of verticalization with and without vestibular input on level of consciousness in patients experiencing disorders of consciousness (DoC).


Eligibility criteria: Inclusion Criteria:

1. unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) following traumatic brain injury (TBI), intracerebral bleeding, ischemic infarction, or hypoxic brain injury
2. Medical clearance by a physician
3. 18-75 years old
4. Mobilization into standing for at least 10 minutes without signs of orthostasis

Exclusion Criteria:

1. Time since injury less than 4 weeks or more than 6 months
2. Mobilization into standing lasts more than 30 minutes
3. Severe osteoporosis
4. Muscle tone that prevents joint motion (Modified Ashworth Scale (MAS) 4)
5. Unstable fractures
6. Decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum)
7. Inability to fit device requirements\*

   * Height 4'8"-6'4", Weight 88-222 lbs., Hip Flexion 0-90˚, Knee Flexion 0-90˚, Plantigrade

Primary outcomes:
measure: Coma Recovery Scale-Revised (CRS-R)
timeFrame: through study completion; an average of 8 weeks
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: through study completion; an average of 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
References:
Clinical trial NCT03311243: Periodontal Therapy in Thalassemia Major Patients
Official title: Effect of Non-surgical Periodontal Therapy on Systemic Inflammation in Thalassemia Major Patients With Chronic Periodontitis: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thalassemia Major
Chronic Periodontitis
Keywords: cytokines
scaling root planing
oral hygiene
systemic inflammation
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 52
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effect of local non surgical periodontal therapy on the systemic pro-inflammatory markers in the β-thalassemia (TM-β) patients with chronic periodontitis and systemically healthy demographically matched controls with chronic periodontitis. Both groups will receive non surgical periodontal therapy.

Detailed description: Treatment modalities in patients with thalassemia include long-term transfusion therapy, iron chelation, splenectomy, allogeneic hematopoietic transplantation and supportive measures. Attempts to downgrade the systemic proinflammation and thereby reducing the morbidity of the disease warrants investigation in patients with β-thalassemia (TM-β). In blood disorders, as with most other diseases, achieving and maintaining inflammatory homeostasis is essential and necessary for survival. Both TM and gingival diseases cause increased levels of pro-inflammatory cytokines in the body fluids. Moreover, higher prevalence of gingival diseases is reported in children with TM. With oral hygiene maintenance and care, down-regulation of the systemic burden of the disease might be attained which will subsequently aid in achieving reduced morbidity in children with TM.

Both the groups will receive non surgical periodontal therapy (scaling and root planing) with the chlorhexidine containing adjunct in the form of a mouthrinse. Additionally, they will be taught standard tooth brushing technique (Fones technique). Participants will receive both verbal instructions and practical demonstrations.

Eligibility criteria: Inclusion Criteria:

1. Written and verbal consent
2. (TM-β) patients with gingivitis
3. Age: ≥10 years
4. Patients who have received or are receiving iron chelation therapy with deferasirox, calcium, vitamin D, and regular erythrocyte transfusion.

Exclusion Criteria:

1. Presence of hepatitis B or C or HIV-AIDS (Human immunodeficiency Virus- Acquired immunodeficiency syndrome).
2. Presence of any other known systemic disease.
3. Use of antibiotics or anti-inflammatory drugs within the past 6 months.
4. Dental prophylaxes in the last 6 months

Primary outcomes:
measure: Systemic pro-inflammatory cytokines
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01495143: Surgical Stress Measured by Microdialysis
Official title: Microdialysis of Paraspinal Muscle in Healthy Volunteers and Patients Underwent Posterior Lumbar Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Glucose
Lactate pyruvate ratio
Glycerol
Paraspinal muscle
Microdialysis
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).

Detailed description: Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.

Eligibility criteria: Inclusion criteria:

* patients who undergo conventional instrumented posterolateral lumbar fusion.

Exclusion criteria:

* previous fusion
* chronic metabolic disease
* tumor or metastasis
* postoperative surgical complications and complications during surgery

Primary outcomes:
measure: The glycerol concentration
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
name: Gang Ren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891043: Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy
Official title: Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Orbitopathy
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Increased oxidative stress has been observed in Graves' disease and therefore, by incorporating an antioxidant such as selenium in patients with mild thyroid ophthalmopathy, inflammatory activity could be reduced or inactivated.

General Objective: To determine the clinical differences between patients with mild thyroid orbitopathy who were administered oral supplementation with selenium and patients who were administered oral placebo.

Detailed description: This is a simple controlled clinical trial. In which 66 eyes of 33 patients were studied. Fifteen patients were assigned to the placebo group and 18 to the Selenium group. We randomized into two groups the patients with mild clinical activity according to CAS score. Group A took placebo pills twice a day which consisted in 100µg of starch, and Group B took a pill of Selenium 100 µg twice a day. All the subjects tool the pills during six months. Patients of both groups where examined and evaluated with CAS score before and after the first, third and sixth month of treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with active mild thyroid orbitopathy according to CAS scale.
* Older than 18 years of age.

Exclusion Criteria:

* Patients with mild thyroid orbitopathy undergoing treatment with corticosteroids.
* Active smokers
* Patients allergic to Selenium
* Follow-up shorter than 6 months

Primary outcomes:
measure: Clinical Activity Score (CAS)
timeFrame: 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03503643: Hemi-Gland Cryoablation for Prostate Cancer at UCLA
Official title: Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostate Disease
Keywords: prostate cancer
cryoablation
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for hemi-gland cryoablation, and elect this treatment option as a standard of care procedure, will be considered for our clinical study and analysis of their outcomes. Subjects will provide informed consent to participate in this study during standard of care clinical visits at the Clark Urology Center at UCLA. Subjects will provide informed consent to allow study staff to abstract data from their medical records.

Brief summary: This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.

The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation.

UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA
* Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer).
* Prostate volume of ≤ 70 cc
* Ability to complete informed consent form

Exclusion criteria:

* Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
* Patients unable to tolerate general or regional anesthesia.

Primary outcomes:
measure: Clinical Response to Cancer Treatment
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life Assessment - Urinary Function
timeFrame: 6 months
Other outcomes:
measure: Quality of Life Assessment - Erectile Function
timeFrame: 6 months
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Leonard S Marks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04377243: Immunotherapy of Chronic Kidney Failure
Official title: Phase II Trial of V8 in Treating Kidney Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Renal Failure Chronic
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
First posted: 2020-05-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Kidney failure can result from inflammatory renal disease in the context of autoimmunity because the kidney is targeted by host's immune response against self. There are many causes to this, but abnormal kidney function tests, i.e., BUN and creatinine, can reveal the disease. Oral delivery of kidney cells is ought to produce the immune tolerance - phenomenon is known as oral tolerance. Preliminary studies produced convincing evidence that this hypothesis holds true and has not produced any adverse side effects. Intended open label Phase II aims to confirm these findings.


Eligibility criteria: Inclusion Criteria:

* Baseline level of creatinine twice above normal

Exclusion Criteria:

* Baseline level of creatinine normal

Primary outcomes:
measure: Effect on creatinine
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
Study officials:
References:
Clinical trial NCT00226343: Depakote-ER for Depressive and Bipolar Depression
Official title: Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2005-09-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.

Detailed description: Study is 6 weeks long, with 7 clinical visits.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS \< 12; MADRS \> 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics

Exclusion Criteria:

* Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality

Primary outcomes:
measure: Anxiety and Depressive Symptom severity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cambridge Health Alliance
name: Robert T Dunn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghaemi SN, Gilmer WS, Goldberg JF, Zablotsky B, Kemp DE, Kelley ME, Bauer AD, Fleck J, Filkowski MM, Stan VA, Dunn RT. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry. 2007 Dec;68(12):1840-4. doi: 10.4088/jcp.v68n1203.
Clinical trial NCT02418143: A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
Official title: A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Disease
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of any subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change out or upgrade.

Brief summary: Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a post market observational study.


Eligibility criteria: Inclusion Criteria:

1. Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade.
2. Signed Informed Consent

Exclusion Criteria:

1. Known sensitivities to porcine material.

Primary outcomes:
measure: Device Related Adverse Events
timeFrame: 1 day post-operative follow up visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aziyo Biologics
name: Director, Clinical Development
role: STUDY_DIRECTOR
References: