louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01826695: Neurodynamic Intervention in Fibromyalgia
Official title: Study of the Effectiveness of a Neurodynamic Intervention in Women With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia, neurodynamic, dexterity
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population.

Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this prospective study was to examine the combined effects of soft tissue mobilization and nerve slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.

Detailed description: Fibromyalgia affects women nine times more than men.The pathophysiology of fibromyalgia is being studied nowadays in order to understand the mechanisms implicated in it.

The treatment propose in this study is a neurodynamic intervention. Neurodynamics is the term used to describe the integration of the morphology, biomechanics and physiology of the nervous system.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada.
* Women who can complete the assessment battery of tests at the beginning and at the end of the study
* Female sex.

Exclusion Criteria:

* Male sex.
* Auditive and visual disturbances.
* Cognitive problems.
* Psychiatric pathology.
* Traumatic pathology of the hand.

Primary outcomes:
measure: Nervous assessment
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Manual dexterity
timeFrame: baseline, 8 weeks
measure: Grip strength
timeFrame: baseline, 8 weeks
measure: Pressure pain measure
timeFrame: baseline, 8 weeks
Other outcomes:
measure: Anxiety and depression
timeFrame: baseline, 8 weeks
Locations:
city: Granada.
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torres JR, Martos IC, Sanchez IT, Rubio AO, Pelegrina AD, Valenza MC. Results of an Active Neurodynamic Mobilization Program in Patients With Fibromyalgia Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Oct;96(10):1771-8. doi: 10.1016/j.apmr.2015.06.008. Epub 2015 Jul 2.
Clinical trial NCT01249495: Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Official title: Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment of Leg Ulcer
Sharp Debridement
Proinflammatory Cytokines
Keywords: leg ulcer
wound therapy
Pro-inflammatory interleukins
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital, Aker
First posted: 2010-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the rate of wound healing using sharp debridement using curette and to compare between such intensive treatment at hospital and treatment in primary care. A correlation between change in wound size and pro-inflammatory cytokines will also be made.

Detailed description: Subjects with chronic venous leg ulcers are treated 3 times a week in the hospital for 6 weeks with weekly sharp debridement. Wound size, pro-inflammatory cytokines, smears and photo are made weekly. The treatment countinue thereafter in primary care 3 times a week in 12 weeks. Wound size, pro-inflammatory cytokines, smears and photo are made every 14 day at the hospital.

Eligibility criteria: Inclusion Criteria:

* Ulcus cruris venosoum
* AAI \> 0.9
* age 18-80
* adress Oslo area
* wound size 2.5-100 cm2
* wound duration \> 6 weeks.

Exclusion Criteria:

* Diabetes mellitus
* Immunosuppresion
* antibiotics \< 14 days
* local antiseptic treatment \< 1 week
* clinical infection.

Primary outcomes:
measure: Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
timeFrame: 01.08.10-01.08.13
Secondary outcomes:
measure: Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.
timeFrame: 01.08.10-01.08.13
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital;Dermatologic Department
name: Tone K Bergersen, MD;PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05014295: Patient Recall of Cancer Screening and Diagnosis
Official title: Patient Recall of Cancer Screening and Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 100
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 purpose of this research is to try to better understand how much information relating to cancer screening and diagnoses that people can recall on their own and to better understand how to help people get better information. In this study, investigators will see if giving time or other resources help individuals remember more and more accurate details about their cancer screening and care.

Detailed description: This is a randomized controlled trial of an intervention to encourage use of online medical records for filling out a cancer screening, diagnosis and treatment questionnaire. Participants will be asked to self-report on cancer screening and treatment. They will then be asked the same questions again a week later.

The control group will have had one week to reflect on the questions, and investigators anticipate some influence of this on responses. The intervention group will be prompted about accessing their medical records from the major local health systems online, with links to directions provided by each hospital system. They will then be asked to fill out the same questionnaire.

Eligibility criteria: Inclusion Criteria:

* diagnosed with breast or prostate cancer within the last 10 years
* have access to the internet with a working email address
* reside in Northeast Ohio

Exclusion Criteria:

-

Primary outcomes:
measure: Completeness of survey
timeFrame: at 1 week (after second survey completed)
measure: Accuracy of survey
timeFrame: at 1 week (after second survey completed)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Cheryl Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108795: The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium
Official title: The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 86
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.

Detailed description: Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II
* preschool-aged children undergoing strabismus surgery

Exclusion Criteria:

* psychological disorders
* emotional disorders
* abnormal cognitive development
* developmental delay
* allergy to the drugs in our protocol

Primary outcomes:
measure: the scale of emergence agitation
timeFrame: up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.
Secondary outcomes:
measure: the effect of remifentanil on the emergence
timeFrame: up to 30 minutes after the discharge form postanesthetic care unit
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
name: Sangjin Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733395: Hood to Coast Injury Study
Official title: Comparison of Two Juice Drinks in Preventing the Symptoms of Muscle Pain Among Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Muscle pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine how certain kinds of fruit juice that contain natural antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain and injury. Participants will be recruited from registered participants in the Hood To Coast Relay. The Hood To Coast Relay Race Officials will post the study on their website to find interested teams. Interested participants will then be contacted by the study staff by phone regarding the study's inclusion and exclusion criteria and to schedule the initial health screening visit. The participants will undergo an initial health screening and survey about muscle soreness, and then drink the investigational juice twice daily for 8 days. On the 7th day of drink administration, the participants will report to the starting location of the Hood To Coast Relay to meet with the investigators for 30 minutes to survey muscle pain and juice tolerability. The participants will then participate in the Hood To Coast Relay, drinking 2 more bottles of juice over the duration of the relay. At the conclusion of the relay, the participants will meet with study investigators to take the same short survey about muscle pain and juice tolerability.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness not to take any anti-inflammatory or pain relieving drugs during the course of the study, and not to seek any other treatment for any symptoms of muscle damage until completion of the study after the race.

Exclusion Criteria:

* The investigators will exclude individuals who have or are using antiepileptic drugs for pain, acupuncture, or transcutaneous electrical nerve stimulation within 3 weeks before enrollment
* Recent use (within 5 half-lives) of topical medications/anesthetics, muscle relaxants, tender point anesthetic injections within 2 months, systemic steroids within 3 months or any investigational drug/device in the prior 30 days.

Primary outcomes:
measure: The administration of tart cherry juice will reduce the symptoms of exercise-induced muscle damage as measured by patients assessment of pain on a standard VAS.
timeFrame: Post Race
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Kerry S Kuehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883695: A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
Official title: A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
2. Subjects who can provide written informed consent.
3. Males or females aged 18-55 years (both inclusive).
4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.
5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.

Exclusion Criteria:

1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
2. Known or suspected history of drug abuse.
3. Addiction to tobacco and alcohol.
4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From screening period up to day 113.
Secondary outcomes:
measure: Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
timeFrame: Post-dose at day 1 to day 113.
measure: Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).
timeFrame: Post-dose at day 1 to day 113.
measure: Maximum observed concentration of SHR-3045 (Cmax).
timeFrame: Post-dose at day 1 to day 113.
measure: Time to maximum observed concentration of SHR-3045 (Tmax).
timeFrame: Post-dose at day 1 to day 113.
measure: Clearance of SHR-3045 (CL).
timeFrame: Post-dose at day 1 to day 113.
measure: Terminal elimination half-life of SHR-3045 (t1/2).
timeFrame: Post-dose at day 1 to day 113.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05527795: Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
Official title: Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Keywords: Melanoma
adjuvant immunotherapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage II, III and IV (resected) melanoma patients treated with surgery and adjuvant immunotherapy in the dermatology unit of Lyon-Sud hospital between January 1st of 2019 and January 1st of 2029, with no residual disease prior to immunotherapy onset.

Brief summary: Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with stage II, III or IV (resected) melanoma
* Treated by surgery and adjuvant immunotherapy between January 1st of 2019 and January 1st of 2029
* Gave informed consent to allow the use of biological samples for research purpose
* Has read the information sheet regarding this study
* With tumor samples available at the biobank center

Exclusion Criteria:

* Patients under 18 years old
* Patients placed under the judicial protection
* Opposed to this study

Primary outcomes:
measure: Duration of response to adjuvant immunotherapy according to clinical features.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT02410655: An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery
Official title: An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Uterine Atony
Postpartum Hemorrhage
Keywords: Uterine atony
Postpartum hemorrhage
Vaginal delivery
Uterotonic
Oxytocin
Bolus
Evidence-based
Protocol
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

Detailed description: A traditional practice in many US hospitals includes use of 10-40 IU of Oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. Many practitioners question high dose oxytocin regimens, timing and duration of Oxytocin administration for postpartum hemorrhage prophylaxis. Given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of Oxytocin with an evidence-based designed algorithm.

Eligibility criteria: Inclusion Criteria:

* Vaginal Delivery

Exclusion Criteria:

* Cesarean Delivery
* Allergy to Oxytocin
* Cardiac Arrhythmia

Primary outcomes:
measure: Estimated blood loss
timeFrame: 24 hours postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lutheran Medical Center
name: Violetta Lozovyy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lutheran Medical Center
name: Jade King, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lutheran Medical Center
name: Roulhac D Toledano, MD, PhD
role: STUDY_DIRECTOR
affiliation: Lutheran Medical Center
name: Kevin Fitzpatrick, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02115555: Advancing Diabetes Management in Adolescents Using Health Information Technology
Official title: Advancing Diabetes Management in Adolescents Using Health Information Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1
diabetes
adolescents
heath information technology
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 129
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will compare three treatment strategies to look at the best clinical outcomes.

The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.

Detailed description: This study will compare three strategies for enhancing adherence to diabetes care in our population. The study will look at which strategy results in the best short-term clinical outcomes for the population. Also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics.

The three arms are:

1. HIT (health information technology) aided approach
2. Contracted conflict-management strategy
3. Combination of the HIT-aided approach and the contracted conflict management strategy

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes diagnosed for at least 6 months
* At least one or more parent/guardian who agrees to participate

Exclusion Criteria:

* Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease

Primary outcomes:
measure: Glycemic Control using HBA1C
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Frequency of self monitoring blood glucose measurement
timeFrame: Baseline, 3 months, 6 months
measure: Quality of Life
timeFrame: Baseline and 6 months
measure: Family dynamics
timeFrame: Baseline and 6 months
measure: Treatment Adherence Behaviors
timeFrame: Once per month for 6 months
Other outcomes:
measure: Satisfaction
timeFrame: 3 month and 6 month
Locations:
city: Carmel
country: United States
facility: Riley Children's Specialties
state: Indiana
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Tamara Hannon, MD
role: PRINCIPAL_INVESTIGATOR
References: