louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00635180: Intraocular Pressure (IOP) and Isometric Exercise
Official title: Changes in Intraocular Pressure and Pulsatile Ocular Blood Flow Measured Continuously During Isometric Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Keywords: Isometric exercise
intraocular pressure
Physiological changes in intraocular pressure during isometric exercise
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate changes in intraocular pressure measured continuously during isometric exercise.


Eligibility criteria: Inclusion Criteria:

* Young, healthy subjects

Exclusion Criteria:

* Known ocular diseases
* Previous ocular trauma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Eye dpt, Ullevaal University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Sven O Semb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03527680: Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis
Official title: Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins (Phenol and P-Cresol ) in Hemodialysis Patients: A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.

Detailed description: Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).

Eligibility criteria: Inclusion Criteria:• Age more than 20 years

* Acceptable performance of alimentary system
* Ability to drink at least 200 ml of water per day
* No history of being allergic to fungi and yeast
* Absence of acute medical illness
* life expectancy more than 3 months
* Accept and sign the consent

Exclusion Criteria:

* Patient's unwillingness to participate in the study
* History of smoking, peritoneal dialysis (PD) or previous kidney transplantation
* Lactation or pregnancy
* Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.

Primary outcomes:
measure: pre- and post-treatment p-cresol levels
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03601780: Local Wound Infiltration in Renal Surgery
Official title: Effect of Local Wound Infiltration Plus Usual Care Versus Usual Care Alone on Pain Relief After Open Renal Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Multimodal analgesia is a rational approach to treat various components of postoperative pain.

Detailed description: Local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.

Eligibility criteria: Inclusion Criteria:

* ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery

Exclusion Criteria:

* history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,

Primary outcomes:
measure: Postoperative pain
timeFrame: The first 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06057480: APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs
Official title: A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pain, Chronic
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.


Eligibility criteria: Inclusion Criteria:

* Subject has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
* Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
timeFrame: end of trial period; 1 month and 3 months post-implant
measure: Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System
timeFrame: end of trial period; 1 month and 3 months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Gainesville
country: United States
facility: The Orthopaedic Institute, PA
state: Florida
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
Study officials:
References:
Clinical trial NCT00523380: Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
Official title: An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Ovarian Cancer
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.


Eligibility criteria: Inclusion Criteria:

* Advanced epithelial Ovarian Cancer (stage IIB-IV)
* Persistent or progressive disease after or relapse within one year of completion of first line therapy
* Measurable or assessable disease
* Eastern Cooperative Oncology Group status less than or equal to 2

Exclusion Criteria:

* History of any other active malignancy
* Signs of CNS metastasis
* More than one prior chemotherapy regimen
* Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks
* First line chemotherapy completed at least 1 month prior to start of treatment

Primary outcomes:
measure: Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
timeFrame: after max. 6 treatment cycles
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Initially
measure: IL-21 antibody formation
timeFrame: For the duration of the trial
measure: Progression free survival
timeFrame: For the duration of the trial
measure: Patient reported outcomes
timeFrame: For the duration of the trial
measure: Biomarker assessments CA-125
timeFrame: For the duration of the trial
Other outcomes:
Locations:
city: Lyon Cedex 08
country: France
facility: Novo Nordisk Investigational Site
city: Marseille
country: France
facility: Novo Nordisk Investigational Site
city: Saint-Herblain Cedex
country: France
facility: Novo Nordisk Investigational Site
city: Villejuif
country: France
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Wiesbaden
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02561780: Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma
Official title: Youth Mental Health Awareness Study and Early Intervention Research Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Education Curriculum
Comparative Effectiveness Research
Early Intervention
Adolescents
Keywords: Mental Health Knowledge
Stigma
Mental Health Literacy
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 534
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study examines the effectiveness of a school based mental health literacy intervention for high school students, on improving mental health knowledge and reducing stigma. Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to either the curriculum or control condition at a two to one ratio. The educational curriculum was integrated within grade 11 and 12 Provincial "Healthy Living" courses, delivered by teachers, and replaced existing educational content on mental health.

Detailed description: There is limited evidence and consensus on the effectiveness of school-based mental health educational programs, and no standardization for mental health education being taught in schools. This study examines the effectiveness of a school-based mental health literacy intervention for adolescents, on knowledge and stigma. A secondary objective was to determine the generalizability and applicability of an educational resource for mental health in high schools.

Eligibility criteria: Inclusion Criteria:

* Students enrolled in the Healthy Living course of participating Ottawa area community high schools.

Exclusion Criteria:

* Students not enrolled in the Healthy Living course of participating Ottawa area community high schools.
* Students with an English reading and comprehension level lower than the sixth grade

Primary outcomes:
measure: Self-Report Knowledge of Mental Illness Scale
timeFrame: Immediately following completed delivery of The Curriculum Guide
measure: Self-Report Attitudes Towards Mental Illness Scale
timeFrame: Immediately following completed delivery of The Curriculum Guide
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Robert P Milin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milin R, Kutcher S, Lewis SP, Walker S, Wei Y, Ferrill N, Armstrong MA. Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):383-391.e1. doi: 10.1016/j.jaac.2016.02.018. Epub 2016 Mar 8.
Clinical trial NCT06347380: Usability Study of the FemPulse System
Official title: Usability Study of the FemPulse System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Keywords: neuromodulation
Lead sponsor: FemPulse Corporation
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.


Eligibility criteria: Key Inclusion Criteria:

* Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician
* Able to read, comprehend, and reliably provide informed consent and study-related information.
* Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
* Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.

Key Exclusion Criteria:

* Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
* Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
* Not an appropriate study candidate as determined by investigator.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Women's Hospital
state: Florida
city: Seattle
country: United States
facility: Univ. of Washington
state: Washington
Study officials:
affiliation: Sponsor GmbH
name: Roshini Jain
role: STUDY_DIRECTOR
References:
Clinical trial NCT05315180: A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
Official title: A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignant Neoplasms
Metastatic Cancer
Keywords: Antineoplastic Agents
KRAS
NSCLC
Colorectal Cancer
Pancreatic Cancer
KRAS G12C
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Pathologically documented, locally-advanced or metastatic malignancy
* Standard treatment is not available or patient declines
* Adequate organ function

Exclusion Criteria:

* Active brain metastases from non-brain tumors.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
* Other protocol specified criteria

Primary outcomes:
measure: Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies
timeFrame: 20 months
measure: determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen
timeFrame: 20 months
Secondary outcomes:
measure: Evaluate the pharmacokinetics of BPI-421286
timeFrame: 20 months
measure: To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286
timeFrame: 20 months
measure: To evaluate the duration of response (DOR) in subjects with CR or PR as best response
timeFrame: 20 months
measure: to evaluate the disease control rate (DCR)
timeFrame: 20 months
measure: To evaluate progression-free survival (PFS) following initiation of BPI-421286
timeFrame: 20 months
measure: To evaluate overall (OS) following initiation of BPI-421286
timeFrame: 20 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shun Lu, Ph.D
state: Shanghai
city: Tianjin
country: China
facility: Dingzhi Huang, Ph.D
state: Tianjin
city: Hangzhou
country: China
facility: Wen Li, Ph.D
state: Zhejiang
city: Hangzhou
country: China
facility: Yun Fan,Ph.D
state: Zhejiang
city: Shanghai
country: China
facility: Shun Lu, Ph.D
Study officials:
References:
Clinical trial NCT00135980: Integrated Care for Cancer Patients; Developing, Implementing and Testing a Programme to Improve Integrated Care
Official title: Integrated Care for Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The purpose of this study is to compose, implement and evaluate a programme to improve the quality of integrated care for patients with cancer.

Literature will be searched for components of integrated care programmes. On the basis of evidence based multi-disciplinary guidelines and literature on integrated care programmes, a set of indicators will be composed. This set will be measured in 6 hospitals on patients with non-small-cell-lung cancer. In two hospitals, an integrated care programme will be implemented and effects on processes and outcomes of care will be measured.


Eligibility criteria: Inclusion Criteria:

* Each new patient that visits the lung specialist in 6 hospitals in the east part of Holland, in the period from September 2004 till March 2005

Exclusion Criteria:

* Mortality

Primary outcomes:
measure: guideline adherence
Secondary outcomes:
measure: hospitalization
measure: satisfaction
measure: quality of life
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Boxmeer
country: Netherlands
facility: MaasHospital Pantein
city: Doetinchem
country: Netherlands
facility: Slingeland Hosptital
city: Ede
country: Netherlands
facility: Gelderse Vallei Hospital
city: Nijmegen
country: Netherlands
facility: CWZ Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
Study officials:
affiliation: Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
name: Rosella Hermens, MSc,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Quality of Care Research, Radboud University Medical Centre
name: Hub Wollersheim, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Ouwens M, Wollersheim H, Hermens R, Hulscher M, Grol R. Integrated care programmes for chronically ill patients: a review of systematic reviews. Int J Qual Health Care. 2005 Apr;17(2):141-6. doi: 10.1093/intqhc/mzi016. Epub 2005 Jan 21.
Clinical trial NCT05046080: Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix
Official title: Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix - a Rare Tumor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with clear cell carcinoma of the cervix, from January 1, 1985 to July 1, 2020

Brief summary: This study aims to provide a comprehensive report on clinicopathologic features, immunohistochemical/biomarker testing and molecular profile of cervical clear cell carcinoma. This study may help researchers learn more about the molecular profile of cervical clear cell carcinoma.

Detailed description: PRIMARY OBJECTIVE:

I. To perform a retrospective clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix at M D Anderson Cancer Center (MDACC) and to delineate the immunohistochemical and molecular profile of these cases.

OUTLINE:

Patients' medical records are reviewed retrospectively, and archival tumor tissue analyzed by immunohistochemistry and next generation sequencing.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with clear cell carcinoma of the cervix at MDACC

Primary outcomes:
measure: Clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anasis Malpica
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545880: Kinesiotaping and Post-dry Needling Soreness
Official title: Effects of Kinesiotaping on Post-Needling Soreness by Dry Needling on Active Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Neck Pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Since Kinesiotaping has been advocated for decreasing tone in the muscle tissues, it would be a potential intervention for this objective.


Eligibility criteria: Inclusion Criteria:

- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature

Exclusion Criteria:

* any contraindication to dry needling
* whiplash injury;
* previous cervical surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone any therapy intervention for the neck are in the previous 6 months;
* fear to needles;
* less than 18 or greater than 65 years of age.

Primary outcomes:
measure: Changes in post-dry needling pain intensity before and after the intervention
timeFrame: Baseline, immediately after, 24 hours after, 48 hours after and 72 hours after treatment
Secondary outcomes:
measure: Changes in cervical related-disability before and after the intervention
timeFrame: Baseline and 72 hours after treatment
measure: Changes in upper extremity related-disability before and after the intervention
timeFrame: Baseline and 72 hours after treatment
measure: Changes in pressure pain sensitivity
timeFrame: Baseline, immediately after and 72 hours after treatment
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: