louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03239626: Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer
Official title: Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_RT Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervix Cancer
Radiotherapy, Adjuvant
Radiotherapy, Intensity-Modulated
Hypofractionated Dose
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group for hypofractionaed IMRT for adjvuant cervical cancer patients
Primary purpose: TREATMENT

Brief summary: To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed cervical cancer
* radical hysterectomy and pelvic lymph node dissection was done
* histologically indicated adjuvant radiotherapy ( more than one as below)

  1. tumor size ≥4 cm
  2. positive lymphovascular invasion
  3. more than half stromal invasion depth
* ECOG performance status 0 or 1
* Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl

Exclusion Criteria:

* positive pelvic lymph node metastasis
* positive distant metastasis (including retroperitoneal lymph node metastasis)
* positive tumor involvement on resection margin
* positive parametrial invasion
* previous history of pelvic radiotherapy
* more than 3 months after radical surgery for cervical cancer
* neoadjuvant chemotherapy was done
* previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix

Primary outcomes:
measure: acute toxicities according to CTCAE v4.0
timeFrame: 3 months
Secondary outcomes:
measure: late toxicities according to CTCAE v4.0
timeFrame: 5-years
measure: Progression free survival rate
timeFrame: 5-years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Park, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06895226: Exercise and Physical Activity in Adults with Acquired Brain Injury
Official title: Exercise and Physical Activity in Adults with Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Acquired brain injury
physical activity
intervention
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Exercise and physical activity in adults with acquired brain injury

Detailed description: Although emerging approaches have emerged in the design of interventions that promote an orientation towards physical activity scientific evidence on their efficacy in this particular population remains limited. This underscores the need for further research to evaluate the efficacy of these intervention approaches in the context of ABI.

Eligibility criteria: Inclusion Criteria:

* Aged more than 18 years of age and present a medical diagnosis of acquired brain injury.
* Have the informed consent completed and signed
* Present a state that allows following indications for the practice of exercise and physical activity.

Exclusion Criteria:

* Have medical comorbidities that contraindicate the safe performance of the program (i.e., cardiac or respiratory instability, uncontrolled seizures).
* Have additional disabling conditions, such as cognitive impairment and/or an inability to communicate with the researcher verbally, in writing, or through an emissary.

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline an through study completion, an average of 1 year
measure: Physical Actvity
timeFrame: Baseline an through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05137626: Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Digoxin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-11-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study of Digoxin and AT-527 (R07496998)


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
timeFrame: Day 1, Day 15
measure: To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
timeFrame: Day 1, Day 15
measure: To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
timeFrame: Day 1, Day 15
measure: To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
timeFrame: Day 1, Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Atea Study Site
state: Quebec
Study officials:
References:
Clinical trial NCT00005126: Vietnam Era Twin (VET) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Blood Disease
Heart Diseases
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To conduct a baseline survey on cardiovascular, respiratory, and other major systemic disease and risk factors in members of the Vietnam Era Twin Registry.

Detailed description: BACKGROUND:

The Vietnam Veteran Twin Registry, maintained by the NAS-NRC, was created with funding from the Veterans Administration. Department of Defense records were searched for subjects born between 1939-1957 and having the same last name and date of birth. Follow-up of induction records determined if the subjects were twins.

The registry supplemented the older World War II Veterans Twin Registry supported by the National Heart, Lung, and Blood Institute. The new registry provided an opportunity to create a resource with Black and Hispanic twins as well as whites. The new registry also included data on greater educational, socioeconomic, and lifestyle diversity than was available in the World War II Veterans Twin Registry.

DESIGN NARRATIVE:

During the first year a mailed questionnaire was designed which provided baseline data on family history, body size, morbidity, psychosocial characteristics, smoking, alcohol consumption, diet, physical activity, and drug use. The baseline data were used for analysis of cardiovascular, pulmonary, and blood diseases, and for follow-up. From the original survey, the Veterans Administration provided magnetic tape data on zygosity, smoking, alcohol consumption, heart, lung, and blood diseases, discharge rank, education, occupation, and family income. The questionnaire was completed by almost 8,900 individuals including over 3,000 twin pairs.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fabsitz RR, Sholinsky P, Goldberg J. Correlates of sleep problems among men: the Vietnam Era Twin Registry. J Sleep Res. 1997 Mar;6(1):50-6. doi: 10.1046/j.1365-2869.1997.00026.x.
Clinical trial NCT00213226: Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
Official title: Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiolitis
Keywords: bronchiolitis
pediatrics
corticosteroids
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department


Eligibility criteria: Inclusion Criteria:

* infants 2 to 24 months of age
* acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
* moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
* only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized

Exclusion Criteria:

* previous wheezing and/or bronchodilator therapy
* hospitalization at 240 minutes
* critically ill patients needing airway stabilization
* patients with low or very high baseline disease severity (RDAI \<5 and \>16)
* patients under 8 weeks of age
* patients on corticosteroids prior to arrival at Emergency Department
* contact with varicella within 21 days
* past history of ventilation for greater than 24 hours
* existing cardiopulmonary disease, multisystem disease or immunodeficiency
* insufficient command of the English language

Primary outcomes:
measure: Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
Secondary outcomes:
measure: Respiratory Assessment Change Score (RACS) at 96 and 144 hours
measure: Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
measure: Proportion of infants with no signs of respiratory distress at 96 and 144 hours
measure: Proportion of infants who are symptomatic at 14 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Suzanne Schuh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuh S, Coates AL, Dick P, Stephens D, Lalani A, Nicota E, Mokanski M, Khaikin S, Allen U. A single versus multiple doses of dexamethasone in infants wheezing for the first time. Pediatr Pulmonol. 2008 Sep;43(9):844-50. doi: 10.1002/ppul.20845.
Clinical trial NCT01032226: Evaluation of CNAP During Anesthesia
Official title: Evaluation of CNAP During Induction and Maintenance of General Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: General Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 45
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 undergoing major surgery with the need for an invasive blood pressure measurement

Brief summary: The purpose of this study is to compare

* the non invasive measurement of arterial pressure (CNAP monitor)
* with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia


Eligibility criteria: Inclusion Criteria:

* Age \>18
* ASA II, III or IV
* weight between 40 and 180 kg; BMI \< 35
* surgical procedure performed in supine position
* normal Allen's test and hand Doppler examination.

Exclusion Criteria:

* cardiac arrhythmias,
* history of vascular surgery or vascular implant in the upper limb

Primary outcomes:
measure: Comparison between both methods of arterial pressure measurement
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06684626: The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment
Official title: The Role of Butirprost® as an Adjuvant in Enhancing the Effect of Antibiotics in Patients Affected by Chronic Bacterial Prostatitis: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Inflammation
Prostate Disease
Chronic Bacterial Prostatitis
Keywords: BACTERIAL PROSTATITIS
ANTIBIOTICS
LUTS
QoL
IPSS
Hyaluronic acid
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bacterial prostatitis (BP) is a common prostatic infection characterized by pain and urinary symptoms, often with negative bacterial cultures from prostatic secretions. It affects young and older men bimodally and significantly impacts quality of life (QoL). Treatment typically involves antibiotics, but a multimodal approach with additional nutraceuticals may enhance outcomes. This work aims to assess the efficacy of Butirprost® in association with fluoroquinolones in patients with Chronic Bacterial Prostatitis (CBP).


Eligibility criteria: Inclusion Criteria:

* patient aged between 18 and 50 years
* symptoms consistent with CBP
* positive Mears-Stamey test

Exclusion Criteria:

* patients younger than 18 years
* history of neurological disease, urinary stones or cancer
* allergy to fluoroquinolones or any components of Butirprost®
* post-void residual \> 50 mL
* Use of alpha-blockers or 5-alpha-reductase inhibitors (5-ARI)
* previous prostatic surgery, antibiotic treatment within four weeks prior to the study
* refusal to provide informed consent and incomplete follow-up data
* Patients testing positive for certain pathogens like Chlamydia trachomatis (Ct), Ureaplasma urealyticum, Neisseria gon-orrhoeae, herpes simplex virus types 1 and 2 (HSV-1/2), and human papillomavirus (HPV)

Primary outcomes:
measure: Change in pain
timeFrame: 30 days
measure: Change in urinary symptoms
timeFrame: 30 days
measure: Change in Quality of Life (QoL)
timeFrame: 30 days
measure: Change in Quality of Life (QoL)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT00715026: Trilogy AB Acetabular Hip System Post Approval Study
Official title: Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Avascular Necrosis
Congenital Hip Dysplasia
Traumatic Arthritis
Keywords: Arthritis
Total Hip
Ceramic
Hip Replacement
Total Hip Arthroplasty (THA)
Joint Disease
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.

Detailed description: To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.

Eligibility criteria: Inclusion Criteria:

* Non-obese patients
* The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
* Patient is willing and able to give informed consent to participate in the follow-up program.
* Patient is suitable for surgery and able to participate in the follow-up program.

Exclusion Criteria:

* Skeletally immature
* Rheumatoid arthritis
* Osteoradionecrosis
* Infection
* Nerve or muscle disease that may have a negative affect on gait or weight bearing
* Loss of abductor musculature in the affected limb
* Poor bone stock
* Poor skin coverage around the hip joint
* Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
* Previous total or cemented hemi-arthroplasty of the affected hip
* Previous pinning or plating of the affected hip
* Patients with heavy labor jobs or extreme activity levels
* Patients who participate in sports activities or require deep flexion
* Patients who are obese
* Patients who have other disabilities
* Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.

Primary outcomes:
measure: Harris Hip Score
timeFrame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years
Secondary outcomes:
measure: Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
timeFrame: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Shrock Orthopedic Research
state: Florida
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Schrock Orthopedic Research
name: Kevin Schrock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania/Penn Presbyterian Hospital
name: Gwo-Chin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02615665: Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases
Official title: Role of CD3+ and NKp46+ Cells in Resected Colorectal Liver Metastases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Liver Metastases
Keywords: NK-cells
T-cells
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal liver metastases scheduled for surgery at our Unit.

Brief summary: The long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome.

Detailed description: The immunoreactivity to CD3+ and NKp46+ cells inside the tumor, at the border between the tumor and the normal liver, and inside the normal liver will be tested by computer-assisted image analyses in patients undergoing liver resection for CLM between 2005 and 2013 preoperatively treated with oxaliplatin or irinotecan with or without bevacizumab or cetuximab. The survival will be assessed in relation to several prognostic factors and to that immunoreactivity.

Eligibility criteria: Inclusion Criteria:

* histological proven colorectal liver metastases
* complete clinical, surgical, pathological and follow-up data

Exclusion Criteria:

* non-radical surgery
* incomplete clinical, surgical, pathological and follow-up data

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
state: Milan
Study officials:
affiliation: Humanitas University, Humanitas Research Hospital IRCCS
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudspeth K, Donadon M, Cimino M, Pontarini E, Tentorio P, Preti M, Hong M, Bertoletti A, Bicciato S, Invernizzi P, Lugli E, Torzilli G, Gershwin ME, Mavilio D. Human liver-resident CD56(bright)/CD16(neg) NK cells are retained within hepatic sinusoids via the engagement of CCR5 and CXCR6 pathways. J Autoimmun. 2016 Jan;66:40-50. doi: 10.1016/j.jaut.2015.08.011. Epub 2015 Aug 30.
citation: Hudspeth K, Pontarini E, Tentorio P, Cimino M, Donadon M, Torzilli G, Lugli E, Della Bella S, Gershwin ME, Mavilio D. The role of natural killer cells in autoimmune liver disease: a comprehensive review. J Autoimmun. 2013 Oct;46:55-65. doi: 10.1016/j.jaut.2013.07.003. Epub 2013 Jul 21.