louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02810002: Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
Official title: Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Blister
Abrasion
Stress Fracture
Ankle Sprain
Patellofemoral Pain Syndrome
Back Pain
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 98
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One hundred infantry recruits will be randomly assigned to two groups. Injuries will be monitored.

Detailed description: One hundred infantry recruits will be randomly assigned to receive experimental infantry boots (DEFINITE-REGULATOR) or standard issued boots (modified Belleville 390 TROP).

Overuse injuries and foot injuries will be monitored over a period of 14 weeks. The intervention group will wear experimental infantry boots and the controls will wear standard issue boots.

Eligibility criteria: Inclusion Criteria:

* Infantry recruits on selected base

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of recruits with at least one injury related to the boots
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Milgrom C, Sorkin A, Gam A, Singer J, Nir I, Kogan B, Finestone AS. The search for the best infantry boot. Disaster Mil Med. 2016 Oct 10;2:14. doi: 10.1186/s40696-016-0024-5. eCollection 2016.
Clinical trial NCT01370902: Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
Official title: A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Innate Pharma
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 92
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: This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
* Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
* Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
* Males must be willing to use highly effective contraception
* Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation

Primary outcomes:
measure: Incidence of adverse events
timeFrame: from trial product administration to week 12
Secondary outcomes:
measure: Antibodies against NNC141-0100
timeFrame: from trial product administration until final visit (week 12 or longer if applicable)
measure: Area under the serum concentration-time curve - SD trial part
timeFrame: from trial product administration until final visit (week 12 or longer if applicable)
measure: Terminal half-life (t½) - SD trial part
timeFrame: from trial product administration until final visit (week 12 or longer if applicable)
measure: Terminal half-life (t½) - MD trial part
timeFrame: from trial product administration until final visit (week 12 or longer if applicable)
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Innate Pharma
name: Renaud Buffet
role: STUDY_DIRECTOR
References:
Clinical trial NCT00073502: Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer
Official title: A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Adenocarcinoma
Gastric Adenocarcinoma
Lead sponsor: OSI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-11-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.


Eligibility criteria: Inclusion Criteria:

Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age \>= 18 years At least one target lesion

Exclusion Criteria:

Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
city: B-3000 Leuven
country: Belgium
facility: Dept Internal Medicine Gastrointestinal Oncology Unit
city: Bristol
country: United Kingdom
facility: Bristol Haematology & Oncology Centre
state: Avon
city: Oxford
country: United Kingdom
facility: ICRF Medical Oncology Unit
state: Oxfordshire
city: Wolverhampton
country: United Kingdom
facility: Deanesly Centre
state: West Midlands
city: Belfast
country: United Kingdom
facility: NICCTU, East Podium, C-Floor
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
city: Manchester
country: United Kingdom
facility: Department of Medical Oncology
Study officials:
References:
Clinical trial NCT04412902: Predictors of Recurrence for High Risk Endometrial Cancer Patients
Official title: Predictors of Recurrence for High Risk Endometrial Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-risk Endometrial Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All high risk endometrial cancer patients

Brief summary: This study will analyze whether there is any difference in recurrence and survival rates among the patients who received different adjuvant therapies.

Detailed description: The incidence of endometrial cancer is gradually increasing nowaday. The postoperative treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of high-risk endometrial cancer is high.The investigators retrospective study will analyze the factors associated with recurrence of endometrial cancer, especially for different adjuvant therapies.

Eligibility criteria: Inclusion Criteria:

* All patients with high risk stage I endometrial cancer and all patients with stage II and stage III endometrial cancer and who underwent therapy in Far Eastern Memorial Hospital from 2009/01/01\~2019/09/17.

Exclusion Criteria:

* Patients with stage I endometrial cancer do not have high risk factors.

Primary outcomes:
measure: Factors affecting overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Factors affecting progression-free survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01701102: Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Official title: Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Knee Surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 18-60
* Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.

Exclusion Criteria:

* Subjects aged \<18 or \>60
* Subjects greater than 190 cm in height
* Patients scheduled for ligament reconstruction or surgery involving bone
* Daily use of narcotics for greater than one week pre-op

Primary outcomes:
measure: Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
timeFrame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT00715702: Safety Study of AZD5672 in Renally Impaired Subjects
Official title: An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: AZD5672
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent.
* Females should not be of childbearing potential
* Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.

Exclusion Criteria:

* Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin \>20mg once daily, medications that prolong QT/QTc interval
* Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
* Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study period
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the treatment period
Other outcomes:
Locations:
city: München
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Charnwood, UK
name: Rod Hepburn
role: STUDY_DIRECTOR
affiliation: APEX GmbH
name: Angelika Weil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06807502: Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
Official title: Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer, Metastatic
Breast Cancer Invasive
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: CTC
Circulating Tumor Cells
Detection
Breast Cancer
Follow-up
Liquid Biopsy
Blood Test
Lead sponsor: ScreenCell
Sponsor class: INDUSTRY
Collaborators: name: AXELYS SANTE
First posted: 2025-02-04
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study with minimal risk and constraints (RIPH2) comparative and open, non-randomized, on an in vitro diagnostic medical device.

A case-control study with longitudinal, prospective, single-center follow-up.
Primary purpose: OTHER

Brief summary: Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.

The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up


Eligibility criteria: INCLUSION CRITERIA

For all participants :

* Age greater than or equal to 18 years

For participants with metastatic breast cancer:

- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.

For participants with non-metastatic invasive breast cancer:

- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)

For healthy volunteers:

* Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest one year before inclusion
* Participant with no history of cancer

EXCLUSION CRITERIA

For all participants:

* Age less than 18 years old
* Refusal to participate or withdrawal of consent
* Pregnant and/or breastfeeding women
* Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.

For participants with breast cancer:

- Absence of CTC during screening

For healthy volunteers:

* History of cancer
* Detection of CTC (positive profile) during screening

Primary outcomes:
measure: Evolution of the kinetics of CTC during treatment
timeFrame: From enrollement to the end of follow up at 9 months
Secondary outcomes:
measure: Molecular characterisation of CTC
timeFrame: From enrollement to the end of follow up at 9 months
Other outcomes:
Locations:
city: Neuilly-Sur-Seine
country: France
facility: CMC Ambroise Paré Hartmann
Study officials:
References:
Clinical trial NCT01442402: APOL1 Gene Variants in African American Kidney Transplant Recipients
Official title: Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Transplant;Failure,Kidney
Kidney Disease
Kidney Failure, Chronic
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American Renal Transplant Patients

Brief summary: Aim 1:

Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans

Aim 2:

Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease

Aim 3:

Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.


Eligibility criteria: Aim 1:

Inclusion Criteria:

* self-reported African American
* 18 years or older
* kidney transplant within 12 years

Aim 2:

Inclusion Criteria for patients with recurrent disease:

* self-reported African American
* 18 years or older
* kidney transplant within 12 years
* recurrent or de novo glomerular disease on allograft kidney biopsy

Inclusion Criteria for control group:

* self-reported African American
* 18 years or older
* kidney transplant within 12 years
* end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy

Exclusion Criteria for control group:

* clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine \>2)

Aim 3:

Inclusion Criteria:

* self-reported African American
* 18 years or older
* scheduled living kidney transplant

Primary outcomes:
measure: Allograft survival
timeFrame: year 1, 3, 5
Secondary outcomes:
measure: Allograft function as measured by serum creatinine
timeFrame: creatinine levels at year-1, year-3 and year-5
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Anil K Chandraker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421902: Acupuncture Treatment for Hot Flashes Study
Official title: Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Hot flashes, prostate cancer, acupuncture
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2007-01-15
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Acupuncture to pevent hot flushes
Primary purpose: TREATMENT

Brief summary: Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks

Detailed description: Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.

Eligibility criteria: Inclusion Criteria:

* Treatment for prostate cancer using hormonal ablation therapy
* Average of three or more hot flashes a day
* Performance Status (Karnofsky ≥ 60)
* Patients must be ≥ 18 years of age
* No other clinically significant disease
* Signed study-specific consent form prior to study entry

Exclusion Criteria:

* Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
* Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)
* Skin infections
* Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.

Primary outcomes:
measure: Relief from the hot flashes as determined by the hot flashes scoring system.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYP- Brooklyn Methodist Hospital
state: New York
Study officials:
affiliation: NY Methodist Hospital
name: Hani Ashamalla, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashamalla H, Jiang ML, Guirguis A, Peluso F, Ashamalla M. Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1358-63. doi: 10.1016/j.ijrobp.2010.01.025. Epub 2010 Jun 3.
Clinical trial NCT01053702: Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Thermal Injury Pain
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2010-01-21
Enrollment: 0
Sex: ALL
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: This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.


Eligibility criteria: Inclusion Criteria:

1. Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury
2. Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days

Exclusion Criteria:

1. Patients with burns caused by chemical exposure or electricity
2. Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection
3. Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries
4. Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments.
5. Women who are pregnant or nursing

Primary outcomes:
measure: Change in procedural pain intensity
Secondary outcomes:
measure: Cumulative analgesic usage
measure: Weekly Patient-rated Global Impression of Change
measure: Additional quality of life assessments
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Paul Tiseo, PhD
role: STUDY_DIRECTOR
References: