louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02885779: Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.
Official title: Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 16
Sex: FEMALE
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: Operating indication of adnexa surgery : unilateral or bilateral adnexectomy

Brief summary: The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.

There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.

The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.


Eligibility criteria: Inclusion Criteria :

* Age \> 18 ans
* OMS = 2
* Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy

Exclusion Criteria:

* Contraindication to coelioscopy intervention

Primary outcomes:
measure: Immediate post operative pains
timeFrame: Up to 1 month
measure: Court term post operative pains
timeFrame: Up to 2 month
measure: Medium term post operative pains
timeFrame: Up to 3 month
Secondary outcomes:
measure: Complications per operating
timeFrame: During surgery
measure: Complications per operating
timeFrame: During surgery
measure: Complications post operating
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du-Rhône
Study officials:
References:
Clinical trial NCT01353079: Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy And Safety Trial Of Sublingual-Oral Immunotherapy (SLIT) In Adults With Allergic Rhinoconjunctivitis Caused By Ragweed Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Lead sponsor: Greer Laboratories
Sponsor class: INDUSTRY
First posted: 2011-05-12
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.


Eligibility criteria: Inclusion Criteria:

* allergic to ragweed

Exclusion Criteria:

* not allergic to ragweed
* history of anaphylaxis
* subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
* Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
* Subjects who have received experimental drug within 30 days prior to study admission
* Subjects who have received anit-IgE medications in the last 12 months
* Subjects who have received ragweed immunotherapy in the last 3 years
* Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
* Subjects refusing to sign epi-pen training form
* Females who are pregnant or breast feeding

Primary outcomes:
measure: Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]
timeFrame: 2011 ragweed pollen season, 8/2011 -10/2011
Secondary outcomes:
measure: Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)
timeFrame: 3 peak weeks of the 2011 ragweed pollen season
measure: Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)
timeFrame: 2011 ragweed pollen season; 8/2011 - 10/2011
measure: Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)
timeFrame: 3 peak weeks of the 2011 ragweed pollen season
Other outcomes:
Locations:
city: Warrenton
country: United States
facility: Site 7
state: Virginia
Study officials:
References:
Clinical trial NCT04424979: Feasibility Tests for Various Prism Configurations for Visual Field Loss
Official title: Visual Field Expansion Through Innovative Multi-Periscopic Prism Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemianopia, Homonymous
Tunnel Vision
Visual Field Defect, Peripheral
Visual Field Constriction Bilateral
Visual Field Defect Homonymous Bilateral
Keywords: Visual field expansion
Prisms
Hemianopsia
Tunnel vision
Visual field loss
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2020-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators will develop and test different configurations of high-power prisms to expand the field of vision of patients with visual field loss to assist them with obstacle detection when walking. The study will involve multiple visits (typically four) to Schepens Eye Research Institute for fitting and testing with the prism glasses. The overall objective is to determine best designs and fitting parameters for implementation in prism devices for future clinical trials.


Eligibility criteria: Inclusion Criteria:

* Visual field loss, either peripheral field loss or hemianopic field loss
* Visual acuity of at least 20/50 in the better eye
* In sufficiently good health to be able to complete sessions lasting 2-4 hours
* Able to independently walk short distances
* Able to give voluntary, informed consent
* Able to speak English

Exclusion Criteria:

* Any physical or mental impairments, including cognitive dysfunction, balance problems or other deficits that could impair the ability to walk or use the prism spectacles
* A history of seizures in the last 6 months
* Hemispatial neglect (subjects with hemianopic field loss only)

Primary outcomes:
measure: Field of view expansion
timeFrame: Through study completion, an average of four months
Secondary outcomes:
measure: Pedestrian detection rate
timeFrame: Through study completion, an average of four months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schepens Eye Research Institute
state: Massachusetts
Study officials:
affiliation: Schepens Eye Research Institute of Massachusetts Eye and Ear
name: Eliezer Peli, MSc, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550779: What Makes People Better at Retrieving Proper Names?
Official title: What Makes People Better at Retrieving Proper Names?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Keywords: cognitive aging
name retrieval
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-09-22
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two mental exercises before performing a proper name production task and completing other measures.
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Participants will perform a brief mental exercise, then see 83 celebrity photographs to produce the names of. Participants will also complete other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to proper name production.

Detailed description: This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Adult participants ages 18-35 and 60-80 will participant in videoconference calls during which they will perform a brief mental exercise, then see 83 celebrity photographs with instructions to name each pictured person. The naming task will be video recorded for later scoring. Participants will also complete other surveys and measures, including some about demographics and other personal characteristics. Participation will take approximately 60-75 minutes. Collected will be de-identified and the aggregate data will give researchers a better understanding about how individual's personality and cognitive traits and the mental exercise performed before the study relate to people's proper name production.

Eligibility criteria: Inclusion Criteria:

* fluent speaker of English
* ages 18-35 or 60-80
* lived in the United States for at least 5 years

Exclusion Criteria:

-

Primary outcomes:
measure: Percent of Familiar Faces With TOT Responses
timeFrame: During the 60-75 minute experimental session
measure: Percent of Known Names With TOT Responses
timeFrame: During the 60-75 minute experimental session
measure: Percent of Unknown Names With TOT Responses
timeFrame: During the 60-75 minute experimental session
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: UCCS
state: Colorado
Study officials:
affiliation: University of Colorado, Colorado Springs
name: Lori James, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05340179: Efficacy of Cervical Epidural Injection and Selective Nerve Root Block
Official title: Comparison of the Efficacy of Cervical Epidural Steroid Injection and Selective Nerve Root Block in Patients With Cervical Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical epidural steroid injections are an accepted treatment modality for radicular pain secondary to disc pathology. With the developing ultrasound technology, ultrasound guided cervical selective nerve root block has been successfully used in the treatment of cervical radiculopathy. We aimed to compare the efficacy of cervical interlaminar epidural injections and cervical selective nerve root block.


Eligibility criteria: Inclusion Criteria:

* Cervical radicular pain based on history and physical exam
* NRS pain score \> 3

Exclusion Criteria:

* Previous spine surgery
* Allergic reactions to drugs used in procedure
* Epidural steroid injection within past 2 years
* Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
* Untreated coagulopathy

Primary outcomes:
measure: Reduction in pain
timeFrame: Change from baseline pain score to 6months
Secondary outcomes:
measure: Neck Disability Index
timeFrame: baseline to 6 months post-procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: selin guven kose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02664779: Determination and Comparison of Short-term Effectiveness of Three Methods Used for Recognition of Arrhythmias in People With Different Degrees of Medical Training (Advanced Life Support Workshop Participants-ALS): Randomized Controlled Educational Experiment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Arrhythmia recognition is a fundamental skill for the provider of advanced life support (ALS). Acquire it is difficult, leading to the birth of systematic methods in an attempt to simplify and optimize, however, it has not compared the effectiveness among the three methods with more evidence among professionals with varying degrees of medical training (ALS Workshop participants).

Objective: To determine and compare the effectiveness of the three most widespread and with more evidence systematic methods (10, 6 and 4 steps) for the recognition of arrhythmias in a short-term and its perceived easiness among ALS workshop participants.

Methods / design: Educational Cuasi experimental trial with pre and post intervention measurement, blind, with randomized allocation, in 84 ALS workshop participants. Three systematic methods to recognize arrhythmias will be taught and their effectiveness to diagnose in a short-term and its perceived easiness will be measured and compared.


Eligibility criteria: Inclusion Criteria:

* • Health professionals

  * Attend a course in Advanced Life Support in Cali (Colombia), during the study period.
  * Voluntarily accept to participate in the study

Exclusion Criteria:

* No

Primary outcomes:
measure: percentage of subjects who achieve scores greater than or equal to 30
timeFrame: 15 minutes after delivered the intervention
Secondary outcomes:
measure: change in the average scores in the groups
timeFrame: 15 minutes after delivered the intervention
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Cruz Roja Colombiana
state: Valle Del Cauca
Study officials:
References:
Clinical trial NCT00569179: A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
Official title: A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Myelodysplastic Syndromes
Leukemia, Myelogenous, Chronic
Keywords: Myeloid Malignancies
Bone Marrow Transplant
AML
ALL
MDS
CML
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically documented AML, ALL, MDS, CML,
* Identification of haploidentical donor
* LVEF \> 45% corrected
* DLCO \> 50% predicted
* Serum Creatinine \<= 2 mg/dL
* Bilirubin \< 2 x ULN
* AST, ALT \< 2 x ULN
* Age ≤ 65 years
* Performance Status 0-1

Exclusion Criteria:

* Patients relapsing \<6 months after autologous SCT are not eligible.
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
* No HIV disease
* Non-pregnant and non-nursing

Primary outcomes:
measure: Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.
timeFrame: through Day 128
Secondary outcomes:
measure: Assess toxicity associated with the infusion of alloreactive NK cells
timeFrame: through Day 128
measure: Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.
timeFrame: through Day 128
measure: Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.
timeFrame: through Day 128
measure: Describe the frequency and type of infections occurring within the first year following transplantation.
timeFrame: through Day 128
measure: Describe immune reconstitution following transplantation.
timeFrame: through Day 128
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Sherif Farag, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769479: A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects
Official title: A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyloidosis
Lead sponsor: Eidos Therapeutics, a BridgeBio company
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects.

Detailed description: It is planned to enroll 14 subjects who will receive single oral doses of active IMP in a sequential manner over 5 periods, with a minimum of 7days between dosing in each period.

Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females
* Body mass index (BMI) of 18.0 to 32.0kg/m² and a body weight\>50kg as measured at screening
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to adhere to the contraception requirements

Exclusion Criteria:

* Subjects who have received any IMP formulation in a clinical research study within the 90 days prior to Period 1, Day 1
* History of any drug or alcohol abuse in the past 2 years
* Subjects with pregnant or lactating partners
* Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed.
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4g of paracetamol per day or HRT/hormonal contraception) in the 14 days before first IMP administration.

Primary outcomes:
measure: Pharmacokinetic Assessments: Cmax
timeFrame: 72 hours
measure: Pharmacokinetic Assessments: AUC
timeFrame: 72 hours
measure: Pharmacokinetic Assessments: Tmax
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Philip Evans, MBChB, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733979: Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-60 years old
* Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* History of alcohol or substance abuse
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in hemoglobin
timeFrame: 4 weeks
measure: Changes in transferrin saturation
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in serum iron
timeFrame: 4 weeks
measure: Changes in ferritin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: