louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02083549: Evaluating URMC's Massive Transfusion Protocol
Official title: Evaluating the Efficacy of the University of Rochester Medical Center's Massive Transfusion Protocol in Trauma Level 1 Patients Utilizing Thromboelastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorders
Trauma
Acute Coagulopathy
Keywords: Massive Transfusion Protocol
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes level 1 trauma patients brought to the trauma bay for resusitation and are initiated under the Massive Transfusion Protocol.

Brief summary: The purpose of the study is to evaluate the efficacy of the University of Rochester Medical Center's current Massive Transfusion Protocol.

Upon arrival of trauma level one designated patients the treating team evaluates the patient's injuries. If the patient is initiated under the facilities Massive Transfusion Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study. Study procedures include collection of a blood sample following the transfusion of each shipment, through shipment 5, of blood products outlined in the current Massive Transfusion Protocol.

Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic state through resuscitation. One final blood sample will be collected 24 hours following the discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.

Due to the critical need for medical intervention, consent procedure will be waived at time of enrollment. An authorized representative for the patient will be identified and approached to obtain consent for use of data collected.


Eligibility criteria: Inclusion Criteria:

* Trauma level 1 patient initiated under Massive Transfusion Protocol
* Age greater than or equal to 18 years old

Exclusion Criteria:

* Females who are pregnant

Primary outcomes:
measure: Efficacy of Blood product ratio
timeFrame: 24 hours
Secondary outcomes:
measure: Haemostasis clot kinetics
timeFrame: 24 hours
Other outcomes:
measure: Standard clinical data
timeFrame: 24 hours
Locations:
city: Rochester
country: United States
facility: Strong Hospital at University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Majed Refaai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639249: Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Phase IIa Study of Safety and Motor Function Restoration in Subjects Treated With SA4503 Following Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Lead sponsor: M's Science Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-20
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: The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.

Detailed description: Further study details as provided by M's Science Corporation:

Eligibility criteria: Key Inclusion Criteria:

* Males or females 18 years of age or older
* Experienced a stroke from 48 to 72 hours before randomization
* A total score of \>/=4 on the NIHSS, or \>/=2 on the upper or lower extremity motor scores of the NIHSS
* Medically and neurologically stable within 24 hours prior to randomization

Key Exclusion Criteria:

* Patients with transient ischemic attack
* Patients with stroke in progression
* Unstable cardiac, hepatic, or renal disease, or other major medical disorder

Primary outcomes:
measure: Safety and tolerability
timeFrame: 4 weeks
Secondary outcomes:
measure: NIHSS
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
Study officials:
affiliation: Southern General Hospital, Glasgow
name: Keith W Muir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Urfer R, Moebius HJ, Skoloudik D, Santamarina E, Sato W, Mita S, Muir KW; Cutamesine Stroke Recovery Study Group. Phase II trial of the Sigma-1 receptor agonist cutamesine (SA4503) for recovery enhancement after acute ischemic stroke. Stroke. 2014 Nov;45(11):3304-10. doi: 10.1161/STROKEAHA.114.005835. Epub 2014 Sep 30.
Clinical trial NCT02521649: Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer
Official title: An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric Cancer
G17DT
PAS
Insegia
Gastrimmune
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Project Services
name: MPS Research Unit
First posted: 2015-08-13
Enrollment: 52
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.


Eligibility criteria: Inclusion Criteria:

Stage I-III Criteria-

* Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
* Absence of metastatic disease evident from:

  * physical examination
  * the most recent chest X-ray
  * abdominal CT or ultrasound scan
* Life expectancy of at least 3 months
* WHO performance status of 0 to 1
* Written informed consent given

Stage IV Criteria-

* Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
* Life expectancy of at least 3 months
* WHO performance status of 0 to 2
* Written informed consent given

Exclusion Criteria:

* History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
* Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
* Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
* Females who were pregnant, planning to become pregnant or lactating
* Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
* Previous G17DT treatment
* Haematological indicators:

  * Haemoglobin \<10.0g/dl
  * White blood cell count \<4.0 x 109/l
  * Platelets \<100 x 109/l

Primary outcomes:
measure: Measurable Antibody Titer
timeFrame: Up to Week 12
Secondary outcomes:
measure: Overall Survival from date of randomization to death or end of study
timeFrame: Up to Last Patient Last Visit, January 2001
measure: Injection Site Reaction
timeFrame: Through Week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05879549: Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia
Official title: Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in Patient With Hemophilia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemophilia A
Hemophilia B
Keywords: hemophilia
exercise
balance
proprioception
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 63
Sex: MALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemophilia is a bleeding disorder caused by a deficiency of clotting factors in the blood. Muscle and joint bleeding are frequently observed in patients with hemophilia. Lower extremity bleeding can adversely affect balance, gait, and proprioception. The goal of this study; To compare the effectiveness of closed kinetic chain exercises and proprioceptive exercises on balance, proprioception and gait parameters in adolescent and young hemophilic individuals with lower extremity joint involvement.

The main question it aims to answer is:

Are the effects of closed kinetic chain exercises and proprioceptive exercises different on balance and walking in hemophilic individuals?


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Hemophilia A and Hemophilia B
* Having a blood factor level below 5%,
* Between 13-25 years old
* History of bleeding to the lower extremity and target joint
* Total lower extremity Hemophilia joint health score ≥3
* Using prophylaxis

Exclusion Criteria:

* Having undergone lower extremity surgery in the last 6 months
* Having a Body Mass Index over 30 kg/m2
* Have an inhibitor
* Using a walking aid

Primary outcomes:
measure: Medio-lateral and Anterior-posterior stability index
timeFrame: 12 weeks
measure: walking speed
timeFrame: 12 weeks
measure: Hemophilia joint health score
timeFrame: 12 weeks
Secondary outcomes:
measure: Single leg stance test
timeFrame: 12 weeks
measure: Proprioception
timeFrame: 12 weeks
measure: 2-dimensional video-based gait kinematic analysis
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrahpaşa
Study officials:
References:
citation: Tat NM, Tat AM, Oner AF, Karaman K, Kaplan S, Can F. Static postural balance evaluation and an investigation of the relationship with joint health in children with severe haemophilia: a controlled cross-sectional study. Haemophilia. 2021 Mar;27(2):e245-e252. doi: 10.1111/hae.14240. Epub 2021 Jan 24.
Clinical trial NCT01038349: Applications for Methotrexate Optimization in Rheumatoid Arthritis
Official title: Applications for Methotrexate Optimization in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Cypress Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care and Rheumatology Clinics

Brief summary: The goal of this study is to enable the study sponsor to assess the impact of a marketed or validated blood test has on physicians' clinical treatment decision making when treating RA patients who have been taking methotrexate.

Ultimately, the blood test will allow treating physicians to modify current methotrexate therapy in partially responding Rheumatoid Arthritis (RA) patients' therapy, on an individualized basis, as a means of improving clinical outcomes.

The study requires a blood sample from RA patients who have been on methotrexate therapy for a minimum of 3 months and are having an inadequate response to therapy. Physicians will then be provided with the results of the test indicating the methotrexate polyglutamate (active metabolites of methotrexate) levels in the patient's red blood cells as a means to help determine whether a patient's exposure to methotrexate has been optimized.

Detailed description: This study is currently enrolling individuals who have an established diagnosis of RA and are receiving methotrexate as part of their therapy. Patients are required to submit a blood sample. There is no cost to volunteers who participate.

Eligibility criteria: Inclusion Criteria:

* Able to read, understand, and sign the informed consent form
* Able to read, write, and speak English
* ≥18 years of age
* Diagnosed with RA within past 24 months (waiver)
* Taking oral methotrexate therapy for a minimum of 3 months
* Considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing MTX dose or changing route of delivery, or adding or switching DMARDs (including but not limited to biologic DMARDs)

Exclusion Criteria:

* Prior exposure of the study center, study physician or study patient to the Avise PG laboratory test
* Patients with known abnormal hepatic and or hematological parameters
* Use of prednisone \>10mg/day (or its equivalent)
* Rheumatologic diagnosis other than primary RA

Primary outcomes:
measure: To assess the impact of the Avise PG test on physician's clinical treatment decision making process when assessing RA patients having an inadequate response to current MTX therapy.
timeFrame: Outcome is determined following the receipt of Avise PG test result
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cypress Bioscience, Inc.
name: R. Michael Gendreau, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01605149: Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence
Official title: Type 1 DM Bone Mineral Density in Childhood and Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with Type 1 DM

Brief summary: Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is unclear how and when it effects the bone density. The investigators are studying the effects of diabetes on bone mass compared to children without diabetes.


Eligibility criteria: Inclusion Criteria:

* We will recruit children from age 5 to age 18 with a diagnosis of Type 1 DM. Children will have various lengths of time since diagnosis.

Exclusion Criteria:

* We will exclude children on anticonvulsants or steroids and children with other concomitant illnesses that interfere with bone mass accrual, except for hypothyroidism on treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura AG Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462249: Impact of Catch-up HPV Vaccination
Official title: Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HPV
HPV Vaccination
Vaccine Preventable Disease
Cervical Lesion
Cervical Cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 354
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 25 and 38 years old in 2022 coming for a HPV or smear test during the study period.

Brief summary: Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed.

HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination.

Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status.

The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.


Eligibility criteria: Inclusion Criteria:

* Age limit
* Patient must have done a HPV or smear test during the study period
* Consent necessary

Exclusion Criteria:

* Age limit
* No HPV or smear test done in the study period
* Patient not able to give her consent

Primary outcomes:
measure: Test HPV and smear test result.
timeFrame: 13 months.
Secondary outcomes:
measure: Test HPV and smear test result.
timeFrame: 13 months.
measure: Test HPV and smear test result.
timeFrame: 13 months.
measure: Test HPV and smear test result.
timeFrame: 13 months.
measure: Test HPV and smear test result regarding the cervical cancer risk factors.
timeFrame: 13 months.
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de BREST
state: Finistère
Study officials:
affiliation: Head of the gynecologic department in Brest Hospital
name: Philippe MERVIEL, PU-PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04639349: Effect of Home Exercise Activity on Cortisol and Depression in COPD During the Pandemic COVID
Official title: Effect of Home Exercise Activity on Cortisol and Depression in COPD Patients During the Pandemic COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: exercise activity during the COVID pandemic is appreciated to be conducted in home especially for chronic chest diseases as chronic obstructive pulmonary disease (COPD) to reduce the chance of viral contamination during the COVID-19 pandemic.

Detailed description: 40 COPD men will be divided to exercise group (20 patients) and control group (20 patients):

the exercise group will receive a exercise session contains a fifty minutes exercise training at home with moderate intensity on the available training devices as bicycle or treadmill in addition to 30 minutes of exercising of upper and lower limb, the session will be repeated three times per week for eight weeks.

The control group will not be trained

Eligibility criteria: Inclusion Criteria:

* stable COPD patients
* patients who will have a training device as bicycle or treadmill in home

Exclusion Criteria:

* diabetic patients
* renal patients.
* liver diseases

Primary outcomes:
measure: cortisol
timeFrame: It will be measured after eight weeks of training
measure: hospital anxiety and depression scale
timeFrame: It will be measured after eight weeks of training
Secondary outcomes:
measure: pulmonary function test
timeFrame: It will be measured after eight weeks of training
measure: Interleukin-8
timeFrame: It will be measured after eight weeks of training
measure: body mass index
timeFrame: It will be measured after eight weeks of training
measure: six minute walking test
timeFrame: It will be measured after eight weeks of training
measure: St. George's respiratory questionnaire
timeFrame: It will be measured after eight weeks of training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847249: AZD9164 Single Ascending Dose Study in Healthy Male Subjects
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Single Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
healthy
inhalation
Healthy males
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examinations
* Use of any prescribed or non-prescribed medication

Primary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: up to 48 hours post-dose.
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: up to 48 hours post-dose.
measure: Local and extrapulmonary effects
timeFrame: up to 48 hours post-dose.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Anders Luts
role: STUDY_DIRECTOR
affiliation: Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden
name: Ulf Malmqvist
role: PRINCIPAL_INVESTIGATOR
References: