louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00502918: Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)
Official title: Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstetrics
Labor
Lead sponsor: Barnev Ltd
Sponsor class: OTHER
First posted: 2007-07-18
Enrollment: 3
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction

Brief summary: The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Detailed description: Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.

To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Eligibility criteria: Inclusion Criteria:

1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
2. Gestational age 37-42 weeks. (GA)
3. Single Fetus.
4. Subjects who understand, agreed and signed the informed consent form.

Exclusion Criteria:

1. Women with abnormal placentation (Placenta previa) -
2. Abnormal fetal presentation (Breech presentation).
3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
4. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Primary outcomes:
measure: Monitoring fetal heart movement
timeFrame: During labour
Secondary outcomes:
Other outcomes:
Locations:
city: Tel - Aviv
country: Israel
facility: Tel Aviv Soraski medical center
Study officials:
affiliation: Sackler School od Medicine , Tel Aviv University
name: Ariel Many, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04601818: Planned Semi-Elective Lung Tx Study
Official title: Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-Of-Concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures
Lung Transplant
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10C cold static preservation upon organ arrival to our hospital using a specific refrigerator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.


Eligibility criteria: Inclusion Criteria:

* Primary lung transplantation
* Informed consent provided

Donor Inclusion: Age\<70

Exclusion Criteria:

* Re-transplantation
* Multi-organ transplantation

Donor exclusion criteria:

* Age \>70y
* Concerns with organ preservation technique

Primary outcomes:
measure: Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)
timeFrame: 72 hours post op
Secondary outcomes:
measure: 1-year survival
timeFrame: procedure up to 1 year post op
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UFHealth Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Mindaugas Rackauskas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04638218: CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - ARR
Official title: CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - Augmented Reality (AR) Rehabilitation Training System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
First posted: 2020-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community.

Our research team had developed the "Augmented Reality (AR) Rehabilitation Training System" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. The system facilitates an active rehabilitative exercise.


Eligibility criteria: Inclusion Criteria

* Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
* Motor impairment in upper-limb, lower-limb, and/or balance;
* No or mild spasticity on the lower-limb or upper-limb (MAS≤2);
* Have sufficient cognition to follow the instructions provided by the rehab system.

Exclusion Criteria

* Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
* Severe shoulder or arm contracture/pain;
* Severe knee or hip contracture/pain
* Pregnant women

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Three months after the last training session
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: Three months after the last training session
measure: Functional Ambulation Category Test
timeFrame: Three months after the last training session
measure: Timed 10-meter Walk Test
timeFrame: Three months after the last training session
measure: 6 Minute Walk Test
timeFrame: Three months after the last training session
measure: Wolf Motor Function Test (WMFT)
timeFrame: Three months after the last training session
measure: Action Research Arm Test (ARAT)
timeFrame: Three months after the last training session
measure: Fugl-Meyer Assessment
timeFrame: Three months after the last training session
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, The Chinese University of Hong Kong
name: Raymond Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091818: Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Official title: A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sedation
Keywords: To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children
treatment
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.

The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.


Eligibility criteria: Inclusion Criteria:

* informed consent from parents
* age between 2 and 18 years
* anticipated need of respirator treatment for more than 24 hrs
* included in study within 48 hrs of admission to intensive care unit (ICU)

Exclusion Criteria:

* severe, unstable circulatory failure
* severe intracranial or spinal trauma with circulatory instability
* sever bradycardia or atrioventricular (A-V) block
* liver failure
* less than 50% chance of anticipated survival
* known allergy to study drugs

Primary outcomes:
measure: Time from end of sedation to extubation
timeFrame: 1-24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Study officials:
References:
Clinical trial NCT05745818: Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Official title: Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periprocedural Myocardial Infarction
Periprocedural Myocardial Injury
Keywords: Colchicine - PCI - PPMI
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IHD patients in IMD sohag university hospital prepared for elective PCI

Brief summary: Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.

Detailed description: Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are:

1. group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour.

   N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.)
2. control group of patients. Number of patients according to sample size equation.

Sample size equation is used to calculate the minimum size of the required sample:

n = (z)2 p (1- p) / d2

* Number of patients according to sample size equation about 300 patients 150 patient in each group of study.
* Estimated study duration 2 years.
* N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on.

Eligibility criteria: Inclusion Criteria:

1. Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .
2. PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).
3. PPMI (rise in post-PCI troponin plus new evidence of ischemia).

Exclusion Criteria:

1. Patients with active infections.
2. Patients taking anti-inflammatory medications.
3. Patients presented with ACS( still rising troponin).
4. Severe renal impairment ( creatinine clearance \< 45 ml/min ).
5. Primary PCI, rescue PCI, pharmacoinvasive therapy.
6. Connective tissue diseases.

Primary outcomes:
measure: MACEs
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04434118: Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients
Official title: Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
COVID
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients fulfilling 2010 ACR-EULAR classification criteria for RA

Brief summary: Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.


Eligibility criteria: Inclusion Criteria:

- Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.

Exclusion Criteria:

* The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.
* Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)
* Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.

Primary outcomes:
measure: The risk of COVID-19 infection among RA patients
timeFrame: 12 week
Secondary outcomes:
measure: The incidence of hospitalization for Covid-19 patients.
timeFrame: 12 week
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00964418: A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)
timeFrame: 0-24 hours (derived on treatment day 6)
Secondary outcomes:
measure: Area under the NN1250 concentration-time curve during one dosing interval at steady state
timeFrame: 0-24 hours (derived on treatment day 6)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Korsatko S, Deller S, Mader JK, Glettler K, Koehler G, Treiber G, Urschitz M, Wolf M, Hastrup H, Sondergaard F, Haahr H, Pieber TR. Ultra-long pharmacokinetic properties of insulin degludec are comparable in elderly subjects and younger adults with type 1 diabetes mellitus. Drugs Aging. 2014 Jan;31(1):47-53. doi: 10.1007/s40266-013-0138-0.
citation: Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.
Clinical trial NCT00814918: Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris
Official title: Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne vulgaris
acne
dermatalogy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-12-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare how efficient two different types of PDTs are when used in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela V-beam Pulse Dye Laser.


Eligibility criteria: Inclusion Criteria:

* 18-79 years of age
* Patients who failed the topical and oral antibiotics after 6 month therapy.
* Patients who failed the topical retinoids after 6 month therapy.
* Patients that are not good candidate to start oral isotretinoin (Accutane) due to contraindications.

Exclusion Criteria:

* Patients who have had Isotretinoin therapy less that 1 year prior to this ALA-PDT procedure.
* Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
* Patients with a history of porphyria.

Primary outcomes:
measure: Acne complete /incomplete therapy and reoccurence
timeFrame: 18 months
Secondary outcomes:
measure: Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
timeFrame: 2-18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Maria Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04920513: Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.
Official title: Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Predisposition
Keywords: Genetics
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients who fulfill the inclusion/exclusion criteria and are diagnosedat KHCC will be invited.

A total of 3000 patients are estimated to participate

Brief summary: The investigators aim to study the pattern and frequency of pathogenic variants among ALL newly diagnosed cancer patients in a genetically distinct population.

Additionally, the investigators will study the uptake rate of "cascade family screening", frequency of pathogenic variants and barriers against testing.


Eligibility criteria: Inclusion Criteria:

* Adult patient, age ≥ 18 years at time of cancer diagnosis
* Pathology proven diagnosis of cancer; any site, any stage (prior history of cancer is allowed)
* Jordanian nationality
* Willingness to participate
* Signed consent form

Exclusion Criteria:

* Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications)
* Non-Jordanian
* Patients with Leukemia, Lymphoma and Myeloma

Primary outcomes:
measure: Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing
timeFrame: 2021-2023
measure: Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing
timeFrame: 2021-2023
measure: To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.
timeFrame: 2021-2023
Secondary outcomes:
measure: Rate of cascade of family member testing of the participants with positive pathogenic mutation
timeFrame: 2021-2023
measure: Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel
timeFrame: 2021-2023
measure: Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing
timeFrame: 2021-2023
measure: To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation
timeFrame: 2021-2023
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: King Hussein Cancer Center
name: Hikmat Abdel-Razeq
role: PRINCIPAL_INVESTIGATOR
References: