louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04208841: Quality Improvement of Person-Centered Care for Maternal Health in Public Facilities in India, Phase 2
Official title: Strengthening Person-centered Accessibility, Respect, and Quality of Maternal Health Services in India, Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Health
Keywords: Maternal Health
India
Person-Centered Care
Quality Improvement
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Population Services International
First posted: 2019-12-23
Enrollment: 1971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services.

Detailed description: After implementing a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India, a second phase was done to evaluate if the "change package" developed during phase one could be implemented in similar facilities to improve the quality of person-centered care (PCC) for a maternal health (MH) services.

Eligibility criteria: Inclusion Criteria for Women:

* Women aged 18-49 years old
* Who agreed to participate
* Who delivered a baby at the facility where data collection is taking place within the last 7 days

Exclusion Criteria for Women:

* Not a women aged 18-49
* Did not agree to participate
* Did not deliver a baby at the facility where data collection is taking place within the last 7 days

Inclusion Criteria for Providers:

* Agreed to participate
* Purposive sampling
* Permanent staff at the facility

Exclusion Criteria for Providers:

* Did not agree to participate
* Not permanent staff at the facility

Primary outcomes:
measure: Person-Centered Maternal Health Scale Score
timeFrame: baseline
measure: Person-Centered Maternal Health Scale Score
timeFrame: About 12 month post baseline
measure: Person-Centered Scale Score
timeFrame: baseline
measure: Person-Centered Scale Score
timeFrame: About 12 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Population Services International
state: Uttar Pradesh
Study officials:
affiliation: University of California, San Francisco
name: Dominic Monatgu, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sudhinaraset M, Giessler K, Nakphong MK, Roy KP, Sahu AB, Sharma K, Montagu D, Green C. Can changes to improve person-centred maternity care be spread across public health facilities in Uttar Pradesh, India? Sex Reprod Health Matters. 2021 Dec;29(1):1-15. doi: 10.1080/26410397.2021.1892570.
citation: Montagu D, Giessler K, Nakphong MK, Green C, Roy KP, Sahu AB, Sharma K, Sudhinarset M. A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India. BMC Health Serv Res. 2020 Dec 4;20(1):1121. doi: 10.1186/s12913-020-05960-6.
Clinical trial NCT06045741: Virtual Reality - A New Vision on Pain
Official title: Virtual Reality - A New Vision on Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Pain, Chronic
Musculoskeletal Disorder
Musculoskeletal Pain
Musculoskeletal Diseases or Conditions
Musculoskeletal Neck Pain
Back Pain
Keywords: Virtual Reality
VR
Long lasting pain
Long-term
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 33
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: Patients with chronic pain conditions, referred to the outpatient clinic at the division of physical medicine and rehabilitation at Vestfold Hospital Trust.

Brief summary: The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.

The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.

VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.


Eligibility criteria: Inclusion Criteria:

* pain duration \> 3 moths
* Master Norwegian spoken language

Exclusion Criteria:

* History of malignant disease
* pain duration \< 3 Months
* Does not master Norwegian spoken language
* Epilepsy

Primary outcomes:
measure: PROMIS Pain interference
timeFrame: Three months
measure: PROMIS Pain intensity
timeFrame: Three months
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Three months
measure: EQ-5D-5L
timeFrame: Three months
measure: PROMIS Physical Function
timeFrame: Three months
measure: PROMIS Emotional Distress - Anxiety
timeFrame: Three months
measure: PROMIS Emotional Distress - Depression
timeFrame: Three months
measure: PROMIS Physical Health - Sleep Disturbance
timeFrame: Three months
measure: PROMIS Social Health - Ability to Participate in Social Roles and Activities
timeFrame: Three months
measure: PROMIS Physical Health - Fatigue
timeFrame: Three months
measure: RTWSE-11 Return ti work self efficacy
timeFrame: Three months
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold
Study officials:
References:
Clinical trial NCT01364441: Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Official title: A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-2950
healthy adult subjects
first in human
safety
tolerability
pharmacokinetics
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria:

* History or presence of clinically significant disease

Primary outcomes:
measure: Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events
timeFrame: up to 8 days
Secondary outcomes:
measure: Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample
timeFrame: up to 8 days
measure: Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions
timeFrame: up to 24 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Clinical Site
state: Texas
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
citation: Suto F, Wood AT, Kobayashi M, Komaba J, Duffy K, Bruce M. Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Ther. 2015 Sep;37(9):2071-84. doi: 10.1016/j.clinthera.2015.07.010. Epub 2015 Aug 4.
Clinical trial NCT02413541: The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 90
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: TREATMENT

Brief summary: This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.


Eligibility criteria: Inclusion Criteria:

* SIRS Criteria \> or = 2 meets definition
* Source of infection \> or = 1 meet definition
* Evidence of organ dysfunction \> or = 1 meet definition

Exclusion Criteria:

* WBC \< 5,000 /ul
* Platelet \< 30,000 / ul
* Pregnancy woman
* Advance stage cancer patients (terminally ill) who is refuse to be resuscitated
* Received blood transfusion \> 5 units in 24 hrs
* Allergy to Polymyxin-B
* High risk and uncontrolled bleeding
* Organ transplant patients
* On immunosuppressive agents within 2 weeks before study
* HIV infection

Primary outcomes:
measure: Functions of cell surface markers
timeFrame: 3 days
measure: Chemotaxis
timeFrame: 3 days
measure: EAA level
timeFrame: 3 days
Secondary outcomes:
measure: Survival rate
timeFrame: 28 days
measure: Sequential Organ Failure Assessment (SOFA Score)
timeFrame: 28 days
measure: Acute Kidney Injury and Renal Replacement Therapy incidences
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: Mechanical ventilation free day
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sasipha Tachaboon
state: Pathumwan
Study officials:
References:
citation: Singhan W, Vadcharavivad S, Areepium N, Wittayalertpanya S, Chaijamorn W, Srisawat N. The effect of direct hemoperfusion with polymyxin B immobilized cartridge on meropenem in critically ill patients requiring renal support. J Crit Care. 2019 Jun;51:71-76. doi: 10.1016/j.jcrc.2019.02.007. Epub 2019 Feb 5.
citation: Srisawat N, Tungsanga S, Lumlertgul N, Komaenthammasophon C, Peerapornratana S, Thamrongsat N, Tiranathanagul K, Praditpornsilpa K, Eiam-Ong S, Tungsanga K, Kellum JA. The effect of polymyxin B hemoperfusion on modulation of human leukocyte antigen DR in severe sepsis patients. Crit Care. 2018 Oct 26;22(1):279. doi: 10.1186/s13054-018-2077-y.
Clinical trial NCT00011141: Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency
Official title: Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Immune-mediated diabetes mellitus
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-02-14
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have significantly lower NK-T cells than normal controls. Other studies have shown that oral administration of lactobacillus can boost NK-T cell activity in children with HIV without side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T cell activity in patients with IMD


Eligibility criteria: Recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell University
state: New York
Study officials:
References:
Clinical trial NCT02556541: Ultrasound-guided Peripheral Vascular Access in Children
Official title: Ultrasound-guided Peripheral Vascular Access in Children - a Single- Blind, Randomized, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasonography
Vascular Access Devices
Pediatrics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 50
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by:

1. Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof.
2. Ultrasound guided cannulation by means of DNTP.

The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.


Eligibility criteria: Inclusion Criteria:

* Requirement for anaesthesia before MRI or operation.
* Routine need of peripheral intravenous cannulation.
* Age 0- 3 years at the date of MR scan

Exclusion Criteria:

* Lack of consent
* Emergency patients needing immediate operation or scan.

Primary outcomes:
measure: First attempt success
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anaesthesiology and Intensive Care
Study officials:
References:
Clinical trial NCT04711941: A ToM Training for People With Multiple Sclerosis: an Efficacy Study.
Official title: Effectiveness of a Novel Theory of Mind Training for People With Multiple Sclerosis: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: theory of mind
rehabilitation
multiple sclerosis
neurodegenerative disease
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 40
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: Theory of Mind (ToM) is the ability to understand and attribute mental states to ourselves and others. People with Multiple Sclerosis (pwMS) could present an impairment of this ability, with negative consequences on their social relationships and Quality of Life (QoL). We aimed to design and implement a novel ToM rehabilitation training, testing its efficacy on the promotion of emotional and mental states understanding, on QoL and on the alexithymia traits.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Relapsing-Remitting (RR), Secondary Progressive (SP) and Primary Progressive (PP) MS;
* age ≥ 18 and ≤ 75 years;
* years of education ≥ 5;
* no change of pharmacological treatment in the 6 months before the enrollment;
* no clinical relapses or use of steroid treatment during 3 months before the enrollment;
* provided informed consent for study participation.

Exclusion Criteria:

* history of nervous system disorders different from MS;
* unstable psychiatric illness, such as psychosis or major depression;
* severe disability with Expanded Disability Status Scale (EDSS) score \> 7.5;
* severe cognitive impairment that would not enable PwMS to answer to questionnaires correctly (i.e. dementia), according to the patient's medical records.

Primary outcomes:
measure: Reading the Mind from the Eyes (RMET)
timeFrame: 4 weeks
measure: Strange Stories
timeFrame: 4 weeks
measure: Faux pas
timeFrame: 4 weeks
measure: False Belief Task
timeFrame: 4 weeks
Secondary outcomes:
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: 4 weeks
measure: Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)
timeFrame: 4 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 4 weeks
measure: The Brief Repeatable Battery of Neuropsychological Test (BRB-NT)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
References:
Clinical trial NCT00984841: Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?
Official title: Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus targeted mailing
Lead sponsor: Scranton-Temple Residency Program
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 467
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if tailored letters sent to diabetic patients will improve care of diabetes.

Detailed description: Diabetes care in the US is less than optimal. Some authors have found that targeted patient letters are also an effective tool to improve outcomes when they are part of a comprehensive disease management plan. Local patient satisfaction surveys had revealed that many patients had sub-optimal understanding of diabetes measures and of the importance of controlling these measures to reduce diabetic complications. We wondered if tailored patient letters and enclosed lab orders when due might increase patient awareness of diabetes measures and increase patient engagement.We hypothesized that the addition of targeted patient letters with enclosed lab orders to an ongoing performance improvement program would further improve diabetes care.

We conducted a randomized controlled study of tailored patient letters and diabetes lab orders at our two resident-based clinics.

Eligibility criteria: Inclusion Criteria:

* All active patients age 18 to 75 years with a diagnosis of diabetes mellitus were eligible.
* An active patient was defined as one having an ICD-9 code on the active problem list identifying the patient as diabetic, and a progress note in the EMR associated with an office visit within the prior 12 months.

Exclusion Criteria:

* None

Primary outcomes:
measure: Diabetes summary quality measure
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Scranton-Temple Health Center
state: Pennsylvania
Study officials:
affiliation: Scranton-Temple Residency Program
name: John R Guzek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06251141: Gum Health Gel in Post Extraction Sockets
Official title: Effectiveness of Gum Health Gel in Minimizing Post Operative Sequelae Associated With the Surgical Removal of Impacted Mandibular Third Molars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impacted Third Molar Tooth
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars

Detailed description: This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars which includes pain , swelling and trismus

Eligibility criteria: Inclusion Criteria: Horizontal and mesioangular impaction in healthy patients older than 18 years old -

Exclusion Criteria:any medically compromised patient and the presence of any infection

-

Primary outcomes:
measure: Decrease of Pain
timeFrame: One week
measure: Increase Soft tissue healing
timeFrame: One week
measure: Decrease in Trismus
timeFrame: One week
measure: Decrease of Swelling
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Collage of dentistry/ university of baghdad
Study officials:
References:
Clinical trial NCT04240041: Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age
Official title: Accuracy of Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age: Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Age and Weight Conditions
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy

Brief summary: Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.


Eligibility criteria: Inclusion Criteria:

* Sure of dates
* Have dating ultrasound with crown rump length between (9 to 12 )weeks
* No hormonal contraception 3 months before conception.
* Regular menstrual cycles.
* Medically free.
* Single pregnancy
* Gestational age 32-36 weeks

Exclusion Criteria:

* Irregular menstrual cycles and not sure of dates
* Multiple pregnancy.
* Fetal anomalies.
* Placenta previa, placental anomalies and poor visualization of the placenta
* Fetal growth restriction
* Pregnant women with medical disorder e.g. diabetes mellitus, Pre-eclampsia, Systemic lupus erythromatosis, hypertension.

Primary outcomes:
measure: Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation
timeFrame: 32-36 weeks gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
state: Abbsia
Study officials:
affiliation: Resident of Obstetrics & Gynecology
name: Ayat Allah Mahmoud, MB BCh
role: PRINCIPAL_INVESTIGATOR
References: