louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02744404: Point of Care Early Infant Diagnosis Patient Impact Study
Official title: Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Clinton Health Access Initiative Inc.
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malawi
name: UNICEF
First posted: 2016-04-20
Enrollment: 1752
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be mother-infant pairs from the general population attending the seven clinics for routine HIV-related, PMTCT and post-natal care services. Study subjects will be infants from mother-infant pairs presenting consecutively to the clinic for EID testing per the national EID guidelines during the study period.

Brief summary: In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.


Eligibility criteria: Inclusion Criteria:

* Younger than 12 months of age
* Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother

Exclusion Criteria:

* Older than 12 months of age
* Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation
* Already initiated ART

Primary outcomes:
measure: ART initiation retention
timeFrame: 6-9 months
Secondary outcomes:
measure: Test turnaround time
timeFrame: 6-9 months
measure: Tests received
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
city: Liwonde
country: Malawi
facility: Machinga District Hospital
city: Mzuzu
country: Malawi
facility: Mzuzu Central Hospital
city: Nsanama
country: Malawi
facility: Nsanama Health Center
city: Ntaja
country: Malawi
facility: Ntaja Health Center
city: Ntcheu
country: Malawi
facility: Ntcheu District Hospital
city: Phalombe
country: Malawi
facility: Migowi Health Center
Study officials:
References:
Clinical trial NCT04964804: Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
Official title: Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed at patients with low back and leg pain. The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers, and the control group underwent puncture under the guidance of ultrasound alone by sonographers.

Detailed description: A total of 60 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. Patients in the experimental group underwent selective lumbar nerve root block puncture under the real-time ultrasound-CT fusion imaging of the sonographer, and the control group underwent puncture under the sole ultrasound guidance of the sonographer. This study was used to compare the difference between the effects of pure ultrasound guidance and ultrasound-CT fusion imaging guidance on selective lumbar nerve root block.

Eligibility criteria: Inclusion Criteria:

Patients who need lumbar nerve root block treatment

Exclusion Criteria:

1. Tumor patients
2. Patients who have had lumbar spine surgery before

Primary outcomes:
measure: 1 month VAS pain score
timeFrame: VAS pain scores were performed 1 month after surgery
measure: 3 month VAS pain score
timeFrame: VAS pain scores were performed 3 month after surgery
measure: 6 month VAS pain score
timeFrame: VAS pain scores were performed 6 month after surgery
measure: 12 month VAS pain score
timeFrame: VAS pain scores were performed 12 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Ultrasound Diagnosis, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jinrui Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT04509804: Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma
Official title: Target Gene Sequencing for Advanced Stage, Relapsed/Refractory Natural Killer/T-cell Lymphoma and the Correlation Between Gene Abmormalities and Chemotherapy Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoid Neoplasm
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-08-12
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to recurit 30 eligile patients who are diagnosed in our hospital.

Brief summary: Although modern radiation techniques combined with chemotherapy has greatly improved the local control and long-term survivals for patients with early-stage NKTCL, relapse and systemic dissemination are common for localized patients. Relapsed/refractory diseases together with advanced stage NKTCLs uaually progress rapidly with poor prognosis (5-year overall survival rate, 0-20%). According to published studies, some recurrent genetic alternations have been identified in NKTCL, including oncogene/tumor suppressive gene abberants, epigenetic changes, cellular signaling pathways abnormalities, cellular apoptosis related genes and so forth. However, the gene profiling techniques and materials vary in different studies, no consensus has been reached on the gene abnormalities of advanced, or relapsed/refractory NKTCL up to now. Additionally, gene sequencing using ctDNA of peripheral blood has been unexploited in NKTCL patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
2. stage III/IV disease; or relapsed or refractory disease after at least one line prior teratment;
3. age ≥ 18 years;
4. ECOG performance status 0-2;
5. at least one measurable lesion;
6. adequate hematological, hepatic, and renal functions;
7. life expectancy of more than 3 months.

Exclusion Criteria:

1. Previously untreated stage I/II disease;
2. with no adequate tumour tissue;
3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Primary outcomes:
measure: Concordance
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Mei Dong
state: Beijing
Study officials:
References:
Clinical trial NCT04216004: Anti-Inflammatory Milk Matrix
Official title: Dairy Food Consumption and Its Effects on Inflammation and the Postprandial Regulation of Muscle Protein Synthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Skeletal Muscle
Inflammation
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is pro-inflammatory, impairs metabolism, and physically limiting. Specifically, muscle in obese persons does not synthesize proteins normally. This further increases metabolic and physical dysfunction. As such, obesity programs should not only focus on weight loss, but muscle metabolic health. Dairy nutrients have anti-inflammatory and anabolic properties, but mostly evaluated in isolation and/or pre-clinical designs. Also, it is unknown if the circulating benefits extend to the muscle. We hypothesize that dairy full-fat milk will improve these obesity characteristics.


Eligibility criteria: Inclusion Criteria:

* Obese (BMI, body mass index ≥30, \<40 kg•m-2)
* Age 40-59
* Pre-menopausal
* Sedentary/insufficiently active for prior 6 months (mo)
* Weight stable for prior 6 mo

Exclusion Criteria:

* Tobacco, nicotine (patch/gum) use (previous 6 mo)
* Alcohol consumption \>10 drinks per week
* Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases)
* Cardiovascular disease, arrhythmias
* Hypogonadism
* Asthma
* History of uncontrolled hypertension
* Orthopedic injury/surgery (within 1 yr)
* Hepatorenal, musculoskeletal, autoimmune, or neurological disease
* History of neuromuscular problems
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
* Consumption of thyroid, androgenic, or other medications known to affect endocrine function
* Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
* Pregnancy
* Allergy to dairy product or lactose intolerance
* Fasting plasma glucose (FPG) ≥ 126 mg/dL
* Oral glucose tolerance test (OGTT) ≥ 200 mg/dL

Primary outcomes:
measure: Fractional synthetic rate of myofibrillar proteins by stable isotope infusion.
timeFrame: 0-5 hours postprandial observation period to ingesting 2 servings of respective Arm.
measure: Blood inflammation markers by flow cytometry.
timeFrame: 1 week observation period to respective Arm within a controlled-feeding intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Freer Hall
state: Illinois
Study officials:
References:
Clinical trial NCT00492804: Elective Neurectomy During Inguinal Hernia Repair
Official title: Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inguinal Hernia
Keywords: inguinal hernia
chronic pain
neurectomy
hypesthesia
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.

It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.

This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.


Eligibility criteria: Inclusion Criteria:

* Uni- or bilateral inguinal hernia
* Karnofsky-index ≥70
* Informed consent

Exclusion Criteria:

* Recurrent inguinal hernia
* Previous inguinal operation
* Emergent operation
* Severe comorbidities

Primary outcomes:
measure: Incidence of postoperative pain
timeFrame: up to three years
Secondary outcomes:
measure: Incidence of hypesthesia or paraesthesia
timeFrame: one and three years
measure: Recurrence rate
timeFrame: one and three years
measure: Rate of intra- and postoperative complications
timeFrame: one and three years
measure: Quality of life
timeFrame: one and three years
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Surgery, Cantonal Hospital of St. Gallen
state: SG
Study officials:
affiliation: Department of Surgery, Cantonal Hospital St. Gallen
name: Martin Thurnheer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03283904: Active Schools: Skelmersdale
Official title: Active Schools: Skelmersdale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Sedentary Lifestyle
Keywords: Children
Schools
Lead sponsor: Edge Hill University
Sponsor class: OTHER
Collaborators: name: West Lancashire Sport Partnership
name: West Lancashire Leisure Trust
First posted: 2017-09-14
Enrollment: 250
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Control vs Intervention clusters of schools
Primary purpose: PREVENTION

Brief summary: The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention.

Detailed description: The multi-component intervention is the third and final phase of the AS:Sk project. It will be implemented and evaluated in four of the seven participating schools. The remaining three schools will act as controls and will not implement any physical activity intervention during the period of the research project. Schools will be randomly assigned to either intervention or control conditions. The multi-component intervention will involve multiple areas of the schools' curricula, environments, or policies being targeted. Decisions regarding these intervention components will be influenced by what was deemed effective, and feasible within phase 2 of the project. Phase 2 included a four week trial of three different single component physical activity interventions across all participating schools. Phase 3 will be implemented for at least eight weeks and if successful, it would then be rolled out in the control schools at the end of the project. Participants from both intervention and control schools will take part in the measures for evaluation in this third and final phase of the project.

Eligibility criteria: Inclusion Criteria:

* Year 5 pupil attending participating schools

Exclusion Criteria:

-

Primary outcomes:
measure: School-day moderate-to-vigorous physical activity (MVPA)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ormskirk
country: United Kingdom
facility: Edge Hill University
state: Lancs
Study officials:
affiliation: Edge Hill University
name: Stuart J Fairclough
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5):534. doi: 10.3390/ijerph14050534.
citation: Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z.
Clinical trial NCT04175704: Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
Official title: A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Chronic Idiopathic Urticaria
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 32
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 study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.

Detailed description: This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo.

Eligibility criteria: Inclusion Criteria:

* Subjects aged ≥ 18 years
* Subjects who are able and willing to provide the informed consent
* Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history.

Exclusion Criteria:

* History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.

Primary outcomes:
measure: To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
timeFrame: 99 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05854004: Effectiveness of TU and MRT to Release Trigger Points to Increase RoM and Pain Relief in Upper TT
Official title: Effectiveness of Therapeutic Ultrasound and Myofascial Release Technique to Release Trigger Points to Increase Range of Motion and Pain Relief in Upper Trapezius Tightness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To find out the Effectiveness of Therapeutic Ultrasound and Myofascial Release Technique to Release Trigger Points to Increase Range of Motion and Pain Relief in Upper Trapezius Tightness


Eligibility criteria: Inclusion Criteria:

* 1. Age between 20-40years.
* 2. Male and female both are included.
* 3. Those having tenderness on a taut muscle band, rise in regular pain, local twitching response, and restricted range of motion of cervical region.

Exclusion Criteria:

* 1. Those having referred pain due to any pathology of cervical.
* 2. Those having any healing fractures over upper back and in neck region.
* 3. Those who have dermatitis over upper back or any clotting disorder.
* 4. Any related wound in neck region or any pathology of shoulder.
* 5. Those who has any degenerative cervical spine disease. (2)

Primary outcomes:
measure: Numaric Pain scale Rating (NPR).
timeFrame: 6 Months.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT01565304: Evaluation of the Effectiveness of the POWER Through Choices Program
Official title: Evaluation of the Effectiveness of the POWER Through Choices Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Sexually Transmitted Infections
Keywords: Teen pregnancy
Sexually transmitted infections
Sexual risk behaviors
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2012-03-28
Enrollment: 1039
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC) curriculum in increasing contraceptive use and delaying sexual initiation among youth living in group foster care homes.

Detailed description: Youth in foster care are at especially high risk for teen pregnancy and associated sexual risk behaviors. The POWER Through Choices (PTC) program is a 10-session sexuality curriculum that aims to increase contraceptive use and delay sexual initiation by empowering youth to make healthy, positive choices about their sexual behaviors. This study uses a cluster randomized design to compare the effectiveness of PTC to usual programs and services provided to youth living in group foster care homes. Study participants will be youth living in group foster homes recruited in four locations: Kern County, CA; Cook County, IL; Baltimore County, MD; and Oklahoma (statewide). The study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the Office of Adolescent Health in the U.S. Department of Health and Human Services.

Eligibility criteria: Inclusion Criteria:

* Resident of group foster care home

Exclusion Criteria:

* Pregnant or parenting

Primary outcomes:
measure: Consistent contraceptive use
timeFrame: 12 months
measure: Sexual initiation
timeFrame: 12 months
Secondary outcomes:
measure: Knowledge of contraceptive use and reproductive health
timeFrame: 6 months
measure: Intentions to delay sexual initiation and unprotected sex
timeFrame: 6 months
measure: Attitudes toward sexual activity and contraceptive use
timeFrame: 6 months
measure: Scores on scale of self-efficacy to avoid sexual risk behaviors
timeFrame: 6 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern County Superintendent of Schools
state: California
city: Baltimore
country: United States
facility: Planned Parenthood of Maryland
state: Maryland
city: Oklahoma City
country: United States
facility: Oklahoma Institute for Child Advocacy
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Roy Oman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Sara Vesely, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mathematica Policy Research
name: Brian Goesling, PhD
role: PRINCIPAL_INVESTIGATOR
References: