louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03564639: Examining Hepatitis C Reinfection Rates in Kenya
Official title: Hepatitis C Reinfection in an Injection Drug Using Population in Kenya: A Follow-up to the TLC-IDU Hepatitis C V Supplement Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is taking place in the Mombasa province in Coastal Kenya and Nairobi, Kenya's capital. Participants were also in the parent study, were infected with HVC, have completed HVC treatment.

Brief summary: The goal of this research project is to build upon the Testing and Linkage to Care for Injecting Drug Users (TLC-IDU) parent study and describe post-cure HCV reinfection in a population of people who inject drugs (PWIDs) in Kenya.

Detailed description: In addition to describing reinfection in a substance using cohort, we will identify individual predictors of HCV reinfection in Kenya, as well as identifying individual utilization intervention approaches and dosing that reduce reinfection risk and treatment cite level risk factors (frequency of visits, community vs hospital location etc.). Determining the risk factors specific to reinfection and understanding the impact of concurrent harm reduction interventions will guide service delivery and implementation of HCV elimination strategies in Kenya and throughout the region.

Eligibility criteria: Inclusion Criteria:

1. Live in Nairobi or coastal Mombasa (Coast Province including Malindi), Kenya;
2. Are injection drug users (IDUs) that ever injected any non-prescribed drugs; and able and willing to provide informed consent.
3. Participates are in the parent study;
4. Complete treatment protocol; and achieve a sustained virologic response (SVR).

Exclusion Criteria:

Not in the above inclusion criteria.

Primary outcomes:
measure: HCV Reinfection
timeFrame: 6-18 months post sustained virologic response (SVR) to HCV treatment.
measure: Evaluate psychoeducational counseling
timeFrame: 6 months
measure: Examine usage of methadone maintenance
timeFrame: 12 months
measure: Examine usage of needle exchange programs
timeFrame: 12 months
measure: Evaluate psychoeducational counseling
timeFrame: 12 months
Secondary outcomes:
measure: HCV reinfection referrals for treatment at Kenyetta National Hospital
timeFrame: 9-16 months post treatment
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: NASCOP
Study officials:
affiliation: Yale University School of Nursing
name: Ann Kurth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03428139: Alpha Lipoic Acid and Chronic Lumbosacral Radicular Pain
Official title: Role of Alpha Lipoic Acid Combined With Pulsed Radiofrequency in Treatment of Chronic Lumbosacral Radicular Pain: Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral
Keywords: lumbosacral radicular pain
pulsed radiofrequency
Alpha Lipoic acid
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 120
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: In this study, we try to evaluate the effect of using ALA as an adjuvant treatment in patients scheduled for pulsed radiofrequency treatment (PRFT) of the affected dorsal root ganglion (DRG) for treatment of Lumbo-Sacral radicular pain.

Detailed description: Study design: The study is prospective, randomized, and open label started in August 2013 and was completed in March 2017 at Assiut University Hospital, Pain Unit after local ethical committee approval. All patients were informed verbally and in writing about the study, and they signed a detailed written informed consent about the procedure and the nature of the study.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years with severe chronic lumbo-sacral radicular pain of more than 6 months duration, not responding to medical treatment, and their Pain scores were \> 7 were included in the study.

Exclusion Criteria:

* coagulopathy, surgical interference, advanced malignancy, known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury, breastfeeding or pregnancy, allergy/sensitivity to lidocaine anesthetic or/ and non-ionic contrast media or/and steroid therapy, active psychiatric or mental conditions and uncontrolled medical condition.

Primary outcomes:
measure: Numerical Pain Rating Scale (NRS)
timeFrame: Before treatment
measure: Numerical Pain Rating Scale (NRS)
timeFrame: 3 months after treatment
measure: Numerical Pain Rating Scale (NRS)
timeFrame: 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University faculty of medicine
name: Abdelrady S Ibrahim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Boxem K, Cheng J, Patijn J, van Kleef M, Lataster A, Mekhail N, Van Zundert J. 11. Lumbosacral radicular pain. Pain Pract. 2010 Jul-Aug;10(4):339-58. doi: 10.1111/j.1533-2500.2010.00370.x. Epub 2010 May 17.
Clinical trial NCT05045339: Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder
Official title: Effectiveness of Ball Exercises on the Stereotypic Behavior of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ball exercises
physical therapy
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autism spectrum disorder (ASD) is a neuro-behavioral disorder associated with repetitive movements. The role of physical therapist towards an autistic child is most neglected one. Therefore, the objective of this study was to see the effectiveness of different ball exercise on stereotypic behavior of children with ASD. Different ball exercises were implemented for 2 months, 3 sessions per week and every session consist of 35 minutes.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed with ASD through experts
* Having recognized stereotypic behavior
* Having Intellectual Deficit (ID) and Attention Deficit Hyperactive Disorder (ADHD)
* Age ranging between 4-16 years
* Consented to take part

Exclusion Criteria:

* Having co-morbidities like schizophrenia and developmental delays
* Severe cases of ASD
* Showing aggressive behavior
* Having disease of cardiovascular or respiratory system
* Children unable to follow the command for exercise completely

Primary outcomes:
measure: Stereotypic Behaviors
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: The University of Faisalabad
state: Punjab
Study officials:
affiliation: The University of Faisalabad
name: Dr Sidra Majeed; PT, MSPP
role: STUDY_DIRECTOR
References:
Clinical trial NCT04973839: Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention
Official title: Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention).

Detailed description: This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR session compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention). After the baseline assessment, participants are randomized to one of 4 possible intervention groups: i) watching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided), ii) watching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided), iii) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided), or iv) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided). In a pre-posttest design, the subjective stress levels of the participants in the for groups will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* fluency in the German language to provide informed consent

Exclusion Criteria:

* muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness
* Mental disorder

Primary outcomes:
measure: Change in perceived stress
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
Secondary outcomes:
measure: Change in positive affect
timeFrame: Change from pre (baseline) to post scores (30 minutes later)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Psychology, Philipps University Marburg
state: Hessen
Study officials:
References:
Clinical trial NCT00002139: Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
Official title: Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Azithromycin
Bacterial Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.

Detailed description: Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral agents, provided regimen has been stable for at least 1 month.

Patients must have:

* HIV infection.
* CD4 count \<= 200 cells/mm3.
* No active opportunistic infection (pending discussion with Pfizer Clinician).

Prior Medication:

Allowed:

* Prior antiretroviral agents.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active intercurrent illness (pending discussion with the Pfizer Clinician).
* Allergies to macrolide antibiotics.
* Signs and symptoms of severe illness that would preclude treatment.

Patients with the following prior conditions are excluded:

* History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Clinically important change in baseline status within 4 weeks prior to study entry.
* Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) within 4 weeks prior to study entry.

Prior Medication:

Excluded:

* Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.

Known drug or alcohol dependence.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Ctr for Phase I Research
state: Kansas
Study officials:
References:
Clinical trial NCT03493139: Physical Activity Across the Curriculum (PAAC 3):Teacher vs. Remotely Delivered Classroom Physical Activity Breaks
Official title: Physical Activity Across the Curriculum (PAAC 3):Teacher vs. Remotely Delivered Classroom Physical Activity Breaks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-04-10
Enrollment: 470
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Classroom Physical Activity Breaks Delivered by Teacher vs. Classroom Physical Activity Breaks Delivered by Video
Primary purpose: PREVENTION

Brief summary: The study is designed to compare two methods of delivering short (\~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote instructor through a video in the classroom. Both delivery methods will promote a variety of whole body movements using large muscle groups. The schools will not be able to choose which group (regular teacher or remote instructor) they will be part of.


Eligibility criteria: Inclusion Criteria:

* 2nd and 3rd grade students

Exclusion Criteria:

* Students who are confined to a wheel chair, blind, or intellectually disadvantaged may be unable perform tests for cardiovascular fitness or MVPA using accelerometers

Primary outcomes:
measure: Moderate-to-vigorous physical activity (MVPA) time during activity breaks
timeFrame: Year 3
Secondary outcomes:
measure: MVPA time during the school day
timeFrame: Year 3
measure: Total daily MVPA
timeFrame: Year 3
measure: Body mass index (BMI)
timeFrame: Fall Semester Year 1
measure: Body mass index (BMI)
timeFrame: Spring Semester Year 1
measure: Body mass index (BMI)
timeFrame: Spring Semester Year 2
measure: Body mass index (BMI)
timeFrame: Spring Semester Year 3
measure: Energy expenditure of activity breaks
timeFrame: Year 2
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szabo-Reed AN, Washburn RA, Greene JL, Ptomey LT, Gorczyca A, Lee RH, Little TD, Lee J, Honas J, Donnelly JE. Physical activity across the curriculum (PAAC3): Testing the application of technology delivered classroom physical activity breaks. Contemp Clin Trials. 2020 Mar;90:105952. doi: 10.1016/j.cct.2020.105952. Epub 2020 Jan 29.
Clinical trial NCT04878939: Evaluation of Incisors' Position Following Anterior Segment Retraction
Official title: Evaluation of Incisors' Position Following Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bimaxillary Protrusion
Keywords: friction
frictionless
CBCT
anterior segment retraction
T loop
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There's scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction.

Detailed description: Thirty females with bimaxillary protrusion were randomly allocated into two groups. In one group, anterior segment retraction was commenced using an elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor. In the other group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force. Three-dimensional analysis of incisors' buccolingual (BL)- torque, mesiodistal (MD)- tip, vertical position changes and root resorption were assessed using cone beam computed tomography scans.

Eligibility criteria: Inclusion Criteria:

* Female patients (Age 13- 25 y)
* Class I molar relation (Angle's classification)
* Bimaxillary protrusion requiring extraction of four first premolars and maximum anchorage.
* full permanent dentition (except 3rd molars)
* Good general and oral health

Exclusion Criteria:

* Systemic disease or syndromes or on anti-inflammatory medication.
* Extracted or missing permanent teeth (other than 3rd molars)
* Badly decayed teeth (other than 1st premolars)
* Parafunctional habits
* History of previous orthodontics treatment

Primary outcomes:
measure: Torque of the incisors
timeFrame: through study completion (Pre/post retraction), an average of 6 months
measure: Tip of the incisors
timeFrame: through study completion (Pre/post retraction), an average of 6 months
measure: Vertical changes of the incisors
timeFrame: through study completion (Pre/post retraction) , an average of 6 months
Secondary outcomes:
measure: Root resorption of the anterior teeth
timeFrame: through study completion (Pre/post retraction), an average of 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future University in Egypt
Study officials:
affiliation: Future University in Egypt
name: Yehia Mostafa, Professor and Chairman
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002439: A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Official title: Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma, Kaposi
HIV Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
Collaborators: name: Ligand Pharmaceuticals
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if ALRT1057 gel is safe and effective in treating Kaposi's sarcoma (KS) when applied to skin .

Detailed description: This is a Phase 3 double-blind study. KS patients are randomized to 1 of 2 treatment arms. They receive either ALRT1057 gel or placebo for 12 weeks. If progressive disease for KS is noted before Week 12, patients are switched to the other blinded treatment arm. If a response or disease progression that has not persisted for at least 4 weeks as of Week 12 occurs, treatment on the blinded arm is continued for up to 4 additional weeks, or until response of disease progression is confirmed. After that time or after 12 weeks of treatment, open-label ALRT1057 may be received.

Eligibility criteria: Information not available

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Walmsley S, Northfelt DW, Melosky B, Conant M, Friedman-Kien AE, Wagner B. Treatment of AIDS-related cutaneous Kaposi's sarcoma with topical alitretinoin (9-cis-retinoic acid) gel. Panretin Gel North American Study Group. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):235-46. doi: 10.1097/00126334-199911010-00004.
Clinical trial NCT02762539: Omega3 PUFA in Head Trauam
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic brain injury (TBI) is major health problem that stands as a significant cause of death and permanent disability. TBI is considered as global public health epidemic. On pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary. Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the ability to impact all four main mechanisms of the secondary injury Patients will be allocated into one of two groups through a random table generation; Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days


Eligibility criteria: Inclusion Criteria:

* mild to moderate head trauma

Exclusion Criteria:

* sensitivity to SMOF lipid severe head trauama

Primary outcomes:
measure: Glasgow coma scale after 48 hour of infusion
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT01176539: Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor
Official title: How Does the New Kai R Spot 100 Respiratory Monitor Compare to the Currently Used Respiratory Monitor for Measuring Respiratory Rate During Overnight Sleep Studies?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration
Lead sponsor: Kai Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 29
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects at the Sleep Center at Stanford Universoty

Brief summary: The purpose of this study is to determine whether the respiratory rate provided by Kai Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the currently used methods, including respiratory chest bands.


Eligibility criteria: Inclusion Criteria:

* Every patient undergoing an overnight polysomnography study can be included.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
Study officials:
References: