louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06892158: Massage Impact on Sleep in Pediatric Oncology
Official title: Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Pediatric Cancer
Chemotherapy Effect
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia, Pediatric
Hematopoietic Stem Cell Transplantation (HSCT)
Keywords: Stem cell transplant (SCT)
Decreased sleep efficiency
Pediatric cancer diagnosis
Circadian activity rhythm (CAR)
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Massage Therapy Foundation
name: Children's National Research Institute
First posted: 2025-03-24
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized, two-group design (intervention arm, IA and control arm, CA).
Primary purpose: TREATMENT

Brief summary: This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).

Detailed description: Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments.

This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication
2. Expected to be an inpatient for at least 21 days
3. Aged 12 to 21 years at enrollment.
4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).

Exclusion Criteria:

1. Cognitive impairment sufficient to preclude completing questionnaires appropriately
2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
3. Previous enrollment

Primary outcomes:
measure: Improvement in total sleep minutes
timeFrame: 3 weeks
Secondary outcomes:
measure: Improvement in sleep quality as demonstrated by circadian activity rhythms (CARs)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Tracey Jubelirer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739258: Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison
Official title: Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison and Set up the Notional Halfway Home in Union Area of Medical Facility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV-infected person
Entamoeba
Cryptosporidium
Giardia
ELISA
PCR
IDU
Gonorrhea
Chlamydial trachomatis
Syphilis
Genital warts
Herpes simplex virus
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-08-21
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The samples are obtained from Kaohsiung prison, Kaohsiung women's prison, Pingtung prison and the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

Brief summary: It is difficult to detect the intestinal protozoal infections among the HIV-infected persons or travelers diarrhea by using the traditional microscopy or staining methods. The purpose of this study aimed at finding out the appropriate diagnostic methods and the infection rate of the intestinal protozoa, including the Entamoeba, Cryptosporidium and Giardia among the HIV-infected persons by using the antigen detection method and biological method. The investigators also tried to analyze the associated HIV infection status and sexual transmitted diseases (STD) including Gonorrhea, Chlamydial trachomatis, Syphilis, Genital warts and Herpes simplex virus in this study. The study will collect the blood, urine and stool samples from 200 intravenous drug user (IDU) with HIV-infected in the prisons, 400 intravenous drug user (IDU) without HIV infected and 100 intravenous drug user (IDU) with HIV infected receiving methadone maintenance treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HIV
* Receiving Methadone Maintenance Treatment
* intravenous drug user (IDU)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaoshing Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT02412358: Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Official title: Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: toothbrushing
plaque control
gingivitis
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: * Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.
* Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

Detailed description: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

Eligibility criteria: Inclusion Criteria:

* having at least five teeth in each quadrant;
* no partial denture;
* no orthodontic banding or retention wires;
* no oral lesions or sites with probing pockets depth ≥ 5 mm;
* routine use of a manual toothbrush.

Exclusion Criteria:

* having any systematic disease which would influence the course of periodontal diseases or the response to the treatment
* smoking

Primary outcomes:
measure: Plaque Index
timeFrame: 2 weeks
measure: Gingival index
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Amir Moeintaghavi
state: Khorasan Razavi
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Amir Moeintaghavi, DDs., Msc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01816958: Neuromodulation to Facilitate the Effect of Ketamine
Official title: Treatment of Thalamocortical Dysrhythmia Using External Neuromodulation to Facilitate the Therapeutic Effect of Ketamine.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Chronic Pain
Substance Abuse
Keywords: thalamocortical dysrhythmia
transcranial magnetic stimulation (TMS)
transcranial Electrical Stimulation (tES)
(N-methyl-D-aspartate) NMDA-R antagonist
ketamine infusion
neuromodulation
synergistic effect
remission
Lead sponsor: The Neuroscience Center, LLC
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients within my own clinic, suffering with chronic emotional and/or somatic pain

Brief summary: application of external neuromodulation along with ketamine infusion.

Detailed description: apply TMS concurrent with ketamine infusion in order to increase the likliehood \& strength of therapeutic benefit

Eligibility criteria: Inclusion Criteria:

* chronically ill,
* treatment-resistant

Exclusion Criteria:

* active psychosis

Primary outcomes:
measure: Global Assessment of Function in DSM-4R
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Deerfield
country: United States
facility: The Neuroscience Center
state: Illinois
Study officials:
affiliation: The Neuroscience Center
name: Steven R Devore Best, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03310658: Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
Official title: Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Laparoscopic Hysterectomy
Lead sponsor: ZSX Medical LLC
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.

Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated Informed Consent Form
* Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
* Female, age 18 years or older
* Indicated for Total Laparoscopic Hysterectomy

Exclusion Criteria:

* HIV
* Hepatitis C
* Diabetics
* Use of systemic corticosteroids
* History of pelvic irradiation
* Active infection
* History of bleeding problems/hemophilia
* Cancer
* Cases in which vaginal cuff closure is intended to be performed robotically
* Pregnant

Primary outcomes:
measure: Device Ease of Use
timeFrame: Immediately following procedure
Secondary outcomes:
measure: Vaginal Cuff Closure
timeFrame: During procedure.
measure: Vaginal Cuff Closure Time
timeFrame: During Procedure.
measure: Total Surgical Time
timeFrame: During Procedure.
measure: Device Use Learning Curve assessed with a Surgeon Survey
timeFrame: Assessed immediately following study completion during surgeon survey.
measure: Sexual Discomfort
timeFrame: Assessed at 1 and 6 week follow-up visits.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
state: Nuevo León
Study officials:
affiliation: ZSX Medical LLC
name: Dan Mazzucco, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05737758: Investigating Clinical Trial Participation for Acne Patients
Official title: An Assessment of Clinical Trial Experiences of Patients With Acne
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acne
Keywords: acne
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acne patients who are actively participating in a clinical study, but have not yet completed enrollment and randomization.

Brief summary: Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will scrutinize the experiences of patients diagnosed with acne as they take part in a separate medical intervention clinical trial. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future acne patients.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with acne
* Patient is able to read, understand and provide written Informed Consent
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Pregnant or lactating women
* Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study

Primary outcomes:
measure: Number of acne patients who decide to join in a clinical study
timeFrame: 3 months
measure: Rate of patients who remain in an acne clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Eichenfield DZ, Sprague J, Eichenfield LF. Management of Acne Vulgaris: A Review. JAMA. 2021 Nov 23;326(20):2055-2067. doi: 10.1001/jama.2021.17633.
citation: Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.
citation: Titus S, Hodge J. Diagnosis and treatment of acne. Am Fam Physician. 2012 Oct 15;86(8):734-40.
Clinical trial NCT02032758: Study of Arm and Putter Movement in Golfers With Golfer's Cramp
Official title: Golfer's Cramp: Correlation of Wrist Movements and Surface EMG With Putter Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Occupational; Cramp(s)
Keywords: Occupational; Cramp(s)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will investigate golfers with visual evidence of an involuntary movement while putting before and after treatment with a low dose of propranolol.

Detailed description: Dystonia affecting athletes has received little research attention and there has been a lack of awareness or interest among both physicians and athletes. Task-specific dystonias or occupational cramps affect people while writing, typing, and or playing a musical instrument. Our group has previously shown that a subset of golfers who complain of the yips appear to have a task-specific dystonia or golfer's cramp. The yips are characterized by an inability to appropriately complete a golf stroke, most often putting and chipping strokes. Most individuals with the yips describe a jerking or shaking movement that interrupts their swing. In many cases the yips are disabling and the golfer, including professional tour players, give up golfing.

Golfers who have evidence of golfer's cramp will putt a series of putts during which they will be monitored for arm movements and putter movements. They will then be treated with a low dose of propranolol to see if there is a change in these parameters.

Eligibility criteria: Inclusion criteria:

* Age 18-75
* Complaint of golfer's cramp/yips
* Visual evidence of a movement disorder during putting
* Able to complete 80 putts during the session

Exclusion criteria:

* Contraindication to treatment with propranolol
* Movement disorder not when putting

Primary outcomes:
measure: Mean Dynamic Change of Rotation at Impact
timeFrame: baseline, approximately 45 minutes after propranolol dosing
Secondary outcomes:
measure: Mean Total Putter Face Rotation Before Impact
timeFrame: baseline, approximately 45 minutes after propranolol dosing
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Charles Adler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06539858: Investigation of the Effect of Massage Application on Functional Status and Depression in Postpartum Mothers
Official title: Investigation of the Effect of Massage Application on Functional Status and Depression in Mothers in the Early Postpartum Period
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depression, Post-Partum
Massage
Functional Status
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young mothers who had just given birth and met the inclusion criteria for the study

Brief summary: Postpartum depression is a condition with high morbidity in mothers and negatively affects all family relationships. It has been observed that depression in the mother at only 2 months of age negatively affects the relationship between the baby and the mother, and that mothers who are depressed and therefore their babies feel more negatively. Symptoms usually start to appear from the 2nd or 3rd week after birth. At the same time, most people focus on the physical characteristics of the mother after birth, such as her reproductive system, while ignoring her full functionality. Full functionality is a multidimensional concept that includes personal care, baby care, family care, social and professional activities. In the first weeks after discharge, the functional status of the mother may differ as a result of the roles she assumes at home. Since the breastfeeding period will begin in new mothers, different treatment methods are preferred instead of drug treatment, one of which is massage therapy. It is thought that massage therapy relaxes the muscles and changes psychological factors. Previous studies conducted on postpartum women show that massage has a positive and healing effect on mothers. While previous studies frequently mention its effects on depression, it has also been observed that there are few studies mentioning its functional status. In light of this information, the aim of this study is to investigate the effects of massage on functional status and depression in postpartum women. For this purpose, there will be 2 groups randomized as intervention and control groups. The intervention will be performed as a 45-minute massage once a week for 4 weeks. Data will be collected before the first intervention and after the last intervention.


Eligibility criteria: Inclusion Criteria:

* Being within the first 6 months postpartum

Exclusion Criteria:

* Having a health condition that prevents lying face down (having stitches from a cesarean section, hypertension, etc.)
* Not being cooperative
* All conditions that contraindicate massage

Primary outcomes:
measure: depression
timeFrame: 4 weeks
measure: functionality
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: University of Yalova
Study officials:
References:
Clinical trial NCT06070558: ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
Official title: ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Temporomandibular Joint Disorders
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints.

This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.


Eligibility criteria: Inclusion Criteria:

* Adult: age ≥ 18 years old;
* Person with the capacity to understand the instructions given;
* Person affiliated to a social security scheme or beneficiary of such a scheme;
* Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.

Exclusion Criteria:

* Person with large-scale metallic dental reconstructions;
* Edentulism more than 5 teeth;
* Claustrophobia;
* Contraindication to performing an MRI examination
* Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code

Primary outcomes:
measure: Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: Curve representing the displacement of the articular discs during TMJ movements
timeFrame: Baseline (day 0)
measure: Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD
timeFrame: Baseline (day 0)
measure: Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.
timeFrame: Baseline (day 0)
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: