louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04346498: Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable
Official title: The Effect of Chest-to-Back Skin-to-Skin Contact on Regulation of Physiological Parameters for Low Birth Weight and/or Premature Infants: a Crossover Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature
Oxygen Saturation
Heart Rate
Respiratory Rate
Sleep Pattern
Lead sponsor: Addis Continental Institute of Public Health
Sponsor class: OTHER
Collaborators: name: Arsi University
name: Adds Continental Institute of Public Health
First posted: 2020-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother

Detailed description: After the study was explained (risks and benefits) and written informed consent was received from participants, an individually controlled randomized crossover clinical trial was conducted to examine the effectiveness of Chest-to-Back (CB) skin-to-skin contact (SSC) compared with the standard. The trial was done in accordance with the protocol, good clinical practice, and the national regulatory and ethics guideline of Ethiopia (which is in line with the Helsinki declaration).

Eligibility criteria: Inclusion Criteria:

* Neonates with LBW (\<2500 grams)
* Born prematurely (\< 37 complete weeks of gestation)

Exclusion Criteria:

* less than 35 weeks of gestation on the day of enrollment to trial
* Malformations or birth disabilities
* Dependent on oxygen or IV fluid
* Any disorder that was deemed necessary for exclusion by the investigator.

Primary outcomes:
measure: Change in skin temperature from baseline
timeFrame: : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
Secondary outcomes:
Other outcomes:
measure: Change from baseline in peripheral arterial oxygen saturation on SCRIP Score
timeFrame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
measure: Change from baseline in heart rate on SCRIP Score
timeFrame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
measure: Change from baseline in respiratory rate on SCRIP Score
timeFrame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
measure: Length of sleep in minute
timeFrame: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days.
Locations:
city: Addis Ababa
country: Ethiopia
facility: Adds Continental Institute of Public Health
Study officials:
affiliation: Director
name: Prof. Yemane Berhane
role: STUDY_DIRECTOR
affiliation: Deputy
name: Prof. Alemayehu Worku
role: STUDY_CHAIR
References:
Clinical trial NCT02404298: Transcriptome Analysis of the Peripheral Blood in CIDP
Official title: Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Autoimmune Diseases
Clarkson Syndrome
Muscular Autoimmune Disorders
Keywords: Transcriptome analysis
peripheral blood
chronic inflammatory demyelinating polyradiculoneuropathy
auto immune diseases
IVIg
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. The investigators used a transcriptomic approach to compare the gene expression profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and after IVIg treatment, in order to identify their mechanism of action in this condition, to lead to a better understanding of CIDP pathophysiology, and potentially determine factors associated with the response to the treatment.

Detailed description: We study the change of the:

* gene profile on transcriptome analysis of peripheral blood
* T cell repertory
* igG dosage
* immunological profile

Before IVIG (T1 time) and and 3 weeks after IVIg treatment (T2 time). On a population of patients having: CIDP, autoimmune muscular disease, Clarkson syndrome, or autoimmune diseases.

We also search for polymorphism of FCgammareceptor, TKPC et CASP3 genes in CIDP patients

Eligibility criteria: Inclusion criteria :

* Age ≥ 18 years old
* Obtained informed consent
* Patient having a definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP corresponding to patients having the EFNS/PNS clinical criteria and at least two EFNS/PNS supportive criteria
* Or
* Patient having a muscular autoimmune disease, or a Clarkson syndrome or other autoimmune disease
* Currently treated by IVIG

Exclusion criteria :

* pregnancy
* breastfeeding

Primary outcomes:
measure: Gene expression profile
timeFrame: 3 weeks
Secondary outcomes:
measure: Gene expression profile in each lymphocytary sub-group
timeFrame: 3 weeks
measure: IgG
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Grooupe Hospitalier Pitié Salpetrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Karine Viala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04198298: Prospective Clinical Trial of Three Apical Sealing Materials
Official title: Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periapical Abscess
Keywords: Cone-Beam Computed Tomography
Microsurgery
Bone Regeneration
Biocompatible Materials
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 59
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 prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

Detailed description: A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

Eligibility criteria: Inclusion Criteria:

* Adult patients, American Society of Anesthesiologists (ASA) classification I and II
* Any tooth with a single chronic periapical lesion requiring apical microsurgery
* Informed consent signed prior to surgery

Exclusion Criteria:

* Background of drug/alcohol abuse
* Adjacent periapical lesion
* Periodontal disease

Primary outcomes:
measure: Rate of remineralization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03309098: Agreement Between Clinician and Instrumented Laxity Assessment
Official title: Agreement Between Clinician and Instrumented Laxity Assessment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ankle Sprains
Ankle Injuries and Disorders
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recreationally active, health adults.

Brief summary: Ankle injuries are the most common acute injury to the active population. It is important to ensure best practices and techniques used in clinics for evaluation are validated and consistent. This study will compare diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries.

Detailed description: Ankle injuries, specifically lateral ankle sprains, are the most common acute injury to the active population (Hootman, Dick, \& Agel, 2007). It is important to insure the use of best practice and ensure that the techniques being utilized in clinics for evaluation are validated and consistent within the techniques. Manual testing and instrumented testing have not yet been tested within the same cohort.

The purpose of this study is to compare the diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries. Participants will be recruited at University of Nebraska at Omahas (UNO) Injury Prevention and Care Clinic and Athletic Training Room in Sapp Fieldhouse. Participants with be members of the UNO Wellness Center or UNO athlete, aged 19-80 years old. During a standard evaluation the participant will have a clinician test manual ligamentous laxity and a blinded clinician testing laxity using an arthrometer. Participation will not alter the normal treatment or care for participants. The author hypothesizes that the diagnostic accuracy for all performed test will be good to excellent when assessed for laxity and moderate to good when assessed for pain.

Eligibility criteria: Inclusion Criteria:

* Membership to University of Nebraska at Omahas Wellness Center: a student taking on campus classes or a paying community member. Acute injury occurred within one week of evaluation.

Exclusion Criteria:

* Any condition that is contraindicated for manual test (i.e. fracture).

Primary outcomes:
measure: Diagnostic accuracy of inversion stress test, eversion stress test and anterior drawer
timeFrame: within 48 hours post-injury
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Adam Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05830045: A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors
Official title: A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion)
3. Eastern Cooperative Oncology Group Performance Status of 0 or 1
4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.
5. Have adequate organ function as described in the protocol.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding
2. HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
3. Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
4. Has an active autoimmune disease that has required systemic treatment in past 2 years.
5. Has an active infection requiring systemic therapy
6. Has received a live vaccine wihtin 30 days of planned start of study treatment
7. Has know history of, or any evidence of interstitial lung disease

Primary outcomes:
measure: Dose-limiting toxicity(DLT)
timeFrame: 21days
measure: Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
timeFrame: up to 96 weeks
measure: Objective Response Rate for phase 1b
timeFrame: up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
affiliation: Sun Yat-sen University
name: Xu Ruihua, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03076645: Measure of Engagement of Epilepsy Patients in Messaging Groups
Official title: Measure of Engagement of Epilepsy Patients in Messaging Groups and Group Characteristics That Influence Engagement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will measure the engagement of people with epilepsy in a mobile phone based messaging platform as well as understand if there is an impact on their self-management

Detailed description: The primary purpose of this study is to assess a person with epilepsy's level of usage of a mobile messaging application for peer support. The secondary purpose is to understand what characteristics of their group drive different levels of usage and improvements in self-management.

Participants can participate as much or little as they want for a minimum of six weeks. Participants will complete an initial and a final questionnaire.

Eligibility criteria: Inclusion Criteria:

* Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application

Exclusion Criteria:

* A diagnosis of learning disability/difficulty, significant mental health conditions; those in care, bereaved, or prisoners. Any other vulnerable individuals (individuals unable to protect themselves against significant harm or exploitation)

Primary outcomes:
measure: Engagement
timeFrame: 6 weeks
Secondary outcomes:
measure: Epilepsy self-management
timeFrame: Change in Baseline to 6 weeks
measure: Epilepsy medication adherence
timeFrame: Change in Baseline to 6 weeks
measure: Epilepsy quality of life
timeFrame: Change in Baseline to 6 weeks
Other outcomes:
Locations:
city: Lewisham
country: United Kingdom
facility: Lewisham & Greenwich NHS Trust
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
city: Maidstone
country: United Kingdom
facility: Kent Community Health NHS Trust
Study officials:
affiliation: Royal Free London NHS Foundation Trust
name: Adina Nash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02052245: Pre/Term Milk Profiling
Official title: Longitudinal Composition of Human Milk for Term and Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Milk
Term Milk
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers who will breast feed their baby

Brief summary: This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins


Eligibility criteria: Inclusion Criteria:

* Having obtained informed consent
* Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks
* Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks
* Age: Mother ≥ 18 years old
* Partial or total breast feeding
* Having a freezer compartment at home (approx. -18°C)
* Good understanding of the French language

Exclusion Criteria:

* Suffering from diabetes (type I or II) before pregnancy
* Alcohol consumption: more than 1 standard drink / day
* Drug addicted
* Subject who cannot be expected to comply with the study procedures.
* Currently participating in an interventional therapeutic clinical trial

Primary outcomes:
measure: Quantification of total protein concentration in human milk
timeFrame: from delivery, up to 4 months
Secondary outcomes:
measure: Quantification of total lipids and carbohydrates
timeFrame: From delivery, up to 4 months
measure: Determination of Calcium and Phosphorous content
timeFrame: From delivery, up to 4 months
measure: Determination of peptide profiles and content
timeFrame: From delivery, up to 4 months
measure: Determination of miRNA content
timeFrame: From delivery, up to 4 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinic of neonatology - Avenue Pierre Decker 2
Study officials:
References:
citation: Garcia-Rodenas CL, De Castro CA, Jenni R, Thakkar SK, Beauport L, Tolsa JF, Fischer-Fumeaux CJ, Affolter M. Temporal changes of major protein concentrations in preterm and term human milk. A prospective cohort study. Clin Nutr. 2019 Aug;38(4):1844-1852. doi: 10.1016/j.clnu.2018.07.016. Epub 2018 Jul 26.
Clinical trial NCT02830945: Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
Official title: Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cardiovascular Disease
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 458
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: American Indians (AI's) are experiencing an epidemic of stroke morbidity and mortality, with higher prevalence and incidence, younger age at onset, and poorer survival than other racial and ethnic groups. With a stroke incidence more than twice that of the general U.S. population, stroke in AI's is a public health problem of staggering scope. AI's also have disproportionate burdens of many risk factors for stroke, including hypertension, smoking, obesity, and diabetes. However, no rigorous, population-based studies of stroke prevention have included AI's. The investigators at WSU, and community partners, have designed the "Family Intervention in the Spirit of Motivational Interviewing" (FITSMI), a program delivered at the household level to encourage lifestyle changes that transform the home environment and reduce stroke risk for all residents. FITSMI uses a "talking circle" format in which facilitators guide participants to identify goals for change and create a tailored plan for sustainable implementation that may target smoking, exercise, diet, or medication adherence. FITSMI requires just 2 sessions (baseline and 1 month post-baseline), with text messaging used to boost long-term adherence. In a group-randomized trial design, the investigators will recruit 360 households where Strong Heart Family Study members aged 45 and older reside. The investigators will assign half to FITSMI and half to a control condition that receives educational brochures.


Eligibility criteria: Inclusion Criteria:

* Household must include one member over the age of 45 (index participant)

Exclusion Criteria:

* Under the age of 11

Primary outcomes:
measure: Stroke Risk Classification
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medstar Health Research
state: Arizona
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Eagle Butte
country: United States
facility: Missouri Breaks Industries Research Inc.
state: South Dakota
city: Seattle
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: WSU-IREACH
name: Lonnie Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05141045: The Effect of Fish Oil Supplementation on Vocal Performance
Official title: The Effect of Fish Oil Supplementation on Vocal Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Range Profile
Reflux Symptom Index
Evaluation of Ability to Sing Easily
Body Composition
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to determine if use of omega-3 PUFA supplement in combination with a singer's training regimen enhances training adaptations and body composition.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy college vocal performers (male and female of all ethnicities) \*Between the ages of 18-28 years
* Majoring in classical voice in the Baylor University School of Music or musical theatre in the Baylor University Department of Theatre Arts.

Exclusion Criteria:

* Previously diagnosed with a voice disorder
* Vegans
* Smokers
* Allergic to fish, shellfish or safflower oil
* Have been taking daily FO n-3 supplement within the past three months, or any supplement known to effect muscle biology (e.g. creatine).

Primary outcomes:
measure: Change in Evaluation of Ability to Sing Easily
timeFrame: baseline and up to 11 weeks
Secondary outcomes:
measure: change in Voice Range Profile
timeFrame: baseline and up to 11 weeks
measure: change in Body composition
timeFrame: baseline and up to 11 weeks
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: LesLee Funderburk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913445: Wound Healing After Emergency Appendicectomy
Official title: Wound Healing and Cosmetic Result After Emergency Appendicectomy in Adult Patients: a Prospective, Randomised Trial Comparing Two Methods of Wound Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Keywords: Appendicitis
appendicectomy
stitches
wound healing
cosmetic results
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 200
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 purpose of this trial is to compare two techniques of wound closure in open appendicectomies in adult patients: continuous, absorbable, intradermal suture and interrupted, non-absorbable sutures.


Eligibility criteria: Inclusion Criteria:

* Adult patient with acute appendicitis

Exclusion Criteria:

* Children

Primary outcomes:
measure: Wound heeling
timeFrame: 14 days after operation
Secondary outcomes:
measure: Cosmetic result
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
References: