louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03065361: Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis
Official title: Assessing the Handgrip Strength, Fine Motor Skills, and Hand Sensitivity of Brazilian Children and Adolescents on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Handgrip Strength
Fine Motor Skills
Sensitivity
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 42
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants of the group A were not randomized children and adolescents performing hemodialysis treatment in two hospitals of Belo Horizonte. Findings obtained in patients were compared to children and adolescents matched by age and sex, which participants were recruited in schools of Belo Horizonte and metropolitan region part of the group B.

Brief summary: The purpose of this study was to assess the handgrip strength; fine motor skills; and hand sensitivity of Brazilian children and adolescents with Chronic Kidney Diseases (CKD). The sample was composed by 42 children and adolescents, 21 on hemodialysis (group A) and the other 21 acted as the control group (group B). The performance of both groups was compared. The outcome measures included Jebsen-Taylor Hand Function Test, the Semmes Weinstein monofilaments test and Jamar Dynamometer.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of CKD with active hemodialysis treatment (only to group A);
* Ability to understand the tests and questionnaires applied.

Exclusion Criteria:

* Neuropsychiatric disease associated; and
* Any medical contraindication against the participation in the study.

Primary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: 30 minutes
Secondary outcomes:
measure: The Semmes Weinstein Monofilaments Test
timeFrame: 10 minutes
measure: Jamar Dynamometer
timeFrame: 15 minutes
Other outcomes:
measure: Edinburgh Handedness Inventory
timeFrame: 15 minutes
Locations:
Study officials:
affiliation: Federal University of Minas Gerais
name: Thais T Souza, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03499561: a Smptomatic Bacteriuria in Pregnancy
Official title: a Symptomatic Bacteriuria in Pregnant Females
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacteriuria in Pregnancy
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2018-04-17
Enrollment: 320
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant non-symptomatic females.

Brief summary: Asymptomatic bacteriuria (ASB) is defined as the presence of at least 105 colony-forming units (CFU)/ml of 1 or 2 bacterial species in clean-voided midstream urine sample from an individual without symptoms of UTI

Detailed description: ASB is common in women and increases in prevalence with age and/or sexual activity, due to short urethra, pregnancy, easy contamination of urinary tract with fecal flora

The pregnant women are two times more commonly affected than age matched non pregnant females. This is due to urinary stasis due to progesterone effect in pregnancy in addition to different morphological and physiological changes occurring during pregnancy The prevalence of ASB is about 3 times higher in diabetic women (ranging from 15% to 30%) than in non-diabetic women (less than 10%)

Eligibility criteria: Inclusion Criteria:

* 1. Pregnant females 2. Non-symptomatic females.

Exclusion Criteria:

* 1. Patients taking antibiotics in the last two weeks. 2. Symptomatic UTI. 3. Suspected urinary tract abnormalities. 4. Urinary catheterization. 5. Renal dialysis.

Primary outcomes:
measure: The number of participants who will discovered to have bacteriuria
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04929561: The Effect of Breastfeeding Support Provided Via Video-conferencing
Official title: The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Anxiety Disorders
Neonatal Outcomes
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.


Eligibility criteria: Inclusion Criteria:

Infants;

* Born between 37 and 42 weeks
* Without severe congenital anomalies

Mothers;

* A single live birth
* Were 18 years of age or over
* At least primary school graduate
* Did not have a disease that prevents breastfeeding
* Had internet access at home or on the phone
* Could speak and understand the Turkish language.

Exclusion Criteria:

* Situations that cause separation of mother and baby
* Hospitalization of the baby in intensive care
* Inability to answer 3 calls in a video call
* They were determined as those who could not be reached during the home visit for the first and second follow

Primary outcomes:
measure: The mean postpartum maternal anxiety level (mean ± SD)
timeFrame: at 2 weeks and 4 weeks after delivery
measure: The mean breastfeeding self-efficacy level
timeFrame: at 2 weeks and 4 weeks after delivery
Secondary outcomes:
measure: Neonatal outcomes-Newborn weight (g)
timeFrame: at 2 weeks and 4 weeks after delivery
measure: Neonatal outcomes-Hypoglycemia of the newborn
timeFrame: at 2 weeks and 4 weeks after delivery
measure: Neonatal outcomes-Need for phototherapy
timeFrame: at 2 weeks and 4 weeks after delivery
measure: Neonatal outcomes-Respiratory morbidity
timeFrame: at 2 weeks and 4 weeks after delivery
measure: Neonatal outcomes-illness requiring hospitalization
timeFrame: at 2 weeks and 4 weeks after delivery
measure: Neonatal outcomes-Food intake other than breast milk
timeFrame: at 2 weeks and 4 weeks after delivery
measure: Neonatal outcomes-Neonatal death
timeFrame: at 2 weeks and 4 weeks after delivery
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University
state: Kahramanmaraş
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Betül Bay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04965961: The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females
Official title: Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sports Drug Abuse
Keywords: erythropoeitin
doping
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Explorative
Primary purpose: OTHER

Brief summary: Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.

Detailed description: In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.

Eligibility criteria: Inclusion Criteria:

* Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants

Exclusion Criteria:

* Age
* Insufficient fitness level
* Blood donation 3 months prior to enrollment
* Altitude exposure 2 months before enrollment
* Hypertension

Primary outcomes:
measure: Change in maximal oxygen uptake
timeFrame: Change from baseline to 5 days after last injection
measure: Change in time trial performance
timeFrame: Change from baseline to 3 days after last injection
measure: Change in total hemoglobin mass
timeFrame: Change from baseline to 3 days after last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
References:
Clinical trial NCT00796861: Trial of Sunitinib for Refractory Malignant Ascites
Official title: Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ascites
Keywords: malignant ascites
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2008-11-24
Enrollment: 4
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: The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

Detailed description: This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.

Eligibility criteria: Inclusion Criteria:

* Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or the inability to receive standard treatment due to performance status (PS\>2).
* Ascites based on paracentesis or CT scan within one month prior to enrollment
* Life expectancy \> 3 months
* Indwelling paracentesis catheters are permitted, paracentesis is permitted at the investigators discretion
* Negative urine pregnancy test for females
* All subjects must agree to use birth control
* All subjects must abstain from eating grapefruit and grapefruit juice. They must tell their physicians about any changes in their medication including over-the-counter and herbal supplements.

Exclusion Criteria:

* History of congestive heart failure
* Creatinine \> 2.0
* Pregnant or nursing
* ALT \> 2.5 times the upper limit of normal
* Blood pressure \> 160/90 (antihypertensives permitted)
* Gastrointestinal or intra-abdominal hemorrhage within the last 6 months
* History of QTc \> 450 milliseconds
* Brain metastasis

Primary outcomes:
measure: Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.
timeFrame: An average of every 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Leah Cream, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04414111: Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation
Official title: Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: DGF
Kidney Transplant; Complications
Keywords: DGF
SGF
Acute rejection
Kidney transplantation
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Mid-America Transplant
First posted: 2020-06-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients

Brief summary: Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.


Eligibility criteria: Inclusion Criteria:

- Adult kidney transplant candidates immediately prior to their kidney transplant surgery

Exclusion Criteria:

* \< 18 years old
* Active immunosuppressive drug use
* Hepatitis C
* HIV

Primary outcomes:
measure: Delayed graft function
timeFrame: 1 week
measure: Slow graft function
timeFrame: 24 hours
Secondary outcomes:
measure: Acute rejection
timeFrame: 1 year
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: Loma Linda University Health Transplantation Institute
state: California
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Henry Randall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05175911: Implementation of the Golden Hour for Preterm Infants : a Quality Improvement Study
Official title: Implementation of the "Golden Hour", an Initial Standardized Stabilization of Preterm Less Than 31 Weeks and/or 1300 g : a Quality Improvement Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: premature birth
golden hour
60 minutes
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature younger than 31 weeks of gestational age or less than 1300 g expected

Brief summary: Effective initial stabilization of preterm neonates in the initial 60 minutes of life ("golden hour") was shown to improve outcomes. Keys components include anticipative and collaborative approach, respiratory support, thermal regulation and early initiation of parenteral nutrition. The objective is to complete the admission within 60 minutes of delivery.


Eligibility criteria: Inclusion Criteria:

* Premature infants (\< 31 weeks' gestation)
* Infants with expected weight less than 1300 g
* Inborn babies

Exclusion Criteria:

* Infants outborn
* Infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, ...)
* Parental refusal

Primary outcomes:
measure: Completion of the procedure : closing time of the incubator
timeFrame: 1 hour
measure: Glycemia at admission and within 24 hours
timeFrame: 24 hours
measure: Thermal stability : temperature at admission and at the end of the procedure
timeFrame: 1 hour
measure: Mortality rate
timeFrame: 3 months
Secondary outcomes:
measure: Process of the procedure:
timeFrame: 1 hour
measure: Incidence of hypotension and bradycardia
timeFrame: 1 hour
measure: Intubation rate and duration of mechanical ventilation
timeFrame: 3 months
measure: Need for surfactant administration and time of administration
timeFrame: 3 days
measure: Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH
timeFrame: 3 months
measure: Duration of hospital stay (only if no transfer)
timeFrame: 3 months
measure: Caregiver's perception of the procedure: stress…
timeFrame: 24 hours
measure: Parental experience of the procedure
timeFrame: 24 hours
measure: Conditions of the procedure : realization during the night shift and team composition
timeFrame: 24 hours
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liège
Study officials:
References:
Clinical trial NCT02802111: Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults
Official title: Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Consumption
Keywords: Beta Agonists
Asthma
Albuterol
Levalbuterol
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction. Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR) following administration of albuterol and

Detailed description: Inhaled β2 adrenoceptor agonists are frequently used to treat reversible lower airway obstruction, or to assist with mucociliary clearance. Albuterol remains the most commonly used β agonist and contains a racemic mixture of two enantiomers. The R enantiomer is the active moiety responsible for the bronchodilation, while the S enantiomer was initially thought to be inactive, although recent studies suggest otherwise. Levalbuterol contains the single R form enantiomer, and in clinical practice it is frequently prescribed not only because of its bronchodilator benefits, but to limit cardiovascular toxicity. Adverse cardiovascular effects remain the main dose-limiting factor for β2 agonists. The primary objective of the investigators study is to compare the change in oxygen consumption following albuterol to that of levalbuterol, in healthy adult volunteers. The investigators hypothesized there would be no clinically significant difference in V'O2 between the two drugs, if equal doses of the R-enantiomer were administered. Secondary objectives were to compare the changes in heart rate and other vital signs between the two drugs.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria:

* Coronary artery disease, history of intolerance to beta agonists

Primary outcomes:
measure: Oxygen Consumption
timeFrame: 0 to 60 minutes
Secondary outcomes:
measure: Heart Rate
timeFrame: 0 to 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Los Angeles
name: Patrick A Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06049511: Oral Self Care Protocol and Oral Mucositis
Official title: The Effect of the Oral Self-Care Protocol on Mucositis and Self-Care Agency According to Orem's Self-Care Deficiency Theory in Patients With Hematologic Malignancies Receiving High-Dose Chemotherapy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucositis Oral
Keywords: oral mucositis
oral self care protocol
Orem's nursing theory
self-care agency
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled group
Primary purpose: PREVENTION

Brief summary: Objective: This study was conducted in order to examine the effect of oral self-care protocol based on Orem's Self-Care Deficiency Theory on oral mucositis and self-care agency.

Method: This study was conducted as a randomized controlled trial between August 2021 and July 2022, patients with hematological malignancies receiving high-dose chemotherapy at the Izmir Ege University Faculty of Medicine Hospital and Izmir Training and Research Hospital. The sample of the study consisted of a total of 60 patients, including 30 application groups and 30 control groups, who met the inclusion criteria using the computer-based stratified randomization method. The study data were collected using "Patient Information Questionnaire," "WHO-Oral Mucositis Toxicity Scale," "Oral Assessment Guide," "Self-Care Agency Scale," "Data Collection Form Prepared According to Orem's Self-Care Deficiency Nursing Theory," "Oral Care Chart," and "Oral Cavity Photography." The oral self-care protocol, which includes training and oral care practices, was applied to the application group for 21 days from the beginning of chemotherapy treatment. The control group was not subjected to any oral care attempts by the researcher and received standard nursing care in the clinic. The data were evaluated by descriptive statistics, the Chi-square test, the Mann-Whitney U test, the Mc Ne-mar test, the Kappa compliance test, and the t test in dependent and independent groups. Keywords: chemotherapy; hematological malignancy; oral mucositis; oral self-care protocol; Orem's theory; self-care agency; nursing


Eligibility criteria: Inclusion Criteria:

* Willing to participate,
* Have the ability to read and write,
* Volunteer for oral cavity photography,
* Possess a platelet value above 20,000/mm3, and
* Have intact oral mucous membrane integrity.

Exclusion Criteria:

* Who received combined radiotherapy and chemotherapy treatments
* Had incomplete questionnaire responses.

Primary outcomes:
measure: World Health Organization Oral Mucositis Toxicity Scale
timeFrame: 21 days
Secondary outcomes:
measure: Oral assessment guide
timeFrame: 21 days
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Medical Faculty Hospital
state: Bornova
Study officials:
References: