louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01251601: The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
Official title: The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV
Pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-12-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited by their HIV clinic providers

Brief summary: The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.


Eligibility criteria: Inclusion Criteria:

* HIV Infected
* Pregnant
* At least 18 years of age
* Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum

Exclusion Criteria:

* Less than 18 years of age
* Hemoglobin \<9 g/dL or Hematocrit \<27.3 at screening

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Chapel Hill
name: Angela DM Kashuba, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Kristine B Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03427801: Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease
Official title: Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia of Chronic Kidney Disease
Keywords: erythropoiesis-stimulating agent
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 78
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: adult patients with stage 4 to 5 chronic kidney disease undergoing palliative care pathway

Brief summary: An observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis.

Detailed description: Erythropoiesis-stimulating agent (ESA) has been commonly used to manage patients with end-stage renal disease receiving dialysis. The effects of ESA, however, are unclear. This study compares the result of erythropoiesis-stimulating agent (ESA) versus supportive care for chronic kidney disease patients receiving palliative care. The investigators design a retrospective observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis. The primary objective is to assess whether ESA can reduce the transfusion burden and hospitalization.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 years and older, who opted for ESA treatment during palliative renal care for \> 360 days between January 1, 2014 and December 31, 2016

Exclusion Criteria:

* patients who had dialysis or kidney transplant treatment

Primary outcomes:
measure: number of red cell transfusion
timeFrame: one year
measure: days of hospitalisation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
state: New Territories
Study officials:
References:
Clinical trial NCT06065501: Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease
Official title: Frailty Trajectories and Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CKD - Chronic Kidney Disease
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).

Detailed description: The study will be conducted on 120 frail patients with CKD, who will be divided into 2 groups: Group 1, consisting of 60 frail patients, will receive PACE intervention (based on mobile social network support) for 6 months. Group 2, comprising 60 frail patients, will receive usual CKD education and consultation for 6 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with CKD stage 1 to 5
* Participants with pre-frail and frail conditions.
* Having access to a mobile phone and is capable of using mobile social network application (Line)

Exclusion Criteria:

* Received renal replacement therapy
* Participants achieved TTM stage 5

Primary outcomes:
measure: Frailty
timeFrame: Before intervention, after initial intervention 3 months, and after intervention 6 months.
Secondary outcomes:
measure: Activity
timeFrame: Before intervention, after initial intervention 3 months, and after intervention 6 months.
measure: Lifestyle
timeFrame: Before intervention, after initial intervention and after intervention 6 months.
measure: Nutrition
timeFrame: Before intervention, after initial intervention 3 months, and after intervention 6 months.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT05763901: IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms
Official title: Evaluation of Motor Control During Developmental Age in Young Patients With Paramorphisms and Dysmorphisms Using Inertial Measurement Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genu Varum
Genu Valgus
Flat Feet
Cavus Foot
Scoliosis Idiopathic
Varus; Talipes
Valgus, Talipes
Laxity of Ligament
Hyperlordosis
Hyperkyphosis
Angular Limb Deformity
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: While various complex pathologies of the developmental age, such as Infantile Cerebral Palsy or Neuromuscular Diseases, are notoriously considered causes of alteration of locomotor development, it is scarcely known whether conditions much more frequent in the pediatric population, the so-called "Paramorphisms or Dysmorphisms", may be associated with more or less noticeable changes in locomotor development.

On a few studies, flat feet and hyperlaxity has been correlated with a motor control delay or poorer motor performance, based on complex clinical tests or on stereophotogrammetry movement analysis.

Although promising, these preliminary studies, in addition to not providing information on the possible influence of other paramorphisms, such as varus and valgus of the knees, do not provide conclusive indications.

The aim of this study is to investigate, through clinical tests and wearable inertial units, the motor control of a pediatric population affected by Paramorphisms or Dysmorphisms and to compare them with a population of healthy controls, matched by age, taken from the recently developed control data set from Bisi and Stagni.


Eligibility criteria: Inclusion Criteria:

* Born at term
* Without known delay in motor development
* Finding of one or more paramorphisms or dysmorphisms of the developmental age (flat or cavus foot, valgus or varus talipes, valgus or varus knee, scoliotic attitude or scoliosis, hyperkyphosis or hyperlordosis, generalized or focused hyperlaxity, heterometry of the AAII, torsional defects AAII)

Exclusion Criteria:

* Preterm birth
* Diagnosis of pathologies compromising motor control (Infantile Cerebral Palsy, Neuromuscular Diseases, Spina Bifida, Arthrogryposis, Genetic Syndromes)

Primary outcomes:
measure: Evaluation and measurement of balance
timeFrame: Baseline
measure: Evaluation and measurement motor competence
timeFrame: Baseline
measure: Measurement of balance
timeFrame: Baseline
measure: Measurement of motor competence
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS-Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT06182501: Interference by Activated Protein C Resistance in the Determination of Protein S Activity
Official title: Interference by Activated Protein C Resistance in the Determination of Protein S Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Resistance to Activated Protein C in the Determination of Protein S Activity
Keywords: protein C
protein S
activated protein C
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 9470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥ 18 years) for whom a sample has been sent to the HUS Hematology Laboratory for measurement of protein S activity between 28/12/2009 and 29/12/2020

Brief summary: Protein S is an anticoagulant protein and a cofactor of protein C. It is recommended to explore it first by a functional (chronometric) technique by assessing its cofactor activity of activated protein C. Existing tests measure the prolongation of a coagulation time. These tests are all dependent on factor V, but some patients have mutations in factor V (including V Leiden) that make them resistant to activated protein C activity. It is suspected that these mutations lead to underestimations of protein S activity by chronometric technique.


Eligibility criteria: Inclusion criteria:

* Patient of legal age (≥ 18 years)
* Patient for whom a sample has been sent to the HUS Hematology Laboratory for measurement of protein S activity between 28/12/2009 and 29/12/2020
* Patient who does not object to the reuse of his/her medical data for scientific research purposes.

Exclusion criteria:

* Minor patient
* Patient with incomplete data

Primary outcomes:
measure: Functional test protein C resistance
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire d'Hématologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06211101: Evaluation of the Effectiveness of the Utilization of the Kangaroo Care Guide
Official title: Evaluation of the Effectiveness of the Utilization of the Kangaroo Care Guide in the Neonatal Intensive Care Unit: An Evidence Utilization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kangaroo Care Trainig
Keywords: Kangaroo Care
trainig
Nurse
NICU
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group (experimental-control)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of kangaroo care guideline-based training for nurses on nurses' knowledge level, kangaroo care practices and Attitude Towards Evidence-Based Nursing scale scores.

The study was parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design.

It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 32 newborn nurses between October 2022 and January 2023. Premature infants in the intervention (n = 16) and control groups (n = 16) were determined by randomization method.

Detailed description: Neonatal nurses in the intervention group were trained on the kangaroo care guide, but no application was made to the control group. Data were collected using the BP Information Form, BP Practice status, and the Attitudes Toward Evidence-Based Nursing Scale. Data were collected as a pretest before the application and as a posttest after the application. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.

Eligibility criteria: Inclusion Criteria:

* Having been working as a nurse in the Neonatal Intensive Care Unit for at least 6 months
* Volunteer

Exclusion Criteria:

* Working as a resuscitation nurse in the unit
* Being on maternity leave

Primary outcomes:
measure: Kangaroo care information form
timeFrame: Change from baseline and post test (15 days later).
measure: Kangaroo care application status
timeFrame: Change from baseline and post test (15 days later).
measure: Attitude Scale Towards Evidence-Based Nursing
timeFrame: Change from baseline and post test (15 days later).
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
Clinical trial NCT04402801: Patient Outcomes of Clinic Transition From Face to Face Encounter to Telemedicine in Cystic Fibrosis
Official title: Impact on Patient Outcomes of Clinic Transition From Face to Face Encounters to Telemedicine in the Cystic Fibrosis (CF) Adult Population at UVA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult CF patients 18 yo and older.

Brief summary: Adult patients with Cystic Fibrosis who are seen at the specialty CF clinic at University of Virginia will be given an option to utilize telemedicine instead of in-person visits for standard clinic visits. Health information from standard of care visits including FEV1, exacerbations, leading to oral or intravenous antibiotics, laboratory results, hospitalization records, and responses to health questionnaires will be recorded for research purposes. Data collected for the research study will be compared to baseline and previous years to determine if there are any deleterious effects for those who transition to telemedicine clinic visits.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-year-old and older) with CF seen in the UVA adult CF clinic who agree to participate in the study.

Exclusion Criteria:

* Patients who cannot consent to the research study. In addition, prisoners will not be included.

Primary outcomes:
measure: FEV1 stability
timeFrame: 12 months
Secondary outcomes:
measure: Exacerbation rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Dana Albon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Somerville LAL, List RP, Compton MH, Bruschwein HM, Jennings D, Jones MK, Murray RK, Starheim ER, Webb KM, Gettle LS, Albon DP. Real-World Outcomes in Cystic Fibrosis Telemedicine Clinical Care in a Time of a Global Pandemic. Chest. 2022 May;161(5):1167-1179. doi: 10.1016/j.chest.2021.11.035. Epub 2021 Dec 10.
citation: Bruschwein HM, Soper M, Jennings D, Somerville L, List R, Compton MH, Turner R, Albon D. Mental health screening of patients with cystic fibrosis through telehealth during COVID-19: Evaluation of feasibility and process adoption. Fam Syst Health. 2022 Sep;40(3):397-402. doi: 10.1037/fsh0000698. Epub 2022 May 23.
Clinical trial NCT01709201: Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
Official title: Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Abuse
Drug Abuse
Keywords: Alcohol abuse
Drug abuse
Diabetes Mellitus
Persistent Asthma
Juvenile Arthritis
Ulcerative Colitis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.


Eligibility criteria: Inclusion Criteria:

* 14-18 years old
* Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year
* Previous participation in the screening validation study
* Evidence of problems related to substance use

Exclusion Criteria:

* Medically or emotionally unstable or otherwise unable to provide assent/consent
* Unable to speak/read English
* Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire

Primary outcomes:
measure: Percent days abstinent
timeFrame: 30 days post baseline
Secondary outcomes:
measure: Medical complications
timeFrame: 30 days post baseline
Other outcomes:
measure: Percent Days Abstinent 90 days post baseline
timeFrame: 90 days post baseline
measure: Medical complications 90 days post baseline
timeFrame: 90 days post baseline
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sharon Levy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Elissa Weitzman, ScD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03902301: Lactobacillus Rhamnosus and PCOS Treatment
Official title: The Effect of Lactobacillus Rhamnosus Supplementation on Body Mass, Hyperandrogenism and Insulin Resistance in Overweight and Obese Polycystic Ovary Syndrome Women - Randomized Nutritional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Polycystic Ovary Syndrome
Hyperandrogenism
Obesity
Keywords: Lactobacillus rhamnosus
Polycystic Ovary Syndrome
insulin resistance
nutrition intervention
probiotic
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.


Eligibility criteria: Inclusion criteria:

* patients diagnosed with PCOS,
* BMI\> 28 kg/m2 (overweight or obesity),
* patients not participating in other similar research programs at the same time,
* no previous operations on ovaries such as: laparoscopy, ovarian cautery etc.,
* written agreement to take part in the research.

Exlusion criteria:

* the use of antibiotics or probiotics within 6 months before the start of the experiment,
* the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months,
* the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
* failure to comply with dietary recommendations established during the nutritional intervention,
* the use of weight loss supplements during the study,
* clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, Crohn's disease, celiac disease),
* pregnancy and breast feeding.

Primary outcomes:
measure: Insulin Resistance
timeFrame: 20 weeks
measure: Oral glucose test OGTT
timeFrame: 20 weeks
measure: Testosterone
timeFrame: 20 weeks
measure: DHEA-SO4
timeFrame: 20 weeks
measure: SHBG
timeFrame: 20 weeks
measure: Free androgen index FAI
timeFrame: 20 weeks
measure: Body weight
timeFrame: 20 weeks
measure: Body height
timeFrame: Baseline
measure: Body composition
timeFrame: 20 weeks
measure: Blood lipid profile: cholesterole
timeFrame: 20 weeks
measure: Blood lipid profile: triglicerydes
timeFrame: 20 weeks
measure: Blood lipid profile: high density lipoprotein
timeFrame: 20 weeks
measure: Blood lipid profile: low density lipoprotein
timeFrame: 20 weeks
Secondary outcomes:
measure: Assessment of qualitative and quantitative of the microbiome
timeFrame: 20 weeks
measure: Assessment of B-glucuronidase and B-glucosiadase activity
timeFrame: 20 weeks
measure: Assessment of short-chain fatty acids
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Life Sciences
Study officials:
References:
Clinical trial NCT01771601: Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2
Official title: Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Near-infrared Spectroscopy, Transition, Caesarean Section
Keywords: Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Augustinus Foundation, Denmark.
First posted: 2013-01-18
Enrollment: 24
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term infants born by elective caesarean section at Rigshospitalet, Denmark

Brief summary: Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.


Eligibility criteria: Inclusion Criteria:

* Term infants
* Elective caesarean section

Exclusion Criteria:

* Thick hair that makes good measurements difficult/impossible
* obvious malformations or syndromes
* Complications in relation to caesarean section
* Depression after birth (APGAR \< 8 after 1 minute)

Primary outcomes:
measure: Cerebral oxygenation
timeFrame: 10 minutes
Secondary outcomes:
measure: Reproducibility
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gorm Greisen
Study officials:
References: