louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02136602: Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome
Official title: Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Diabetes Mellites Effect on Fetus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with diabetes mellites

Brief summary: Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.

Detailed description: Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated.

So high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.

Eligibility criteria: Inclusion Criteria:

* above 35 weeks pregnancy
* diabetic mothers
* single intrauterine pregnancy

Exclusion Criteria:

* any other medical disorder

Primary outcomes:
measure: To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShamsU
Study officials:
affiliation: Ain Shames university
name: Mohammed M Elsafty, obs&gyn lecturer.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06078202: A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers
Official title: Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ABBV-903
Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-903
timeFrame: From 0 - 96 hours
measure: Time to Cmax (Tmax) of ABBV-903
timeFrame: From 0 - 96 hours
measure: Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
timeFrame: From 0 - 96 hours
measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-903
timeFrame: From 0 - 96 hours
measure: Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903
timeFrame: From 0 - 96 hours
measure: AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903
timeFrame: From 0 - 96 hours
measure: AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
timeFrame: From 0 - 96 hours
measure: Number of Participants with Adverse Events
timeFrame: Up to 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 259438
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04162002: Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions
Official title: Effects of Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hand Rejuvination
Lead sponsor: DeNova Research
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2019-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions.


Eligibility criteria: Inclusion Criteria:

1. Males and females of ages 28 and above.
2. Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. -

Exclusion Criteria:

1. Males and females below age of 28.
2. Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.
3. Subjects who are pregnant or nursing.
4. Subjects with a known allergy or sensitivity to any component of the study ingredients.
5. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
6. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
7. Subjects with diseases, injuries, or disabilities of the hand, including those with autoimmune disease affecting the hand, hand implants, Dupuytren's contracture, history of hand tumor, vascular malformations, Raynaud's disease and patients at risk for tendon rupture.
8. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded. -

Primary outcomes:
measure: The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05824702: A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine
Official title: A Social Network Approach for Improving Medication Assisted Treatment and HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: HIV
Drug Treatment
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Ukrainian Institute on Public Health Policy
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized clinical trial of behavioral intervention
Primary purpose: TREATMENT

Brief summary: The aim of this study is to pilot a peer education for people on medication assisted treatment (MAT). People on MAT will be trained to be peer educators and provide outreach to the educators social network members who inject drugs, some of whom will be HIV positive.

Detailed description: The, goal of the intervention is to increase medication assisted treatment (MAT) uptake and retention in order to enhance as well as HIV medical care and antiretroviral therapy (ART) adherence among those social network members who use drugs and those living with HIV who use drugs. The project will quantitatively and qualitatively assess barriers to MAT and ART uptake and adherence, while using peer educators to promote MAT and ART among their network members. Finally, the project aims to determine the effect size for guiding the planning of larger intervention and the feasibility and acceptability of this intervention for HIV prevention and improvement in HIV-related health outcomes among people living with HIV who inject drugs (PLWH PWID). The intervention will be deployed in Ukraine, a setting with high HIV incidence rates among PWID, low levels of viral suppression among HIV positive PWID, and low rates of MAT uptake.

Eligibility criteria: Inclusion Criteria:

* On methadone for at least 1 year and rated by the staff as low risk for relapse
* Report at least 1 drug network member living with HIV, not on methadone, and seen weekly
* Willing to talk with drug users in their network about medication for drug dependence and accompany them to methadone clinic

Exclusion Criteria:

• Persons that are currently psychotic, suicidal, or cognitively impaired such that they cannot provide informed consent will be excluded from participation.

Primary outcomes:
measure: Number of Participants Enrolled in drug treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: Ukrainian Institute on Public Health Policy
state: Kyiv
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl A Latkin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479102: Prevention of Iron Deficiency in 2nd Year of Life
Official title: Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron Deficiency
Anemia
Keywords: Iron supplementation
Babies
Prevention
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-05-25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.


Eligibility criteria: Inclusion Criteria:

* Healthy babies without iron deficiency

Exclusion Criteria:

* Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rahat
country: Israel
facility: Clalit Health Services Child Health Center
Study officials:
affiliation: Clalit Health Services
name: Hanna Shalev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06370702: Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Official title: Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States.


Eligibility criteria: Inclusion Criteria:

* Had a PICC placed in the past 24 hours by the Vascular Access Team
* Patient is admitted to either Bethesda North Hospital or Good Samarian Hospital

Exclusion Criteria:

* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Has a bleeding disorder/diagnosis
* Has a severe limb disfunction whereby they would be unable to perform the grip exercises

Primary outcomes:
measure: Deep vein thrombosis
timeFrame: from PICC placement to PICC removal, up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Nurse Researcher
name: Rachel Baker, PhD, RN
role: STUDY_CHAIR
References:
Clinical trial NCT04788602: The Applications and Influences of Transthoracic Echocardiography in Stroke Patients
Official title: The Applications and Influences of Transthoracic Echocardiography in Stroke Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: the Impact of Echocardiography on the Recurrence of Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute stroke and receiving echocardiography

Brief summary: Transthoracic echocardiography (TTE) is known to be an effective modality in assessing cardiac function as well as the structure of the heart. It was estimated that between 15% and 30% of ischemic strokes were due to a cardioembolic source, Therefore, TTE has been assumed as an important screening tool in patients with ischemic stroke, as atrial fibrillation is one of the leading risk factors. However, current guidelines have little evidence in whether performing TTE can alter clinical management and prevent a future stroke. We aim to present the association of performing TTE and clinical outcomes in stroke patients.


Eligibility criteria: Inclusion Criteria:

* patients with acute stroke and receiving echocardiography

Exclusion Criteria:

* patients with acute stroke and not receiving echocardiography

Primary outcomes:
measure: recurrent stroke
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Emergency Medicine, National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04035902: Intraoperative IV Iron on Postoperative Red Blood Cell Recovery
Official title: Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Keywords: iron
arthroplasty
red blood cell
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative recovery of RBC mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without IV-iron supplementation during surgery


Eligibility criteria: Inclusion criteria

* Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
* Patients provided a written informed consent.
* Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
* Patients with preoperative serum hemoglobin concentration \>10 g/dL

Exclusion criteria

* Patients with history of anaphylaxis, iron overload, active infection.
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Primary outcomes:
measure: postoperative hematocrit (%)
timeFrame: 7 days after surgery
Secondary outcomes:
measure: volume of post-operative bleeding (ml)
timeFrame: 7 day
measure: intraoperative blood transfusion (ml)
timeFrame: 1 day
measure: post-operative blood transfusion (ml)
timeFrame: 7 days
measure: post-operative serum ferritin level (ng/ml)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05382702: Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
Official title: Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding and Eating Disorders
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-05-19
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.


Eligibility criteria: Inclusion Criteria:

* female
* DSM-5 eating disorder
* score 16 or higher on the Clinical Impairment Assessment
* experience nausea or stomachache after eating at least "sometimes"
* 18 to 40 years old
* body mass index between 18.5 and 26.5 kg/m2

Exclusion Criteria:

* medical conditions affect appetite or weight
* Recent pregnancy or current breastfeeding
* Dairy, strawberry or honey food allergy
* Specific phobia, blood-injection-injury type

Primary outcomes:
measure: Subjective rating of fear
timeFrame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
measure: Skin conductance
timeFrame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
measure: Gastrointestinal distress
timeFrame: -10 minutes, 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
measure: Cholecystokinin response
timeFrame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
measure: Peptide YY response
timeFrame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
measure: Subjective rating of fullness
timeFrame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
measure: Urges to restrict food intake
timeFrame: 60 minutes post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: Katherine J Forney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645302: Intensive Monitoring Scheme of Lidocaine Cataplasms
Official title: Intensive Monitoring Scheme of Lidocaine Cataplasms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Reaction to Drug
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have used Lidocaine Cataplasms at least 1 consecutive time between January 1, 2021 and April 1, 2022.

Brief summary: In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).


Eligibility criteria: Inclusion Criteria:

* All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022.

Exclusion Criteria:

* Unable to obtain complete medication information.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: January 1, 2021 - April 1, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
References: