louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01175603: Preventing Postpartum Depression in African American Home Visiting Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: depression, African American, home visiting, prevention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Abell Foundation
First posted: 2010-08-05
Enrollment: 82
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.

Detailed description: This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child \< 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.

Eligibility criteria: Inclusion Criteria:

* pregnant or has child \< 6 months of age
* enrolled in home visiting program
* exhibiting elevated depressive symptoms and/or personal history of clinical depression

Exclusion Criteria:

* no current clinical depression at time of enrollment

Primary outcomes:
measure: Depressive symptoms
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: 1 week post intervention
measure: Depressive Symptoms
timeFrame: 3 months post-intervention
measure: Depressive symptoms
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Depressive episodes
timeFrame: 3 months post-intervention
measure: Depressive Episodes
timeFrame: 6 Months Post-Intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: People's Community Health Center
state: Maryland
city: Baltimore
country: United States
facility: DRUM Healthy Families
state: Maryland
city: Baltimore
country: United States
facility: Maternal and Infant Nursing Program
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital Perinatal Depression Outreach Program
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Shiv D Tandon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162903: Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants
Official title: The Role of Nitric Oxide, Endothelin-1, and Inflammatory Mediators in the Patency of Ductus Arteriosus in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus
Keywords: Preterm infant, Patent ductus arteriosus, Nitric oxide,Endothelin-1
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The cardiopulmonary functions of these preterm babies may be adversely affected by the patency of ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1 and the dilating effect of prostaglandins, inflammatory mediators, and concentration of oxygen.

OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the patency of ductus arterious in preterm infants is probably due to inappropriate production of endogenous nitric oxide and the interaction with various inflammatory mediators and prostaglandins, which is different from those of term infants. In addition, the secretion of endothelin is probably decreased. The purpose of this study is to monitor the changes of these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus in preterm infants.

METHODS AND MATERIALS

1. Inclusion criteria:

   1. Preterm infants with gestational age less than 32 weeks or birth weight less than 2000 gm.
   2. Informed consent
2. Numbers of study population:

   With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively)
3. Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and nitrate), endothelin-1, and cGMP
4. Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon signed rank test for comparing data obtained between the PDA and non-PDA patients, the PDA patients before and after intravenous indomethacin, and those who are responsive or refractory to the therapy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of the patency of ductus arteriosus

Exclusion Criteria:

* Congenital anomalies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Wu Shiun Hsieh, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00058903: Treatment of Cholestatic Pruritus With Sertraline
Official title: Treatment of Cholestatic Pruritus With Sertraline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Liver Cirrhosis, Biliary
Hepatitis C
Keywords: Cholestatic
Pruritus
Sertraline
primary biliary cirrhosis
hepatitis C
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to find an effective and well-tolerated medical therapy for itching due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are currently being enrolled in the study. Persons participating in the study are given sertraline, a medication which is also often used for depression,to treat their itching. The dose is gradually increased as the effect on itching and any other potential side effects are carefully monitored.


Eligibility criteria: * Itching for at least 3 months
* Primary biliary cirrhosis or hepatitis C
* Elevated alkaline phosphatase for at least 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
References:
Clinical trial NCT06769503: Effect of Aromatherapy on Anxiety in Relatives of Emergency Patients.
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergency Service, Hospital
Aromatherapy
Anxiety
Keywords: emergency department
aromatherapy
anxiety
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It will be conducted as a randomized controlled experimental study in a pre-test-post-test control group experimental model.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to determine the effect of aromatherapy (lavender oil) application on the anxiety level of relatives of patients admitted to the emergency department.

The hypotheses of the study are as follows:

H1: Aromatherapy (lavender oil) application has an effect on the anxiety level of relatives of patients presenting to the emergency department.

H0: Aromatherapy (lavender oil) application has no effect on the anxiety level of relatives of patients presenting to the emergency department.

Detailed description: In the experimental group; After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. The participants will be made to smell lavender oil dropped on gauze by the researchers for an average of 3-5 minutes. After the intervention, the state and trait anxiety scales will be applied as a post-test approximately 15 minutes later.

In the control group; After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. No intervention will be made to the participants in the control group. After a certain waiting period (after an average of 15 minutes), the state and trait anxiety scales will be applied as a post-test.

Eligibility criteria: Inclusion Criteria:

1. Being 18 years of age or older
2. Not having a problem with smell
3. Accompanying the patient
4. Not having a psychiatric problem

Exclusion Criteria:

1. Refusing to participate in the study or wanting to leave
2. Having an upper respiratory tract infection
3. Known history of allergy (lavender oil)
4. Having a chronic respiratory disease

Primary outcomes:
measure: anxiety level
timeFrame: It will take approximately 30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Bitlis Eren University
name: Şerafettin OKUTAN, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06786403: The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers
Official title: Investigating the Effectiveness of the Supplement Containing Enteric-coated Bromelain (Anaheal 1200 GDU) in Healing Wounds, Pain, and Inflammation in Patients Over 18 Years Old with Diabetic Foot Ulcers Compared to Placebo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Diabetic Foot Ulcer (DFU)
Keywords: diabetic foot ulcer
bromelain
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 70
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: This study will be conducted on people over 18 with diabetic foot ulcers.. The first group will receive the standard treatment along with bromelain supplement and the second group will receive the standard treatment and placebo. The informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process. Wound surface area, rate of pain, rate of inflammatory factors (ESR and CRP) will be assessed at baseline and every two weeks.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Patients diagnosed with diabetic foot ulcers of category 0, 1 and 2 according to the Wagner criteria
* Patients aware of the study process for monitoring after filling out the informed consent form

Exclusion Criteria:

* People who are allergic to pineapple, celery, carrot and fennel
* Pregnant and lactating women
* Severe kidney failure (GFR\<30)
* Severe liver failure (Child Pugh B, C)
* Patients with hemophilia
* People taking anticoagulant drugs, anti-platelet and thrombolytic
* Patients with irregular heartbeat and tachycardia
* Patients with asthma

Primary outcomes:
measure: Wound surface area
timeFrame: At baseline and every 2 weeks until the end of treatment at 8 weeks
Secondary outcomes:
measure: The amount of pain
timeFrame: At baseline and every 2 weeks until the end of treatment at 8 weeks
measure: The amount of inflammation
timeFrame: At baseline and every 4 weeks until the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iran
Study officials:
name: Mobina Tajdari, PharmD Student
role: PRINCIPAL_INVESTIGATOR
name: Kamyab Andarzbakhsh, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02679703: Polarity Action in Electrical Stimulation Transcutaneous Donors for Treatment Areas Burned Patients
Official title: Polarity Action in Electrical Stimulation Transcutaneous for Treatment of Graft Donor Areas in Patients Autogenous Burned: Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of the polarity of the electric current in healing.

Detailed description: The objective of this study is to evaluate the effect of the polarity of the current in healing. Both will be compared to the effects of electrical stimulation of high voltage (HVES) and neuromuscular transcutaneous electrical stimulation (TENS) in the treatment of donor sites (DA) of burn patients. It is a prospective, controlled clinical, randomized, blinded. Will be assessed 60 subjects aged 18-59 years, of both sexes, underwent the surgical procedure of grafting (PCE) were randomly divided into small blocks 5:5:5 three groups: undergoing therapeutic procedure with HVES undergoing therapeutic procedure with TENS and control. Therapeutic procedures will be applied around the DA, thigh or scalp, after 24 hours of PCE until complete healing. The variables will be the healing time estimated by the removal of the dressing rayon, clinical evaluation, scar quality, the Vancouver scale; pain, the pain numerical scale evaluation (PNS); blood perfusion by thermography; quality of healing by digital imaging, quantification of areas of crusts by the software Image J; skin biomechanical aspects as firmness, the durometer being performed reassessment at the end of treatment. Data will be submitted to analysis of normality by the Shapiro-Wilk test and the effect of behavior among groups and pre- and post-intervention will be evaluated by ANOVA-two way followed by post-hoc (Bonferroni) or Friedman, with p \<0.05. Comparing groups, before a normal distribution is applied ANOVA followed by Tukey, and otherwise will be applied the Kruskal-Wallis test and post-hoc Dunn, p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Victims of second deep degree and third degree burns, aged between 18 and 59 years
* Both sexes
* Underwent the surgical procedure of grafting (PCE) with donor area of the scalp or thigh thick standardized mean (0.20 mm).

Exclusion Criteria:

* Diabetes,
* Infectious processes
* Use of medications that alter the healing process (corticosteroids, chemotherapy, radiotherapy, among others)
* Cognitive impairment
* Agreeing not to sign the Consent Form and Clarified or that do not fit the inclusion criteria described.

Primary outcomes:
measure: Time
timeFrame: One year
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06735703: Group B Streptococcus Infection and PROM Incidince
Official title: Incidince of PROM with GBS Infection and Prophylaxis Against It
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature Rupture of Fetal Membranes
Group B Streptococcal Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with prom

Brief summary: To investigate incidince of prom with GBS infection and role of prophylaxis against it


Eligibility criteria: Inclusion Criteria:

* Pregnant women with prom after 34 wks festation

Exclusion Criteria:

* Bleeding disorder
* emergency conditions

Primary outcomes:
measure: Incidince of prom with GBS infection and prophylaxis against it
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00564603: Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy
Official title: Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Post Operative Analgesia
Patient-Controlled Analgesia
Abdominal Surgeries
Keywords: Glucocorticoid
Opioids
Balanced analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2007-11-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.


Eligibility criteria: Inclusion Criteria:

1. ASA physical status I-II
2. Chinese
3. 19-64yr
4. Uterus myoma

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
2. Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
4. Those who were not willing to or could not finish the whole study at any time.
5. Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

Primary outcomes:
measure: Visual analog scale (VAS) of pain
timeFrame: 0-48h after surgeries
Secondary outcomes:
measure: First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
timeFrame: 0-48h after surgeries
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05244603: Application of Ideal Binary Masking to Disordered Speech
Official title: Application of Ideal Binary Masking to Disordered Speech
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Dysarthria
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for listeners with hearing loss, to investigate its potential application to overcome speech-in-noise difficulties for listeners understanding dysarthric speech. Successful completion of this project will demonstrate proof-of-concept for the application of this signal processing technique to dysarthric speech in noise, and inform the development of an R01 proposal to perform a large-scale evaluation of the technology, and clinically meaningful implications, in a broad range of disordered speech types and severities.


Eligibility criteria: Inclusion Criteria:INCLUSION CRITERIA for All Participants

* Native speakers of American English
* No history of speech or language impairment
* No significant prior contact with persons having neurogenic speech disorders

INCLUSION CRITERIA for Participants with Normal Hearing

* 18 to 70 years of age
* Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age)
* Auditory thresholds of 25 dB HL or better bilaterally at octave frequencies from 250-4000 Hz (if over 55 years of age)

INCLUSION CRITERIA for Participants with Sensorineural Hearing Loss

* 18 to 90 years of age

Exclusion Criteria:

* EXCLUSION CRITERIA for All Participants
* Mild or profound hearing loss
* Conductive or mixed hearing loss
* Asymmetric hearing loss
* Obvious concomitant cognitive or mental impairment
* Unable to achieve upward of 20% words correct

Primary outcomes:
measure: Percent Correct Speech Intelligibility
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
References:
citation: Borrie SA, Yoho SE, Healy EW, Barrett TS. The Application of Time-Frequency Masking To Improve Intelligibility of Dysarthric Speech in Background Noise. J Speech Lang Hear Res. 2023 May 9;66(5):1853-1866. doi: 10.1044/2023_JSLHR-22-00558. Epub 2023 Mar 21.