louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00061724: Medical and Surgical Treatment of Esophageal Reflux
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: Esophageal
Reflux
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-06-04
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this project is to lay the groundwork for a proposed clinical trial to compare the effectiveness of two approaches to gastroesophageal reflux disease: treatment with medications and treatment with anti-reflux surgery. This project includes a non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge potential participants' willingness to enroll in the proposed clinical trial.


Eligibility criteria: Inclusion criteria:

* age 18-80
* diagnosis of gastroesophageal reflux disease
* have taken proton pump inhibitor medications

Exclusion criteria:

* prior esophageal surgery
* other serious medical conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Hines VA Medical Center
state: Illinois
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
References:
Clinical trial NCT06031324: The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress
Official title: The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Distress Syndrome
Lung Ultrasonography Score
Keywords: Respiratory distress syndrome
Lung ultrasonography
Newborn
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 120
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term and late-preterm premature newborns with respiratory distress symptoms in the first 30 minutes after birth

Brief summary: Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.


Eligibility criteria: Inclusion Criteria:

* Having symptoms of respiratory distress that begin soon after birth,
* \> 34 gestational age,
* \>1900 gr birth weight,
* Family consent

Exclusion Criteria:

* Congenital anomaly
* Chromosomal anomaly
* Hydrops fetalis
* Congenital heart disease

Primary outcomes:
measure: Enrollment of a targeted number of patients
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
Study officials:
References:
Clinical trial NCT01073124: Sensitivity Diagnosing Traumatic Knee Injuries With and Without Injection of Blue Dye Into the Knee Joint
Official title: Sensitivity of the Saline Load Test With and Without Methylene Blue Dye in the Diagnosis of Traumatic Knee Arthrotomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Knee Arthrotomy
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2010-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if adding blue dye improves the saline load test, which is a way to detect a traumatic intraarticular knee injury by injecting normal saline into the knee and looking for outflow through the wound.


Eligibility criteria: Inclusion Criteria:

* Individuals with diagnosis warranting elective knee arthroscopy

Exclusion Criteria:

* Pregnant women
* Decreased knee range of motion (flex \< 125, ext \<0)
* Active infection of knee joint
* history of or current intraarticular knee malignancy
* history of open traumatic injury of the knee

Primary outcomes:
measure: Volume (mm) injected at time of outflow
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Paul D Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02470624: Chinese Acute Ischemic Stroke Treatment Outcome Registry
Official title: Chinese Acute Ischemic Stroke Treatment Outcome Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Techpool Bio-Pharma Co., Ltd.
First posted: 2015-06-12
Enrollment: 10000
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: acute ischemic stroke patients

Brief summary: This is a multi-center registry study. The investigators will include 10,000 patients with confirmed acute ischemic stroke in China. The aim of the study is to survey current treatment situation in China and compare the effectiveness and safety between different intervention regimens.

Detailed description: Stroke is a common disease in China. Compared to western countries, there are many treatment regimens used in clinical practice in China. But their treatment effects are not well validated. The aim of the study is to survey current treatment situation in China and compare the effectiveness and safety between different intervention regimens.

Eligibility criteria: Inclusion Criteria:

1. age ≥18 yesrs
2. confirmed diagnosis of an ischemic stroke
3. admission within 1 week after onset of stroke or within treatment time window for patients of thrombolysis treatment
4. signed informed consent

Exclusion Criteria:

1. with intracerebral hemorrhage
2. with severe morbid (estimated survival duration less than 3 months)
3. could not provide follow-up information

Primary outcomes:
measure: death or severe disability
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Yining Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun W, Ou Q, Zhang Z, Qu J, Huang Y. Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China. BMC Complement Altern Med. 2017 Jul 6;17(1):357. doi: 10.1186/s12906-017-1863-4.
Clinical trial NCT01001624: Melanil in the Treatment of Melasma
Official title: Efficacy of Melanil in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melasma
Keywords: Cosmetic
Facial cream
Melasma
Melanil
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Melasma
* Fitzpatrick's skin types I to IV
* Signed informed consent
* Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).

Exclusion Criteria:

* Fitzpatrick's skin types V and VI
* Treatment with steroids within the duration of the clinical trial.
* Oral contraception within the duration of the clinical trial
* Usage of other cosmetics within the duration of the clinical trial
* Treatment with Clofazimine within the duration of the clinical trial

Primary outcomes:
measure: MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
timeFrame: 52 weeks
Secondary outcomes:
measure: Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
timeFrame: 52 weeks
measure: Photographs, at the beginning of the study and at weeks 8, 12 and 52.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
state: Havana
Study officials:
affiliation: "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
name: Alfredo Abreu Daniel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03203824: The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals
Official title: The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this graduate student study is to determine if ingestion of dark chocolate (70% cacao) will change brain frequencies between visualization at a state of rest and a state of exercise performance via electroencephalography (EEG) in vigorously active individuals.

Detailed description: The procedures include: On day one, participants will fill out a dark chocolate Likert scale, physical activity assessment, and demographic questionnaire. Day two and three, on consecutive days will include, three EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. The second day all three measurements will be recorded without dark chocolate (70% cacao). The third day all three measurements will be recorded again. Measurements 2 and 3 will be recorded savoring dark chocolate and after fully ingesting the dark chocolate respectively.

Eligibility criteria: Inclusion Criteria:

* 21-45 years of age
* vigorously active individuals, based on the General Physical Activities defined by Level of Intensity guidelines, greater than 75 minutes per week
* enjoy dark chocolate

Exclusion Criteria:

* Caffeine, sedatives, or tranquilizers within 12 hours of study
* Creatine or other performance enhancing steroid supplementation within 24 hours of study
* Ginseng supplementation within 24 hours of study
* Barbiturates within at least 36 hours of study
* Currently taking antiepileptic medications
* Any allergies, colds or sinus infections day of the study

Primary outcomes:
measure: EEG Wave Band Activity without dark chocolate ingestion
timeFrame: change from baseline to during visualization of rest for one minute
measure: EEG Wave Band Activity without dark chocolate ingestion
timeFrame: change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
Secondary outcomes:
measure: EEG wave band activity with dark chocolate ingestion
timeFrame: change from baseline to during visualization of rest for one minute
measure: EEG wave band activity with dark chocolate ingestion
timeFrame: change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda U
state: California
Study officials:
affiliation: Loma Linda University
name: Georgia Hodgkin, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06332924: Primipara Pregnant Women and Motivational Interview
Official title: The Effect of Positive Birth Motivational Education on the Perception of Traumatic Birth in Primipara Pregnant Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: Positive birth
Motivational interviewing training
Primiparous pregnant women
Perception of traumatic birth
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group.
Primary purpose: PREVENTION

Brief summary: The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.

This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data.


Eligibility criteria: Inclusion Criteria:Must be between the ages of 20-35, have a primipara pregnancy (30-34 weeks of gestation), be a Turkish citizen, have no history of risky pregnancy, have no psychological disorders, and wish to participate in the study voluntarily.

-

Exclusion Criteria:Having an unplanned or involuntary pregnancy, having a threat of premature birth, wanting to leave the job at any time.

-

Primary outcomes:
measure: Primipara Pregnant Women and Traumatic Birth
timeFrame: Once a week for 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SağlıkBilimleriU
name: enzel köksaldı
role: STUDY_DIRECTOR
References:
Clinical trial NCT00836524: Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?
Official title: "Kan IUGR og præeclampsi Forudsiges ud Fra YKL-40 målt i Serum?" "Metoder Til at Vurdere om Den Gravide Har Risiko for at Udvikle Svangerskabsforgiftning og/Eller væksthæmning Hos Fosteret".
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrauterine Growth Restriction
Preeclampsia
Keywords: IUGR
Preeclampsia
ultrasound
YKL-40
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Region Zealand
name: University of Copenhagen
First posted: 2009-02-04
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending nuchal transcluency examination at Gynækologisk-Obstetrisk dept. Roskilde University Hospital

Brief summary: Objective: To investigate the role of maternal serum YKL-40 and uterine artery doppler, at gestational age 12, 20, 25 and 32 weeks, and the relation to preeclampsia and intrauterine growth restriction. The serum marker YKL-40 is related to conditions involving inflammation, infection, tissue remodeling, fibrosis and cancer. IUGR and preeclampsia are known to be related to inflammation and tissue remodeling.

Methods: women attending screening for downs syndrome is scanned with uterine artery doppler and delivered blood samples at GA 12, 20, 25 and 32 respectively. When pregnancy outcome is registered by medical records blood samples are retrieved and analyzed for serum YKL-40. Serum YKL-40 are correlated to the presence of bilateral notching, preeclampsia and different degrees of intrauterine growth restriction.


Eligibility criteria: Inclusion Criteria:

* Pregnant danish speeking women

Exclusion Criteria:

* Conditions/diseases involving chronical inflammation, or immunological activity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Gynækologisk-Obstetrisk Afdeling, Sygehus Nord
state: Region Sjælland
Study officials:
affiliation: Dept of Pathology Herlev Hospital, Denmark
name: Estrid Høgdall, PhD leader
role: STUDY_DIRECTOR
affiliation: Dept. of oncology and medicine, Herlev Hospital, Denmark
name: Julia S. Johansen, Dr med prof
role: STUDY_DIRECTOR
References:
citation: Gybel-Brask D, Hogdall E, Johansen J, Christensen IJ, Skibsted L. Serum YKL-40 and uterine artery Doppler -- a prospective cohort study, with focus on preeclampsia and small-for-gestational-age. Acta Obstet Gynecol Scand. 2014 Aug;93(8):817-24. doi: 10.1111/aogs.12432. Epub 2014 Jun 20.
Clinical trial NCT05887024: Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.
Official title: Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-laminectomy Syndrome
Keywords: Sciatica
low back pain
post-laminectomy syndrome
Radial Shock Wave Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2023-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A. Control group (Group A) thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

B. Study group (Group B) thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
Primary purpose: TREATMENT

Brief summary: The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question:

1. what is the effect of Shock Wave Therapy on low back pain and sciatica caused by post-laminectomy fibrosis? patients in the study group will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).


Eligibility criteria: Inclusion Criteria:

1. Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring.
2. Both genders will be recruited.
3. Their age will range from: 30-50 years (Sharaf, et al., 2022).
4. Recruited patients will be randomly assigned in to two equal groups.
5. Unilateral radicular sciatica.
6. Constant back pain OR aggravated by movement,
7. Restricted lumbar range of motion.
8. Tenderness at the site of incision.
9. Duration of symptoms: three weeks to six months postoperatively

Exclusion Criteria:

1. Past history of vertebral fracture.
2. Spinal cord compression.
3. Vertebral tuberculosis.
4. Polyneuropathy.
5. Diabetic peripheral neuropathy.
6. Spinal tumor.
7. Recurrent disc herniation after surgery.
8. Spondylolisthesis.
9. Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases.
10. Potential pregnancy.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain algometry
timeFrame: 4 weeks
measure: Lumbar Range Of Motion
timeFrame: 4 weeks
measure: The Oswestry Disability Index: (ODI)
timeFrame: 4 weeks
measure: Sensory Nerve Conduction Study (NCS)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: