louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01378689: Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
Official title: Improving Bone Health Among RA Patients on Chronic Glucocorticoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effect of Glucocorticoids and Synthetic Analogues
Osteoporosis
Rheumatoid Arthritis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Medco Health Services, Inc
First posted: 2011-06-22
Enrollment: 4659
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This quality improvement project is aimed at improving health care by identifying low cost strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with their physicians about osteoporosis prevention and treatment (improving doctor-patient communication). The investigators will implement a direct to patient intervention to the population of interest (patients on chronic glucocorticoids) via story-telling, using an Internet based video. The target audience is people on chronic glucocorticoids not already receiving bones-specific osteoporosis medications to determine differences in post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis therapies.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 5 milligrams of prednisone or glucocorticoid dose equivalent for greater than or equal to 90 days within the previous 12 months
* Medco member for entire study period
* Refill steroid prescription online

Exclusion Criteria:

* anti-osteoporosis medication in previous 12 months

Primary outcomes:
measure: Number of participants receiving Anti-osteoporosis Treatment
timeFrame: within 3 - 12 months of exposure to video
Secondary outcomes:
measure: Calcium and Vitamin D use
timeFrame: within 3 - 12 months of exposure to video
measure: Patient-Physician Communication
timeFrame: within 3 - 12 months of exposure to video
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kenneth G Saag, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warriner AH, Outman RC, Allison JJ, Curtis JR, Markward NJ, Redden DT, Safford MM, Stanek EJ, Steinkellner AR, Saag KG. An Internet-based Controlled Trial Aimed to Improve Osteoporosis Prevention among Chronic Glucocorticoid Users. J Rheumatol. 2015 Aug;42(8):1478-83. doi: 10.3899/jrheum.141238. Epub 2015 Jul 1.
Clinical trial NCT04672889: Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis
Official title: Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Bacteria Flora Disturbance
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to understand the life history of the breast milk flora, explore its composition, source of strains, and ability to colonize the baby's intestinal environment, to find out strains with the potential of probiotics in breast milk

Detailed description: This is a double-blind and randomized study. After being discharged from the hospital, the subject was notified to consume the Babyguard breast milk probiotic daily for 1 month, and observe whether the mother's stool, breast milk and baby stool samples can find the same strain. The clinical diagnosis items of the bacterial strains of mother feces, breast milk and baby feces samples are evaluated by the doctor.

Eligibility criteria: Inclusion Criteria:

* At least 20 years old, pregnant women with non-high-risk pregnancy risk assessed by obstetricians and gynecologists, healthy mothers and infants with no abnormal obstetric examination results

Exclusion Criteria:

* Pregnant women who have used oral or injectable antibiotics within three months before delivery, or women who need a cesarean section for any reason during pregnancy

Primary outcomes:
measure: Microflora of mother's feces
timeFrame: 4-6 weeks after the baby is born
measure: Group. B Streptococcus (GBS) screening
timeFrame: 35-37 weeks of pregnancy
measure: The microflora of maternal blood
timeFrame: 4-6 weeks after the baby is born
measure: Metabolic analysis of maternal urine
timeFrame: 4-6 weeks after the baby is born
measure: Bacteria analysis of breast milk
timeFrame: 4-6 weeks after the baby is born
measure: Bacteria analysis of infant feces
timeFrame: 4-6 weeks after the baby is born
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
Study officials:
affiliation: National Taiwan University Hospital
name: Ming Shiang Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541189: Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
Official title: A 8-week, Multi Center(10),Single Arm, Open-labeled Prospective Study of Valsartan 160 mg in 200 Mild to Moderate Chinese Hypertension Patients Forced Titrated From 2-week Therapy of Valsartan 80 mg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
* All treatment-naive patients need to have 140mmHg≤MSSBP\<180mmHg and 90mmHg≤MSDBP\< 110mmHg at visit 1
* For patients on mono antihypertensive therapy, MSSBP/MSDBP should \<160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and \<180mmHg AND MSDBP≥90 mmHg and \<110mmHg

Exclusion Criteria:

* Severe hypertension
* Malignant hypertension
* Secondary hypertension
* Renal dysfunction(serum creatinine \> 2.0mg(176.8μmol/L)at visit 1)
* Hepatic disease
* History of hypertensive encephalopathy or cerebrovascular accident within 6 months
* History of myocardial infarction, coronary revascularization within 6 months
* Type 1 diabetes mellitus
* patietns with HbA1c \>8% at visit 1
* Women in pregnancy and lactation
* Potentially fertile female patients not using effective contraceptive methods
* Be allergy to study drug.

Other protocol defined inclusion/exlusion criteria may apply

Primary outcomes:
measure: Change from baseline and week 2 in blood pressure at week 10
timeFrame: Baseline, 2 week and 10 weeks
Secondary outcomes:
measure: Percentage of of patients who achieve BP<140/90mmHg
timeFrame: Baseline and 10 weeks
measure: Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10
timeFrame: Baseline and 10 weeks
measure: Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10
timeFrame: Baseline and 10 weeks
measure: Number of patients with adverse events, serious adverse events
timeFrame: during 10 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06010589: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers
Official title: Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* over 19 year old

Exclusion Criteria:

* Pancreatitis
* Diabetic ketoacidosis

Primary outcomes:
measure: Cmax,ss of DWJ1558
timeFrame: At pre-dose (0 hour), and post-dose 1 to 72 hour.
measure: AUCt of DWJ1558
timeFrame: At pre-dose (0 hour), and post-dose 1 to 72 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus YANGJI Hospital
Study officials:
References:
Clinical trial NCT00969189: Evaluation of the Pediatric Igel Airway in 250 Children
Official title: A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
Child
Infant
Keywords: anesthesia
child
infant
laryngeal mask
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal United Hospital Bath NHS Trust
First posted: 2009-09-01
Enrollment: 120
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children between 10 - 30 kgs infants between 5-10 kgs

Brief summary: Once a child has been anaesthetised and is fully asleep, a special airway tube called a laryngeal mask is often inserted into their mouth to help with their breathing. This tube is removed just before the child wakes up.

A new type of airway tube, called an i-gel airway, has been developed for children, which is hoped will be easier to insert, safer once in position, and will be less likely to cause a sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has been available for adults since 2007, and early trials have shown very encouraging results.


Eligibility criteria: Inclusion Criteria:

* All children weighing 5 -30kg
* Classified by the American Society of Anesthesiology (ASA) as grade 1-2,
* Scheduled for elective surgery under general anaesthesia, in whom a LMA or PLMA would otherwise be used for airway maintenance and in whom neuromuscular blocking drugs will not be used.

Exclusion Criteria:

* Inability of patient or parents to understand the study or consent process
* Neck pathology
* Previous or anticipated airway problems
* Pathology of airway, respiratory tract, upper gastrointestinal tract
* Increased risk of regurgitation or aspiration
* Weight \>30kg or \<5 kg
* ASA 3 and above,
* Emergency surgery

Primary outcomes:
measure: Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
timeFrame: during anaesthesia
Secondary outcomes:
measure: Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae
timeFrame: during anaesthesia and up to 24 hours postoperatively
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: UH Bristol NHS Foundation Trust
state: Avon
Study officials:
affiliation: UH Bristol NHS Foundation Trust
name: Michelle White, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00451789: Risk Factors of Minor Head Injury
Official title: Risk Factors of Minor Head Injury in Traumatological Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minor Head Injury
Intracranial Bleeding
Traumatic Brain Injury
Keywords: Minor head injury
iintracranial bleeding
traumatic brain injury
Cranial computed tomography
anticoagulatory drugs
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-03-26
Enrollment: 12500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Introduction and Aims:

The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.

Detailed description: Minor head injury (MHI)is one of the most common diagnoses in emergency rooms and traumatological outpatient departments. The aim of this study is to find clear evidence which risk factors are the most important in MHI patients to develop intracranial bleeding. We hypothetize that anticoagulation is one of the main risk factors for intracranial bleeding.

Eligibility criteria: Inclusion Criteria:

* Minor head injury, dizziness, nausea, vomiting

Exclusion Criteria:

* no injury to the head

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department for Traumatology/Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Wolfgang Machold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karni A, Holtzman R, Bass T, Zorman G, Carter L, Rodriguez L, Bennett-Shipman VJ, Lottenberg L. Traumatic head injury in the anticoagulated elderly patient: a lethal combination. Am Surg. 2001 Nov;67(11):1098-100.
citation: Wojcik R, Cipolle MD, Seislove E, Wasser TE, Pasquale MD. Preinjury warfarin does not impact outcome in trauma patients. J Trauma. 2001 Dec;51(6):1147-51; discussion 1151-2. doi: 10.1097/00005373-200112000-00021.
citation: Wolf H, Machold W, Frantal S, Kecht M, Pajenda G, Leitgeb J, Widhalm H, Hajdu S, Sarahrudi K. Risk factors indicating the need for cranial CT scans in elderly patients with head trauma: an Austrian trial and comparison with the Canadian CT Head Rule. J Neurosurg. 2014 Feb;120(2):447-52. doi: 10.3171/2013.10.JNS13726. Epub 2013 Dec 6.
Clinical trial NCT01789489: 3D Ultrasound - Based Hysteroscopy Versus Virtual Hysteroscopy
Official title: Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometrial or Uterine Pathology
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.


Eligibility criteria: Inclusion Criteria:

- Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt of endometrial / uterine pathology suspected by ultrasound or hysterography.

Exclusion Criteria:

* Current Pregnancy.
* Genital infection

Primary outcomes:
measure: Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Hôpital FOCH 40, rue Worth 92150 Suresnes
name: Stéphanie FAY, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00002289: The Effects of Thymopentin on HIV Infectivity of Blood Cells and Semen in HIV-Infected Patients
Official title: Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Semen
Thymopentin
Leukocytes, Mononuclear
HIV Seropositivity
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.

Patients must have the following:

* Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (PBMC) on two separate occasions.
* Voluntarily sign consent.
* Patients with HIV "wasting syndrome" are allowed.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS as defined by the CDC.
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Patients with the following are excluded:

* AIDS as defined by the CDC.
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Intravenous drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Annandale
country: United States
facility: Immunobiology Research Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT05010889: Quality of Life After POEM for Achalasia
Official title: Health-Related Quality of Life After Peroral Endoscopic Myotomy for Patients With Achalasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Achalasia
Keywords: Esophageal Achalasia, Peroral Endoscopic Myotomy, Quality of Life
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients schedule to undergo POEM for treatment of symptomatic achalasia in one tertiary hospital.

Brief summary: Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. At present, POEM has become one of the standard therapies for achalasia. Limited studies have focused on the patient's quality of life before and after POEM. The present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (ASQ) and the short form (SF)-36 scale.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy
* Scheduled to undergo POEM for treatment of achalasia

Exclusion Criteria:

* Coagulopathy and systemic disorders that precluded safe general anesthesia

Primary outcomes:
measure: Achalasia symptom questionnaire (ASQ)
timeFrame: Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment
measure: Short form (SF)-36
timeFrame: Baseline, Change from Baseline SF-36 score at 3 months and 12 months after treatment
Secondary outcomes:
measure: Eckardt score
timeFrame: baseline, 3 months and 12 months after treatment
measure: Gastroesophageal reflux disease questionnaire (GerdQ) score
timeFrame: baseline, 3 months and 12 months after treatment
measure: Reflux esophagitis on post-POEM endoscopy
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xiangbin Xing, MD, PhD
role: STUDY_DIRECTOR
References: