louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03297242: Study the Effect of Probiotics Combined With Bismuth Quadruple Rescue Therapy on H Pylori Infective Patients
Official title: A Retrospective Study of the Efficacy of Compound Lactobacillus Acidophilus Combined With Bismuth Quadruple Rescue Therapy on Patients With H Pylori Eradication Failures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori eradication
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mainland in China

Brief summary: Retrospectivly follow-up the outpatients for H pylori eradication failures more than 2 times in the digestive department of Changhai hospital from 2015-2017,analyse the eradication rates and adverse effects of the therapy with 2w's compound lactobacillus acidophilus followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme.

Detailed description: H pylori infection rate has been up to half of the world population. H pylori infection is associated with various diseases, especially gastric cancer.

With the increasingly resistant to antibiotics,the eradication rate has decreased a lot with traditional triple therapy. Exploring a valid scheem for patients who have failed multiple times is important.

Probiotics can improve gastrointestinal microenvironment, then release the adverse effects during the eradication process.Additionally,there is also a lot evidence that probiotics can inhibit H plori，but still controversially.

There is a low resistant rate about furazolidone and tetracycline. In this study investigators observe the efficacy of the therapy 2w's compound lactobacillus acidophilus followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme on patients who have failed more than 2 times. 4 to 6 weeks after the therapy, if Urea Breath Test (UBT) is nedative which means eradicating H plori successfully.

Eligibility criteria: Inclusion Criteria:

* H pylori eradication had failed more than 2 times
* Patients had never used furazolone and tetracycline
* The age varied from 18 to 80 years old

Exclusion Criteria:

* H pylori initial eradication or had failed only 1 time
* The age was lower than 18,or higher than 80 years old
* Patients who had serious heart pulmonary disease ,live renal disease, or any cancers
* Pregnant women

Primary outcomes:
measure: urea breath test
timeFrame: 4-6 weeks after the quadruple therapy
Secondary outcomes:
measure: adverse effects
timeFrame: 1month
Other outcomes:
Locations:
Study officials:
name: Zhao S Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384342: Maintenance Therapy of Narrow-band UV-B Therapy in Patients With Vitiligo
Official title: Maintenance Therapy of Narrow-band UV-B Therapy in Patients With Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phototherapy
Vitiligo
Maintenance Therapy
Narrow-band UV-B
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy.

The aim of this study was to evaluate the efficacy of Narrow-band UV-B therapy for the prevention of relapse in vitiligo.

Detailed description: For a total period of 12 months, perform Narrow-band UV-B treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.

An independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.

Eligibility criteria: Inclusion Criteria:

1. Patients with age of 19 years or older
2. Patients of generalized vitiligo with lesions on the trunk
3. Patients who had treated with Narrow-band UV-B therapy previously and achieved more than 75% lesion improvement
4. Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

1. Patients under the age of 19
2. Patients with localized vitiligo and segmental vitiligo
3. Patients who are in a state of physical or mental impairment to perform treatment or pregnant
4. Patients with spreading of vitiligo lesions
5. Patients who do not want to do thie study or who refuse to write a consent form
6. Any other person deemed unsuitable for the examination at the discretion of the examiner

Primary outcomes:
measure: Recurrence of vitiligo
timeFrame: change from baseline area score at 12 months
Secondary outcomes:
measure: The assessment of patient satisfaction
timeFrame: at baseline and at 12 months
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyonggi-do
Study officials:
References:
Clinical trial NCT01920542: Dexmedetomidine on Pediatric Heart Operation
Official title: Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Injury
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Detailed description: dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic stability for operative procedure. It had been already reported that dexmedetomidine reduce the impairment of renal functon after cardiac operation in adult. we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Eligibility criteria: Inclusion Criteria:

* 1-6yr pediatric cardiac patients

Exclusion Criteria:

* previous renal dysfunction

Primary outcomes:
measure: renal function
timeFrame: from anesthetic induction up to postoperative 2h
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Cneter
Study officials:
affiliation: Gachon University Gil Medical Center
name: Kyung Cheon Lee, M.D., Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00006142: Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phenylketonuria
Keywords: inborn errors of metabolism
phenylketonuria
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2000-08-04
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: OBJECTIVES:

I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria.

Detailed description: PROTOCOL OUTLINE: This is a multicenter study.

Patients receive a phenylalanine restricted diet based on a medical food such as Phenyl-free, Lofenalac, PKU 3, or Maximum XP (may be supplemented with tyrosine as needed) to achieve a target blood phenylalanine level of 2-6 mg/dL. The diet begins approximately 3 months prior to conception and continues until delivery of the baby. Patients are evaluated once a month before conception and weekly during pregnancy. Patients also undergo sonographic examination at 8, 20, 28, and 34 weeks gestation. At birth, the cord blood is evaluated for plasma amino acids. If the baby is found to have an elevated phenylalanine level, blood and urine are obtained to determine the baby's genetic status. Phenylalanine and tyrosine levels are checked in the baby daily for three days after birth.

The baby is followed for physical and mental development at 3 and 6 months and then annually thereafter.

Eligibility criteria: * Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Bobbye M. Rouse
role: STUDY_CHAIR
References:
Clinical trial NCT04417842: Connect Lung Outcomes With Bronchodilator Use
Official title: CLOUD Study: Connect Lung Outcomes With Bronchodilator Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Lead sponsor: Pulmonary Critical Care Associates of Baltimore
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients 18 years of age or older who are being seen in the pulmonary clinic including Asthma and COPD patients.

Brief summary: To determine the accuracy of the Respimetrix flow-volume monitoring device in measuring the patient's inspiratory capacity as compared to gold-standard measurements of inspiratory capacity on pulmonary function testing. Accuracy will be assessed before and after (A) pulmonary function testing and before and after (B) the administration of an inhaled bronchodilator medication.

Detailed description: 1. Specific Aim #1: Compare the performance of the flow-volume test device to standard pulmonary function measurements.

   The investigators hypothesize that measurements of inspiratory capacity with the Respimetrix test device will:

   A. Accurately measure the inspiratory capacity as assessed on standard pulmonary function tests, and will B. Correlate with other measures of pulmonary function including spirometry (vital capacity, forced expiratory volume in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual volume).
2. Specific Aim #2: Examine the ability of the flow-volume test device to track changes in standard pulmonary function measurements after the administration of an inhaled bronchodilator.

The investigators hypothesize that the Respimetrix test device will:

A. Accurately measure changes in inspiratory capacity in response to a standard dose of a short acting inhaled beta-agonist (4 puffs albuterol), B. Correlate with immediate changes in pulmonary function parameters including spirometry (vital capacity, forced expiratory volume in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual volume).

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older who are being seen in the pulmonary clinic including Asthma and Chronic Obstructive Pulmonary Disease (COPD) patients.
* Patients must be willing and able to provide informed consent to participate in the study.
* Patients must be able to use a metered dose inhaler.

Exclusion Criteria:

* Contraindication to inhaler use
* Tracheostomy
* Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
* Unable to understand informed consent (e.g., non-English speakers)

Primary outcomes:
measure: Validation
timeFrame: 1 year
Secondary outcomes:
measure: Validation
timeFrame: 1 year
Other outcomes:
Locations:
city: Towson
country: United States
facility: Pulmonary and Critical Care Associates Of Baltimore
state: Maryland
Study officials:
References:
Clinical trial NCT02551406: Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients
Official title: Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Home Mechanical Ventilation
Neuromuscular Disease
Keywords: nocturnal hypoventilation
capno-oxymetry
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ventilated neuromuscular disease patients followed at the Franch national reference center of Garches.

Brief summary: Different tools may be used to monitor the efficacy of home mechanical ventilation. Investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.

Detailed description: Home mechanical ventilation (HMV) is used to treat hypoventilation, and its efficacy is mostly assessed by daytime blood gases and nocturnal oxymetry (SpO2). Transcutaneous CO2 measure (TcCO2) has shown higher sensitivity than SpO2 to detect hypoventilation in neuromuscular diseases (NMD) patients. No data exist on the prognostic value of these techniques to monitor mechanical ventilated NMD patients.

Basing on retrospective data review, investigators aimed to compare the prognostic value of the data obtained using different tools to assess residual hypoventilation in the cohort of ventilated NMD patients followed at our reference center.

Eligibility criteria: Inclusion Criteria:

* neuromuscular disease
* age ≥18 years
* mechanically ventilated
* capno-oxymetry performed between 2009 and 2011

Exclusion Criteria:

* Long-term oxygen therapy

Primary outcomes:
measure: Time to first ICU admission
timeFrame: 6 years
Secondary outcomes:
measure: Mortality
timeFrame: 6 years
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
References:
citation: Ogna A, Nardi J, Prigent H, Quera Salva MA, Chaffaut C, Lamothe L, Chevret S, Annane D, Orlikowski D, Lofaso F. Prognostic Value of Initial Assessment of Residual Hypoventilation Using Nocturnal Capnography in Mechanically Ventilated Neuromuscular Patients: A 5-Year Follow-up Study. Front Med (Lausanne). 2016 Sep 13;3:40. doi: 10.3389/fmed.2016.00040. eCollection 2016.
Clinical trial NCT04208906: Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
Official title: Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cardiac Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.

In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.


Eligibility criteria: Inclusion Criteria:

* children under 7 years old

Exclusion Criteria:

* Hyperbilirubinemia
* Skin disease at sensor attachment site
* Single ventricle physiology

Primary outcomes:
measure: Validation of Masimo O3 value
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Other
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Song IS, Kang P, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Validation of the Masimo O3 regional oximetry device in pediatric patients undergoing cardiac surgery. J Clin Monit Comput. 2022 Dec;36(6):1703-1709. doi: 10.1007/s10877-022-00815-3. Epub 2022 Feb 15.
Clinical trial NCT03040206: Risk Stratification of Nodal PTCL
Official title: Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral T-Cell Lymphoma, Not Otherwise Specified
Angioimmunoblastic T-cell Lymphoma
Anaplastic Large Cell Lymphoma, ALK-negative
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Chonnam National University Hospital
name: Kyungpook National University Hospital
name: Keimyung University Dongsan Medical Center
name: Korea University Anam Hospital
name: Korea University Guro Hospital
name: Dong-A University Hospital
name: Pusan National University Hospital
name: Yeungnam University Hospital
name: Inje University
name: Chungnam National University Hospital
name: Samsung Medical Center
First posted: 2017-02-02
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)

Brief summary: This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma \[ALCL\], anaplastic lymphoma kinase \[ALK\]-negative)
* Patients diagnosed with between January 1, 2004 and April 30, 2016
* initially treated with curative intent
* Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of diagnosis and at the end of primary treatment

Exclusion Criteria:

* Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas)
* Patients with ALCL-ALK+
* Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end of treatment available for review

Primary outcomes:
measure: progression-free survival
timeFrame: 5 year
Secondary outcomes:
measure: overall survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk Nationla University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Ho-Young Yhim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164006: Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
Official title: A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Hodgkin's Lymphoma
* Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Patients who had prior Allogeneic hematologic stem cell transplant are excluded

Primary outcomes:
measure: Maximum Tolerated Dose acceptable for participants
timeFrame: 21 days (1 cycle of therapy)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 1 year
Other outcomes:
measure: Duration of Response
timeFrame: Up to 1 year
Locations:
city: Duarte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: San Diego
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Sarasota
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Detroit
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
Study officials:
References: