louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06050824: A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
Official title: A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: H. Pylori Infection
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.

The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.

About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.

All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.

Biopsies will be classified using the Updated Sydney system of classification of gastritis

Detailed description: The patients will be randomized (closed envelopes) into one of two groups:

1. patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
2. patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.

H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.

Eligibility criteria: Inclusion Criteria:

* All patients who presented with epigastric pain and dyspeptic symptoms

Exclusion Criteria:

1. Patients recently (within 6 months) treated with anti-H. pylori therapy.
2. Allergy to any drugs used in our protocol
3. Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
4. Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
5. Presence of GI malignancy.
6. Pregnancy or lactating women.
7. Unable or refuse to give consent. -

Primary outcomes:
measure: Eradication of H. pylori infection after treatment
timeFrame: 4 weeks after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Helwan University
Study officials:
References:
Clinical trial NCT02700724: Observation Versus Immediate Surgery of Low Risk Bladder Cancer
Official title: Observation Versus Immediate Surgery of Low Risk Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.


Eligibility criteria: Inclusion Criteria:

* History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:
* total tumor burden ≤3cm in size (multiple lesions permitted)
* low grade appearance (grade 1 or grade 2)
* noninvasive appearance (Ta)
* no history of carcinoma in situ (CIS) or lesions concerning for CIS
* negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)

Exclusion Criteria:

* High grade and/or invasive and/or carcinoma in situ disease
* Concomitant upper tract urothelial carcinoma
* Any patient who is pregnant or who may have plans to become pregnant.
* Positive cytology

Primary outcomes:
measure: Event-Free Survival
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with disease progression (either stage or grade)
timeFrame: 12 months
measure: Patient-reported Costs
timeFrame: At baseline and 3 months, 6 months, 9 months and 12 months.
measure: Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
timeFrame: At baseline and 3 months, 6 months, 9 months and 12 months.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel D. Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03870724: Women and Risk of Type 2 Diabetes
Official title: Women and Risk of Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Prevention
Cardiovascular diseases
Physical activity
Ethnic differences in health
Risk factors
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian Diabetes Association
First posted: 2019-03-12
Enrollment: 383
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle aged women, previous participants in the STORK G study still living in Norway

Brief summary: This is a follow-up survey of women, 10-12 years after they were included in the population-based Stork Groruddalen study of pregnant women, primarily set up to study gestational diabetes and related health issues in pregnancy in a multiethnic population. The investigators will now update the information about the health status of these women to study the development of risk factors for type 2 diabetes and cardiovascular diseases.

Detailed description: The STORK-Groruddalen is a cohort study of 823 pregnant women. Participation rate was high due to facilitation for ethnic minorities and data collection at the local Health Centres, set up to study ethnic differences in health to inform prevention strategies to reduce these differences. The investigators have published many papers from this well charatertized cohort, about gestational diabetes and related health issues in pregnancy. Participants have agreed to be contacted for subsequent follow-up surveys.

The inivestigators are now planning a follow-up study of these woman during 2019-2022, to study trajectories for risk factors for type 2 diabetes and cardiovascular diseases such as BMI, blood pressure, lipids, behavioural factors, physical activity and mental health and other health issues. The investigators will collect selfreported information through questionnaires, perform clinical measurements and take blood samples and buccal swabs. Collecting updated information about a range of health outcomes for women in this cohort will, together with already collected data, enable us to study the development of risk factors for type 2 diabetes and cardiovascular diseases in a life course perspective.

Eligibility criteria: Inclusion Criteria:

* Previous participants in the STORK G study still living in Norway

Exclusion Criteria:

* Moved out of Norway

Primary outcomes:
measure: Type 2 diabetes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo, Faculty of Medicine, Institute of Health and Society
Study officials:
affiliation: University of Oslo
name: Anne Karen Jenum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05975424: LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1
Official title: A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: Lineage Cell Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received administration of AST-OPC1 under clinical study protocol AST-OPC1-01

Brief summary: This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.

Detailed description: Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term safety in subjects for 15 years post AST-OPC1 administration.

Eligibility criteria: Inclusion Criteria:

* Subjects who received AST-OPC1 under Study AST-OPC1-01
* Reconfirmation of consent for long-term follow-up

Exclusion Criteria:

•Subjects who, for geographic or compliance reasons, are inappropriate candidates for participation in a long-term follow-up study in the opinion of the Investigator

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Up to 15 years after AST-OPC1 injection
measure: Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1
timeFrame: Up to 5 years after AST-OPC1 injection
measure: Changes at the injection site as monitored by MRI
timeFrame: Up to 5 years after AST-OPC1 injection
Secondary outcomes:
measure: Changes in neurologic function as assessed by the ISNCSCI
timeFrame: Up to 5 years after AST-OPC1 injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: RUSH University Medical Center
state: Illinois
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Lineage Cell Therapeutics, Inc.
name: Gary Hogge, DVM, MS, PhD
role: STUDY_CHAIR
References:
citation: Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
Clinical trial NCT05757024: Effect Of High Power Laser On Radiotherapy Induced Trismus.
Official title: Effect Of High Power Laser Therapy On Radiotherapy Induced Trismus In Head And Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trismus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study Randomized controlled study will be conducted to study (the effect of high power laser therapy on radiotherapy induced trismus in head and neck cancer patients).

the study group will receive high power laser therapy in combination with conventional tempromandibular joint exercises.

the control group will receive conventional tempromandibular joint exercises.


Eligibility criteria: Inclusion Criteria:

* head and neck cancer patients who complain of decreased mouth opening and received or receiving radiotherapy.
* patients who complain from pain and inflammation in the tempromandibular joint due to radiotherapy.
* radiotherapy should be above 40 GY.
* patient ages between 20 to 65 years old.

Exclusion Criteria:

* patients with poor general health.
* patients with difficulties in filling questionnaire.
* patients who are complaining of other tempomandibular problems other than trismus such as (disc discplacement and trumatic mandibular fractures.

Primary outcomes:
measure: pain level
timeFrame: one month (4 weeks)
measure: mouth opening
timeFrame: one month (4 weeks)
Secondary outcomes:
measure: quality of life improvement
timeFrame: one month (4 weeks)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
affiliation: Faculty of physiacl therapy cairo university
name: Mohammed Hussein Elgendy, proffessor
role: STUDY_DIRECTOR
References:
citation: Zecha JA, Raber-Durlacher JE, Nair RG, Epstein JB, Elad S, Hamblin MR, Barasch A, Migliorati CA, Milstein DM, Genot MT, Lansaat L, van der Brink R, Arnabat-Dominguez J, van der Molen L, Jacobi I, van Diessen J, de Lange J, Smeele LE, Schubert MM, Bensadoun RJ. Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols. Support Care Cancer. 2016 Jun;24(6):2793-805. doi: 10.1007/s00520-016-3153-y. Epub 2016 Mar 17.
citation: Borges, Marcela Maria Fontes, et al.
Clinical trial NCT04927624: Transversus Abdominis Plane Block Versus Quoadratus Lumborum Block on Infants
Official title: Comparison of Postoperative Analgesic Efficiency of Transversus Abdominis Plane Block and Quoadratus Lumborum Block on Infants Who Underwent Single Sided Inguinal Hernia Repair: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transversus Abdominis Plane Block
Quoadratus Lumborum Block
Keywords: infant
analgesic efficiency
Regional anesthesia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.

Detailed description: Infants are more sensitive to the side effects of general anesthesia than older children. This may be associated with the incomplete maturation of organ systems effective in pharmacodynamics. Regional anesthesia applications provide safe and effective analgesia by reducing the need for opioids. Regional anesthesia applications in infants require experience and complication rates due to central blocks are high. However, in recent years, the use of ultrasound (USG) has increased the use of safe and effective trunk blocks. There are studies on the use of Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block (QLB) in children. However, there is no comparative study on its use in infants.

In our study, we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.

Eligibility criteria: Inclusion Criteria:

* 1 month to 1 year
* who were scheduled for unilateral inguinal hernia operation
* American Society of Anesthesiologists (ASA) physical score I-II

Exclusion Criteria:

* Patients with ASA II-IV
* coagulopathy
* skin infection at the block application site
* bupivacaine allergy
* bilateral inguinal hernia operation
* additional operation in different region
* laparoscopic inguinal hernia operation
* younger than 1 month
* with a history of prematurity

Primary outcomes:
measure: FLACC
timeFrame: up to 24 hours
measure: first analgesic need times
timeFrame: up to 24 hours
Secondary outcomes:
measure: frequency of need for analgesics
timeFrame: up to 24 hours
measure: complications
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Research and Training Hospital
Study officials:
References:
Clinical trial NCT06027424: Blood Pressure and Obstructive Sleep Apnea
Official title: The Changes in Blood Pressure in Patients With Obstructive Sleep Apnea Following an Overnight Sleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-09-07
Enrollment: 2037
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence

Brief summary: Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). The relationship between AHI and changes of blood pressure deserves further investigation.

Detailed description: Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30% of patients with hypertension have OSA, and the prevalence is even higher in those of resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on blood pressure measurements and the nocturnal changes following an overnight sleep.

Eligibility criteria: Inclusion Criteria:

(1). Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence; (2). Feasibility to measure BP via wrist monitors; (3). Confirmation of wakefulness through electroencephalography.

Exclusion Criteria:

(1). Failure to measure BP via wrist monitors; (2). Age younger than 18 years; (3). Sleep efficiency less than 50%; (4). Central sleep apnea ≥ 50%

Primary outcomes:
measure: Blood pressure, before sleep and after awakening
timeFrame: 20:30 pm ~ 06:00 am next day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT05426824: The Whole-course Management of Pegaspargase in ENKTL
Official title: A Prospective, Multi-center Study of Whole-course Management of Pegaspargase in Extranodal NK/T Cell Lymphoma (ENKTL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Extranodal NK/T Cell Lymphoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective, multi-center study of the whole-course management of pegaspargase in Extranodal NK/T cell lymphoma (ENKTL). Based on a complete population pharmacokinetic model of pegaspargase in ENKTL patients, the time node of asparaginase monitoring and the principle of dose adjustment will be formulated. Besides, the proportion of "silent inactivation" of asparaginase in ENKTL patients and its effect on the prognosis of patients will also be explored. The treatment plan is as follows: (1) During 8 early (stage I/II) ENKTL patients receiving P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (2) During 4 early (stage III/IV) ENKTL patients receiving PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (3) During 72 (including above 12 patients) ENKTL patients receiving P-GOD/PEMD, the activity of pegaspargase and anti-pegaspargase in peripheral blood will be detected on D9 and D16 of each cycle of treatment.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed first-line ENKTL patients according to WHO 2016
* Willingness to provide written informed consent.

Exclusion Criteria:

* Patients are unsuitable for the enrollment according to investigator's judgement.

Primary outcomes:
measure: Plasma activity curve of pegaspargase
timeFrame: Plasma activity measurement of pegaspargase [time frame: Day3, Day4, Day5, Day6, Day7, Day8, Day10, Day12, Day14, Day16, Day18, and Day21 of first use of pegaspargase]
Secondary outcomes:
measure: the proportion of "silent inactivation"
timeFrame: days 7, 14, 21 of treatment
Other outcomes:
measure: The 2-year PFS rate
timeFrame: 2-year of Treatment
measure: AUC
timeFrame: Days 7, 14 of treatment
measure: MIC
timeFrame: Days 7, 14 of treatment (steady state)
measure: Cmax
timeFrame: Days 7, 14 of treatment (steady state)
Locations:
city: Nanjing
country: China
facility: Hematological Department, People's Hospital of Jiangsu Province
state: Jiangsu
Study officials:
affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
name: Wei Xu
role: PRINCIPAL_INVESTIGATOR
References: