louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04617613: Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait
Official title: Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Kuwait
First posted: 2020-11-05
Enrollment: 603
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: Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait.

Detailed description: Helicobacter pylori (H. pylori) induced chronic infection is associated with peptic ulcer, chronic gastritis, gastric cancer, and increasing antibiotic resistance. Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer in the high-risk population. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait. We enrolled treatment-naive dyspeptic patients with gastric biopsy-proven chronic gastritis secondary to H. pylori in a prospective, open-label, randomized study conducted at the gastroenterology outpatient clinics of Haya Habeeb gastroenterology center in Kuwait. Patients were randomized into two groups: the first group received the standard triple therapy (omeprazole, amoxicillin, and clarithromycin) for 14 days; and the second group received quadruple therapy (omeprazole, amoxicillin, clarithromycin, and metronidazole) for 14 days. All patients were tested for the eradication of H. pylori by carbon-13 urea breath test (13C-UBT) one month after completion of eradication therapy.

Eligibility criteria: Inclusion Criteria:

* Male and female dyspeptic subjects aged ≥18 years with any nationality
* Patients with gastric biopsy-proven H. pylori related chronic gastritis and no other abnormalities in the upper gastrointestinal tract upon endoscopy
* Patients who were naive to treatment for H. pylori infection.

Exclusion Criteria:

* Pregnant or breastfeeding females
* Patients who were previously treated for H. pylori infection
* Patients who received any antibiotics, bismuth or acid-suppressant drugs within the last month

Primary outcomes:
measure: Negative 13-Carbon urea breath test
timeFrame: One month
measure: Adverse events
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Alfadhli A, Alboraie M, Afifi M, Dangi A. A Randomized Clinical Trial Comparing Triple Therapy versus Non-bismuth based Quadruple Therapy for the Eradication of Helicobacter Pylori in Kuwait. J Glob Infect Dis. 2022 Aug 26;14(3):99-105. doi: 10.4103/jgid.jgid_13_22. eCollection 2022 Jul-Sep.
Clinical trial NCT04508413: A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
Official title: An Exploratory, 14-week, Open-label Clinical Food Study to Evaluate the Effects of KB295 in Adult Patients With Ulcerative Colitis (UC) Presenting With Mild-to-moderate UC Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Microbiome
Ulcerative Colitis
Kaleido
Kaleido Biosciences
KB295
Oligosaccharide
Glycan
Pathogens
Microbiome metabolic therapy
MMT
Mild-to-moderate UC
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms


Eligibility criteria: Inclusion Criteria:

* Be male or female, ≥18 and ≤75 years of age
* Confirmed diagnosis of UC (\>6 months) by endoscopy
* Mild-to-moderate UC with at least 4 weeks of UC symptomatology prior to screening
* Stable medication regimen for at least 2 weeks prior to screening, if on medication for UC

Exclusion Criteria:

* Possible or confirmed diagnosis of Crohn's disease or indeterminate disease
* History of isolated distal proctitis
* Use of any antidiarrheal medications within the last 1 week prior to screening
* Antibiotic treatment within the past 28 days prior to screening
* Any non-UC related immunosuppressive medications other than purine analogs. Systemic corticosteroids including prednisone \> 10 mg per day are excluded.
* Major intra-abdominal surgery related to the bowel within 24 weeks prior to the screening period and/or planned invasive surgery/hospitalization during the study
* Major medical comorbidities, or other conditions in the opinion of the PI, that might impact the patient's safety or compliance, or the interpretation of the study results
* Treatment with any other investigational drugs within 28 days prior to the screening visit

Primary outcomes:
measure: Number of patients experiencing any treatment-emergent adverse events (TEAEs)
timeFrame: Day -1 to Day 84
measure: Number of patients experiencing discontinuations due to adverse events (AEs)
timeFrame: Day -1 to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Atlantia Food Clinical Trials
state: Illinois
city: Austin
country: United States
facility: Elligo Health Research, Inc.
state: Texas
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
affiliation: Kaleido Biosciences
name: Mark Wingertzahn, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06776913: Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.
Official title: Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity (body Mass Index &amp;amp;gt;30 Kg/m2)
Screening Colonoscopy
Keywords: obesity
Screening Colonoscopy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Doctors pick which one to use based on personal preference and what is available.


Eligibility criteria: Inclusion Criteria:

* BMI greater than 30
* Screening and surveillance colonoscopy

Exclusion Criteria:

* Colon surgery
* Therapeutic colonoscopy
* Inflammatory bowel disease
* Terminated procedure due to stool burden, stenosis, or obstructive mass.
* Colonoscopy for anemia
* History of incomplete colonoscopy due to technical difficulties

Primary outcomes:
measure: Composite of reaching the cecum in less than 10 minutes without changing the scope type.
timeFrame: From time of randomization to end of procedure. Assessed day of surgery.
Secondary outcomes:
measure: Cecal intubation rate (CIR)
timeFrame: From time of randomization to end of procedure. Assessed day of surgery.
measure: Terminal ileum intubation rate (TIIR)
timeFrame: From time of randomization to end of procedure. Assessed day of surgery.
measure: Insertion time (IT)
timeFrame: From time of randomization to end of procedure. Assessed day of surgery.
measure: Withdrawal time
timeFrame: From time of randomization to end of procedure. Assessed day of surgery.
measure: Ancillary maneuvers used
timeFrame: From time of randomization to end of procedure. Assessed day of surgery.
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Weston
state: Florida
Study officials:
References:
Clinical trial NCT02081313: Natural History and Biological Study of Netherton Syndrome
Official title: Syndrome de Netherton : Aspects Cliniques, Physiopathologiques et Identification de Cibles thérapeutiques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Netherton Syndrome
Healthy
Keywords: Netherton syndrome
Immune system
Skin barrier
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-03-07
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at studying the natural history of Netherton syndrome (NS), to identify the consequences of LEKTI deficiency on the immune system and to characterize new molecular mechanisms involved in the disease.


Eligibility criteria: Inclusion Criteria:

* Adult or child (no age limit)
* Confirmed diagnosis of Netherton syndrome
* Signed informed consent form for the patient or his legal representative

Exclusion Criteria:

* Bleeding disorder precluding skin biopsy

Primary outcomes:
measure: Measurement of seric cytokines levels
timeFrame: 3 months after patient recruitment
Secondary outcomes:
measure: Pattern of skin abnormalities
timeFrame: 3 months after patient recruitment
Other outcomes:
Locations:
city: Paris
country: France
facility: Imagine Institute for genetic diseases
Study officials:
affiliation: INSERM U1163
name: Alain Hovnanian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05721313: Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study
Official title: Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Furcation Defects
Keywords: Periodontal disease
Furcation defects
Root resection
Lead sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot cohort study
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test in 10 patients with advanced furcation involvement on molars. The main question\[s\] it aims to answer are:

• Is it possible to carry out root resection without endodontic treatment on molars? Tooth vitality will be checked (positive response to cold test). Root resection will be carried out under local anestesia.

Following visits will be carried out for re-evaluation/maintenance according to clinical care every 3 mounths until 3 years follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with stage III-IV periodontitis
* Compliantpatient, as shown by full mouth plaque score\<30%
* Previous non-surgical periodontal therapy within 6 mounths
* Maxillary or mandibular molar affected by periodontal furcation involvement and scheduled for root resection
* Positive to sensibility testing (cold/electric pulp tests)
* No prosthesis or large restorations
* Sufficiently divergent roots to make root resection feasible
* Root trunk lenght at 3 mm as measured in periapical radiograph

Exclusion Criteria:

* Systemic contraindications to perform periodontal surgery/root resection
* Fused roots
* Presence of periapical radiolucency
* Furcation class III affecting all roots of maxillary molar

Primary outcomes:
measure: Tooth vitality (positive response to cold test)
timeFrame: 3-year follow-up
measure: No periapical lesion
timeFrame: 3-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Centro Odontoiatrico Mediterraneo
state: CT
Study officials:
References:
Clinical trial NCT02195713: Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
Official title: Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oliguria
Polyuria
Lead sponsor: Potrero Medical
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patient that needs a Foley catheter

Brief summary: Urine output and urine drain line pressure were monitored while urine was drained into either:

1. Accuryn Urine Output Monitor (Potrero Medical) OR
2. Criticore Monitor (Bard Medical)

Detailed description: The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.

Eligibility criteria: Inclusion Criteria:

* Patient must ≥ 18 years of age
* Patient has a Foley catheter and urine collection system is in place per standard clinical decision
* Estimated length of placement of the Foley is 48 hours minimum
* Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA)
* Subject or subject's legally authorized representative is able to give informed consent before entering the study

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Clinical signs or symptoms of a urinary tract infection (UTI)
* Clinical signs or symptoms of a vaginal infection
* Currently has bladder or urethral trauma
* Use of investigational drug/device therapy within the past 4 weeks

Primary outcomes:
measure: Urine Output of SOC Device Versus Accuryn
timeFrame: 2 - 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Burn Center at Doctors Hospital
state: Georgia
city: Galveston
country: United States
facility: The University of Texas Medical Branch (UTMBP)
state: Texas
Study officials:
affiliation: UTMB
name: George Kramer
role: PRINCIPAL_INVESTIGATOR
affiliation: Joseph M. Stills Burn Center
name: Bruce Friedman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830113: Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects
Official title: Effects of Non-surgical Treatment of Chronic Periodontitis on Insulin Resistance and Glucose Tolerance in Non-diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Prediabetes
Keywords: periodontitis
diabetes
prevention
impaired glucose tolerance
insulin resistance
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Yaounde 1
First posted: 2016-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects.

Detailed description: Subjects with chronic periodontitis will undergo non-surgical periodontal treatment (NSPT) consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. Periodontal parameters (plaque index, gingival bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using KITT, glucose tolerance using oral glucose tolerance test and serum CRP level by immunoturbidimetry will be measured before and 3 months after the NSPT.

Eligibility criteria: Inclusion Criteria:

* Chronic periodontitis
* Non diabetic individual

Exclusion Criteria:

* Known diabetes
* Periodontal treatment less than 6 months prior to inclusion
* Having less than 20 natural teeth

Primary outcomes:
measure: Glucose tolerance
timeFrame: 3 months
measure: Insulin sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: Composite periodontal health
timeFrame: 3 months
measure: Inflammation
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Yaoundé 1 and Yaoundé Central Hospital
name: Eugene Sobngwi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nana Nana AR, Tsobgny Tsague NF, Lontchi-Yimagou E, Bengondo Messanga C, Tankeu A, Katte JC, Balti Vounsia E, Dehayem M, Sobngwi E. Effects of non-surgical treatment of chronic periodontitis on insulin resistance and glucose tolerance in subjects without diabetes (PARODIA 2 study). J Investig Med. 2021 Oct;69(7):1377-1381. doi: 10.1136/jim-2021-001831. Epub 2021 Jul 14.
Clinical trial NCT06879613: Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants
Official title: Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants at the Bamenda Regional Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: University of Bamenda
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if breastmilk, massage or no intervention works for pain management during vaccination of term infants. It will also learn about the safety of these 3 approaches. The main questions it aims to answer is:

Does breastmilk, massage or no intervention works for pain management during vaccination of term infants?

Researchers will compare breastmilk, massage or no intervention for pain management during vaccination of term infants.


Eligibility criteria: Inclusion Criteria:

* Neonates born at or after 37 completed weeks of gestation.
* Neonates scheduled to receive the DTC-HepB-Hib-1 immunization.
* Time from last feeding should be greater than or equal to 30 minutes.

Exclusion Criteria:

* Term neonates with major congenital abnormalities like limb contractures, limb deformities.
* Term neonates with any neurological conditions like hydrocephalus, cerebral palsy or birth asphyxia.
* Infants with acute illness.
* Infants randomized for no intervention but mothers breastfeed before pain evaluation to calm the babies from crying.

Primary outcomes:
measure: Neonatal infant pain score (NIPS)
timeFrame: The pain scores for all the arms was done 2 minutes before vaccination and 30 seconds after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Bamenda
country: Cameroon
facility: Bamenda Regional Hospital
state: Northwest Region
Study officials:
References:
Clinical trial NCT00171613: A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
Official title: A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothalamic Obesity
Keywords: Obesity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.


Eligibility criteria: Inclusion Criteria

- Patient must provide written informed consent

Exclusion Criteria

* Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403
* Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol
* Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot
* Any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment Refer to the original protocol for details of inclusion \& exclusion criteria. Any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol.

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in BMI
Secondary outcomes:
measure: Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: