louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03910647: Effect of Daily Use Proton Pump Inhibitors for One Month on Kidney Function
Official title: the Effect of Daily Use of Proton Pump Inhibitors for One Month on Renal Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Proton Pump Inhibitor Allergy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study to: evaluate the association between prolonged use of PPI and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

Detailed description: Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of Helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy,and gastroesophagial reflux diseases . Although PPIs have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases,PPIs may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury The increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged PPI therapy on renal function.

Eligibility criteria: Inclusion Criteria:

* patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function
* patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function

Exclusion Criteria:

* 1- cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.

  2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration \>_ 126 mg/dl ,random glucose level of \>200 mg/dl.

  3-patients take corticosteroid 4-patients with hypersensitivity to these drugs

Primary outcomes:
measure: kidney function
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: samir k abdel-hameed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: mohammad y kobeisy, prof
role: STUDY_DIRECTOR
References:
citation: Desbuissons G, Deray G, Mercadal L. [Proton pump inhibitors and kidney]. Nephrol Ther. 2018 Apr;14 Suppl 1:S115-S124. doi: 10.1016/j.nephro.2017.06.005. Epub 2017 Dec 20. French.
citation: Mak SK, Loo CK, Wong PN, Lo KY, Tong GM, Lam EK, Wong AK. A retrospective study on efficacy of proton-pump inhibitor-based triple therapy for eradication of Helicobacter pylori in patients with chronic renal failure. Singapore Med J. 2003 Feb;44(2):74-8.
Clinical trial NCT04344847: Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin
Official title: Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Excision Margin
Keywords: Gastrointestinal stromal tumour
Coincidental GIST with LSG
Gastric GIST
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-04-14
Enrollment: 338
Sex: ALL
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: With institutional review board approval from Zagazig University Hospitals 338. A double-centre prospective study was conducted on prospectively collected data of all morbidly. 17 patients in Zagazig University Hospitals, Faculty of Medicine, Egypt and 321 patients done in bariatric surgery excellence unit in a tertiary hospital in Riyadh-KSA.
Primary purpose: TREATMENT

Brief summary: LSG is thought to be the best choice for obese patients with conincidental GISTs, as a tumour can be resected along with resecting the stomach within the same procedure. The primary endpoint is that, how much does GIST suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

Detailed description: The incidence of unsuspected GIST in LSG specimens in our series was high in comparison to cases reported in the literature.

GISTs could be safely removed laparoscopically during LSG surgery with negative microscopic resection margins, with 1-2cm safety margin. Margins less than 1cm, high mitotic rate are adverse prognostic factors.

Examining the whole stomach before resection is mandatory and can easily be done during LSG, GIST can be removed safely with LSG

Eligibility criteria: Inclusion Criteria:

All morbid obese patients with BMI more than 35

Exclusion Criteria:

* previous gastric surgery
* patients with hiatus hernia
* age under 21 years

Primary outcomes:
measure: Excision of GIST during LSG
timeFrame: 4 years from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Saudi german hospital
Study officials:
References:
citation: Lyros O, Moulla Y, Mehdorn M, Schierle K, Sucher R, Dietrich A. Coincidental Detection of Gastrointestinal Stromal Tumors During Laparoscopic Bariatric Procedures-Data and Treatment Strategy of a German Reference Center. Obes Surg. 2019 Jun;29(6):1858-1866. doi: 10.1007/s11695-019-03782-y.
citation: Mazer L, Worth P, Visser B. Minimally invasive options for gastrointestinal stromal tumors of the stomach. Surg Endosc. 2021 Mar;35(3):1324-1330. doi: 10.1007/s00464-020-07510-x. Epub 2020 Mar 27.
citation: Inaba CS, Dosch A, Koh CY, Sujatha-Bhaskar S, Pejcinovska M, Smith BR, Nguyen NT. Laparoscopic versus open resection of gastrointestinal stromal tumors: survival outcomes from the NCDB. Surg Endosc. 2019 Mar;33(3):923-932. doi: 10.1007/s00464-018-6393-8. Epub 2018 Aug 31.
Clinical trial NCT05000047: Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
Official title: 3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ear Mold Impression Procedure
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with anatomically typical external auditory canals/meatus who have any degree, type, and configuration of hearing impairment.

Brief summary: Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.


Eligibility criteria: Inclusion Criteria:

* Hearing impairment (any degree, type, and configuration)

Exclusion Criteria:

* Absent or abnormal external auditory canal and/or external auditory meatus.
* Positive history of external/middle ear surgery.

Primary outcomes:
measure: Elapsed Time in Minutes to Complete Bilateral Ear Impressions
timeFrame: Day one
Secondary outcomes:
measure: Subjective Feedback of Overall Experience of Both Ear Impression Procedures
timeFrame: Day one
measure: Subjective Feedback, Pleasantness of Experience
timeFrame: Day one
measure: Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting
timeFrame: Day one
measure: Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)
timeFrame: Day 1
measure: Sub-investigator Clinician Subjective Rating of Individual Potential for Improvement When Performing Each Procedure 1 (no Potential for Improvement) to 3 (a Lot of Potential for Improvement)
timeFrame: Day 1
measure: Sub-investigator Clinician Subjective Rating of Individual Confidence That Method of Impression Will Yield a Quality Custom Product for the Participant on a Scale From 1 (Not at All Confident) to 3 (Very Confident).
timeFrame: Day 1
measure: Clinician Subjective Rating of Overall Experience of Each Procedure.
timeFrame: Day 1
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
affiliation: Sonova USCS
name: Kevin Seitz-Paquette
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03859947: High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis
Official title: Comparison of Heated humidiﬁed High-flow Nasal Cannula Flow Rates (1-L/kg/Min vs 2-L/kg/Min) in the Management of Severe Bronchiolitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-invasive Ventilation
Pediatric Pulmonary Disease
Keywords: Bronchiolitis
Emergency department
High-flow nasal cannula
Flow rate
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2019-03-01
Enrollment: 168
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with a clinical diagnosis of severe bronchiolitis, aged less than 24 months and presenting to the emergency department

Brief summary: Objective: The investigators aimed to compare the heated humidified high-ﬂow nasal cannula (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe bronchiolitis presenting to the pediatric emergency department.

Study design: The investigators performed a study in which all patients were allocated to receive these two flow rates. The primary outcome was admitted as treatment failure, which was defined as a clinical escalation in respiratory status. Secondary outcomes covered a decrease of respiratory rate (RR), heart rate (HR), the clinical respiratory score (CRS), rise of peripheral capillary oxygen saturation (SpO2) and rates of weaning, intubation and intensive care unit (ICU) admission.

Keywords: Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of severe bronchiolitis
* Must be less than 24 months
* Must have presented to the emergency department

Exclusion Criteria:

* Immediate invasive ventilation and/or intensive care unit admission
* Congenital heart disease,
* Chronic lung disease
* Neuromuscular disease
* Netabolic disease
* Craniofacial anomalies
* Immunocompromised
* Bacterial pneumonia
* Pneumothorax
* Nasal trauma

Primary outcomes:
measure: Treatment failure rate
timeFrame: Within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University School of Medicine, Pediatric Emergency Department
Study officials:
References:
Clinical trial NCT04851847: A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM
Official title: A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Intrabony Defects
Guided Tissue Regeneration
Keywords: resorbable collagen membrane
Lead sponsor: Collagen Matrix
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 65 years, male or female;
2. patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999;
3. Only solitary lesion site requires surgical treatment and must meet the following criteria:

   1. The baseline PD≥7 mm ;
   2. After debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected;
   3. The wideness of the keratinized gingiva≥2 mm;
   4. Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm;

Exclusion Criteria:

1. The test tooth has open surgical debridement history within the most recent one years;
2. Known allergy to collagen of animal origin;
3. Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;

Primary outcomes:
measure: The change of CAL at 12 weeks after surgery
timeFrame: 12 weeks
measure: The change of CAL at 24 weeks after surgery
timeFrame: 24 weeks
measure: The change of PD at 12 weeks after surgery
timeFrame: 12 weeks
measure: The change of PD at 24 weeks after surgery
timeFrame: 24 weeks
Secondary outcomes:
measure: The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.
timeFrame: 12 weeks
measure: The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References:
Clinical trial NCT04376047: Reverse Trendelenburg Position Versus Semi-recumbent Position in Obese Critically Ill Patients
Official title: Effect of Reverse Trendelenburg Position Versus Semi-recumbent Position on Ventilation and Oxygenation Parameters in Obese Critically Ill Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation and Oxygenation
Obese; Positioning
Critically Ill
Keywords: Reverse Trendelenburg position
semi-recumbent position
ventilation
oxygenation
obese patients
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group pre-test and repeated post-test study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to assess the effect of reverse Trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients

Detailed description: Obese critically ill patients' position significantly impacts on their ventilation and oxygenation status. It is also associated with mechanical ventilation success or failure and may be a main determinant of the obese patients' outcome. Reverse Trendelenburg position is recommended for obese patients but in critical illness with mechanical ventilation little is known about its effect on respiratory therapeutic targets. This trial was conducted in four general intensive care unit of Alexandria Main University hospital in Alexandria, Egypt. One hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were randomly assigned by a computer program to either reverse Trendelenburg position group (n=55) which is the intervention group or semi-recumbent position group (n=55) which is the routine unit position. Patients were positioned in the study positions 4 times per day. Patients were maintained in the study positions for 2 hours each time. Baseline ventilation and oxygenation parameters were assessed immediately before positioning then it was reassessed every 10 minutes after positioning for 30 minutes.

Eligibility criteria: Inclusion Criteria:

* body mass index ≥ 30
* Mechanically ventilated

Exclusion Criteria:

* Trauma
* Shock
* Acute respiratory distress syndrome

Primary outcomes:
measure: Respiratory dynamic compliance
timeFrame: 30 minute form positioning time
measure: Respiratory minute volume
timeFrame: 30 minute form positioning time
measure: Partial pressure carbon dioxide
timeFrame: 30 minute form positioning time
measure: Partial pressure oxygen
timeFrame: 30 minute form positioning time
measure: Hypoxemic index
timeFrame: 30 minute form positioning time
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT04061447: Tailored Juice-guided Eradication Therapy
Official title: Tailored Antibiotic Susceptibility-guided Therapy Via Gastric Juice PCR for First-line H Pylori Eradication, a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: gastric juice guided therapy
H.pylori eradication
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to investigate the efficacy of tailored anti-microbial susceptibility guided-therapy via gastric juice PCR, compared with empirical standard triple therapy.

Detailed description: The eradication of H. pylori is an important clinical issue due to its association with many gastrointestinal diseases such as peptic ulcer and even gastric cancer. However, with the global trend of increasing antibiotic resistance, the eradication rate of clarithromycin-based standard triple therapy has declined to less than 80%. To overcome such alarming antibiotic resistance, antimicrobial susceptibility-guided therapy is recommended. However, the literature on gastric juice PCR as susceptibility-guided therapy is scant; therefore, the investigators conducted this prospective randomized controlled trial with the aim of investigating the efficacy of antibiotic susceptibility-guided therapy via gastric juice PCR for first-line eradication.

Eligibility criteria: Inclusion Criteria:

1. male or non-pregnant female aged more than 20 yeasrs
2. H.pylori infection
3. Mental and legal ability to give a written infomed consent

Exclusion Criteria:

1. pregnant women
2. previous allergic reaction to antibiotics (clarithromycin, amoxicillin, levofloxacin, metronidazole and Proton-pump inhibitor(rabeprazole)
3. patients with previous gastric surgery
4. the coexistence of serious concomitant illness(for example, decompensated liver cirrhosis, uremia)

Primary outcomes:
measure: The rate of H.pylori eradication
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Deng-Chyang Wu, MD, PHD
role: STUDY_CHAIR
affiliation: Kaohsiung Medical University
name: Chao-Hung Kuo, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04216147: Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
Official title: Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
nerve compression syndrome
median nerve
physical therapy technique
percutaneous needle electrolysis
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 140
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: The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS).


Eligibility criteria: Inclusion Criteria:

* Over 18 years.
* CTS diagnosed by Electromyography (EMG)
* Symptoms of CTS + EMG

Exclusion Criteria:

* Difficulty expressing your feelings properly
* Unsurpassed fear of needles
* History of adverse reactions to needles
* Epilepsy and / or allergies to metals.
* Difficulty expressing your feelings properly
* Existence of diffuse peripheral neuropathy or cervical radiculopathy
* History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)

Primary outcomes:
measure: Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Secondary outcomes:
measure: Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
measure: Change of pain level
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
measure: Change of Semmes Weinstein Mini monofilament kit
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
measure: Change of the Hand Dynamometer
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
measure: Changes of the Muscles strength by Kendall´s scale
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
measure: Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)
timeFrame: Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Other outcomes:
measure: Direct and indirect health cost measures
timeFrame: 12 months after treatments
Locations:
Study officials:
References: