louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04341454: Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Official title: A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-04-10
Enrollment: 327
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Detailed description: This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Eligibility criteria: Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
* Those who had experienced one or more subjective symptoms of gastritis

Exclusion Criteria:

* Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
* Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

Primary outcomes:
measure: Improvement rate of gastric mucosal erosion
timeFrame: at 2 weeks after the IP administration
Secondary outcomes:
measure: Cure rate of gastric mucosal erosion
timeFrame: at 2 weeks after the IP administration
measure: Cure rate of gastric mucosal edema
timeFrame: at 2 weeks after the IP administration
measure: Improvement rate of gastric mucosal erythema
timeFrame: at 2 weeks after the IP administration
measure: Improvement rate of gastric mucosal bleeding
timeFrame: at 2 weeks after the IP administration
measure: Improvement rate of subjective symptoms
timeFrame: at 2 weeks after the IP administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
References:
Clinical trial NCT05499754: Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter
Official title: The Effect of Supralottic Airway Devicess on Hemodynamic Response and Optic Nerve Sheath Diameter. PROSEAL LMA, SUPREMA LMA, I-JEL LMA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Pressure Increase
Supraglottic Airway Device
Optic Nerve Sheath Diameter
Keywords: Supraglottic airway device
hemodynamic response
optic nerve sheath diameter
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90

Brief summary: Direct laryngoscopy and tracheal intubation are associated with increases in intraocular pressure (IOP), intracranial pressure (ICP), heart rate (HR), and blood pressure. The use of supraglottic airway devices (SADs) are known to be beneficial in overcoming the disadvantages of laryngoscopy and tracheal intubation, especially ocular and pressure stress responses. In recent years, it has been reported that ultrasonographic measurement of optic nerve sheath diameter (ONSD) can be used in the diagnosis of increased ICP. The aim of our study is to compare the effects of Proseal laryngeal mask airway (pLMA), Suprem laryngeal mask airway (sLMA) and I-gel on hemodynamic response and ONSD during insertion in adult patients.


Eligibility criteria: Inclusion Criteria:

* ASA physical status of I-II
* elective surgery
* non-ophthalmic procedures
* 1-2 h duration
* general anaesthesia
* supine position

Exclusion Criteria:

* Mallampati and ASA status ≥III,
* a history or suspect of difficult airway,
* previous intracranial/ocular surgery,
* cerebral edema/high intracranial pressure,
* glaucoma,
* uncontrolled hypertension

  -, diabetic retinopathy,
* obstetric patients,
* those who refused to participate in the study

Primary outcomes:
measure: OPTIC NERVE SHEATH DIAMETER
timeFrame: 10 min after using supraglottic airway devices
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Gamze Küçükosman
Study officials:
References:
Clinical trial NCT06251154: Clinical Comparison of Two Soft Contact Lenses
Official title: A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Detailed description: The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Eligibility criteria: Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. They were of legal age (18) and capacity to volunteer.
  2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
  3. They were willing and able to follow the protocol.
  4. They were wearing soft contact lenses, or had done so within the past two years.
  5. They were able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

* Subjects will not be eligible if:

  1. They had an ocular disorder which would normally contra-indicate contact lens wear.
  2. They had a systemic disorder which would normally contra-indicate contact lens wear.
  3. They were using any topical medication such as eye drops or ointment.
  4. They were aphakic.
  5. They had had corneal refractive surgery.
  6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
  7. They were pregnant or lactating.
  8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
  9. They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Overall Score
timeFrame: 15 minutes
Secondary outcomes:
measure: Subjective Comfort
timeFrame: 15 minutes
measure: Subjective Vision
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codina, PhD MCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696054: Laboratory Diagnosis of Spontaneous Bacterial Peritonitis
Official title: Diagnostic Performance of Different Scores for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Tropical Medicine and Gastroenterology Department

Brief summary: This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites

Detailed description: Based on clinical diagnosis, SBP is commonly underdiagnosed because of its nonspecific or asymptomatic presentation. Therefore, a diagnostic paracentesis should be performed in all cirrhotic patients with ascites who require emergency room care or hospitalization, who demonstrate signs/symptoms suggesting SBP, or who present gastrointestinal bleeding, in order to exclude SBP. Several non-invasive methods were tried in many studies for SBP diagnosis, as alternatives to diagnostic paracentesis, e.g., fecal calprotectin. Moreover, numerous scores were proposed for SBP diagnosis with variable accuracies, such as procalcitonin, ESR, and CRP (PEC) index, the modified Wehmeyer SBP scoring system, and Mansoura scoring system. This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites. participants will be subjected to: Clinical evaluation: medical history and physical examination, Routine Laboratory investigations, Serum procalcitonin, Ascitic fluid study, Ascitic fluid culture with antibiotic sensitivity, Abdominal ultrasonography. The following scores will be calculated: Modified Child Pugh score, MELD score, MELD Na score, PEC index, Modified Wehmeyer score, and Mansoura score.

Eligibility criteria: Inclusion Criteria:

* cirrhotic patients with ascites

Exclusion Criteria:

Infections other than SBP.

* malignancy.
* Antibiotic therapy before hospital admission.
* Chemotherapy or radiotherapy within 1 month before admission.
* Pancreatic diseases.
* contraindication to paracentesis

Primary outcomes:
measure: PEC index
timeFrame: five months
measure: Modified Wehmeyer score
timeFrame: five months
measure: Mansoura score
timeFrame: five months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03933254: Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
Official title: Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intraocular Pressure
Intracranial Pressure
Pneumoperitoneum
Keywords: Intraocular pressure
Optic nerve sheath diameter
Pneumoperitoneum
Laparoscopy
Laparoscopic surgery
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be ASA 1 or 2 physical status patients undergoing elective laparoscopic cholecystectomy.

Brief summary: Pneumoperitoneum created during laparoscopic surgeries has some effects on human physiology. Increased intraabdominal pressure results in increased intrathoracic pressure, and eventually may result in increased intracranial and intraocular pressures. In this study we aimed to identify intraocular and intracranial pressure changes during the perioperative period due to the pneumoperitoneum created for laparoscopic cholecystectomy surgeries. Intraocular pressure will be measured directly from the eye. Intracranial pressure will be estimated by measuring optic nerve sheath diameter changes ultrasonographically.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) 1 or 2 physical status patients
* Elective surgeries

Exclusion Criteria:

* Patients with glaucoma
* ASA 3 or above patients
* Emergency surgeries

Primary outcomes:
measure: Intraocular pressure
timeFrame: Throughout the operation (usually about 1 hour).
Secondary outcomes:
measure: Intracranial pressure
timeFrame: Throughout the operation (usually about 1 hour).
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730054: Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
Official title: Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Pain
Respiration
Sedation
Keywords: Remifentanil
clonidine
acute pain
respiration
sedation
cognitive function
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

Detailed description: To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

-

Primary outcomes:
measure: Relief of pain(VAS reduction)
timeFrame: Experimental
Secondary outcomes:
measure: Reduction in Minute ventilation
timeFrame: Experimental
measure: Reduction in CO2 stimulated Minute Ventilation
timeFrame: experimental
measure: Reduction in BIS score
timeFrame: Experimental
measure: Performance on Stroop test
timeFrame: Experimental
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
Study officials:
affiliation: Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
name: Jon B Bergmann, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892554: The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)
Official title: The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phenylketonuria
Keywords: Phenylketonurias
Docosahexaenoic Acids
Neuropsychological Tests
Female
Adolescent
Adult
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Atlanta Clinical and Translational Science Institute
First posted: 2009-05-04
Enrollment: 33
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if taking supplemental DHA improves measures of processing speed and executive function in teen and adult women with PKU.


Eligibility criteria: Inclusion Criteria:

* Females
* Phenylketonuria
* Ages 12 years and older
* Able to complete neuropsychological testing

Exclusion Criteria:

* Pregnancy
* Currently taking DHA supplement

Primary outcomes:
measure: Cognitive processing speed
timeFrame: 0 months, 4.5 months
measure: Executive function
timeFrame: 0 months, 4.5 months
Secondary outcomes:
measure: Plasma and red blood cell DHA concentrations
timeFrame: 0 months, 4.5 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Rani H. Singh, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi SH, Kable JA, Evatt ML, Singh RH. A randomized, placebo-controlled, double-blind trial of supplemental docosahexaenoic acid on cognitive processing speed and executive function in females of reproductive age with phenylketonuria: A pilot study. Prostaglandins Leukot Essent Fatty Acids. 2011 Dec;85(6):317-27. doi: 10.1016/j.plefa.2011.09.004. Epub 2011 Oct 14.
Clinical trial NCT06361654: Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers
Official title: Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers, a Longitudinal Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Climber
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: climber

Brief summary: Climbing is a booming sport with an increasing number of participants. When practicing this sport, there is a muscular imbalance between the flexor and extensor systems (especially in the fingers), with the flexors of the fingers exerting greater force than the extensors. In addition, upper limb injuries, particularly the fingers, are very common.

The study will be carried out on club-licensed climbers, as they are better supervised. They will be recruited through requests sent to various clubs. The measurements will be taken during different climbing sessions, after the warm-up.

The study will include measurements on different climbers. Informed consent and personal data will be collected from the climbers before the measurements are taken. The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer. The climbers will then continue their usual training for 1 year. For 1 year after the measurements, the climbers will be contacted every month by telephone to collect the different injuries they may have suffered in relation to climbing, as well as the number of hours they have spent climbing in the past month. After 1 year, the annual number of hours of climbing and the annual number of injuries can be calculated for each climber. Injury is defined as any medically diagnosed lesion of the musculoskeletal system of the upper limb or pain that prevents the practice of a sport whose aetiology is climbing. These data are used to calculate the "athlete exposure" (A-E), i.e. the incidence of injury per 1000 hours of practice. As the study population is large, this allows for variations in exposure between subjects.


Eligibility criteria: * A male or female climber who has been a member of a climbing club for at least 1 year;
* Have a level of 6a "on sight" or higher;
* Fluent in spoken and written French;
* Over 18 years of age.

Exclusion Criteria:

* Declaration of a medically diagnosed upper limb injury at the time of testing;
* Presence of any pathology that prevents climbing or taking finger or wrist measurements;
* Volunteers for whom it is impossible to collect data by telephone.

Primary outcomes:
measure: Athlete exposure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen, University Hospital
state: Normandie
Study officials:
References:
Clinical trial NCT05662254: PERsonalized Mood Augmentation Trial for Depressed Mood
Official title: PERsonalized Mood Augmentation Trial for Depressed Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood.

Detailed description: The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood. After an initial period (2-4 weeks) of mood and lifestyle monitoring using smartphone and smartwatch data, participants will be assigned to an evidenced-based behavioral plan that target their lifestyle for 6 weeks. The trial will evaluate changes in depressed mood, associated health behaviors and cognition.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate depression per PHQ9 symptom ratings

Exclusion Criteria:

* active substance abuse/dependence
* psychotic disorders
* bipolar disorder
* eating disorder
* displaying acutely suicidal behaviors

Primary outcomes:
measure: PHQ9
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Health Psychiatry
state: California
Study officials:
affiliation: University of California, San Diego
name: Jyoti Mishra, PhD
role: PRINCIPAL_INVESTIGATOR
References: