louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00606710: Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
Official title: Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia, Ventricular Fibrillation
Heart Failure
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
First posted: 2008-02-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with risk of developing life threatening ventricular arrhythmias with and without heart failure

Brief summary: The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.


Eligibility criteria: Inclusion Criteria:

* ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
* CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
* Geographically stable patients who are available for follow-up at a study centre
* Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

* Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
* Patients currently requiring dialysis
* Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
* Enrolled in any concurrent study
* Patients implanted with the following leads which will not be abandoned:
* Atrial or right ventricular unipolar leads
* Patch defibrillation leads
* Non-compatible defibrillation leads (e.g. 5/6mm)

Primary outcomes:
measure: Appropriate detection of ventricular arrhythmias
timeFrame: Predischarge
Secondary outcomes:
measure: Appropriate shock conversion
timeFrame: Predischarge
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: KAS Gentofte Hospital
city: Ashkelon
country: Israel
facility: Barzilay Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: KAS Gentofte Hospital
name: Poul Erik Bloch Thomsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184910: Usefulness of Serum Pepsinogen and Gastrin as the Predictive Biomarker of Atrophic Gastritis, Intestinal Metaplasia and Gastric Cancer in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrophic Gastritis
Keywords: atrophic gastritis, pepsinogen, Helicobacter pylori
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 108
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Over 19 years, the patients who have gastrointestinal discomfort or get esophagastroduodenoscopy (EGD) for health check up, the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer

Brief summary: It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for atrophic gastritis and whether gastric atrophy based on the PG test would be improved after H. pylori eradication.


Eligibility criteria: Inclusion Criteria:

1. over 19 years
2. the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy (EGD) for health check up
3. the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer

Exclusion Criteria:

1. gastrectomy history
2. advanced gastric cancer (impossible to get the gastrectomy)
3. Helicobacter eradication history
4. the patients who have chronic disease
5. cancer patients except gastric cancer within 6 months
6. who cannot perform this study according to research's decision
7. who have bleeding tendency (ex. taking antiplatelet agent, low platelet count or abnormal coagulation time)

Primary outcomes:
measure: the change of pepsinogen level before and after H. pylori eradication
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT05103410: Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy
Official title: Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Analgesia
Hysterotomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The analgesic effect of perioperative use of aripiprazole has not been fully investigated.

So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.


Eligibility criteria: Inclusion Criteria:

* Physical status American Society of Anesthesiologist (ASA) I or II
* Electively scheduled for laparoscopic hysterectomy,

Exclusion Criteria:

* Patients who refuse to participate
* Body mass index (BMI) \> 30
* ASA physical status \> II
* Diabetes
* Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
* Coagulation abnormalities
* Pregnancy
* Known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis)
* History of drug addiction or alcohol abuse
* Mental retardation interfering with the evaluation of pain scores or PCA programs .

Primary outcomes:
measure: First time to analgesic requirement
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Total opioid consumption
timeFrame: First 24 hours postoperatively
measure: Visual analogue scale (VAS)
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT06533410: Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia： Specificity and Sensitivity in Clinical Practice
Official title: Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia： Specificity and Sensitivity in Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Hebei Provincial Hospital of Traditional Chinese Medicine
name: BAODING NO.1 HOSPITAL OF TCM
name: Inner Mongolia Hospital of Traditional Chinese Medicine
name: Shenzhen Hospital of Traditional Chinese Medicine
name: Suzhou Hospital of Traditional Chinese Medicine
First posted: 2024-08-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic widespread pain: pain on the left side of the body, pain on the right side, pain above the waist, and pain below the waist. In addition, axial bone pain (cervical or anterior chest or thoracic or lower back pain) must be present. In this definition, shoulder and hip pain are considered pain on each affected side. "Lower back pain" is thought to be lower pain.)

Brief summary: This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age; Patients with chronic widespread pain; Able to complete the questionnaire.

Exclusion Criteria:

* Terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.

Primary outcomes:
measure: Diagnosis of fibromyalgia with the Polysymptomatic Distress Scale(PDS)
timeFrame: up to 1 week
Secondary outcomes:
measure: QOL as measured by Short Form-36 Health Status Questionnaire(SF-36)
timeFrame: up to 1 week
measure: Fibromyalgia symptoms severity as measured by the Rebised Fibromyalgia Impact Questionnaire(FIQR)
timeFrame: up to 1 week
measure: Depression scores as measured by Beck depression inventory(BDI)
timeFrame: up to 1 week
measure: Stress scores as measured by Perceived Stress Scale(PSS)
timeFrame: up to 1 week
measure: Sleep scores as measured by Pittsburgh sleep quality index(PSQI)
timeFrame: up to 1 week
measure: Fatigue was measured by the Multidimensional Fatigue Inventory(MFI-20)
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00178581: Enteral Glutamine Supplementation for the Patient With Major Torso Trauma
Official title: Early Enteral Glutamine Supplement to Enteral Nutrition Support of the Major Torso Trauma Patient: Proposal for a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Trauma
Critical Illness
Shock
Keywords: Trauma
Critical Illness
Shock
Enteral Nutrition
Glutamine
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-15
Enrollment: 20
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: Glutamine is considered a conditionally essential amino acid during critical illness. After severe trauma, glutamine supplementation into the gastrointestinal tract may help maintain bowel function. We hypothesize that for the major torso trauma patient, high dose glutamine given enterally during resuscitation from shock and continued during enteral nutrition support is absorbed, available systemically and preserves gut integrity.

Detailed description: In this prospective, randomized, controlled trial of patients with major torso trauma, high-dose enteral glutamine and enteral nutrition will be given to research subjects while controls will receive isocaloric, isonitrogenous enteral support. Enteral tolerance, bowel integrity and permeability will be evaluated. The systemic appearance of glutamine will be measured.

Eligibility criteria: Inclusion Criteria:

* Adult trauma patients meeting criteria for shock resuscitation
* Major torso trauma
* Admission to the Shock/Trauma Intensive Care Unit

Exclusion Criteria:

* Age \<18 years
* Pregnant
* Expected survival \< 24 hours
* Bowel in discontinuity
* Renal failure: baseline serum creatinine\>3.0 and/or dialysis
* Admission total bilirubin \>10 mg/dl
* History of cirrhosis or cirrhosis apparent on exploratory laparotomy
* Asystole or CPR required

Primary outcomes:
measure: Gut function
Secondary outcomes:
measure: Systemic appearance of glutamine
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: University of Texas Medical School at Houston
name: Margaret M McQuiggan, MS, RD, CNSD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35. doi: 10.1177/014860710803200128.
Clinical trial NCT03002181: Pain Neurophysiology Education for Sport Therapy Students
Official title: The Effect of Pain Neurophysiology Education on Sport Therapy Students Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge
Attitude
Behavior
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain

Detailed description: This single-blind, randomised control trial aims to investigate the effect of a brief 70 minute Pain Neurophysiology Education session on sport therapy students knowledge, attitudes and clinical behaviour towards athletes with chronic pain. Participants will be selected from first year undergraduate and postgraduate sport therapy cohorts. Random number generator will assign participants into two subgroups. Group 1 will receive a control education on clinical 'red flags'. Red flags are questions that are routinely asked by therapists in clinical practice to screen for sinister pathology. Group 2 will receive education called 'Pain Neurophysiology Education' (taken from the Explain Pain publication). This mode of education uses the neurophysiology of pain to explain the experience, and has been used as an educational tool for patient, healthcare practitioners and students alike. Data collection (completion of three questionnaires) will take place immediately prior, and immediately after each education session.

The change in these outcomes pre and post intervention will subsequently be compared between groups.

Eligibility criteria: Inclusion Criteria:

* 1st year undergraduate sport therapy students
* 1st year postgraduate, pre-registration sport therapy students
* Enrolled at Teesside University, UK.

Exclusion Criteria:

* Previous detailed pain education on either PNE or Red Flags.

Primary outcomes:
measure: Pain Neurophysiology Quiz. (knowledge)
timeFrame: Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.
measure: The Health Care Pain Attitudes and Impairment Relationship Scale. (attitudes)
timeFrame: Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.
measure: Clinical Vignette. (clinical recommendations)
timeFrame: Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05712681: Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Onconic Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers


Eligibility criteria: Inclusion Criteria:

* A healthy adult aged between 19 and 45 years old
* BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening

Exclusion Criteria:

* The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
* The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
* The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
* The subject who has other clinically significant diseases or history
* The subject who has a history of drug abuse
* The subject who cannot withstand the insertion and maintenance of pH catheters

Primary outcomes:
measure: Cmax of JP-1366
timeFrame: Pre-dose(0 hour) and up to 34 hours in each period
measure: AUClast of JP-1366
timeFrame: Pre-dose(0 hour) and up to 34 hours in each period
Secondary outcomes:
measure: Gastric pH
timeFrame: Pre-dose(0 hour) up to 24 hours after Investigational product administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Central
Study officials:
References:
Clinical trial NCT04052581: Prospective Collection of Outcome Data Post POEM-TIF Procedure
Official title: Assessment of Safety and Outcomes in Patients Undergoing a Standard-of-care Combined POEM-TIF Procedure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Achalasia
Gastroesophageal Reflux Disease
Keywords: Per oral Endoscopic Myotomy
Transoral Incisionless Fundoplication
POEM
TIF
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Northwell Health
First posted: 2019-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient age \> 18 years old who have been diagnosis with either type I or type II Achalasia that has been proved by manometry

Brief summary: Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.


Eligibility criteria: Inclusion Criteria:

* Adult patient age greater than 18 years old
* Manometrically proven diagnosis of either type I or type II achalasia.

Exclusion Criteria:

* Achalasia type III, or other esophageal dysmotility disorders.
* Completion of POEM with evidence of mucosal injury or compromise
* Previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, Heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy
* Esophageal lumen diameter greater than 4 cm
* Sigmoidization of the esophagus
* Large esophageal diverticula
* Known active gastroesophageal malignancy
* Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
* Cirrhosis with portal hypertension, varices, and/or ascites
* Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
* Acute gastrointestinal bleeding
* Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet \< 50,000

Primary outcomes:
measure: Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Mouen Khashab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229281: Short Term Group Therapy for Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Enrollment: 30
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: Assessing Anxiety in patient suffering from anxiety disorders (NOT OCD or PTSD)before and after group therapy


Eligibility criteria: Inclusion Criteria:

* Anxiety disorder (other than OCD or PTSD)
* Eligibility to participate in group therapy

Exclusion Criteria:

* OCD
* PTSD
* Suicidal thoughts
* Psychotic state
* Severe hostile personality disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259181: A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration
Official title: Examination of the Immersion of Provisional Crown Material in Chlorhexidine Gluconate on Dental Plaque Formation in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Plaque
Keywords: chlorhexidine gluconate
polymethylmethacrylate
Anti-Bacterial Agents
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-29
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Chlorhexidine gluconate (CHX), as an anti plaque agent, is commonly used with a variety of products. In this study we, the investigators at Hadassah Medical Organization, intend to examine the efficacy of a single dip in CHX of provisional restoration prior to oral cementation. If the protocol is effective, we intend to calibrate it and recommend clinical use of the protocol. The examination of biofilm formation will be both with electron microscope and confocal scanning laser microscope.


Eligibility criteria: Inclusion Criteria:

* Any volunteer without systemic condition

Exclusion Criteria:

* Intake of antibiotic drug three months prior to experiment

Primary outcomes:
measure: calibration of a preventative protocol for biofilm formation measured by confocal scanning laser microscope and scanning electron microscope
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael M Perez Davidi, DMD
role: STUDY_DIRECTOR
References: