louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01223456: Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use
Official title: A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes Mellitus
Keywords: Saxagliptin
type 2 diabetes
clinical practice
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: several private and government hospitals

Brief summary: This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus
* Prescribed Saxagliptin by patient's attending physician

Exclusion Criteria:

* Known allergic or serious adverse reaction to Saxagliptin
* Pregnant or breastfeeding patients

Primary outcomes:
measure: Adverse events observed during the treatment duration
timeFrame: Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up
measure: Clinical Response determined by cure rate
timeFrame: Up to three (3) months after initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Batangas City
country: Philippines
facility: Research Site
state: Batangas
city: Cebu City
country: Philippines
facility: Research Site
state: Cebu
city: Davao City
country: Philippines
facility: Research Site
state: Davao
city: Iloilo City
country: Philippines
facility: Research Site
state: Iloilo
city: Las Pinas City
country: Philippines
facility: Research Site
state: Manila
city: Makati
country: Philippines
facility: Research Site
state: Manila
city: Pasig
country: Philippines
facility: Research Site
state: Manila
city: Quezon City
country: Philippines
facility: Research Site
state: Manila
city: Mabalacat
country: Philippines
facility: Research Site
state: Pampanga
city: Manila
country: Philippines
facility: Research Site
Study officials:
affiliation: AstraZeneca Philippines
name: Milagros Tan, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Philippines
name: Emmanuel Arca, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02272556: Investigating the Role of the Polyol Pathway in the Central Nervous System
Official title: Investigating the Role of Polyol Pathway in the Central Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2014-10-23
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.


Eligibility criteria: Inclusion Criteria:

* Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI \> 30 kg/m\^2) OR age-matched lean, healthy control subjects (BMI \< 25 kg/m\^2)
* Age 18-55
* BMI 18-45 kg/m\^2

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL
* Hgb \< 10 mg/dL
* ALT \> 2.5 x ULN
* Untreated thyroid disease
* Uncontrolled Hypertension
* Known Neurological Disorders
* Untreated Psychiatric Disorders
* Malignancy
* Bleeding Disorders
* Smoking
* Current or recent steroid use in last 3 months
* Illicit drug use
* Pregnancy, actively seeking pregnancy, or breastfeeding
* Inability to enter MRI/MRS

Primary outcomes:
measure: Metabolite Measurements by MRS
timeFrame: 4 hours post hyperglycemia
Secondary outcomes:
measure: Hunger Ratings
timeFrame: 4 hours post hyperglycemia
measure: Satiety Ratings
timeFrame: 4 hours post hyperglycemia
measure: Cognitive State
timeFrame: 4 hours post hyperglycemia
Other outcomes:
measure: Cerebrospinal fluid cell count
timeFrame: 2 weeks post MRS testing
measure: protein levels
timeFrame: 2 weeks post MRS testing
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert Sherwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01878656: Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergence Agitation
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
* patients scheduled for orthognathic surgery

Exclusion Criteria:

* severe cardiopulmonary disease
* psychological disease
* patients who cannot understand Korean

Primary outcomes:
measure: The Incidence of Emergence Agitation Using Four-point Categorical Scale
timeFrame: Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.
Secondary outcomes:
measure: The Time to Extubation
timeFrame: Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.
Other outcomes:
measure: Postoperative Pain
timeFrame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
measure: Sense of Suffocation
timeFrame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT05964556: Relationship Between the Functional Movement Screen and Isokinetic Muscle Strength of Knee in Different Sport Branches
Official title: The Relationship Between The Functional Movement Screen and Isokinetic Muscle Strength of Knee in Different Sport Branches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Strength
Sport Injury
Muscle Contraction
Keywords: Functional movement screen
H/Q ratio
isokinetic systems
muscle strength
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Carried out with 60 athletes between the ages of 12-30 who are interested in different or same sports branches.

Brief summary: This study was conducted to demonstrate the correlation between the functional movement screen and the isokinetic muscle strength with objective data. Investigators conclude that the use of FMS in combination with isokinetic systems will provide more detailed information on the prevention of injuries to sports and the improvement of performance.

Detailed description: This study was conducted to demonstrate the correlation between the functional movement screen and the isokinetic muscle strength with objective data. 60 athletes involved in volleyball, greco-roman, speed skating, athletics and taekwondo branches were included in the study. The functional movement of the athletes was assessed by Functional Movement Screening, lower extremity isokinetic muscle strength was assessed by ISOMED 2000® isokinetic device.

Eligibility criteria: Inclusion Criteria:

* Those who voluntarily agreed to participate in the study
* Have at least 3 years of licensed sports experience

Exclusion Criteria:

* Those who have had or have ongoing orthopedic problems in the last 6 months

Primary outcomes:
measure: Funtional Movement Screen (FMS)
timeFrame: 20 minutes
measure: Isokinetic Measurement of Knee Muscles
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
state: Guneysu
Study officials:
affiliation: Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
name: TUGBA BIRBEN, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00674856: A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Official title: A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Failure
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

Detailed description: This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
* Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria:

* Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
* A history of alcohol or drug abuse.
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
* Clinically relevant abnormal ECG
* Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
* Participation within 30 days prior to screening in another investigational study.

Primary outcomes:
measure: To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.
timeFrame: 8 days
Secondary outcomes:
measure: To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.
timeFrame: 8 days
measure: To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.
timeFrame: 8 days
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
city: Minneapolis
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT02549456: Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
Official title: Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: natural orifice surgery
natural orifice specimen extraction
taTME
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Universidade da Coruña
First posted: 2015-09-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.

Detailed description: Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Medically fit patient.
2. Non metastatic pathologically proven sigmoid colon cancer.
3. Non metastatic pathologically proven rectal cancer.
4. Patient continent for stool.

Exclusion Criteria:

1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
2. Patients with cardiac or chest problems that cannot withstand insufflation.
3. Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
4. Obstructed or perforated cancer.
5. Patients with metastatic colorectal cancer.
6. Incontinent patients.

Primary outcomes:
measure: Feasibility
timeFrame: 24 hour
measure: operative time
timeFrame: 24 hour
measure: Operative blood loss
timeFrame: 24 hour
measure: Wound complications
timeFrame: two week
measure: Major intraoperative complications
timeFrame: 24 hour
measure: Major postoperative complications
timeFrame: two weeks
Secondary outcomes:
measure: Adequacy of lymphadenectomy
timeFrame: one month
measure: Grading of quality and completeness of mesorectal excision
timeFrame: one month
measure: Longitudinal safety margin
timeFrame: one month
measure: short term oncologic outcome
timeFrame: 6 months - one year
measure: Functional outcome
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Oncology center Mansoura University
state: Dakahlia
Study officials:
affiliation: Head of general and digestive surgery department, CHUAC, universidade da Coruna
name: Jose F Noguira, MD
role: STUDY_DIRECTOR
affiliation: Professor of surgical oncology, Oncology center Mansoura University
name: Sherif Z Kotb, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03486756: Internet-delivered CBT for Asthma-related Anxiety: Feasibility
Official title: Internet-delivered Cognitive Behavior Therapy for Asthma-related Anxiety: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Anxiety
Stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 30
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
Intervention model description: This is an uncontrolled feasibility study with one arm.
Primary purpose: TREATMENT

Brief summary: This is a study to investigate acceptability and feasibility of a novel protocol on exposure-based CBT for asthma-related fear delivered over the Internet (Internet-CBT).

Detailed description: Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. In a prior study (ClinicalTrials.gov ID: NCT03158194) a protocol for exposure-based CBT was developed for asthma-related anxiety. The aim of the current study is to evaluate acceptability and feasibility of our protocol for asthma-related fear when delivered over the Internet (Internet-CBT). The plan is to include 30 participants that will all receive the intervention in this uncontrolled feasibility study.

Eligibility criteria: Inclusion Criteria:

* asthma diagnosed by a physician
* anxiety or stress related to asthma

Exclusion Criteria:

* severe psychiatric disorder
* chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma

Primary outcomes:
measure: Catastrophizing about asthma Scale
timeFrame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Secondary outcomes:
measure: Penn State Worry Questionnaire
timeFrame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
measure: Asthma control test
timeFrame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
measure: Asthma Quality of Life Questionnaire
timeFrame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
measure: Short Health Anxiety Inventory (SHAI)
timeFrame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
measure: Perceived Stress Scale
timeFrame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Study officials:
affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
name: Catarina Almqvist Malmros, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnert M, Sarnholm J, Andersson E, Bergstrom SE, Lalouni M, Lundholm C, Serlachius E, Almqvist C. Targeting excessive avoidance behavior to reduce anxiety related to asthma: A feasibility study of an exposure-based treatment delivered online. Internet Interv. 2021 Jun 17;25:100415. doi: 10.1016/j.invent.2021.100415. eCollection 2021 Sep.
Clinical trial NCT03566056: Early Recovery Outcomes After Standardized Fast-track Whipples Procedure
Official title: Early Recovery Outcomes After Standardized Fast-track Whipples Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included is chosen from all the patients in the surgery ward when they have undergone the Whipples procedure and furthermore meet the criteria listed above.

Brief summary: Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation.

Nevertheless, no studies have in detail described the acute (\<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc..

The purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.


Eligibility criteria: Inclusion Criteria:

* the patient has undergone the Whipple procedure
* The patient is over 18 years ol
* The patient has signed a consent statement from the postoperative therapy ward

Exclusion Criteria:

* The patient did not receive 125 mg of methylprednisolone prior to the operation
* The patient did only undergo pancreatectomy
* The patient wasn't given epidural anesthesia
* the patient was given anesthesia through a mask

Primary outcomes:
measure: Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)
timeFrame: 6 am on the day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: