louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00044668: Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination
Official title: An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: exenatide
exendin-4
diabetes
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2002-09-05
Enrollment: 155
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination
* BMI 25-45 kg/m\^2
* HbA1c between 7.5 % and 12.0 %, inclusive

Exclusion Criteria:

* Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening
* Patients previously treated with AC2993
* Patients presently treated with insulin

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit
timeFrame: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit
timeFrame: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Diagnostic Units Hungary Kft.
city: Budapest
country: Hungary
facility: Peterfy Teaching Hospital
city: Budapest
country: Hungary
facility: Uzsoki Street Municipal Hospital
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References:
citation: Ivanyi T, Fovenyi J, Faludi P, Han J, Macconell L, Wille S, Kiljanski J. Long-term effects of adding exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary. Clin Ther. 2012 Jun;34(6):1301-13. doi: 10.1016/j.clinthera.2012.04.022. Epub 2012 May 16.
citation: Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Clinical trial NCT06902168: Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy
Official title: Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diving
Aquatic
Muscle Spasticity
Motor Function
Children
Spastic Cerebral Palsy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.

Detailed description: Cerebral palsy (CP) is a common neurological disorders that affect movement and muscle coordination in childhood. Hydrotherapy is one of the most popular supplementary treatments for children with neuro-motor impairments, particularly children with CP.

Hydrotherapy may be more suitable for children with CP because of the properties of water, and it may be more motivating for children than land-based exercise. Buoyancy makes it easier for children with moderate to severe mobility limitations to move in the water than to move and exercise on land.

Eligibility criteria: Inclusion Criteria:

* Age from 2 to 5 years.
* Both sexes.
* Children diagnosed with spastic cerebral palsy, categorized according to the Gross motor function classification system (GMFCS) levels IV, V.

Exclusion Criteria:

* Botulinum toxin treatment or surgery in the preceding three months.
* Botox injections before or during the application of the program.
* Dorsal rhizotomy.

Primary outcomes:
measure: Gross motor function measurement-66
timeFrame: 8 weeks after intensive swimming program
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University (faculty of physical education)
state: Benha
Study officials:
References:
Clinical trial NCT03632668: Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072
Official title: An Open-label, Two-period, One-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Hypertension
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 38
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in healthy male volunteers.

Detailed description: To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2071 and AD-2072.

Eligibility criteria: Inclusion Criteria:

* Healthy male between 19 and 50 years of age at the time of screening
* Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2

Exclusion Criteria:

* Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine\*hematologic, cardiovascular, urinary, psychiatric
* Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
* HDL values less than 35 mg/dL
* AST, ALT values over than 1.5 times of ULN at screening
* A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

Primary outcomes:
measure: Peak Plasma Concentration
timeFrame: pre-dose to 24 hours
measure: Area under the plasma concentration versus time curve
timeFrame: pre-dose to 24 hours
Secondary outcomes:
measure: Time to reach Cmax
timeFrame: pre-dose to 24 hours
measure: Elimination half-life
timeFrame: pre-dose to 24 hours
measure: Clearance
timeFrame: pre-dose to 24 hours
measure: Volume of distribution
timeFrame: pre-dose to 24 hours
measure: Number of participants with adverse events
timeFrame: From Day 1 up to Day 46
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194168: Ectopic Pregnancy Biomarkers
Official title: Serum Bank for Assessment of Markers of Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Keywords: ectopic pregnancy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: National Institutes of Health (NIH)
First posted: 2005-09-19
Enrollment: 1306
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing treatment for infertility at the University of Pennsylvania Penn Fertility Practice

Brief summary: In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput system. The patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. The goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.


Eligibility criteria: Inclusion Criteria:

* Reproductive-aged women
* Currently pregnant based on serum human chorionic gonadotropin level
* Present for care for pregnancy due to vaginal bleeding and/or pelvic cramping
* Final diagnosis of one of the following:

  1. Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
  2. Diagnosed ectopic pregnancy
  3. Ultrasound confirmation of a nonviable gestation (less 14 weeks) such as an anembryonic gestation or a fetal demise

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Women's and Children's Hospital
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Philadelphia
country: United States
facility: University of Pennsylvania Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnhart KT, Guo W, Cary MS, Morse CB, Chung K, Takacs P, Senapati S, Sammel MD. Differences in Serum Human Chorionic Gonadotropin Rise in Early Pregnancy by Race and Value at Presentation. Obstet Gynecol. 2016 Sep;128(3):504-511. doi: 10.1097/AOG.0000000000001568.
citation: Rausch ME, Sammel MD, Takacs P, Chung K, Shaunik A, Barnhart KT. Development of a multiple marker test for ectopic pregnancy. Obstet Gynecol. 2011 Mar;117(3):573-582. doi: 10.1097/AOG.0b013e31820b3c61.
Clinical trial NCT05850468: Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.
Official title: Assistant Professor of Anesthesia, Intensive Care and Pain Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Spine Fusion
Keywords: multimodal analgesia, regional blocks, spine surgeries
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 140
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: opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

Detailed description: patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery

Eligibility criteria: Inclusion Criteria:

- spine surgery ASAI,II

Exclusion Criteria:

* revision surgery hypotension bradycardia

Primary outcomes:
measure: number of patients (percentage) having intraoperative systolic hypertension
timeFrame: during operation(intraoperatively)
measure: number of patients(percentage) having tachycardia
timeFrame: during operation(intraoperatively)
Secondary outcomes:
measure: VAS score
timeFrame: every 30 minutes for 2 hours postoperatively
measure: incidence of bradycardia
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams hospitals
Study officials:
affiliation: assistant professor of anesthesia
name: sanaa wasfy, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowland M, Thomson PD, Guichard A, Melmon KL. Disposition kinetics of lidocaine in normal subjects. Ann N Y Acad Sci. 1971 Jul 6;179:383-98. doi: 10.1111/j.1749-6632.1971.tb46915.x. No abstract available.
Clinical trial NCT05201768: Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation
Official title: Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 36 individual

Brief summary: THE OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION.

Detailed description: The gait, balance, fall risks and kinesiophobia of individuals with Alzheimer's Dementia will be evaluated and compared with healthy individuals.

Eligibility criteria: Inclusion Criteria:

* INDEPENDENT walker diagnosed with Alzheimer's Dementia

Exclusion Criteria:

* Having a disability to do physical activity Those who have had an operation in the last 6 months

Primary outcomes:
measure: Age
timeFrame: 5 month
measure: Body Mass Index
timeFrame: 5 month
Secondary outcomes:
measure: The Tinetti Gait and Balance Test (TGBT)
timeFrame: 5 month
measure: Mini Mental State Test
timeFrame: 5 month
measure: Tampa Scale
timeFrame: 5 month
measure: The Time Up Go Test
timeFrame: 5 month
measure: The Gait Speed Measurement Test (GSMT)
timeFrame: 5 month
measure: Fall Risk Self-Assessment Scale
timeFrame: 5 month
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
affiliation: Kırıkkale University
name: Oğuzhan Doğancı
role: STUDY_CHAIR
References:
Clinical trial NCT01590368: A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
Official title: A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy Subjects
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent
* Be a healthy volunteer and be over 18 years of age
* Willing to attend two scheduled visits for application and removal of the device and adverse event review
* Have healthy unbroken skin

Exclusion Criteria:

* Subjects with a history of sensitivity to any one of the components of the device being studied
* Subjects who have a history of skin related disorders to the chest.
* Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
* Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace

Primary outcomes:
measure: Product Performance : Remain in place
timeFrame: 30 minutes
measure: Product Performance: Perform
timeFrame: 30 minutes
Secondary outcomes:
measure: Safety: Adverse Events
timeFrame: 2 days
measure: Skin Rating
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
affiliation: North Cheshire Hospital
name: Barbara A Schofield
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151968: Traditional Blind Versus Ultrasound-guided Peribulbar Blockade
Official title: Traditional Blind Versus Ultrasound-guided Peribulbar Blockade
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal and Infra-ocular Pathology
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 80
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: Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. This is a blind injection and can be associated with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure of the eye etc. It also has a high failure rate resulting in need for additional injections, further exposing the patient to possible complications. The investigators propose to perform the peribulbar block with ultrasound to guide the block needle placement and injection. The investigators hypothesize that ultrasound guided peribulbar blocks would have higher success rate (less need for additional injections) and that the total amount of local anaesthetics used would be decreased.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing vitrectomy surgery

Exclusion Criteria:

* Lack of informed consent
* Coagulopathic disorder, anticoagulated with INR (international normalized ratio) \> 1.5 or platelet count less than 75 x 10\^9/L
* Pathological myopia. Inability of patient to lie down for 2 hours for the operation -Local infection at site of needle entry

Primary outcomes:
measure: Failure of peribulbar block
timeFrame: 10 minutes after block performed
Secondary outcomes:
measure: Quality of the block
timeFrame: 5 and 10 min after block performed
measure: Incidence of Supplemental Peribulbar injections
timeFrame: Operative day 0
measure: Volume of Total Local Anaesthetic Used
timeFrame: Operative day 0
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT04866368: Comparison of Erector Spinae Plane Block and Penile Block in Hypospadias Surgery
Official title: Comparison of Sacral Erector Spinae Plane Block and Dorsal Penile Block in Pain Management in Patients Undergoing Hypospadias Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Analgesia
Keywords: Regional anaesthesia
Pediatric anesthesia
Erector spinae plane block
Penil block
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to compare ultrasound-guided sacral erector spinae plane block and dorsal penile block on postoperative analgesic effect in hypospadias surgery.

Detailed description: ASAI-II, 1-9 years old patients with hypospadias diagnosis and operated in Kahramanmaraş Sütçü İmam University hospital and Kocaeli University hospital were randomized with closed envelope technique and divided into two groups as penile block or erector spinae plane block. Erector spinae plane block or penile block application (by Gözen Öksüz, Can Aksu) will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. Vital signs such as pulse, sp02, blood pressure will be monitored before, during and at the end of the operation. At the end of the operation and after the patient is awakened 5. min., 30 min. 1., 2., 4., 6., 12., 24. hourly FLACC pain scores, number of analgesic use within 24 hours, patient family satisfaction (1: dissatisfied, 2: satisfied, 3: very satisfied), complication rates will be recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaraş Sütçü İmam University Hospital and Kocaeli University Hospital

Exclusion Criteria:

* American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site

Primary outcomes:
measure: FLACC score
timeFrame: during postoperative 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sütcü Imam University
Study officials:
References: