louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03387956: Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting
Official title: Intravenous Dexamethasone Combined With Intrathecal Atropine to Prevent Morphine-related Nausea and Vomiting After Cesarean Delivery: A Randomized Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Keywords: Postoperative Nuasea
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting.

Detailed description: One of the gold standards for analgesia following cesarean delivery is intrathecal morphine, which is not devoid of complications namely postoperative nausea and vomiting. We evaluated the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after cesarean delivery under spinal bupivacaine plus morphine anesthesia.

Eligibility criteria: Inclusion Criteria:

* females
* 18-40 years of age
* elective cesarean delivery under bupivacaine spinal anesthesia

Exclusion Criteria:

* renal disease
* preeclampsia
* liver disease
* cardiac disease
* Coagulopathy
* chronic cough
* nausea
* vomiting
* patient refusal

Primary outcomes:
measure: postoperative nausea
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT02280356: Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Official title: Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Radiation Therapy
Brachytherapy
14-163
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.


Eligibility criteria: Inclusion Criteria:

* Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
* Pathologically-proven diagnosis of prostate adenocarcinoma
* PSA 10-20ng/mL or
* Gleason =7 or
* Clinical stage T2b/c
* Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
* Age ≥18
* KPS≥70
* Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
* International Prostate Symptom Score ≤15

Exclusion Criteria:

* Prior prostate surgery (including TURP)
* Prior history of chronic prostatitis or urethral stricture
* Inflammatory bowel disease
* Prior history of pelvic radiotherapy
* Unable to give informed consent
* Metastatic disease.

Primary outcomes:
measure: Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
timeFrame: 12 months
Secondary outcomes:
measure: Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Follow Up Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marisa Kollmeier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02474056: The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients
Keywords: decreased blood volume vein volume flow ultrasound exam
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 0
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: patients admitted at haemek medical center

Brief summary: We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation

Detailed description: Patients with clinical signs of loss of the effective blood volume will undergo ultrasound examination of several major veins. The purpose of this examination is to determine vein volume(size) and flow. The ultrasound examination will be done before fluid resuscitation, after fluid administration,and three days after admission

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* decreased effective blood volume
* Systolic blood pressure \< 100
* Pulse rate \> 110

Exclusion Criteria:

* age \<18 years old
* pregnancy
* patient requires urgent surgical intervention

Primary outcomes:
measure: blood volume
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: Doron Kopelman, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00609856: Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Official title: Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Secondary Drug Failure
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Skane County Council Research & Development Foundation
First posted: 2008-02-07
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.

Detailed description: The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:

* Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
* Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
* Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin

Exclusion Criteria:

* heart failure (NYHA II-IV)

Primary outcomes:
measure: Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
timeFrame: 26 weeks
Secondary outcomes:
measure: Effect of pioglitazone vs. insulin glargine on BNP
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö University Hospital
Study officials:
affiliation: Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden
name: Leif Groop, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00986856: Fucidin® Cream in the Treatment of Impetigo
Official title: A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Impetigo
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients.

To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream.

To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of impetigo,
* Patients aged 2-11 years,
* Patients of either sex,
* Patients whose parent(s) has(ve) provided written consent, AND
* Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.

Exclusion Criteria:

* Patients with other active inflammatory dermatitis at the area of impetigo,
* Patients with a temperature above 38.5 C rectally (or equivalent), OR
* Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.

Primary outcomes:
measure: Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
timeFrame: EOT: Visit at Day 25
Secondary outcomes:
measure: Number of Patients With Clinical Success at Visit 2
timeFrame: Visit 2: Day 4
measure: Number of Patients With Clinical Success at Visit 3
timeFrame: Visit 3: Day 11
measure: Number of Patients With Clinical Success at EOT
timeFrame: EOT: Visit at day 25
measure: Number of Patients With Bacteriological Success at Visit 2
timeFrame: Visit 2: Day 4
measure: Number of Patients With Bacteriological Success at Visit 3
timeFrame: Visit 3: Day 11
measure: Number of Patients With Bacteriological Success at EOT
timeFrame: EOT: Visit at day 25
measure: The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).
timeFrame: EOT: Visit at day 25
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Institute of Internal Medicin, Haukeland University Hospital
city: Göteborg
country: Sweden
facility: Vårdcentrum Kungshöjd
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References:
Clinical trial NCT05618756: CBD, Nutrient Metabolism and Energy Intake
Official title: Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Lipid Metabolism Disorders
Appetitive Behavior
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.


Eligibility criteria: Inclusion Criteria:

• Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and \<30.0

Exclusion Criteria:

* Currently engage in \>10 hours moderate or vigorous intensity physical activity per week
* Have consumed CBD or cannabis at all within the past two months
* Have used CBD or cannabis regularly (\>2x in a week) within the past four months
* Are suffering from any clinically significant illness
* Have regularly used tobacco within the previous 6 months (\> 2/week)
* Currently use any prescription or over-the-counter medications (except for hormonal contraception and simple painkillers)
* Have given a standard blood donation within 30 days of screening
* Are currently pregnant or lactating
* Are allergic/intolerant to any ingredients in food items provided during the study

Primary outcomes:
measure: Energy intake
timeFrame: ~5-30 minutes (time taken to eat a single meal)
measure: Postprandial Glycaemia
timeFrame: 3 hours
measure: Postprandial Triglyceridaemia
timeFrame: 3 hours
Secondary outcomes:
measure: Postprandial Insulinaemia
timeFrame: 3 hours
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References:
Clinical trial NCT03034356: Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Official title: Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-01-27
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.

Detailed description: Cognitive symptoms are not currently well-managed in Veterans with schizophrenia, leading to substantially diminished quality of life. Improved treatment strategies clearly are needed. Recent studies suggest taht an overactive hippocampus is associated with cognitive deficits in the illness. Based on findings that the anti-epileptic drug levetiracetam (LEV) reduces hippocampal activity and improves cognition in other clinical populations while being safe and well-tolerated, this study will examine the effects of the drug on hippocampal activity and cognition in Veterans with schizophrenia. In this crossover design, participants will take LEV for 4 weeks and placebo pills for 4 weeks, but will not know the order in which they are taking them.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Good general health
* Normal vital signs (blood pressure, pulse, respiration)

Exclusion Criteria:

* Substance abuse
* Significant neurological disorders
* Significant head trauma/injury
* Pregnancy
* MRI-specific exclusion criteria, e.g.,:

  * claustrophobia
  * weight\>400 lbs
  * metal in the body

Primary outcomes:
measure: Neurocognitive function
timeFrame: 4 weeks
Secondary outcomes:
measure: Resting-state neuronal response
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jason R. Tregellas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06029556: Effects of Early Mobility Protocols in Cardiac ICU
Official title: Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CABG
Keywords: Early mobility
Physical activity
Kinesiophobia
Functional capacity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In this study the investigator aim to find the effects of early mobility on different physical activity protocols in post CABG patients. Physical activity, functional status, functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen saturation, length of hospital stay and sternal instability. To compare the physical activity protocol used by physical therapist.

Detailed description: Current study will compare two different early mobility protocols and will help in assessing best protocol to be use in cardiac ICU for better outcomes of patients.

Eligibility criteria: Inclusion Criteria:

* Age 40-70 years
* Both Genders
* Extubated patients with no Complication
* Post CABG (Elective)
* Vitally stable
* 1st CABG
* Selective CABG surgeries

Exclusion Criteria:

* Post anesthesia Psychosis
* Corrective surgeries
* Post CABG Stroke
* Infectious wound
* Participants with a physical disability
* Intra-aortic balloon pump (IABP)

Primary outcomes:
measure: Functional Status score Questionnaire
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
measure: BAECK PHYSICAL ACTIVITY QUESTIONNAIRE
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
measure: 6 minute walk Test
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
measure: Tampa Scale of Kinesiophobia
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Secondary outcomes:
measure: STERNAL INSTABILITY SCALE:
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
measure: BORG RATING OF PERCEIVED EXERTION
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
measure: Length of Hospital stay
timeFrame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
state: KPK
Study officials:
affiliation: Riphah International University
name: Sumaiyah Obaid, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04882956: BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration
Official title: Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Age-related Macular Neovascular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macula Lutea Degeneration
Keywords: macular degeneration
BEOVU
Eylea
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 40
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: Age-Related macular neovascularization degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management.

Detailed description: Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab (BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea; Regeneron, Tarrytown,NY)

Eligibility criteria: Inclusion Criteria:

* • Age-Related macular neovascularization degeneration

Exclusion Criteria:

* other causes of macular neovascularization degeneration
* other macular diseases

Primary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha University
name: Tarek Elhamaky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02500056: Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
Official title: Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
Chronic pain
Mesh
Lichtenstein hernioplasty
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.

Detailed description: The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* unilateral primary reducible inguinal hernia
* elective operation
* consent to participate in the study.

Exclusion Criteria:

* age \<18 years
* irreducible
* strangulated
* recurrent hernia
* inability to understand the questionnaire
* unwillingness to participate in the study

Primary outcomes:
measure: Chronic Pain
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Chronic Pain
timeFrame: 3-year follow-up
measure: Foreign Body Feeling
timeFrame: 6-month follow-up
Other outcomes:
Locations:
Study officials:
References: