louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01988610: Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
Official title: Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: cognition
prediabetes
mood
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of cortisol,a stress hormone in the body, on memory and attention in people with a history of depression, but who are not in the midst of a current depressive episode.

Cortisol may affect parts of the brain associated with memory and attention directly. It may also indirectly affect the brain by controlling how much insulin the body makes. Insulin is thought to impact cognition by changing the amount of sugar available in certain parts of the brain.

The investigators are studying this question by giving patients a medication, called Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare results from several groups of people, including differences between men and women, and between those with and without insulin resistance.

Detailed description: The specific aims of this study are threefold:

1. To evaluate the association between glucose utilization and neuropsychological performance on tests of verbal memory and attention among patients with a history of depression, but who are euthymic, at baseline;
2. To evaluate changes in neuropsychological test performance among patients with a history of depression and who have insulin resistance who are treated with open-label mifepristone and,
3. To explore interactions between changes in patients' glucose tolerance profiles and changes in verbal memory and attention. An exploratory aim is to explore the interaction of changes in cortisol awakening response and changes in verbal memory and attention within subjects with and without IGT, as well as the potential mediating effects of gender.

Eligibility criteria: Inclusion Criteria:

* Ages 50-70
* History of depression, not currently depressed.

Exclusion Criteria:

* History of type 1 or type 2 diabetes.
* Use of a medication that interacts with Mifepristone.

Primary outcomes:
measure: Cognition
timeFrame: 3 months
Secondary outcomes:
measure: Hamilton Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Psychiatry, 401 Quarry Rd
state: California
Study officials:
affiliation: Stanford University
name: Natalie Rasgon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01183910: A Novel Oral Natural Extract for the Treatment of Senile Purpura
Official title: A Randomized, Double-Blind, Placebo-Controlled Study To Assess the Safety and Efficacy of a Novel Oral Natural Extract for the Treatment of Senile Purpura
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PURPURA
Keywords: PURPURA
SENILE PURPURA
BATEMAN'S PURPURA
Lead sponsor: Nexgen Dermatologics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A randomized, double-blind, placebo controlled study to assess the safety and effectiveness of a novel oral natural extract to improve the appearance of the skin of patients with senile purpura.


Eligibility criteria: Inclusion Criteria:

* Patients with evidence of purpura on physical exam

Exclusion Criteria:

* Preexisting condition that would not allow the patients to take oral calcium supplement

Primary outcomes:
measure: IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA
timeFrame: 6 WEEKS
Secondary outcomes:
measure: ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION
timeFrame: 6 WEEKS
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Berlin Center of Medical Aesthetics
state: Florida
Study officials:
affiliation: STUDY PROTOCOL, INC
name: JOSHUA M BERLIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05232110: Compassionate Use of Pozelimab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-09
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide compassionate use of pozelimab

Detailed description: Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02220010: Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?
Official title: Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healing Time of Post Operative Pancreatic Fistulas
Keywords: Post operative pancreatic fistulas
Pancreatic stenting
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Lund University Hospital
name: University Hospital, Linkoeping
name: Norrlands University Hospital
First posted: 2014-08-19
Enrollment: 60
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: Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage reduces healing time. A pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further.

Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation.

In an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a B och C fistula (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by randomizing between pancreatic stent with drains versus only drains.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Left sided or distal pancreatic resection
* Grade B or C fistula on postoperative day 3 or later

Exclusion Criteria:

* Do not want to participate in study
* Can not read patient information in swedish
* The papilla can not be endoscopically reached

Primary outcomes:
measure: POPF healing time (days)
timeFrame: 12 days (median hospital stay)
Secondary outcomes:
measure: POPF grade (A,B,C)
timeFrame: 12 days (median hospital stay)
Other outcomes:
measure: Blood chemistry
timeFrame: 12 days (median hospital stay)
measure: Morbidity
timeFrame: 12 days (median in hospital stay)
measure: Mortality
timeFrame: < 90 days after the operation
measure: Hospital stay
timeFrame: 12 days (median hospital stay)
Locations:
city: Stockholm
country: Sweden
facility: Dep of Surgical Gastroenterology, Karolinska University Hospital
Study officials:
References:
Clinical trial NCT04877210: Effects of Topical Insulin on Levels of Tear Inflammatory Mediators
Official title: Effects of Topical Insulin on Levels of Tear Inflammatory Mediators Compared to Standard Artificial Tears and Normal Saline in Diabetics With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dry Eye
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 60 samples are take to determine the effects of topical insulin on tear inflammatory mediators interleukin 1a, interleukin 6 and matrix metalloprotenase 9 in diabetics with dry eye disease.

Detailed description: Tear samples are taken to compare the levels of inflammatory markers (IL 1a, IL6 and MMP 9) pre-and post treatment with topical insulin in normal saline compared to standard therapy and normal saline in diabetics with dry eyes and also to correlate the IL 1a, IL6 and MMP 9 levels with clinical outcomes in diabetics with dry eyes treated with topical insulin in normal saline, standard therapy and normal saline

Eligibility criteria: Inclusion Criteria:

* all diabetics aged 18 - 50 years of age with at least mild OSDI scores

Exclusion Criteria:

* Diabetics on contact lenses
* Diabetic with history of ocular surgery in the preceding 3 months
* Post menopausal women
* Known mild dry eye with prior usage of topical therapy who are unable to discontinue
* Known case of allergic eye disease
* Sjogren's syndrome patients
* Unwilling or unable to attend 6 follow up and sampling sessions

Primary outcomes:
measure: Biochemical marker 1
timeFrame: 4 weeks
measure: Biochemical marker 2
timeFrame: 4 weeks
measure: Biochemical marker 3
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: PPUKM
Study officials:
affiliation: PPUKM
name: Mae-Lynn C. Bastion
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06402110: Femoral Triangle Block Versus Adductor Canal Block in Arthroscopic Anterior Cruciate Ligament Reconstruction
Official title: Femoral Triangle Block Versus Adductor Canal Block for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Triangle Block
Adductor Canal Block
Anterior Cruciate Ligament Reconstruction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the postoperative analgesic effect of femoral triangle block (FTB) and adductor canal block (ACB)after arthroscopic anterior cruciate ligament (ACL) reconstruction.

Detailed description: The number of patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction has risen over the past decade. ACL reconstruction is associated with moderate to severe postoperative pain leading to hypertension, tachycardia, increased O2 demand, and myocardial stress.

Eligibility criteria: Inclusion Criteria:

* Age from 21 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Undergoing elective arthroscopic Anterior Cruciate Ligament (ACL) reconstruction.

Exclusion Criteria:

* Revisional surgery.
* Body mass index (BMI) \>35kg/m2.
* Coagulopathy.
* Infection at site of intervention.
* Hypersensitive to the study drugs.
* Chronic analgesic use.
* Neuromuscular disease.
* Drug abuse.
* Cognitive impairment.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time of 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Pain score using Numeric Rating Scale (NRS)
timeFrame: 24 hours postoperatively
measure: Quadriceps strength
timeFrame: 24 hours postoperatively
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT03962010: A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
Official title: A Phase 2, 12-Week, Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate Efficacy and Safety of GX-G6 on Glycaemic Control Versus Placebo and Open-Label Dulaglutide in Patients With Uncontrolled Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 78
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: GX-G6-002 is a Phase 2, 12-week, randomized, parallel group, multi-centre, double blind, placebo-controlled and an open-label active comparator study.

Detailed description: This study aims to establish the dose-response relationship of 4 dose cohorts of GX-G6 compared with double-blind placebo. These treatment cohorts will also be compared with open-label active control.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of T2DM ≥ 6 months prior to screening
2. HbA1c level of 7-10% (inclusive)

Exclusion Criteria:

1. Have known type 1 diabetes mellitus (T1DM)
2. History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening
3. Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
4. Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening.
5. Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00498810: COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
Official title: COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.


Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient or his/her legal representative
* Incisional hernia requiring elective surgical repair

Exclusion Criteria:

* No written informed consent
* Emergency surgery (incarcerated hernia)
* All incisional or parastomal hernias not originating at the midline
* All recurrent hernias
* All patients with mesh placed intra-abdominally during surgery have to be withdrawn

Primary outcomes:
measure: recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: Perioperative morbidity rate
measure: Postoperative pain
measure: Long term complication rate
measure: Recurrence rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278210: National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug
Official title: National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy Intractable
Focal Epilepsy
Keywords: EEG-fMRI
brain imaging
presurgical evaluation
epilepsy surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 290
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.

Brief summary: The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.

To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.


Eligibility criteria: Inclusion Criteria:

* \> 8 years old
* intractable focal epilepsy
* presurgical evaluation or "phase 1" planified
* with focal EEG activity : more than 3 EEG interictal epileptic events per hour
* patient and/or legal representant given their written consent for their participation in the study

Exclusion Criteria:

* MRI contraindication
* pregnancy
* uncomfortable prolonged lying position
* frequent primary or secondary generalised seizure with tonic clonic movements (\>2 per week)
* previous epilepsy surgery
* important mental retardation

Primary outcomes:
measure: Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation
timeFrame: 1 year after surgery
measure: Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG
timeFrame: 1 year after surgery
measure: Quality of life score (QOLIE 31)
timeFrame: 1 year after surgery
measure: Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)
timeFrame: 1 year after surgery
measure: Distinction of patients according to the type of their epilepsy: temporal / extra temporal.
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Louise Tyvaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672212: Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease
Official title: Effect of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) During General Anesthesia in Children Undergoing EDAS (Encephaloduroarteriosynangiosis) Surgery for Moyamoya Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of analgesia with ANI would reduce intraoperative opioid consumption during EDAS surgery.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients receiving EDAS surgery for Moyamoya disease

Exclusion Criteria:

* ASA (American society of anesthsiologists classification) 4-5
* Emergency surgery
* patients with chronic pain on medication

Primary outcomes:
measure: the mean hourly intraoperative sufentanil requirement
timeFrame: from induction of anesthesia to end of operation, about 5 hours
Secondary outcomes:
measure: the amount of non-opioids analgesic requirements
timeFrame: from induction of anesthesia to end of operation, about 5 hours
measure: the amount of vasoactive agents requirements
timeFrame: from induction of anesthesia to end of operation, about 5 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT00559312: The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD
Official title: A 6-week Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Fluticasone 250μg/Salmeterol 50μg Combination (FSC 250/50) on Exertional Dyspnea in Patients With Symptomatic Mild COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: mild COPD
dyspnea
exercise
combination therapy
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy \[i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)\] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.


Eligibility criteria: Inclusion Criteria:

* Stable mild COPD,
* FEV1/FVC\<0.7 and FEV1\>60% predicted,
* Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score \<9, MRC dyspnea scale \>2),
* Cigarette smoking history ≥20 pack-years.

Exclusion Criteria:

* Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
* Important contraindications to clinical exercise testing,
* Use of daytime oxygen,
* History of Asthma.

Primary outcomes:
measure: Dyspnea intensity (Borg rating at a standardized time during exercise)
timeFrame: 6 weeks
Secondary outcomes:
measure: Exercise endurance time
timeFrame: 6 weeks
measure: Measurements of small airway function
timeFrame: 6 weeks
measure: Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Respiratory Investigation Unit at Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University and Kingston General Hospital
name: Denis E O'Donnell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: