louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01548430: A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
Official title: A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Males or females ≥ 50 years of age.
* Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
* Weight ≥ 50 kg.
* Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam.
* Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease.

Exclusion Criteria:

* Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder.
* Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.

Primary outcomes:
measure: Number of participant with adverse events
timeFrame: Day 0 to Day 84
Secondary outcomes:
measure: Evaluation of participant plasma TTP4000 concentrations
timeFrame: Day 0 to Day 84
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Durham
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
Study officials:
affiliation: TransTech Pharma, Inc.
name: Robert Hernandez, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05011630: Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary
Official title: Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraabdominal Abscess After Procedure
Keywords: pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 539
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical populations

Brief summary: Background Intra-abdominal abscess (IAA) is one of the most serious surgical infectious complications on pancreaticoduodenectomy (PD) patients. Preoperative biliary drainage (PBD) is considered as a risk of surgical infectious complications. However, the reason why PBD caused IAA was unknown. In this study, we hypothesize that bile contamination may increase the rate of IAA as bile from residual common bile duct (CBD) leaks and contaminates the abdominal cavity.

Methods We retrospectively collected PD patients with performance of bile culture between 2007 and 2019 in our institute. As to bile culture, we used a swab to do intraoperative bile cultures after transection of the CBD. IAA was defined as a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.


Eligibility criteria: Inclusion Criteria:

* all pancreaticoduodenectomy patients

Exclusion Criteria:

* no bile cultures

Primary outcomes:
measure: Intraabdominal abscess
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Ming Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081430: Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds
Official title: The Immediate Effects of Cervicothoracic Manipulation vs. Stretching on Upper Trapezius Pressure Pain Thresholds and Cervical Spine Range of Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurophysiological Mechanisms Manipulation
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the immediate effects of cervicothoracic manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and cervical ROM.


Eligibility criteria: Inclusion Criteria:

1. Absence of current neck pain
2. Aged 18 - 70 years
3. Able to lie on stomach or back without difficulty

Exclusion Criteria:

1. 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
2. History of neck whiplash injury
3. Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
5. Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
6. Prior surgery to neck or upper back
7. A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
8. Diagnosis from physician of fibromyalgia syndrome
9. Currently pregnant, or could be pregnant

Primary outcomes:
measure: Pain Pressure Threshold
timeFrame: up to 10 minutes
Secondary outcomes:
measure: Cervical Range of Motion
timeFrame: up to 10 minutes
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: UNLV
name: Emilio J Puentedura, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCF
name: William J Hanney, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03750630: A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan
Official title: A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vision Status
Keywords: vision, children, adolescent
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Students with age between 3 to 18 years old

Brief summary: The purpose of this research project is to develop a vision surveillance system, in order of understanding the vision health status of children and adolescents in Taiwan.

Detailed description: The purpose of this research project is to develop a vision surveillance system, in order of understanding the vision health status of children and adolescents in Taiwan. It can serve as a basis for the government to establish a nationwide vision surveillance system, invest research resources, and make national policies.

This research project also classified the urbanization of sampling school as high, medium and low based on the location of school.This research project explored and analyzed the health status of myopic schoolchildren and associated factors such as families, genetics, school environment, living environment and behaviors among north, south, west and east regions of Taiwan.

Eligibility criteria: Inclusion Criteria:

- Students with age between 3 to 18 years old

Exclusion Criteria:

1. Students have any special ocular disease.
2. non-compliance with screening protocol
3. orthokeratology user

Primary outcomes:
measure: Refractive status
timeFrame: 1 day
Secondary outcomes:
measure: Axial length
timeFrame: 1 day
measure: Intraocular pressure
timeFrame: 1 day
measure: Corneal thickness
timeFrame: 1 day
measure: Fundus examination
timeFrame: 1 day
measure: Serious and non-Serious Adverse Events
timeFrame: 1 day
measure: Questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00732030: Low Cylinder Toric
Official title: Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Keywords: Toric IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Cataracts
* Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)

Exclusion Criteria:

* Preoperative ocular pathology
* Planned monovision

Primary outcomes:
measure: Uncorrected Distance Visual Acuity
timeFrame: 6 months
measure: Best Corrected Distance Visual Acuity
timeFrame: 6 Months
measure: Residual Refractive Cylinder
timeFrame: 6 Month
Secondary outcomes:
measure: Patient Satisfaction Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01544530: Cooling to Optimize Organ Life in Donor Study
Official title: Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Organ Transplantation From Brain-dead Donors
Keywords: Brain-death
organ donation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 4
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: The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years;pronounced dead as per hospital brain-death criteria
* Accepted by organ procurement organization for organ donation
* Subjects within 3 hours of brain death pronouncement

Exclusion Criteria:

* Consent cannot be obtained from authorized representative;mean arterial pressure \< 60 mmHg and/ or more than 2 vasopressor and/or inotrope use
* Presence of 2nd or 3rd degree heart block
* Ongoing extracranial hemorrhage
* International normalized ratio \> 3.0
* Donors with human-immunodeficiency virus infection
* Pregnancy

Primary outcomes:
measure: Feasibility and safety
timeFrame: From enrollment to organ procurement (average of 24 hours)
Secondary outcomes:
measure: Six-month hospital free survival in recipients
timeFrame: 6 months
measure: Interleukin-6
timeFrame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
measure: Actual no. of organs transplanted
timeFrame: At the time of organ procurement
measure: Malondialdehyde
timeFrame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
measure: Death receptor-5
timeFrame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
measure: lactate
timeFrame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
measure: Urinary isoprostanes
timeFrame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02896530: Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review
Official title: Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Thrombosis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with arterial Thrombosis and Inflammatory Bowel Disease

Brief summary: Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

Detailed description: Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

However, the association between IBD and arterial thromboembolic events such as cases of myocardial infarction, stroke, aortic thrombus, mesenteric ischemia, peripheral arterial disease and members senior, was described less and remains a subject of debate. These arterial complications occur in young subjects accountability of IBD remains debated, and no clear pathophysiology. Here the investigators describe a series of 6 cases of patients with IBD who developed severe arterial complications, and whose cause was retained digestive inflammatory underlying disease.

This study is report of six (6) cases that will be described

Eligibility criteria: Inclusion Criteria:

* Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Assessment of change of the number of thromboembolic events or venous or arterial
timeFrame: Month 6, year 2
Secondary outcomes:
measure: Assessment of the relevance of anti thrombosis treatment
timeFrame: Month 6, year 2
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT05807230: Three-level Network Rehabilitation Model
Official title: Stroke Rehabilitation System of Oriental and Western Medicine Based on Three-level Network Rehabilitation Model Under the Background of Medical Alliance in Huzhou
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Primary Medical Care
Lead sponsor: The First People's Hospital of Huzhou
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement.

Researchers randomly assigned 90 patients to either group A or Group B, 45 in each group. Group A adopted the conventional three-level rehabilitation model; Group B adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of Chinese and Western medicine. Fugl-Meyer motor score was used to assess the patient's motor ability, Berg balance scale was used to assess the patient's balance ability, National Institute of Health stroke scale was used to assess the patient's neurological function, and modified Barthel index was used to assess the patient's ability of daily living.


Eligibility criteria: Inclusion Criteria:

* Patients whose primary disease is stroke, whose diagnosis conforms to the "Chinese and Western Medicine Emergency Diagnosis and Treatment Expert Consensus for Acute Ischemic Stroke";
* confirmed by imaging MRI or CT;
* hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop.

Exclusion Criteria:

* Patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past;
* patients with lumbar spine or sacral spinal stenosis in the past;
* patients with previous epilepsy;
* patients with previous history of stroke;
* patients with heart and renal failure;
* Patients who cannot cooperate with treatment.

Primary outcomes:
measure: Fugl-Meyer motor score
timeFrame: Assessment was made after 3 months of intervention
measure: The Berg balance scale
timeFrame: Assessment was made after 3 months of intervention
measure: National Institute of Health stroke scale
timeFrame: Assessment was made after 3 months of intervention
measure: Barthel index
timeFrame: Assessment was made after 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Huzhou
country: China
facility: The First People's Hospital of Huzhou City
state: Zhejiang
Study officials:
References:
Clinical trial NCT06216730: Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study
Official title: Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ampullary Adenoma
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed.

Detailed description: Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension

Eligibility criteria: Inclusion Criteria:

* Papillary adenoma which seems suitable for curative endoscopic resection.
* 18 years or older.
* Capable of providing written and oral informed consent.

Exclusion Criteria:

* Patients with intraductal extension of \>1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.(16)
* Failure to place a PD stent in patients with normal pancreatic duct anatomy.
* Refusal to provide informed consent.

Primary outcomes:
measure: Primary outcome will be safety i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis (at 9 months follow-up).
timeFrame: 1 YEAR(2024-2025)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00747630: Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)
Official title: Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Fetal Alcohol Syndrome
Teen Pregnancy
Keywords: Fetal Alcohol Syndrome
Teen pregnancy
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2008-09-05
Enrollment: 99
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.

Detailed description: Teenage mothers are asked to participate in the study and then randomized into an intervention or control group. Both groups take a multiple choice survey and then are randomized to either watch a video about FAS or not. After the video (or not for the controls) they then take a post video short answer survey. The survey results are then scored and statistical analysis performed to determine whether the video intervention increased their knowledge about FAS and their likelihood to drink alcohol during pregnancy.

Eligibility criteria: Inclusion Criteria:

* Pregnant teens aged 12 to 16 years

Exclusion Criteria:

Primary outcomes:
measure: To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol.
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Grand Expectations
state: Texas
Study officials:
affiliation: Texas Tech Department of Pediatrics
name: Tammy Camp, MD
role: PRINCIPAL_INVESTIGATOR
References: