louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00778492: Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Official title: Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bleeding
Keywords: Thrombelastogram
Microvascular bleeding
antiplatelet medication
cardiac surgery
consumption of blood products
preoperative platelet mapping derived from modified TEG
postoperative bleeding
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis.

Brief summary: Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.

Detailed description: Study Design:

Prospective observational study with blinded assessment of study endpoint variables. Collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. The information will be collected from 60 patients undergoing cardiac surgery in the Department of Cardiac Surgery of Sheba Medical Center.

Study endpoints

1. Primary endpoint- resternotomy for bleeding after the surgery.
2. Secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery with the history of aspirin and/or ADP receptor antagonist for at least 7 days prior the surgery

Exclusion Criteria:

* Emergent surgery
* Heart transplant surgery
* Implantation of ventricular assist devices
* Enrollment into conflicting study

Primary outcomes:
measure: Re-sternotomy d/t Bleeding
timeFrame: Hospitalization Period
Secondary outcomes:
measure: Chest tube output during first 24 hours after the surgery
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Sergey Preisman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Alexander Kogan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01148992: Interactions Between Intravenous (IV) Cocaine and Lofexidine
Official title: Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cocaine Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2010-06-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.

Detailed description: To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.

Eligibility criteria: Inclusion Criteria:

* Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
* Be between 18 and 50 years of age, inclusive.
* Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
* Be able to verbalize understanding of the consent form and provide written informed consent.
* Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:

  * diaphragm and condom by partner
  * intrauterine device (that does not contain progesterone) and condom by partner
  * sponge and condom by partner
  * complete abstinence from sexual intercourse

Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.

Exclusion Criteria:

* Please contact site for more information

Primary outcomes:
measure: Adverse Event and Cardiovascular Response
timeFrame: Daily, up to 9 days
Secondary outcomes:
measure: Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
timeFrame: Daily, up to 9 days
measure: PK of Lofexidine
timeFrame: Daily, up to 9 days
measure: Visual Analog Scale (VAS)
timeFrame: Daily, up to 9 days
measure: Brief Substance Abuse Craving Scale (BSCA)
timeFrame: Daily, up to 9 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT01503892: Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Official title: Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Peripheral Neuropathy
Keywords: Small Fiber Neuropathy
Metanx Effect on Small Fiber Neuropathy
Metanx Effect on Diabetic Peripheral Neuropathy
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
Collaborators: name: Goldfarb Foundation
name: Pamlab, L.L.C.
First posted: 2012-01-04
Enrollment: 100
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: This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetics
* Pre-diabetics
* Symptoms of peripheral neuropathy

Exclusion Criteria:

* Pregnancy
* Under age 18
* HIV (+)

Primary outcomes:
measure: Increased intraepidermal nerve fiber density
timeFrame: 1 year
Secondary outcomes:
measure: Subjective improvement
timeFrame: 1 year
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital and Health Network
name: Edwin S. Hart III, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842892: Implication of Stiffness of the Hamstrings, Achilles Tendon and Calf Muscles for Jumping Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Compliance
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: For optimal jumping performance an adequate interaction of muscles and tendons is required. A parameter in the functional evaluation of both structures is their stiffness (resistance of the tissue against deformation by external forces). It is unclear so far if higher stiffness values of tendon or muscle or a specific stiffness relation of both tissues is the cause of better jumping performance. The present study examines this based on the Achilles tendon and the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps (squat jump, counter-Movement Jump, Drop-Jump).

The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional study, the jump height of the participants will be measured for each jump form: squat jump (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form is determined randomly. The measurements are carried out within one day. Furthermore the international physical activity questionnaire will be used in order to assess the level of physical activity.

As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar tendon will be detected. The measurement is carried out before the jumps (there are three jumps after one sample jump performed). The measurement is executed non-invasively and completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on the examined tissue will be exerted and measured how much of this can be compressed.


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Drug intake in the past 48 hours
* Pregnancy
* Muscle soreness

Primary outcomes:
measure: Tissue Stiffness (calf muscles, achilles tendon, hamstring and patellar tendon) using two different tissue compliance meter (Indentometer Pro; Myoton Pro).
timeFrame: 15 Min.
Secondary outcomes:
measure: Jumping performance (counter movement jump, drop jump, squat jump) using a contact time mat (Refitronic)
timeFrame: 10 Min
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Department of Sports Medicine, Goethe University Frankfurt/Main
state: Hessen
Study officials:
References:
Clinical trial NCT03743389: Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes
Official title: Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mediastinal Nodes
Keywords: uniportal video-assisted thoracoscopic surgery
mediastinal nodes
chest drainage
pigtail catheter
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.


Eligibility criteria: Inclusion Criteria:

1. Between 18 and 80 years of age.
2. Diagnosed with potentially resectable mediastinal mass.
3. With indication for uniportal-VATS.
4. For whom informed consent will be obtained before the study.

Exclusion Criteria:

1. Previous thoracic surgery at the same side.
2. Have to receive open surgery although uniportal-VATS is planned.
3. Pregnancy.
4. Refuse to sigh the consent

Primary outcomes:
measure: total drainage volume
timeFrame: 1 month
measure: tube duration
timeFrame: 1 month
Secondary outcomes:
measure: post-operative pain
timeFrame: 3 days after operation
measure: rate of subcutaneous emphysema
timeFrame: 1 month
measure: infection rate of incision
timeFrame: 1 month
measure: length of hospital stay after surgery
timeFrame: 1 month
measure: rate of chest tube re-insertion or thoracocentesis
timeFrame: 1 month
measure: satisfaction of the incision after healing
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06976489: The Food Effect on PK Characteristics and Safety Profiles of PA-111
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Food Effect on the Safety and the Pharmacokinetics of PA-111 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Mixed Dyslipidemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

Detailed description: The purpose of this study is to compare and evaluate the effect of food on the safety and pharmacokinetic profiles of PA-111 in healthy adult subjects.

Eligibility criteria: Inclusion Criteria:

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied

Primary outcomes:
measure: Maximum concentration of drug in plasma (Cmax)
timeFrame: pre-dose (0hour) to 72hours
measure: Area under the plasma concentration-time curve during dosing interval (AUCt)
timeFrame: pre-dose (0hour) to 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT02260089: Telmisartan in Mild to Moderate Hypertensive Patients
Official title: A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM


Eligibility criteria: Inclusion Criteria:

* Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex

Exclusion Criteria:

* Suspected or known diagnosis of arterial hypertension with a secondary cause
* Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
* Systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 115 mm Hg
* Laboratory test values two fold above the upper normal limit
* Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
* New York Heart Association class III or IV heart failure
* History of stroke in the 6 months prior to entry into the study
* Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels \> 140 mg/dL on 3 consecutive assessments
* Patients who were included in another investigational drug study in the past 30 days

Primary outcomes:
measure: Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
timeFrame: Baseline, up to 12 weeks after start of treatment
Secondary outcomes:
measure: Assessment of treatment response for SBP/DBP (in %)
timeFrame: Baseline, up to 12 weeks after start of treatment
measure: Changes from baseline in blood pressure values
timeFrame: Baseline, up to 12 weeks after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 16 weeks
measure: Number of patients with clinically significant changes in laboratory values
timeFrame: Up to 16 weeks
measure: Number of patients with clinically significant changes in ECG
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00898989: Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis
Official title: Evaluation of Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inclusion Body Myositis
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2009-05-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Written consent

Exclusion Criteria:

* Current infection
* Cancer within 1 year
* Immune deficiency

Primary outcomes:
measure: muscle strength
timeFrame: 2 evaluations at an interval of 9 months
Secondary outcomes:
measure: immune response
timeFrame: 1 measure at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitié-Salpêtrière
Study officials:
References:
Clinical trial NCT04100889: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Alzheimer Disease
Alzheimer Disease 1
Alzheimer Disease 2
Alzheimer Disease 3
Alzheimer Disease 4
Alzheimer Disease 5
Alzheimer Disease 6
Alzheimer Disease 7
Alzheimer Disease 8
Alzheimer Disease 9, Late-Onset
Alzheimer Disease 10
Alzheimer Disease 11
Alzheimer Disease 12
Alzheimer Disease 13
Alzheimer Disease 14
Alzheimer Disease 15
Alzheimer Disease 16
Alzheimer Disease 17
Alzheimer Disease 18
Alzheimer Disease 19
Alzheimer Disease, Early Onset
Alzheimer Disease, Late Onset
Alzheimer Disease Focal
Keywords: Microbiome
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are 18 years of age or older and have been diagnosed with Alzheimer's disease.

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Alzheimer's disease.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Alzheimer's disease.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients age 18 and older
3. Diagnosis of Alzheimer's disease or dementia by a physician
4. Mini Mental Status Exam score less than 26

Exclusion Criteria:

1. Refusal to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 2 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Alzheimer's Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References: