louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01818648: Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome
Official title: Acute Effects of a Glucagon-like Peptide 1 Analog, Exenatide, on Gastrointestinal Motor Function and Permeability in Patients With Short Bowel Syndrome on Home Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Short Bowel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.


Eligibility criteria: Patients with short bowel syndrome, between the ages of 18-85 who are dependent on parenteral nutrition for at least a year and are being closely followed by the Mayo Clinic Home Parenteral Nutrition Program (HPN) with at least one multisystem evaluation a year.

Primary outcomes:
measure: Change in 24hr Gastrointestinal and Colonic Transit before and after Exenatide vs placebo
timeFrame: In both arms participants will undergo GI transit measurements on 2 seperate occasions for a total of 24 hours, with a wash out period of 48 hours in between transit studies.
Secondary outcomes:
measure: Change in 24hr Intestinal Permeability before and after administration of Exenatide vs placebo
timeFrame: In both arms participants will undergo intestinal permeability measurements on 2 seperate occasions for 24 hours,with a wash out period of 48 hours in between permeability studies. .
Other outcomes:
measure: Change in 24hr Stool Weight before and after administration of Exenatide vs placebo
timeFrame: In both arms participants will collect stool weight for 24 hours in 2 seperate occasions with a wash out period of 48 hours in between collections.
measure: Change in 24hr Urine Volume before and after administration of Exenatide vs placebo
timeFrame: In both arms participants will collect urine volume for 24 hours in 2 seperate occasions with a wash out period of 48 hours in between collections.
Locations:
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104948: A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of DA-8031 After Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Premature Ejaculatory Dysfunction
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 106
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic parameters of DA-8031 as well as safety profile.


Eligibility criteria: Inclusion Criteria:

* 20-45 years healthy male subjects
* Body weight :60-90kg, BMI between 18.5-25

Exclusion Criteria:

* show SBP(Systolic Blood Pressure) =\<100mmHg or \>=140mmHg, or DBP(Diastolic Blood Pressure)=\<60mmHg or \>=90mmHg, or tachycardia (PR(Pulse Rate)\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers

Primary outcomes:
measure: To characterize the pharmacokinetic parameters such as AUC(Area under concentration-time curve), Cmax, Tmax, T1/2, fe, and CL/F of DA-8031 by as assessment of plasma and urine concentration
Secondary outcomes:
measure: To evaluate the safety and tolerance of DA-8031 by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events collected by investigator questionnaire and subjects spontaneous report
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Institute, Seoul National University Hospital
state: Chongno-Gu, Yon-Gon Dong 28
Study officials:
References:
Clinical trial NCT00991848: Lidocaine on Manifestations of Fibromyalgia
Official title: Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibromyalgia
Chronic Pain
Keywords: Lidocaine;
Fibromyalgia
signs
symptoms
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.

Detailed description: Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study.

Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.

Eligibility criteria: Inclusion Criteria:

* pain in the four quadrants of the body for at least 3 months
* sleep disorders
* fatigue
* subjective edema
* depression
* paresthesia.

Exclusion Criteria:

* alterations in thyroid
* rheumatological
* renal and hepatic function
* trauma
* rheumatic, neuromuscular or psychiatric disease
* infectious arthropathy
* other pain syndromes
* drug hypersensitivity
* pregnancy

Primary outcomes:
measure: effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Rioko K Sakata, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06018948: Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients
Official title: The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Obesity, Morbid
Dexmedetomidine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 90
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: Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.

Detailed description: Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.

The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .

Eligibility criteria: Inclusion Criteria:

* Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) \<70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
* Aged 18-50 years.
* Scheduled for abdominal surgery.

Exclusion Criteria:

* Patients with Forced expiratory volume1/forced vital capacity\<7.
* Uncontrolled cardiac, respiratory, hepatic or renal diseases.
* Allergy to the study drug

Primary outcomes:
measure: Intraoperative oxygenation
timeFrame: Intraoperative
Secondary outcomes:
measure: Dynamic Lung compliance
timeFrame: Intraoperative
measure: Post-operative pain
timeFrame: 24 hour postoperatively
measure: Dead space (dead space to tidal volume)
timeFrame: Intraoperative
measure: Quality of recovery score
timeFrame: 24 hours Postoperatively
measure: Time to first rescue analgesia
timeFrame: 24 hours Postoperatively
measure: Static lung compliance
timeFrame: Intraoperative
measure: Lung compliance
timeFrame: 24 hours
measure: Plateau pressure
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02906748: Parathyroid Auto-transplantation: Prospective Randomized Trial of the Personalized Site
Official title: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parathyroid Autologous Transplantation
Keywords: parathyroid autografting
thyroidectomy
survival rate
hypoparathyroidism
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 280
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. So the investigators took the forearm as the aim place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and not-grafted forearm.


Eligibility criteria: Inclusion Criteria:

* patients with indications for PA treatment during cervical surgery

Exclusion Criteria:

* patients suffering secondary hypoparathyroidism with forearm fistulization

Primary outcomes:
measure: parahthyroid hormone gradient by comparing between grafted and non-grafted forearm
timeFrame: 1 months, 3 months and 6 months
Secondary outcomes:
measure: hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml)
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Department of Thyroid and Breast Surgery Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
name: Gaosong Wu, PhD
role: STUDY_DIRECTOR
References:
citation: Cui Q, Kong D, Li Z, Wang K, Zhang D, Tang J, Liao X, Yuan Q, Gong Y, Wu G. Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial. Trials. 2019 Jan 31;20(1):96. doi: 10.1186/s13063-019-3195-9.
Clinical trial NCT05669248: A Follow-up Study of Immune Dysregulation in Patients With COVID-19
Official title: A Follow-up Study of Immune Dysregulation in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Immunosuppression
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest.

Brief summary: In order to detect the immunosuppression status of COVID-19 patients, this study collected blood samples of COVID-19 patients on the 10th, 20th and 30th days after the onset of symptoms, and detected the proinflammatory, anti-inflammatory factors，immunosuppressive marker，immune cells in the blood samples to evaluate the immunosuppression status of COVID-19 patients.

Detailed description: After SARS-CoV-2 infection, the patient's immune system is overactivated. While the immune cells release a large number of proinflammatory factors, anti-inflammatory response starts at the same time. Anti-inflammatory factors such as IL-4, IL-10, and IL-37 will be compensated to resist the release of proinflammatory factors and prevent the further development of systemic inflammatory response. However, when the anti-inflammatory factor is excessively released, it will cause compensatory response syndrome, leading to immunosuppression. Whether the level of anti-inflammatory factors continues to rise, and whether it will lead to the persistence of later immunosuppression is unknown. Therefore, this study intends to recruit COVID-19 patients, detect the pro-inflammatory and anti-inflammatory factors，immunosuppressive marker，immune cells in 10 days, 20days, and 30days after the symptoms appear, and evaluate the immunosuppression status of patients with COVID-19

Eligibility criteria: Inclusion Criteria:

1. Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest.
2. Study participant is 18 years of age or older

Exclusion Criteria:

1. Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy
2. Pregnancy or breastfeeding
3. Patients receiving chemotherapy or other cancer treatment

Primary outcomes:
measure: The concentration of inflammatory markers (IL-1β、IL-2、 IL-2R 、IL-4 、 IL-6 、 IL-8、 IL-10 、IFN-γ、TNF-α 、VEGF, etc.) in peripheral blood.
timeFrame: 10, 20, 30days
measure: The concentration of immunosuppression makers(HLA-DR, PD-1, TIM-3,etc.) in peripheral blood.
timeFrame: 10, 20, 30days
measure: The number of immune cells(Th1/Th2 cell, Treg cell, MDSCs,etc.) in peripheral blood.
timeFrame: 10, 20, 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00881348: Dermacyd Infantile (Lactic Acid) - Photo Evaluation.
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Infantile (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Objective:

To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).


Eligibility criteria: Inclusion criteria:

* Phototype Skin I, II, III and IV
* Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.

Exclusion criteria:

* Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
* Lactation or gestation
* Use of Anti-inflammatory drugs 30 days and/or immunosuppressant drugs during 3 months before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Previous atopy
* History of sensitivity or irritation for topic products
* Active cutaneous diseases which can interfere in the study results
* Use of new drugs and/ or cosmetics during the study
* Cutaneous reactivity
* Previous participation in studies, which had used the product
* Volunteers who have immunodeficiency congenital or acquired.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
timeFrame: During 5 weeks (i.e. treatment period)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02697448: Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.
Official title: Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 135
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: Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation

Detailed description: A side effect of some volatile anesthetics, such as isoflurane and desflurane, is enhanced automaticity, accounting for secondary atrial pacemakers. Volatile anesthetics also have varying effects on the AV node and His-Pukinje system. These agents also prolong the QT interval and, for this reason, volatile anesthetics as a group have at times been avoided for atrial fibrillation ablation due to the fear that they may affect the efficacy of the ablation and increase recurrence. However, sevoflurane does not have the effects shown for other volatile anesthetics cardiac conduction. At this point there has not been a study comparing propofol, a non volatile anesthetic typically used in these cases, to sevoflurane, a volatile anesthetic, to determine if volatile anesthetics should be avoided during these procedures. This study will challenge the existing belief that sevoflurane increases the length of time to ablate atrial fibrillation and also decreases the efficacy of the ablation.

Eligibility criteria: Inclusion Criteria:

* have paroxysmal atrial fibrillation
* undergoing their first ablation.

Exclusion Criteria:

* none

Primary outcomes:
measure: Procedure Duration
timeFrame: 1 day
measure: Time to Extubation
timeFrame: Procedure end time to time of extubation
Secondary outcomes:
Other outcomes:
measure: Post-Operative Pain
timeFrame: Post-Op Day 1
measure: Number of Participants With Post-Operative Nausea and Vomiting
timeFrame: Time of procedure end to post-op day 1
measure: Post-Operative Alertness
timeFrame: Post-Op Day 1
measure: Incidence of Atrial Fibrillation
timeFrame: 2 weeks post-op, 3 months post-op, and 6 months post-op.
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: George J Guldan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03469648: Intraoperative Air-Test
Official title: Incidence of Intraoperative Positive Air-Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With ASA Status I-III Scheduled for Surgery
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included consecutive patients who were scheduled for surgery with general anesthesia and mechanical ventilation

Brief summary: Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse.

The aim of this study is to non-invasively describe the incidence of intraoperative atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt to describe the association between positive Air-Test and the patient´s preoperative or intraoperative variables.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) I-IV
* General Anesthesia
* Mechanical ventilation

Exclusion Criteria:

* age \< 18 years old
* pregnancy
* patients undergoing cardiothoracic surgery
* ASA physical status V

Primary outcomes:
measure: Patients with positive Air-Test
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Carlos Ferrando
city: Valencia
country: Spain
facility: Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Study officials:
References:
citation: Ferrando C, Tusman G, Suarez-Sipmann F, Leon I, Pozo N, Carbonell J, Puig J, Pastor E, Gracia E, Gutierrez A, Aguilar G, Belda FJ, Soro M. Individualized lung recruitment maneuver guided by pulse-oximetry in anesthetized patients undergoing laparoscopy: a feasibility study. Acta Anaesthesiol Scand. 2018 May;62(5):608-619. doi: 10.1111/aas.13082. Epub 2018 Jan 29.
citation: Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosda R, Valls P, Villena A, Serralta F, Jurado A, Carrizo J, Navarro J, Parrilla C, Romero JE, Pozo N, Soro M, Villar J, Belda FJ. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study. BMJ Open. 2017 May 29;7(5):e015560. doi: 10.1136/bmjopen-2016-015560.