louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03401606: Controlled Sedation for Cataract Surgery
Official title: Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Failed Conscious Sedation During Procedure
Keywords: sedation
dexmedetomidine
remifentanil
cataract surgery
surgeon satisfaction
patient satisfaction
Lead sponsor: Fundación Universitaria de Ciencias de la Salud
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 98
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 evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

Detailed description: This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.

Eligibility criteria: Inclusion Criteria:

* subject has cataract,
* subject older than 18 years,
* local anesthesia and sedation.

Exclusion Criteria:

* general anesthesia,
* history of consumption of sedatives.

Primary outcomes:
measure: Surgeon and patient satisfaction
timeFrame: Intraoperative
Secondary outcomes:
measure: Heart rate
timeFrame: Intraoperative
measure: Mean arterial pressure
timeFrame: Intraoperative
measure: Hemoglobin oxygen saturation
timeFrame: Intraoperative
measure: Surgery duration
timeFrame: Intraoperative
Other outcomes:
measure: Hypotension
timeFrame: Intraoperative
measure: Respiratory depression
timeFrame: Intraoperative
measure: Oxygen desaturation
timeFrame: Intraoperative
measure: Internation
timeFrame: Intraoperative
Locations:
Study officials:
affiliation: Fundacion universitaria de ciencias de la salud
name: Luis Muñoz, Md
role: STUDY_DIRECTOR
References:
Clinical trial NCT02342106: Assessment of Myeloid Cell Constitution in the Follicular Fluid of Women Undergoing In-vitro Fertilization
Official title: Assessment of Myeloid Cell Constitution in the Follicular Fluid of Women Undergoing In-vitro Fertilization (IVF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-01-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IVF treatment.

Brief summary: The investigators will study the immune cell subpopulations in follicular fluid of patients undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will corelate the presence of immature myeloid cells to the ovarian stimulation response as indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level developed on the day of human chorionic gonadotropin (hCG) administration.

Detailed description: The study will be an observational study using discarded material from patients undergoing IVF treatment. On the day of ovum pick up, the fluid aspirated from the first follicle in each ovary will be saved and analyzed for cellular content by fluorescence-activated cell sorter (FACS) analysis and cytokine and hormone by Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR). In addition, a total of 5cc of blood will be drawn from the patient when introducing the intravenous line for analysis of immune cell composition,hormones and cytokine levels. During the whole study number of oocytes retrieved,number of mature oocytes,number of fertilizations,implantation rates and clinical pregnancy rates will be documented as well.

Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF treatment
* Infertility caused by one of the following : endometriosis, severe male factor, tubal occlusion, or unexplained.

Exclusion Criteria:

* An early follicular phase (day 2-4) FSH level \> 20 mIU/mL
* Abnormal uterine cavity
* Any contraindication for pregnancy
* Systemic disease
* History of alcohol or drug abuse

Primary outcomes:
measure: Amount of immature myeloid cells accumulate in the ovarian follicular fluid as measure of correlation with ovarian response to gonadotropins.
timeFrame: 36 hours after hCG injection
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center Hadera Israel
name: Ofer Limonad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03699306: Comparison of Three Methods for NG Tube Placement
Official title: Comparison of Three Methods for NG Tube Placement in Intubated Patients in the Emergency Department During 2016-2018
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unconsciousness
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background and Aim: Tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. This method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. The purpose of this study was to compare the three methods of the NG tube placement in intubated patients in the emergency department of university-affiliated hospitals of Isfahan from2016 to 2018.

Materials and Methods: This study was a randomized and prospective clinical trial. The statistical population of this study was all patients who had been referred to the emergency department of Al-Zahra and Ayatollah Kashani hospitals in Isfahan between2016and2018. The sample size was 25 in each group, and in total 75 subjects. The first group was NG tube insertion by the conventional method, the second group was using brake cable and the third group was embeddedby highwayman's hitch or draw hitch, using a silk thread. For all patients, demographic characteristics and possible complications were recorded. Finally, the data were analyzed using SPSS20 software at two statistical levels of descriptive and inferential.


Eligibility criteria: Inclusion Criteria:

* all intubated patients, referred to the emergency department

Exclusion Criteria:

* the presence of symptoms of skull base fracture,
* bleeding disorders and coagulopathies,
* maxillofacial trauma, which led to deformity and impairment of NG tube,
* upper respiratory tract diseases and anomalies,
* nasal congestion and nostril stenosis,
* esophageal disorder (esophageal stenosis and esophageal varicose vein),
* and a history of head and neck radiotherapy.
* Patients who had been intubated in other centers and being referred to these two centers were also excluded.

Primary outcomes:
measure: success rate
timeFrame: Intraoperative (time from entry of the NG tube through nostril til entering inside the stomach or whenever the operator declared.)
Secondary outcomes:
measure: procedure duration
timeFrame: Intraoperative (from nostril entry til sromach entry or operatoe declaration as the end of procedure)
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-Zahra University Hospital
city: Isfahan
country: Iran, Islamic Republic of
facility: Mehdi Nasr Isfahani
Study officials:
References:
Clinical trial NCT00448006: Clinical Feasibility Study of Allium's Biliary Stent
Official title: A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From "Malignant Biliary Duct Obstruction" (Endoscopic Insertion)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malignant Obstruction of the Common Bile Duct
Keywords: common
bile
duct
biliary
malignant
obstruction
stent
Lead sponsor: Allium, Ltd.
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.

Detailed description: Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years or older
* Patient has malignant obstructive jaundice
* Patient is unfit for surgery
* Patient is capable of giving informed consent
* Patient is willing to comply with study requirements

Exclusion Criteria:

* Patient has a benign biliary duct obstruction
* Patient cannot tolerate any form of antibiotic treatment
* Patient is currently receiving anticoagulation therapy
* Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)

Primary outcomes:
measure: Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion.
timeFrame: up to 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Simon Bar-Meir, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00648206: Testing Alcohol Only Samples for Drugs and Drugs Only Samples for Alcohol
Official title: Retrospective Study of Unrequested Analytical Data in DUID-cases From a 2 Week Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Driving Under the Influence
Keywords: driving under the influence
psychoactive substances
blood samples
Prevalence of psychoactive substances in road traffic
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Internal Affairs, Finland
name: European Commission
First posted: 2008-04-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drivers of motorised vehicles in general road traffic

Brief summary: This study intends to supply information about the prevalence of psychoactive drugs and alcohol in suspected DUI samples which are suspected of only one of these rather than both drugs and alcohol.

Police samples for suspected DUI samples that have been sent for alcohol analysis or drug analysis only will be screened for drugs and alcohol respectively.

Detailed description: There are 3 different possibilities for forensic analysis of suspected driving under the influence samples. Testing for alcohol or drugs only or testing for both alcohol and drugs.

Often if the primary suspicion of the apprehending police officer is of driving under the influence of drugs or alcohol then only laboratory analysis concerning that primary suspicion is requested.

The study aims to provide information about those 'missed cases' where only analysis for drugs or alcohol is carried out. Traffic police samples from a 2 week period are to be screened for both drugs and alcohol, even if the primary suspicion is only one of these.

The study is part of the EU-project DRUID. Altogether 13 European countries are participating in DRUID.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* driver of a motorised vehicle

Exclusion Criteria:

* 17 years or younger
* not the driver of a motorised vehicle

Primary outcomes:
measure: assessment of both alcohol and drugs in suspected DUI cases
timeFrame: 2 weeks
Secondary outcomes:
measure: prevalence of psychoactive substances in the general driving population
timeFrame: three years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Public Health Institute
Study officials:
affiliation: National Public Health Institute, Helsinki, Finland
name: Pirjo Lillsunde, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01911806: Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Nonspecific Low Back Pain
Keywords: Back care pillow
chronic non-specific low back pain
randomized controlled trial
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.


Eligibility criteria: Inclusion Criteria:

* Males or females
* Age 20 - 69 years old.
* Patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day
* Patients with low back pain who have pain for more than 3 months
* Patients have pain at lower back without refer to leg
* Patients have moderate to severe pain of numerical rating scale (pain score ≥ 4)

Exclusion Criteria:

* Pregnant patients
* Underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery
* Patients have Quada equine syndrome
* Patients with nerve root symptoms (neurological deficit)

  1. Patient have refer pain to leg area of same dermatome is problem.
  2. Abnormal reflex of lower extremity.
  3. Muscle weakness of area myotome is problem.

Primary outcomes:
measure: Pain Scores on the Numerical rating scale
timeFrame: three months
Secondary outcomes:
measure: Scale of lumbar range of motion measure by Modified - Modified Schober Test
timeFrame: three months
Other outcomes:
measure: Roland-Morris Disability Questionnaires (RMDQ)
timeFrame: three months
Locations:
city: Khon Kaen
country: Thailand
facility: School of physical therapy,Faculty of associated medical science,Khon Kaen University
Study officials:
References:
Clinical trial NCT00956306: A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Official title: A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Udenafil,DA-8159,hepatic impairment,healthy volunteers
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Adult males aged 20 to 64 years at screening.
2. Non-smokers
3. In case of hepatic impaired patients
4. In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients
5. Subjects within ±20% of the ideal body weight
6. Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

1.History of portosystemic shunt surgery.

Primary outcomes:
measure: Pharmacokinetics (AUC and Cmax), Safety
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: HYO-SUK LEE, Ph D.
role: STUDY_CHAIR
affiliation: Asan Medical Center, University of Ulsan Colledge of Medicine
name: Young-Suk Lim, Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Hwi Young Kim, Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Sook-Hyang Jeong, Ph D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06053606: The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
Official title: The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: atrial fibrillation
ganglionated plexus
autonomic modulation
cryoablation
cryoballoon
expandable balloon
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.


Eligibility criteria: Inclusion Criteria:

* primary PVI
* paroxysmal atrial fibrillation
* sinus rhythm at the admission
* participant meets clinical criteria for PVI

Exclusion Criteria:

* LA diameter \<38 mm or \>50 mm
* LVEF \<40%
* intrinsic sinus node disease
* advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block)
* previous cardioneuroablation procedure
* pregnancy
* contraindications to anticoagulation treatment
* any other clinical contraindications to PVI
* known atropine intolerance

Primary outcomes:
measure: difference in the rate of persistent parasympathetic modulation
timeFrame: 3 months
Secondary outcomes:
measure: difference in time to first AF episode
timeFrame: 12 months
measure: difference in left atrial dwell time
timeFrame: periprocedural
measure: difference in radiation dose
timeFrame: periprocedural
measure: difference in contrast volume
timeFrame: periprocedural
Other outcomes:
measure: occurence of persistent phrenic nerve palsy
timeFrame: periprocedural
Locations:
city: Wroclaw
country: Poland
facility: Institute of Heart Diseases, Wroclaw Medical University
state: Dolnoslaskie
Study officials:
affiliation: Wroclaw Medical University
name: Piotr Niewinski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04723706: Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients
Official title: Immunological Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Disorders and Bone Marrow Failure, Hematopoietic Stem Cell Transplantation (HSCT) or Cellular Therapy (CART)
Keywords: vaccine
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any SCT or CART post COVID vaccine

Brief summary: For many patients with hematologic disorders and bone marrow failure, hematopoietic stem cell transplantation (HSCT) or cellular therapy (CART) offers a curative treatment option. Patients after SCT or CART have a variable period of immune deficiency in the post-treatment period. The response to vaccination may affect the outcome of the transplant patients. the immunogenicity of vaccines in this immunosuppressed population is uncertain and variable. HSCT and CAR-T recipients are in a COVID-19 high-risk group and conferring immunity by vaccination at the earliest effective timepoint is desirable. At present, the immunogenicity and efficacy of SARS-CoV-2 vaccines in immune-impaired patients including autologous and allogeneic HSCT recipients is unknown. Furthermore, the impact of GvHD and IST on SARS-CoV-2 vaccine immunogenicity is unknown. the investigators aim to evaluate the vaccination response to COVID vaccines after SCT and CART

Detailed description: so for participants with SCT or CART who decide to get their vaccines, the investigators will measure response by therapy by measuring COVID-19 serology IgG at the following schedule: Baseline +5 days after vaccination; 1 month +/- 10 days (after the first dose), 2 months +/- 10 days (after the 2nd dose), 3 months +/- 10 days, 6 months +/- 10 days and 12 months +/- 10 days In addition, also the investigators will collect CD4 and Total IgG which is the standard of care of these patients post SCT and CART

Eligibility criteria: Inclusion Criteria:

* any SCT or CART post COVID vaccine

Exclusion Criteria:

* none

Primary outcomes:
measure: estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine
timeFrame: up to one year post vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: