louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00011297: Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal
Official title: Alcohol Research Center - Treatment and Implications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2001-02-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
* Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days).
* Have a clinical withdrawal assessment prior to study.
* Must be medically acceptable for study treatment. Considerations include no past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
* Able to read, write, and speak English.
* Have a negative urine drug screen for benzodiazepines or other sedative hypnotics, opiates, and stimulates prior to entering the study.

Exclusion Criteria:

* Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
* Use of pharmacological agents within the last 14 days that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.
* History of alcohol withdrawal seizures, epilepsy or delirium tremens.
* Diagnosis of schizophrenia, bipolar disorder or dementia.
* Liver function tests higher than normal.
* History of hepatic encephalopathy, jaundice, ascites, diabetes, or renal disease.
* Females who are pregnant or nursing.
* Subjects with known sensitivity of previous adverse reaction to gabapentin, lorazepam, or other benzodiazepines.
* History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
* Unable to provide an informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT03870997: Influenza Vaccination Digital Interventions for People Living With Diabetes
Official title: Influenza Vaccination Digital Interventions for People Living With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2019-03-12
Enrollment: 94321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall objective of this prospective randomized controlled study is to assess and quantify the impact of digital interventions to increase vaccination rates and vaccination-related outcomes in a connected population with self-reported diabetes. The digital intervention will be delivered via a campaign sent to participants, with interventions varying with each study arm. Participants will be blinded to study participation status.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Lives in the U.S.

Exclusion Criteria:

* \< 18 years old
* Does not live in the U.S.

Primary outcomes:
measure: Number of Participants With Self-reported Influenza Vaccination in People With Diabetes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
References:
citation: Lee JL, Foschini L, Kumar S, Juusola J, Liska J, Mercer M, Tai C, Buzzetti R, Clement M, Cos X, Ji L, Kanumilli N, Kerr D, Montanya E, Muller-Wieland D, Ostenson CG, Skolnik N, Woo V, Burlet N, Greenberg M, Samson SI. Digital intervention increases influenza vaccination rates for people with diabetes in a decentralized randomized trial. NPJ Digit Med. 2021 Sep 17;4(1):138. doi: 10.1038/s41746-021-00508-2.
Clinical trial NCT01710683: Early Mobilisation Following Discectomy
Official title: Early Mobilisation Following Discectomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Reduced Hospital Stay Without Complication
Keywords: Discectomy
1st postoperative day
Intensive exercise training
Randomized controlled trial
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: Copenhagen University Hospital, Denmark
First posted: 2012-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic.

Brief summary: After lumbar discectomy 1st postoperative day high intensity exercise training reduced hospital stay, pain and sick leave without side effects in the two year follow-up period.

Detailed description: Postoperative pain is a major cause of delayed convalescence after discectomy. Different analgesic treatments with the use of local analgesics and steroid can reduce the immediate postoperative pain and convalescence after surgery. In orthopaedic and abdominal surgery accelerated stay programs with early mobilisation have reduced pain in the early postoperative periode. The late convalescence after discectomy for herniated disc disease can be reduced with the use of epidural steroids.

Eligibility criteria: Inclusion Criteria:

* Patients with primary lumbar herniated disc disease who have received and performed a standardized conservative treatment program with intensive exercises.
* Oral and written acceptance.
* Age 18 and above.

Exclusion Criteria:

* Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion.
* Patients with cauda equina syndrome who needed acute operative treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Aalborg Hospital, Aarhus University
Study officials:
affiliation: Northern Orthopaedic Department, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
name: David S. Krum-Moeller, M.D.
role: STUDY_CHAIR
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
name: Lene R. Lauridsen, M.D.
role: STUDY_CHAIR
affiliation: Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen
name: Henrik Kehlet, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03405883: Uterine Microbiome in Women with Repeated Implantation Failure and Normal Fertile Women
Official title: Comparative Analysis of the Uterine Microbiome in Women with Repeated Implantation Failure and Normal Fertile Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Repeated Implantation Failure
Normal Fertile
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Center for Microbial Ecology and Technology - Ghent University
First posted: 2018-01-23
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * For RIF women: absence of pregnancy after transfer of in total 5 embryos of high quality embryos
* For NF women: live birth after spontaneous conception or IUI (max 9x)

Brief summary: Characterization of the uterine microbiome in women with repeated implantation failure as well as in normal fertile women.

Detailed description: In the midluteal phase of the cycle, a vaginal swab and endometrial biopsy will be obtained.

Eligibility criteria: Inclusion Criteria:

* Women between their 18th and 40th birthdays (max 39 years and 364 days at the day of signing the informed consent)
* Able to understand, read and speak Dutch and hence to provide written and oral informed consent
* Negative serological tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Rapid plasma reagin (RPR) for syphilis

Exclusion Criteria:

* Hormonal contraception in current cycle
* Presence of intra-uterine device
* Antibiotic treatment in the current cycle

Primary outcomes:
measure: Midluteal uterine microbiome profile
timeFrame: 1 week
Secondary outcomes:
measure: Midluteal vaginal microbiome profile
timeFrame: 1 week
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Hans Verstraelen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05180383: Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Open Trial
Official title: Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide and Self-harm
Suicide
Suicide, Attempted
Suicidal Ideation
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Brown University
First posted: 2022-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility criteria: Inclusion Criteria:

* Presence of suicidal ideation and/or suicidal behavior in the past month
* Between the ages of 18 and 70
* Able to read, write, and understand English well enough to complete study procedures
* Owns a smartphone

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with completion of study procedures

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 1 month
measure: Acceptability of Research (Recruitment)
timeFrame: Baseline
measure: Acceptability of Research (Dropout)
timeFrame: 1 month
measure: Acceptability of Research Procedures
timeFrame: 1 month
measure: Acceptability of MAPS Intervention
timeFrame: 1 month
measure: Satisfaction with MAPS Intervention
timeFrame: 4 weeks
measure: Ecological Momentary Assessment (EMA) Adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: Suicidal Ideation and Behavior
timeFrame: 1 month
measure: Rehospitalization
timeFrame: 1 month
measure: Emergency Department Visits
timeFrame: 1 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
Clinical trial NCT01637883: Benzydamine HCl for Postoperative Sore Throat
Official title: Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: For Intervention
Keywords: benzydamine HCl
endotracheal tube
postoperative sore throat
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 86
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: PREVENTION

Brief summary: To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.

Detailed description: The investigators will assign patients into either the benzydamine hydrochloride or the control group. The whole ETT cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years
* ASA status I-II
* Mallampati grade I-II
* Duration of surgery less than 4 hours
* Patients placed in the supine position

Exclusion Criteria:

* Undergoing oral, cervical spine or thyroid surgery
* More than one attempt of ETT intubation or intubated with a technique of rapid sequence induction with cricoid pressure
* Insertion of nasogastric/orogastric tube or esophageal stethoscope
* Complaint of sore throat or hoarseness
* Presence of upper respiratory tract infection within 7 days prior to the operation
* Gastroesophageal reflux
* Known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (NSAIDs)

Primary outcomes:
measure: analgesic effect
timeFrame: 24 hours
Secondary outcomes:
measure: side effects of benzydamine hydrochloride
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110 Thailand
name: Sasikaan - Nimmaanrat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421083: Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess Efficacy and Safety of Tadalafil (LY450190) in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Spinal Cord Injuries
Keywords: Erectile dysfunction as a result of traumatic spinal cord injury
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-01-11
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* males who developed erectile dysfunction as a result of spinal cord injury. Injury must have occurred 6 months before the start of the study.
* at least 4 sexual intercourse attempts during the first 4 weeks of the study without medication assistance
* no use of other erectile dysfunction treatment for at least 4 weeks before receiving the first dose of study drug. Also cannot use any other erectile dysfunction treatment during the study.

Exclusion Criteria:

* Impotence caused by other primary sexual disorders including premature ejaculation or untreated endocrine diseases such as diabetes, hypopituitarism, hypothyroidism, or hypogonadism
* History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection and history of penile implant.
* History of cardiac conditions including angina requiring certain treatment with nitrates; heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
* Significant renal problems within 6 months before starting the study. Also, active liver disease including jaundice at beginning of study.
* History of other central nervous system injuries, other than spinal cord injury, 6 months before starting the study.

Primary outcomes:
measure: Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.
Secondary outcomes:
measure: Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05112783: Nasal Intubation：a Comparison of Different Endotracheal Tubes
Official title: Compare the Effects of Two Different Endotracheal Tubes on The Secretion and Bleeding Volume of Patients During Intubation to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation Complication
Keywords: Endotracheal Tube intubation General Anesthesia (ETGA)
nasotracheal tube
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.

Detailed description: 1. Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
2. Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
3. Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV.
4. Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
5. Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
6. Anesthesia intubation inducer：Propofol 1mg/kg
7. Intubation
8. Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
9. Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
10. Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.

Eligibility criteria: Inclusion Criteria:

* Age:20-65 years
* Undergoing oro-maxillofacial surgery
* Opening mouth \> 3 cm
* Denied any systemic disease.
* American Society of Anesthesiologists (ASA) class:I-III

Exclusion Criteria:

* Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance \< 6cm)
* Previous head and neck surgery history
* Upper abnormal airway diagnosed
* Easily epistaxis
* Both sides nasal cavities obstruction

Primary outcomes:
measure: success rate
timeFrame: 10 minutes
measure: time
timeFrame: 10 minutes
Secondary outcomes:
measure: post-anesthesia care
timeFrame: 2 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin District
Study officials:
affiliation: Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Pin-Yang Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05458583: The Periodontal Status and Failure Rates With Different Retainer Bonding Techniques Using One-step Adhesive
Official title: Comparison of Periodontal Status and Failure Rates With Different Retainer Bonding Methods and Adhesives: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Inflammation
Keywords: failure rate
periodontal status
retainer
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to evaluate fixed retainers, bonded with either direct or indirect techniques using one- or two-step adhesives, in terms of periodontal status and failure rates.


Eligibility criteria: Inclusion Criteria:

* Good treatment outcomes
* good oral hygiene
* No systemic or periodontal problems
* No extraction or missing anterior teeth and restorations

Exclusion Criteria:

- Patients unwilling to wear a fixed retainer

Primary outcomes:
measure: Plaque index measurements
timeFrame: at the bonding session
measure: Plaque index measurements
timeFrame: 6 months (T1) after bonding
measure: Plaque index measurements
timeFrame: 12 months (T2) after bonding
measure: Gingival index measurements
timeFrame: at the bonding session
measure: Gingival index measurements
timeFrame: 6 months (T1) after bonding
measure: Gingival index measurements
timeFrame: 12 months (T2) after bonding
measure: Calculus index measurements
timeFrame: at bonding session
measure: Calculus index measurements
timeFrame: 6 months after bonding
measure: Calculus index measurements
timeFrame: 12 months after bonding
Secondary outcomes:
measure: Failure rate
timeFrame: during 1-year follow-up
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Dentistry Department of Orthodontics
Study officials:
References: