louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04394364: Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries
Official title: Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 20
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: Patients undergoing chest surgeries

Brief summary: Bispectral index(BIS) is commonly used to monitor the depth of anesthesia. The electroencephalographic signal is collected and analyzed by the device, resulting a number related to the awareness of the patient. Electromyography is also recorded. The aim of the study is recording and analyzing the data of BIS and try to find it's relation to intraoperative neuromuscular blockade.


Eligibility criteria: Inclusion Criteria:

* ASA class between 1 and 3
* Patients scheduled for chest surgery

Exclusion Criteria:

* Neuromuscular diseases
* Mental and psychiatric disturbance
* ASA class over 4
* Drug abuse
* Aboriginals

Primary outcomes:
measure: Establishing the predicting model of intraoperative electromyographics of BIS monitor and train-of-four of neuromuscular transmission monitor
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT00286364: Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-02-03
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We want to investigate if early follicular phase downregulation and androgen priming, by use of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs of improvement compared to standard short antagonist protocol


Eligibility criteria: Inclusion Criteria:

* Indication and wish for IVF/ICSI treatment
* Womens age 20-39 years (both inclusive)
* Regular menstrual cycle within normal range
* Body Mass Index: 18-30 kg/m2 (both inclusive)
* Negative pregnancy test before treatment
* A maximum of 3 earlier IVF/ICSI treatments that did not result in pregnancy

Exclusion Criteria:

* serious systemic disease
* Presence of polycystic ovarian syndrome (PCOS)
* Earlier poor response with less than 4 mature follicles
* Earlier participation in the investigation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet
state: Copenhagen East
Study officials:
affiliation: The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet
name: Kristine Lossl, medical doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lossl K, Andersen CY, Loft A, Freiesleben NL, Bangsboll S, Andersen AN. Short-term androgen priming by use of aromatase inhibitor and hCG before controlled ovarian stimulation for IVF. A randomized controlled trial. Hum Reprod. 2008 Aug;23(8):1820-9. doi: 10.1093/humrep/den131. Epub 2008 May 15.
Clinical trial NCT01010464: An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen
Official title: Effect of an Adhesion Reduction Plan on Enteric Adhesions, Obstruction, and Fistulae in the Management of the Surgical Open Abdomen: A Prospective, Randomized Clinical Trial in Trauma and Emergency General Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Open Abdomen
Keywords: Adhesions
Open abdomen
Laparotomy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2009-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Detailed description: Adhesions are a common consequence of abdominal surgery. Trauma and emergency general surgery patients may require an open abdomen and undergo a series of abdominal operations, which may be increasingly complicated by the presence of adhesions. Adhesions appear soon after the initial operation and gradually mature within days. The effects of adhesion development on subsequent surgery may include: increased procedure time; difficulty differentiating, exposing, and accessing tissue planes; and increased risk of inadvertent enterotomy. Complications of adhesions include enteric obstruction and enterocutaneous fistulae. This study will determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the extent and severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Eligibility criteria: Inclusion Criteria:

* Trauma patients with open abdomen after initial laparotomy
* Emergency surgery patients with open abdomen after initial laparotomy
* Able to obtain consent from patient or LAR before any research initiated

Exclusion Criteria:

* Seprafilm application at initial laparotomy
* Patient is a prisoner
* Inability to obtain informed consent
* Consentable person does not speak English

Primary outcomes:
measure: Extent and severity of adhesions
timeFrame: Each abdominal re-entry and re-exploration
Secondary outcomes:
measure: Time for lysis of adhesions
timeFrame: Each abdominal re-entry and re-exploration
measure: Incidence of complications
timeFrame: Hospital admission
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: William C. Chiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01759264: An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience (FAIR)
Official title: An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Fecal Calprotectin
Crohn's Disease
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-01-03
Enrollment: 101
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with moderate-to-severe Crohn's Disease

Brief summary: The objective of this observational study was to assess changes in fecal calprotectin levels and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's Disease who were treated with adalimumab.


Eligibility criteria: Inclusion Criteria:

1. Crohn's Disease participants were defined as:

1. Active luminal, moderate-to-severe Crohn's Disease with Crohn's disease activity index (CDAI) greater than 220, who started Adalimumab treatment in a normal clinical practice setting.
2. Fecal Calprotectin greater than or equal to 150 microgram/g.
3. Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

Exclusion Criteria:

1. Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
2. Participants who had undergone colectomy other than ileocecal resection.
3. Pregnancy or breast feeding.
4. Contraindication to any anti-tumor necrosis factors (TNF) agent.
5. Any drug dependency.

Primary outcomes:
measure: Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram
timeFrame: At Week 4
Secondary outcomes:
measure: Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram
timeFrame: At Week 8 and 12
measure: Mean Percent Change of Fecal Calprotectin From Baseline
timeFrame: Week 4, 8, and 12
measure: Percentage of Participants With Remission of Crohn's Disease
timeFrame: At Week 4, 8, and 12
measure: Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment
timeFrame: At Week 4, 8, and 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: SoRa Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06657664: Effect of Cryotherapy and Laser Application on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases
Official title: Effect of Cryotherapy and Laser on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irriversible Pulpitis With Apical Peridontitis
Hot Tooth
Keywords: cryotherapy Low Level Laser Therapy LLLT single visit endodontic treatment irriversible pulpitis Apical peridontitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical study.
Primary purpose: TREATMENT

Brief summary: This study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain .

Detailed description: one of the most popular complications after single visit endodontic treatment is pain either spontaneous or on biting so in this study we choose one of the most difficult and challenging cases " Hot tooth " to compare lasers and cryotherapy different applications to reduce post operative pain after single visit endodontic treatment

Eligibility criteria: Inclusion Criteria:

* • Vital teeth display symptomatic apical periodontitis (Symptomatic apical periodontitis was determined based on the clinical symptoms of severe preoperative pain (visual analogue scale \[VAS\] \> 60) and severe percussion pain (VAS \> 60).

  * Teeth, with a periapical index score (PAI) of 2 or 3 indicating small changes in bone structure and slight mineral loss respectively.
  * Mobility less than 1 mm in either direction.
  * Absence of periodontal pocket around the tooth.
  * Symptomatic pulpitis with spontaneous pain or lingered by cold or heat.
  * Teeth without pus or inflammatory exudates draining through the canal.
  * Teeth without anatomic variations

Exclusion Criteria:

* • Patient with any systemic disease.

  * Immunocompromised patients.
  * Pregnant or lactating patients.
  * Apparently narrow roots in which apical preparation with the #40 file would be overzealous.
  * Retreatment cases.
  * Necrotic painful teeth with absence of sinus tract for drainage.
  * Patients on analgesics or sedative medication up to 6 hours before treatment

Primary outcomes:
measure: post operative pain
timeFrame: preoperative, after 24 hours, on the third , fifth, one week & two weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
References:
Clinical trial NCT00311064: Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight
Official title: Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Inflammation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-04-05
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Purpose:

The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.

Detailed description: Material and Method:

This study falls in two fields:

First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated.

280 overweight (body mass index \[BMI\] \> 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly.

Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30 kg/m2
* BMI \< 45 kg/m2
* Healthy
* Over 18 years of age
* No earlier preterm delivery (before 37)
* Singleton pregnancy
* 14 weeks +/- 1 week of gestation

Exclusion Criteria:

* BMI \> 45 kg/m2
* Earlier preterm delivery (before 37)
* Not singleton pregnancy
* Medically treated diseases

Primary outcomes:
measure: perinatal mortality
measure: congenital malformations and preeclampsia
measure: gestational hypertension and gestational diabetes mellitus (GDM)
measure: preterm delivery
measure: too large infants (> 2 standard deviation [SD])
Secondary outcomes:
measure: delivery by caesarian section
measure: induction of labour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Obstetric Clinic, Juliane Marie Centret
state: Østerbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Bettina Breitowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00226564: Genetic Determinants of Opioids Analgesia
Official title: The Effect of mu Opioid Receptor Polymorphism on the Response to Alfentanil During Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The response to opioids varies greatly among individuals. Some of these variability is accounted for by genetic factors.

The present study was designed to evaluate the possibility that genetic polymorphism in the gene encoding for mu opioid receptor may explain variability in the response to alfentanil during lithotripsy.


Eligibility criteria: Inclusion Criteria:

* Age \> 20

Exclusion Criteria:

* Regular use of opioid drugs
* Known hypersensitivity to alfentanil

Primary outcomes:
measure: Total alfentanil dose used during the procedure.
measure: The extent of respiratory depression.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05795764: Crisis Response Planning for Military Personnel
Official title: Moderators of the Effectiveness of Crisis Response Planning (CRP) for Military Personnel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal
Suicide Threat
Suicidal Ideation
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Naval Health Research Center
name: Ohio State University
First posted: 2023-04-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a randomized trial comparing outcomes of active duty service members who present to the emergency department at risk for suicide and receive care from providers trained in crisis response planning versus those providing treatment as usual.


Eligibility criteria: Inclusion Criteria:

* Active duty service members
* \>18 years old
* Present to the emergency department at NMCSD with a primary concern related to suicidal ideation, plan, intention, or attempt, or are assessed as being at elevated risk of suicidal behavior
* Able to understand and speak English
* Able to provide consent

Exclusion Criteria:

* Unable to provide informed consent due to impaired mental status (e.g., acute intoxication, psychosis, mania, altered consciousness)

Primary outcomes:
measure: Self-Injurious Thoughts and Behaviors Interview (SITBI-R)
timeFrame: Through study completion, an average of 1 year
measure: Scale for Suicidal Ideation (SSI)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: Naval Health Research Center
name: Kristen H Walter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04198064: Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy
Official title: Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 201
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether utilization of the "bag squeeze" technique during flexible cystoscopy changes pain scores using a study questionnaire designed by the team which comprises a validated Lingard pain rating scale.


Eligibility criteria: Inclusion Criteria:

* Male
* Undergoing flexible cystocopy at University Health Network that have undergone a flexible cystocopy and did not demonstrate difficulty during exploration (meatal stenosis or urethral stricture), simultaneous removal or ureteral stents or bladder biopsies or have a chronic history of pelvic pain

Exclusion Criteria:

- Patients that do not meet the inclusion criteria.

Primary outcomes:
measure: Pain Rating
timeFrame: The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Heidi Wagner
state: Ontario
Study officials:
References:
Clinical trial NCT00695864: Effect of Ondansetron for Withdrawal Symptoms
Official title: Effect of Ondansetron for Withdrawal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Withdrawal Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 31
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: We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.


Eligibility criteria: Inclusion Criteria:-Over 18 years of age

* No medical contraindications to medication
* Able to fulfill research procedures Exclusion Criteria:-Subjects who are unable to respond to our questionnaires or to stimuli as required by the experimental protocol will be excluded.
* Subjects will be excluded if they have a history of significant psychiatric disorders that would prevent them from engaging in a treatment program.
* Participating in other studies that would interfere with the procedures in this study
* Known or apparent pregnancy

Primary outcomes:
measure: Change in Withdrawal Symptoms With Placebo and With Ondansetron
timeFrame: Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sean Mackey
role: PRINCIPAL_INVESTIGATOR
References: