louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05351710: A Randomized Controlled Trial of an Exposure-Based Treatment for Perfectionism
Official title: A Randomized Controlled Trial of an Exposure-Based Treatment for Perfectionism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perfectionism
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 85
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: TREATMENT

Brief summary: This study is examining the efficacy of a computerized, exposure-based, intervention for perfectionism.

Detailed description: The aim of this study is to further test the efficacy of a short-term, computerized exposure-based treatment for perfectionism (ETP) by comparing it to a stress management condition. ETP consists of three tasks in which participants will repeatedly make mistakes during eight sessions over a two-week period (one session every 2 days).

Eligibility criteria: Inclusion Criteria:

- Score of at least 29 on the Frost Multidimensional Perfectionism Scale- Concern over Mistakes subscale

Exclusion Criteria:

* Currently participating in psychotherapy
* Any changes to psychotropic medications in the past four weeks

Primary outcomes:
measure: Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale
timeFrame: Baseline, post treatment (2 weeks), and follow-up (6 weeks)
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Baseline, post treatment (2 weeks), and follow-up (6 weeks)
measure: Generalized Anxiety Disorder-7
timeFrame: Baseline, post treatment (2 weeks), and follow-up (6 weeks)
measure: Social Phobia Inventory (SPIN)
timeFrame: Baseline, post treatment (2 weeks), and follow-up (6 weeks)
measure: ED-15
timeFrame: Baseline, post treatment (2 weeks), and follow-up (6 weeks)
measure: Irrational Procrastination Scale
timeFrame: Baseline, post treatment (2 weeks), and follow-up (6 weeks)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Department of Psychology
state: Florida
Study officials:
affiliation: Florida State University
name: Jesse R Cougle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04792710: Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Official title: Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prevention of Postpartum Sepsis
Lead sponsor: University of Pretoria
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised placebo controlled trial
Primary purpose: PREVENTION

Brief summary: Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection

Detailed description: All pregnant patients scheduled for emergency or elective Caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. Patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. Outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. Five hundred patients will be recruited in each arm

Eligibility criteria: Inclusion Criteria:

18 years and older Willing and able to provide written informed consent

Exclusion Criteria:

* women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole

Primary outcomes:
measure: Efficacy of reducing surgical site infection
timeFrame: Seven days post-operatively
Secondary outcomes:
measure: Efficacy of reducing urinary tact infections
timeFrame: Three days post-operatively
measure: Efficacy of reducing postpartum endometritis
timeFrame: Seven days post-operatively
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Kalafong Provincial Tertiary Hospital
state: Gauteng Province
Study officials:
References:
Clinical trial NCT05763810: Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Official title: Analgesic Effects of Erector Spinae Plane Block Versus Superficial Parasternal Intercostal Plane Block Combined With Rectus Sheath Block After Off Pump Cardiac Surgery: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 22
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: This study aims to compare the analgesic effects of erector spinae plane block versus Superficial Parasternal Intercostal Plane Block block along with rectus sheath block after off-pump cardiac surgery

Detailed description: General anaesthesia will be used for all patients. induction by midazolam 0.05-0.1 mg/kg, fentanyl 2-5 µ/kg, propofol 1-2 mg/kg, and atracurium 0.5 mg/kg for intubation. Maintenance by sevoflurane in oxygen-air mixture. regional blocks will be used after the induction of anaesthesia. Intraoperative analgesia will be maintained by fentanyl infusion 1-2 µ/kg/h while morphine sulphate 2.5-5mg will be used as rescue analgesia when pain score\>4 beside acetaminophen 1000 mg /6 hours

Eligibility criteria: Inclusion Criteria:

* American Society of anaesthesiologists physical status classification II-III
* Elective off-pump cardiac surgery

Exclusion Criteria:

* Cognitive impairment
* Allergy to local anaesthetics
* Renal and/or hepatic dysfunction
* Ejection fraction\< 45%

Primary outcomes:
measure: Total opioid consumption
timeFrame: Perioperative.
Secondary outcomes:
measure: Pain intensity at rest and exercise
timeFrame: Perioperative.
measure: Extubation time
timeFrame: Perioperative
measure: Duration of post anaesthesia care unit stay
timeFrame: Perioperative
measure: Postoperative nausea
timeFrame: Perioperative
measure: Postoperative vomiting
timeFrame: Perioperative
measure: Duration of hospital stay
timeFrame: Postoperative up to 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: Shebin Elkom
Study officials:
affiliation: Menoufia University
name: Abd-Elazeem A Elbakry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: Amal G Safan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: Islam M El-Desoky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788710: A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
Official title: A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain Following a Total Abdominal Hysterectomy
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Exclusion Criteria:

* Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
* Patient has uncontrolled high blood pressure
* Patient has a history of drug and/or alcohol abuse within the last 5 years
* Patient has taken part in another investigational study within 4 weeks of the start of study
* Patient is breast-feeding
* Patient has an active ulcer or inflammatory bowel disease

Primary outcomes:
measure: Average Pain Intensity at Rest Over Days 1 to 3
timeFrame: 3 Days
Secondary outcomes:
measure: Average Total Daily Dose of Morphine Over Days 1 to 3
timeFrame: 3 days
measure: Average Elicited Pain Upon Sitting Over Days 1 to 3
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Viscusi ER, Frenkl TL, Hartrick CT, Rawal N, Kehlet H, Papanicolaou D, Gammaitoni A, Ko AT, Morgan LM, Mehta A, Curtis SP, Peloso PM. Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study. Curr Med Res Opin. 2012 Aug;28(8):1323-35. doi: 10.1185/03007995.2012.707121. Epub 2012 Jul 16.
Clinical trial NCT00613210: Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation
Official title: Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: preterm delivery
shory cervix
amniotic fluid sludge
uterine artery doppler
singeltone
normal amniotic fluid index
without rupter of membranes
24-34 weeks of gestation
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women that visit a tetriary hospital for follow up

Brief summary: to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor


Eligibility criteria: Inclusion Criteria:

* pregnancy between 24-34 wees of gestation

Exclusion Criteria:

* lack prenatal care
* fetal malformations stractural or genetical
* plcenta previa
* cerclage
* women who underwent conization of cervix
* polyhydramnious
* premature rupture of membranes
* induction of labor d/t medical condition preterm
* women with hypertension, diabetis or preeclampsia
* susp IUGR
* women with a chronic illness that may interupt pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: soroka medical center sonar unit of obstetrics and gynecology department
name: Limor Man
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: limor man, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05585710: Pulsed Lavage in Implant-Based Breast Reconstruction
Official title: Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Reconstruction
Keywords: breast reconstruction
implant-based breast reconstruction
pulsed lavage
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two cohorts will be established. One cohort will include patients who undergo pulsed lavage to wash out the mastectomy pocket. The other cohort will include patients who do not receive pulsed lavage.
Primary purpose: PREVENTION

Brief summary: To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

Detailed description: After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout.

The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.

Eligibility criteria: Inclusion Criteria:

* Female
* Between 18 and 75 years of age, inclusive
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
* Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

Exclusion Criteria:

* Male
* \< 18 years of age or \> 75 years of age
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy

Primary outcomes:
measure: Post-op Complications
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Richard J Fix, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03127410: Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study
Official title: Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction

Detailed description: The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction. The central hypothesis of this pilot study is that a cluster of lumbopelvic stress tests will be able to identify a subgroup of patients with low back pain who will respond favorably to mechanical lumbar traction. If these clinical tests can identify a subgroup of patients with low back pain who respond favorably to lumbar traction, additional studies, including randomized clinical trials will be necessary to further test and validate the use of this cluster of clinical tests. The rationale for this research is to examine the connection between provocative lumbar compression testing and lumbar traction as a means of decompression

Eligibility criteria: Inclusion Criteria:

* Complaints of low back pain with or without pain into the lower extremities
* Pain of at least 2/10 according to the Numeric Pain Rating Scale
* Score of at least 20 or greater on the Oswestry Disability Index

Exclusion Criteria:

* Medical red flags consistent with non-mechanical back pain (i.e. recent weight loss, history of cancer, night sweats, fever)
* Previous surgery to the lumbar spine
* Current pregnancy
* Any neurological symptoms in the lower extremities
* Evidence of central nervous system involvement
* The inability to lie prone for 15 minutes

Primary outcomes:
measure: Change in Disability
timeFrame: 14 days
Secondary outcomes:
measure: Change in Pain
timeFrame: 14 days
measure: Change in perceived outcome
timeFrame: 14 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University-Dallas
state: Texas
Study officials:
References:
Clinical trial NCT06079710: Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children
Official title: Jiangxi Provincial Children's Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emergence Agitation
Anesthesia
Children's Surgery
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who meet the inclusion criteria for surgery at Jiangxi Provincial Children's Hospital

Brief summary: The purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children


Eligibility criteria: Inclusion Criteria:

1. The age of the child is 1-10 years old, regardless of gender;
2. ASA grading I to II;
3. Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia

Exclusion Criteria:

1. Respiratory infection occurred within 1 week before surgery;
2. Potential or existing contraindications to general anesthesia;
3. Significant abnormalities in blood routine or biochemical indicators;
4. Patients with cognitive function, mental illness, or neurodevelopmental delay;
5. Unable to cooperate in completing the test, the child's guardian refused to participate;
6. Other reasons why researchers believe it is not suitable to participate in this experiment.

Primary outcomes:
measure: Incidence of emergence agitation
timeFrame: The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
Secondary outcomes:
measure: emergence time
timeFrame: Approximately 5 min-2 hours
measure: Postoperative pain intensity
timeFrame: The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours
measure: Compatibility during anesthesia induction period
timeFrame: Anesthesia induction period, up to 2 minutes
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
state: Jiangxi Provincial
Study officials:
References:
Clinical trial NCT01388010: Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women
Official title: "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adult Women
Keywords: probiotics
gastrointestinal well being
digestive symptoms
healthy population
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 336
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.


Eligibility criteria: Inclusion Criteria:

* Female free-living subject aged from 18 to 60 years.
* Subject with a body mass index between 18 and 30.
* Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
* Subject with normal stool frequency

Exclusion Criteria:

* Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea...)
* Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
* Subject having taken antibiotics in the last 4 weeks
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Subject with known lactose intolerance or immunodeficiency
* Subject with known allergy to product component (milk protein for example)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: RPS Research France
Study officials:
References:
Clinical trial NCT03425110: The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults
Official title: The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Birmingham and Solihull Mental Health NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult outpatients with pharmacoresistant epilepsy referred to and accepted by the epilepsy clinic will be eligible to participate.

Brief summary: The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Detailed description: Epilepsy is a common neurological condition. Unfortunately, just over 30% of patients with epilepsy (PWE) do not become seizure free with anti-epileptic drugs. Some patients may be suitable for epilepsy surgery. Alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. The evidence base for the use of ketogenic diet in adults is limited. There are a few prospective studies and no randomised control trial to date.

This study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. The intervention is a modified ketogenic diet. The carbohydrate load will be between 20-30gm per day. Blood ketones and blood sugars will be monitored. The primary outcome measure is seizure frequency at 12 months. There are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.

Eligibility criteria: The study will have no formal inclusion/exclusion criteria as it is purely observational and it will be the clinical team's decision as to whether or not people are seen by the dietary clinic based on established dietary clinic protocols.

Primary outcomes:
measure: 50% responder rate
timeFrame: Twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Complex Epilepsy Service, The Barberry, BSMHFT
state: West Midlands
Study officials:
affiliation: Consultant Epileptologist and Neuropsychiatrist
name: Manny Bagary, Dr
role: STUDY_DIRECTOR
References: