louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01178489: Recovery at the Post Anaesthetic Care Unit After Hip and Knee Arthroplasty
Official title: Recovery at the Post Anaesthetic Care Unit After Fast-track Hip and Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PACU Stay After THA Under Spinal Anaesthesia
PACU Stay After TKA Under Spinal Anaesthesia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing primary, unilateral, total hip or knee arthroplasty

Brief summary: To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.

Detailed description: In this prospective, consecutive, observational cohort study we examine:

1. Patient related problems in the PACU after hip and knee arthroplasty simply to answer the question "Why in PACU?", using a modified version of the national guidelines for patient observation in PACU.
2. The time spent in PACU with the modified version of the national guidelines for patient observation in PACU.
3. If the modified version of the national guidelines for patient observation in PACU results in patient related problems in the ward afterwards.

Eligibility criteria: Inclusion Criteria:

* primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia

Exclusion Criteria:

* Bilateral arthroplasty
* Revision arthroplasty
* General anaesthesia

Primary outcomes:
measure: Time to meet PACU discharge criteria
timeFrame: 3 hours
Secondary outcomes:
measure: Actual discharge time from PACU
timeFrame: 3 hours
measure: Clinical and logistic factors detaining patients in PACU
timeFrame: 3 hours
measure: Potential complications at the surgical ward
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Troels H Lunn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018589: Cicatrix Cream in Post Surgical Scars and Epidermic Burn
Official title: Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Surgical Scars
Epidermic Burn
Keywords: Post surgical scars
Epidermic burn
Cicatrix cream
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.


Eligibility criteria: Inclusion Criteria:

* Patient with lesions characteristic of the investigated illness.
* Signed informed consent

Exclusion Criteria:

* Patient that refer manifestations of high sensibility to the medication or to some of the components of the product
* Patient that don't want to participate in the study
* Patient not very cooperative
* Family responsible not very cooperative

Primary outcomes:
measure: Reduction of the areas of lesions at 2 months (end of the treatment)
timeFrame: 2 months
Secondary outcomes:
measure: Coloration of the lesions at 2 months (end of the treatment)
timeFrame: 2 months
measure: Adverse effects
timeFrame: 2 months
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: Juan Manuel Marquez Pediatric Hospital
state: Havana
Study officials:
affiliation: Juan Manuel Marquez Pediatric Hospital
name: Edelisa Moredo Romo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06729489: Endoscopy in Anemic Children
Official title: Gastrointestinal Endoscopic Findings in Children With Referactory Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Refractory Iron Deficiency Anemia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assess the role of Upper and lower gastrointestinal endoscopy in evaluation of refractory iron deficiency anemia in children


Eligibility criteria: Inclusion Criteria:

* children with iron deficiency anemia not responding to medical treatment for more than 6 weeks

Exclusion Criteria:

* children with iron deficiency anemia responding to medical treatment Children below 1 years and above 18 years old

Primary outcomes:
measure: Endoscopic findings in children with referactory iron deficiency anemia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine sohag university
Study officials:
References:
Clinical trial NCT04807829: Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Official title: A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Suicidal Ideation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 0
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: Suicide is a major crisis worldwide with rates projected to continue to increase. There is currently a dearth of novel pharmacologic treatment options for suicide available on the market. The endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. The aim of the study is to determine whether treatment with Nabilone is capable of reducing suicidal ideation in adults after 3 days.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Current suicidal ideation
* Columbia Suicide Severity Rating Scale (CSSRS) score of ≥ 4 and Scale for Suicide Ideation (SSI) first 5 items, score of ≥4
* Current major depressive episode as evidenced by MADRS score ≥ 20

Exclusion Criteria:

* Current diagnosis of a Diagnostic and Statistical Manual V (DSM-V) psychotic disorder, psychotic symptoms, or personality disorder.
* Recent (\<72 hrs) use of illicit substances
* Comorbid substance use disorder diagnosis
* Urine drug screen (UDS) positive for tetrahydrocannabinol (THC)
* Pregnant or nursing women
* Unstable medical condition

Primary outcomes:
measure: Change in Suicidal Ideation and Behavior as assessed by an abbreviated version of the Columbia-Suicide Severity Rating Scale (CSSRS)
timeFrame: baseline, day 3
Secondary outcomes:
measure: Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: baseline, day 3
measure: Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI)
timeFrame: baseline, day 3
measure: Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7)
timeFrame: baseline, day 3
Other outcomes:
measure: Biomarkers
timeFrame: baseline, day 3
Locations:
city: Houston
country: United States
facility: Harris County Psychiatric Center (HCPC)
state: Texas
Study officials:
affiliation: UTHealth
name: Rodrigo Machado-Vieira, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06031129: Butorphanol in Pain Following Ablation for Hepatic Tumor
Official title: Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Pain
Microwave Ablation
Hepatic Tumor
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
First posted: 2023-09-11
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this investigation was to evaluate the influence of Butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. Employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either Butorphanol (experimental group) or normal saline (control group). Primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the 6-hour mark (VAS) and comprehensive pain assessment outcomes.


Eligibility criteria: Inclusion Criteria:

patients performing Microwave Ablation sign the informed consent

Exclusion Criteria:

Patients with a body mass index \> 30 kg/m2 a history of depression opioid dependence poorly controlled hypertension (systolic blood pressure \> 180 mmHg) myocardial infarction severe liver disease significant abdominal pain before surgery patients with sensory system or language dysfunctions who could not cooperate to complete the scale pregnant women.

Primary outcomes:
measure: Visceral Pain
timeFrame: during the surgery
Secondary outcomes:
measure: Visceral Pain
timeFrame: 6-hour after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hosipiatl
state: Jiangsu
Study officials:
References:
Clinical trial NCT05586529: Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia
Official title: Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypocalcemia
Keywords: Cholecalciferol, post-operative hypocalcemia, thyroidectomy
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia

Detailed description: Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery

Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years)
* Scheduled for TT
* Thyroid cancer treated with total thyroidectomy without lymph node dissection

Exclusion Criteria:

* Lack of written consent
* Thyroid cancer treated with TT and lymph node dissection
* Mediastinal goiter with need for sternotomy
* Medication with thiazide diuretics, digitalis or lithium therapy
* Previous neck operations or radiation
* Preexisting hyperparathyroidism
* Chronic kidney failure.

Primary outcomes:
measure: Post-operative hypocalcemia
timeFrame: After 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pak-Emirates Military Hospital
state: Punjab
Study officials:
affiliation: Resident
name: Mubashra Badar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593029: A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
SEP-363856
Antidepressant Therapy
ADT
Depression
Depressive Disorder
Major Mood Disorders
Mental Disorders
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-25
Enrollment: 1030
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 is a Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder (MDD)


Eligibility criteria: Inclusion Criteria:

* Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode
* Current major depressive episode must be at least 8 weeks and no longer than 2 years in duration
* History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode

Exclusion Criteria:

* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
* Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major or mild neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent/ follow study directions/ or otherwise safely participate in the study, borderline or antisocial personality disorder.
* Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
* Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

Primary outcomes:
measure: Montgomery Åsberg Depression Rating Scale (MADRS)
timeFrame: From baseline to week 14
Secondary outcomes:
measure: Clinical Global Impression - Severity of Illness (CGI-S)
timeFrame: From baseline to week 14
Other outcomes:
Locations:
city: New York
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: New York
Study officials:
References:
Clinical trial NCT03744429: A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
Official title: A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Diet on Breast Milk Composition
Keywords: Breast Milk
Mediterranean Diet
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.


Eligibility criteria: Inclusion Criteria:

* ≤4.5 months postpartum
* BMI 30 - 50 kg/m2
* ≥ 18 years of age
* Singleton pregnancy
* Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum
* Mother has a breast pump
* Mother is willing to collect breast milk for a 24 hour period.

Exclusion Criteria:

* Pre-existing conditions (e.g. diabetes, hypertension, heart disease)
* Use of recreational drugs, tobacco, or alcohol
* Use of medications or supplements for which breastfeeding is contraindicated
* Child has internal metal which may be an NMR safety concern

Primary outcomes:
measure: Change in breast milk fat concentration by mid-infrared spectroscopy
timeFrame: The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Clark Sims, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470129: Clinical Performance of Two Fissure Sealants
Official title: Klinische Bewährung Zweier Fissurenversiegler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries Pit and Fissure Limited to Enamel
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children


Eligibility criteria: Inclusion Criteria:

participants

* ASA Status 1
* all dentinal lesions are restored
* consent of parents and patient
* instruction and demonstration of oral hygiene

teeth:

* first and second molars of the permanent dentition
* healthy teeth without caries
* molars with primary lesions

Exclusion Criteria:

participants

* no consent
* allergies to methacrylates or other ingredients of dental products

teeth:

* molars with occlusal cavities (UniViSS score occlusal \> M)
* Molars with untreated dentinal lesions
* premolars, incisors, deciduous teeth
* teeth with huge occlusal restorations
* hypomineralized teeth or other defects

Primary outcomes:
measure: Retention of the Sealant
timeFrame: 7-28 days
measure: Retention of Sealant
timeFrame: 12 months
measure: Retention of Sealant
timeFrame: 24 months
measure: Retention of Sealant
timeFrame: 36 months
Secondary outcomes:
measure: Caries
timeFrame: 7-28 days
measure: Caries
timeFrame: 12 months
measure: Caries
timeFrame: 24 months
measure: Caries
timeFrame: 36 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Prof. Jan Kühnisch
state: Bavaria
city: Wädenswil
country: Switzerland
facility: Zahnarztpraxis Graeser
state: Zürich
Study officials:
References:
Clinical trial NCT00576329: Topical 0.4% Ketorolac and Vitreoretinal Surgery
Official title: Topical 0.4% Ketorolac for the Inhibition of Miosis During Vitreoretinal Surgery: a Randomized, Placebo-controlled, Double-masked Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Surgery
Keywords: vitreoretinal surgery, ketorolac, Acular, mydriasis
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2007-12-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Detailed description: Other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Eligibility criteria: Inclusion Criteria:

* Age of 18, routine elective vitrectomy

Exclusion Criteria:

* history of trauma, uveitis, prior intraocular surgery within 3 months, requirement of mechanical pupil dilation, prior inclusion of other eye

Primary outcomes:
measure: Change in pupil size during vitreoretinal surgery
timeFrame: Surgery
Secondary outcomes:
measure: Postoperative pain and inflammation
timeFrame: 1 day
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Eye Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Stephen J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SJ, Lo WR, Hubbard GB 3rd, Srivastava SK, Denny JP, Martin DF, Yan J, Bergstrom CS, Cribbs BE, Schwent BJ, Aaberg TM Sr. Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial. Arch Ophthalmol. 2008 Sep;126(9):1203-8. doi: 10.1001/archopht.126.9.1203.