louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00224172: Ambulatory Care Characteristics as Predictors of Mortality and Re-Admission
Official title: Ambulatory Care Characteristics as Predictors of Mortality and Re-Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ambulatory Care Patients Who Were Hospitalized in 2001 at the Cornell Campus of the New York-Presbyterian Hospital
Keywords: Pre-hospitalization characteristics
Post-hospitalization characteristics
Psychosocial measures
Predict re-hospitalization
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of this study is to construct a prognostic model to identify risks of poor outcomes at one year following hospital discharge of patients treated in an ambulatory cate setting. The study will incorporate pre-hospitalization characteristics, hospitalization events, comorbidity burden, psychosocial measures and post-hospitalization care characteristics to predict re-hospitalization and mortality at one year.

Detailed description: This model will identify potentially modifiable variables in the post-hospitalization clinic setting that result in increased rates of hospital readmission and mortality. Specifically, it is hypothesized that longer time to first outpatient visit after hospitalization, multiple providers, poor follow-up with scheduled appointment and discrepancies between discharge and outpatient medication lists will be predictors of adverse outcomes. Utilizing statistical modeling methods, it will be possible to recognize at risk patients, to identify modifiable risk factors and outpatient care characteristics, and in the future, to direct patient specific interventions to improve outcomes.

Eligibility criteria: Inclusion Criteria:

1. All patients admitted to New York Presbyterian Hospital and followed in Cornell Internal Medicine Associated for at least one year prior to admission.

Exclusion Criteria:

1. Patients who do not wish to participate in the study.
2. Patients who are not followed in Cornell Internal Medicine Associates.

Primary outcomes:
measure: Psychosocial measures
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04143672: Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
Official title: A Cohort Study on Association Between Pain Sensitivity by Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
pain sensitivity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational study
Primary purpose: SCREENING

Brief summary: This study aims to investigate the potential association between pain sensitivity questionnaire score, the severity of postoperative pain, and postoperative analgesic requirement in patients with open colorectal cancer surgery. This information may be used to guide the optimal postoperative pain management, and ultimately improve patient's quality of life.

Detailed description: We plan to investigate the predictive ability of the PSQ as well as experimental parameters of pain sensitivity using electronic algometer and other known risk factors for postoperative pain in 100 patients scheduled for open colorectal cancer surgery.

The following items are investigated before surgery; Age, sex, level of education, type of surgery, past surgical history, presence of chronic pain, the expected maximal pain score (VAS) after surgery, Pain catastrophizing scale, anxiety scale (HADS-A), Pain sensitivity questionnaire, and pain threshold measured by electronic algometer.

The total opioid consumption is investigated for 24 and 48 hours after surgery. In addition, the severity of postoperative pain is measured by the 11-point VAS at 24 and 48 hours after surgery. Patient satisfaction with postoperative pain control is also investigated at 48 hours after surgery using the 7-point patient's satisfaction scale.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or above
* Patients scheduled for open colorectal cancer surgery under general anesthesia
* ASA status I-III
* Ability to read and understand the information sheet, questionnaires, and the - consent form
* Patients scheduled for using IV-PCA after surgery

Exclusion Criteria:

* Unable to read and understand the information sheet, questionnaires, and the consent form
* Severe medical or psychological diseases
* Patients with preoperative chronic pain

Primary outcomes:
measure: Total fentanyl consumption during 24 hours
timeFrame: postoperative 24 hours
measure: Total fentanyl consumption during 48 hours
timeFrame: postoperative 48 hours
Secondary outcomes:
measure: Postoperative pain score
timeFrame: postoperative 24, 48 hours
measure: Patient satisfaction for postoperative pain management
timeFrame: postoperative 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jintae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05009472: Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients
Official title: Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Rapid Protocol and Face Mask Using CBCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: cleft palate patient
Rapid maxillary expansion RME
cone beam computed tomography CBCT
expansion
face mask
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2021-08-17
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: maxillary expansion in cleft palate patient with expander and using face mask.

Detailed description: patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible.

rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening).

with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .

Eligibility criteria: Inclusion Criteria:

* ● Patients of both sexes.

  * Cleft lip and palate patients.
  * All patient age range 8-12 years.
  * All the case showed maxillary arch constriction and deficiency.
  * All patients had maxillary permanent first molars.
  * Primary lip adhesion and palatal closure.

Exclusion Criteria:

* • Absent maxillary permanent first molars.

  * Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before.
  * Less than two dental unit beside maxillary first molar.
  * Uncooperative patients/parents.

Primary outcomes:
measure: Changes in 3 dimensions of skull before and after expansion
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine for Girls Al-Azhar University
state: Nasr City
city: Cairo
country: Egypt
facility: Taghreddd
Study officials:
affiliation: Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity
name: dr. mohsena ahmad, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04675372: Dexmedetomidine Facilitate Analgesia
Official title: Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Limb Fracture
Nerve Block
Keywords: Dexmedetomidine
nociceptive index
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 181
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: HEALTH_SERVICES_RESEARCH

Brief summary: Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.

Detailed description: Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.

Eligibility criteria: Inclusion Criteria:

* aged from 18 to 80 years old
* American Association of anesthesiologists (ASA) grade Ⅱ \~ IV
* body mass index (BMI) 18.5-40
* planning undergoing peripheral nerve block

Exclusion Criteria:

* incomplete effect of nerve block
* Alzheimer's disease
* implanted cardiac pacemakers
* mental illness
* epilepsy
* autonomic nervous system diseases
* projected the duration of the operation was more than 3 hours

Primary outcomes:
measure: nociceptive index
timeFrame: During operation
Secondary outcomes:
measure: hypoxemia
timeFrame: During operation
measure: systolic blood pressure
timeFrame: During operation
measure: heart rate
timeFrame: During operation
measure: diastolic blood pressure
timeFrame: During operation
measure: muscular activity
timeFrame: During operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: China International Neuroscience
state: Beijing
Study officials:
References:
Clinical trial NCT00992472: Bioavailability of Prochlorperazine Suppositories, 25 mg
Official title: Bioavailability of Prochlorperazine Suppositories, 25 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare prochlorperazine plasma concentrations produced after administration of the test formulation with those produced after administration of a marketed reference product.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Prochlorperazine or related drugs

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: PharmaKinetics Laboratories, Inc
state: Maryland
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Ferguson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070472: Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
Official title: Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction at Term
Keywords: labor induction at term using a titrated oral misoprostol solution
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.


Eligibility criteria: Inclusion Criteria:

1. term,
2. singleton
3. no contraindication to prostaglandins
4. vertex
5. no exposure to vaginal prostaglandins in the index pregnancy

Exclusion Criteria:

1. parity \> 3
2. severe PIH: BP\> 160/100, abnormal LFT's, proteinuria \>1g/day
3. previous uterine surgery
4. regular uterine contractions
5. maternal age \> 45
6. twins

Primary outcomes:
measure: Rate of vaginal delivery within 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Uterine hyperstimulation rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: debbie J Robinson, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638872: Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
Official title: Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Ulcer
Foot Ulcer Unhealed
Keywords: diabetes
foot ulcer
polydeoxyribonucleotide
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 215
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

Detailed description: This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 45-80yrs
* Minimum schooling 5yrs
* Type I or II diabetes since at least 5yrs with a stable metabolic control
* Foot ulcer since minimum 2 weeks
* Ulcer \>1cm and \<16cm at day 0
* Ulcer grade 1 or 2 wagner scale
* Wound free of necrotic debris
* TcPO2 \>29mmHg
* Not pregnant or lactant

Exclusion Criteria:

* Non-consenting patient
* History of alcohol or drug abuse
* Gangrene on any part of the affected foot
* Ongoing untreated infections
* Ulcer over a charcot deformity
* Use of a systemic cicatrizant drug in the past 10 days
* Malnutrition
* Neurological or psychiatric pathologies
* Liver or kidney insufficiency
* Corticosteroid or immunosuppressive or cytotoxic therapy
* Other severe pathologies
* Proven hypersensitivity to the drug or to any related component

Primary outcomes:
measure: reduction of ulcer rate
timeFrame: 3 months
Secondary outcomes:
measure: safety and tolerability of the compound
timeFrame: 6 months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: Mastelli srl, via Bussana Vecchia, Sanremo, Italy
name: Giulia Cattarini
role: STUDY_DIRECTOR
References:
Clinical trial NCT02947672: Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting
Official title: Effect of Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting Following Laparoscopic Gynecological Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries.


Eligibility criteria: Inclusion Criteria:

1. Adult Female patients
2. American society of anesthesiologist class I \& II
3. Undergoing Laparoscopic gynecological surgeries

Exclusion Criteria:

1. Patient refusal to participate in the study
2. Patients with coagulopathy or under anticoagulation therapy.
3. Infection near the site of needle insertion.
4. Body mass index \> 40kg/m2
5. Patients with any neurological or neuromuscular disorder or history of seizures.
6. Known allergy to any drug used in the study.

Primary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 24 hours
Secondary outcomes:
measure: Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT02217072: Educational Support Interventions for Children in Care
Official title: A Randomized Controlled Trial of Educational Support Interventions for Children in Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Learning Problems
Keywords: academic performance
cognitive development
children in care
prevention of school failure
Lead sponsor: VIVE - The Danish Center for Social Science Research
Sponsor class: OTHER
Collaborators: name: Ministry of Social Affairs
First posted: 2014-08-15
Enrollment: 190
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13).

Detailed description: A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13). One intervention is school-based and involves a team of professionals at the child's school, and the other is a home-based tutoring intervention provided by the foster parents. The participants in the study are assigned to three groups (the two intervention groups and control group). Based on power calculation we aim to recruit approximately 180-200 foster children, their foster parents and public schools to participate in the study.

Eligibility criteria: Inclusion Criteria:

* age 6-13
* fostercare placement
* placement in a participating municipality

Exclusion Criteria:

* persuasive developmental disorders
* special education students

Primary outcomes:
measure: Academic performance
timeFrame: 17 months after intervention start
Secondary outcomes:
measure: Cognitive functions
timeFrame: 17 months after intervention start
Other outcomes:
measure: well-being
timeFrame: 17 months after intervention start
Locations:
city: Copenhagen
country: Denmark
facility: SFI - The Danish National Centre for Social Research
Study officials:
affiliation: SFI - The Danish National Centre for Social Research
name: Misja Eiberg, Ph.d. fellow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03775772: Oral Health, Bite Force and Dementia
Official title: Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Oral Hygiene
Chewing Problem
Keywords: oral health
bite force
chewing efficiency
dementia
elderly
aged
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study aims: The primary aim is to identify influencing variables on oral hygiene / oral health and bite force in patients with dementia.


Eligibility criteria: Inclusion Criteria:

* \> 59 years
* no acute processes being present
* no known cranio-mandibular dysorder (CMD) or finding of any CMD during study participation
* non or Maximum of one dental hygiene treatment in the last 12 months

Exclusion Criteria:

* younger than 60 years
* acute processes in the oral-facial Region
* known CDM case
* more than one dental hygiene treatment in the last 12 months

Primary outcomes:
measure: Oral Health (dental examination)
timeFrame: 1 year
measure: Chewing function I (examination with force gauge meter)
timeFrame: 1 year
Secondary outcomes:
measure: Nutrition I (questionnaire/ assessment of nutritional state)
timeFrame: 1 year
measure: Nutrition II (examination for weight and body-size)
timeFrame: 1 year
measure: Chewing function II (two-coloured chewing gum to test efficacy)
timeFrame: 1 year
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Clinic of General, Special Care and Geriatric Dentistry
Study officials:
affiliation: University of Zurich
name: Julia Kunze, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jockusch J, Hahnel S, Nitschke I. Use of handgrip strength measurement as an alternative for assessing chewing function in people with dementia. BMC Geriatr. 2022 Sep 24;22(1):769. doi: 10.1186/s12877-022-03452-2.
citation: Jockusch J, Hopfenmuller W, Nitschke I. Influence of cognitive impairment and dementia on oral health and the utilization of dental services : Findings of the Oral Health, Bite force and Dementia Study (OrBiD). BMC Oral Health. 2021 Aug 14;21(1):399. doi: 10.1186/s12903-021-01753-3.