louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02363608: Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit
Official title: Caring Canines: Outcomes From an Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Care
Keywords: Canine-Assisted
15-010
post surgery patients
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Staff and inpatients on the 15th floor.

Brief summary: The purpose of this study is to describe the effects of canine-assisted activity visits on patients and staff in a hospital setting. The Caring Canines program uses dogs who have been trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the dog's handler) and the volunteer's dog that has been trained and tested to have a good personality and to follow commands. A visit typically lasts about 10-15 minutes with the patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan Kettering currently has Caring Canine dogs visit patients but the investigators don't yet know the impact of these visits on patients and staff. The investigators would like to see how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of well-being. Two groups of patients will take part in this study - the first group will receive standard post surgery care and will not receive a visit from the Caring Canines program and the second group will receive daily visits (Tuesday -Friday) from the Caring Canines program while they are on M15. The purpose of this study is to look at differences in well-being between patients who have the visits with the dogs and patients who do not.


Eligibility criteria: Inclusion Criteria:

Patients

* Age greater than 21
* Admitted to M15 following a Monday or Tuesday surgery
* Ability to speak and read English.

Staff

* Age greater than 21
* Works at least one day shift a week on M15
* Ability to speak and read English

Exclusion Criteria:

Patients

* Self reported allergy to dogs
* Medical need to be in an isolation room
* Medical need to be in a Protective Environment room .

Staff

* Self reported allergy to dogs

Primary outcomes:
measure: change from baseline in the follow-up PHQ-4 scores
timeFrame: 1 year
measure: difference in baseline and follow-up ProQOL scores (For Staff)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Pamela Ginex, EdD, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02049723: Assessment of GERD Knowledge Level Among Patients With it in Korea
Official title: How Much do Patients With Gastroesophageal Disease Know About Their Own Disease in Korea?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophagitis, Reflux
Keywords: Gastroesophageal reflux disease
Knowledge
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with GERD who visit the secondary or tertiary University hospital for their treatment

Brief summary: * 1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey)
* 2. Questionnaires for multicenter survey:

  1. Questionnaire 1 - include items for basic characteristics of participant patients
  2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health Services Research 2008;8:236 (Prof. Jorgen Urnes)
* 3. Subjects: patients with GERD in secondary or tertiary hospital
* 4. Participant institutes: GERD club members, The Korean Society of Neurogastroenterology and Motility

Detailed description: Validation process to produce Korean version of GERD knowledge test

1. Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company
2. Expert's review of the forward translated knowledge test : among members of GERD club,
3. Pilot survey among nurses and some patients
4. Korean Version, provisional
5. Backward translation: through certified translation company
6. Consultation with Prof. Jorgen Urnes about backward translated knowledge test
7. Korean Version, final
8. Print and distribution
9. Study start

Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as GERD by doctors

Exclusion Criteria:

* Patients without GERD

Primary outcomes:
measure: Proportion (%) of patients with GERD who seek more information on GERD which represents the necessity of effective educational programs on the disease in Korea
timeFrame: 1 year
Secondary outcomes:
measure: Average score in GERD knowledge test which means GERD knowledge level of the patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Yeon-Soo Kim
state: Gangwon
Study officials:
affiliation: Professor, Department of Internal Medicine, Kosin University Gospel Hsopital
name: Moo In Park, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02311023: Intermittent Fasting in Refractory Epilepsy
Official title: A Single Centre Open Six Months Study of Intermittent Fasting for the Treatment of People With Refractory Epilepsy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open trial of intermittent fasting in a group of patients with refractory seizures. Patients will continue on the diet for 6 months to assess the impact of the diet on seizure frequency.

Detailed description: A proportion of people with epilepsy continue to have seizures despite all conventional treatment options. The classical ketogenic diet and its variants have been shown to help some of these people. However, these diets require significant medical and dietician supervision,and is frequently not well tolerated. There is a need to develop other diet therapy that is easier to administer and more acceptable to the patient. This trial undertaken in adult overweight UCLH outpatients examines the effect of an intermittent fasting diet on seizures. Subjects may consume their normal diet for 5 days a week. On 2 days in a week, they consume only 25% of their daily calorie requirement. Subjects will continue on the diet for 6 months. Intermittent fasting has been shown in animal studies to activate a number of signalling pathways which are thought to reduce seizure thresholds. Has intermittent fasting in humans might be expected to reduce seizures.

Eligibility criteria: Inclusion Criteria:

* Experiencing at least 2 seizures per month
* .BMI of 25 or over

Exclusion Criteria:

* Current/previous eating disorder
* Pregnancy

Primary outcomes:
measure: Daily total number of seizures
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chalfont St Peters
country: United Kingdom
facility: UCLH , The Epilepsy Society
state: Buckinghamshire
Study officials:
References:
Clinical trial NCT01446523: S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
Official title: Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Keywords: endotoxins HE
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2011-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal hepatic encephalopathy.

Detailed description: 60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion \& exclusion criteria will be the part of study. Study patients will be divided in to two groups ( n=30 in each group).

Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3 months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )

Exclusion Criteria:

* Recent history of gastrointestinal bleed in last 6 weeks
* Active ongoing infection
* Creatinine \>1.5mg%
* Electrolyte impairment. (S. Sodium \< 130 meq/L, S. Potassium 3.5 meq/L or \>5.0meq/L)
* H/O use of psychotropic drugs in last 6 weeks
* Recent alcohol use (\< 6 week )
* H/O TIPS or shunt surgery.
* Hepatocellular Carcinoma
* Severe comorbidity as Congestive Heart Failure, Pulmonary disease, Neurological and Psychiatric problems impairing quality of life
* Poor vision precluding neuropsychological assessment

Primary outcomes:
measure: Improvement of minimal hepatic encephalopathy
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
measure: correlation between inflammatory mediators and grades of encephalopathy
timeFrame: Baseline and at 12 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: BC Sharma
state: Delhi
Study officials:
affiliation: GB Pant Hospital
name: Barjesh c Sharma, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jain L, Sharma BC, Srivastava S, Puri SK, Sharma P, Sarin S. Serum endotoxin, inflammatory mediators, and magnetic resonance spectroscopy before and after treatment in patients with minimal hepatic encephalopathy. J Gastroenterol Hepatol. 2013 Jul;28(7):1187-93. doi: 10.1111/jgh.12160.
Clinical trial NCT05271123: Pulmonary Functions in Relation to Gross Motor Function Level
Official title: Pulmonary Functions in Relation to Gross Motor Function Level in The Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Children with cerebral palsy
* age was from 3 to 11years old
* They were able to sit independently and to follow instructions
* Children who can blow air independently.

Brief summary: Aim: To investigate the relation between forced expiratory volume at first second and peak expiratory flow with gross motor function level in the children with cerebral palsy.

Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old.

Detailed description: Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old. Children were evaluated using spirometer to assess forced expiratory volume at first second and peak expiratory flow and gross motor function classification system to assess the functional level.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy
* age was from 3 to 11years old
* They were able to sit independently and to follow instructions.
* Children who can blow air independently.

Exclusion Criteria:

* Uncontrolled convulsions
* Any psychiatric disorders

Primary outcomes:
measure: FEV1
timeFrame: baseline ( enrolment)
measure: PEF
timeFrame: baseline ( enrolment)
measure: GMFCs
timeFrame: baseline ( enrolment)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
affiliation: Cairo University
name: Mai Abbass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03348423: Evaluation of DEX-IN During Outpatient Procedures
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Peri-procedural pain
Pain
Anxiety
Analgesia
Anxiolysis
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 45
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: The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.


Eligibility criteria: Inclusion Criteria:

* Voluntarily provide written informed consent
* Be planned to undergo a selected office-based or outpatient procedure
* Be naïve to the planned procedure, i.e. no repeated or revision procedures
* Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.

Exclusion Criteria:

* Known allergy to any study treatment or excipient
* Have another painful physical condition or anxiety related diagnosis that may confound study assessments
* Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
* Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery

Primary outcomes:
measure: Evaluation of Pain Intensity - Mean Pain Score During Procedure
timeFrame: Up to 4 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Research Center
state: California
Study officials:
References:
Clinical trial NCT05115123: Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy
Official title: Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: National Hepatology & Tropical Medicine Research Institute
First posted: 2021-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies on the impact of perioperative duloxetine for treatment of acute postoperative pain have yielded positive outcomes with respect to reduction opioid consumption. The aim of the present study is to investigate the role of perioperative duloxetine on the management of postoperative pain in patients undergoing LC.


Eligibility criteria: Inclusion Criteria:

* 1. Patients who are scheduled to undergo elective LC

Exclusion Criteria:

1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

Primary outcomes:
measure: Change in postoperative pain between the two groups using visual analogue score (VAS)
timeFrame: 24 Hours postoperative
Secondary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 24 Hours postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
citation: Mansour NO, Boraii S, Elnaem MH, Elrggal ME, Omar T, Abdelraouf A, Abdelaziz DH. Evaluation of preoperative duloxetine use for postoperative analgesia following laparoscopic cholecystectomy: A randomized controlled trial. Front Pharmacol. 2022 Sep 29;13:944392. doi: 10.3389/fphar.2022.944392. eCollection 2022.
Clinical trial NCT00150423: To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Official title: An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 384
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: To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy
* Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

* Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.

Primary outcomes:
measure: Safety Efficacy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05094323: Analgesia After Video-Assisted Thoracic Surgery
Official title: Analgesic Efficacy of Ultrasound-Guided Deep Serratus Anterior Plane Block, Local Wound Infiltration, and Thoracic Paravertebral Block After Uniportal Video-Assisted Thoracic Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post Operative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Detailed description: Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Adequate postoperative pain relief is imperative to hasten functional recovery, accelerate discharge from the hospital, and reduce chronic postsurgical pain.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for uniportal VATS under general anesthesia, ASA status I-III, aged from 18 to 70 years old of both sex.

Exclusion Criteria:

* Contraindications to regional block
* Pregnancy
* Body mass index (BMI) \> 30 Kg/m2
* Psychiatric diseases
* Severe renal, liver, or cardiac dysfunction

Primary outcomes:
measure: Time to first analgesic requirement
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain intensity
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Seham M. Moeen
Study officials:
affiliation: Assiut University
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00838838: Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
Official title: Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Paraplegia
Bone Density
Osteoporosis
Keywords: Testosterone replacement therapy
Hypogonadism
Osteoporosis
Immobilisation
Paraplegia
Testosterone
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients \> 18yrs in medical practices fulfilling all criteria for documentation.

Brief summary: Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).


Eligibility criteria: Inclusion Criteria:

* Male patients \> 18yrs
* Osteoporosis prophylaxis/therapy with

  * vitamin D 800 - 1200 mg per day,
  * calcium 800 - 1000 mg per day,
  * Fosamax 70 once a week.
* Standardised physiotherapy exercise programme.
* No proliferative bone disease.
* No history of calcium oxalate stones.
* No use of aromatase inhibitors.
* No use of 5-alpha reductase inhibitors.

Nebido group:

* No contraindications to use of Nebido (known prostate or breast carcinoma or suspicion thereof, no past or present history of liver tumours);
* No known hypersensitivity to testosterone or excipients of Nebido

Exclusion Criteria:

* Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours, hypersensitivity towards the active pharmaceutical ingredient or other ingredients.

Primary outcomes:
measure: Bone mineral density (CT lumbar spine)
timeFrame: 12 weeks after 4th injection
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: