louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00974415: Study of the Carbon Dioxide Treatment for Fat Reduction
Official title: A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight
Keywords: BMI classification-overweight
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.


Eligibility criteria: Inclusion criteria:

* Male or female subject ages ≥ 18 years old
* Body mass index (BMI) between 18.5-24.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).

Subject in good health

* Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
* Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion criteria:

* Pregnant or lactating or intends to become pregnant in the next 9 months.
* Unable to understand the protocol or to give informed consent
* Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
* Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months.
* History of asthma or chronic obstructive pulmonary diseases
* Active skin disease or skin infection in the treatment area
* Bleeding tendency or coagulopathy
* Subject who are allergic to lidocaine
* Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject

Primary outcomes:
measure: Reduction of flank circumference
timeFrame: 6 months
Secondary outcomes:
measure: 10-point pain visual analog scale
timeFrame: 4 weeks
measure: Any adverse events
timeFrame: 6 months
measure: Patient satisfaction, determined by using patient satisfaction questionnaires.
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082115: Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
Official title: Functional Outcome of Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Unilateral Cerebral Palsy
Keywords: Mirror Therapy
Task Oriented Training
Hand Function
Unilateral Cerebral Palsy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Selected Physical Therapy Program, Mirror Therapy, Task Oriented Training
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy.

Detailed description: Dysfunction in the upper limbs and hand function is one of the most common symptoms in children with cerebral palsy (CP), particularly children with unilateral CP which intern has the potential to limit the involvement of these children in life activities and cause distress and suffering for both children and their parents. Different rehabilitation intervention procedures addressing upper extremity dysfunction are essential to promote better use of disabled arms and hands in daily activities and achieving functional independence at home, in school and in the community. However, there is little evidence directed toward which intervention procedure is more effective on hand function therefore, there is need to compare between the functional outcome of mirror therapy versus task-oriented training on hand function in children with unilateral cerebral palsy.

Eligibility criteria: Inclusion Criteria:

1. Children ages will be ranged from 5 to 8 years old.
2. Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale.
3. Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System).
4. Ability to sit alone.
5. Sufficient cognition to follow simple verbal instructions.

Exclusion Criteria:

1. Fixed contracture or deformities in the upper limb.
2. Visual or auditory defects.
3. Botulinuim toxin injection in the last 6 months before the study.
4. Previous surgical intervention in the upper limb.

Primary outcomes:
measure: Grip Strength
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Range of Motion
timeFrame: Up to 12 weeks
measure: Upper Extremity Skills
timeFrame: Up to 12 weeks
measure: Hand Dexetrity
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01312415: The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
Official title: A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Knee Replacement
Keywords: total knee arthroplasty
total knee replacement
local infiltration analgesia
intra-articular local anaesthesia
patients undergoing total knee arthroplasty (total knee replacement)
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.

We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for unilateral total knee replacement
* Consent to spinal anaesthesia
* ASA Grade I to III

Exclusion Criteria:

* Patient refusal
* Mini-Mental Score \< 25 (see appendix 3)
* Allergy to bupivacaine, morphine, paracetamol, diclofenac
* Skin lesions/infection at site of injection
* Uncorrected renal dysfunction
* Coagulation disorders
* chronic pain condition other than knee pain

Primary outcomes:
measure: Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Opioid consumption in total in the first 48 hours postoperatively
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: St Mary Orthopedic Hospital
Study officials:
affiliation: Cork University Hospital
name: Denise M McCarthy, MB FCARSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCarthy D, McNamara J, Galbraith J, Loughnane F, Shorten G, Iohom G. A comparison of the analgesic efficacy of local infiltration analgesia vs. intrathecal morphine after total knee replacement: A randomised controlled trial. Eur J Anaesthesiol. 2019 Apr;36(4):264-271. doi: 10.1097/EJA.0000000000000943.
Clinical trial NCT04380415: Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
Official title: Fitbit Atrial Fibrillation From PPG Data Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Fitbit LLC
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 450000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.


Eligibility criteria: Inclusion Criteria:

* Adults 22 years of age or older
* Capable of giving informed consent
* U.S. resident
* No prior history of atrial fibrillation or atrial flutter
* Fitbit account, with one of the following devices paired:
* Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware.

Exclusion Criteria:

* Diagnosis or history of Atrial Fibrillation at time of consent
* Diagnosis or history of Atrial Flutter at time of consent
* Current use of anticoagulation medication
* Cardiac pacemaker or implantable cardioverter-defibrillator

Primary outcomes:
measure: Simultaneous measurement of AF ≥ 30 seconds with detection
timeFrame: 7 days
Secondary outcomes:
measure: Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms
timeFrame: 7 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: PlushCare
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Lubitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23.
Clinical trial NCT01948115: Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)
Official title: Prospective Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV) in Singleton Pregnancy in Breech Presentation at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breech Presentation in Pregnancy
Keywords: Breech presentation
equimolar mixture of oxygen and nitrous oxide
external cephalic version
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 150
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 variety of breech presentation at term is about 3-4% of all births. Our study aims to assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some patients algic or relaxed, the success rate seems more important.

It's a single blind prospective randomized controlled study, comparing success rate of ECV after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).

We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary outcome.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* pregnancy at term (≥36 weeks)
* singleton foetus in breech or transverse presentation
* acceptance of ECV
* signature of informed consent

Exclusion Criteria:

* contraindications of ECV: placenta praevia, obstacle praevia, multiple pregnancy, foetal death, foetal heart rhythm disorder, lack of amniotic fluid, HIV-positive patient
* contraindications of equimolar mixture of oxygen and nitrous oxide : patient who require pure oxygen ventilation, disorders of consciousness that impede the cooperation of the patient, pneumothorax, pulmonary embolism, ocular surgery

Primary outcomes:
measure: Number of women with success after ECV
timeFrame: 20 minutes
Secondary outcomes:
measure: Pain during ECV
timeFrame: 20 minutes
measure: Frequency of nausea/vomiting
timeFrame: 1 hour
measure: Number of interrupted procedures
timeFrame: 20 minutes
measure: Number of cephalic presentation at birth
timeFrame: 2 month
measure: Number of cesarean at birth
timeFrame: 2 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Julie ESBELIN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dochez V, Esbelin J, Misbert E, Arthuis C, Drouard A, Badon V, Fenet O, Thubert T, Winer N. Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial. Acta Obstet Gynecol Scand. 2020 Mar;99(3):391-398. doi: 10.1111/aogs.13753. Epub 2019 Nov 18.
Clinical trial NCT01820715: A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain
Official title: A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Neuropathy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* 20≤ Age ≤ 70
* Diagnosed with Type I or Type II diabetes
* HbA1c ≤ 11%
* Patients with diabetic neuropathic pain for at least 3 months
* Patients corresponding to average pain level of 4 points or mor for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

* Neuropathic pain due to other causes
* Another stronger pain other than neuropathic pain
* Abnormality in blood pressure, weight
* Positive reaction in HIV, HBV or HCV
* A medical history of mental illness within 6 months
* The grade of BDI(Beck Depression Inventory) exceeds 21 points
* History of drug/alcohol abuse

Primary outcomes:
measure: Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test
timeFrame: 12 Weeks
measure: Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event
timeFrame: 12 weeks
Secondary outcomes:
measure: Average pain score
timeFrame: 12 Weeks
measure: Most severe pain score
timeFrame: 12 weeks
measure: overnight pain score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
affiliation: Hanyang University
name: Yoo Heon Ahn, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
name: Bong Yeon Cha, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Kyung Soo Ko, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Tae Sun Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Young Soo Park, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Christian Hospital
name: Choon Hee Chung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: In Joo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03474315: Interactive Patient's Assistant - LUCY
Official title: Interactive Patient's Assistant to Optimize Long-term Care in Patients With Chronic Health Failure and Determine Which Parameters of CIED Indicate the Requirement for Ambulatory Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Keywords: Cardiac implantable electronic device
Cardiac resynchronization therapy
Implantable cardioverter-defibrillator
Machine learning
Mobile application
Patient's assistance
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be consisted of one patient group: 600 CHF patients with implanted ICD or CRT admitted to regulatory ambulatory visit.

Brief summary: Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient.

Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.


Eligibility criteria: Inclusion Criteria:

* 18-90 years old
* Chronic heart failure (NYHA class I to III)
* Implanted ICD or CRT (at least 30 days before inclusion)

Primary outcomes:
measure: Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.
timeFrame: 1 day
Secondary outcomes:
measure: Ambulatory visit qualified as meaningful due to alarming condition related to ICD.
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Medical Informatics and Telemedicine
state: Mazowieckie
Study officials:
References:
Clinical trial NCT03227315: Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?
Official title: Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Distress Tolerance
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Patients that will happen sleeve gastrectomy

Brief summary: Preoperative anxiety level of patients affects postoperative analgesic consumption. However, there were no studies that showed a relationship between the level of stress tolerance and analgesic consumption in the literature. In this study, investigators wanted to investigate the effect of stress tolerance on analgesic consumption of patient.

Detailed description: After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire, Distress Tolerance Scale and Beck anxiety scale.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 2,6,12 and 24 hours). and patients with VAS\> 3 will receive 2 mg of morphine.The relationship between total analgesic consumption and the stress tolerance will be evaluated.The study will be performed with 69 sleeve gastrectomy patients(BMI\>30).

Eligibility criteria: Inclusion Criteria:

* Between 18 and 60 years
* Planned to sleeve gastrectomy
* An American Society of Anesthesiologists score of 1 or 2 BMI\>30

Exclusion Criteria:

* Psychiatric diseases
* Rejected to participation

Primary outcomes:
measure: The effect of patient anxiety tolerance on analgesic consumption
timeFrame: one time in four months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
city: Tokat
country: Turkey
facility: Hakan Tapar
Study officials:
affiliation: Gaziosmanpasa university
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References: