louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02845427: Closed Suction Drain or Not After Total Hip Arthroplasty
Official title: Closed Suction Drain or Not After Total Hip Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Closed Suction Drain
Wound Hematoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 100
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: Comparative randomised study to clarify which better to use or no use of closed suction drain system after total hip arthroplasty regarding amount of blood loss, need for blood transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early post-operative rehabilitation. Patients will be followed up for one month postoperative clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view plain x-ray of the hip).

Detailed description: Total Hip Arthroplasty (THA) wounds are prone to formation of hematomas. Hematomas may increase the incision tension, leading to wound discharge and providing a good medium for bacteria, increase post-operative pain, limitation of range of motion of hip joint and prolong post-operative rehabilitation duration, also may cause ecchymosis, and tension vesicles around the surgical wound.

So use of closed suction drain system may reduce these complications. Nevertheless some recent studies have claimed that drainage can cause other complications and does not reduce hematoma formation and risk for infection. Furthermore, some studies have shown that drainage increase blood loss after THA which may both lead to increase blood transfusion requirements and provide an entry point for skin microorganisms.

Some other studies have found that no significance between use and non use of suction drain after THA.

So the investigators will take this issue for study a comparison between benefits and hazards of use and non use of suction drain after THA.

Eligibility criteria: Inclusion Criteria:

* Primary total hip arthroplasty (THA)

Exclusion Criteria:

* Revision cases
* Uncontrolled bleeding tendency (prothrombin conc. Less than 70%)
* History of deep venous thrombosis
* Sever liver impairment (liver failure)
* Sever renal impairment (S. creatinine more than 3)

Primary outcomes:
measure: change in Hb level
timeFrame: preoperative and 24 hrs postoperative
Secondary outcomes:
measure: amount of blood loss
timeFrame: upto 24 hrs postoperative
measure: amount of blood transfusion
timeFrame: upto 24 hrs postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT03142373: Effect of CV4 and Rib Raising Techniques on Autonomic Balance
Official title: Variations of Heart Rate Variability and Skin Conductance Reveal the Influence of CV4 and Rib Raising Osteopathic Techniques on the Autonomic Nervous System: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Disease
Osteopathy
Keywords: heart rate variability
autonomic nervous system
osteopathic manipulative treatment
skin conductance
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Heart rate variability (HRV) and skin conductance (SC) highlight autonomic activity and the balance of autonomic nervous system (ANS) which regulates involuntary physiological functions. The modulation of ANS tonic activity is a target of osteopathic manipulative treatment (OMT). The main aim of the present study was to verify whether CV4 and RR osteopathic techniques influence ANS activity.

Trial design. A randomized-controlled clinical trial was performed from June 2010 to January 2011.

Methods. 32 healthy adults were selected. At enrollment, all healthy subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR technique), and Placebo group (PL technique). HRV and SC was recorded during the session respectively with heart rate monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All data analysis was performed using SPSS statistical software and the significance level set at p≤0.05.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* between 18-65 years old
* both gender

Exclusion Criteria:

* BMI ≥ 30
* pregnancy
* menstrual flow during the session
* chronic pain
* chronic drug treatment
* presence of skin, cardiovascular, psychiatric and neurological diseases
* medical history of surgical interventions
* OMT in the previous 3 months

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 1200 seconds
Secondary outcomes:
measure: Skin Conductance
timeFrame: 1200 seconds
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: Chiara Arienti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06164860: The Effect of Ketogenic Diet Versus Mediterranean Diet in Patients With Obesity and Psoriatic Arthritis
Official title: The Effect of Ketogenic Diet Versus Mediterranean Diet on Clinical and Biochemical Markers of Inflammationand in Patients With Obesity and Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Obesity and Psoriasis
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare the effectiveness of Mediterranean diet (MD) with the isocaloric Ketogenic diet (KD) on clinical and biochemical markers of inflammation in patients with obesity, psoriasis (PSO) and psoriatic arthritis (PsA).

Detailed description: Overall, twenty patients with body mass index (BMI) \>30 kg/m2, PSO and PsA under constant systematic treatment for at least 3 months will be included in the study. They will randomly assign to two groups, starting either with MD or KD for a period of 8 weeks. After a 6-week washout interval, the two groups will cross over to the other type of diet for the same 8-week period. The primary endpoint is the change in Psoriasis Area and Severity Index (PASI) and the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention. Secondary endpoints are changes in biochemical markers of inflammation (IL-6, IL-17, IL-22, IL-23) , in metabolic and anthropometric parameters.

Eligibility criteria: Inclusion Criteria:

1. age above 18 years
2. body mass index (BMI) \>30 kg/m2
3. diagnosis of psoriasis and psoriatic arthritis under constant systematic treatment with biologic agents and/or synthetic disease-modifying anti-rheumatic drugs (DMARDs) for at least 3 months.
4. ΔPASI SCORE\<75, with moderate or severe activity in joints ( \> 3 swollen \&\> 3 tender joints ή DAPSA\< 14).

Exclusion Criteria:

1. participation in another study
2. eGFR\<60ml/min/1.73m2
3. malignancy
4. severe hepatic disorder
5. HbA1C\>10%
6. use of glucagon-like-petide-1 analogues

Primary outcomes:
measure: PASI score
timeFrame: eight weeks
measure: DAPSA score
timeFrame: eight weeks
Secondary outcomes:
measure: Interleukins
timeFrame: eight weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Vaia Lambadiari
state: Attiki
Study officials:
References:
Clinical trial NCT03992560: A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Official title: A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2019-06-20
Enrollment: 218
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: The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.

The primary endpoint will be assessed by calculating the difference in the proportion of responders (\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant).


Eligibility criteria: Inclusion Criteria:

* \>18yrs of age
* Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1
* Stable on optimal medical therapy for at least 3 months
* Ischaemic aetiology
* Patients with atrial fibrillation can be included

Exclusion Criteria:

* Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant
* Requirement for endocardial pacing
* Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning
* Significant claustrophobia
* Significant renal impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
* Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
* Participation in other studies with active treatment/ investigational arm
* Pregnant or planning to become pregnant in the next 7 months

Primary outcomes:
measure: >15% reduction in end systolic volume
timeFrame: 6 months
Secondary outcomes:
measure: 5% absolute increase in left ventricular ejection fraction
timeFrame: 6 months
measure: >10% reduction in end diastolic volume
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
Study officials:
References:
Clinical trial NCT06450860: Developing a Nutrition Support Assessment Tool
Official title: Developing and Testing a Nutrition Support Assessment Tool - An Implementation Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nutrition Assessment
Food Insecurity
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: The MANNA Institute
First posted: 2024-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The research team developed the Nutrition Support Assessment Tool (NSAT) that incorporates key patient life information (e.g., ability to cook, access to refrigerator/stove, medical conditions and nutritional status) to facilitate individualized nutrition referral. The overall goal of this study is to refine and test the NSAT as a systematic approach to provide individualized nutrition needs screening and referral for patients being discharged from the acute care setting at Jefferson Health. The investigators hypothesize the NSAT will be successful in identifying individualized nutrition referrals that are deemed acceptable and appropriate by enrolled participants.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Currently admitted to Thomas Jefferson University or Methodist Hospital or Emergency Department
* Has working phone number and is willing to participate in follow-up data collection
* Eats by mouth
* Lives in MANNA's geographic service area
* Patient reports food insecurity or malnutrition using existing screening tools

Exclusion Criteria:

* Unwilling to provide consent
* Unsheltered/unhoused
* Lives in or is being discharged to facility that provides daily meals (e.g., long term care, incarcerated)
* On hospice or has life expectancy of less than 4 months, per clinician
* Not consentable
* Deaf or has other major communication barriers that compromises ability to participate in study activities

Primary outcomes:
measure: Reach of Nutrition Interventions
timeFrame: Baseline
Secondary outcomes:
measure: Uptake of Nutrition Interventions
timeFrame: Week 1 & Week 4
measure: Acceptability of Nutrition Intervention
timeFrame: Week 1 & Week 4
measure: Appropriateness of Nutrition Intervention
timeFrame: Week 1 & Week 4
measure: Satisfaction with Nutrition Intervention
timeFrame: Week 4
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05334160: Pain and Abdominal Breathing Exercises
Official title: Evaluation of the Postoperative Effects of Preoperative Abdominal Breathing Exercises in Laparoscopic Cholecystectomy Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Breathing
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gallbladder surgerysurgery patients who will be operated under general anesthesia.

Brief summary: Postoperative evaluation of patients who did and did not do preoperative abdominal breathing exercises.

Detailed description: The respiratory type and pattern of all patients will be recorded before gallbladder surgery.

In Group P, abdominal breathing training will be given to the patients in this group. They will perform abdominal breathing for at least 5 minutes 6 times a day until surgery.

In Group C,patients who are not given abdominal breathing.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, NRS scores of the patients will be evaluated (in the recovery room, 1,2,6,12 and 24 hours.

Preoperative anxiety, postoperative discharge time and analgesic consumption of all patients will be recorded.

Eligibility criteria: Inclusion Criteria:

* Planned to gall bladder surgery
* An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria:

* Severe cardiovascular disease
* Respiratory disease
* Psychiatric disease
* Those who have chronic pain

Primary outcomes:
measure: Opioid consumption
timeFrame: During postoperative up to 24 hours
measure: NRS
timeFrame: During postoperative up to 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Hakan Tapar
Study officials:
References:
Clinical trial NCT06102460: Pre-sleep Macros on Sleep Quality and Recovery
Official title: The Effect of Pre-sleep Milk-derived Protein to Support Sleep Quality and Recovery in Elite Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Milk Specialties Global
First posted: 2023-10-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete all 4 interventions with at least a 1 week wash out period in between.
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to assess the effect of eating before bed (2 hours after dinner, 30mins before bed) and the effects this has on sleep and recovery measures in elite female athletes.

Participants will be randomized to 4 possible groups in a double-blind randomized cross over design. Each group will ingest 40 grams of one of the following nutrients as a liquid shake for 3 consecutive nights:

1. Casein Protein
2. a-lactalbumin Protein
3. Carbohydrate
4. Placebo

There will be at least 1 week washout period between each intervention.

Sleep and recovery outcome measures will be obtained through a WHOOP 4.0 wearable healthy tracking device. Subjective sleep and recovery will be obtained through subjective questionnaires. Food will be logged by participants on intervention days. Blood glucose will be measured using continuous glucose monitors.


Eligibility criteria: Inclusion Criteria:

* NCAA Division I female athlete
* Wearing WHOOP 4.0 device for \>3 months

Exclusion Criteria:

* Musculoskeletal injuries limiting participation in regular team practice.
* Cardiometabolic diseases limiting participation in regular team practice.
* Pre-diagnosed sleep condition that would negatively affect sleep quality or quantity (sleep apnea, restless leg syndrome, night-feeding syndrome)
* Allergy to any dietary supplement used in protocol - e.g., lactose intolerant.
* Use of sleep aids such as but not limited to, melatonin.

Primary outcomes:
measure: Sleep
timeFrame: Data obtained from device 12 hours after ingestion of supplement
measure: Recovery
timeFrame: Data obtained from device 12 hours after ingestion of supplement
Secondary outcomes:
measure: Subjective sleep score
timeFrame: Data obtained 1-2 hours after after subject awakes
measure: Subjective recovery score
timeFrame: Data obtained 1-2 hours after after subject awakes
measure: Blood glucose control
timeFrame: Continuous (24hours/day) during intervention days/nights
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Institute of Sports Sciences and Medicine - Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT02502760: Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Postoperative Complications
Perioperative Care
Colorectal Surgery
Frail Elderly
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Sir Mortimer B. Davis - Jewish General Hospital
First posted: 2015-07-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer patient undergoing resection
* Frail or intermediately frail patients (Fried score 2 and above)

Exclusion Criteria:

* Unable to communicate in French or English
* Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)

Primary outcomes:
measure: Post operative complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: 6 Minutes Walk Test Distance
timeFrame: 4 weeks after discharge
measure: Hospital Length of Stay
timeFrame: 3-6 days
measure: Readmission rates
timeFrame: 30 days after discharge
measure: Anxiety and Depression
timeFrame: 30 days after discharge
measure: Health Related Quality of Life
timeFrame: 30 days after discharge
Other outcomes:
measure: Cost Effectiveness of treatment
timeFrame: 30 days after hospital discharge
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center; Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
Study officials:
affiliation: Professor, Department of Anesthesia
name: Franco Carli, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
citation: Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.
Clinical trial NCT00784160: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).


Eligibility criteria: Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin I,II, III e IV;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation;
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study;

Primary outcomes:
measure: The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References: