louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03048539: Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery
Official title: Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Transoral Endoscopic Thyroidectomy
Conventional Thyroidectomy
Keywords: Endoscopic surgery
Thyroidectomy
Quality of life
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who underwent thyroid lobectomy

Brief summary: The purpose of this study is to determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also.

Detailed description: Regarding type of surgery, doctor will just advice about risk and benefit of any type of surgery. And then patient will select by himself. Patients are not assigned to endoscopic or conventional group.

This study start to enrolled patients after surgery. And the quality of life will be observed at 2, 6 and 12 weeks, respectively.

Eligibility criteria: Inclusion Criteria:

* Patient who underwent thyroid lobectomy for benign thyroid nodule less or equal 5 cm

Exclusion Criteria:

* previous neck surgery
* suspected thyroid carcinoma
* patient who failure endoscopic thyroidectomy and change to conventional surgery

Primary outcomes:
measure: Change in quality of life after surgery
timeFrame: 2,6,12 weeks
Secondary outcomes:
measure: Postoperative complication
timeFrame: 2,6, and 12 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Pornthep Kasemsiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
citation: Kasemsiri P, Trakulkajornsak S, Bamroong P, Mahawerawat K, Piromchai P, Ratanaanekchai T. Comparison of quality of life between patients undergoing trans-oral endoscopic thyroid surgery and conventional open surgery. BMC Surg. 2020 Jan 29;20(1):18. doi: 10.1186/s12893-020-0685-3.
Clinical trial NCT04592939: Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
Official title: Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Hip Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated


Eligibility criteria: Inclusion Criteria:

* femoral revision patients with the use of a modern titanium, fluted, tapered stem.

Exclusion Criteria:

* include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing

Primary outcomes:
measure: Return to function
timeFrame: 1 year
measure: Postoperative Complications
timeFrame: 1 year
measure: Implant survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01970839: Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study
Official title: Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Nerve Conduction
Oxyneurogram Index
Keywords: Tourniquet
Endoneural
Ischemia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There are a number of risk factors for development of chronic pain that have been evaluated including age, gender, type and duration of surgery, duration of pain prior to surgery and tourniquet application. There is some scientific evidence from animal studies demonstrating that prolonged tourniquet application can result in lack of oxygen supply to nerves, and subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans. In this study the investigators will indirectly assess the evidence for abnormalities caused by tourniquet application on subjects' nerves using well established devices to determine the function of these nerves.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Over 18 years of age

Exclusion Criteria:

* Neurological disease
* Diabetes mellitus
* History of nerve injury
* Chronic pain
* Alcoholism
* Blood pressure measurements greater than 140/80 and infection in the monitored area

Primary outcomes:
measure: Changes in sensory nerve conduction
timeFrame: baseline, 5 minutes
measure: Changes in oxyneurogram index
timeFrame: baseline, 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Srini Pyati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184639: Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes
Official title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 71
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe.

A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Current intensified insulin treatment
* Injection of insulin Semilente®MC at bedtime for at least 6 weeks
* BMI maximum 32 kg/m\^2
* HbA1c \> 5.5 % and \< 12.0 %

Exclusion Criteria:

* Current treatment with premixed insulin(s)
* Impaired hepatic or renal function
* Recurrent major hypoglycaemia

Primary outcomes:
measure: Fasting plasma glucose
timeFrame: after 16 and 32 weeks, respectively
Secondary outcomes:
measure: Adverse events
measure: HbA1c results at the end of each treatment period
measure: Blood glucose
measure: Standard Laboratory Safety Parameters
measure: Hypoglycaemia
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06851039: Effects of the Short-Chain Fatty Acids-Targeted Dietary Interventions on the Selected Autonomic Functions in Humans
Official title: Effects of the Resistant Starch and Sodium Butyrate Supplementation on the Respiratory and Cardiovascular Autonomic Control in Humans
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Keywords: resistant starch
short-chain fatty acids
gut microbiota
peripheral chemoreflex
arterial baroreflex
autonomic nervous system
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Recent data feature short-chain fatty acids (SCFAs), products of gut microbial fermentation, as modulators of the blood pressure of the host. Such modulation may evoke (or arise from) changes in the autonomic reflexive mechanisms, but the link remains unexplored. Therefore, the study aims to explore potential relationship between the dietary intervention-induced changes in the SCFA plasma/fecal content and alterations in the sensitivity of the cardio-respiratory autonomic reflexes.

In this cross-over, placebo-controlled study, a group of healthy volunteers will undergo three distinct stages of a four-week dietary intervention, separated by at least two weeks of washout periods. During each stage, participants will receive one of the following interventions:

* raw potato starch (a source of resistant type 2 starch, which is a substrate for the endogenous production of SCFAs)
* sodium butyrate (a direct, exogenous source of this SCFA)
* an amylase-accessible waxy maze starch (a placebo). Plasma and fecal SCFA concentrations will be measured, along with the comprehensive evaluation of the cardio-respiratory parameters and the sensitivity of the autonomic reflexive mechanisms.


Eligibility criteria: Inclusion Criteria:

* age 18-40 years

Exclusion Criteria:

* chronic disease of the nervous, cardiovascular or respiratory system
* disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
* blood pressure-lowering treatment within the past year
* tobacco smoking within the past year
* antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment

Primary outcomes:
measure: Arterial baroreflex sensitivity
timeFrame: From the beginning to the end of a supplementation period at 4 weeks.
measure: Peripheral chemoreflex sensitivity
timeFrame: From the beginning to the end of a supplementation period at 4 weeks.
Secondary outcomes:
measure: Plasma short-chain fatty acids
timeFrame: From the beginning to the end of a supplementation period at 4 weeks.
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
state: Lower Silesia
Study officials:
References:
Clinical trial NCT01675739: Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy
Official title: Effectiveness of Fixed Preparation-to-Colonoscopy Interval Using Short Message Service (SMS) for Afternoon Colonoscopy: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness of SMS to Fix PC Interval
Keywords: colonoscopy
bowel preparation
short message service
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.

Detailed description: Bowel preparation quality for colonoscopy is influenced by several factors and preparation-to-colonoscopy (PC) interval is one of the important factors. The bowel preparation with split-dose PEG (polyethylene glycol) is an obviously uncomfortable process, it is usually difficult to ingest PEG in time. Therefore, the investigators conducted a prospective randomized control study to evaluate the effectiveness of fixed PC interval for satisfactory bowel preparation in the afternoon colonoscopy using mobile phone short message service (SMS), which reported that it could increase patient's compliance in other practical era

Eligibility criteria: Inclusion Criteria:

* 18 and 80 years who were scheduled for afternoon colonoscopy (screening or surveillance)

Exclusion Criteria:

* unavailable mobile phone nor SMS
* age younger than 18 years
* pregnancy
* breastfeeding
* history of large-bowel resection
* renal failure (serum creatinine ≥ 3.0 mg/dL \[normal 0.8-1.4\])
* drug addiction or major psychiatric illness
* allergy to PEG
* refusal to participate in the study.

Primary outcomes:
measure: the Ottawa bowel preparation scale
timeFrame: at the end of time of the colonoscopic examination (about 30 minutes-1hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
Study officials:
affiliation: Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
name: Tae Oh Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060239: Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS
Official title: Exploration of the Mechanism of Movement Improvement During Rapid Eye Movement (REM) Sleep Behaviour Disorder (RBD) in Parkinson's Disease Using Near-infrared Spectroscopy (NIRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Near infrared Spectroscopy
REM sleep behaviour disorder
Supplementary motor area
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
Collaborators: name: Université Montpellier
First posted: 2017-02-23
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's disease and to explore the neuronal network involved in this improvement using NIRS.

Detailed description: The aim of this study is to compare the quality of movement during REM sleep during RBD episodes and movement awake without and with dopaminergic treatment while measuring cortical activity using NIRS.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's Disease (Hughes AJ et al., 2001)
* Patients with REM sleep behaviour sleep disorder according to the ICSD2 (International Classification of Sleep Disorders 2) criteria and frequent reported several times per week by the spouse
* Informed written consent signed
* Patient aged 40 to 90 years
* Affiliate or benefiting from a social security scheme.

Exclusion Criteria:

* Atypical Parkinson's Syndromes
* Patient not accepting polysomnography

  * Contraindications to cerebral Magnetic Resonnance Imaging (MRI): pacemaker, cochlear implants, certain heart valves, claustrophobia, pregnancy.
  * Limit of validity of the MRI: if the patient presents dyskinesias preventing immobile maintenance of a few minutes in the MRI for the acquisition of images

Primary outcomes:
measure: Difference of signal NIRS on the supplementary motor area (SMA) during the movement realized during the REM sleep behaviour disorder (RBD) and reproduced in standby in the patient parkinsonian in "on".
timeFrame: 24 hours
Secondary outcomes:
measure: Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby.
timeFrame: 24 hours
measure: Difference of movement speed measured by accelerometers under different conditions.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Beau Soleil
Study officials:
References:
Clinical trial NCT05577039: Preoperative RRI and Long-term Risk for CKD
Official title: Preoperative Renal Resistive Index to Predict Long-term Development of Chronic Kidney Disease in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Acute Kidney Disease
Chronic Kidney Disease
Cardiac Surgery
Renal Resistive Index
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2022-10-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective cardiac surgery patients

Brief summary: Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Both preoperative and postoperative elevation of RRI has shown promise in early detection of AKI after cardiac surgery. Further, elevated RRI before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. The role of preoperative RRI in predicting long-term renal and cardiovascular complications after elective surgery is however not known. The aim of this study is to assess the role of preoperative RRI to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at Karolinska University Hospital between September 2014 and April 2015
* Preoperative measurement of RRI performed with satisfactory Doppler reading
* Written informed consent

Exclusion Criteria:

* Kidney transplant
* Dialysis-dependent kidney disease
* Cancelled surgery
* Missing follow-up data

Primary outcomes:
measure: Long-term renal dysfunction
timeFrame: 5 years after surgery or end of follow-up
Secondary outcomes:
measure: Short-term renal dysfunction
timeFrame: 30 days after surgery
measure: Intermediate renal dysfunction
timeFrame: 90 days after surgery
measure: Major adverse kidney events (MAKE)
timeFrame: 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital
name: Daniel Hertzberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05834439: Flower Print Activity Applied to the Elderly in the Nursing Home
Official title: The Effect of Flower Printing Activity Applied to the Elderly in the Nursing Home on the Anxiety Levels of the Elderly: A Single-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Gardening
Anxiety
Nursing Caries
Keywords: Gardening, Floral print, Elderly, Anxiety, Nursing
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be carried out in order to determine the effect of the flower pressure activity applied to the elderly in the nursing home on the anxiety levels of the elderly.

Detailed description: This research will be carried out in order to determine the effect of the flower pressure activity applied to the elderly in the nursing home on the anxiety levels of the elderly.

Hypotheses H0 = Flower pressure activity applied to the elderly in the nursing home does not affect the anxiety level of the elderly.

H1= Flower pressure activity applied to the elderly in the nursing home reduces the anxiety level of the elderly.

Eligibility criteria: Inclusion Criteria:

* Has no physical handicap that may hinder the activity of flower printing,
* No vision or hearing loss that may hinder the activity of flower printing,
* Open to communication and cooperation,
* The elderly who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Have a serious medical disability,
* Having a serious psychiatric diagnosis,
* Severely demented and
* The elderly who do not want to continue the research will be excluded from the research.

Primary outcomes:
measure: Change in Geriatric Anxiety Scale
timeFrame: day 0 and day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Hacer GOK UGUR
state: Altınordu
Study officials:
affiliation: Ordu Univercity
name: Hacer GÖK UĞUR, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783939: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.
Official title: Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 31
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
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 prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).


Eligibility criteria: Inclusion criteria:

* Age between 10 and 20 years old;
* Integral skin test in the region;
* Use of cosmetic product of the same category;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
* Atopic antecedent or allergic to cosmetic product;
* Active cutaneous disease in the evaluation area;
* Diseases which cause immunology decrease, such as diabetes and HIV;
* Endocrinal pathologies;
* Intense solar exposure 15 days before the evaluation;
* Treatment until four months before the selection;

The above information is not intended to contain all considerations relevant to a patient¿s potential participation in a clinical trial.

Primary outcomes:
measure: The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
timeFrame: From the treatment start to the end of 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: