louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03068182: Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects.
Official title: Cardiovascular Responses to Arm Crank Exercise Versus to Treadmill Exercise in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Rate Variability
Keywords: Exercise ,Autonomic cardiac function ,Adult subjects
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 130
Sex: MALE
Minimum age (years): 25
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignments
Primary purpose: PREVENTION

Brief summary: Cardiovascular response to exercise affects the capacity of all body organs depending upon intensity, duration and mode of exercises. The aim was to compare acute effects of arm crank with treadmill moderate intensity exercises on heart rate variability in normal participants.

Detailed description: A one hundred thirty male volunteers were equally and randomly assigned to; Group-I: Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes. Group-II: Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes. Halter heart rate monitor and automatic sphygmomanometer were used to measure heart beat intervals and arterial blood pressure respectively.

Eligibility criteria: Inclusion Criteria:

* Normal adult non-obese male subjects , their age ranges from 25-36 years.
* They were asymptomatic for cardiovascular and respiratory diseases.
* They currently did not receive any medical prescriptions.
* All participants were asked to avoid strenuous exercise, give up caffeine and alcohol beverages to have sufficient rest for 2 days before measurement sessions to avoid any carry over effects of stimulants or depressants on autonomic functions

Exclusion Criteria:

* Any participant had medical history of cardiovascular and pulmonary disorders or received any interfering medications with study was excluded

Primary outcomes:
measure: Heart rate variability
timeFrame: 45 minutes
Secondary outcomes:
measure: Blood pressure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: University of Dammam
state: Estern pronince
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Alsayed A Shanb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imam Abdulrahman Bin Faisal University
name: Enas F Youssef, PhD
role: STUDY_DIRECTOR
References:
citation: White DW, Raven PB. Autonomic neural control of heart rate during dynamic exercise: revisited. J Physiol. 2014 Jun 15;592(12):2491-500. doi: 10.1113/jphysiol.2014.271858. Epub 2014 Apr 22.
Clinical trial NCT04674982: Vibration and During Heel Lance Procedures in Newborns
Official title: The Effect of Vibration on Pain During Heel Lance Procedures in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heel Lance Procedures
Keywords: newborns
vibration
pain
heel lance
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns.

.

Detailed description: Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.

Eligibility criteria: Inclusion Criteria:

* Gestational age 38 and older

Exclusion Criteria:

* Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
* Genetic and congenital anomalies
* Congenital metabolic disorders,
* those who had undergone cardiopulmonary resuscitation,
* Stayed in the neonatal intensive care unit for any reason,
* Heel blood could not be collected at the first attempt,
* Osteogenesis imperfecta
* Had been given an analgesic within the preceding 6 hours

Primary outcomes:
measure: G Power software was used to calculate the sample size of the study.
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
References:
citation: Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.
Clinical trial NCT05176782: Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
Official title: Randomized Clinical Trial: Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare HTK cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of Fallot planned for total repair.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients with tetralogy of Fallot spectrum.
* Sex (males and females)
* Age 6 months- 5 years.

Exclusion Criteria:

* Persistent left SVC draining in the coronary sinus.
* Mental or neurologic disorders.
* Preoperative critically ill patients.
* Parents or legal guardian refusal.
* Fallot repair with transannular patch( as it will affect on the RV function as a single agent after reperfusion)

Primary outcomes:
measure: • Vasoactive-Inotropic Score
timeFrame: From time of separation of cardioplumonary bypass till 24 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Samar Soliman
state: Nasr City
Study officials:
References:
Clinical trial NCT00655382: Dynamic MRI Evaluation Post Operative Stapled Trans Anal Rectal Resection (STARR) Procedure
Official title: Dynamic MRI Evaluation Post op STARR Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Defecation Syndrome
Outlet Obstruction
Keywords: dynamic pelvic mri
dynamic mri
STARR procedure
STARR
ODS
obstructive defecation syndrome
outlet obstruction
obstructed defecation
stapled trans anal rectal resection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2008-04-09
Enrollment: 10
Sex: FEMALE
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: NON_PROBABILITY_SAMPLE
Study population: Patients who had STARR procedure performed at Mayo Clinic - Jacksonville

Brief summary: The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.

Detailed description: The use of dynamic pelvic MRI has greatly impacted our preoperative evaluation of pelvic floor disorders, both anatomically and functionally. The STARR procedure is a new approved procedure for patients with obstructive defecation, who have failed conservative therapy of medications and aggressive pelvic floor retraining. Most patients have also been screened for colonic transit problems. The traditional study for evaluating these patients was defecating proctograms. With the advent of the dynamic pelvic MRI, we are now beginning to understand the interaction of the entire pelvic structure in the complex act of defecation. This study is providing us a different view of the pelvic structures to better understand the pathophysiology of this disorder. The defecating proctogram, though informative in certain cases, lacks information outside the rectum. We wish to evaluate and compare our preoperative dynamic pelvic MRI with a six month dynamic pelvic MRI in 10 patients. We also will compare pre and post op obstructive defecation scores (ODS). We expect this small sample to direct us to a much more pointed evaluation of this disorder.

Eligibility criteria: Inclusion Criteria:

* Patients willing to have a follow-up with a dynamic pelvic MRI and complete an obstructive defecation score (ODS) at 6 month post STARR procedure at Mayo Clinic - Jacksonville

Exclusion Criteria:

* Patients with medical devices/implants or who cannot have follow-up dynamic pelvic MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Paul D. Pettit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04229082: Next Generation Probiotics (NGPs) for Metabolic Health
Official title: Next Generation Probiotics (NGPs) for Metabolic Health - Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: Oy Medfiles Ltd
name: 4Pharma Ltd.
First posted: 2020-01-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General adult population

Brief summary: To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects


Eligibility criteria: Inclusion Criteria:

1. Females.
2. Age between 20 to 50 years.
3. Obtained his/her informed consent after verbal and written information.
4. Sufficient general health and orientation for participating in the study as evaluated by the study personnel.
5. Have a high probability for compliance with and completion of the study.
6. Available for study visits and availability for food
7. Normal gastrointestinal function.
8. Willingness to provide faecal, urine and blood samples and keep food diary

Exclusion Criteria:

Lactobacillus Rhamnosus GG or reuteri, bifidobacteria enriched products) in the past 6 weeks. 12. Use of anti-obesity drugs. 13. Active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months. 14. Special diets e.g. Vegetarian, Vegan, Diets with intention to use certain limited food groups only (like paleo diet, egg-grape diet etc.) 15. History of chronic active inflammatory disorders. 16. History of bariatric surgery. 17. Regular use of non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs. 18. Ongoing or recent (last 3 months) antibiotic treatment. 19. Immunosuppression or ongoing therapy causing immunosuppression. 20. Use of vitamin supplementations beyond Recommended Daily Intake levels during the previous 2 months and during the study, except for vitamin D supplementation up to 20 μg/day.

Primary outcomes:
measure: evaluate the differences in the intestinal microbiota profile between lean and obese subjects.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03910582: Personalized FET in RIF Patients With Displaced Dating
Official title: A Randomized Clinical Trial of Endometrial Histological Dating for Personalized Frozen-thawed Embryo Transfer (pFET) in Patients With Repeated Implantation Failure (RIF) in Natural Cycle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 117
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The endometrium becomes receptive as a result of a series of timed hormonal events during the menstrual cycle. The exposure of the endometrium to progesterone after ovulation initiates morphological and functional alterations that result in the change from a pre-receptive to a receptive endometrium. The morphological changes observed on histology for each specific day after ovulation were described by Noyes and his colleagues in 1950. An endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be "out of phase" However, the clinical application of the Noyes criterion is relatively limited. We have verified the Noyes criterion in natural cycle in previous study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (PO+3/5/7/9/11)(unpublished data).

The clinical value of the endometrial histological dating in RIF patients in natural cycle is still to be answered. In this study, we tried to investigate the clinical effects of pFET in unexplained RIF patients according to the use of classic histologic endometrial dating to estimate the timing of the window of implantation and to adjust embryo transfer time in natural cycle.


Eligibility criteria: Inclusion Criteria:

1. RIF patients (RIF is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers);
2. Out of phase dating patients;
3. FET in natural cycle;
4. Single blastocysts embryo transfer;

Exclusion Criteria:

1. uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum), intrauterine adhesions, endometriosis,adenomyosis, hydrosalpinx, and uterine fibroids (submucosal fibroids, non-mucosal fibroids\> 4 cm and/or endometrial pressure);

Primary outcomes:
measure: ongoing clinical rate
timeFrame: 6 weeks
Secondary outcomes:
measure: implantation rate
timeFrame: 2 weeks
measure: clinical pregnancy rate
timeFrame: 4 weeks
measure: early abortion rate
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00465582: B14 Meningococcal Carriage in Seine-Maritime Population: Prevalence Study and Search of Risk Factors
Official title: B14 Meningococcal Carriage in Seine-Maritime Population: Prevalence Study and Search of Risk Factors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Meningococcal Infections
Keywords: carriage
Neisseria meningitidis
risk factors
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 3296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dieppe Population 0 to 25 yaers old.

Brief summary: Our main objectives are to evaluate the importance of meningococcal carriage and to determine the predisposing factors


Eligibility criteria: Inclusion Criteria:

* Living in the area of Dieppe
* Parental authority assent if necessary

Exclusion Criteria:

* Child under supervision

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: François Caron
state: Seine-Maritime
Study officials:
affiliation: Service des Maladies Infectieuses
name: Francois Caron, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00722982: Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
Official title: Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coxarthrosis
Keywords: coxarthrosis
hip
RSA
DXA
C-stem AMT
Marathon
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Ringerike hospital HF, Hønefoss Norway
name: Ortomedic AS, Lysaker Norway
name: Helse Sor-Ost
First posted: 2008-07-28
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70 patients admitted to orthopedic clinic Ringerike hospital for coxarthrosis are planned to be included in stydy. The all should agree in a written form to participate in study. They are randomized to be operated THA with Exeter- or C-stem AMT femur prostesis. Marathon acetabular prosthesis will be used for all patients included.

Brief summary: Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis

In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis.

The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years


Eligibility criteria: Inclusion Criteria:

* coxarthrosis

Exclusion Criteria:

* age over 80
* major medial condition such as renal failure, chronic obstructive lung disease heart failure etc

Primary outcomes:
measure: Migration of femur- and acetabular prosthesis measured by RSA
timeFrame: 2008-2012
Secondary outcomes:
measure: Periprosthetic osteolysis of proximal femur
timeFrame: 2008-2012
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Lars Nordsletten, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06531382: Danish Nurses Attitudes Towards Addressing Sexual Health
Official title: Nurses Attitudes Towards Addressing Sexual Health - a Danish Crossectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexuality
Communication
Sexual Dysfunction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: nurses

Brief summary: Health professionals, within the field of cancer, attitude towards addressing sexual health with patients is unknown.

The aim is to investigate the attitudes of Danish cancer nurses towards addressing sexual health in their clinical work, as well as to assess differences in perceived competences and knowledge.

Method: The questionnaire Health professionals Attitudes towards Sexual Health-Danish version (PA-SH-D) is sent out to Danish cancer nurses via the Professional Society for Cancer Nurses. The questionnaire is sent out via a link via the RedCap database.

The questionnaire link is sent out to members of the Professional Association for Cancer Nurses under the Danish Nursing Council, and it is sent out via their membership register.

Detailed description: Health professionals, within the field of cancer, attitude towards addressing sexual health with patients is unknown.

The aim is to investigate the attitudes of Danish cancer nurses towards addressing sexual health in their clinical work, as well as to assess differences in perceived competences and knowledge.

Method: The questionnaire Health professionals Attitudes towards Sexual Health-Danish version (PA-SH-D) is sent out to Danish cancer nurses via the Professional Society for Cancer Nurses. The questionnaire is sent out via a link via the RedCap database.

The questionnaire link is sent out to members of the Professional Association for Cancer Nurses under the Danish Nursing Council, and it is sent out via their membership register.

Eligibility criteria: Inclusion Criteria:

* Nurses working within the area of onkology or hematology in a danish hosptial or primary sector
* nurses having daily contact with patients with a cancer diagnosis

Exclusion Criteria:

* nurses not having daily contact with patients
* nurses not working within hematology or oncology

Primary outcomes:
measure: Attitudes toward adressing sexual health
timeFrame: July 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
References: