louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00952510: Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients
Official title: MaNeS (Maastricht Neck Study): Development of Chronic Disability in Neck Pain Patients After a Motor Vehicle Accident
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Whiplash Injuries
Keywords: Range of motion, articular
Cervical spine
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is based on 100 whiplash patients which underwent a measurment of the cervical movements and gave permission to recontact them for further research.

Brief summary: Rationale: Neck complaints are often caused by motor vehicle accidents and particular after rear-end collision. Patients complain about neck pain after a whiplash trauma, which lead to mobility restrictions of the cervical spine. It is estimated that 20% develop a chronic pain disorder after 1 year, called a chronic whiplash syndrome.

Objective: the primary objective is to investigate the natural course of active-and passive range of motion and principally the difference score between active-and passive cervical range of motion after a whiplash trauma. The secondary objectives are: investigate the predictive value of active-and passive range of motion and chronicity. Further, the correlation between the degree of restriction of the active and passive backward flexion and chronicity will be investigated. Finally, the correlation between the possible predictive factors such as pain, ideas and feeling about pain, memory and attention, events of the last year and complaints after the motor vehicle accident and chronicity are examined.

Study design and study population: a prospective cohort of 100 whiplash patients which underwent a measurement of the cervical movements and gave permission to recontact them for further research.


Eligibility criteria: Inclusion Criteria:

* Patients have had a measurement of the cervical range of motion.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system.
timeFrame: 31-12-2010
Secondary outcomes:
measure: Investigate the correlation between active- and passive cervical movement restraints and: NRS, TSK, PCS, NDI, CES-D, TAS, EPQ, CFQ, Holmes-Rahe scale, Rand 36, PSS-SR
timeFrame: 31-12-2010
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Jacob Patijn, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509910: Implementation of a GDT Algorithm for Major Surgery Patients
Official title: Implementation and Effects of Pulse-contour-automated SVV/CI Guided Goal Directed Fluid Therapy Algorithm for the Routine Management of Major Abdominal Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colectomy
Pancreatectomy
Fluid Therapy
Keywords: Major abdominal surgery
Goal directed therapy
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major abdominal surgery (Colorectal and pancreatic surgery)

Brief summary: This study examines the effect of an algorithm for GDT for patients undergoing major surgery under routine conditions.

Detailed description: Goal directed fluid management in major abdominal surgery has been shown to reduce perioperative complications. The approach aims to optimize the intravascular fluid volume by use of minimally invasive devices which calculate flow-directed variables such as stroke volume (SV) and stroke volume variation (SVV). The investigators aim to show the feasibility of routinely implementing such hemodynamic monitoring during major abdominal surgery, and to evaluate its effects in terms of perioperative fluid management and postoperative outcomes.

Eligibility criteria: Inclusion Criteria:

* pancreatic surgery
* colorectal surgery

Exclusion Criteria:

* admission for revisional surgery

Primary outcomes:
measure: Length of stay in hospital
timeFrame: 90 days
Secondary outcomes:
measure: intraoperative crystalloid volume
timeFrame: 1 day
measure: intraoperative colloid volume
timeFrame: 1 day
measure: Length of stay at ICU
timeFrame: 90 days
measure: Total amount of complications per patient
timeFrame: 90 days
measure: Insufficiance of bowel anastomosis
timeFrame: 90 days
measure: Pneumonia
timeFrame: 90 days
measure: ACS
timeFrame: 90 days
measure: acute renal failure
timeFrame: 90 days
measure: Sepsis
timeFrame: 90 days
measure: Intraabd. Infection
timeFrame: 90 days
measure: wound infection
timeFrame: 90 days
measure: UTI
timeFrame: 90 days
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University Hospital of Marburg, Department of Anesthesia
Study officials:
affiliation: Phillips University
name: Thomas Kratz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06013410: Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
Official title: Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jinhua Hospital
First posted: 2023-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main questions it aims to answer are:

Question 1: the microbiome difference of the biofilm between IBS and healthy patients.

Question 2: the metabolic product patterns between IBS and healthy patients.

Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will be collected during the examination.

Researchers will compare the IBS and healthy control groups to see if there was the disease-specific pattern in the microbiome and metabolic product of the biofilm.


Eligibility criteria: Inclusion Criteria:

* IBS patients with IV type; no abdominal surgery;

Exclusion Criteria:

* age \<18 y;
* major disease;
* alcoholic addicted;
* antibiotic use in past 3 months;
* severe gastrointestinal disease
* severe cardiac disease;
* pregnant;
* ICU in past 1 year;
* vegeterian;
* immune disease (SLE etc.)
* mental disease;

Primary outcomes:
measure: mirobiome difference of the fecal between IBS and health controls
timeFrame: Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
measure: mirobiome difference of the fecal between IBS and health controls
timeFrame: Fecal samples will be collected 7 days after the colonoscopy test (T2)
measure: Metabolic changes between IBS and Healthy controls
timeFrame: 1 day biopsy will be collected during the colonoscopy test
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01218412: Web-based Physical Activity Program
Official title: Investigation of Web-based Motivational Interviewing to Increase Physical Activity Participation Among Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Physical Activity
Keywords: Physical Activity
Motivational Interviewing
Web-based
Physician Referral
Lead sponsor: Karnes, Sasha
Sponsor class: INDIV
Collaborators: name: University of Wisconsin, Whitewater
First posted: 2010-10-11
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The specific aims of the proposed study are:

* 1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an informational web-based comparison group, in enhancing physical activity (PA) participation; and
* 2. To assess the mechanisms by which web-based MI enhances PA through changes in targeted cognitive mediators.

The specific hypotheses of the study include that:

* Hypothesis 1: Web-based MI will increase PA;
* Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased readiness to participate in PA;
* Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;
* Hypothesis 4: Cognitive variables will mediate increases in PA participation.

Detailed description: Increasing physical activity (PA) is a public health priority. There is preliminary support for application of Motivational Interviewing (MI) for physical activity (PA), web-applications for PA promotion, web-based MI for behavior change, and finally web-based MI for PA. Based on collective findings in these areas of inquiry, it is necessary to investigate the efficacy of MI as a method that lends readily to practical applications for PA promotion. The current study seeks to investigate whether web-based MI can be applied in an adult population to enhance PA participation using a physician referral scheme. Additionally, mechanisms of behavior change are considered in order to inform future research and intervention.

Eligibility criteria: Inclusion Criteria:

* Adults referred through primary care due to insufficient physical activity standards based on Centers for Disease Control (CDC) guidelines for aerobic activity.
* Must have internet access and e-mail.
* Cleared by physician for physical activity participation.

Exclusion Criteria:

* Greater than 10,000 steps per day on average based on baseline pedometer screening over the course of 7 days.

Primary outcomes:
measure: Physical Activity (pedometer recordings)
timeFrame: 1 week post-intervention
measure: Physical activity (self-report)
timeFrame: 3-months post-intervention
Secondary outcomes:
measure: Cognitive Mediators
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora RiverCenter
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Sasha L. Karnes, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966212: Parent Education for Young Teen Females
Official title: Reducing Alcohol & Risks Among Young Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prevention
Lead sponsor: Education Development Center, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study has the potential to improve understanding of the link between early alcohol and sexual initiation and to provide a proven, selective, female-focused intervention for addressing these risks. The goal is to set young women on a course that protects their health and reduces the burden that problem drinking and HIV disease is taking on African American and Latino communities.

Detailed description: The aims of this study are to to characterize and address the combined risks of early alcohol use and early sexual initiation within a population of urban African American and Latina adolescent females who are at high risk for HIV, AIDS, and other STI. Past research by the investigative team has documented that nearly 10% of females in our target population have initiated sex by fall of 7th grade and more than half have done so by spring of 10thgrade. Although alcohol use is more comparable with national figures, the combination of early alcohol and early sexual initiation is troubling, yet under-addressed by existing interventions. We will develop and test an intervention that builds upon a promising strategy for influencing adolescents: parent education. Three parenting mechanisms shown to influence adolescent risk behavior are targeted: parental monitoring, household rule setting, and communication. Informed by a community advisory board and a series of focus groups, a set of three audio-cds for parents of young adolescents will be developed. Through dramatic role-model stories, these CDs will help parents address alcohol prevention and the link between early alcohol use and sexual initiation and risk taking. Families and middle school daughters will then be enrolled into a randomized pilot test of the intervention's efficacy. Parent and student surveys will be conducted at baseline and 3-month post-intervention follow up to assess whether the intervention is beneficial in terms of promoting positive parenting practices, positive attitudes toward healthy behaviors, and reducing girls' risks.

Eligibility criteria: Inclusion Criteria:

* 8th grade girls and parents at participating schools

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: positive parenting practices
timeFrame: 3 months
measure: alcohol use
timeFrame: 3 months
measure: risk behaviors
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: Education Development Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT04976712: Core Temperature in Patients With OHCA
Official title: Core Temperature in Patients With Out of Hospital Cardiac Arrest in South Tyrol - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Out-Of-Hospital Cardiac Arrest
Accidental Hypothermia
Temperature Change, Body
Keywords: Out-Of-Hospital Cardiac Arrest
Accidental Hypothermia
Core Temperature
Lead sponsor: Azienda Sanitaria dell'Alto Adige
Sponsor class: OTHER
Collaborators: name: Institute of Mountain Emergency Medicine
First posted: 2021-07-26
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with out of hospital cardiac arrest transferred to hospital

Brief summary: A prospective observational study aiming to monitor core temperature via an esophageal probe in out of hospital cardiac arrest during transport and until arrival in hospital. Insertion of an esophageal temperature probe will be done on scene during ongoing resuscitation manoeuvres based on European Resuscitation Council Guidelines 2015 (or newer). Environmental temperature influence and hypothermia prevention interventions will be monitored.

Detailed description: Prospective observational study to evaluate the body temperature difference in patients in out of hospital cardiac arrest on site and at arrival at the hospital.

If the patient fulfills the inclusion criteria and after establishment of CPR measures according the ERC resuscitation guidelines (2015 or newer) an esophageal probe will be inserted and bodytemperature is measured; on site ambiental temperature will also be measured. Weather conditions, altitude on site, activity of the patient and hypothermia protection (eg. clothes) will bei documented. On arrival in hospital the body temperature will be measured with the esophageal probe;

Eligibility criteria: Inclusion Criteria:

* Out of hospital cardiac arrest
* Patients transferred to hospital
* \> 18 years

Exclusion Criteria:

* Obvious signs of death
* Obvious lethal injury/injuries incompatible with life
* Confirmation of death on scene
* \< 18 years

Primary outcomes:
measure: Core temperature at hospital arrival
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Core temperature at ROSC
timeFrame: through study completion, an average of 1 year
measure: Environmental temperature on scene
timeFrame: through study completion, an average of 1 year
measure: Time of resuscitation from OHCA to ROSC
timeFrame: through study completion, an average of 1 year
measure: OHCA rhythm at arrival of ALS team
timeFrame: through study completion, an average of 1 year
measure: Use of mechanical chest compression device on prehospital intervention
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bruneck
country: Italy
facility: Bruneck Regional Hospital
Study officials:
affiliation: Azienda Sanitaria dell'Alto Adige
name: Rosmarie Oberhammer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02058212: Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)
Official title: Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: ICSI
antioxidants
ROS
endometriosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ROS plays an essential role in the pathogenesis of many reproductive processes. High follicular fluid ROS levels are associated with negative IVF outcomes.

is plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?

Detailed description: Study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient Participants/materials, setting, methods: was done in the Egyptian centre for IVF from March 2013 to October 2013 . 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .

Eligibility criteria: Inclusion Criteria:

* patients with endometriosis

Exclusion Criteria:

patients with no endometriosis , not suitable for ICSI-

Primary outcomes:
measure: plasma reactive oxygen species affection by antioxidant treatment
timeFrame: 3 months
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: egyption centre for IVF
city: Maadi
country: Egypt
city: Maadi
country: Egypt
Study officials:
name: olfat nouh riad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02505412: Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients
Official title: Prevalence of Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients: is Cardiac Screening Needed?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurofibromatosis Type 1
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive asymptomatic NF1 patients, aged 0-17y and 11 month, who will visit the investigators' Neurofibromatosis tertiary outpatients clinics

Brief summary: Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?


Eligibility criteria: Inclusion Criteria:

* asymptomatic NF1 patients
* aged 0-17y and 11 months

Exclusion Criteria:

* clinical heart failure,
* history of cardiovascular disease
* chronic renal insufficiency

Primary outcomes:
measure: myocardial deformation indices as measured in percentage (change of original length)
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03804112: TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up
Official title: TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Pain
Vasculitis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-01-15
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient previously identified with a TIPC syndrom

Brief summary: TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound


Eligibility criteria: Inclusion Criteria:

- Patients with at least one episode of TIPIC syndrome for more than 12 months

Primary outcomes:
measure: Assess the incidence of recurrence of TIPIC syndrome after a first episode
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Centre Hospitalier de Saint-Anne
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de TOURS
Study officials:
References: