louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00175591: The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
Official title: The Effect of Femoral Nerve Block on Opioid Requirements Following Femoral Fracture Fixation With Flexible Nails in the Paediatric Population: A Double Blind, Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Postoperative
Keywords: Femur fracture
morphine sparing
preemptive analgesia
Post-operative pain and post- operative opioid use
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

* Femoral shaft fracture requiring intra-medullary nailing
* Surgery performed within 24 hours of injury
* Ability of child or family to use patient-controlled analgesia (PCA)
* No allergy or sensitivity to bupivacaine
* Informed consent and assent

Exclusion Criteria:

* Open femur fractures
* Closed fractures needing open reduction
* Fractures associated with neurovascular complications
* Fractures associated with compartment syndrome
* Repeat femoral surgeries
* Patients who received a femoral nerve block more than 1 hour prior to surgery
* Complex associated injuries or pre-existing condition that will delay time to ambulation
* Children who are allergic and/or sensitive to bupivacaine

Primary outcomes:
measure: Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
timeFrame: until patient discharge
Secondary outcomes:
measure: Pain rating
timeFrame: immediately post-op
measure: Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate
timeFrame: every 8 hours
measure: Time to discharge
timeFrame: from end of surgery
measure: Time (hours) from end of surgery to sitting on bed with legs hanging over the side
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital, Department of Orthopaedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kishore Mulpuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00288691: Menorrhagia Study in Women With Treatment-resistant Menorrhagia
Official title: A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menorrhagia
Keywords: Treatment-resistant menorrhagia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: TAP Pharmaceutical Products Inc.
First posted: 2006-02-08
Enrollment: 26
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

* Organic causes of menorrhagia
* Current hormone treatment

Primary outcomes:
measure: Individual relative change in uterine bleeding scores by PBAC
timeFrame: Pretreatment cycle treatment phase
Secondary outcomes:
measure: Endometrial thickness
timeFrame: End of treatment
measure: Adverse events collection
timeFrame: Whole treatment period
measure: Bleeding pattern
timeFrame: Treatment period
measure: Endometrial histology incl. immunohistochemical evaluations
timeFrame: End of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04313491: Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers
Official title: Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers: Quasi Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Cervical Pain
Musculoskeletal Pain
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Brunel University
First posted: 2020-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effectiveness of a workplace yoga intervention in reducing the frequency of pain involving the head and neck area.


Eligibility criteria: Inclusion Criteria:

* Office workers
* Willing to participate an give consent

Exclusion Criteria:

* Secondary headache
* Neck injury
* Trauma
* Critically ill
* Cognitive impairment
* Pregnancy

Primary outcomes:
measure: Frequency of headache, neck and shoulder pain
timeFrame: From baseline to 6-week post intervention
Secondary outcomes:
measure: Severity of head, neck and shoulder pain
timeFrame: From baseline to 6-week post intervention
measure: Analgesics use
timeFrame: From baseline to 6-week post intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Yog Kulam
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_DIRECTOR
affiliation: Brunel University
name: Monomita Nandy
role: STUDY_CHAIR
References:
Clinical trial NCT00847691: GENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .
Official title: GENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: economic evaluation
diagnostics
sarcoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2009-02-19
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a strong clinical and histological suspicion of sarcoma

Brief summary: The clinical and histological diagnosis of sarcomas is often very difficult. The identification of chromosomal and molecular anomalies, such as amplifications, deletions or fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their benign counterparts. However, the cost of the cytogenetic and molecular techniques for the detection of these alterations is often a limitation to their use. The aim of our study is to evaluate the direct cost of the molecular techniques in comparison to the cost that would be generated by an appropriate therapy and care management of the patient in case of an erroneous diagnosis.


Eligibility criteria: Inclusion Criteria:

* patients with biopsy or excision of sarcoma (suspected or diagnosed)
* sampling reviewed by pathologists
* frozen sampling
* clinical data available

Exclusion Criteria:

* opposition of patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Departement de Pathologie de l'Institut Bergonié
city: Lille
country: France
facility: Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille
city: Lyon
country: France
facility: Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard
city: Nice
country: France
facility: Laboratoire de Génétique des Tumeurs Solides
city: Paris Cedex 5
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: Service d'Anatomo-Pathologie, Centre Paul Strauss
city: Strasbourg
country: France
facility: Unité de Biologie Moléculaire, CHU de Hautepierre
city: Villejuif
country: France
facility: Département de biologie et de pathologie médicales, Institut Gustave roussy
Study officials:
affiliation: Laboratoire de Génétique des Tumeurs Solides
name: Florence PEDEUTOUR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04168294: The Influence of Sedation for Endoscopy on Cognitive Function
Official title: The Influence of Sedation for Endoscopy on Cognitive Function
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophagogastroduodenoscopy
Deep Sedation
Cognition Disorders
Keywords: Esophagogastroduodenoscopy
Deep Sedation
Cognition Disorders
Patient Discharge
Automobile Driving
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Radom select patients who undergo EGD in Renji Hospital, School of Medicine, Shanghai Jiaotong University. Patients who are recruited all received nine year compulsory education and fit for the inclusion criteria. Moreover, all patients received approval from the local institutional review board.

Brief summary: It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.

Detailed description: One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.

Eligibility criteria: Inclusion Criteria:

1. The scores of MMSE are more than 26.
2. The AHA grade I and II.

Exclusion Criteria:

1. The AHA grade III, IV or V.
2. binge drinking.
3. Take sedatives, sleeping agents and some drug which may affect the study in a month.
4. Psychiatric disorders.
5. The dysfunction of heart, lung, liver and kidney.

Primary outcomes:
measure: NCT-A test outcome measure
timeFrame: 30 minutes
measure: DST test outcome measure
timeFrame: 30 minutes
measure: number cancellation test outcome measure
timeFrame: 30 minutes
Secondary outcomes:
measure: heart rate outcome measure
timeFrame: 5 minutes
measure: SpO2 outcome measure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine,Shanghai Jiao Tong University
name: Wei-Ping Li
role: STUDY_CHAIR
References:
Clinical trial NCT04082494: Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.
Official title: Impact on Postoperative Wellbeing in the PACU After General or Regional Anaesthesia Through Consecutive Implementation of Personalized Musical Entertainment and a Variety of Beverages. A Pre-post-post Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Postoperative Pain
Keywords: wellbeing
Postoperative Pain
postoperative disturbances after anaesthesia
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 1613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative disturbances for patients' well-being in the PACU after general or spinal anaesthesia will be assessed. Influence of the offer of beverages and music will be assessed regarding their wellbeing, satisfaction and pain.


Eligibility criteria: Inclusion Criteria:

* elective stationary adult patients capable and willing of filling out the questionnaire

Exclusion Criteria:

* participation in other studies about wellbeing influence
* incapability of filling out the questionnaire
* patients that do not wish to participate

Primary outcomes:
measure: Postoperative Wellbeing
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Pain assessment
timeFrame: approximately 2 hours after surgery
measure: Administered milligram of opioids for pain medication
timeFrame: approximately 2 hours after surgery
measure: Postoperative complications in the postanaesthesia care unit
timeFrame: approximately 2 hours after surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Hospital LKH Graz
Study officials:
References:
Clinical trial NCT02969694: Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men
Official title: Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychoactive Substances Consumers
Keywords: addiction
hypersexuality
psychostimulants
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who have sex with men and who take psychostimulants products in sexual contexts

Brief summary: Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.

Evaluation using an hetero-assessment questionnaire about the link between hypersexual disorder and the use of synthetic cathinone.

Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and the medico-psycho-social consequences of those practices.


Eligibility criteria: * Inclusion Criteria:

  * Patients ≥ 18 years
  * Male homosexual and / or bisexual who come to the CSAPA at the Croix-Rousse Hospital, Lyon France following the use of psychostimulants products in sexual contexts
  * Patients who have received clear information and not opposed to participate in the study
  * Patients affiliated to a social security scheme or similar
  * Patients not undergoing a measure of legal protection
* Exclusion Criteria:

  * Opposition to participation in the study
  * Patients \< 18 years
  * Pregnant women or breastfeeding
  * Deprived of individual liberty

Primary outcomes:
measure: G-STAT questionnaire
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00055094: Treatment of Acute HIV Infection to Preserve Immune Function
Official title: Immune Control of HIV Replication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Immune system
Helper T-Cells
Acute Infection
Treatment naive
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: While most people with HIV experience significant destruction of their immune systems, some people appear to have preserved immune function and can control the virus without drugs. Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to control the virus once the drugs are stopped. This study will evaluate the immune system response of HIV infected people who are treated with anti-HIV drugs soon after being infected.

Detailed description: Studies have identified a potent CD4 T helper (Th) cell response in some infected people, and have shown a correlation between virus-specific Th cells and low levels of viremia. Early institution of potent antiviral therapy in the earliest stages of acute HIV infection have led to strong Th cell responses, analogous to those seen in people who are able to control viremia in the absence of antiviral therapy. This may be because potent antiviral therapy is able to protect virus-specific Th cells as they become activated, and thus these cells are not lost in the earliest stages of infection. This study will characterize the immune response of patients with acute HIV infection who receive antiretroviral therapy and will determine the effects of interruption of therapy in those people who have immune responses to HIV that are similar to patients with long-term non-progressing infection.

Participants in this study will be followed through June 2004. Study visits vary from only once to every month and are scheduled at the discretion of the study officials. Study visits include an interview and blood tests.

Eligibility criteria: Inclusion Criteria

* Acute HIV infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Bruce Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015794: Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
Official title: Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2009-11-18
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators aim to quantitate the extent of cervical and upper thoracic brown adipose tissue (BAT) activation in lean and obese humans via positron emission tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological adrenergic stimulus will result in activation of BAT in these participants, and that this activation will be reduced in obese patients. This study will provide important preliminary information with respect to allowing the investigators to progress with longer trials with specific beta 3 AR agonists.


Eligibility criteria: Inclusion Criteria: healthy group

* Males aged 20 - 40 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Fasting plasma glucose \< 6.1 mmol/L and 2 hour OGTT glucose \< 7.8 mmol/L
* Unmedicated
* No major illness
* BMI 18 - 25

Inclusion Criteria: obese group

* Males aged 20 - 40 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Unmedicated
* No major illness
* BMI 30+
* Weight \< 100 kg
* Height \< 185 cm

The inclusion criteria (Obese participants) of body weight less than \~100 kg is implemented as the PET-CT scanner to be utilised (protocol described subsequently) has a limited patient volume. Therefore to fit within the criteria of BMI \> 30, only patients of height \~183 cm or less can be recruited, and inclusion of borderline participants will be discussed with co-investigators from the Alfred Hospital Nuclear Medicine Department.

Exclusion Criteria: healthy group

* Unable to give informed consent
* Smokers
* Lactose intolerance

Exclusion Criteria: obese group

* Unable to give informed consent
* Smokers
* Lactose intolerance
* Participant in research projects involving ionising radiation within the past 5 years
* claustrophobia

Primary outcomes:
measure: BAT activity via PET-CT
timeFrame: Baseline and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Prahran
country: Australia
facility: Alfred Hospital Heart Centre
state: Victoria
Study officials:
References:
citation: Carey AL, Formosa MF, Van Every B, Bertovic D, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Ephedrine activates brown adipose tissue in lean but not obese humans. Diabetologia. 2013 Jan;56(1):147-55. doi: 10.1007/s00125-012-2748-1. Epub 2012 Oct 13.
Clinical trial NCT04061694: Immediate Loading and Fully Guided Surgery: Single Implants
Official title: Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osseointegration Failure of Dental Implant
Lead sponsor: Folktandvården Skåne AB
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age who had signed an informed consent
* in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.

Exclusion Criteria:

* general contraindications for oral surgery
* patients with inadequate oral hygiene
* need for bone grafting or ridge augmentation.

Primary outcomes:
measure: Number of Participants With Implant Survival
timeFrame: 12 months
measure: MBL
timeFrame: 12 months
measure: Pink Esthetic Score
timeFrame: 12 months
measure: White Esthetic Score
timeFrame: 12 months
measure: Oral Health Impact Profile - 14
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Centre of Dental Specialist Care
state: Scania
Study officials:
affiliation: Göteborg University
name: Ann Wennerberg, PhD
role: STUDY_DIRECTOR
References: