louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01832649: Exercise as an Adjunctive Treatment for Cocaine Dependent Patients
Official title: Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Dependence
Keywords: Exercise
Cocaine dependence
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if exercise added to usual treatment improves cocaine dependence treatment. The primary objective of this study is to investigate if exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if exercise can reduce negative mood states, improve quality of life and facilitate abstinence of cocaine.

Detailed description: This study is designed as two-groups, randomized controlled trial to evaluate the effectiveness of an 8-week exercise program added to usual treatment compared with a health education program in 20 cocaine dependent patients. These participants will be randomized to one of the following two groups: a) exercise group: supervised moderate-vigorous exercise in group based on strength and calisthenics exercises, b) control group: supervised health education in group. All participants must have DSM-IV diagnosis of cocaine dependence as the primary disorder and must be in treatment.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of cocaine dependence as primary disorder
* age between 18 and 60 years
* current psychosocial cocaine treatment

Exclusion Criteria:

* medical problems that contraindicate the participation in an exercise program
* family history of sudden death and/or early death due to cardiovascular reasons
* current inclusion in a regular exercise program

Primary outcomes:
measure: Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)
timeFrame: weekly, up to 8 weeks
Secondary outcomes:
measure: Mood states measured by Profile of Mood States (POMS)
timeFrame: weekly, up to 8 weeks
measure: Quality of life measured by 36-item Short-Form Survey (SF-36)
timeFrame: monthly, up to 2 months
measure: Change in Physical fitness (BMI, functional capacity and strength)
timeFrame: Change from Baseline Physical Fitness at 2 months
measure: Percent days abstinent defined as the ratio between the number of negative cocaine urine test and the number of realised cocaine urine test
timeFrame: weekly, up to 8 weeks
measure: Change in cocaine craving measured by means of visual analogue scale (VAS)
timeFrame: Change from Baseline Cocaine Craving at 2 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Nuria Siñol Llosa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02294149: Vit D3 and Omega 3 in Chemo Induced Neuropathy
Official title: A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Neuropathy
Keywords: chemotherapy
Omega 3
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether administration of mammalian Omega 3 FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due to chemotherapy.

Detailed description: The primary objective of this study is to evaluate the impact of mammalian oil Omega 3 FA with Vitamin D3 supplementation on resolution or prevention of Taxanes or Platinum induced peripheral neuropathy compared with placebo. Patients will be allocated to receive the Omega 3 FA \& Vitamin D3 supplements or placebo for 6 months. Approximately 600 patients in total will be enrolled in the 2 study arms. The evaluation of neuropathy will be accomplished by electromyography (EMG), Total neuropathy score(TNS), Brief pain inventory (BFI) and the 11-item FACT/GOG-Ntx, version 4 questionnaire (a subscale validated to assess neuropathy due to chemotherapy). In addition, other validated functional measures such as "Time to button a six hole shirt" and "50 ft walk speed test" will be used to test patients physical limitations imposed by peripheral neuropathy. All our patients will undergo an EMG at their first visit, in 3 months and after 6months. Previously mentioned functional measures will also be completed at the patients' first visit, in 3 months and after 6 months.

Eligibility criteria: Inclusion Criteria:

* Will be receiving chemotherapy(Platinums and/or Taxanes) in the following 2 weeks.
* Histologically confirmed diagnosis of cancer
* ECOG 0 to 2

Exclusion Criteria:

* Prior chemotherapy treatment
* Pre-existing peripheral PN due to DM,HIV, alcohol abuse, thyroid dysfunction and hereditary PN associated disorders.
* Taking any nutritional supplement( fish oil, vitamins and minerals) at least there months before enrollment.

Primary outcomes:
measure: percentage of participants with a 50% decreases in Total neuropathy score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill university health center, Royal Victoria hospital
state: Quebec
Study officials:
References:
Clinical trial NCT01378949: Psoas Compartment Block Versus Fascia Iliaca Block After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: pain score
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-06-23
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A psoas compartment block has been used with good results for postoperative pain relief after total hip arthroplasty (THA). However, case reports describing serious complications after the use of this block, have been reported. The fascia iliaca compartment block (FICB) has been shown to be a reliable block for postoperative pain relief for procedures and injuries involving the hip. The investigators have not found any literature that has compared these two blocks. This study will compare the two blocks when used for post-operative pain relief after THA.


Eligibility criteria: Inclusion Criteria:

* ASA Class I-III
* Patients undergoing THA for osteoarthritis

Exclusion Criteria:

* Skin infections adjacent to block site
* Allergy to local analgesics
* Patient unable to understand visual analogue scale (VAS)

Primary outcomes:
measure: Pain score of patients who have been given FICB for post-operative pain relief after THA
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05369936: Pain Perception: on Relationships Between Dental Anxiety and Olfaction
Official title: Pain Perception: on Relationships Between Dental Anxiety and Olfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Dental Pain
Essential Oil
Keywords: Dental Anxiety
Dental Pain
Emotional changes
Olfaction
Essential Oil
Lavender
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 350
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided into a control group in which the patients will be subjected to vapors of plain distal water, and lavender group where the patients will inhale vapors of the lavender oil to stimulate olfaction
Primary purpose: PREVENTION

Brief summary: the objective of this study is to evaluate the ability of olfaction in obtaining positive emotional and behavioral responses toward dental anxiety and pain in patients undergoing different dental procedures.

Detailed description: All patients who meet inclusion criteria of the study will be given a written consent and enrolled into a randomized double-blinded controlled study (investigator and patients are blinded about the study). Patients will be divided into lavender and control groups. Patients in lavender group will subjected 2 % lavender vapors. In control group, patients will inhale distal water vapors

Eligibility criteria: Inclusion Criteria:

1. Adult females over 18 years,
2. Attending morning sessions of clinics (9 am)
3. Liable for administration of local anesthesia, tooth preparation either for filling procedures or crown preparations, endodontic treatment, teeth extraction, or subgingival scaling

Exclusion Criteria:

1. Males
2. Females who had allergies, bronchial asthma, common cold, pulmonary diseases, migraine, or taking antidepressants, anxiolytic drugs, opioids, or other medications that affect our results

Primary outcomes:
measure: Anxiety score
timeFrame: 20 minutes before exposure to vapors
measure: Anxiety score
timeFrame: 20 minutes After exposure to vapors
measure: Anxiety score
timeFrame: 24 hours After exposure to vapors
Secondary outcomes:
measure: Pain Score
timeFrame: 20 minutes before exposure to vapors
measure: Pain Score
timeFrame: 20 minutes after exposure to vapors
measure: Pain Score
timeFrame: 24 hours after exposure to vapors
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Ghada Amin Khalifa
state: Buraydah
Study officials:
affiliation: Qusaiba Hospital, Qassim, Saudi Arabia
name: Sarah AM Alkanan, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia
name: Hadeel S Alhaweri, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Dentistry, Qassim University, Saudi Arabia
name: Ghada A Khalifa, Professor
role: STUDY_DIRECTOR
affiliation: College of Dentistry, Qassim University, Saudi Arabia
name: Shaimaa MS Ata, Lecturer
role: STUDY_CHAIR
References:
Clinical trial NCT02463149: Pilot Evaluation of Youth Chef Academy
Official title: Pilot Evaluation of Youth Chef Academy: A Plant-based Cooking Program for Urban Middle School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Child
Keywords: School health
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 248
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based experiential culinary and nutrition literacy curriculum for middle-school students. The primary study hypothesis was that students assigned to YCA would demonstrate greater improvement in F/V and whole grain consumption compared to students in the control group. Eight classrooms in eight public K-8 schools participated in the project. Classrooms were assigned to intervention or control condition in a non-randomized manner. YCA was delivered by project staff to all of the students in the four intervention classrooms. Students completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum cohort).


Eligibility criteria: Inclusion Criteria:

* Student in intervention or control classroom

Exclusion Criteria:

-

Primary outcomes:
measure: Change in fruit and vegetable consumption
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in whole grain consumption
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02573649: The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study
Official title: Effects of Closed-loop Stimulation vs. DDD Pacing on Prevalence and Timing of Haemodynamic Variations and Clinical Prodromes Induced by Head-up Tilt Test in Patients With Refractory Cardioinhibitory Vasovagal Syncope. The TIRECS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal, Neurally-Mediated
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.

Detailed description: A total of 30 patients with refractory cardioinhibitory vasovagal syncope receiving a Biotronik pacemaker with Closed-loop Stimulation (CLS) algorithm will be enrolled in the study. Two head-up tilt test (HUTT), one during DDD 60/min pacing with CLS algorith turned off (CLS-OFF) and the other during DDD-CLS pacing (CLS-ON), will be performed one week apart; patients will be randomly and blindly assigned to group A (n=15, first HUTT in CLS-ON mode) or B (n=15, first HUTT in CLS-OFF mode). During HUTT heart rate, blood pressure, and the incidence of clinical prodromes and syncope wil be recorded.

Eligibility criteria: Inclusion Criteria:

* Refractory cardioinhibitory vasovagal syncope treated with permanent pacemaker;
* Pacemaker Biotronik with Closed-loop Stimulation algorithm
* Ability to perform a head up tilt test
* Completion of the 18th year of age

Exclusion Criteria:

* Contraindications to head up tilt test

Primary outcomes:
measure: Haemodynamic response during head up tilt test.
timeFrame: 45 minutes
measure: Incidence of prodromal symptoms during head up tilt test.
timeFrame: 45 minutes
measure: Incidence of syncope during head up tilt test.
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: Pietro Palmisano
state: Lecce
city: Novara
country: Italy
facility: Dell'Era Gabriele
Study officials:
affiliation: Cardiology Unit, Card G. Panico Hospital, Tricase, Italy
name: Pietro Palmisano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01988649: Oxytocin and Pain Sensitivity and Threshold
Official title: The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Keywords: Pain
Oxytocin
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In addition,oxytocin have an important roles in sexual reproduction , in particular during and after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin has been commonly used to improve breastfeeding in lactating women. A review of safety , side effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did not review any differences from placebo. The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain.

The main objective of the current investigation was to evaluate the effect of intranasal oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain threshold compared to intranasal saline .

Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in humans.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females volunteers
* English speaking
* Age \<20 and \> 35

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy to preservatives
* Mental disease
* Chronic pain
* Current use of analgesics
* Anxiety or depression Drop Out: volunteer request

Primary outcomes:
measure: Pain sensitivity and threshold
timeFrame: 120 minutes
Secondary outcomes:
measure: Side effects of Oxytocin
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: David Walega, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamasue H, Yee JR, Hurlemann R, Rilling JK, Chen FS, Meyer-Lindenberg A, Tost H. Integrative approaches utilizing oxytocin to enhance prosocial behavior: from animal and human social behavior to autistic social dysfunction. J Neurosci. 2012 Oct 10;32(41):14109-17. doi: 10.1523/JNEUROSCI.3327-12.2012.
Clinical trial NCT04393649: First Level Socio-geriatric Evaluation: ESOGER Databank
Official title: First Level Socio-geriatric Evaluation in Period of Physical and Social Distancing in Frail Older Patients and Older Community Dwellers: ESOGER Databank
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID
Social Isolation
Anxiety
Frailty
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 20000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the older patients and community dwellers living at home in Montreal contacted by the researchers and corresponding to the criteria.

The project is about a constitution of a databank.

Brief summary: Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.


Eligibility criteria: The inclusion criteria are:

1. Older (i.e., 70-years-old and over) adults OR caregiver living at home with an adult answering to inclusion criteria
2. Living and staying at home because of physical and social distancing
3. Understanding and writing the different languages of the recruitment centre (i.e., French, English, Chinese.)
4. Agree to participate in the study

The exclusion criteria are:

1. A concomitant participation to another medical trial
2. Living in semi-autonomous residence or CHSLD

Primary outcomes:
measure: COVID-19 symptoms
timeFrame: 1 day
measure: issues related to medication and food delivery and access to home care
timeFrame: 1 day
measure: physical frailty
timeFrame: 1 day
measure: psychological frailty
timeFrame: 1 day
Secondary outcomes:
measure: Caregiver burden
timeFrame: 1 day
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT03648749: Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
Official title: Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2018-08-27
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group will be studied during no intervention (no feedback about speech) and intervention (feedback about speech) phases.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Detailed description: This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Eligibility criteria: Inclusion Criteria:

* diagnosed with idiopathic Parkinson's disease and hypophonia by a neurologist at least 6 months prior to participation.
* stabilized on antiparkinsonian medication.
* good general health.
* pass a 40 decibel hearing screening.
* proficient enough in English to participate in speech testing.

Exclusion Criteria:

* history of stroke or an additional neurological or motor control disorder.
* history of speech impairment that is unrelated to Parkinson's disease.

Primary outcomes:
measure: Average speech-to-noise ratio
timeFrame: Single two-hour visit.
Secondary outcomes:
measure: Percent Speech Intelligibility Score (PSIS)
timeFrame: Single two-hour visit.
measure: Ratings of Experience with the Device
timeFrame: Single two-hour visit.
Other outcomes:
Locations:
city: London
country: Canada
facility: LawsonHRI
state: Ontario
Study officials:
affiliation: Western University
name: Scott Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References: