louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02505438: Application of Deuterated Water (D2O) to Define the Etiology of Musculoskeletal Decline in Ageing and the Efficacy of Nutritional Supplementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: The Dunhill Medical Trust
First posted: 2015-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Maintaining muscle mass and function is important in healthy ageing to maintain quality of life. Loss of muscle mass is major problem, as beyond the age \~50, muscle mass declines by \~1-2% a year. To prevent this loss, the investigators need to understand the mechanism regulating muscle mass as we age. In this project the investigators aim to determine these mechanisms using a new technique of heavy water ingestion, this allows measurement of multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long periods (6 weeks) as people go about their normal everyday activities. The investigators also aim to determine the influence of resistance exercise training on older muscle, as well as differences between men and women in muscle responses to exercise and nutrition HMB (beta-hydroxy-beta-methylbutyrate).


Eligibility criteria: Inclusion Criteria:

* Young (18-30y) and old (60-75y) individuals who are generally healthy and recreationally active

Exclusion Criteria:

* Active cardiovascular disease
* Cerebrovascular disease including previous stroke, aneurysm (large vessel or intracranial)
* Respiratory disease including pulmonary hypertension or Chronic obstructive pulmonary disease, Hyper/ hypo parathyroidism, hyper/ hypothyroidism,
* Cushing's disease, diabetes
* Active inflammatory bowel disease
* Renal disease
* Malignancy
* Recent steroid treatment (within 6 mo), or hormone replacement therapy Clotting dysfunction
* Musculoskeletal or neurological disorders
* Any disease requiring long-term drug prescriptions, including statins

Primary outcomes:
measure: Muscle Protein Synthesis
timeFrame: 0-6 Weeks
measure: Muscle Strength
timeFrame: 0-6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital Medical School
Study officials:
affiliation: University of Nottingham
name: Ken Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922038: Rewarding Sexually Transmitted Infection (STI) Prevention and Control in Tanzania
Official title: Encouraging Safe Sexual Practices Among Youth Using Cash Rewards: A Randomized Trial in the Kilombero/Ulanga Districts, Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: World Bank
name: Health Effects Institute
name: William and Flora Hewlett Foundation
name: Population Health Research Institute
name: University of California, San Francisco
name: RTI International
First posted: 2009-06-17
Enrollment: 2411
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project evaluates the effect of a combined economic and psycho-social intervention to reduce risky sexual activity and its consequences. The main hypothesis to be tested is that risky sexual activity and resulting sexually transmitted infections (STIs) can be reduced through an intervention of counseling, regular STI testing, and positive reinforcement using cash rewards. The intervention is being implemented in a population of young people in rural Tanzania where more conventional behavioral change interventions have had limited effect in battling a generalized HIV epidemic.


Eligibility criteria: Inclusion Criteria:

* Plan to live in study area for next 12 months

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Prevalence of sexually transmitted infections measured in laboratory testing (Chlamydia, Gonorrhea, Syphilis, Trichomonas, Mycoplasma genitalium, HSV-2, HIV)
timeFrame: 4, 8, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Berkeley
name: William H Dow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Walque D, Dow WH, Nathan R, Abdul R, Abilahi F, Gong E, Isdahl Z, Jamison J, Jullu B, Krishnan S, Majura A, Miguel E, Moncada J, Mtenga S, Mwanyangala MA, Packel L, Schachter J, Shirima K, Medlin CA. Incentivising safe sex: a randomised trial of conditional cash transfers for HIV and sexually transmitted infection prevention in rural Tanzania. BMJ Open. 2012 Feb 8;2(1):e000747. doi: 10.1136/bmjopen-2011-000747. Print 2012.
Clinical trial NCT02909738: Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator
Official title: Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Exertion
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The investigators would like to test how well healthy human volunteers power a modified oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a bicycle instead of wall power so that it can be used in low resource countries where the power supply is unreliable.

Detailed description: The investigators would like to test how many healthy people can power the oxygen concentrator by pedaling the bike for at least 30 minutes. If the healthy volunteers can bike for at least 30 minutes, the investigators assume they are pedaling at or below their lactate threshold. The investigators have literature values which suggest bigger people should be able to output more work, and the investigators wish to use a sample of the population to verify that most of the people can power our system. The investigators have a good estimate of the power required by our system, and the investigators want to verify the average person can actually do what we calculated is necessary.

Eligibility criteria: Inclusion Criteria:

* Volunteers will be included if they are between 18 and 45 years of age and if they do not have physical restrictions which would preclude them from riding a bike for 30 minutes.

Exclusion Criteria:

* 1)anyone with known cardiovascular, pulmonary, or metabolic disease or

  2)an age of greater than 45 or

  3) one or more of the following symptoms:
  * On medication for their heart
  * Suffer from pains in their chest
  * Ever feel faint of have spells of severe dizziness
  * High blood pressure
  * Currently on blood pressure medication
  * Have a bone or joint problem such as arthritis that has been aggravated by exercise
  * Unaccustomed to vigorous exercise
  * Have experienced unusual heart beats such as skipped beats or palpitations
  * Experience shortness or loss of breath while walking with others your own age
  * Have been diagnosed with diabetes

Primary outcomes:
measure: Capable of pedaling the bike for 30 minutes
timeFrame: 30 minutes from the start time
measure: Average heart rate
timeFrame: Average for the 30 minute pedaling session
measure: volume of oxygen generated
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT03363438: Knowledge Attitudes Behaviours and Practices Regarding HIV of Sex Workers in the French Antilles
Official title: Knowledge Attitudes Behaviours and Practices Regarding HIV of Sex Workers in the French Antilles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sex workers living in the french antilles

Brief summary: The aim of the study was to determine the knowledge attitudes, behaviours and practices of sex workers regarding HIV in Martinique, guadeloupe and Saint martin.


Eligibility criteria: Inclusion Criteria:

* sex worker living in the french antilles

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Knowledge regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey
timeFrame: one year
measure: Attitudes regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey
timeFrame: one year
measure: Behaviours regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey
timeFrame: one year
measure: Practices regarding HIV of Sex Workers in the French Antilles - Questionnaire Survey
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03562338: Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise
Official title: Modelo Preditivo Para os Resultados de Sucesso Com um Programa Combinado de Terapia Manual e exercício em indivíduos Com Dor Cervical crónica de Origem não-especifica
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Neck Pain
Keywords: chronic nonspecific neck pain
disability
predictive model
rehabilitation
pain intensity
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.


Eligibility criteria: Inclusion Criteria:

* Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
* Adults between 18 and 65 years of age and literate in Portuguese;

Exclusion Criteria:

* History of cervical trauma and/or history of surgery in the prior 6 months;
* Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
* Pregnancy

Primary outcomes:
measure: Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
timeFrame: 3 weeks
measure: Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks.
timeFrame: 6 weeks
measure: Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months.
timeFrame: Follow-up 3 months
measure: Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks.
timeFrame: 3 weeks
measure: Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks.
timeFrame: 6 weeks
measure: Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months.
timeFrame: Follow-up 3 months
Secondary outcomes:
measure: Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks
timeFrame: 3 weeks
measure: Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks
timeFrame: 6 weeks
measure: Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 months
timeFrame: Follow-up 3 months
Other outcomes:
Locations:
Study officials:
affiliation: NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
name: Lúcia Domingues
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01633138: Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
Official title: Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Mental Disorders
Keywords: cognitive remediation therapy
substance abuse treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-07-04
Enrollment: 40
Sex: ALL
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 investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.

Detailed description: Forty individuals seeking treatment for an alcohol or cocaine use disorder at the Substance Abuse Treatment Unit (SATU) will be randomized to receive cognitive remediation therapy with or without additional compensation based on performance. Participants will use the computerized cognitive remediation program (PSSCogRehab 2012) three times per week for four weeks. The primary outcome measure will be an improved performance on the computerized tasks, with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration, memory) as measured by neuropsychological tests between baseline and post-treatment.

Eligibility criteria: Inclusion Criteria:

* 18 to 60 years old
* Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
* Abstinence from all drugs/alcohol for 30 days
* Mild cognitive impairment
* Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
* Fluent in English and 6th grade reading ability

Exclusion Criteria:

* Severe cognitive impairment indicative of dementia
* Untreated bipolar or psychotic disorder
* Have current legal case pending such that incarceration during 4-week study is likely

Primary outcomes:
measure: Improvement in performance scores on computerized cognitive remediation tasks
timeFrame: 4 weeks
Secondary outcomes:
measure: Improved cognitive function on neuropsychological tests
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Brian D Kiluk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00656838: Focusing Implementation to Bring Effective Reminders (FIBER)
Official title: Focusing Implementation to Bring Effective Reminders (FIBER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon
rectal
cancer
screening
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Henry Ford Health System
First posted: 2008-04-11
Enrollment: 85289
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: FIBER is 4-year study that will evaluate the implementation of a large-scale population-based colorectal cancer screening patient reminder and coordinated follow-up program. The CRC screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit, integrated health system in Oregon and Washington. FIBER consists of 1)a practical randomized controlled trial at the start of the program, followed by 2) a longer-term cohort study as all remaining eligible patients receive the program, and 3)a qualitative evaluation. FIBER will evaluate the factors that are associated with implementation success across multiple levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general surgeons, pathologists), and other health plan staff and systems.


Eligibility criteria: Inclusion Criteria:

* KPNW members since 2005
* Men and women, aged 50-80 who were due for CRC screening during a 24-month period of time.

Exclusion Criteria:

* KPNW members who were part of a previous quantitative study.

Primary outcomes:
measure: To determine the effectiveness and maintenance of a colon-rectal cancer screening patient reminder program.Identify patient, primary care team, and system factors important to implementation success.
timeFrame: Year 2, 3
Secondary outcomes:
measure: Create, refine, and disseminate an implementation guide for colon-rectal cancer screening reminder programs by combining the findings from the primary aim.
timeFrame: Years 3, 4
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Foundation Hospital
name: Adrianne C. Feldstein, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619538: Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
Official title: Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Diverticulosis, Colonic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.


Eligibility criteria: Inclusion Criteria:

* Adult patient with a score ASA between I and III
* Patient scheduled for elective major abdominal surgery (by laparotomy) for cancer or diverticulosis
* Patient that signed the consent form

Exclusion Criteria:

* - Patient treated in emergency situation
* Patient with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* Patient that needs a surgery for restoration of continuity
* Patient pregnant, breastfeeding, or during periods of genital activity using no contraception.
* Patient with contraindications to nefopam, morphine, or paracetamol
* Patient with chronic obstructive pulmonary disease, renal or severe hepatic impairment
* Patient under analgesics treatment
* Patient who participated in a clinical study in the previous 6 months.

Primary outcomes:
measure: Estimate morphine consumption
timeFrame: over 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nîmes University Hospital
name: Jacques RIPART, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558738: Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations
Official title: Non Interventional Study (NIS): Clinical Investigation for Evaluation of the Safety and Efficacy of Ectoin Ear Spray and Normison Ear Spray in Skin Treatment of Outer Ear Canal Irritations: A Mulitcenter Non Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pruritus
Dermatitis
Otitis Externa
Keywords: dermatitis and irritations at the outer ear canal
prevention of subacute otitis externa
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care ENT units study the therapeutic process in this observational trial in total of 60 patients in three centres with dermatological irritations of the outer ear canal and pruritus

Brief summary: In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.


Eligibility criteria: Inclusion Criteria:

* according to instructions for use

Exclusion Criteria:

* otitis media, acute otitis media
* acute otitis externa
* earache
* perforation of the ear-drum (membrana tympani)
* infections at the ear
* systemic corticosteroid treatment or local at the ear

Primary outcomes:
measure: Pruritus at outer ear canal
timeFrame: 14 days
Secondary outcomes:
measure: Severity of pruritus
timeFrame: 14 days
measure: Dermatitis
timeFrame: 14 days
measure: burning issue on skin
timeFrame: 14 days
measure: Tolerability
timeFrame: 14 days
measure: Efficacy
timeFrame: 14 days
measure: Change in number of adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Elmshorn
country: Germany
facility: HNO Praxis Elmshorn
city: Lueneburg
country: Germany
facility: HNO Moeller
city: Norderstedt
country: Germany
facility: HNO Bergmann-Omar
Study officials:
affiliation: HNO Praxis Elmshorn
name: Uwe Sonnemann, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02605538: Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
Official title: Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystic Fibrosis
Hepatitis A
Hepatitis B
Tuberculosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2015-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

Detailed description: Initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis A and B vaccine.

The connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis B and to measure whether the immunization is related to specific interferon gamma response against Mycobacterium tuberculosis.

Eligibility criteria: Inclusion Criteria:

* CF patients not previously immunized against hepatitis A or B
* Healthy volunteers not previously immunized against hepatitis A or B
* Age over 1 year

Exclusion Criteria:

* Previously transplanted patients
* Previous vaccination with hepatitis vaccine
* Known allergy against components in Twinrix (TM)

Primary outcomes:
measure: Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
timeFrame: 6 months for vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm CF Center, KArolinska University Hospital
Study officials:
affiliation: Stockholm CF Center, Karolinska University Hospital
name: Ferenc Karpati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: