louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04045080: Hand Rehab Using AMADEO in PD Patients
Official title: The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.


Eligibility criteria: Inclusion Criteria

* Idiopathic PD diagnosed according to the Gelb's criteria;
* Hoehn-Yahr stage 1- 3
* "On" state
* MMSE score ≥ 24
* Willing and able to give written informed consent;
* Willing and able to comply with the study procedures.

Exclusion Criteria

* A specific kind of fluctuation: Sudden on-off fluctuations
* History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
* History of stereotaxic brain surgery for PD;
* Mini-mental examination (MMSE) score less than 24 at screening;
* Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
* Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;
* Presence of severe dyskinesia prior to baseline;
* Any other medical or psychiatric condition that may compromise the patient's participation in this study;

Primary outcomes:
measure: Nine hole peg test
timeFrame: 1 month
Secondary outcomes:
measure: Bipolar surface electromyography
timeFrame: 1 month
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi "Bonino-Pulejo"
Study officials:
affiliation: IRCCS Centro Neurolesi
name: Rocco S Calabrò
role: STUDY_CHAIR
References:
Clinical trial NCT00139880: A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease
Official title: A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of \< 200 mg carbidopa and \< 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.

Detailed description: See approved Package Insert for Adverse Event information.

Eligibility criteria: Inclusion Criteria:

* Stable Parkinson's disease

Exclusion Criteria:

* idiopathic PD with Hoehn and Yahr state II or III

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Schwarz
state: Wisconsin
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02664480: Assesment of Salivary Alpha-amylase Levels Before and After Ovulation
Official title: Assesment of Salivary Alpha-amylase Levels Before and After Ovulation: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salivary Amylase
Keywords: Salivary Alpha-amylase
ovulation
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pcos women will included the study population. Because ovulation don't happen.

Brief summary: Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.

Detailed description: Saliva is a readily available specimen, which can be collected by noninvasive procedures and contains many hormones, drugs and antibodies of interest in screening and diagnosis. With a salivary specimen, one can collect multiple specimens at the optimum times for diagnostic information. Saliva can be collected in remote sites by unskilled personnel and, is stable at ambient temperatures for several weeks. Because of diurnal and monthly variations, several steroid hormones need multiple samples collected early in the morning or late at night or at the same time every day for a month to give meaningful results. Such collections are often very expensive, inconvenient or impossible to do with blood.

Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PCOS (study group)
* Reproductive age regular menses women

Exclusion Criteria:

* pregnancy,
* breastfeeding,
* known liver disease,
* alcohol abuse,
* diabetes mellitus,
* smoking
* treatment with oral glucocorticoids
* treatment with hormonal contraceptives.

Primary outcomes:
measure: Changes of Salivary Alpha-amylase activity
timeFrame: 3rd and 24th day of menstrual cyclus
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Etimesgut Military Hospital
name: Mustafa Öztürk, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00466180: Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Once-a-day
Adherence
Nevirapine
Patient noncompliance
Administration and dosage
Treatment Experienced
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 62
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: Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day.

We hypothesized that once-daily dosing improves adherence.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
* plasma HIV RNA\<400 cp/ml during the previous 4 months on 2 occasions
* accept adherence electronic monitoring
* written informed consent signed

Exclusion Criteria:

* asparate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5N if hepatitis virus B or C were negative
* AST or ALT\>1.25N if hepatitis virus B or C were positive

Primary outcomes:
measure: MEMS adherence by electronic devices
timeFrame: 28-week period (randomized phase)
Secondary outcomes:
measure: Virologic efficacy (RNA HIV<400cp/ml)
measure: Immunologic efficacy (CD4 count cells)
measure: Tolerance (hepatic, cutaneous, ANRS safety grade scale)
measure: Pharmacokinetics (nevirapine dosages)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Jean-Jacques Parienti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.
citation: Parienti JJ, Massari V, Reliquet V, Chaillot F, Le Moal G, Arvieux C, Vabret A, Verdon R; POSOVIR Study Group. Effect of twice-daily nevirapine on adherence in HIV-1-infected patients: a randomized controlled study. AIDS. 2007 Oct 18;21(16):2217-22. doi: 10.1097/QAD.0b013e3282eff388.
Clinical trial NCT02665780: Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour
Official title: Assessing the Effect of Periodontal Debridement, Tongue Cleaning and Mouth Rinsing for the Treatment of Oral Malodour
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Halitosis
Keywords: halitosis, periodontal debridement, chemotherapeutics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath

Detailed description: The majority of bad breath producing bacteria can be found in pockets around the gums and the top of the tongue. It is generally agreed that one of the most effective means of controlling the production of bad breath gases from these bacteria is their mechanical removal. Tongue cleaning has shown consistent results in the reduction of bad breath, while dental cleaning has shown positive, but less conclusive results. The addition of a mouth rinse to mechanical measures has shown medium-term effectiveness, however there is currently no information available that describes the long-term impact of mechanical and chemical measures for the treatment of bad breath and the appropriate interval for follow-up and on-going management to prevent difficult cases.

Eligibility criteria: Inclusion Criteria:

Organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan

-

Exclusion Criteria:

* Moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers

Primary outcomes:
measure: Reduction of oral malodour below threshold
timeFrame: 1, 12, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Leeann Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750980: Microbiota and Allergy
Official title: Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 48
Maximum age (years): 84
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with food allergy, children with respiratory allergy and health controls aged 48-84 months

Brief summary: Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.


Eligibility criteria: Inclusion Criteria:

* Children with sure diagnosis of food allergy,
* children with sure diagnosis of respiratory allergy

Exclusion Criteria:

* age at enrollment \<48 months or \>84 months;
* eosinophilic disorders of the gastrointestinal tract;
* chronic systemic diseases;
* congenital cardiac defects;
* acute or chronic infections;
* autoimmune diseases;
* immunodeficiencies;
* chronic inflammatory bowel diseases;
* celiac disease;
* cystic fibrosis or other forms of primary pancreatic insufficiency;
* genetic and metabolic diseases;
* food intolerances;
* malignancy;
* chronic pulmonary diseases;
* malformations of the respiratory tract or of the gastrointestinal tract;
* pre-, pro- or sinbiotic use in the previous 3 months;
* antibiotics or gastric acidity inhibitors use in the previous 3 months.

Primary outcomes:
measure: Evaluation of gut microbiome features in allergic children and in healthy controls.
timeFrame: at enrollment
Secondary outcomes:
measure: Gut microbiome and allergy disease course
timeFrame: at enrollment
measure: Evaluation of gut microbiome features in children affected by different allergies (food and respiratory)
timeFrame: at enrollment
measure: Evaluation of gut microbiome features in children affected by different type of food allergy
timeFrame: at enrollment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References:
citation: De Filippis F, Paparo L, Nocerino R, Della Gatta G, Carucci L, Russo R, Pasolli E, Ercolini D, Berni Canani R. Specific gut microbiome signatures and the associated pro-inflamatory functions are linked to pediatric allergy and acquisition of immune tolerance. Nat Commun. 2021 Oct 13;12(1):5958. doi: 10.1038/s41467-021-26266-z.
Clinical trial NCT02386280: Prevention of Drug Use in Adolescence: Intervening in Parenting Styles
Official title: Prevention of Drug Use in Adolescence: Intervening in Parenting Styles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Substance-Related Disorders
Keywords: Primary Prevention
Substance-Related Disorders
Family
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether brief motivational intervention is associated with the change of parenting style in parents of teenagers seeking to prevent drug use among their children.


Eligibility criteria: Inclusion Criteria:

* Parents of adolescents aged 10-15 years who call for the service call 132 looking for a program to prevent drug use and accept to participate in the study after reading the Statement of Consent

Exclusion Criteria:

* Be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by IC

Primary outcomes:
measure: Measure the reduction risk factors for the use of drugs
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: FUHSPortoAlegre
state: RS
Study officials:
References:
Clinical trial NCT01606280: Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation
Official title: Reporting of Amyloidosis Stem Cell Transplantation Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyloidosis
Keywords: Amyloidosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient receiving transplantation

Brief summary: This study examines the value of stem cell transplantation in managing light chain amyloidisis.

Detailed description: 1. How does age at diagnosis affect prognosis in primary amyloidosis?
2. How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis?
3. How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis?
4. How does initial treatment affect prognosis in primary amyloidosis?

4. How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?

Eligibility criteria: Inclusion Criteria:

* Eligible for Stem cell transplantation less than age 75

Exclusion Criteria:

* Creatinine \> 3.0
* BNP \> 10000

Primary outcomes:
measure: Survival
timeFrame: up to 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT02667080: Sperm Quality in Consecutive Sperm Samples After 4-7 Days and 2 Hours of Sexual Abstinence
Official title: Parameters of Sperm Quality in Consecutive Sperm Samples From Males Partners of Couples Seeking Treatment for Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Semen Quality
Keywords: Semen quality
Sexual Abstinence
sperm motility
DNA fragmentation
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2016-01-28
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples referring for ART treatment.


Eligibility criteria: Inclusion Criteria:

* male age between 18 and 50
* able to understand and read Danish

Exclusion Criteria:

* complete azospermia
* significant psychological illness
* significant cardiovascular disease

Primary outcomes:
measure: Routine semen quality assessment
timeFrame: After liquefaction (30-35 minutes after ejaculation)
Secondary outcomes:
measure: Outcome of ART treatments
timeFrame: up to one year after the sampling
Other outcomes:
Locations:
city: Dronninglund
country: Denmark
facility: Aalborg University Hospital, Dronninglund Fertility Clinic
Study officials:
affiliation: Aalborg University Hospital, Gynecology Department
name: Ole Bjarane M.D., Ph.D., M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Aalborg University, Faculty of Medicine, Department of Health Science and Technology
name: Hiva Alipour, D.V.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University, Faculty of Medicine, Department of Health Science and Technology
name: Fereshteh Dardmeh, D.V.M.
role: STUDY_CHAIR
affiliation: University of the Western Cape, Capetown, South Africa
name: Gerhard Van DerHorst, Ph.D.
role: STUDY_CHAIR
affiliation: Aalborg University Hospital, Gynecology Department
name: Christina Hnida, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03597880: Preoperative Evaluation of Airway
Official title: Evaluation of Airway on Undervent Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Difficult Intubation
Keywords: difficult airway, obese patient,
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: retrospective clinical trial
Primary purpose: SCREENING

Brief summary: Evaluation of airway markers of patients who have undergone obesity surgery.

Detailed description: The investigators evaluated the airway parameters recorded preoperatively for patients with BMI\> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.

Eligibility criteria: Inclusion Criteria:

1. BMI\>30kg/m2
2. 18\<age \<65
3. elective surgery planned
4. ASA II-III

Exclusion Criteria:

1. BMI\<30kg/m2
2. 18\>age \>65
3. ASA IV

Primary outcomes:
measure: airway evaluation for menagement in obese patient
timeFrame: 3 year
measure: mallampati score
timeFrame: 3 year
measure: thyromental distance
timeFrame: 3 year
measure: neck circumference
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yeditepe UH
name: nurcan kizilcik
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langeron O, Birenbaum A, Le Sache F, Raux M. Airway management in obese patient. Minerva Anestesiol. 2014 Mar;80(3):382-92. Epub 2013 Oct 14.