louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01790100: A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Official title: A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2013-02-13
Enrollment: 20
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 the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

Detailed description: Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.

Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.

Eligibility criteria: Key Inclusion Criteria:

* Subjects (male and female) must be between 18-60 years of age
* Subjects must have Chronic Hepatitis C
* Subjects must be treatment naive
* Subjects must have laboratory values at screening within limits as specified by the protocol

Key Exclusion Criteria:

* Evidence of cirrhosis
* Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
* any other cause of significant liver disease in addition to hepatitis C
* Diagnosis of or suspected hepatocellular carcinoma

Primary outcomes:
measure: Safety
timeFrame: Week 12
Secondary outcomes:
measure: evidence of HCV RNA viral load reduction
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Arensia, Republican Clinical Hospital
Study officials:
References:
Clinical trial NCT00676000: Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
Official title: Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Dyspareunia
Surgical Mesh
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. There are different ways to close the vaginal wall over the mesh used in these procedures. Currently, there is no accepted standard method of closing the vaginal wall. The purpose of this study is to find out the best way to close the surgical wound in the vagina. We will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). We hope to show in our study that one method of closure is better than the other.


Eligibility criteria: Inclusion Criteria:

* Scheduled for surgery to correct anterior vaginal prolapse with mesh kit

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Mesh exposure
timeFrame: One year
Secondary outcomes:
measure: Pain
timeFrame: One year
measure: Dyspareunia
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Danielle Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071000: Preschool Children Motor Development
Official title: Effect of Neurodevelopmental Stimulation on Motor and Cognitive Development in Neurotypical Healthy Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persisting Primitive Reflexes
Keywords: motor development
fundamental motor skills
executive functions
neurodevelopmental
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The preschool age period is crucial for motor and cognitive development, which retention primary reflexes can negatively influence. Primary reflexes are fixed motor patterns controlled from developmentally lower areas of CNS and are necessary for delivery, survival or rudimentary movement activation during infancy and should be progressively inhibited. Primary reflexes' retention increases the risk of blocks for further cognitive and motor development in higher, mainly cortical areas. Children in preschool and school age with non-inhibited primary reflexes displayed a poor level of fundamental movement skills and worse attention, self-regulation or working memory capacity. Children with the problems above usually pass a movement program based on developmental kinesiology, like Neurodevelopmental stimulation (NVS). NVS contains exercises that simulate situations for adequate processing of the primary reflex and allow the brain to correct and inhibit this reflex. Even though in the Czech preschool environment, almost 13% of children with neurotypical development have significant positive responses to at least one primary reflex, there are no methods to inhibit primary reflexes to improve motor and cognitive development positively. Therefore, this project aims to find how the NVS intervention will influence the performance in the selected area of motor and cognitive development, with the follow-up three-month retesting. Population for this project are preschool children aged 4-6 years old.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* strong ADHD/learning disorders diagnosed

Primary outcomes:
measure: TGMD-2
timeFrame: 8 months
measure: IDS / IDS-P
timeFrame: 8 months
measure: Primitive (primary) reflexes
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00107900: Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Official title: A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthroplasty, Replacement, Hip
Thrombosis
Keywords: Deep Vein Thrombosis,
Anticoagulant,
Venous thromboembolic
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-04-12
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

Detailed description: The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Eligibility criteria: Inclusion Criteria:

* Unilateral hip replacement

Exclusion Criteria:

* Patients scheduled for bilateral hip replacement in same procedure
* Patients with increased risk of bleeding
* Uncontrolled hypertension (BP greater than 180/100 mmHg)
* Patients less than 111 lbs or more than 243 lbs
* Patients on long-term anticoagulants
* Patients with contraindications to venography
* Patients with medical history of venous thromboembolism
* Patients with impaired hepatic function
* Known to be pregnant
* Lactating women

Primary outcomes:
measure: Prevention of Venous Thromboembolism (VTE)
timeFrame: 2 weeks
Secondary outcomes:
measure: Change From Baseline for Prothrombin Time (PT) Results
timeFrame: end of treatment
measure: Change From Baseline for International Normalized Ratio (INR) Results
timeFrame: end of treatment
measure: Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
timeFrame: end of treatment
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Local Institution
state: Georgia
Study officials:
References:
Clinical trial NCT00033059: Assessment of Potential Interactions Between Cocaine and Tolcapone - 1
Official title: Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the potential interactions between intravenous (IV) cocaine and tolcapone.

Detailed description: Double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.

Eligibility criteria: Inclusion Criteria:

Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence

Exclusion Criteria:

Additional criteria available during screening at the site

Primary outcomes:
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Thomas Newton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059459: Effect of Atmospheric Pollution on Obstructive Lung Diseases
Official title: Effect of Atmospheric Pollution Due to Particulate Matter on Obstructive Lung Diseases in San Nicolas, Buenos Aires Province, Argentina
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases, Obstructive
Keywords: Lung Diseases, Obstructive
Air Pollution
Particulate Matter
Lead sponsor: National Council of Scientific and Technical Research, Argentina
Sponsor class: OTHER_GOV
First posted: 2017-02-23
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province, Argentina.

Brief summary: Several studies have demonstrated the association between atmospheric pollution and chronic respiratory diseases. The magnitude of this association and its dependence of local factors are still unknown in Argentina, particularly for obstructive lung diseases like asthma and chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the effect of atmospheric pollution due to particulate matter (PM) on asthma and COPD exacerbations in adults. A prospective cohort study will be carried out in patients attending the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province, Argentina. Patients will be followed for 12 months after recruitment. The outcome variables will be the frequency of hospitalizations or emergency department consults for asthma or COPD exacerbations and related conditions, and the impact of COPD on a person's life as measured by the COPD assessment test (CAT) questionnaire. The exposure will be the pollution level in the particular address, measuring PM10 concentrations with portable equipment. Other variables as air temperature, humidity, and individual patient risk factors will be considered as potential confounders or effect modifiers. The associations will be estimated through regression models, i.e. logistic and Poisson regressions and recurrent event survival analysis. The results of this study should provide elements to estimate the risk of chronic respiratory diseases associated with atmospheric pollution, and to evaluate strategies for risk assessment in the local community.


Eligibility criteria: Inclusion Criteria:

* Patients with asthma or COPD attending the pulmonary service.

Exclusion Criteria:

* Patients who refuse to participate in this study or to sign the informed consent document.

Primary outcomes:
measure: Asthma or COPD hospitalizations or emergency department visits
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life associated with obstructive lung diseases
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: National Scientific and Technical Research Council, Argentina
name: Pablo Orellano, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04796259: Malt-derived Ingredients and Their Prolactinotrophic Effects
Official title: Malt-derived Ingredients and Their Prolactinotrophic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Response to Food Ingredient Consumption
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.


Eligibility criteria: Inclusion Criteria:

* Subjects who have/are

  1. Willing and able to provide written informed consent
  2. Healthy women aged 18 to 40.
  3. BMI in the range of 18 to 30.
  4. Willing to undergo an experiment in the follicular phase of the menstrual cycle i.e. day 0 to 14 of the menstrual cycle starting from the first day of the period.

Exclusion Criteria:

* Subjects who have/are
* Allergic to tested products
* Under regular medication including oral contraceptive pills or other form of hormonal replacement therapy.
* Under medications which affects prolactin levels.
* Pregnant or lactating or planning to conceive during the study period.
* Smokers, or excessive alcohol consumption (alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer) or other substance abuse.
* Not willing and/or not able to comply with the study procedures and requirements.
* Suffering from pre-existing medical conditions and chronic illnesses that in the opinion of the investigator may interfere with the study.
* Family or hierarchical relationships with research team members

Primary outcomes:
measure: Prolactinotrophic effect
timeFrame: 2 hours post consumption
Secondary outcomes:
measure: Gastrointestinal tolerability
timeFrame: 2 hours post consumption
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Société des produits Nestlé/Metabolic Unit
Study officials:
affiliation: Société des Produits Nestlé S.A./NIHS
name: Jose M. Ramos Nieves, M.Sc.; Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Société des Produits Nestlé S.A./CIL
name: Pamela Sun
role: STUDY_DIRECTOR
References:
Clinical trial NCT03635359: Automated Screen for Fetal Aneuploidy
Official title: Fluidic Automated Screening for Trisomy Study I
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trisomy 21 and Other Fetal Aneuploidy
Keywords: fetal
screening test
trisomy
aneuploidy
copy number variant
Lead sponsor: BioCeryx
Sponsor class: INDUSTRY
Collaborators: name: Brugmann University Hospital
name: University of British Columbia
name: Royal Prince Alfred Hospital, Sydney, Australia
name: Hospital Universitario Virgen de la Arrixaca
name: Hospital CUF Descobertas, Lisbon, Portugal
name: University College London Hospitals
First posted: 2018-08-17
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.

Brief summary: The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old and can provide informed consent;
2. Subject has a viable singleton or twin pregnancy;
3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
4. Subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free DNA test results, standard serum screening result, or fetal ultrasound abnormality.
5. OR the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.

Exclusion Criteria:

1. Subject (the mother) has known aneuploidy;
2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.

Primary outcomes:
measure: Comparison of blood test to fetal karyotype
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Brussels
country: Belgium
facility: University Hospital Brugmann
city: Vancouver
country: Canada
facility: University of British Columbia
city: Lisbon
country: Portugal
facility: Hospital CUF Descobertas
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: BioCeryx
name: Thomas J Musci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764959: Retrospective Study of the Linear™ Hip
Official title: Post-Market Study of the Linear™ Hip System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Femoral Fracture
Correction of a Functional Deformity
Avascular Necrosis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who meet the indications for use of the Linear Hip device AND who meet the inclusion/exclusion criteria

Brief summary: The purpose of this study is to evaluate the use and efficacy of the Encore Linear™ Hip System in a group of 200 patients for whom data has already been collected.


Eligibility criteria: Inclusion Criteria:

* Have hip joint disease related to one or more of the following

  * osteoarthritis
  * rheumatoid arthritis
  * femoral fracture
  * correction of a functional deformity
  * avascular necrosis of the natural femoral head
* Skeletal maturity
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant
* No infection present
* No known materials sensitivity
* Patient is over 18 years of age

Exclusion Criteria:

* Skeletal immaturity
* Infection or sepsis
* Insufficient bone quality that may affect the stability of the implant
* Muscular, neurologic or vascular deficiencies which compromise the affected extremity
* Alcoholism or other addictions
* Prisoners
* High levels of physical activity
* Patient is pregnant
* Loss of ligamentous structures
* Materials sensitivity
* Patient is under 18 years of age

Primary outcomes:
measure: The use and efficacy of the Encore Linear™ Hip System
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vero Beach
country: United States
facility: Hussamy Orthopedics
state: Florida
Study officials:
affiliation: Hussamy Orthopedics
name: Omar Hussamy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: