louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03369860: Neuro-cognitive Bases of Joint Action
Official title: Basi Neuro-cognitive Dell'Interazione Motoria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Social Interaction
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The ability to interact with conspecifics is crucial in life, yet there is no consensus on the underlying cognitive and neural mechanisms beyond those associated with imitative behaviors. This project aims to define a coherent model of non-imitative (complementary) motor interactions. The investigators hypothesize that these might be substantially based on the ability to integrate one's own and a partner's action within a unitary, dual- person (dyadic), motor plan that incorporates a shared goal.

With a novel "minimally-joint" paradigm the investigators will test this hypothesis and measure with behavioral measures (i.e., reaction times) whether the supposedly automatic tendency to imitate others is modulated by the need to coordinate with a partner to achieve a shared goal.

This paradigm will be also applied during a functional MRI experiment to describe the underlying neurophysiological patterns; using dynamic causal modeling the investigators will measure how the brain regions relevant for dyadic motor control are functionally linked.

This converging experimental strategy will permit to compare competing psychological and neural models of motor interactions in healthy participants, opening new experimental avenues for studies in adult neuropsychological patients and in children with typical and atypical social development.


Eligibility criteria: Inclusion Criteria:

* right handed; no contraindication to MRI

Exclusion Criteria:

* contraindication to MRI

Primary outcomes:
measure: Reaction Times
timeFrame: 1 year
measure: BOLD activations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
References:
Clinical trial NCT04039360: SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer
Official title: Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Treatment
Keywords: Left-sided colonic tumor
Intestinal obstruction
Self-expanding metallic stent
Neoadjuvant chemotherapy
Stoma
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 11 patients included seven (63.6%) men and four (36.4%) women. The median age of the patients was 67 years (range, 43-72 years)

Brief summary: This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Detailed description: Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

Eligibility criteria: Inclusion Criteria:

1. histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
2. Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2

Exclusion Criteria:

1. history of any other cancer
2. multiple primary colorectal cancers
3. distant metastases
4. hereditary nonpolyposis colorectal cancer
5. familial adenomatous polyposis

Primary outcomes:
measure: stoma rate
timeFrame: 3 years after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02272660: Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty
Official title: Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: preemptive analgesia
parecoxib sodium
total knee arthroplasty
total hip arthroplasty
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 74
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: TREATMENT

Brief summary: Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Detailed description: Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.

We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
2. Age between 18-65 years.
3. Chinese ethnicity.

Exclusion Criteria:

1. patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
2. patient exhibited allergy to parecoxib sodium.
3. lactating or pregnant.
4. any other conditions not suitable for surgery as evaluated by the surgeon in charge.

Primary outcomes:
measure: To evaluate the Morphine consumption in each group patients
timeFrame: 4 hours to 6 days after the surgery
Secondary outcomes:
measure: To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration
timeFrame: 4 hours to 6 days after the surgery
measure: To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty
timeFrame: 4 hours to 6 days after the surgery
measure: Function recovery of knee Range of Motion (ROM) for patients received surgery
timeFrame: 3 and 6 days after the surgery
Other outcomes:
measure: Testing of body temperature,routine blood examination, IL-6 and IL-10
timeFrame: hospital admission and 1, 3, 6 days after the surgery
Locations:
city: Beijing
country: China
facility: The Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: PUMC
name: Zhihong Wu, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00127660: Effect of Nutrition Labeling on Fast Food Choices
Official title: Effect of Nutrition Labeling on Fast Food Choices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Behavior
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-08-08
Enrollment: 605
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: A study examining menu choices made at fast food restaurants.

Detailed description: To examine the effect of point-of-purchase calorie information and value size pricing on fast food meal choices a randomized 2 × 2 factorial experiment was conducted in which participants ordered a fast food meal from one of four menus that varied with respect to whether calorie information was provided and whether value size pricing was used.

Eligibility criteria: Inclusion Criteria:

* Must be 16 years old or older
* Must regularly eat at fast food restaurants

Exclusion Criteria:

* Non-english speakers

Primary outcomes:
measure: Total Calories of Meal Ordered
timeFrame: single study visit
measure: Energy Intake
timeFrame: After meal
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Division of Epidemiology & Community Health, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lisa J Harnack, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: results from an experimental trial. Int J Behav Nutr Phys Act. 2008 Dec 5;5:63. doi: 10.1186/1479-5868-5-63.
citation: Fitch RC, Harnack LJ, Neumark-Sztainer DR, Story MT, French SA, Oakes JM, Rydell SA. Providing calorie information on fast-food restaurant menu boards: consumer views. Am J Health Promot. 2009 Nov-Dec;24(2):129-32. doi: 10.4278/ajhp.08031426.
citation: Rydell SA, Harnack LJ, Oakes JM, Story M, Jeffery RW, French SA. Why eat at fast-food restaurants: reported reasons among frequent consumers. J Am Diet Assoc. 2008 Dec;108(12):2066-70. doi: 10.1016/j.jada.2008.09.008.
Clinical trial NCT04469660: Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India
Official title: Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychological Stress
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare Professionals of Max Super Speciality Hospital,Saket,New Delhi

Brief summary: To Study the epidemiology of psychological distress among healthcare professionals of Max Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess the implications for providing psychological interventions(or therapeutic services)

Detailed description: To Study the epidemiology of psychological distress among healthcare professionals of Max Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess the implications for providing psychological interventions(or therapeutic services).

Hypothesis: There is likelihood of psychological distress impacting healthcare professionals' mental well-being as a result of their role in the healthcare setup during the COVID-19 pandemic. Study design-The questionnaire assessing the psychological wellbeing shall be administered via digital means of communication to healthcare professionals and support staff (doctors, nurses, paramedics, front office and support staff) across Max Super Speciality Hospital, Saket, New Delhi that currently employs 1295 individuals in the current category.

Participation in the study will be voluntary and informed consent will be sought prior to the survey administration. Participants' responses will remain anonymous, with an assurance of confidentiality.

Eligibility criteria: Inclusion Criteria Healthcare professionals working in Max Super Speciality Hospital Saket New Delhi Healthcare professionals inclusive of doctors, nurses paramedics front office employee and support staff Healthcare professionals above 18 years of age Healthcare professionals residing in India

Exclusion Criteria Non-employees of Max Super Speciality Hospital Saket New Delh Healthcare professionals residing outside India

Primary outcomes:
measure: Therapeutic Sessions emphasizing on Stress
timeFrame: 3 Months
Secondary outcomes:
measure: Resilience building and planning
timeFrame: 3 Months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital Saket
state: Delhi
Study officials:
affiliation: Max Super Speciality Hospital,Saket,New Delhi
name: Hiba Siddiqui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002260: Stopping Heavy Periods Project
Official title: Levonorgestrel Intrauterine System Versus Oral Contraceptives for Heavy Menses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Uterine Bleeding
Abnormal Uterine Bleeding, Ovulatory Dysfunction
Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.

Detailed description: This study is designed to be conducted within the context of a patient's standard/usual/typical care from their primary gynecologic care provider. We hypothesize that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related quality of life at 6 months and one year. To test this hypothesis, we plan to enroll 59 women from several sites who present for gynecologic care and self-report heavy menstrual bleeding into a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.

Eligibility criteria: Inclusion Criteria:

* Self-reported heavy menstrual bleeding
* Age 18-51 years
* Etiology of heavy menstrual bleeding from either ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E)

Exclusion Criteria:

* Plan pregnancy in the next year
* Menopausal
* Currently has a copper IUD in place
* History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS

Primary outcomes:
measure: Menstrual Bleeding Questionnaire
timeFrame: Completed 5 times over a one year time period
Secondary outcomes:
measure: Treatment Failure
timeFrame: Information collected at four time points during a one year period post randomization
Other outcomes:
Locations:
city: Providence
country: United States
facility: Gynecologic practices affiliated with Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital
name: Kristen A Matteson, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01516060: The Neurocognitive Sub-study of Encore1
Official title: The Neurocognitive Sub Study of Encore1:A Randomised, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral-naïve HIV-Infected Individuals Over 96 Weeks A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The HIV Netherlands Australia Thailand Research Collaboration
First posted: 2012-01-24
Enrollment: 71
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood


Eligibility criteria: Inclusion Criteria:

* All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.

Exclusion Criteria:

* Existing neurological brain disease
* Recent (\<6months ) head injury
* Current major depression or psychosis
* Current alcohol abuse
* Intended use of recreational drugs during study period
* Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)

Primary outcomes:
measure: The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV
timeFrame: 48 weeks
Secondary outcomes:
measure: The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.
timeFrame: Week 24
measure: To assess dynamic changes in neurocognitive function over the total duration of follow-up.
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIVNAT Research Collaboration
Study officials:
affiliation: Kirby Institute
name: Rebekah Puls
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04187794: Rheumatic Diseases: Evaluation of Health LIteracy, Medication adhereNce and Knowledges
Official title: Assessment of the Literacy Level of Patients With Chronic Rheumatic Diseases and Association With the Level of Knowledge and Medication Adherence: For a Better Integration of Patients' Literacy Levels Into Their Therapeutic Management.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
Treatment Adherence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) hospitalized (conventional or day hospitalization) or in consultation

Brief summary: A medication non-adherence is reported in chronic rheumatic diseases, in a context of complex and long-term treatments (injectable/per os targeted therapies, biosimilar...). Understanding and integrating the patient into a shared medical decision are key factors for adherence. From this perspective, the level of literacy (an individual's ability to find, understand and use health information) must be explored in order to adapt the communication of information. These are currently insufficiently adapted to the individual understanding of patients. In practice, literacy assessment is very poorly integrated into routine care, while several tools are validated in French. In rheumatology, foreign studies have shown that literacy is positively related to knowledge level. The results remain contradictory regarding its association with medication adherence. Today, the literacy level of patients with rheumatic diseases and its impact on adherence has not been studied in France, although these evaluations would be useful to adapt interventions individually. The acceptance of patients to complete a literacy assessment questionnaire during their care should also be analysed as a condition of its deployment.


Eligibility criteria: Inclusion Criteria:

* patient older than 18 years
* Having at least 6 months of disease-modifying rheumatic treatment (methotrexate and/or targeted treatment (anti-JAK) and/or subcutaneous biotherapies)
* Understanding French,
* With good visual acuity.

Exclusion Criteria:

* Patients with cognitive disorders
* Pregnant, parturient and lactating women
* Persons deprived of their liberty
* Major persons who are subject to a legal protection measure (guardianship, curators)
* Persons not affiliated to a social security system

Primary outcomes:
measure: Correlation between Literacy and medication levels
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de rhumatologie Hôpital Edouard Herriot
Study officials:
affiliation: Service hospitalier de rhumatologie
name: Anne Laure YAILIAN, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308594: Oral Dexamethasone for the Treatment of Cervical Radiculopathy
Official title: Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Radiculopathy
Keywords: cervical radiculopathy
dexamethasone
corticosteroid
oral
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2006-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether dexamethasone is effective in the treatment of pain and disability resulting from a compressed spinal nerve in the neck (cervical radiculopathy).

Detailed description: Cervical radiculopathy is causes both short and long term pain and diability. The current proven treatments include pain killers or surgery if there if patients experience progressive weakness or signs or spinal cord compression. Observations in both animal models and humans indicate that there is an inflammatory component to it. Corticosteroids (such as dexamethasone)are potent anti-inflammatories which may benefit people suffering from this condition. There is some evidence to support neck injections of drug directly onto the nerve root. This mmethod of drug delivery has been implicated with some serious complications such as paralysis and stroke. Delivering these medications in a pill form may provide a similar benefit without some of the serious complications.

Eligibility criteria: Inclusion Criteria:

* Ages 18 - 60
* arm and neck pain consistent with cervical radiculopathy
* Neck Disability Index score of at least 15 (moderate)
* symptom onset between 2 weeks and 6 months prior to enrollment

Exclusion Criteria:

* Actively immunosuppressed state
* clinical red flags consistent with possible infection or malignancy
* acute febrile illness or infection requiring antibiotics
* upper motor neuron signs consistent with myelopathy
* previous orthopedic neck surgery in the area of that nerve root
* known hepatic dysfunction
* schizophrenia
* pregnancy/nursing mothers
* previous chronic corticosteroid use
* diabetes mellitus on treatment
* rapidly improving course
* osteoporosis
* hypersensitivity to product components
* systemic fungal infection
* recent administration of live vaccine
* active tuberculosis
* glaucoma
* peptic ulcer disease

Primary outcomes:
measure: Neck Disability Index
Secondary outcomes:
measure: Visual Numeric Scale for arm & neck pain
measure: Days missed from work
measure: Cervical Radiculopathy Neurologic Impairment Scale
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Dave R Hooper, MD BSc
role: PRINCIPAL_INVESTIGATOR
References: