louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03022734: Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis
Official title: A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer, Metastatic
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.


Eligibility criteria: Inclusion Criteria:

* pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
* over 19 years
* Eastern Cooperative Oncology Group 0-1
* Proper organ function
* more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
* Who should sign on the Informed consent form before participate the trial.

Exclusion Criteria:

* Metastasis in other organ except liver
* Chronic active hepatitis or cirrhosis
* History of treatment for metastatic colorectal cancer
* Subject pregnant or breast feeding
* Uncontrolled disease
* Have had adjuvant therapy
* Uncontrolled peripheral nerve infection
* Alcoholic or drug addict
* Subject currently is enrolled in or ≤30 days from ending other clinical trial.
* History of other type of cancer except resolved from skin cancer and cervical cancer.

Primary outcomes:
measure: complete resection (R0) rate for rectal and liver lesions
timeFrame: after surgical resection, an average of 24 weeks
Secondary outcomes:
measure: Response rate (RECIST V1.1)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT06246734: Companion Robotic Pets and Older Adults
Official title: Effect of Companion Robotic Pets on Older Adult Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Social Behavior
Caregiver Burden
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Allegheny County Department of Human Services, Area Agency on Aging
First posted: 2024-02-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This research will assess the effect of companion robotic pets on the wellbeing of older adults and their family caregivers.

Detailed description: Social robot pets have been shown to have a positive impact on age-related physical, cognitive, emotional, and social challenges that affect independence and quality of life. These "pets" are designed to interact with people as a real pet might. They purr when stroked, make eye contact, have a heartbeat, turn toward a person when touched, are warm, and appear lifelike. Does introduction of such a pet reduce loneliness or promote engagement in older adults with cognitive or physical disability?

This research will determine if:

1. Older adults with disabilities engage with such robotic companions;
2. Placing a robotic pet in a home enhances mood and positive affect in older people;
3. Caregivers to these adults find the robots beneficial for their own mood and time use.

In a single-blind randomized controlled trial over 6-8 weeks, we hypothesize that older adults in the intervention arm will engage with the pets and show benefit in mood as reported by family caregivers.

Eligibility criteria: Inclusion Criteria:

1. Participating in Family Caregiver Support Program or OPTIONS Program administered by Allegheny County Area Agency on Aging
2. Provide unpaid family or friend caregiver support for at least 6 months
3. Older person aged 50+
4. Able to provide verbal informed consent

Exclusion Criteria:

1. Uncomfortable with robot pet companion in home
2. Family Caregiver \< 18 years age

Primary outcomes:
measure: Change in Positive Affect Scale from Baseline to 6-8 weeks
timeFrame: Baseline and Follow-up, 6-8 weeks later
measure: Change in Negative Affect from Baseline to 6-8 weeks
timeFrame: Baseline and Follow-up, 6-8 weeks later
Secondary outcomes:
Other outcomes:
measure: Engagement with Pet
timeFrame: Follow-up interview, 6-8 weeks after baseline
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven M Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179034: Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Official title: Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Dependence, Other Tobacco Product
Keywords: tobacco
electronic cigarettes
menthol
flavors
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.


Eligibility criteria: Inclusion Criteria:

* Ages 18-20 years
* Able to read and write
* Cigarette smoker
* Use of e-cigarettes in the past 30 days

Exclusion Criteria:

* Seeking smoking cessation treatment
* Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
* Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
* Current or past history of psychosis or other psychiatric diagnosis such as major depression
* Any significant current medical condition

Primary outcomes:
measure: Liking/effect score of the e-cigarette
timeFrame: Every 30 min for 120 min during lab session
Secondary outcomes:
measure: Maximum value of money at which the e-cigarette is chosen over money
timeFrame: Every 30 min for 120 min during lab session
measure: Change scores from baseline in Nicotine Withdrawal
timeFrame: Every 30 min for 120 min during lab session
measure: Change scores from baseline in Tobacco Craving
timeFrame: Every 30 min for 120 min during lab session
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC
state: Connecticut
Study officials:
affiliation: Yale University
name: Dana Cavallo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06511934: Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Official title: Intuitive, Complete Neural Control of Tablet Computers for Communication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brainstem Stroke
ALS
Tetraplegia
Spinal Cord Injuries
Cervical Spinal Cord Injury
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: Stanford University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-07-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Detailed description: The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site
* Prior enrollment in BrainGate2 clinical trial (NCT00912041)

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)

Primary outcomes:
measure: Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Masssachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Leigh R Hochberg, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00057434: Vitamin A Therapy for Tuberculosis
Official title: Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Tuberculosis
HIV Infections
Keywords: Vitamin A
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-04-03
Enrollment: 1140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.

Detailed description: By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available. Prior to the discovery of antibiotic treatment, cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is essential for normal immune function, and Vitamin A supplementation is used in many countries to reduce mortality in children. Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This study will determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB.

All study participants will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for the following 6 months. Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo. Participants will be followed for 24 months after study enrollment.

Eligibility criteria: Inclusion Criteria:

* Sputum-confirmed pulmonary tuberculosis
* Resident of Zomba or Blantyre Districts, Malawi
* Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

Exclusion Criteria:

* Prior treatment for tuberculosis

Primary outcomes:
measure: Mortality
Secondary outcomes:
measure: Morbidity
Other outcomes:
Locations:
city: Zomba
country: Malawi
facility: Zomba Central Hospital
Study officials:
affiliation: Johns Hopkins University
name: Richard D. Semba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semba RD, Kumwenda J, Zijlstra E, Ricks MO, van Lettow M, Whalen C, Clark TD, Jorgensen L, Kohler J, Kumwenda N, Taha TE, Harries AD. Micronutrient supplements and mortality of HIV-infected adults with pulmonary TB: a controlled clinical trial. Int J Tuberc Lung Dis. 2007 Aug;11(8):854-9.
Clinical trial NCT03031834: Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Official title: Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Autonomic Neuropathy
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2017-01-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus with both autonomic and peripheral neuropathy

Exclusion Criteria:

* Hypertension, coronary heart disease

Primary outcomes:
measure: Changes in R-R variation during deep breathing
timeFrame: 2 years
measure: Changes in response to Valsalva maneuver
timeFrame: 2 years
measure: Changes in 30:15 ratio
timeFrame: 2 years
measure: Changes in blood pressure response to standing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02029534: Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
Official title: Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiothoracic Surgery
Post-operative Atrial Fibrillation
Keywords: post-operative atrial fibrillation
POAF
A-Fib
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.

Detailed description: This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Age 19 or older
* Undergoing elective cardiothoracic surgery

Exclusion Criteria:

* Emergency cardiothoracic surgery
* History of permanent atrial fibrillation
* Acute coronary syndrome within 7 days
* Antiarrhythmic drug use in the past 3 months
* Receiving maximal tolerated dose of statin therapy
* Receiving fibrate therapy
* History of statin intolerance
* Significant liver impairment (aspartate aminotransferase/alanine aminotransferase(AST/ALT)\>2x ULN)
* Serum Creatinine \> 3 mg/dl
* Pregnancy or breastfeeding

Primary outcomes:
measure: Occurrence of atrial fibrillation by hospital discharge
timeFrame: Hospital discharge, an expected 5-7 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Hospital discharge, an expected 5-7 days
measure: Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Aiman Smer, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04374734: Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure
Official title: Automated Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS (Severe Acute Respiratory Syndrome)
Keywords: SARS
Severe Acute Respiratory Syndrome
Automated quantification
Lung volume
Thorax imaging
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting a situation at risk of acute respiratory failure

Brief summary: Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result.

The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Presenting a situation at risk of acute respiratory failure
* Requiring thorax imaging when they were treated.

Exclusion Criteria:

* Patients with anatomically incomplete thoracic imaging (e.g., technical acquisition error).

Primary outcomes:
measure: Retrospective study of the relationship between severe forms of ARF and the extent of lung involvement
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d' Anesthésie Réanimation Chirurgicale
Study officials:
References:
Clinical trial NCT03112434: Muscle Elastography in Spastic Cerebral Palsy
Official title: Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unilateral Spastic Cerebral Palsy
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
First posted: 2017-04-13
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unilateral spastic CP with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent. Consent may be obtained from a parent or legal guardian, as applicable.

Brief summary: To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent.
* Consent may be obtained from a parent or legal guardian, as applicable.

Exclusion Criteria:

* Prior surgical procedure in the affected upper extremity
* Unrelated orthopedic injury to the affected upper extremity
* Current oral or intrathecal antispasticity therapy
* Prior Botulinum toxin type A injection in preceding 6 months

Primary outcomes:
measure: Muscle Elasticity
timeFrame: From immediate pre-injection to 1 month post-injection.
measure: Muscle Elasticity
timeFrame: From immediate pre-injection to 1 month post-injection.
Secondary outcomes:
measure: Functional measures
timeFrame: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
measure: Functional measures
timeFrame: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT01799434: Dynamic Postural Control After Exercise
Official title: Influence of an Exercise on the Dynamic Postural Control in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Control
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 83
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg standing and in jump landing, followed by stabilization or side jumps, and to compare athletes of different levels with control subjects.


Eligibility criteria: Inclusion Criteria:

* competitive level (participation in any league) for the high performance athletes group
* participation in sport for 0.5-4 hours per week for the recreationally active subjects

Exclusion Criteria:

* current history of a lower extremity injury requiring training cessation on the day of testing
* neurological diseases
* vestibular or visual disturbances
* cardiovascular diseases medication affecting balance

Primary outcomes:
measure: Change of force ratio of ground reaction forces in/after landing from baseline
timeFrame: 1, 5, 10, 15, 20 min after exercise
measure: Change of the velocity of the center of pressure (COP) from baseline
timeFrame: 1, 5, 10, 15, 20 min after the exercise
Secondary outcomes:
measure: Change of rate of perceived exertion (Borg Scale) from baseline
timeFrame: every 10 min during and 1, 5, 10, 15, 20 min after exercise
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital, Department of Orthopedics, Trauma Surgery and Spinal Cord Injury
Study officials:
References: