louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02463981: Anterior Insula Regulation and Pain Empathy
Official title: Voluntary Anterior Insula Regulation Impacts Pain Empathy and Functional Connectivity: a Real-time fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Insula Activity During Regulation
Empathic Responses After Anterior Insula Regulation
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts pain empathy.

Detailed description: In the present study, investigators plan to use the real-time fMRI neurofeedback to train healthy subjects to learn volitional control over their own anterior insula (AI) activity. Then the effect of AI regulation will assessed by examining subjects' empathic responses and functional connectivity changes. Subjects were separated into two groups randomly. While the experimental group received specific neurofeedback from their own AI, the control group received sham NF from an unspecific region.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* pregnancy;
* medical or psychiatric illness.

Primary outcomes:
measure: Neural Activity of Anterior Insula During Neorofeedback Training
timeFrame: three days.
measure: Pain Empathy Rating Scores
timeFrame: three days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01062581: University of Minnesota Transplant Registry
Official title: University of Minnesota Transplant Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplant Recipient
Transplant Donation
Keywords: Recipient
Donor
Organ Transplant
Registry
University of Minnesota
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University of Minnesota Transplant Center University of Minnesota Medical Center, Fairview

Brief summary: Under Transplant Information Services (TIS), the University of Minnesota Transplant Registry (UMTR) will serve as the repository for core research data.

Detailed description: UMTR is a system of ongoing registration of cases seen in the transplant program at the University of Minnesota. The registry will: (1) provide core outcomes data and background information necessary to conduct outcomes management research in solid organ transplantation and advanced lung disease, and (2) support cutting edge research through existing program specific databases in liver, intestine, pancreas, islet, kidney, heart and lung transplantation.

Eligibility criteria: Inclusion Criteria:

* Received a transplanted organ at the University of Minnesota
* Living donor who donates an organ at the University of Minnesota

Exclusion Criteria:

* Did not receive a transplant at the University of Minnesota
* Did not donate an organ at the University of Minnesota

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Transplant Information Services
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Arthur Matas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276481: Prospective Evaluation of Taste Function In Multiple Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation
Official title: Prospective Evaluation of Gustatory Function (Taste) In Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: melphalan
stem cell transplantation
17-404
hematopoietic cell transplantation
HCT
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be identified by the Adult Bone Marrow Transplant team. They are usually identified in clinic when a treatment plan that includes conditioning chemotherapy has been scheduled.

Brief summary: The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.


Eligibility criteria: Inclusion Criteria:

* Age 21 or above with diagnosis of multiple myeloma (myeloma is almost unheard of in patients less than 21 years of age).
* Scheduled to receive conditioning chemotherapy with melphalan followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation
* English or Spanish speaking
* Calculated creatinine clearance \> 40 mL/min

Exclusion Criteria:

* Prior head and neck radiation.
* Severe periodontal infection. Poor oral hygiene and dentition as determined by pre HCT dental assessment.
* Pregnancy
* Patients with pre-existing moderate-severe dysgeusia

Primary outcomes:
measure: Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT
timeFrame: Change from baseline assessment up to 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sergio Giralt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383681: Retrospective Study of Patients With Spasticity in the Spanish Population
Official title: Observational Study To Establish The Methodology Used In The Evaluation, Treatment And Assessment Of Progression Of Spasticity In The Spanish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of spasticity are selected from rehabilitation departments within the Spanish health system.

Brief summary: This is a retrospective study of patients with spasticity in the Spanish population.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of spasticity

Exclusion Criteria:

* Current enrollment in a clinical trial

Primary outcomes:
measure: Physician Assessment of Spasticity
timeFrame: Baseline
measure: Physician Assessment of Spasticity
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Mataro
country: Spain
state: Barcelona
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03221881: Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer
Official title: The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Patients with newly diagnosed breast cancer;
2. Age \>18 years;
3. Eastern Cooperative Group (ECOG) performance status 0-2;
4. measurable disease (as per radiological imaging); life
5. expectancy \>12 months;
6. adequate haematologic blood profile;
7. normal liver and kidney function;
8. adequate cardiac function;
9. no metastatic disease;
10. negative pregnancy test (premenopausal women);
11. signed informed consent.

Exclusion Criteria:

1. Level 2 cardiac toxic effects were deﬁned as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ;
2. Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures);
3. Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;

Primary outcomes:
measure: PCR rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: MRI
state: Beijing
Study officials:
affiliation: Investigator
name: Shan Baoen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04480281: Intravenous Lidocaine in Open Lung Resection Surgery
Official title: Intravenous Lidocaine Reduces Pain Scores and Opioid Consumption in Open Lung Resection Surgery: A Prospective Randomized Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lidocaine
Pain, Postoperative
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in colorectal surgery.

However, no study has evaluated the effect of a continuous lidocaine infusion for open lung resection in the post-operative period. The present study aims to evaluate the influence of IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery


Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists (ASA) scores of I, II or III.
* Left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (ICU) for at least 24 hours (h).

Exclusion Criteria:

* patient's refusal to participate
* ASA score of IV or higher
* severe hepatic or renal insufficiency
* allergy to lidocaine, morphine or NSAIDs
* cardiac arrhythmias or
* epilepsy,
* delayed extubation for more than 2 h postoperatively
* urgent surgery

Primary outcomes:
measure: Opioid consumption in the post operative period
timeFrame: Doses were measured for twenty four hours in the post operative period
measure: Pain scores at rest and at cough
timeFrame: Measurements were made for 24 hours in the post operative period
Secondary outcomes:
measure: Pulmonary complications
timeFrame: Measurements were recorded for 24 hours in the post operative period
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
Study officials:
References:
citation: Swenson BR, Gottschalk A, Wells LT, Rowlingson JC, Thompson PW, Barclay M, Sawyer RG, Friel CM, Foley E, Durieux ME. Intravenous lidocaine is as effective as epidural bupivacaine in reducing ileus duration, hospital stay, and pain after open colon resection: a randomized clinical trial. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):370-6. doi: 10.1097/AAP.0b013e3181e8d5da.
citation: Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.
Clinical trial NCT02076581: MyoSense- Automated Muscle Hypertonicity Classification System
Official title: MyoSense- Automated Muscle Hypertonicity Classification System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Dystonia
Cerebral Palsy
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-03-03
Enrollment: 53
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.

Brief summary: It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.


Eligibility criteria: Inclusion Criteria:

* Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
* Over the age of five.

Exclusion Criteria:

* Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
* Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
* Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
* Under the age of five.

Primary outcomes:
measure: Correlation between clinician and device measured abnormal tone type.
timeFrame: For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Valley View
country: United States
facility: Great Lakes NeuroTechnologies
state: Ohio
Study officials:
affiliation: Great Lakes NeuroTechnologies Inc.
name: Joseph P Giuffrida, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552981: Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
Official title: Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Keywords: common cold
Finnish sauna
rct
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2007-11-02
Enrollment: 157
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: In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:

1. the inhalation of warm air for inducing a warming of the throat and
2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration of the common cold will be assessed. The interventions will consist of visits with a duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be fully dressed.


Eligibility criteria: Inclusion Criteria:

* symptom duration between 2 and 24 hours
* at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever
* no usage of medication bought in a pharmacy
* informed consent

Exclusion Criteria:

* fever \>38.5°C
* systolic blood pressure below 100 mmHg or above 160 mmHg
* severe chronic disease, which makes study participation impossible
* pregnancy

Primary outcomes:
measure: Symptom Score for Common Cold
timeFrame: Area under the curve day 2 to 7
Secondary outcomes:
measure: Usage of medication against common cold
timeFrame: Day 1 to 7
measure: generalized feeling ill on a numeric rating scale 0-10,
timeFrame: Day 1, 2, 3, 5 and 7
measure: safety (adverse events and serious adverse events)
timeFrame: 1 to 7 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Study officials:
affiliation: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
name: Claudia M. Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pach D, Knochel B, Ludtke R, Wruck K, Willich SN, Witt CM. Visiting a sauna: does inhaling hot dry air reduce common cold symptoms? A randomised controlled trial. Med J Aust. 2010 Dec 6-20;193(11-12):730-4. doi: 10.5694/j.1326-5377.2010.tb04127.x.
Clinical trial NCT02489981: Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
Official title: Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (Patients With Severe Persistent Asthma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-07-03
Enrollment: 359
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with severe asthma

Brief summary: The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.


Eligibility criteria: Inclusion criteria:

* Patients diagnosed with severe persistent bronchial asthma
* Patient aged \>= 15 years
* Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS (Inhaled corticosteroids) treatment.

Exclusion criteria:

* Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
* Patients who have been enrolled this study before.

Primary outcomes:
measure: Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
timeFrame: Week 52
Secondary outcomes:
measure: Change From Baseline in Asthma Control Status at Week 52
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital Felício Rocho
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02988310: Comparison of Gait Characteristics in Individuals With Above and Below Knee Limb Loss
Official title: Comparison of Gait Characteristics in Individuals With Trans Femaoral and Trans Tibial Limb Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Keywords: Limb Loss
Gait Characteristics
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with unilateral below or above knee limb loss

Brief summary: Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.

Detailed description: Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this study.

Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index, gait speed) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 4nd and 6th minutes at walk.

Eligibility criteria: Inclusion Criteria:

* Individuals with unilateral above knee lower limb loss and below knee limb loss
* Age between 20-55 years
* Using conventional type socket design Dynamic foot using

Exclusion Criteria:

* Have passive joint limitation at extremities
* Surgery at last 1 year
* Systemic problems such as neurological disorders, rheumatoid disorders
* Another orthopedic anomalies

Primary outcomes:
measure: Step length assesment while walking.
timeFrame: Initially evaluation at first minute
Secondary outcomes:
measure: Ambulation index assessment while walking.
timeFrame: Initially evaluation at first minute
Other outcomes:
Locations:
Study officials:
References: