louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01831388: Breath Training Exercise for the Reduction of Chronic Dyspnea
Official title: Breath Training Exercise for the Reduction of Chronic Dyspnea: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pulmonary Disorder
Keywords: Dyspnea
Breath Training Exercise
12-261
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test whether a breath training exercise program may be used to make patients with chronic lung conditions feel less short of breath, whether such a program is well received by patients and whether a future larger study is worthwhile.

The breath training exercise program uses some breathing techniques derived from Yoga practices. They were shown to help patients experiencing shortness of breath feel less short of breath in other settings. Whether the training is beneficial to patients with chronic lung conditions, especially those with a history of cancer affecting their lungs, is not clear. This study would help us answer that question.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required as the symptom of dyspnea, not cancer itself, is targeted)
* If diagnosed with lung cancer, must have completed definitive treatment more than 6 months prior
* At least moderate dyspnea defined by a BDI score of 6 or less in the Self- Administered Computerized Versions of the Baseline and Transition Dyspnea Indexes(SAC-BDI/TDI)13,14 (This cutoff score is close to the score of 5.7 used to define "moderate dyspnea" in the publication that validated the instrument and is selected by attending physicians in the Pulmonary Service as a good indication of "moderate dyspnea" in clinical practice. A typical person with BDI of 6, for example, would be a 52 year old woman who has to pause when walking because of dyspnea and/or has eliminated doing an activity because of dyspnea).
* Able to safely complete the Six Minute Walk Test (6MWT)15 as per attending physician's clinical judgment.
* Respiratory functions clinically stable for the preceding 3 months and expected to be stable for the next 3 months as determined by project PIs and other Pulmonary Medicine faculty.

Exclusion Criteria:

* Life expectancy less than 6 months
* Any cause of dyspnea that is determined by the investigators as readily reversible by other means (e.g. pleural effusion, pulmonary embolism, acute infection, anemia Hb\<9.0, etc.)
* Non-English speaking

Primary outcomes:
measure: the feasibility
timeFrame: 2 years
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: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03153488: Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
Official title: Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Methylphenidate
Amphetamine
Attention Deficit Hyperactivity Disorder
Treatment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2017-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 6-month trial in adults to find out if certain neuromarkers can predict individual treatment response to stimulant medications for Attention Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-45, will complete an MRI scan at MIT prior to beginning medication for ADHD as determined by a treating clinician outside the context of this study.


Eligibility criteria: Inclusion Criteria:

* Male and female adults ages 18-55
* A diagnosis of DSM-V ADHD based on clinical assessment supported by the ADHD module of a structured diagnostic interview
* Proficiency in English
* Right-handed

Exclusion Criteria:

* Any contraindication for the use of a stimulant medication
* Investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild)
* Any contraindications for MRI examination (metallic implants, such as pacemakers, surgical aneurysm clips, or known metal fragments in the body)
* Women who are currently pregnant or breastfeeding, as confirmed by a urine pregnancy test
* Clinically significant abnormal baseline laboratory values, including systolic and diastolic blood pressure parameters above 140 and 90, respectively and resting heart rate outside 60-100 bpm

Primary outcomes:
measure: ADHD Clinical Global Impressions Scale - Severity (CGI-S)
timeFrame: 6 months
measure: ADHD Clinical Global Impressions Scale - Improvement (CGI-I)
timeFrame: 6 months
Secondary outcomes:
measure: Connectomic Variation Prediction of Medicine Response
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01676688: Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home
Official title: Safety Study of Alfalastin (Human Alpha-1 Antitrypsin, 33.33 mg/ml) Administered at Home to Patients Suffering From Severe Forms of Primary Deficiency in Alpha-1 Antitrypsin, Phenotype PIZZ or PISZ, With Pulmonary Emphysema.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: alpha-1 antitrypsin
deficiency
Alfalastin
safety
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above 18 y.o, suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ or PiSZ with pulmonary emphysema, currently treated , once a week, as per routine practice by ALFALASTIN® at home or in out-of-hospital location.

Brief summary: The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at home or in out-of hospital locations.

Detailed description: Non interventional, observational, longitudinal, prospective, multicenter, non comparative study.

Eligibility criteria: Participation Criteria:

* Patients above 18 y.o,
* suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ or PiSZ with pulmonary emphysema,
* currently treated as per routine practice, once a week, by ALFALASTIN® at home or in out-of-hospital location
* and having signed informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pneumology - CHU Rouen, France
name: Cuvelier Antoine, Prof.
role: STUDY_DIRECTOR
affiliation: Pneumology - CHU Lyon, France
name: Mornex Jean-François, Prof
role: STUDY_CHAIR
affiliation: Pneumology - Hôpital Bichat Paris, France
name: Thabut Gabriel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06185088: MENDD Tolerance Assessment Study
Official title: Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Short Bowel Syndrome
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening. Radial and longitudinal forces are both required, and two devices will be used to create forces in order to test tolerability of said forces. This is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device.

This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults. Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome (SBS).

This trial will not be testing a treatment for SBS, and individuals with SBS are ineligible for recruitment.


Eligibility criteria: Inclusion Criteria:

* Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.

Exclusion Criteria:

* Inflammatory bowel disease of small bowel Pregnant Short bowel syndrome Bleeding disorder Chronic pain disorder Individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter.

Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed

Primary outcomes:
measure: Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch
timeFrame: 1-2 Minutes
Secondary outcomes:
measure: Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch
timeFrame: Approximately 1 minute
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Meghan A Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002988: Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation
Official title: Endomyocardial Botulinum Toxin Injection Can Prevent Drug-Resistant Paroxysmal Atrial Fibrillation: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* drug-resistant PAF

Exclusion Criteria:

* Previous heart surgery and AF ablation procedure
* Emergency CABG
* Unstable angina or heart failure
* Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation)
* Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
* Requiring concomitant valve surgery
* Left ventricle ejection fraction \<35%
* Left atrial diameter \>55 mm
* Unwillingness to participate

Primary outcomes:
measure: serious adverse events
timeFrame: 1 year
Secondary outcomes:
measure: number of paroxysms
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02324088: Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer
Official title: Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Breast Cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 174
Sex: FEMALE
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: To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC).


Eligibility criteria: Inclusion Criteria:

* histologically proven breast cancer
* inflammatory breast cancer
* no metastatic site
* age \> or = 18 and \< or = 60
* OMS score: 0, 1, 2
* life expectancy \> or = 3 months
* Normal (isotopic or ultrasonography) left ventricular ejection fraction
* Normal haematological, liver, and kidney functions
* patients who gave their written informed consent.

Exclusion Criteria:

* non inflammatory breast tumour with a cutaneous permeation nodule
* presence of a metastatic site
* medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side
* patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour
* medical history of congestive heart failure even medically controlled
* medical history of myocardial infarction during the 6 months before the inclusion in the study
* active infection or other severe underlying pathology which could possibly prevent the patient from receiving treatments
* administration of another chemotherapy during the study
* pregnant or breast feeding patients (the patients of childbearing age must be placed under efficient contraception)
* patients whose social or psychological state does not allow to consider a correct adherence to the treatment and to the required medical follow-up
* WHO score 3,4
* unbalanced diabetes
* polysorbate 80 allergy

Primary outcomes:
measure: disease-free survival rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Paoli Calmette Marseille
name: Patrice Viens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goncalves A, Pierga JY, Ferrero JM, Mouret-Reynier MA, Bachelot T, Delva R, Fabbro M, Lerebours F, Lotz JP, Linassier C, Dohollou N, Eymard JC, Leduc B, Lemonnier J, Martin AL, Boher JM, Viens P, Roche H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.
Clinical trial NCT00272688: Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit
Official title: Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-01-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open, observational health economic study to estimate marginal cost and health consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa administered continuously


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of of idiopathic Parkinsons disease
* Motor fluctuations despite optimised per oral treatment

Exclusion Criteria:

* Severe dementia, confusion, psychosis or depression
* Patients with contraindications against levodopa treatment

Primary outcomes:
measure: Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa
timeFrame: one year
measure: Quality of life at three, six, nine and twelve months(Assessed by Nottingham Health Profile (NHP), Parkinson Disease Questionnaire (PDQ39), 15D Quality of life)
Secondary outcomes:
measure: Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England)
Other outcomes:
Locations:
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Dept Neurology, Ulleval University Hospital
Study officials:
affiliation: HØKH - Helse Ost Health Services Research Centre, Akershus University Hospital, Norway
name: Christofer Lundqvist, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept Neurology, Akershus University Hospital, Norway
name: Antonie Beiske, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02555488: Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy
Official title: Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of the Canal While Root Retreatment in Patients With Periradicular Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Periradicular Disease
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.

Detailed description: Conventional techniques of root canal treatments such as mechanical instrumentation and chemical debridement with antimicrobial irrigants, such as Sodium hypochlorite (NaOCl) and chlorhexidine and use of calcium hydroxide do not always suffice to predictably render root canals free of bacteria Using the high-power diode laser is a new approach of disinfection allowing access to the previously unavailable areas, such as the tubular network. This study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.

Eligibility criteria: Inclusion Criteria:

- endodontic retreatment of teeth with periradicular lesion.

Exclusion Criteria:

-

Primary outcomes:
measure: bacterial colony forming unit(CFU/ML)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: saranaz azari-marhabi, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03002688: OSUWMC EEI Sequential Cataract Patient Experience Project
Official title: OSUWMC EEI Sequential Cataract Patient Experience Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Surgery Experience
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified by their status presenting for surgery with one specific surgeon (A.T.) at the Eye and Ear Center at Gowdy Fields. Access will be through the preoperative anesthesia assessment performed by the attending anesthesiologist.

Brief summary: The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract surgeries to assess if the second experience of cataract surgery differs from the initial experience.

Detailed description: Each patient is scheduled to undergo two sequential cataract extractions under topical anesthesia with local anesthetic eye drops and minimal sedation- one on each eye. The surgeon, basic surgical procedure, anesthetic technique, and approximate length of procedure are reasonably similar and the patients act as their own control. Subjects in the study will answer very brief questions regarding anxiety and comfort about their surgery before and after each procedure, and on the day after their second surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing sequential cataract surgeries within a 6 week time period performed by the ophthalmologist, Amit Tandon, MD.
2. Aged 18 years and older.

Exclusion Criteria:

1. Cognitive impairment causing inability to participate in survey
2. Language barrier causing an inability to participate in survey
3. Healthcare POA or guardian leading to an inability to consent to survey
4. Physician autonomy; patients that are inappropriate for the study as deemed by investigator

Primary outcomes:
measure: Pain
timeFrame: First and second cataract extraction surgery occuring within 6 weeks
measure: Anxiety
timeFrame: First and second cataract extraction surgery occuring within 6 weeks
measure: Awareness
timeFrame: First and second cataract extraction surgery occuring within 6 weeks
measure: Comfort Level
timeFrame: First and second cataract extraction surgery occuring within 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Deborah Lowery, MD
role: PRINCIPAL_INVESTIGATOR
References: