louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01810627: Application of Megavoltage Imaging to Reduce Artifact After Seed Implants
Official title: Application of Megavoltage Imaging to Reduce Artifact Following Interstitial Seed Implants for Prostate Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.


Eligibility criteria: Inclusion Criteria:

Male 50-80 years of age Eligible for interstitial brachytherapy implants

Exclusion Criteria:

-

Primary outcomes:
measure: Change in prostate volume measured in cm^3
timeFrame: One month post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: William St. Clair, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03724227: Expanded Access for ACE-011
Official title: Expanded Access for ACE-011
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Myelodysplastic Syndrome
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-10-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to ACE-011.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Celgene
state: New Jersey
Study officials:
References:
Clinical trial NCT01367327: Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Official title: Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Paraparesis, Spastic
Keywords: Exercise
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.


Eligibility criteria: Inclusion Criteria:

* children with SD, aged 5 to 13 year-old, and GMFCS level between I to III
* able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
* able to follow verbal instructions

Exclusion Criteria:

* have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
* have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
* hearing loss or using hearing aid
* have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders

Primary outcomes:
measure: Gross Motor Function Measure
timeFrame: 12 weeks
Secondary outcomes:
measure: Intrinsic Motivation Inventory-Chinese Version
timeFrame: 12 weeks
measure: Exercise Adherence and Volume
timeFrame: 12 weeks
measure: Motor Control Variables of the STS Movement
timeFrame: 12 weeks
measure: Pediatric Evaluation of Disability Inventory
timeFrame: 12 weeks
measure: One-repetition maximum of loaded sit-to-stand test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: Institute of Physical Therapy, National Taiwan University
name: Hua-Fang Liao, MS
role: STUDY_CHAIR
References:
citation: Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.
citation: Peng YC, Lu TW, Wang TH, Chen YL, Liao HF, Lin KH, Tang PF. Immediate effects of therapeutic music on loaded sit-to-stand movement in children with spastic diplegia. Gait Posture. 2011 Feb;33(2):274-8. doi: 10.1016/j.gaitpost.2010.11.020. Epub 2010 Dec 24.
Clinical trial NCT01109927: Early Insulin Treatment in Patients With Latent Autoimmune Diabetes
Official title: Early Insulin Treatment in Patients With Latent Autoimmune Diabetes (LADA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes, Autoimmune
Diabetes Mellitus, Adult-Onset
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Landstinget Kronoberg, Sweden
First posted: 2010-04-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed against the insulin producing beta cells in the pancreas. These patients have a progressive beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes Animal studies in diabetes prone mice have demonstrated potential positive effects of early insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of this study was to investigate the effect of early insulin treatment of LADA patients, in respect to residual beta-cell function and metabolic control, compared to a group who were conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not before it was clinically needed.

Detailed description: All adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic antibodies. Patients clinically classified as Type 2, not insulin requiring at diagnosis and positive for at least one autoantibody are eligible for inclusion. After randomisation to insulin treatment or diet and/or OHA, the patients are followed up with fasting C-peptide every third month. A glucagon test is performed, and stimulated C-peptide and HbA1c, + clinical data and body weight are recorded at baseline and after 12, 24 and 36 months. The final outcome of the study is C-peptide, and change in C-peptide compared to baseline level, and HbA1c, after 36 months.

Eligibility criteria: Inclusion Criteria:

* \>18 yrs
* Positive for pancreatic autoantibodies

Exclusion Criteria:

* \<18 yrs
* Significant concomitant diseases
* Not able to follow protocol

Primary outcomes:
measure: Glucagon stimulated C-peptide
timeFrame: 36 months after entering the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02139527: CARES Lumbar Artificial Disc Registry
Official title: The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Degenerative Disc Disease
Keywords: arthroplasty
spinal
CHARITE
PRODISC-L
PRODISC
disc
replacement
lumbar
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2014-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that undergo lumbar total disc replacement (TDR); this includes patients treated with either the CHARITE disc or the ProDisc-L disc

Brief summary: The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.

Detailed description: The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.

Eligibility criteria: Key Inclusion Criteria:

* Treated with the lumbar TDR.
* Signed IRB approved consent document.

Key Exclusion Criteria:

* None known.

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI) Score
timeFrame: 3, 6, 12, 24, 36, 48, and 60 months post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02070627: Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study
Official title: Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Cholecystitis
Acute Cholangitis
Keywords: acute cholecystitis
acute cholangitis
cholecystectomy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2014-02-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-89
* Planned laparoscopic cholecystectomy

Exclusion Criteria:

* Inability to provide informed consent
* Pregnant
* Allergy to ICG, iodine, and/or shellfish
* Lactating

Primary outcomes:
measure: Adverse events related to use of indocyanine green (ICG)
timeFrame: Injection to 2 wk follow-up
measure: Anatomic identification with NIRF-C and IOC
timeFrame: Intraoperative
measure: Procedure time
timeFrame: Intraoperative
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: Vimal K Narula, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911727: Fast-track Discharge After Elective Cesarean Section
Official title: Fast-track Discharge After Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Period
Keywords: Cesarean section
Postnatal Care
Lead sponsor: Herning Hospital
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.

The aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.

The study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.

This study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.


Eligibility criteria: Inclusion Criteria:

* Planned elective CS of multiparous women
* Singleton pregnancy
* Gestational age at least 37+0 weeks
* Prepregnancy BMI \<35

Exclusion Criteria:

* Lack of consent
* Women with no or little understanding of and ability to speak Danish
* Expected maternal or neonatal complications after delivery

Primary outcomes:
measure: Parents' Postnatal Sense of Security
timeFrame: Measured one week after delivery
Secondary outcomes:
measure: Pain scores
timeFrame: During the first week postpartum
measure: Use of analgesia
timeFrame: During the first week postpartum
measure: Mobilization
timeFrame: 5 days postpartum
measure: Breastfeeding
timeFrame: 6 months after delivery
measure: Readmissions
timeFrame: 28 days postpartum
measure: Surgical complications
timeFrame: 28 days postpartum
measure: Complications in the postnatal period
timeFrame: 28 days postpartum
measure: Contacts to the health care system
timeFrame: 28 days postpartum
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Department chairman
name: Byrjalsen, MD
role: STUDY_CHAIR
References:
citation: Jones E, Stewart F, Taylor B, Davis PG, Brown SJ. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2021 Jun 8;6(6):CD002958. doi: 10.1002/14651858.CD002958.pub2.
Clinical trial NCT04024527: High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment
Official title: Efficacy of High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori Rescue Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 306
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: Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.


Eligibility criteria: Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

* Less than 18 years old or older than 80 years
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01662427: Nocturnal Parkinson's Disease Symptoms Study Group
Official title: Nocturnal Parkinson's Disease Symptoms Study Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Quality of life
Noctural Parkinson's Disease Symptoms
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 30
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: Parkinson's disease patient and care givers

Brief summary: To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in Parkinson's disease patients and caregivers.


Eligibility criteria: Inclusion Criteria:

Idiopathic Parkinson's disease patient

Exclusion Criteria:

1. Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular Parkinsonism, exposure to toxin, Encephalitis
2. Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)
3. Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's disease, Juvenile Huntington's disease

Primary outcomes:
measure: To assess Noctural Parkinson's Disease Symptoms
Secondary outcomes:
measure: To assess quality of life in Parkinson's Disease patient
measure: To assess quality of life in caregiver of Parkinson's Disease patient
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Roongroj Bhidayasiri
state: Bangkok
Study officials:
References:
Clinical trial NCT02979327: Cardiovascular Effects of Adderall in Healthy Adults.
Official title: Cardiovascular Effects of Adderall in Healthy Adults. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamics
Cardiovascular System
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is designed to investigate the cardiovascular response (blood pressure, heart rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Adults 18 years of age and older
2. Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness
3. Subjects who are on no medications
4. Subjects with no prior history of regular amphetamine use, and non-prescription stimulants
5. Nonsmokers

Exclusion Criteria

1. Subjects with known cardiovascular disease, thyroid disease
2. Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence
3. Subjects currently taking medications
4. Prior history of regular amphetamine use, or non-prescription stimulants
5. Smokers
6. Pregnant subjects
7. Known lactose intolerance (due to presence of lactose in the prepared medication)
8. Family history of sudden cardiac death

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline and 3 hours
measure: Diastolic Blood Pressure
timeFrame: Baseline and 3 hours
measure: Mean Arterial Pressure (MAP)
timeFrame: Baseline and 3 hours
measure: Heart Rate
timeFrame: Baseline and 3 hours
Secondary outcomes:
measure: Plasma Norepinephrine
timeFrame: baseline and 3 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Anna Svatikova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00223327: Measurement of Bite Force in Humans
Official title: Measurement of Bite Force in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Pulp Necrosis
Periapical Periodontitis
Keywords: pain
Normal pulp and normal periodontal status
Chronic apical periodontitis of pulpal origin
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 89
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal subjects and patients with orofacial pain presenting in the dental clinic.

Brief summary: This protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.

Detailed description: This clinical trial consists of two parts. We will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).

Eligibility criteria: Inclusion Criteria:

1. Patient must be at least 16 years of age.
2. Clinical indication for non-surgical root canal therapy (NSRCT).
3. 1st or 2nd maxillary or mandibular molar or premolar
4. Diagnosis must be chronic apical periodontitis (CAP) with or without symptoms.
5. Intact, mature apices.
6. American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

1. Failure to meet any of the above
2. Previous NSRCT
3. Previous pulpotomy or pulpectomy
4. Suppurative apical periodontitis
5. Patients taking medications which can affect their pain rating or medications which affect their immune system (such as glucocorticoids)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center at San Antonio, Texas
name: Asma A Khan
role: PRINCIPAL_INVESTIGATOR
References: