louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04305509: Outcomes After Chiropractic Spinal Manipulative Therapy With Lumbar Disc Herniation and Radiculopathy
Official title: Outcomes After Chiropractic Spinal Manipulative Therapy for Patients With Lumbar Disc Herniation and Radiculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Keywords: long-term outcome
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The same patients who were recruited for the study EK-22/2009: Patients with lumbar disc herniation that is treated with spinal manipulation

Brief summary: In a study that was approved nine years ago (EK-22/2009) we could show (i) that spinal manipulative therapy (SMT) is a very effective and safe treatment for acute and chronic lumbar disc herniation (LDH); (ii) that SMT is as effective and less expensive than lumbar nerve root injections and (iii) that the recurrence rate up to one year was very low in acute and in chronic LDH patients. However, the long-term outcome of this conservatively treated LDH patients is unknown. Thus, the objective of this amendment is to investigate the proportion of long-term recurrences in these patients who were treated with SMT for their LDH and to compare these results with already existing data from other treatments, e.g. surgery. This is important information to know whether this conservative method is a sustainable approach for treating LDH.

Detailed description: All 148 patients with magnetic resonance imaging-confirmed disc herniation who were recruited for the study EK 22-2009 will be re-contacted to assess the course of their back problem during the past approx. nine years using a questionnaire.

Eligibility criteria: Inclusion Criteria:

-The same patients who were recruited for the study EK-22/2009

Exclusion Criteria:

* The same as for study EK-22/2009:

Patients with specific pathologies of the lumbar spine that are contraindications to chiropractic manipulative treatment, such as tumors, infections, inflammatory spondylarthropathies, acute fractures, Paget's disease and severe osteoporosis, will be excluded. Also excluded will be patients with previous spinal surgery, signs of cauda equina syndrome (CES), sequestration of disc material, body mass index \>30, spondylolisthesis, neurogenic claudication and pregnancy.

Primary outcomes:
measure: intensity of low back pain
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Chiropraktik am Schaffhauserplatz
Study officials:
affiliation: Universitätsklinik Balgrist
name: Lukas Mayr, M Chiro Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920309: Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy
Official title: Rapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal Dominant Polycystic Kidney Disease
rapamycin
ADPKD
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after renal transplantation.

This trial is designed to determine whether rapamycin is safe and effective treatment for patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and urine samples will also be collected to evaluate for change in biomarkers with treatment.

Detailed description: This is a 2 year, open label trial to evaluate the role of rapamycin as treatment for ADPKD. Patients will be randomized 2:1 to the rapamycin arm or to standard therapy. The dose of rapamycin will be adjusted so that patients obtain 24 trough levels of 4-6ng/ml. There will be a volumetric MRI measurement at the start and end of the treatment period. Patients will be monitored every 4 months throughout the study.

Eligibility criteria: Inclusion Criteria:

* adult ADPKD patients aged 18-70
* combined kidney volume \>1200 ml
* estimated creatinine clearance \>60 ml/min
* absence of implanted ferromagnetic objects

Exclusion Criteria:

* Age \>70
* uncontrolled hyperlipidemia
* Proteinuria \>500 mg/day
* unstable cerebral aneurysm
* active coronary artery disease
* diagnosis of another systemic condition affecting kidney function (ie: diabetes, hepatitis B or C, HIV)
* diagnosis of cancer other than skin cancer
* pregnancy or lactation
* presence of implanted ferromagnetic objects

Primary outcomes:
measure: Total Kidney Volume (mL)
timeFrame: 2 years
Secondary outcomes:
measure: Glomerular Filtration Rate (Kidney Function)
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale University
name: Neera K Dahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594307: Blood Pressure Monitor Clinical Test (Cuff Range: 13.5 Cm-22cm)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: BP
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 85
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resident of a community

Brief summary: The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 13.5 cm-22 cm.


Eligibility criteria: Inclusion Criteria:

* cuff circumference: 13.5cm-22cm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01336907: Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)
Official title: Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Age Related Macular Degeneration
Choroidal Neovascularization
Keywords: CNV
AMD
Wet-treated CNV
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CNV subjects

Brief summary: The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment.

The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.


Eligibility criteria: Inclusion Criteria:

* For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis.

  * Intent to treat the study eye (SE)
  * Corrected VA better than 6/45 (20/150) in SE
  * Subject is capable and willing to sign a consent form and participate in the study
  * Age \> 55 years
  * Subject declared that he or she knows how to operate a computer mouse

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in SE
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the SE by biomicroscopy
* Any ocular surgery performed within 3 months prior to study entry in the SE \* Participation in another study

Primary outcomes:
measure: Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Intercommunal de Creteil
Study officials:
affiliation: Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
name: Giuseppe Querques, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05153707: Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome
Official title: Evaluation of a Clinical Pharmacist-led Discharge Education Service in Patients With Acute Coronary Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 177
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: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.

Detailed description: This prospective, randomized controlled study was conducted in patients with acute coronary syndrome in an cardiology service of tertiary training and research hospital. The clinical pharmacist, within the scope of the discharge education services, provided medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally \[by using Teach back method especially for patients with low health literacy\]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model). The control group received standard care.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the cardiology department due to acute coronary syndrome
* Older than 18 years old

Exclusion Criteria:

* Patients who transferred to another ward
* Patients with active malignancy
* Patients with alzheimer and/or dementia diagnosis
* Patient with \>%80 visual loss or deaf muteness reported at medical record

Primary outcomes:
measure: 30 days hospital re-admission for cardiac reasons
timeFrame: 30 days
Secondary outcomes:
measure: Hospital re-admission for cardiac reasons
timeFrame: 3 months, 6 months, and 12 months
measure: Hospital re-admission for any reasons
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Emergency service visits
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Major Adverse Cardiovascular Event
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Death for cardiac reason
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Death for any reason
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Medication Adherence
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Quality of Life Measurement
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Achieved Target Low-density Lipoprotein Value
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Betul Okuyan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162407: A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin
Official title: A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insulin Using Microperfusion Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 13
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.


Eligibility criteria: Inclusion Criteria:

* Healthy males between 19 and 50 years inclusive
* The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
* Body Mass Index (BMI) below 27 kg/m\^2
* Fasting blood glucose maximum 6 mmol/l

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last 3 months

Primary outcomes:
measure: Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration
timeFrame: 8 hours
Secondary outcomes:
measure: Steady state glucose infusion rate (GIR)
timeFrame: 8 hours
measure: Steady state insulin interstitial concentration
timeFrame: 8 hours
measure: Ratio of steady state serum insulin concentration to interstitial insulin concentration
timeFrame: 8 hours
measure: Insulin concentration profiles
timeFrame: 8 hours
Other outcomes:
Locations:
city: Graz
country: Austria
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02659007: Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga
Official title: Less Neuropathy After Yoga
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Neuropathy
Keywords: yoga
balance
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The long-term goal is to identify and establish effective mind-body interventions (as an aspect of complementary and alternative medicine) to improve health and Quality of Life (QoL) for people with disabilities. Preliminary data suggest that engagement in yoga is feasible and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. The central hypothesis is that individuals who complete yoga will have significantly better balance, mobility, and QoL after 8 weeks of yoga.

Detailed description: assessments completed before and after yoga. yoga was delivered twice a week for 8 weeks for one hour each session. Yoga included sitting, standing, and floor postures, breath work, and meditation

Eligibility criteria: Inclusion Criteria:

* Anyone age 18 and over with DPN from Diabetes Mellitus and a balance impairment. and be able and willing to attend twice weekly sessions for 8 weeks.

Exclusion Criteria:

* not have consistently engaged in yoga for greater than a year.

Primary outcomes:
measure: change in Neuro-QoL
timeFrame: baseline and 8 weeks
measure: change in Berg balance Scale
timeFrame: baseline and 8 weeks
measure: change in 6 minute walk
timeFrame: baseline and 8 weeks
measure: change in 10 meter walk
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06690307: Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
Official title: The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Laparoscopic Hysterectomy
Keywords: oxycodone
patient-controlled intravenous analgesia
laparoscopic hysterectomy
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 64
Sex: FEMALE
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: This study is designed to evaluate the efficacy and safety of hydrocodone in patient-controlled intravenous analgesia (PCIA) during gynecological laparoscopy, thus to explore suitable PCIA scheme to optimize postoperative pain management for patients undergoing gynecological laparoscopic surgeries.

Detailed description: The controlled group will receive sulfentanil for PCIA, and the test group will receive hydrocodone for PCIA. NRS scores at 1, 6, 24 and 48 hours post-surgery will be recorded. The usage of rescue analgesics and adverse events will also be recorded.

Eligibility criteria: Inclusion Criteria:

* selective laparoscopic hysterectomy
* general anesthesia
* ASA classification I - III
* aged 18 - 65 years

Exclusion Criteria:

* allergy to oxycodone or any other drugs will be used in the study
* preoperative opioids medication
* opioids abuse
* hepatic or renal dysfunction
* cardiovascular or pulmonary dysfunction
* lack of full civil capacity or refuse to participate

Primary outcomes:
measure: NRS scores
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: NRS scores
timeFrame: 1, 24, 48 hours after surgery
measure: rescue analgesics usage
timeFrame: from the end of surgery to the first usage (up to 48 hours post-surgery)
measure: PCIA pressing times
timeFrame: 48 hours after surgery
measure: anal exhaust time
timeFrame: from the end of surgery to the first anal exhaust (up to 48 hours post-surgery)
measure: adverse events
timeFrame: within 48 hours after surgery
measure: NRS scores
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated hospital of Nantong University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00367107: Autism in Adult Patients and the Effects on Caregivers
Official title: Autism: Long Term Course and Impact
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Keywords: Autism spectrum disorders
long-term outcomes
caregiver burden
birth cohort
nested case-control study
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-08-22
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: autisem

Brief summary: Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. Few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. We therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents.

Working hypothesis and aims: The primary objectives of the study are:

1. Determine clinical status and functioning of autistic adults.
2. Study the influence of raising and caring for an individual with autism on the well-being of the parents.


Eligibility criteria: Inclusion Criteria:

* Autism or autism spectrum disorder
* Understands the informed consent
* Hebrew Speaker

Exclusion Criteria:

* Severe acute or chronic illness
* Substance abuse
* In control subjects: Autism or autism spectrum disorder in subject or siblings
* In control subjects: participating sibling

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Mental Health Epidemiology & Psychosocial Aspects of Illness, The Gertner Institute for Epidemiology and Health Policy Research
name: Raz Gros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05009407: CD160 Expression in Corneal Vessels
Official title: CD160 Ans Corneal Graft: Expression in Corneal Vessels
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Graft Rejection
CD160
Angiogenesis
Lymphangiogenesis
Keywords: Corneal Graft Rejection
CD160
Angiogenesis
lymphangiogenesis
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-year-old or more patients enrolled for penetrating keratoplasty or deep anterior lamellar keratoplasty surgeries at the Robert Debré University Hospital, Reims, France

Brief summary: Despite improvements in corneal transplantation, anti-angiogenic and anti-lymphangiogenic factors remain to be be identified. CD160 is an anti-angiogenic target: its expression seems to be restricted to some immune cells and to activated endothelial cells. We hypothesized that CD160 is expressed in blood and lymphatic human corneal neovessels and is involved in corneal graft rejection pathogenesis

Detailed description: After informed consent, patients enrolled for corneal graft surgery at the Robert Debré University Hospital, Reims, France, will be included.

Routine general and eye examination including cornea photographs will be performed.

During surgery, a quarter of patients' cornea and of donors' corneoscleral rim will be spared for immunohistochemistry analyzes.

Eligibility criteria: inclusion criteria :

* 18-year-old or more patients
* enrolled for penetrating keratoplasty or deep anterior lamellar keratoplasty surgeries at the Robert Debré University Hospital, Reims, France
* considered able to give an informed written consent exclusion criteria :
* none

Primary outcomes:
measure: Micro-vascular densities
timeFrame: 1 year
Secondary outcomes:
measure: Percentages of those vascular structures marked with anti-CD160 and/or CD105 and/or aSMA
timeFrame: 1 year
measure: Evaluation of clinical blood vascular densities on photographs with help of ImageJ software
timeFrame: 1 year
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: