louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01447160: Effectiveness of Facet Joint Infiltration in Low Back Pain
Official title: Effectiveness of Facet Joint Infiltration in Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Back Pain
Keywords: facet joint
back pain
osteoarthritis
infiltration
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 60
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 purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.

Detailed description: Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.

They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).

Eligibility criteria: Inclusion Criteria:

* low back pain up to 3 months
* pain on back extension
* radiologic findings of facet joint osteoarthritis

Exclusion Criteria:

* other causes of back pain
* fibromyalgia
* diabetes, arterial hypertension or glaucoma not well controlled
* patients with contrast allergy

Primary outcomes:
measure: pain visual analogic scale
timeFrame: baseline
measure: pain visual analogic scale
timeFrame: 4 weeks
measure: pain visual analogic scale
timeFrame: 12 weeks
measure: pain visual analogic scale
timeFrame: 24 weeks
Secondary outcomes:
measure: Rolland Morris questionnaire
timeFrame: baseline
measure: Rolland Morris questionnaire
timeFrame: 4 weeks
measure: Rolland Morris questionnaire
timeFrame: 12 weeks
measure: Rolland Morris questionnaire
timeFrame: 24 weeks
measure: SF-36 questionnaire
timeFrame: baseline
measure: SF-36 questionnaire
timeFrame: 4 weeks
measure: SF-36 questionnaire
timeFrame: 12 weeks
measure: SF-36 questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sao Paulo federal University
state: SP
Study officials:
affiliation: Sao Paulo Federal University
name: Luiza Ribeiro, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02250560: A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
Official title: An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia B
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-26
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate.

Exclusion Criteria:

-

Primary outcomes:
measure: Assessment of control of prevention of bleeding
timeFrame: End of study (Day 5 to Day 10)
Secondary outcomes:
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road
city: London
country: United Kingdom
facility: Haemophilia Centre, The Royal London Hospital, White Chapel
city: London
country: United Kingdom
facility: Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street
city: Manchester
country: United Kingdom
facility: Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road
city: Southampton
country: United Kingdom
facility: Haemophilia Centre, Southampton General Hospital, Tremona Road
Study officials:
References:
Clinical trial NCT01451476: Human Skin Aging: Clinical Parameters and Gene Expression Profiling
Official title: Human Skin Aging: Clinical Parameters and Gene Expression Profiling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ageing
Keywords: Ageing
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy females age 18 or older

Brief summary: Skin aging is a complex process involving genetic and environmental factors. The investigators hope to learn more about how human genes and their function can contribute to skin aging and human health.

Detailed description: This study includes answering a survey on prior sun exposures, donating two small pieces of skin (4mm each), one blood draw, complexion analysis, photographs, and non-invasive tests such as skin surface lipid analysis. Your blood and tissue will be sent for DNA analysis and gene expression profiling.

Eligibility criteria: Inclusion Criteria:

* healthy female, age 18 or older,
* Fitzpatrick type 1 or 2 skin,
* able to read and understand written consent form,
* body mass index normal or overweight range,
* willing to take blood tests and donate skin samples

Exclusion Criteria:

* pregnant or lactating,
* history of cosmetic surgery affecting the face,
* use of prescription anti-aging medications for 2 weeks prior to study,
* use of dietary supplements for 2 weeks prior to study, use of tanning beds or excessive light exposure (\>2 hours) in the past 2 weeks,
* medical conditions which at the discretion of the investigator will have significant impact on ability to judge subjects' skin characteristics and age, sunless tanner use in past 2 weeks

Primary outcomes:
measure: Assessment of age related gene expression changes in skin
timeFrame: Cross sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Dermatology
state: California
Study officials:
affiliation: Stanford University
name: Alfred Lane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Anne Chang, MD
role: STUDY_DIRECTOR
References:
citation: Xu J, Spitale RC, Guan L, Flynn RA, Torre EA, Li R, Raber I, Qu K, Kern D, Knaggs HE, Chang HY, Chang AL. Novel Gene Expression Profile of Women with Intrinsic Skin Youthfulness by Whole Transcriptome Sequencing. PLoS One. 2016 Nov 9;11(11):e0165913. doi: 10.1371/journal.pone.0165913. eCollection 2016.
Clinical trial NCT06599476: Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Official title: Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Advanced Radiation Centers of New York
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.

The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.

Study visits:

* Screening
* Spacer placement
* Treatment planning simulation
* End of the radiation treatment
* 1,3,and 6-months FU visits.


Eligibility criteria: Inclusion Criteria:

1. Patients with prostate cancer ≥ 18 years of age.
2. Patients are in one of the following risk groups:

   * T1-T3 prostate cancer with no posterior extra capsular extension
   * Gleason score ≤ 7
3. Planned for radiation treatment with rectal spacer.
4. Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

1. Metastatic disease.
2. Previously treated localized adenocarcinoma of the prostate.
3. Active Inflammatory bowel disease requiring treatment with steroids.
4. Prior total prostatectomy.
5. Current urinary tract infection.
6. Acute or chronic prostatitis.

Primary outcomes:
measure: Dosimetry
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Advanced Radiation Centers of New York
state: New York
Study officials:
References:
Clinical trial NCT01961076: Overnight Feeding Study in Glycogen Storage Disease Type 1
Official title: New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycogen Storage Disease Type 1 (GSD 1)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this clinical cross-over study, we will compare the efficacy of different oral nutrition regimens for night-time glucose control in adult GSD 1 patients. Three different over-night nutrition regimens (=interventions) will be compared in each patient sequentially, (1) uncooked corn starch (UCSS, "Maizena"), (2) modified corn-starch, (3) other carbohydrate (starch) containing meal. During each intervention, glucose profiles will be continuously monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the technical quality of glucose sensor readings. Between the interventions, the patients follow their normal prescribed diet.


Eligibility criteria: Inclusion criteria:

* Glycogen storage disease type 1 (type 1a and 1b)
* Stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements.

Exclusion criteria:

* Unstable night-time glucose control during the last 8 weeks with frequent (\> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks.
* Pregnancy or breast feeding
* Drug or alcohol abuse
* Acute gastrointestinal problems (e.g. acute gastroenteritis)
* Known malignancy (e.g. hepatocellular carcinoma)

Primary outcomes:
measure: Maximum fasting time over-night (h)
timeFrame: Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
name: Giatgen Spinas, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293876: Corneal Lesions in Intensive Care Unit (ICU) Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center
Official title: Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratitis
Corneal Ulcer
Keywords: Corneal Diseases
Corneal Ulcer
Nursing Diagnosis
Intensive Care Units
Nursing
Randomized Clinical Trial
Lead sponsor: Hospital Risoleta Tolentino Neves
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2014-11-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.

Detailed description: Critically ill patients are at higher risk for corneal injury and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. There is a scale for assessing the risk for corneal injury. Thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. The specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. Patients and methods: This study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .

Eligibility criteria: Inclusion Criteria:

* Ramsay sedation scale 5 or 6
* Glasgow coma scale lower than 7
* Use of oxygen therapy by facial device above 6 liters per minute or mechanical ventilation
* Blink reflex less than 5 times per minute or ocular globe exposure

Exclusion Criteria:

* Less than 48 hours in Intensive Care Unit

Primary outcomes:
measure: Keratitis
timeFrame: Five days
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital Risoleta Tolentino Neves
state: Minas Gerais
Study officials:
affiliation: Hospital Risoleta Tolentino Neves
name: Andreza Werli-Alvarenga, RN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01347476: Aggressive Prostate Cancers in Elderly Patients
Official title: Patients Aged More Than 70 Had More Aggressive Prostate Cancers and Higher Risk of Biochemical Recurrence in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: prostate-specific antigen
radical prostatectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 1333
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who underwent radical prostatectomy for the treatment of clinically localized prostate cancer

Brief summary: Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.

Detailed description: Patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter BCR-free survival than younger ones. Definite treatment of clinically localized prostate cancer should be actively considered in well-selected healthy patients older than 70 years.

Eligibility criteria: Inclusion Criteria:

* clinically localized prostate cancer
* good health status
* follow-up period more than 12 months

Exclusion Criteria:

* insufficient clinical data
* poor health status
* clinically advanced prostate cancer

Primary outcomes:
measure: biochemical recurrences (BCR)
timeFrame: 5 year-BCR
Secondary outcomes:
measure: pathologic outcomes
timeFrame: postoperative 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung Yong Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JK, Cho SY, Jeong CW, Lee SB, Ku JH, Hong SK, Byun SS, Kwak C, Him HH, Lee SE, Jeong H. Patients aged more than 70 had higher risk of locally advanced prostate cancers and biochemical recurrence in Korea. BJU Int. 2012 Aug;110(4):505-9. doi: 10.1111/j.1464-410X.2011.10927.x. Epub 2012 Feb 7.
Clinical trial NCT00693576: The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
Official title: The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Renal Transplantation
Keywords: renal transplant
panel reactive antibody
sensitization
simvastatin
immunological
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-06-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative kidney for transplantation and are at the risk of post transplantation rejection more than other transplanted patients. We evaluated the effect of simvastatin on PRA and post transplant outcome of these sensitized patients. We also performed a descriptive study.

Detailed description: The presence of panel reactive antibodies (PRAs) in the sera of renal transplant candidates is associated with hyperacute or delayed humoral immune responses against the graft after transplantation .

In addition, these sensitized patients wait for a long time to find a cross-match negative kidney for renal transplantation . As a result, some modalities have been used for desensitization including plasmapheresis and intravenous immunoglobulin (IVIG) in combination with immunosuppressive drugs .

However, recently, the use of statins such as simvastatin, pravastatin and etc. has been proposed to be safer and more effective for desensitization .

Eligibility criteria: Inclusion Criteria:

1. patients with ESRD on hemodialysis or peritoneal dialysis
2. On the waiting list for renal transplant
3. PRA more than 25%

Exclusion Criteria:

1. Pregnant women
2. Patients who need ongoing blood products
3. Patients taking other therapies to decrease PRA
4. Patients listed for multi-organ transplant other than kidney
5. Patients with liver failure

Primary outcomes:
measure: effect of simvastatin on panel reactive antibody
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: shiraz university of medical science
name: jamshid roozbeh, associate professor
role: STUDY_DIRECTOR
affiliation: shiraz university of medical science,internal medicine department
name: azar Sattarinezhad, internal medicine resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: mohammad mahdi sagheb, assistant professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909376: Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?
Official title: Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Pregnancy
Ultrasonography
outcome
adverse
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 450
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with one fetus who has no malformations.

Brief summary: Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.

The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who choose to have a ultrasound done in the early second trimester.

Exclusion Criteria:

* More than one fetus,
* No agreement to participate in the study,
* Malformative fetus.

Primary outcomes:
measure: nuchal cord entanglement
timeFrame: at birth
Secondary outcomes:
measure: SGA
timeFrame: at birth
measure: Admission to intensive care unit
timeFrame: at birth
measure: meconium
timeFrame: at birth
measure: fetal distress
timeFrame: at birth
measure: low APGAR score
timeFrame: 1 minute, 5 minutes after birth
measure: need for c section
timeFrame: at birth
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Ori Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02503176: An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dry Eye With Sjögren's Syndrome
Keywords: Dry eye syndromes
Corneal diseases
Conjunctival diseases
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.


Eligibility criteria: Inclusion Criteria:

* Dry eye patients with Sjögren's syndrome finished KCT1301 study

Exclusion Criteria:

* Patients with poor adherence to medication of study drug in KCT1301 study

Primary outcomes:
measure: Incidences of adverse events
timeFrame: 52 weeks
Secondary outcomes:
measure: Score of the corneal staining
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References: