louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00264082: Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis
Official title: "Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2005-12-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.


Eligibility criteria: Inclusion Criteria:

1. Histologic or cytologic documentation of breast cancer.
2. Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
3. Age \> 18
4. Written informed consent prior to study entry
5. Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
6. Life expectancy of at least 6 months.
7. We will include patients who have had previous or current radiation therapy to breast

Exclusion Criteria:

1. Concurrent malignancy with a second primary
2. Stage I, Stage II and Stage III
3. ECOG Performance Status 3 or 4.
4. Renal Failure - serum creatinine \>2.O mg/dL at screening
5. AST or ALT \> ULN X 3. at screening
6. Bilirubin \> 3.0 mg/dL at screening
7. Pregnant women
8. Prior or current bisphosphonate therapy
9. Any skeletal related event due to malignancy prior to study enrollment.
10. Patients with osteoporotic fractures prior to study enrollment.
11. Allergy to bisphosphonates
12. Any radiation therapy for the treatment of bone metastases \<4 weeks prior to study start.
13. Any chronic medical condition which would preclude performance or adherence to protocol requirements
14. Inability to provide informed consent

    -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center, 529 S. Jackson St.
state: Kentucky
Study officials:
affiliation: University of Louisville, James Graham Brown Cancer Center
name: Leela Bhupalam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295982: Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cancer
Keywords: Laparoscopic nephrectomy
one day surgery
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
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 describe the postoperative outcomes after laparoscopic transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of our experiences from the previous study to optimize the postoperative outcomes.


Eligibility criteria: Inclusion criteria:

1. Patient between 25-80 years old.
2. Diagnosed as Cancer Renis
3. Can read and understand Danish
4. No cardiac disease lead to close cardiologic observations
5. Any T, any N any M stadia.

Exclusion criteria:

1. Mentally sick patient
2. Dement
3. Living alone
4. Cardiac problem
5. Per operative bleeding with the need to blood transfusion
6. Operation time at afternoon

Primary outcomes:
measure: postoperative hospital admission
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde Hospital
Study officials:
affiliation: Zealand University Hospital
name: Nessn H Azawi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02566382: Preliminary Study of Feasibility of Arthrodesis Scapula-humeral Under Arthroscopy
Official title: Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroscopy Arthrodesis Gleno-humeral
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 1
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: Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.

Detailed description: This trial is about the arthrodesis shoulder blade/humerus under arthroscopy. The main aim of this study is to be able to carry out a fusion scapula-humeral supplements in 6 months. It is required to provide the benefice risk over to reduce the hospitalisation 48 hours.

Eligibility criteria: Inclusion Criteria:

* Patient having a deficit scapula-humeral mobility
* Impossibility of being operated for a preserving nervous surgery
* Patient affiliation with a social security
* Patient who signed inform consent

Exclusion Criteria:

* Patient with No mobility in all the articulations of the shoulder
* Callus malunion of the higher end of the humerus or the glen of the scapula
* Unable to sign an inform consent

Primary outcomes:
measure: Radiological fusion gleno humeral on side and front view after the 6th month of the arthroscopy interventional
timeFrame: 6 months
Secondary outcomes:
measure: Blood loss
timeFrame: 3 days
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest university hospital
state: Bretagne
Study officials:
References:
Clinical trial NCT03385382: Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema
Official title: Macular Thickness and Vessel Density Changes After Dexamethasone Implant and Ranibizumab Intravitreal Injection in Diabetic Macular Edema: 6-month Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with no proliferative moderate DR stage (simplified version of the ETDRS classification aimed by the American Academy of Ophthalmology Guidelines Committe) and cystoid macular edema type without subretinal fluid component were recruited

Brief summary: Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the Ophthalmologic Clinic of University "G. d'Annunzio", Chieti-Pescara, Italy.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* BCVA greater than 0.5 LogMAR in the study eye at baseline examination
* Presence of recent DME
* CMT \> 300µm as measured using the SD-OCT at the baseline examination

Exclusion Criteria:

* Any previous ocular surgery in the last 6 months
* Laser treatments
* Prior ocular trauma
* Retinal vascular diseases
* Vitreo-retinal interface diseases
* Medium lens opacities (according to Lens Opacities Classification System)

Primary outcomes:
measure: Central macular thickness
timeFrame: 6 months
Secondary outcomes:
measure: visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00592982: Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
Official title: Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bisphosphonate-associated ONJ
Osteomyelitis of the Jaw
Osteolytic Lesions of the Jaw
Osteoradionecrosis of the Jaw
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 25
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: Primary Care Clinic

Brief summary: 1. Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron emission tomography(PET).
2. Bisphosphonate-associated ONJ can be diagnosed and characteristically differentiated from other bony pathologies of the jaw(osteomyelitis, osteolytic lesions, and osteoradionecrosis)by PET imaging.

Detailed description: Is to review medical records of approximately 1000 patients with bisphosphonate-associated ONJ who have had PET imaging at the time of diagnosis. Also to review medical records of patients who have been diagnosed with jaw osteomyelitis, osteoradionecrosis, and cancerous lytic lesions who received PET imaging at the time of diagnosis.

If sufficient information regarding presentation and treatment cannot be obtained form the medical record, approximately 300 patients will contacted by mail (and phone if necessary) by the PI or sub-investigators to question them regarding the onset of symptoms, treatment interventions, and outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bisphosphonate-associated ONJ, osteomyelitis, osteoradionecrosis,and osteolytic lesions who received PET imaging at presentation

Exclusion Criteria:

* Anyone who has not been diagnosed with bisphosphonate-associated ONJ, osteomyelitis, osteoradionecrosis,or osteolytic lesions who received PET imaging at presentation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Brendan Stack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Osteonecrosis of the Jaw and Bisphosphonates 2005. NEJM 353: 99-102. 2. Marx RE. 2003 Pamidronate (AREDIA) and Zoledronate (ZOMETA) induced avascular necrosis of the jaws: a growing epidemic J Oral Maxillofac Surg 61:1115-1118 3. Hellstein JW, Marek CL. 2005. Bisphosphonate Osteochemonecrosis (Bis-Phossy Jaw): Is This Phossy Jaw of the 21st Century? J Oral Maxillofac Surg 63: 682-689. 4. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL. 2004. Osteonecrosis of the Jaws Associated With the Use of Bisphosphonates: A Review of 63 Cases. J Oral Maxillofac Surg 62:527-534. 5. Clarke BM, Boyette JR, Vural EA, Suen JY, Anaisse EJ, Stack BC. Bisphosphonates and Jaw Osteonecrosis: Our Experience. Otolaryngol Head Neck Surg. 2007 Mar;136(3):396-400.
Clinical trial NCT00345982: Augmenting Clozapine With Sertindole - SERCLOZ
Official title: Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Treatment-resistant
sertindole
clozapine
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2006-06-29
Enrollment: 50
Sex: ALL
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: The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.

Detailed description: Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.

Eligibility criteria: Inclusion Criteria:

* ICD10 diagnosis of schizophrenia (F20.0-3)
* Clozapine treatment minimum 6 months
* Total PANSS \>65
* No antipsychotic other than clozapine drug 1 month prior inclusion

Exclusion Criteria:

* QTc \>500 ms
* Violence to SPC of clozapine or Serdolect
* Major depression
* Significant substance misuse interfering with participating in the study
* Cardiovascular disease

Primary outcomes:
measure: PANSS total score
timeFrame: 12 weeks
Secondary outcomes:
measure: GAF
timeFrame: 12 weeks
measure: WHOQOL-BREF
timeFrame: 12 weeks
measure: CGI
timeFrame: 12 weeks
measure: DAI
timeFrame: 12 weeks
measure: Cognitive test
timeFrame: 12 weeks
measure: Fasting glucose
timeFrame: 12 weeks
measure: Lipids
timeFrame: 12 weeks
measure: Hb1Ac
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Psychiatric Hospital
Study officials:
affiliation: Aalborg Psychiatric Hospital
name: Jimmi Nielsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen J, Emborg C, Gydesen S, Dybbro J, Aagaard J, Haderup K, Glyngdal P, Fabricius S, Thode D, Lublin H, Andersen T, Damkier P, Taylor D. Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study. J Clin Psychopharmacol. 2012 Apr;32(2):173-8. doi: 10.1097/JCP.0b013e318248dfb8.
citation: Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Acta Psychiatr Scand. 2012 Jul;126(1):31-9. doi: 10.1111/j.1600-0447.2012.01840.x. Epub 2012 Feb 22.
Clinical trial NCT01861782: Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA
Official title: Comparison Between Dead Sea Solar and Water Treatment to "Sulfur Pool" and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective open label crossover self controlled study. The study population will randomly be divided into two groups.

The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16 participants and one of 14 participants) and will be comprised of 3 main stages:

1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol)
2. 12-month washout period
3. Crossover of the two groups and second exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol).

The population in the study will be composed of patients diagnosed and treated for rheumatoid arthritis at the Soroka University Medical Center who are 18 and above of age.

The patients will be selected by the PI and his team and addressed regarding their willingness to participate in the study.


Eligibility criteria: Inclusion Criteria:

1. Male and female ≥ 18
2. Patients with diagnosed rheumatoid arthritis
3. Patients with moderate disease activity (DAS28 \> 3.2)

Exclusion Criteria:

1. Patients who suffer from Photosensitivity
2. Patients with Suspected Lupus Erythematoides
3. Patients with tendency to sudden loss of consciousness and/or dizziness
4. Patients under chemotherapeutic treatment
5. Patients with Active Malignancy
6. Patients with lowest level of physical functioning (class 4)
7. Patients with serious uncontrolled concomitant chronic disease
8. Drug Abuser
9. Patients with severe peripheral venous insufficiency
10. Pregnant women

Primary outcomes:
measure: Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments.
timeFrame: up to 4 months
Secondary outcomes:
measure: Assessing the change between baseline and several occasions after each one of proposed the treatments
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Ein Bokek
country: Israel
facility: Lot Spa Hotel at the Dead Sea
Study officials:
References:
Clinical trial NCT06010082: The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women
Official title: The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women: A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is a strong correlation between sleep disturbance and indications of stress, anxiety, and depression. However, in Egypt no research has looked into how better sleep for expectant mothers might be achieved by inexpensive, pleasurable, non-invasive music listening. Therefore, the aim of this study was to investigate how music listening affects pregnant women's psychological status, and sleep quality.

Detailed description: This study used a randomized controlled trial (RCT) design and adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study utilized a simple random sampling technique to select participants in proportion to the total number of pregnant women in the outpatient Medical National Institute in Damanhur city, Egypt.

Eligibility criteria: Inclusion Criteria:

In third trimester, 30-34th weeks of pregnancy, age ranging from 18-35 years old, singleton pregnancy, willing to participate

Exclusion Criteria:

having any physical or mental health disorders

Primary outcomes:
measure: Depression, Anxiety, and Stress Scale
timeFrame: 2 months
measure: Sleep Quality
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria university
Study officials:
References:
Clinical trial NCT03074682: Novel Device for Rapid Fluid Administration
Official title: Fluid Administration With LifeFlow vs Push/Pull
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Related Sepsis
Keywords: Resuscitation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to determine if a new device is more effective in fluid administration than devices currently used when resuscitating pediatric patients in septic shock. This study will take place in a simulation lab setting and will not include the use of patients.

Detailed description: In this study, participants will be randomized to one of three devices in a Pediatric Intensive Care Unit simulation setting. Each participant will be provided the device, a 1L NS bag, tubing and a 22g IV. In each scenario, the objective will be to administer 3 20cc/kg boluses within a 15 minute period to the simulated patient.

Eligibility criteria: Inclusion Criteria:

* Pediatric emergency medicine or pediatric intensive care unit nurses, pediatric residents, medics and attendings.

Exclusion Criteria:

* Inability to operate equipment due to illness or physical impairment.

Primary outcomes:
measure: Successful Administration of 60 mL/kg
timeFrame: 20 minutes
Secondary outcomes:
measure: Time to Complete Fluid Administration
timeFrame: Up to 20 minutes
measure: NASA Task Load Index (TLX)
timeFrame: 15 minutes
Other outcomes:
measure: Post Intervention Survey
timeFrame: 15 minutes
Locations:
city: New Haven
country: United States
facility: Departments of Pediatrics and Emergency Medicine, Yale University
state: Connecticut
Study officials:
References:
citation: Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583.
Clinical trial NCT01188382: Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly
Official title: Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Elderly
Keywords: Intracranial pressure
resistance
CSF outflow
elderly
reference value
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy elderly

Brief summary: Objective. The intracranial pressure and cerebrospinal outflow resistance are essential parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the compliance of the system. The objective of this study was to determine the reference values in the elderly.

Methods. Elderly people (60-82 years), considering themselves healthy, were recruited through an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance imaging apparatus. Subjects were eligible if they did not have any psychiatric or neurological disorder or signs of advanced atherosclerotic disease. Intracranial pressure and outflow resistance were determined by a constant pressure infusion method with the patient in the supine position. The study population consisted of 40 subjects (mean age 70 years; 23 women).


Eligibility criteria: Inclusion Criteria:

* Healthy
* 60-82 years

Exclusion Criteria:

* Psychiatric or neurological disorder or advanced atherosclerotic disease

Primary outcomes:
measure: CSF outflow resistance
Secondary outcomes:
measure: Intracranial pressure
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dep Clincial Neuroscience, Umeå university
Study officials:
affiliation: Umeå University
name: Jan I Malm, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobsson J, Qvarlander S, Eklund A, Malm J. Comparison of the CSF dynamics between patients with idiopathic normal pressure hydrocephalus and healthy volunteers. J Neurosurg. 2018 Nov 16;131(4):1018-1023. doi: 10.3171/2018.5.JNS173170. Print 2019 Oct 1.