louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00149071: Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
Official title: Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: Transcranial magnetic stimulation (TMS)
Major depression
treatment resistant major depression
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
Collaborators: name: Medicon Valley Academy
First posted: 2005-09-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram

Detailed description: In this study we aimed at investigating to what degree rTMS applied over the left dorsolateral cortex relieves depressive symptoms when the treament is combined with antidepressive medication. The study will also be able to supply knowledge on how long any possible effect of the rTMS treatment lasts.

In the first 12 weeks of the trial participants are randomised to either rTMS combined with escitalopram or sham rTMS combined with escitalopram. rTMS is given daily for the first 3 weeks.

The next phase is a relapse prevention study where the responders from the initial phase are randomised to either active or placebo escitalopram for 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Major depression Hamilton score above 18
* Age 18 to 75

Exclusion Criteria:

* Pregnancy og breastfeeding
* Mental retardation and organic brain disease
* Alcohol and substance abuse
* Metal implants in brain, pacemakers and other electronic implants

Primary outcomes:
measure: depression scores
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerod
country: Denmark
facility: Psychiatric research unit, Hilleroed Hospital,
Study officials:
affiliation: Psychiatric research Unit, Hilleroed Hospital, Denmark
name: Line G Bretlau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511471: Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Official title: Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platelet Reactivity
Keywords: Ticagrelor
platelet reactivity
clopidogrel
haemodialysis
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clopidogrel administration is commonly prescribed in patients undergoing percutaneous coronary intervention, in patients with previous stroke and in patients under chronic hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Ticagrelor is a new oral direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel responders and non-responders. It has also been shown that in patients with chronic kidney disease (creatinine clearance \<60 mL/min)ticagrelor achieved an absolute risk reduction of cardiovascular death, myocardial infarction, and stroke greater than that of patients with normal renal function. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily for 15 days. Platelet reactivity will be determined at the end of the treatment period. Bleeding events, major adverse cardiac events and any side effects until Day 15 will be reported in a descriptive manner.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years
* Chronic renal failure under haemodialysis
* Platelet reactivity under clopidogrel 75mgx1 ≥235 PRU
* Informed written consent

Exclusion Criteria:

* Recent (within 1 month) PCI or ACS
* Requirement for oral anticoagulant prior to the Day 14 visit
* PLTs\<100.000 / μL), Hct \<28%, Hct \> 52% at randomization
* Increased risk of bradycardiac events.
* Severe uncontrolled chronic obstructive pulmonary disease
* Known severe hepatic impairment
* History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
* Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
* Recent (\<6weeks)major surgery including CABG
* Recent (\<6weeks)stroke or any prior intracranial bleeding

Primary outcomes:
measure: Platelet reactivity assessed by VerifyNow P2Y12 assay
timeFrame: Day 15
Secondary outcomes:
measure: Bleeding events according to TIMI criteria
timeFrame: Day 15
measure: Major adverse cardiovascular events
timeFrame: Day 15
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Agios Andreas General Hospital, Nephrology Department
state: Achaia
city: Rio
country: Greece
facility: Cardiology Department Patras University Hospital
state: Achaia
Study officials:
References:
Clinical trial NCT06070571: Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group
Official title: Clinical Assessment of Antibacterial Anti-inflammatory Activities of Yarrow Moringa Herbal Combinations in Bucco Adhesive Films
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gingivitis
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind, prospective, randomized, intra-individual comparative, single-center clinical study was conducted. Participants were placed in parallel groups, and the study was performed in the Department of Operative Dentistry and Periodontology, Dental School and Hospital, Minia university to compare the antibacterial activity of yarrow Moringa herbal combinations nanoparticles in compared to Chlorhexidine as a potential treatment for gingivitis.


Eligibility criteria: Inclusion Criteria:

* a minimum of four natural uncrowned teeth in one quadrant present
* good general health
* can follow instructions

Exclusion Criteria:

* were pregnant or breastfeeding
* evidence of antibiotic use during the 4 weeks prior to the study
* were allergic to personal care/consumer products or their ingredients

Primary outcomes:
measure: antibacterial and anti inflammatory activities
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
state: المنيا
Study officials:
affiliation: faculty of pharmacy, Deraya university
name: soad ali, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00654771: Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation
Official title: Prospective Comparison of Catheterized and Clean Catch Urine Specimens for Determination of Protein/Creatinine Ratio in Evaluation of Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Proteinuria
Hypertension
Pregnancy
Keywords: protein/creatinine ratio
clean catch urine
catheterized urine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation
First posted: 2008-04-09
Enrollment: 76
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.

Brief summary: The purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Detailed description: Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. However, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. At our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. However, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. Thus, the purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Eligibility criteria: Inclusion Criteria:

* Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia

Exclusion Criteria:

* Ruptured membranes
* Any vaginal bleeding or spotting
* Pre-existing urinary tract infections or patients who are found to have a concurrent urinary tract infection upon culture of urine
* Patients who have previously been enrolled in the study

Primary outcomes:
measure: Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens
timeFrame: time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Beatrice A Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652678: Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
Official title: Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abnormalities, Radiation-Induced
Keywords: Breast cancer
Radiation effects
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: Carol M. Baldwin Breast Cancer Research Fund, Inc.
First posted: 2008-04-04
Enrollment: 38
Sex: FEMALE
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study subjects will be drawn from patients with a history of treatment for breast cancer with lumpectomy followed by radiation therapy.

Brief summary: Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Detailed description: Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

Eligibility criteria: Inclusion Criteria:

* Breast cancer treatment: lumpectomy followed by external beam XRT to breast
* Age at the time of radiotherapy treatment: 45-65 years old
* XRT dose to breast: \>/= 4500 and \</= 5200 cGy, fraction size 180 or 200 cGy
* Dose distribution: no area receiving \>/= 112% of prescribed dose
* Follow-ups: patients must be \>/= 2.5 years post-treatment

Exclusion Criteria:

* Reconstructive surgery to involved breast

Primary outcomes:
measure: correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject
timeFrame: at least 2.5 years following lumpectomy and radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Peter J Hahn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117078: Aranesp® Monthly Preference Study - 2
Official title: Aranesp® Monthly Preference Study - 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Disease
Keywords: Kidney disease, Renal, CKD (Chronic Kidney Disease)
CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen
Aranesp®, Darbepoetin alfa, QW dosing
Q2W dosing, Q4W dosing
Patient preference, Subject preference
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).


Eligibility criteria: Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 8 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Self-injecting at home with Procrit® - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Primary outcomes:
measure: Subject preference
Secondary outcomes:
measure: Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02680678: The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section
Official title: Prevention of Postspinal Hypotension After Spinal Anesthesia for Caesarian Section, the Comparison of Crystalloid and Colloid Infusions and Their Timing Via Perfusion Index and Plethysmographic Variability Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Anesthesia, Spinal and Epidural, in Pregnancy
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction
Primary purpose: PREVENTION

Brief summary: Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.

Detailed description: To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.

Eligibility criteria: Inclusion Criteria:

* pregnant 37-41 weeks
* one fetus
* scheduled for C/S under spinal anesthesia
* accepting to participate

Exclusion Criteria:

* Emergency surgery
* placenta previa
* preeclampsia
* cardiovascular and cerebrovascular comorbidities
* morbid obesity (BMI\>40)
* pregnancy weeks \<36 and \> 41
* The use of vasoconstrictors
* Severe Anemia ( Hb \<9 g/dl)
* Refusal or known contraindication for spinal anesthesia

Primary outcomes:
measure: Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
timeFrame: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Balikesir University Faculty of Medicine
Study officials:
affiliation: Balikesir University School of Medicine Department of Anesthesia and Reanimation
name: Hafize Fisun Demir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789178: Cognitive and Memory Function in Patients With Fibromyalgia
Official title: Cognitive and Memory Function in Patients With Fibromyalgia and Their Influence on Disability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Cognitive Impairment
Keywords: memory disturbances
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-11-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients with fibromyalgia 30 patients with RA 20 healthy controls

Brief summary: Patients suffering from Fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests.

Their results will be compared to those with active RA associated with pain and with a normal control group.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from fibromyalgia patients suffering from active RA

Exclusion Criteria:

* Patients with depressive disorders Patients treated with SSRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
References:
Clinical trial NCT03801278: An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
Official title: An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Recurrent Bladder Cancer
Keywords: Single patient
Lead sponsor: Five Prime Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer

Detailed description: This protocol is intended to provide access to bemarituzumab (FPA144 an investigational agent) to a single patient with recurrent bladder cancer who had a response to study drug on FPA144-001. That study is closing and this expanded access protocol allows this single patient to continue receiving this agent.

Eligibility criteria: Inclusion Criteria:

1. Understand and sign an Institutional Review Board-approved informed consent form prior to receiving bemarituzumab
2. Previously enrolled on the FPA144-001 study, received bemarituzumab and obtained clinical benefit from the investigational product (IP) administration

Exclusion Criteria:

1. Pregnancy and lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00004778: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome
Keywords: cardiovascular and respiratory diseases
neonatal disorders
rare disease
respiratory distress syndrome
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Children's Hospital of Philadelphia
First posted: 2000-02-25
Enrollment: 1090
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery.

II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease.

III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Participants are stratified by participating institution.

Participants are randomly assigned to 1 of 2 treatment groups. The first group is treated with intravenous thyrotropin-releasing hormone (TRH) and intramuscular injections of betamethasone or dexamethasone. The second group receives a placebo in place of TRH.

Postnatal therapy with surfactants, prophylactic steroids, and indomethacin is allowed.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Threatened premature delivery at 24 to 30 weeks gestation, i.e.: Premature labor Premature rupture of membranes Elective premature delivery medically indicated Fetal lung maturity immature or unknown --Prior/Concurrent Therapy-- No more than 72 hours since any initial corticosteroids --Patient Characteristics-- The following complications exclude: Fetal distress Amnionitis Severe maternal bleeding uncontrolled with transfusion or volume replacement Fetal or maternal heart disease Significant fetal blood loss Maternal blood pressure 140/90 mm Hg or higher with or without treatment Maternal hyperthyroidism Maternal hyperprolactinemic condition Significant fetal anomaly Multiple gestation with demise of 1 or more fetuses Nonimmune hydrops No participation in other clinical research projects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Roberta A. Ballard
role: STUDY_CHAIR
References: