louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02445547: Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease
Official title: Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn Disease
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
Collaborators: name: Shaanxi Provincial People's Hospital
First posted: 2015-05-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.


Eligibility criteria: Inclusion Criteria:

* above 18 years of age
* moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450)
* had received hormone maintenance therapy for more than 6 months

Exclusion Criteria:

* active tuberculosis
* malignancy
* HIV
* syphilis
* hepatitis B
* hepatitis C

Primary outcomes:
measure: Crohn's disease activity index
timeFrame: 12 months
Secondary outcomes:
measure: Harvey-Bradshaw index
timeFrame: 12 months
measure: Corticosteroid dosage
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi Ail
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT05397847: Rational Drug Use in Elderly People
Official title: The Effect of Nursing Interventions Applied at Home for Rational Drug Use and Raising Awareness in Elderly Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rational Drug Use
Keywords: rational drug use
elderly individuals
nurse
education
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Irrational drug use, which is an important public health problem worldwide, is common in the elderly. While irrational drug use negatively affects all age groups, it poses a significant threat to the health of the elderly. This study aims to examine the effects of 8-week interventions, which include training, counseling and awareness-raising nursing practices for rational drug use and awareness development, through home visits to elderly individuals; planned in a randomized controlled experimental design.

The research will be carried out between May-July 2022 in Halkapınar Central Family Health Center located in Konya province Halkapınar district. The study group will be randomly assigned 35 experimental and 35 control groups, a total of 70 elderly individuals. Attempts made for the experimental group for eight weeks; Education through home visits on rational drug use will include counseling, guidance on rational drug use, and the delivery of a medicine box. The control group will continue with the routine applications. Taking into account the right of the control group to be informed about ethics after the post-tests, the training, guide and medicine box will also be given to the control group through home visits given to the experimental group. Data will be collected by face-to-face interview method using the Elderly Information Form, Rational Drug Use Scale and Rational Drug Use Awareness Scale.


Eligibility criteria: Inclusion Criteria:

* Be 65 years or older
* Living in Halkapınar
* Registering with the Central Family Health Centre
* Be able to speak Turkish

Exclusion Criteria:

* Having a score below 24 on the Standardized Mini Mental Test
* Having any communication or medically diagnosed mental problems
* Being bedridden
* Having a neurological problem

Primary outcomes:
measure: Using medicine with care
timeFrame: 6 weeks
measure: Rational Drug Use Awareness
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04139447: DAnalysis of the Distribution of Adrenal Steroids in a Control Population
Official title: Analysis of the Distribution of Adrenal Steroids in Blood and Urine Measured by Mass Spectrometry Coupled to Liquid Chromatography in a Control Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Disease
Keywords: Adrenal steroids
mass spectroscopy
liquid chromatography
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: AREM (Association Régionale Endocrinologie Métabolisme)
First posted: 2019-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Biomedical research to analyze the distribution of blood and urinary adrenal steroid values in a population of 60 healthy controls.

Brief summary: This is a biomedical research study on the determination of adrenal steroids. It has been proposed in recent years as a tool for the diagnostic orientation of an adrenal pathology. The main objective is to analyze the distribution of blood and urinary adrenal steroid values in a population of 60 controls. The secondary objective is to establish reference values for each of these parameters, if their distribution permits, and to study the possible link between the blood pressure level, the orthostatism state, the potassium level and these adrenal steroids.


Eligibility criteria: Inclusion Criteria:

* Negative blood pregnancy test
* Normosalt diet
* Men and women ≥ 18 years
* Being able and willing to give written informed consent

Exclusion Criteria:

* Personal history of diabetes, high blood pressure, adrenal pathologies.
* Family history of adrenal pathologies.
* Taking of the following drugs:

Antihypertensives drugs: ACE inhibitor, Angiotensin II receptor, beta-blocker, thiazide diuretic, loop diuretic, anti-aldosterone, dihydropyridine-type calcium antagonist.

* Hormone replacement therapy, cyproterone acetate
* NSAID (except occasional intake), corticosteroid
* Antidepressant: serotonin reuptake inhibitor (paroxetine, fluoxetine, sertraline, citalopram)
* Contraception or estrogen / progestin treatment (progestins only allowed)
* Not be able to keep standing position.

Primary outcomes:
measure: difference of the distribution of blood steroid values in a population control group
timeFrame: At baseline
measure: difference of the distribution of urinary steroid values in a population control group
timeFrame: At baseline
Secondary outcomes:
measure: Blood pressure taken while sitting, lying or standing
timeFrame: At baseline
measure: blood concentration of kaliemia
timeFrame: at baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Claire Douillard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00360347: A Study of Mircera in Anemic Patients With Multiple Myeloma
Official title: Open Label, Randomized, Exploratory Study to Investigate the Hemoglobin Dose-response, the Safety and the Pharmacokinetic Profile Following Subcutaneous Administration of Mircera Once Every Three Weeks to Anemic Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-08-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult anemic patients with multiple myeloma. In the first stage of the study, patients will be randomized to receive subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0, 3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of hemoglobin increase will be made at week 6. In the second stage, further groups of patients will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* confirmed diagnosis of multiple myeloma;
* anemia (hemoglobin \<=11g/dL at screening visit).

Exclusion Criteria:

* transfusion of red blood cells during 2 months prior to first planned dose of study medication;
* therapy-resistant hypertension;
* relevant acute or chronic bleeding within 3 months prior to planned start of study treatment;
* recombinant human erythropoietin or erythropoiesis-stimulating drug therapy within 3 months prior to planned start of study treatment.

Primary outcomes:
measure: Hemoglobin level, and change from baseline, at week 6
Secondary outcomes:
measure: Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure
Other outcomes:
Locations:
city: Praha
country: Czechia
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: unaffliated
name: Malgorzata Rokicka, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831047: The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
Official title: The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ptosis, Eyelid
Conjunctiva Inflamed
Eye Manifestations
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 and above able to provide informed consent to participate
* Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention

Exclusion Criteria:

* Adults unable to consent
* Individuals less than 18 years of age
* Prisoners
* Pregnant women.
* Known contradictions or sensitivities to study medication (oxymetazoline)
* Ocular surgery within the past 3 months or refractive surgery within the past six months
* Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
* Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
* Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
* Presence of an active ocular infection
* Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
* Inability to sit comfortably for 15 - 30 minutes

Primary outcomes:
measure: Change in Palpebral Fissure Height
timeFrame: Baseline, Day 1
Secondary outcomes:
measure: Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale
timeFrame: Baseline, Day 1
measure: Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance
timeFrame: Baseline, Day 1
measure: Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance
timeFrame: Baseline, Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami Bascom Palmer Eye Institute
name: Wendy W. Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204347: Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder
Official title: Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Borderline Personality Disorder
Keywords: risperidone
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutica
First posted: 2005-09-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).

Detailed description: Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen.

Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of BPD

Exclusion Criteria:

* Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.

Primary outcomes:
measure: Clinical Global Impression
measure: Brief Symptom Inventory
Secondary outcomes:
measure: Beck Depression Inventory
measure: Quality of Life Enjoyment and Satisfaction Questionnaire
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Celia T. Huston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04766047: The Effect of Dexmedetomidine on Kidney Function in EVAR
Official title: The Effect of Dexmedetomidine on the Incidence of Acute Kidney Injury in EVAR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Dexmedetomidine
Endovascular Aortic Repair
Keywords: Acute kidney injury, Dexmedetomidine, EVAR
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate the effect of dexmedetomidine on the incidence of postoperative acute kidney injury in patients undergoing EVAR under general anesthesia

Detailed description: This study will compare the incidence of AKI after elective EVAR conducted under general anesthesia with and without administration of dexmedetomidine. The AKI will be evaluated through measuring NGAL and c-cystatin.

Eligibility criteria: Inclusion Criteria:

* elective EVAR under general anesthesia
* adult patients 18- 85 years old
* American society of anesthesiologists (ASA) physical status I - IV

Exclusion Criteria:

* refusal to participate or sign the informed consent form
* GFR \< 50ml/mim
* Bradyarrhythmia \<50/min
* Hemodynamic instability
* Known allergy to Dexmedetomidine
* Severe hepatic insufficiency

Primary outcomes:
measure: Incidence of Acute Kidney Injury
timeFrame: 1st Postoperative Day
Secondary outcomes:
measure: Incidence of postoperative ICU admission
timeFrame: Operation day to 5th postoperative day
measure: Incidence of arrhythmia
timeFrame: Up to 24 hours after surgery
measure: Incidence of Postoperative Delirium
timeFrame: Operation day to 4th postoperative day
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univeristy of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Konstantinos Stamoulis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097147: Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Viibryd
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female, aged 18 through 45 years, inclusive
* Currently sexually active
* If female, non pregnant and agree to use acceptable for of contraception during
* If male, be sterile or have partner use contraception.

Exclusion Criteria:

* Have sexual dysfunction
* Have history of diagnosis or treatment of any disorder related to sexual functioning.
* Clinically significant disease state, in the opinion of the examining physician, in any body system
* History of alcohol or other substance abuse or dependence within the previous 5 years

Primary outcomes:
measure: Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score
timeFrame: From Baseline to Day 35
Secondary outcomes:
measure: Proportion of subjects meeting criteria for sexual dysfunction.
timeFrame: 5 Weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Overland Park
country: United States
facility: Forest Investigative Site 002
state: Kansas
city: St. Paul
country: United States
facility: Forest Investigative Site 003
state: Minnesota
city: Charlottesville
country: United States
facility: Forest Investigative Site 004
state: Virginia
Study officials:
affiliation: Forest Laboratories
name: Maju Mathews, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01679847: Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Elemene
pharmacokinetics
Blood-brain barrier
Lead sponsor: Dalian Holley Kingkong Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: malignant patients

Brief summary: The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.


Eligibility criteria: Inclusion Criteria:

* histopathological or cytopathology diagnosis of malignancy
* heart, liver and renal function is normal
* Expected survival time is more than 3 months
* Signed informed consent

exclusion Criteria:

* non cancer patient
* accepted elemene administration in 1 month
* Expected survival time is less than 3 months
* no Signed informed consent
* heart, liver and renal function is abnormal

Primary outcomes:
measure: blood and cerebrospinal fluid concentration
timeFrame: 0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: liang xiaohua, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018447: Combination Osteogenic Therapy in Established Osteoporosis
Official title: Combination Osteogenic Therapy in Established Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis, Post-Menopausal
Keywords: osteoporosis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued.

Detailed description: This is a 3-yr, single center, open label, active controlled, randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. Patients will be assigned to 1 of 3 groups: 1) PTH 1-34; 2) Fluoride; 3) PTH and fluoride. The treatment period is 3 years with 3-month cycles of therapy. PTH will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle. Fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg fluoride/day), during the last 2 months of each cycle. Calcium will be provided 800mg/day during month 1 and 1500-2000mg for months 2 and 3 of each cycle.

Eligibility criteria: * Female, aged 60-80,
* Postmenopausal greater than or equal to 5 years,
* BMD -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below young adult mean in the other site, or -2.0 with fracture.
* Vertebral fracture 0-1.

Exclusion Criteria:

* More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L spine.
* Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight.
* Present cardiac disease present.
* Diseases or conditions known to affect bone metabolism.
* Therapies with drugs that affect bone metabolism within 6 months.
* Fluoride or Biophosphonates at any time.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Jerry L. Pettis Memorial Veterans Medical Center
state: California
Study officials:
References: