louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06798259: Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment
Official title: Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Migraine Headache
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: . The patients will be recruited from the Neurology clinic, Beni Suef University Hospital.

Brief summary: Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.

Detailed description: assessment if Autonomic dysfunction in patients with migraine by using cardiovascular assessment by HOTLER MONITORING and table tilt test and neurophysiology assessment by sympathetic skin response

Eligibility criteria: Inclusion Criteria:

* 1.fulfilling ICHD-3 criteria for migraine 2. migraine for at least 3 months.

Exclusion Criteria:

brain imaging showing structural brain lesions. .medications that could impact autonomic function such as tricyclic antidepressants, anticholinergics, or opioids.

* Patients with concomitant medical illness causing autonomic dysfunction such as: diabetes, cardiovascular, demyelinating or degenerative neurological disorders.
* Contraindications for performing the tilt test
* Pregnant patients.

Primary outcomes:
measure: Autonomic dysfunction in patients with migraine
timeFrame: baseline
Secondary outcomes:
measure: Cardiovascular assessment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Benisuef
country: Egypt
facility: Benisuef university hospital
Study officials:
References:
Clinical trial NCT03692559: The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections
Official title: The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Keywords: CRBSI
CLABSI
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 331
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.

Detailed description: The study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern Taiwan. The investigators used block randomization to assign patients to the study group or control group. In study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. Study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. The investigators defined the infection outcome according to culture results, and the guidelines by Infectious Diseases Society of America and Centers for Disease Control and Prevention, USA. Analysis was done by SPSS version 23. The investigators used percentage and average to study characteristics of participants. The investigators used Chi-Square or Fisher's exact test and Poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. The investigators used Kaplan-Meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. The investigators used logistic regression model to analyze factors associated with development of bloodstream infections.

Eligibility criteria: Inclusion Criteria:

* Adults older than 20 years old
* Patients with central venous catheters
* Agree to participate in this study, and fill out the study consent

Exclusion Criteria:

* PICC patients placed
* Patients with bloodstream infection
* Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)

Primary outcomes:
measure: Catheter-related blood stream infections density after dressing change
timeFrame: up to 18 months
Secondary outcomes:
measure: Central Line-Associated Bloodstream Infection density after dressing change
timeFrame: up to 18 months
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Meng-lan Teng
role: STUDY_CHAIR
References:
Clinical trial NCT01838759: Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
Official title: Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Keywords: Bioimpedance spectroscopy
Hypervolemia
Hypovolemia
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Bulent Ecevit University Hospital with the presentation of hyponatremia

Brief summary: We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia

Detailed description: * Up to now, "Hyponatremia" differentially diagnosed by physical examination, plasma and urine osmolalities, Echocardiography and biochemical measurements.
* The purpose of this study is to determine whether bioimpedance spectroscopy can be used for the detection of hypovolemia and hypervolemia for the differential diagnosis of hyponatremia.

Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study with written informed consent
* Older than 18-years

Exclusion Criteria:

* The presence of pacemaker or defibrillator
* Artificial joints, pin or amputation
* Pregnancy or lactating.

Primary outcomes:
measure: Accuracy of volume status measured by bioimpedance spectroscopy
timeFrame: Six months
Secondary outcomes:
measure: Laboratory data and echocardiography
timeFrame: 6 Months
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Bulent Ecevit University Hospital
Study officials:
affiliation: Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey
name: Ender Hur, Assoc.Prof.
role: STUDY_CHAIR
References:
citation: Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15.
citation: Kose SB, Hur E, Magden K, Yildiz G, Colak D, Kucuk E, Toka B, Kucuk H, Yildirim I, Kokturk F, Duman S. Bioimpedance spectroscopy for the differential diagnosis of hyponatremia. Ren Fail. 2015 Jul;37(6):947-50. doi: 10.3109/0886022X.2015.1040418. Epub 2015 Apr 27.
Clinical trial NCT05844059: Lower Urinary Tract Symptoms After Intravesical Therapy
Official title: Lower Urinary Tract Symptoms After Intravesical Therapy With Mitomycin C or BCG in Patients With Carcinoma of the Bladder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy Effect
Chemotherapeutic Toxicity
Lower Urinary Tract Symptoms
Overactive Bladder
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with urinary bladder carcinoma requiring instillation therapy

Brief summary: With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.


Eligibility criteria: Inclusion Criteria:

* Urinary bladder carcinoma requiring instillation therapy
* Complete resection of the tumor
* No intravesical chemotherapy in the last 3 months

Exclusion Criteria:

* Patients who are unable to complete the questionnaires
* Patients who are not willing to participate
* Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)

Primary outcomes:
measure: Effect of instillation therapy on quality of life
timeFrame: During the study period approximately 12 months
measure: Effect of instillation therapy on sexuality
timeFrame: During the study period approximately 12 months
measure: Effect of instillation therapy on lower urinary tract symptoms
timeFrame: During the study period approximately 12 months
Secondary outcomes:
measure: Complications during instillation therapy
timeFrame: During the study period approximately 12 months
measure: Discontinuation rate of instillation therapy
timeFrame: During the study period approximately 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Nikolaos Pyrgidis
state: Bavaria
Study officials:
References:
Clinical trial NCT00519259: Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 1
Official title: Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Methamphetamine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2007-08-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.


Eligibility criteria: Inclusion Criteria:

* Must be able to provide written informed consent
* Must have a body mass index between 18 and 30
* Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis
* Must have a negative drug test at screening and admission
* If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

* Please contact the site for more information

Primary outcomes:
measure: Tolerability
Secondary outcomes:
measure: Safety
measure: Pharmacokinetic parameters
measure: Cardiovascular responses
measure: Psychological effects of lobeline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Langley Porter Psychiatric Institute
state: California
Study officials:
affiliation: Langley Porter Psychiatric Institute
name: Reese Jones, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02607059: Epidemiologic Registry PETHEMA LMA 2015
Official title: Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2015)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AML
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute myeloid leukemia

Brief summary: Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach

Detailed description: To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with acute myeloid leukemia

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: characteristics of the patients diagnosed of AML
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References:
citation: Martinez-Cuadron D, Megias-Vericat JE, Serrano J, Martinez-Sanchez P, Rodriguez-Arboli E, Gil C, Aguiar E, Bergua J, Lopez-Lorenzo JL, Bernal T, Espadana A, Colorado M, Rodriguez-Medina C, Lopez-Pavia M, Tormo M, Algarra L, Amigo ML, Sayas MJ, Labrador J, Rodriguez-Gutierrez JI, Benavente C, Costilla-Barriga L, Garcia-Boyero R, Lavilla-Rubira E, Vives S, Herrera P, Garcia-Belmonte D, Herraez MM, Vasconcelos Esteves G, Gomez-Roncero MI, Cabello A, Bautista G, Balerdi A, Mariz J, Boluda B, Sanz MA, Montesinos P. Treatment patterns and outcomes of 2310 patients with secondary acute myeloid leukemia: a PETHEMA registry study. Blood Adv. 2022 Feb 22;6(4):1278-1295. doi: 10.1182/bloodadvances.2021005335.
Clinical trial NCT01403259: SOX as Salvage Treatment in Nasopharyngeal Carcinoma
Official title: Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
S-1
Oxaliplatin
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 16
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: The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.

Detailed description: The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.

Eligibility criteria: Inclusion Criteria:

* Age range: 18-75 years old
* Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma
* Prior exposure of at least one line of platinum-containing regimen
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧50ml/min
* Without \> 1 grade of neuropathy

Exclusion Criteria:

* With curable treatment option
* With CNS involvement
* Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
* Treated with \> 2 lines of palliative chemotherapy
* With prior exposure of S-1 or oxaliplatin
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Significant active infection
* Pregnant or lactating women

Primary outcomes:
measure: Median progression-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate
timeFrame: 6 weeks
measure: Median overall survival
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04438759: Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility
Official title: Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Outpatient Hysteroscopy and Endometrial Biopsy in Subfertility Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: virtual reality
hysteroscopy
infertility
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.
Primary purpose: TREATMENT

Brief summary: This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.


Eligibility criteria: Inclusion Criteria:

* undergoing fertility treatments
* for which outpatient hysteroscopy has been prescribed
* for different possible indications: suspicion of intracavitary pathology, recurrent implantation failure, recurrent early pregnancy loss, ...

Exclusion Criteria:

1. Hearing impairments and blindness
2. Motion sickness
3. Any known anatomical characteristics that may make performing the office procedure impossible.
4. The unwillingness of the patient to undergo an office hysteroscopy
5. Denial or withdrawal of informed consent

Primary outcomes:
measure: Change in pain experience as assessed using visual analog scale
timeFrame: 1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel CRG
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: valerie schutyser
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00749359: PAXIL CR Bioequivalence Study
Official title: An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder
Keywords: healthy volunteers
paroxetine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.


Eligibility criteria: Key Inclusion:

Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.

Key Exclusion:

Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; \>14 drinks/week for men or \>7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.

Primary outcomes:
measure: Paroxetine blood levels
timeFrame: measured up to 168 hours after a single dose.
Secondary outcomes:
measure: Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs
timeFrame: measured up to 168 hours after a single dose and throughout study
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: