louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05996692: Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions
Official title: Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Walking
Adherence
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with FM according to the criteria of the American College of Rheumatology (ACR) and recommended pharmacological therapy within the last 1 year

Brief summary: Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.

Detailed description: Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.

Purposes of this study were (1) to assess whether walking as exercise was prescribed by their physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate the frequency of patients who walk regularly as exercise, (3) to clinically compare patients who walk regularly as exercise and those who do not, and (4) to determine factors related to adherence to walking prescriptions.

Eligibility criteria: Inclusion Criteria:

* be between 18-70 years old
* female gender
* Pharmacological therapy has been recommended in the last 1 year

Exclusion Criteria:

* neurological disease or orthopedic problem presence that may be the reason of functional impairment
* neurological deficit presence

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: through study completion, an average of one month
measure: The Tampa Scale for Kinesiophobia
timeFrame: through study completion, an average of one month
measure: Visual Analogue Scale
timeFrame: through study completion, an average of one month
measure: Pain Catastrophizing Scale
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gaziler Physical Medicine and Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT01655992: A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
Official title: A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Keywords: capecitabine
Tegafur，Gimeracil and Oteracil Potassium Capsules
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 386
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.

Detailed description: Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed breast cancer
* Pretreated metastatic breast cancer not more than 2 lines chemotherapy
* Have not been previously treated with capecitabine,oral fluracil
* ECOG performance status of ≤ 1
* Be female and ≥ 18 and ≤ 75 years of age
* Have at least one target lesion according to the RECIST criteria 1.1

Exclusion Criteria:

* Pregnant or lactating women
* ECOG ≥ 2
* Have been treated with capecitabine
* Evidence of CNS metastasis
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
* Abnormal laboratory values: hemoglobin \< 10.0 g/dl, absolute neutrophil count \< 1.5×10\^9/L, platelet count \< 100×10\^9/L, serum creatinine \> upper limit of normal (ULN), serum bilirubin \> ULN, ALT and AST \> 5×ULN, AKP \> 5×ULN
* Serious uncontrolled intercurrent infection
* Life expectancy of less than 3 months

Primary outcomes:
measure: progression free survival
timeFrame: 6 months
Secondary outcomes:
measure: response rate
timeFrame: 1.5 months
measure: overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan Univeristy Cancer Hospital
name: Xi-chun Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002292: A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS
Official title: Inhaled Versus Intravenous Pentamidine in Pneumocystis Carinii Pneumonia in the Acquired Immunodeficiency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Injections, Intravenous
Administration, Inhalation
Aerosols
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Previous history of adverse reaction to pentamidine.
* History of asthma.
* Pulmonary Kaposi's sarcoma.

Patients with the following are excluded:

* Previous history of adverse reaction to pentamidine.
* History of asthma.
* Pulmonary Kaposi's sarcoma.
* Inability to understand the consent procedure.

All patients hospitalized at Cedars-Sinai Medical Center with AIDS and possible Pneumocystis carinii pneumonia (PCP) will be eligible.

* Patients with HIV antibody or AIDS and a clinical presentation suggesting PCP are eligible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rosemont
country: United States
facility: LyphoMed Inc
state: Illinois
Study officials:
References:
citation: Soo Hoo GW, Mohsenifar Z, Meyer RD. Inhaled or intravenous pentamidine therapy for Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):195-202. doi: 10.7326/0003-4819-113-3-195.
citation: Conte JE Jr, Chernoff D, Feigal DW Jr, Joseph P, McDonald C, Golden JA. Intravenous or inhaled pentamidine for treating Pneumocystis carinii pneumonia in AIDS. A randomized trial. Ann Intern Med. 1990 Aug 1;113(3):203-9. doi: 10.7326/0003-4819-113-3-203.
Clinical trial NCT02385292: Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation
Official title: Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Oculeve, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 23
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of this study are:

* To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
* To compare the goblet cell count following application between the intranasal and extranasal applications
* To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

Detailed description: In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

* Active intranasal device application
* Active extranasal device application

Eligibility criteria: Inclusion Criteria:

* Bilateral dry eyes
* Capable of providing written informed consent

Exclusion Criteria:

* Chronic or recurring epistaxis (nosebleeds)
* Blood coagulation disorder
* Uncontrolled or poorly controlled diabetes
* Heart or pulmonary disease
* Females who are pregnant, planning a pregnancy or nursing

Primary outcomes:
measure: Fluorescein Tear Clearance With Application
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
measure: Level of Tear Proteins Pre and Post Administration
timeFrame: Day 1
measure: Level of Inflammatory Mediators Pre and Post Administration
timeFrame: Day 1
measure: Goblet Cell Count Following Application
timeFrame: Day 1
Locations:
city: Sacramento
country: United States
facility: Grutzmacher, Lewis & Sierra
state: California
city: Houston
country: United States
facility: Baylor College of Medicine, Department of Ophthalmology
state: Texas
Study officials:
affiliation: Grutzmacher, Lewis & Sierra
name: Richard Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.
Clinical trial NCT01486992: mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Esophageal Carcinoma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 40
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: There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Nimotuzumab plus Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
* Age 18 to 75 years old
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Life expectancy of ≥3 month
* Karnofsky performance status ≥80
* WBC\>3,500/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Normal ECG/cardiac function
* Good compliance
* Having signed informed consent

Exclusion Criteria:

* More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
* Known hypersensitivity to study drugs
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
* Pregnancy or lactation period

Primary outcomes:
measure: overall survival
timeFrame: 2 years
measure: adverse events
timeFrame: 2 weeks
Secondary outcomes:
measure: progression-free survival
timeFrame: 1year
measure: response rate
timeFrame: 6 weeks
measure: disease control rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhang Xiaodong
state: Beijing
Study officials:
References:
Clinical trial NCT04246892: Impact of Alarm Reduction on Delirium in ICU
Official title: Impact of Alarm Reduction on Delirium in ICU
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Delirium
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients admitted to ICU, and who meet inclusion criteria

Brief summary: Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.


Eligibility criteria: Inclusion Criteria:

* age\>18 years, admission to ICU

Exclusion Criteria:

* length of stay in ICU\<24 hours, moribund patient, deafness, dementia, psychiatric pathology, delirium at admission, acute neurological pathology at admission (stroke, epilepsy, neuro-infection), hepatic encephalopathy, admission for cardiac arrest, admission for voluntary drug intoxication, pregnancy

Primary outcomes:
measure: prevalence of delirium, according to a ICDSC score>3
timeFrame: at the end on the ICU stay, an average of 6 days
Secondary outcomes:
measure: prevalence of sub-syndromic delirium in each group, according to a ICDSC score<4 and absence of delirium
timeFrame: at the end on the ICU stay, an average of 6 days
measure: length of mecanical ventilation (days)
timeFrame: at the end on the ICU stay, an average of 6 days
measure: length of stay in ICU (days)
timeFrame: at the end on the ICU stay, an average of 6 days
measure: in patients presenting a delirium, duration of delirium (days) defined by the number of days with a ICDSC score>3
timeFrame: at the end on the ICU stay, an average of 6 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Lev VOLKOV
role: STUDY_DIRECTOR
References:
Clinical trial NCT00200889: Mapping Auricular Vagus Nerve Circuitry
Official title: Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Acupuncture
Magnetic Resonance Imaging, Functional
Brain Mapping
healthy volunteers
Neuromodulation
gastric MRI
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to "Congruent" or "Incongruent" briefing groups. The Congruent group receives briefings including expectations of stimulation effects on gastric motility consistent with prior research in the literature. The Incongruent group receives briefings including expectations of stimulation effects on gastric motility inconsistent with prior research in the literature.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.

Detailed description: Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring.

This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.

Eligibility criteria: Inclusion Criteria:

* Adults 18-65
* Functional dyspepsia

Exclusion Criteria:

* Any condition contraindicating an fMRI brain scan

Primary outcomes:
measure: Brain activity during functional magnetic resonance imaging (fMRI)
timeFrame: 1 hour
measure: Stomach activity during gastric magnetic resonance imaging (MRI)
timeFrame: 30 minutes
Secondary outcomes:
measure: Electrogastrography (EGG)
timeFrame: 2 hours
measure: Electrocardiography (ECG)
timeFrame: 2 hours
measure: Respiration
timeFrame: 2 hours
measure: Skin Conductance Levels (SCL)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Vitaly Napadow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122689: Dietary Inorganic Nitrate and the Enteral Microbiome
Official title: Influence of Exogenous Dietary Inorganic Nitrate on Downstream Metabolites of the Enteral Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Health
Keywords: microbiome
nitrate
diet
dietary nitrate
cardiovascular
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A growing body of data shows that the enteral microbiome has an effect on cardiovascular diseases. Exogenous inorganic dietary nitrate mediates cardioprotective effects and has been shown to have an influence on the oral microbiome. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet.

Whether dietary nitrate influences the enteral microbiome and downstream metabolites like short-chain fatty acids (SCFA) and TMAO will be investigated in the present study.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40-80 years
* no regular medication intake
* no chronic diseases

Exclusion Criteria:

* Regular systemic drug intake
* Active smoking
* Chronic diseases
* Acute diarrhea or vomiting
* Short gut syndrome
* Pregnancy or breastfeeding

Primary outcomes:
measure: Change of the enteral microbiome composition
timeFrame: 30 days
Secondary outcomes:
measure: Change of the oral microbiome composition
timeFrame: 30 days
measure: Change of circulating SCFA levels
timeFrame: 30 days
Other outcomes:
measure: Changes in the oral-enteral microbiome axis
timeFrame: 30 days
measure: Changes in arterial stiffness parameters
timeFrame: 30 days
measure: Changes in blood pressure
timeFrame: 30 days
measure: Change of the nitrate-nitrite-NO metabolism
timeFrame: 30 days
measure: Genetic variants (single nucleotide polymorphism)
timeFrame: 30 days
measure: Epigenetic changes
timeFrame: 30 days
measure: Changes in TMAO levels
timeFrame: 30 days
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: Clinic of cardiology and angiology, University Hospital Essen
name: Tienush Rassaf, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00094289: Interactions Between Cocaine and Ethanol and Disulfiram - 1
Official title: Interactions Between IV Cocaine and Ethanol and Oral Disulfiram
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Alcohol-Related Disorders
Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-10-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.

Detailed description: This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.

Eligibility criteria: Inclusion Criteria:

* Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment.
* Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements.

Exclusion Criteria:

* Please contact site for more information.

Primary outcomes:
measure: Safety assessments
measure: Psychological effects
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
city: San Antonio
country: United States
facility: University of Texas Hlth Sci Ctr San Ant
state: Texas
Study officials:
affiliation: University of Texas Health Sci Cntr, San Antonio
name: John Roache, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: