louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01238263: Autologous Serum Skin Testing in Patients With Atopic Dermatitis Autologous Serum Skin Testing in Patients With Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis, Serum Skin Test
Keywords: Atopic dermatitis, autologous serum skin testing, IgE autoantibodies
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 90

Brief summary: Recently, IgE-type autoantibodies against self proteins have been detected in the serum of the atopic dermatitis patients. The role of this IgE autoantibodies involved in the pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between the severity of the disease and the serum levels of this autoantibodies. The autologous serum skin testing is applied to both atopic dermatitis patients and healthy control and the results are estimated in this study.The investigators detected 70% positive autologous serum skin testing in atopic dermatitis patients and test positivity was higher in patients with atopy history, moderately severe disease calculated by SCORAD index and high serum IgE levels.


Eligibility criteria: Inclusion Criteria:

* Sixty AD patients and 30 healthy individuals

Exclusion Criteria:

* . The patients showing evidence of any other disease are not included to our study. No drug was allowed fourteen days prior to the test, including antihistamines and steroids.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02078063: Analgesia for Insertion of Intrauterine Contraception
Official title: Mepivacaine for Pain Relief at Insertion of Intrauterine Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insertion of Intrauterine Contraception
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of long acting reversible contraception (LARC) such as implants or intrauterine contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of being independent of user error and are considered to be underused, especially among young individuals where oral methods have high rates of user failure. IUC is often underused in young or nulliparous women due to fear of pain at insertion.

10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the uterine cavity through a hydrosonography catheter before the tenaculum has been applied but prior to sounding and to insertion of the IUC.

The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a hydrosonography catheter prior to any instrument placement will provide more effective pain relief than instillation of 10 ml placebo (sodium chloride 9mg/ml).

Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group.

Secondary objectives: To evaluate acceptability of the procedure.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age and
* opting for IUC for contraception
* with a negative pregnancy test
* willing to participate in the study after it has been explained orally and in written

Exclusion Criteria:

* previous conisation,
* known cervical stenosis,
* signs of ongoing genital infection,
* known uterine abnormality,
* any condition resulting in bleeding disorder or contraindication to any local anestetic will be excluded

Primary outcomes:
measure: pain
timeFrame: On day of insertion
Secondary outcomes:
measure: Acceptability
timeFrame: 30 minutes after insertion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Obstetrics and Gynecology, Danderyd Hospital
city: Stockholm
country: Sweden
facility: Upplands Väsby Ungdomsmottagning
Study officials:
affiliation: Karolinska Institutet
name: Helena Kopp Kallner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Envall N, Lagercrantz HG, Sunesson J, Kopp Kallner H. Intrauterine mepivacaine instillation for pain relief during intrauterine device insertion in nulliparous women: a double-blind, randomized, controlled trial. Contraception. 2019 Jun;99(6):335-339. doi: 10.1016/j.contraception.2019.02.003. Epub 2019 Mar 1.
Clinical trial NCT00758563: Train New Examiners Via Modified Gingival Margin Plaque
Official title: Train New Examiners Via Modified Gingival Margin Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 15
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: TREATMENT

Brief summary: The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Must discontinue oral hygiene for 24-hrs.after initial appointment.
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus).
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can affect salivary flow
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance.
* History of allergy to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Mean Gingival Plaque Units
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Northampton Community College
state: Pennsylvania
Study officials:
name: Terry Sigal-Greene
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06027463: The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
Official title: The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Postoperative Risk Factors for Patients With Carotid Artery Stenosis
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of the study is adults aged 18-90 who have been diagnosed with head and neck artery stenosis and risk events after head and neck revascularization and seek medical treatment in neurosurgery departments of tertiary comprehensive hospitals.

Brief summary: The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis


Eligibility criteria: Inclusion Criteria:

* (1) All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;

  (2) Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;

  (3) Patients with symptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 50% found on angiography;

  (4) Asymptomatic head and neck artery stenosis and risk events after head and neck revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 60% found on angiography;

  (5) Asymptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, with a non-invasive examination of stenosis degree less than 70%, but angiography or other examinations indicate that the stenosis lesion is in an unstable state;

  (6) Symptomatic head and neck artery stenosis and risk events after head and neck revascularization, non-invasive examination of head and neck artery stenosis and risk event degree after head and neck revascularization at 50% to 69%

Exclusion Criteria:

* (1) Patients with poor overall condition and intolerance to general anesthesia;

  (2) Patients with mental illness or severe mental illness;

  (3) Severe respiratory system diseases;

  (4) Pregnant and lactating women;

  (5) Participating in another clinical study;

  (6) Patients with advanced tumors or those who are expected to die within one year;

Primary outcomes:
measure: Recurrence of cerebral infarction
timeFrame: half a year
Secondary outcomes:
measure: Death
timeFrame: one year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT05256563: A Biomarker for Personalized Care in Post-Stroke Spatial Neglect
Official title: A Biomarker for Personalized Care in Post-stroke Spatial Neglect
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spatial Neglect
Stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-02-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See Inclusion and Exclusion Criteria

Brief summary: More than 30,000 Veterans are hospitalized for stroke each year, and in the critical first months of recovery, at least half are disabled by abnormal 3-D spatial function (spatial neglect). Their self-care, mobility, and ability to return home are severely limited.

Detailed description: Spatial Neglect (SN)is an underdiagnosed stroke-related condition--and a specific core set of symptoms--Aiming Spatial Neglect-- may have a major adverse effect on outcome. These same symptoms may predict excellent response to spatial neglect therapy. The investigators seek to develop a biological parameter for treatment assignment. In this two-year study, the investigators will enroll 45 people with right brain stroke who are at high risk of SN. The investigators will examine clinical brain images, behavioral assessment and research brain images at baseline and recovery at 3 and 6 months after study entry.

Eligibility criteria: Inclusion Criteria:

* Stroke survivors \>18 years
* 1-8 months post-stroke
* Can undergo testing and give informed consent

Exclusion Criteria:

* Other serious
* Chronic neurological disorders
* Evidence of other serious strokes
* Inability to undergo testing or give informed consent

Primary outcomes:
measure: Change in functional ability for daily life tasks assessed on the FONE-FIM at 3 months
timeFrame: baseline to 3 months
measure: SN severity at baseline
timeFrame: baseline
measure: Change in functional ability assessed by the Barthel Index at 3 months
timeFrame: baseline to 3 months
measure: Change in functional ability for daily life tasks assessed on the FONE-FIM at 6 months
timeFrame: baseline to 6 months
measure: SN severity at 3 months
timeFrame: 3 months post-baseline
measure: SN severity at 6 months
timeFrame: 6 months post-baseline
measure: Change in functional ability assessed by the Barthel Index at 6 months
timeFrame: baseline to 6 months
Secondary outcomes:
Other outcomes:
measure: Number of stroke survivors that have evidence of Aiming SN
timeFrame: baseline
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Anna M. Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01136863: Felodipine Event Reduction Study
Official title: Felodipine Event Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
felodipine
moderate to high risk patients
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Shanxi Kangbao Pharmaceutical company
name: Beijing Hypertension League Insititute
First posted: 2010-06-04
Enrollment: 9800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized, placebo-controlled,parallel-group trial. The primary objective is to compare the long-term effects on the incidence of fatal and non-fatal stroke (and secondarily of other cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5 mg once a day) or of a placebo, in hypertensive patients whose blood pressure had preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg once a day) to be continued in association with felodipine or placebo, throughout the trial.


Eligibility criteria: Inclusion Criteria:

* SBP of 210 mmHg or less and DBP less than 115 mmHg if under antihypertensive treatment; SBP 160-210 mmHg or DBP 95-115 mmHg if untreated. Presence of at least one or two risk factors or cardiovascular diseases Informed consent obtained

Exclusion Criteria:

stroke or myocardial infarction during the previous 6 months; secondary hypertension; unstable angina; cardiomyopathy or significant valvular disease; serum creatinine greater than 178 mmol/l (2.0 mg/dl); gout; uncontrolled diabetes(fasting plasma glucose \> 10 mmol/l, 180 mg/dl despite therapy); serious pulmonary or hepatic disease; known contraindications to study drugs; unwillingness to cooperate

Primary outcomes:
measure: Composite of fatal and non-fatal stroke
timeFrame: During the study period
Secondary outcomes:
measure: all cause death
timeFrame: during the study period
measure: cardiac event
timeFrame: during the study period
measure: All cardiovascular events
timeFrame: during the study period
measure: new onset diabetes
timeFrame: during the study period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital
Study officials:
affiliation: Fu Wai Hospital
name: Lisheng Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Zhang X, Liu L, Zanchetti A; FEVER Study Group. Is a systolic blood pressure target <140 mmHg indicated in all hypertensives? Subgroup analyses of findings from the randomized FEVER trial. Eur Heart J. 2011 Jun;32(12):1500-8. doi: 10.1093/eurheartj/ehr039. Epub 2011 Feb 22.
Clinical trial NCT01898663: DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML
Official title: Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: High-risk Soft Tissue Sarcoma
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Consistent with the diagnosis of AML
* Age≥18 years at time of consent
* KPS(Karnofsky Performance Scale) ≥70
* Patient's written informed consent
* No steroid therapy within 4 weeks of first DC vaccination
* Stable disease, complete response and partial response(WHO, RECIST)
* Predicted survival≥3 months

Exclusion Criteria:

* Serious dysfunction of vital organs(heart, liver or kidney)
* Received organ transplantation
* Patients with other malignancies or brain metastases
* History of autoimmune diseases
* Pregnant and breast-feeding patient
* Active or chronic infectious diseases
* History of allergy or hypersensitivity to study product excipients
* Currently participating in another clinical trial
* Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
* Unfit for participating in this clinical trial in investigators' opinions

Primary outcomes:
measure: PFS/OS
timeFrame: 1 years after DC/CIK treatment
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 3 days within DC/CIK treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematopoietic Stem Cell Transplantation
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Chen Hu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02275663: Azacytidine Plus FLAG for Relapsed or Refractory AML
Official title: Phase 2 Study of 5 Days Azacytidine Priming Prior to Fludarabine, Cytarabine and Granulocyte-Colony Stimulating Factor (G-CSF) Combination for Patients With Relapsed or Refractory AML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: relapsed AML
refractory AML
azacytidine
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2014-10-27
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

1. Age 16 to 60
2. Patients with a diagnosis of relapse or refractory AML (≥ 20% blast in bone marrow).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
4. Patients must have preserved organ function as defined below:

   * Creatinine ≤ 1.5 mg/dl
   * Total bilirubin ≤ 1.5x upper limit of the normal
   * Alanine aminotransferase (ALT) ≤ 2x upper limit of the normal
   * Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

1. Patients with a diagnosis of acute promyelocytic leukemia (AML -M3)
2. Pregnant women
3. Patients previously treated with fludarabine are allowed to participate.
4. Patients with Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: complete response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: leukemia free survival
timeFrame: 1-3 years
measure: overall survival
timeFrame: 1-3 yeears
measure: one year leukemia free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: King Fahad Medical City
name: Ibraheem H Motabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03118063: Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
Official title: Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Injuries
Low Back Pain
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Contextualization: Trigger points are muscle nodules found in muscles. We can observe five different types of trigger point, in clinical practice two of them stand out, the active trigger point; Which is painful; And latent; Asymptomatic; Both of which are sensitive to palpation. Once the individual present these muscle nodules can develop pain and motor dysfunction. Studies indicate that the prevalence of trigger points is 95% of individuals with chronic musculoskeletal pain, but this prevalence is not yet clear in individuals with low back pain.

Objective: To compare the pain and function levels of patients with acute and chronic low back pain who, when asymptomatic, had trigger points compared to the pain and function levels of patients with acute and chronic low back pain who, when asymptomatic, had no trigger points.

Study design: Cohort study, two arms, blind evaluator, prospectively enrolled at baseline.

Location: This research will be conducted in the physiotherapy department at the Rehabilitation Center of the Brotherhood of Santa Casa de Misericórdia de São Paulo (ISCMSP).

Patients: 400 asymptomatic individuals Follow-up: Asymptomatic individuals will be assessed at baseline and over 3 years. You will be asked to contact the research department within 6 weeks of low back pain (acute) and after 12 weeks of low back pain (chronic). Participants will be allocated to two groups, trigger point group (n = 200) and group without trigger point (n = 200).

Outcomes: The pain intensity, function level and trigger point pain intensity outcomes will be evaluated at the baseline, within 6 weeks for the patient to present pain in the lumbar (acute) and after 12 weeks the pain persists (chronic)


Eligibility criteria: Inclusion Criteria:

* Men and women;
* Age between 18 - 40 years;
* Asymptomatic;
* There is no treatment for lumbar spine, hip or knee.

Exclusion Criteria:

* Anterior lumbar spine surgeries;
* Severe spinal diseases (fracture, tumor, ankylosing spondylitis);
* Root conditions (herniated disc, spondylolisthesis);
* Congenital malformation;
* Pregnant women.

Primary outcomes:
measure: Function
timeFrame: 24 hours
measure: Pain scale
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Claudio Cazarini Júnior
state: São Paulo
Study officials:
References: