louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01381055: Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
Official title: Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cutaneous Leishmaniasis
Keywords: Cutaneous leishmaniasis
Pentoxifylline
Meglumine antimoniate
L. braziliensis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Federal University of Bahia
First posted: 2011-06-27
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

* Safety concerns:

  * AST, ALT \>3 times upper limit of normal range
  * Serum creatinine or BUN \>1.5 times upper limit of normal range
  * Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
  * Immunodeficiency or antibody to HIV
  * Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
  * Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
* Lack of suitability for the trial:

  * Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
  * Any history of prior anti-leishmania therapy
  * Any condition which compromises ability to comply with the study procedures
* Administrative reasons:

  * Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
  * Anticipated non-availability for study visits/procedures

Primary outcomes:
measure: Cure rate or complete cicatrization of the ulcer.
timeFrame: 6 months
Secondary outcomes:
measure: Initial cure rate or complete cicatrization of the ulcer
timeFrame: 2 months
Other outcomes:
Locations:
city: Corte de Pedra
country: Brazil
facility: Posto de Saúde de Corte de Pedra
state: Tancredo Neves/Bahia
Study officials:
affiliation: Federal University of Bahia
name: Paulo Roberto L Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706055: Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)
Official title: Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis (MS)
Interferon
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 629
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: Adult MS patients starting Betaferon therapy

Brief summary: This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria
* Age \>/= 18 years old
* Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon
* Minimum 6 months wash-out period from previous IFNβ
* Written Informed Consent signed

Exclusion Criteria:

* Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier
* Patients receiving treatment with IFN beta other than Betaferon (Bayer)

Primary outcomes:
measure: Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
timeFrame: 6 months
measure: MS patient with Flu-Like Symptoms (FLS) demographic profile
timeFrame: Up to 1 month
measure: Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
timeFrame: 6 months
Secondary outcomes:
measure: The impact of FLS on patients daily activities as measured by current professional/educational status
timeFrame: From baseline up to 6 months
measure: Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period
timeFrame: 6 months
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01511055: Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
Official title: Phase II, Prospective, Non-Randomized Trial Investigating the Intra-Operative Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system.

This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in \> 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.


Eligibility criteria: Inclusion Criteria:

Women who are:

* Diagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers
* Scheduled to undergo surgical cytoreduction via laparotomy
* At least 18 years of age
* Capable and willing to provide informed consent

Exclusion Criteria:

Women with:

* Known sarcomatous histologies
* Recurrent ovarian cancer
* Planned surgical approach via laparoscopy or robotic surgery
* A history of anaphylactic reactions to Folate-FITC or insects
* Inability or unwillingness to provide informed consent

Primary outcomes:
measure: Sensitivity and Specificity of Intra-operative Imaging Using Folate-FITC for Identification of Ovarian Cancer Metastatic to the Peritoneum and Lymph Nodes
timeFrame: 1 week
Secondary outcomes:
measure: Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17).
timeFrame: Duration of hospitalization with a maximum of 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sean C Dowdy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02003755: The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral palsy
Continuous passive motion
Hypertonia
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a group of disorders of the development of movement and posture but often changing motor impairment syndromes. The spastic subtypes are the most common manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated range of motion could reduce muscle's activation effectively. The polyarticular movement training might increase joint range of motion and reduce the muscle activation. But the polyarticular movement training is difficulty for some individuals with CP. The single joint movement training may achieve the same effect as the polyarticular movement training. The purpose of this study was to investigate the effects of continuation passive range of motion (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Spastic CP
* Modified Ashworth scale of Soleus \> 1
* Ankle range of motion \> 10 degrees

Exclusion Criteria:

* Fracture on lower Lower extremities
* BOTOX on ankle \< 5 mouths

Primary outcomes:
measure: Muscle tone tests
timeFrame: Baseline, 1, and 4 months.
measure: Ankle range of motion
timeFrame: Baseline, 1, and 4 months.
measure: Hoffman reflex (H-reflex)
timeFrame: Baseline, 1, and 4 months.
Secondary outcomes:
measure: Leg girth
timeFrame: Baseline,1 ,and 4 mouths.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT00789555: Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Official title: Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perennial Allergic Rhinitis
Keywords: nasal allergy
nasal spray
seasonal allergy
perennial allergy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 1260
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).


Eligibility criteria: Inclusion Criteria:

1. Sign informed consent;
2. Normal nasal exam;
3. History of perennial allergic rhinitis;
4. Allergy to perennial allergen documented by allergy testing;
5. Age 12 years and older;
6. Must follow instructions;
7. Must make required study visits;
8. Negative pregnancy test and adequate birth control methods for females of childbearing potential;
9. Refrain from certain allergy medications during the study;
10. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Nasal disorders;
2. Use of substances that affect the nasal septum;
3. Exposure to industrial metal plating solutions;
4. Uncontrolled, severe, or unstable diseases;
5. Hypersensitivity to the study drug or nasal spray components;
6. Relative of site staff with access to the protocol;
7. Participation in another investigational study within 30 days or at the same time as this study;
8. Medical Monitor decision;
9. Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
timeFrame: Baseline (Day 0), Exit (Month 12 or sooner)
measure: Self-Rated Relief Assessment at Day 30
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)
timeFrame: Baseline (Day 0), Exit (Month 12 or sooner)
measure: Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)
timeFrame: Baseline (Day 0), Exit (Month 12 or sooner)
measure: Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)
timeFrame: Baseline (Day 0), Exit (Month 12 or sooner)
measure: Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)
timeFrame: Baseline (Day 0), Exit (Month 12 or sooner)
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01512355: The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 88
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.


Eligibility criteria: Inclusion Criteria:

* the patient undergoing the strabismus surgery in severance hospital

Exclusion Criteria:

* delayed development
* mental retardation
* cerebral palsy
* preoperative EKG abnormality e.g. cardiovascular conduction disorder

Primary outcomes:
measure: objective pain score
timeFrame: immediate postoperative period up to 1hour after surgery
measure: pediatric anesthesia emergence delirium (PAED) scale
timeFrame: immediate postoperative period up to 1hour after surgery
measure: 5-point agitation scale
timeFrame: immediate postoperative period up to 1hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02618655: Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
Official title: Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fever of Unknown Origin
Tick-borne Diseases
Keywords: TBDs；diagnosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
First posted: 2015-12-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all the people who have fever with unknown origin

Brief summary: The study will use several laboratory diagnoses in the diagnosis of patients with fever，to find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.

Detailed description: Tickborne Diseases(TBDs) spread throughout many countries and regions. In recent years, the incidence has a tendency to rise continuously. The clinical symptoms and laboratory features of tick-borne diseases are always of no specific, and the diagnostic methods available, such as observing the pathogen after cultivation or by the method of Gimenez、serological tests for antibody always can't make a timely diagnosis, especially in the early period of the disease. The development of polymerase chain reaction(PCR) has been applied for pathogen detection, and showed high sensitivity and specificity,and may contribute to early diagnose，but no standardized method of PCR has been as yet proposed. This study mean to explore several laboratory diagnoses to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.

Eligibility criteria: Inclusion Criteria:

* patients have fever more than one week
* temperature is higher than 38℃ Celsius degree
* full of physical examination and laboratory examination have been carried out after one week，but still cannot make a definite diagnosis

Exclusion Criteria:

* fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor
* we find that the patient selected does not meet the selection criteria within the observation period
* patients leave with automatic discharge

Primary outcomes:
measure: Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood
timeFrame: within the first 14 days in hospital
Secondary outcomes:
measure: the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach
timeFrame: up to three years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Organization Name Beijing Friendship Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: wenjie Qi, archiater
role: STUDY_DIRECTOR
References:
Clinical trial NCT00992355: Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
Official title: Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Phacoemulsification
Treatment duration
Lead sponsor: Veroia General Hospital
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 97
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial compares two regimens of topical therapy:

* tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
* combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

* corneal edema
* conjunctival redness
* anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.


Eligibility criteria: Inclusion Criteria:

* Phacoemulsification (due to cataract)
* Uneventful phacoemulsification surgery

Exclusion Criteria:

* Disruption of the anterior lens capsule
* Age-related macular degeneration
* Proliferative diabetic retinopathy
* Glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Veroia
country: Greece
facility: Department of Ophthalmology, Veroia General Hospital
Study officials:
References:
Clinical trial NCT00569114: Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients
Official title: A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Tragara Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.


Eligibility criteria: Inclusion Criteria (include but are not limited to):

* Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC.
* Measurable or evaluable disease as defined by RECIST
* Must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
* ECOG perfromance status of 0,1, or 2.

Exclusion Criteria (include but are not limited to):

* Radiation therapy (excluding CNS therapy) \< 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
* Evidence of New York Heart Associatation Class III or greater cardiac disease.
* History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
* Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.
* Systemic central nervous system metastases. The patient must be stable after radiotherapy for \>/= to 2 weeks and off corticosteroids for \>/= to 1 week.
* Pregnant or nursing women.
* Patients who are primarily refactory to erlotinib.

Primary outcomes:
measure: Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
timeFrame: Baseline, 8, 15 and 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
Study officials:
affiliation: Tragara Pharmaceuticals
name: Sara Zaknoen, MD
role: STUDY_DIRECTOR
References: