louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06966999: Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
Official title: Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Acquired Comitant Esotropia
Keywords: Botulinum toxin
esotropia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess and compare the efficacy of two-year follow-up botulinum toxin type A （BTXA) in the treatment of acute acquired comitant esotropia (AACE) across five age groups: ≤6 years, \>6 to ≤12 years, \>12 to ≤20 years, \>20 to ≤30 years, and \>30 years. For patients \>12 years presenting with large-angle esotropia (\>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute acquired comitant esotropia (AACE) with sudden onset and diplopia
* Normal eye movements with deviation difference ≤5 prism diopters (PD) in all gaze directions
* Hyperopia \< +3.00 diopters
* \<10 PD reduction in esotropia with hypermetropic spectacle correction
* No prior extraocular muscle surgery
* Absence of congenital/developmental anomalies affecting treatment outcomes

Exclusion Criteria:

* Deviation difference \>5 PD in any gaze direction
* Hyperopia ≥ +3.00 diopters
* History of extraocular muscle surgery
* Presence of congenital/developmental anomalies potentially impacting outcomes

Primary outcomes:
measure: the cumulative motor success rate
timeFrame: 2 years
Secondary outcomes:
measure: the sensory success rate
timeFrame: 2 years
Other outcomes:
measure: the hazard ratio (HR) for the risk of AACE relapse
timeFrame: 2 years
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00108199: Generalization of Training in Schizophrenia
Official title: Generalization of Training in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
vocational rehabilitation
neuropsychology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study examines whether patients with schizophrenia can benefit from a problem-solving training intervention and whether a work-related social skills training intervention leads to improvements in the patient's performance at work.


Eligibility criteria: Inclusion Criteria:

* Veterans with schizophrenia or schizoaffective disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT00161642: Study Evaluating CMD-193 in Advanced Malignant Solid Tumors
Official title: A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Malignant Tumors
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
* Tumor expression of Lewis Y antigen ( \> or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
* Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-193.
* Significant prior allergic reaction to recombinant human or murine proteins

Primary outcomes:
measure: Physical examinations
measure: hematology panels
measure: ECG
Secondary outcomes:
measure: Radiographic tumor evaluations
measure: blood sampling for pharmacokinetic assessments
Other outcomes:
Locations:
city: Lebanon
country: United States
state: New Hampshire
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06623942: Prostasin Levels in Preeclamptic Women
Official title: Prostasin Levels in Preeclampsia: A Comparative Study With Healthy Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The groups in this study will be selected consists of pregnant women receiving care at a referral center for maternal care.

Brief summary: This study will aim to compare maternal serum prostasin levels between women diagnosed with preeclampsia and healthy normotensive pregnant controls. Participants will be divided into two main groups: those with preeclampsia and those with uncomplicated pregnancies. The preeclampsia group will further be subdivided based on the severity of the condition. Maternal serum samples will be collected from all participants, and prostasin levels will be measured using ELISA. Statistical analyses will be performed to evaluate whether prostasin levels are significantly elevated in the preeclampsia group, particularly in those with severe features, and to assess its potential as a biomarker for the condition.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Preeclampsia: Defined by new-onset hypertension (systolic Blood Pressure ≥140 mmHg and/or diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
* Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.

Exclusion Criteria:

* Multiple Pregnancies
* Pregestational Diabetes
* Chronic Hypertension
* Systemic Diseases (Chronic kidney disease, autoimmune diseases)
* Fetal Anomalies
* Premature Rupture of Membranes.

Primary outcomes:
measure: Maternal Serum Prostasin Levels
timeFrame: Up to 8 weeks (Patients will be followed from inclusion in the study until the end of their pregnancy.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cam and Sakura City Hospital
Study officials:
References:
Clinical trial NCT06087042: Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions
Official title: Association of Serum and Salivary Dipeptidyl Peptidase-4 (DPP-4) With Oral Cancerous and Precancerous Lesions; an Observational Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Premalignant Lesions as Leukoplakia and Lichen Planus
Oral Cancer
Keywords: oral cancer
saliva
serum
dipeptidyl peptidase
potentially malignant lesions.
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult individuals entering in the out patient clinics of oral medicine and diagnosis department

Brief summary: Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in carcinogenesis.

Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15 patients having oral squamous cell carcinoma. Group II: 15 patients with potentially malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy participants having no oral mucosal lesions acting as a control group (Group III). Serum and whole unstimulated salivary samples were collected from all participants to evaluate dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity and diagnostic accuracy of DPP-4 among different groups.


Eligibility criteria: Inclusion Criteria:

* systemically healthy
* No current medication,
* both genders with age ranging from 30 to 65 years old.
* having oral leukoplakia, oral lichen planus or oral squamous cell carcinoma

Exclusion Criteria:

* systemic disease
* pregnancy
* lactation
* being diagnosed with any other oral mucosal lesion

Primary outcomes:
measure: DPP-4 level detection
timeFrame: level of DPP-4 is measured after the completion of all sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: faculty of dentistry, Fayoum university
Study officials:
affiliation: faculty of dentistry, Fayoum university
name: Nayroz Tarrad, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03919942: Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment
Official title: Effect of Oxyflower® Gel as a Coadjuvant in Pericoronitis Treatment: Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pericoronitis
Keywords: Quality of life
Pericoronitis
Phytotherapy
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical effect and the impact on the quality of life of the coadjuvant treatment with Oxyflower® gel in cases of pericoronitis in lower third molar, compared to chlorhexidine gel and placebo gel.

Detailed description: This study consist of 51 participants diagnosed with pericoronitis who received coadjuvant treatment with gel. The participants were submitted to emergency treatment, with local debridement and irrigation with saline solution followed by topical application of the randomized gel: oxyflower®, chlorhexidine, or placebo gel. In cases of pericoronitis with systemic signs / symptoms, such as fever, malaise and lymphadenopathy, systemic antibiotic therapy was prescribed one hour before debridement, lasting seven days. All participants received oral hygiene guidelines and were instructed to apply the same gel twice daily for one week . After 30 days, it was performed tooth removal for cases in which there is not enough space for dental eruption; or distal wedge surgery when there is space for dental eruption with excessive gingiva in the distal. It was evaluated as outcomes: pain, quality of life, depth of probing, level of bone crest in the distal of second molar, buccal opening and extent of edema / erythema. A comparative analysis was performed between the groups, before and after treatment.

Eligibility criteria: Inclusion Criteria:

* signs / symptoms of pericoronitis with
* spontaneous pain
* ASA I or II
* Consent to participate

Exclusion Criteria:

* Periodontal status level IV
* Smokers
* antibiotic therapy in the last 2 months

Primary outcomes:
measure: Change from Baseline Quality of life
timeFrame: baseline, 30 days
measure: Change from Baseline Pain
timeFrame: baseline, 1,3,7,15 and 30 days
Secondary outcomes:
measure: Change from Baseline trismus
timeFrame: baseline, 1,3,7,15 and 30 days
measure: change from edema / erythema
timeFrame: baseline, 1, 3, 7, 15 and 30 days
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Universidade Federal dos Vales do Jequitinhonha e Mucuri
state: Minas Gerais
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Patricia F Gonçalves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01234142: A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
Official title: A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Cohort, Escalating Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of A Varenicline Transdermal Delivery System In Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: varenicline transdermal percutaneous transcutaneous transdermal delivery system patch
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.


Eligibility criteria: Inclusion Criteria:

* Healthy
* male or female
* adult cigarette smokers of any race

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or Day 0.
* Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC24); observed maximum plasma concentration (Cmax) in a given dosing interval and time of maximum plasma concentration (Tmax)
timeFrame: Days 1, 7 and 14
measure: Observed accumulation ratio (Rac)
timeFrame: Days 7 and 14
measure: Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF)
timeFrame: Days 7 and 14
measure: Terminal half life (t1/2)
timeFrame: Day 14-Day 19
Secondary outcomes:
measure: Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation)
timeFrame: Days 1-14 (24 hpd); Days 1, 7-8 (1 and 12 hpd); Day 14 (1,6,12,24,48,72,96 and 120 hpd)
measure: VAS scores for nausea (using a Visual Analog Scale)
timeFrame: Days 1-19 (daily)
measure: Daily adhesion score (as measured by the Rating Scale for Adhesion)
timeFrame: Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd)
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01993342: Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients
Official title: Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: adipocytokines
osteoarthritis
inflammation
ultrasonography
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with knee osteoarthritis and synovial effusion who attende to a Rheumatologist unit for this problem. We made the visit and anonimously we kept the results of examination and ultrasonography in our database and we freezed synovial fluid. Now we will determine the adipocytokines and classic inflammatory parameters in this synovial fluid

Brief summary: The purpose of this study is to determine the concentration of different adipocytokine (adiponectin, leptin, resistin, visfatin, osteopontin) and an inflammation classic markers as Interleukine 1 beta, tumor necrosis alfa, interleukine 6 and high sensibility reactive c protein in the synovial fluid of knee osteoarthritis patients, and compare with the inflammation detected with ultrasonography evaluation of the joint. In last years, some studies appeared focusing on the role of adipocytokines in osteoarthritis and they correlated adipocytokines with cartilage degradation and x-ray degree; in our study we will focused in the importance of adipocytokines in the inflammatory changes more than in joint destruction.


Eligibility criteria: Inclusion Criteria:

* aged 50 to 81
* primary osteoarthritis of the knee
* synovial effusion in examination
* patient who have the results in our database

Exclusion Criteria:

* any other rheumatic conditions as rheumatoid arthritis or another inflammatory disease
* secondary knee osteoarthritis
* history of knee surgery
* any conditions that at investigator criteria exclude the patient from study procedures

Primary outcomes:
measure: Determination of adipocytokine levels (adiponectin, leptin, resistin, visfatin, osteopontin) in synovial fluid
timeFrame: We determine adipocytoquines in one month, all patients in the same determination kit
Secondary outcomes:
measure: Knee inflammation parameters detected by ultrasonography
timeFrame: three months
measure: To determine additional classic parameters of inflammation in synovial fluid as Interleukine 1 beta, Interleukine 6 and tumor necrosis factor alfa
timeFrame: We determine this inflammatory parameters in one month in all patient at the same time
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Tauli Sabadell
state: Barcelona
Study officials:
affiliation: Hospital Parc Tauli
name: Joan Calvet, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Parc Tauli
name: Cristobal Orellana, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01660542: An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Locally Advanced Breast Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 96
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis
2. no evidence of systemic metastasis pathologically or radiologically
3. age at the time of diagnosis between 20 and 70 years
4. patients with previously untreated primary breast cancer including chemotherapy
5. general performance status with ECOG 0-2
6. sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)
7. sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)
8. sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline phosphatase level ≤ 1.5 times the upper normal limit)
9. sufficient cardiac function (normal electrocardiography within 1 month or LVEF\>50% by echocardiography or MUGA scan within 3 months)
10. patients who agree to enroll this clinical trial and sign the written informed consent voluntarily

Exclusion Criteria:

1. patients with evidence of distant metastases
2. patients with other previous malignancy except breast cancer
3. pregnant (positive hCG test 1 week before registration) or lactating patient
4. uncontrolled serious infection
5. patients with psychiatric disease or epilepsy
6. patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina
7. male breast cancer
8. patients with poor general condition who are not able to understand or sign the written informed consent

Primary outcomes:
measure: Pathologic Complete Response
timeFrame: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References: