louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00426998: Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD
Official title: A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Macular Degeneration
Keywords: Choroidal neovascularization due to age-related macular degeneration
Lead sponsor: Retinal Consultants Medical Group
Sponsor class: OTHER
First posted: 2007-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

1. Patients are men or women of age 55 or older
2. Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
3. patients have not received previous treatment for subfoveal CNV due to AMD.
4. Patients have a visual acuity between 20/40 and 20/320-

Exclusion Criteria:

1. Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
2. Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
3. Patients who use medications that may induce photosensitivity.
4. Patients who have undergone YAG capsulotomy within the last month.
5. Subjects currently involved in any experimental procedure within the last 12 weeks.
6. Female patients who are pregnant, fecund or breast-feeding.

   -

Primary outcomes:
measure: percentage of patients losing 3 or more lines of visual acuity
measure: percentage of patients gaining 3 or more lines of visual acuity
measure: mean change from baseline in visual acuity
measure: OCT evidence of active CNV leakage
measure: fluorescein angiographic evidence of active CNV leakage
measure: number of retreatments
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
Study officials:
affiliation: Retinal Consultants Medical Group, Inc.
name: Joel A Pearlman, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015898: Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma
Official title: Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma
photodynamic therapy
photo chemotherapy
basal cell epithelioma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 28
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 evaluate the efficacy of photodynamic therapy in treatment of Basal cell carcinoma (BCC) and factors that affect response rate.

Detailed description: Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.

Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.

Eligibility criteria: Inclusion Criteria:

* Histologically proven BCCs

Exclusion Criteria:

* Rodent ulcer
* Morphea type
* ANA +
* History of photosensitivity or photodermatosis or ingestion of phototoxic
* Drugs during last month
* Pregnancy
* Breast feeding
* Age\< 18
* History of another therapeutic intervention for bcc during last 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Skin Research Center
name: Zohreh Tehranchi-nia, assist.prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05070598: Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
Official title: A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HER2-positive Gastric Cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 35
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: According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);


Eligibility criteria: Inclusion Criteria:

- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Exclusion Criteria:

* rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Primary outcomes:
measure: ORR (Objective control rate)
timeFrame: up to 12 months
Secondary outcomes:
measure: DCR (Disease control rate)
timeFrame: up to 12 months
measure: PFS (Progression-Free survival)
timeFrame: up to 12 months
measure: OS(Overall survival)
timeFrame: up to approximately 24 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
Study officials:
affiliation: Shengjing Hospital
name: Caigang Liu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT03718598: Carpal Tunnel Syndrome in Pregnant Women
Official title: Effectiveness of Home Exercise in Pregnant Women With Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Exercise
Keywords: Carpal tunnel syndrome
home exercise
pregnant women
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-Probability Sample: Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer

Brief summary: The purpose of our study is to evaluate the effectiveness of the home exercise program in patients who develop Carpal tunnel syndrome (CTS).

Detailed description: Materials and Method: Thirty-three patients with CTS (mild to moderate) were included to randomized, single-blind, controlled clinical trial. Based on EMG results and clinical examination, patient group was divided two part as mild and moderate CTS (group 1) and normal (group 2). The Sick Boston Carpal Tunnel Syndrome Questionnaire form was filled in face-to-face method.

Cases in this study: Patients who had pain and numbness problems at the hands of the Bezmiâlem Vakif University Polyclinic for Women and Obstetrics were then directed to the Bezmiâlem Vakif University Physical Therapy Rehabilitation Policlinic. After the examination and clinical testing of each patient (Tinel test, Phalen's test, Reverse Phalen's and Durkan's Carpal Compression test), the patients were directed to Bezmiâlem Vakif University Neurology Policlinic. Based on electromyography (EMG) results and clinical examination, the group was classified as mild and moderate CTS (group 1) and normal (group 2). A disease exercise form was distributed for all patients to do exercises.

Eligibility criteria: Inclusion Criteria:

* Provocation tests during the examination and physical examination to match the median nerve distribution those who have symptoms of numbness, tingling, weakness and pain in the hands that have lasted at least 1 month.
* Patients with confirmed mild-moderate idiopathic CTS on EMG.

Exclusion Criteria:

* Previously undergone carpal tunnel surgery
* Gestational diabetes mellitus,
* Eclampsia, preeclampsia
* Thyroid disorders
* Arthropathies
* Hand or wrist trauma
* Bilateral fractures
* Severe cts
* Atrial fibrillation
* Cervical radiculopathy
* Peripheral neuropathy
* Thoracic outlet syndrome
* Diabetes mellitus
* Hypothyroidism
* Hyperthyroidism
* Rheumatologic disease

Primary outcomes:
measure: Sick Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: Patients were evaluated before treatment and 1 month after the birth.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06544798: Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
Official title: Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to the follow-up group or active treatment group based on the group to which they were randomized in Study MGT-AQP1-201.
Primary purpose: TREATMENT

Brief summary: This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.

Detailed description: Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.

Eligibility criteria: Inclusion Criteria:

* Received study drug in Study MGT-AQP1-201

Exclusion Criteria:

* Withdrew consent to participate in Study MGT-AQP1-201.

Primary outcomes:
measure: Number of participants with study drug-related adverse events and serious adverse events
timeFrame: From study start until Month 60 post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
References:
Clinical trial NCT06739798: Comparison of Binocular Spectacle Prescription Versus Patching Therapy in Refractive Amblyopia Patients
Official title: Comparison of Binocular Spectacle Prescription Versus Patching Therapy in Refractive Amblyopia Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amblyopia
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors.

Detailed description: There will be a comparison of two treatment methods i.e. Patching and Binocular Spectacle Prescription used to cure amblyopia patients. In binocular spectacle correction, we will slightly blur the good eye and fully correct the amblyopic eye so that binocular functions stimulate and improve after the treatment. Literature suggests that Patching improve monocular functions but there is no significant improvement in binocular functions.

Eligibility criteria: Inclusion Criteria:

* Anisometropic amblyopia
* Anisometropia \> 1.00 D( difference between eyes in SE)
* Astigmatism \>1.50 D
* VA in amblyopic eye 20/40 -20/200(6/12-6/60) or less than 20/200
* VA in the better eye or fellow eye 20/30 (6/9) or better

Exclusion Criteria:

* Strabismic amblyopia
* Deprivation amblyopia
* Isoametropic amblyopia
* History of ocular trauma, IOL implant
* Media opacity
* Any ocular/retinal pathology
* Optic nerve pathology
* Ptosis
* Any gaze control abnormalities

Primary outcomes:
measure: Binocular single vision
timeFrame: 12 Months
measure: Visual Acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jhang
country: Pakistan
facility: LRBT primary eyecare centre 18 Hazari
state: Punjab
Study officials:
References:
Clinical trial NCT01586598: Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
Official title: Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injury of Trigeminal Nerve
Surgery
Mandibular Prognathism
Keywords: Mandibular Nerve
Orthognathic Surgery
Sagittal Split Osteotomy
Sensory Retraining
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether sensory retraining exercise could improve lip numbness caused by bilateral sagittal split of mandible.

Detailed description: The study is a prospective randomized controlled trial. The patients receiving bilateral sagittal split osteotomy and having lip numbness or paraesthesia will be included in this study. 80 patients will be included and randomized into two groups and there are 40 patients in each group. The control group is to maintain follow up in clinic and do not receive any sensory retraining exercise. The experimental group is requested to perform sensory retraining at home by themselves.

Eligibility criteria: Inclusion Criteria:

1. Taiwanese adult (18-40 y/o)
2. Developmental dentofacial disharmony (Class III)
3. Patients received orthognathic surgery (BSSO alone or with maxillary procedure)

Exclusion Criteria:

1. Medical condition associated with systemic neuropathy
2. Unwilling to sign informed consent
3. Congenital anomaly or acute trauma affecting the face
4. Previous facial surgery
5. Positive pain sensation at first week of post-surgery
6. Altered sensation before OGS as numbness or unusual feeling
7. Cleft lip and palate

Primary outcomes:
measure: sensory function test
timeFrame: one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chiung Shing Huang, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273098: School-Based Bladder Health Intervention
Official title: Understanding and Enhancing Schoolchildren's Bathroom Habits: Uncovering Barriers and Promoting Healthy Bladder Habits
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Dysfunction
Lower Urinary Tract Symptoms
Urinary Tract Infections
Urinary Tract Infections in Children
Keywords: School-Based Intervention
Bathroom Policy
Healthy Bladder Behaviors
Bladder Health Education
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children.

Detailed description: In order to promote healthy bladder behaviors among school children, we will conduct a randomized control trial in schools. The research team will provide support for a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies that are TBD (e.g. mobile technology bathroom passes).

The study will involve 4-8 fourth grade classrooms within 2 elementary schools that meet the historical criteria for \>50% students receiving free school lunch.

Eligibility criteria: Inclusion Criteria:

* 4th grade students from elementary schools that meet the historical criteria for \>50% students receiving free school lunch.

Exclusion Criteria:

* Not meet the inclusion criteria

Primary outcomes:
measure: Bathroom use
timeFrame: 4 years
measure: Symptom score
timeFrame: 4 years
measure: Urine volume
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Kathleen Kan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06266598: Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity
Official title: The Effect of Anti-diabetic Treatment Applied in Childhood Obesity on Zinc, Zinc α-2 Glycoprotein and Peroxisome Proliferation Activating Receptor-γ Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Childhood Obesity
Insulin Resistance
Keywords: Obesity
Metformin
Biomarker
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 52
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.
Primary purpose: TREATMENT

Brief summary: In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.


Eligibility criteria: inclusion criteria:

* Body mass index (BMI) \> 95th percentile
* Having insulin resistance
* Having a family history of Type 2 diabetes mellitus (T2DM)

exclusion criteria;

* Alcohol consumption and smoking
* Having T1DM and T2DM
* History of drug use

Primary outcomes:
measure: Insulin resistance (HOMA-IR) level
timeFrame: three months
measure: Weight loss rate
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri̇
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
References:
Clinical trial NCT03546998: Epidermoid Cancer Development in Esophageal Achalasia
Official title: Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achalasia
Epidermoid Carcinoma
Keywords: epidermoid carcinoma
esophageal achalasia
risk factors
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 681
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: 681 patients admitted at the division of Clinica Chirurgica II of the University of Bologna from 1973 and undergone surgery, pneumatic dilations or medical therapy for esophageal achalasia.

Brief summary: Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

Detailed description: In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

Eligibility criteria: Inclusion Criteria:

* diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry

Exclusion Criteria:

* pseudoachalasia

Primary outcomes:
measure: Detection of epidermoid carcinoma of the esophagus
timeFrame: 1 year
Secondary outcomes:
measure: Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux
timeFrame: 1 year
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Division of Thoracic Surgery Maria Cecilia Hospital
state: RA
Study officials:
affiliation: Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna
name: Sandro Mattioli, MD
role: PRINCIPAL_INVESTIGATOR
References: