louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05529589: Comparison of Restoration in Vitreous Hemorrhage Patients With DME After or Not Removing Inner Limiting Membrane
Official title: Comparative Study of Anti-VEGF Effect and Visual Function in Vitreous Hemorrhage Patients With Diabetic Macular Edema After Pars Plana Vitrectomy With Inner Limiting Membrane Peeling or Not
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Edema Due to Diabetes Mellitus
Vitreous Hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with vitreous hemorrhage with DME who need vitreous surgery are of all ages and sexes

Brief summary: This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not


Eligibility criteria: Inclusion Criteria:

* Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery

Exclusion Criteria:

1. The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
2. The patient with a history of anti-VEGF therapy
3. Patients with DME in the contralateral eye requiring anti-VEGF therapy
4. Patients with contraindications of vitreous cavity resection
5. The patient has a history of intraocular surgery
6. The patient has active inflammatory disease
7. The patient has other retinal diseases that affect vision
8. The patient has other systemic diseases that required treatment with anti-VEGF drugs
9. Patient with contraindications to anti-VEGF therapy

Primary outcomes:
measure: Thickness change of retinal macular area
timeFrame: 12 months
measure: Change of visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Change of eye pressure
timeFrame: 12 months
measure: B-mode ultrasound imaging
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06157489: Effect of Kinesio Tape on Oral and Pharangeal Swallowing Phases in Children With Spastic Cerebral Palsy
Official title: Effect of Kinesio Tape on Oral and Pharangeal Swallowing Phases in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia, Oropharyngeal, Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active Comparator: Kinesiotape Group In active group, KT was applied in masseter muscle, orbicularis oris and infrahyoid muscles for facilitating suprahyoid muscle and oral sensorimotor exercise In sham group will receive the oral sensorimotor exercise only
Primary purpose: TREATMENT

Brief summary: The purpose of current study is to investigate the effect of kinesio tape in children with spastic cerebral palsy having oropharyngeal dysphagia

Detailed description: The study tageted rhe children with spastic cerebral palsy from both sexes will be selected from hospital of Tanta university

Inclusion criteria:

1. Age ranges from 2 to 7 years.
2. The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
3. Diagnosed as spastic diplegia or quadriplegia.
4. Able to understand and follow instructions.

Exclusion criteria:

Children will be excluded if they have any of the following criteria:

1. Severe visual and auditory problems.
2. History of maxillary, head or neck surgical procedures.
3. Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.

Eligibility criteria: Inclusion Criteria:

1. Age ranges from 3 to 7 years.
2. The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
3. Diagnosed as spastic diplegia or quadriplegia.
4. Able to understand and follow instructions.

Exclusion Criteria:

Children will be excluded if they have any of the following criteria:

1. Severe visual and auditory problems.
2. History of maxillary, head or neck surgical procedures.
3. Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.

Primary outcomes:
measure: Oral motor assessment sacle
timeFrame: 1 month
Secondary outcomes:
measure: ultrasonography
timeFrame: 1 month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Hadeer samy abd elaziz
Study officials:
References:
Clinical trial NCT00002089: An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy
Official title: An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Azithromycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of azithromycin given chronically for the treatment of Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available MAC therapy.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Disseminated MAC as defined by current (within the last month) positive blood, bone marrow, or liver biopsy culture for MAC, and considered symptomatic (fever, night sweats, anorexia, weight loss, fatigue, or malaise).
* At least 2 months of prior treatment with available combination MAC therapy or less than 2 months of such accompanied by unacceptable adverse effects.
* Life expectancy of more than 2 weeks.
* Approval of eligibility from Pfizer Clinical Monitor.
* Consent of parent or guardian if under legal age of consent.

NOTE:

* Patients who have completed acute treatment with azithromycin for MAC in protocol 066-131 or 066-148 will be exempt from inclusion criteria 1 and 2 and can continue therapy through this protocol if their physician feels they have benefitted from prior azithromycin therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known hypersensitivity or intolerance to macrolide antibiotics.
* Inability to take oral medications or current condition that is likely to interfere with absorption (e.g., gastrectomy).

Concurrent Medication:

Excluded:

* Other MAC therapy instituted during the first 2 months of the study.
* Other investigational drugs, with the exception of those available through a Treatment IND program.

Patients with the following prior conditions are excluded:

History of hypersensitivity or intolerance to azithromycin.

Prior Medication:

Excluded:

* Other investigational drugs within 7 days of enrollment, with the exception of Treatment IND drugs (such as ddC).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Groton
country: United States
facility: Pfizer Central Research
state: Connecticut
Study officials:
References:
Clinical trial NCT00193089: Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer
Official title: Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: GlaxoSmithKline
First posted: 2005-09-19
Enrollment: 60
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: In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Detailed description: Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* Overexpression of the Her-2 oncogene
* Age \> 18 years
* Measurable disease
* Able to perform activities of daily living with minimal assistance
* No previous chemotherapy for metastatic disease
* One or more previous hormonal therapies for metastatic disease.
* Adequate bone marrow, liver and kidney function
* Patients with \< grade 1 peripheral neuropathy are eligible.
* Must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Abnormal heart function
* Previous treatment with trastuzumab
* Brain metastases untreated
* Pre-existing symptomatic peripheral neuropathy
* Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Infante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer. 2009 Feb;9(1):23-8. doi: 10.3816/CBC.2009.n.004.
Clinical trial NCT00180089: Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Official title: Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia
Graft-Versus-Host Disease
Keywords: graft-versus-host disease
budesonide
stem cell transplantation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Dr. Falk Pharma GmbH
First posted: 2005-09-16
Enrollment: 242
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Detailed description: The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Eligibility criteria: Inclusion Criteria:

* planned allogenic stem cell or bone marrow transplantation
* HLA identity (max. 1 mismatch)
* standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
* written informed consent

Exclusion Criteria:

* history of allogenic transplantation
* in vitro T-cell depleted transplant
* pretreatment with budesonide within the previous 4 weeks
* known intolerance to budesonide
* gastrointestinal infections
* portal hypertension
* concomitant infectious diseases
* liver cirrhosis, impaired liver function
* severe mental disorder
* lack of compliance
* drug or alcohol abuse
* pregnancy, lactation
* childbearing potential without effective contraception

Primary outcomes:
measure: incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary outcomes:
measure: safety
measure: grade of acute GI GVHD
measure: incidence of chronic GI GVHD
measure: incidence of infectious complications
measure: overall and disease-free survival 1 yr after transplant
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medical Department I, Technical University Hospital
Study officials:
affiliation: Medical Department I, Technical University Hospital, Dresden, Germany
name: Stephan Miehlke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmelz R, Bornhauser M, Schetelig J, Kiani A, Platzbecker U, Schwanebeck U, Grahlert X, Uharek L, Aust D, Baretton G, Schwerdtfeger R, Hampe J, Greinwald R, Mueller R, Ehninger G, Miehlke S. Randomised, double-blind, placebo-controlled trial of oral budesonide for prophylaxis of acute intestinal graft-versus-host disease after allogeneic stem cell transplantation (PROGAST). BMC Gastroenterol. 2014 Nov 26;14:197. doi: 10.1186/s12876-014-0197-7.
Clinical trial NCT02130089: Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Official title: Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease Requiring Hemodialysis
Lead sponsor: Academy of Nutrition and Dietetics
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 50
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 purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.


Eligibility criteria: Inclusion Criteria:

* Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
* Able to sign the locally approved informed consent
* Willing to receive dietitian education on sodium and fluid control during normal dialysis time
* Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years

Exclusion Criteria:

* On hospice or international equivalent
* Receiving corticosteroid treatment
* Less than 18 years old
* On interdialytic parenteral nutrition
* Transfer to another facility expected within 3 months
* Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool

Primary outcomes:
measure: Average Percent Interdialytic Weight Gain
timeFrame: monthly for 7 months
Secondary outcomes:
measure: Thirst Intensity
timeFrame: monthly for 7 months
measure: Sodium and Fluid Knowledge
timeFrame: Monthly for 4 months
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Board of Health
Study officials:
affiliation: Auckland Board of Health
name: Sandra McLellan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109589: Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy
Official title: Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy - a Study From Norwegian General Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Diagnoses (ICPC-2)
Prescriptions of Antibiotics by General Practitioners
Prescriptions of ATC J01 and R Drugs in Participants
Keywords: antibiotics
prescriptions
pregnancy
children
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 60000
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Contacts with general practitioner in different parts of Norway. Women aged 15-60 yrs and children 0-2 yrs are selected.

Brief summary: The main objective is to investigate the incidence of Respiratory Tract Infections (RTIs) and antibiotic prescriptions in children and during pregnancy, the different drugs chosen by their doctors according to diagnosis, and compliance by patients. Further to investigate the possible effect of antibiotic use during pregnancy on RTIs and antibiotics and respiratory drug prescriptions in children the first two years after birth.

Specific study objectives:

* RTIs and antibiotic prescriptions in pre-school children

  * Frequency of diagnoses and antibiotic prescriptions
  * The proportion of broad spectrum antibiotics chosen
* Prescription patterns and treatment compliance during pregnancy

  * Incidence of diagnoses, compared with not pregnant patients
  * Choice of antibiotics in RTIs
  * Prescription collection from pharmacies
* Antibiotics and respiratory medication in children aged 0-2 yrs

  * Compare prevalence in children of mothers with frequent RTIs/antibiotic prescriptions during pregnancy and prevalence in children of mothers with few or no consultations during pregnancy
  * Incidence of wheezing and asthma diagnoses and incidence og respiratory prescription drugs when the mother has received antibiotics in pregnancy


Eligibility criteria: Inclusion Criteria:

* Contact with general practitioner in the time of registration

Exclusion Criteria:

* Men (except children aged 0-2 yrs)
* Women in ages 2-14 and above 60 yrs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Antibiotic Centre for Primary Care, University of Oslo
Study officials:
References:
Clinical trial NCT05031689: Green Banana Peel Extract for Melasma Treatment
Official title: Green Banana Peel Extract for Melasma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melasma
Keywords: Melasma
banana
skin
sunscreen
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

Detailed description: Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.

Eligibility criteria: Inclusion Criteria:

* Female patients with melasma.
* Patients aged 18 years or over and 60 years or less.
* Patients who agree to participate in the study. -

Exclusion Criteria:

* Patients who have other types of facial hyperchromia.
* Patients who give up, for any reason, to continue treatment.
* Patients who have any type of allergic reaction to the product.

Primary outcomes:
measure: Clinical analysis of Melasma
timeFrame: 3 months
measure: Quality of life analysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Vale do Sapucaí University
state: Minas Gerais
Study officials:
affiliation: Vale do Sapucaí University
name: Adriana R dos Anjos Mendonça, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02022189: Review of Kidney Biopsies of Dent Disease Patients
Official title: Systematic Review of Clinical Biopsies of Dent Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dent Disease
Keywords: Dent
Dents
Dent Disease
Renal Biopsy
Kidney Biopsy
Clinical Biopsy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the Dent Registry with a previous renal biopsy

Brief summary: This study is being done to obtain pathology reports from all patients in the Dent disease registry who have had a kidney biopsy. The investigator will collect the biopsy slides and reports in an attempt to determine if they have any common findings.

Detailed description: If the patient agrees to be in the study, the patient will be asked to participate in the following:

* Sign a consent form indicating the patient's willingness to participate.
* Provide a signed medical release form allowing the investigator to request your official kidney biopsy reports, and also allowing the investigator to request the original slides for review. At the end of the study, all slides will be returned to the referring facility.
* The investigator will also review your medical record

Eligibility criteria: Inclusion Criteria:

* All patients in the Dent Disease Registry with a previous renal biopsy.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Biopsy changes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John C Lieske, M.D.
role: PRINCIPAL_INVESTIGATOR
References: