louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00428064: Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients
Official title: A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Renal allograft
Renal
Kidney
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 408
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.


Eligibility criteria: Inclusion Criteria:

* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
* Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion Criteria:

* Evidence of active systemic or localized major infection at the time of initial sirolimus administration
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
* Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery

Primary outcomes:
measure: Equivalence of graft survival at month 12
Secondary outcomes:
measure: Renal function; biopsy-confirmed acute rejection, grade of acute rejection; subject and graft survival; incidence of infection, malignancy, treatment failure, and of chronic rejection as determined by protocol biopsies; quality of life.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Friend P, Russ G, Oberbauer R, Murgia MG, Tufveson G, Chapman J, Blancho G, Mota A, Grandaliano G, Campistol JM, Brault Y, Burke JT; Rapamune Maintenance Regimen (RMR) Study Group. Incidence of anemia in sirolimus-treated renal transplant recipients: the importance of preserving renal function. Transpl Int. 2007 Sep;20(9):754-60. doi: 10.1111/j.1432-2277.2007.00506.x. Epub 2007 Jun 12.
Clinical trial NCT06167564: Allergy Diagnostic Test Based on Microchip Technology
Official title: Development of a Diagnostic Test System Based on Microchip Technology for the Detection of IgE-dependent Allergic Reactions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergy
Allergy;Food
Allergy Pollen
Allergy Drug
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
First posted: 2023-12-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Group of adult participants with IgE-dependent allergic reactions. Routine blood serum IgE levels will be compared with the newly developed microarray-based diagnostic test system.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum.

Detailed description: The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum samples and to assess the sensitivity and specificity of the developed system.

Eligibility criteria: Inclusion Criteria:

* Type I allergy (food, drug, pollen)
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* Acute or chronic diseases in the stage of decompensation (except allergy)
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Primary outcomes:
measure: Serum IgE levels of the specific pollen allergens
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: IBCE
name: Andrei Hancharou, Dr
role: STUDY_DIRECTOR
affiliation: IBCE
name: Antonina Osipova, Dr
role: STUDY_DIRECTOR
affiliation: IBCE
name: Ekaterina Shamova, r
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05855564: Implementing a School-based Mindfulness Curriculum
Official title: Implementing a School-based Mindfulness Program in Primary School Curriculum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: student mental health
school-based mindfulness training
students with special needs
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The outcomes and implementation processes of the school based mindfulness program, as a universal prevention program in classroom as and support group programs for students with special education needs will be investigated. The study of classroom program will apply quasi-experimental design, comparing the pretest and posttest of seven primary schools with implementation of mindfulness programs with three schools with ordinary school activities only. A total of 800 students will be recruited to receive an eight session mindfulness program in classroom as a universal prevention program. Ten support group for students with special education needs will apply mindfulness programs, and its outcome will be evaluated using repeated time measures.


Eligibility criteria: Inclusion Criteria:

* students in participating schools
* students with parent's consent

Exclusion Criteria:

* student without parent's consent

Primary outcomes:
measure: positive self-perception
timeFrame: immediately before the intervention, and immediately after the intervention
Secondary outcomes:
measure: peer relationship
timeFrame: before the intervention, and immediately after the intervention
measure: attitude towards school
timeFrame: before the intervention, and immediately after the intervention
measure: organized, nondisruptive, and nonimpulsive behaviors
timeFrame: before the intervention, and immediately after the intervention
measure: executive functioning
timeFrame: before the intervention, and immediately after the intervention
measure: creativity
timeFrame: before the intervention, and immediately after the intervention.
measure: self-regulation
timeFrame: before the intervention, and immediately after the intervention
measure: cortisol
timeFrame: before the intervention, and immediately after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
city: Hong Kong
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT00776464: Treating Onychomychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Onychomycosis
Lead sponsor: Nomir Medical Technologies
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to treat 4 toes at a time to eliminate Onychomycosis


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* positive onychomycosis
* negative pregnancy

Exclusion Criteria:

* peripheral neuropathy

Primary outcomes:
measure: Complete or near complete disappearance of toenail fungus
timeFrame: 360 days
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Nomir Medical
state: Massachusetts
Study officials:
References:
Clinical trial NCT01608464: Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer
Official title: A Trial Comparing Pre-operative Chemo-radiotherapy With Cisplatin and Fluorouracil Versus Chemotherapy With Docetaxel and Irinotecan in PET Non Responders Resectable Cancer Esophagus: a Multicenter Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma of Esophagus
Keywords: Randomized trial,
Pre-operative chemo-RT with CDDP and 5-FU
Multicenter study
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 170
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
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 is to improve their outcome by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

Detailed description: This study is aimed at improving the outcome of resectable non PET responders, esophageal carcinoma, by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

Eligibility criteria: Inclusion Criteria:

* Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction.
* No distant metastases.
* Signed written informed consent.
* Age less than 75 years.
* Potentially resectable tumor (radiological evidence of resection with no residual disease).
* ECOG 0 to 2.
* Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT and AST of less than 4 upper limits of normal.
* Normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/L and platelets more than 100,000 /ml

Exclusion Criteria:

1. Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up
2. Prior treatment with other anti cancer therapy or radiation therapy.
3. Legal incapacity.
4. Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.
5. Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.

Primary outcomes:
measure: Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group
timeFrame: 5 yrs
Secondary outcomes:
measure: Rate of conversion from PET non responder to responder with each type of salvage therapy
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
name: Shouki Bazarbashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00533364: Effect of SBG in Patients With Breast Cancer
Official title: A Phase I/II Study to Assess the Effect of Soluble Beta-1,3/1,6-glucan in Combination With Standard Therapy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is set up to determine whether soluble beta-glucan (SBG) has

* unfavourable side effects
* beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
2. Primary tumor or metastases are HER2-ICH3+ or FISH+
3. Measurable or non-measurable disease
4. The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
5. Expected lifetime of more than 12 weeks
6. Age ≥ 18 years
7. Performance status ≤ 2 according to World Health Organization (WHO) scale
8. The patient must be able to comply with the protocol
9. Verbal and written informed consent

Exclusion Criteria:

1. Women who are pregnant or breast-feeding. A negative pregnancy test must be provided during the screening period for fertile women. Fertile women must use effective contraceptive methods
2. Clinical symptoms indicating central nervous system involvement
3. Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
4. Left ventricular ejection fraction (LVEF) \< 50% of normal range
5. Reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l and neutrophil counts \< 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l
6. Reduced liver function defined by bilirubin \> 3 x upper normal limit and/or ASAT/ALAT \> 3 x upper normal limit and/or alkaline phosphatase \> 3 x upper normal limit.
7. Reduced renal function defined by serum creatinine \> 2 x upper normal limit

Primary outcomes:
measure: Asess the safety of SBG in combination with standard antibody and chemotherapy treatment
timeFrame: 21 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevål University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Erik Wist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01965964: Translation of the Sydney Swallow Questionnaire and Validation of the German Version
Official title: Sydney Swallow Questionnaire: Translation of a Questionnaire Relating to the Function of Swallowing and Validation of the German Version
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Keywords: Dysphagia, Swallowing functions, Questionnaire in German
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Dysphagia for at least half a year

Brief summary: Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. The tool is specifically designed to evaluate important aspects of swallowing function The questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.


Eligibility criteria: Inclusion criteria: - patients with diagnosed dysphagia "of any causes"

* sufficient proficiency in german
* voluntary participation

Exclusion criteria: - insufficient knowledge of the german language

* cognitive limitations
* reduced general state of health

Primary outcomes:
measure: Percentage of patients able to understand and fill out the german translation of the questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Otorhinolaryngology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Otorhinolaryngology
name: Joerg E Bohlender, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946764: To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 41 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00420264: ThermaChoice III Under Local Sedation in the Office Setting
Official title: Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Uterine Bleeding
Lead sponsor: Female Pelvic Medicine & Urogynecology Institute of Michigan
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2007-01-11
Enrollment: 21
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.

Detailed description: A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.

Eligibility criteria: Inclusion Criteria:

* Heavy uterine bleeding

Exclusion Criteria:

* Uterine or cervical cancer
* Unable to tolerate office hysteroscopy
* Uterine fibroid tumors that distort endometrial cavity
* Uterine cavity greater than 12 cm
* Patients with hyperplasia or premalignant changes of the endometrium
* Active genital or urinary tract infections
* Intrauterine device
* Pregnant or want to become pregnant

Primary outcomes:
measure: Tolerability of Uterine Ablation in the office setting
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Valley Gynecologists, PC
state: Michigan
Study officials:
affiliation: Grand Valley Gynecologists, PC
name: Jason B Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443664: External Micropulse Diode Laser Transscleral Trabeculoplasty (EMDLT) for Severe Open Angle Glaucoma
Official title: External Micropulse Diode Laser Transscleral Trabeculoplasty(EMDLT) For Severe Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Primary Open Angle Glaucoma
Keywords: Primary Open Angle Glaucoma
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prove that external contact micropulse diode laser trabeculoplasty (EMDLT) can significantly lower intraocular pressure in cases of advanced open angle glaucoma.

Detailed description: Micropulse diode laser trabeculoplasty applied through a gonioscopy len has been shown to be effective in lower the pressure for patients with primary open angle glaucoma (POAG). We believe that applied externally, the contact diode micropulse laser will be effective in lowering intraocular pressure for patients with advance open angle glaucoma with minimal side effects

Eligibility criteria: Inclusion Criteria:

* • Diagnosis of Primary Open Angle Glaucoma

  * Advanced glaucoma with intraocular pressure higher than 21mmHg on one or more topical medications (for at least 2 months)
  * Visual acuity worse than 6/6
  * Age more than 21 years
  * Poor candidate for additional filtration surgery

Exclusion Criteria:

* • Age less than 21 years

  * Any eye surgery within 2 months of enrolment
  * Any patient with rubeosis
  * Unable to give informed consent

Primary outcomes:
measure: The amount of pressure lowering after EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment.
Secondary outcomes:
measure: Study of safety of EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY (EMDLT) treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Paul TK Chew, MBBS,MMedOph
role: PRINCIPAL_INVESTIGATOR
References:
citation: The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13.
citation: Kramer TR, Noecker RJ. Comparison of the morphologic changes after selective laser trabeculoplasty and argon laser trabeculoplasty in human eye bank eyes. Ophthalmology. 2001 Apr;108(4):773-9. doi: 10.1016/s0161-6420(00)00660-6.
citation: Ho CL Micropulse Diode Trans-scleral Cyclophotocoagulation Asian Journal of ophth. 2001 supplement. vol 3,no 3,4
citation: Ingvoldstad DD, Krishna R, Willoughby L. MicroPulse Diode Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in the treatment of Open angle glaucoma. Presented at ARVO 2005, Poster 123.