louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03427021: A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Official title: A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: GI Patients on Oxaliplatin Containing Regimen
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate whether exposure to ice chips in the mouth (oral ice chips) during oxaliplatin treatment prevents or reduces symptoms of cold sensitivity.


Eligibility criteria: Inclusion Criteria:

* Individuals ≥18 years of age will be enrolled.
* Patients must have histologic confirmation of a solid tumor malignancy that will be treated with a regimen that contains full-dose oxaliplatin.
* Patients may be receiving treatment in the neoadjuvant, adjuvant or metastatic setting.
* Patients must be treatment-naïve to platinum-agents at the time of enrollment. Prior treatment with non-platinum agents is permitted.

Exclusion Criteria:

* Any active intraoral infection, including yeast infection (thrush) or active oral herpes simplex virus at the time of enrollment.
* Patients may not have dentures.
* Patients may not have a disorder that may result in altered taste sensation at baseline. This includes but is not limited to: persistent dry mouth.

Primary outcomes:
measure: overall intraoral cold sensitivity score
timeFrame: a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Kim Reiss Binder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076621: Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months
Official title: A 12 Month Non-interventional (Observational), International, Multi-centre, Prospective Study to Evaluate the Bleeding Pattern of Ultra-low Dose Continuous Combined Hormone Replacement Therapy Containing 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate (Eviana®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Postmenopausal Bleeding
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The postmenopausal women (who are ammenorrheic) are to be offered participation in the study at the discretion of the treating physician following the decision to prescribe 0.5 mg estradiol and 0.1 mg norethisterone acetate for the treatment of their menopausal symptoms.

Brief summary: This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) for 12 months.


Eligibility criteria: Inclusion Criteria:

* Informed consent, permitting the data to be processed within the scope of the study, is obtained from the patient before any study-related activities
* Postmenopausal amenorrhoeic women
* Treatment with previously combined HRT discontinued at least 3 months prior to start of 0.5 mg estradiol and 0.1 mg norethisterone acetate treatment

Primary outcomes:
measure: Bleeding profile during the 52 weeks of treatment with 0.5 mg estradiol and 0.1 mg norethisterone acetate evaluated by bleeding, and bleeding or spotting rates
timeFrame: At every lunar month (28 days)
Secondary outcomes:
measure: Change in bleeding profile
timeFrame: During the 52 weeks of treatment
measure: Change in mean number of hot flushes per week
timeFrame: During the 52 weeks of treatment
Other outcomes:
Locations:
city: Rud
country: Norway
city: Göteborg
country: Sweden
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00303121: Compliance and Administration Technique in Topical Drug Therapy of Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Compliance
Therapy
Administration technique
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2006-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Clinic-based evaluation of patients compliance with topical medications in the treatment of glaucoma. Also assessing effectiveness of delivery techniques among these patients.


Eligibility criteria: Inclusion Criteria:

glaucoma 18 years of age or older

Exclusion Criteria:

Recent ocular surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Yvonne M Buys, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194584: Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs
Official title: Building on Family Strengths: An Educational Program for Parents of Children With On-Going Health Care Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Keywords: children
chronic illness
parent education
parent support
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2005-09-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The long-term goal of this research is to strengthen parents' abilities to manage the complexities of childhood chronic illness. To achieve this goal, the team of parents, health care professionals, and researchers proposes the following specific aim:

* Develop, implement, and test a unique psycho-educational program, Living with Childhood Chronic Illness (the Program), for effectiveness with parents of children who have chronic illnesses.

The investigators propose the following hypotheses:

At both 6 and 12 month follow-up points, parents taking part in the intervention, in contrast to control parents, will have:

1. Greater perceived self-efficacy regarding their ability to manage the child's chronic condition;
2. Greater parental ability to involve their child in shared management activities;
3. Greater parental ability to cope at 6 and 12 months following the end of the intervention;
4. Greater emotional health; and
5. Greater parental perceived family quality of life.

Detailed description: Parents will enroll in the study by contacting the study number: 206-987-1000 or by sending an email message to family.strengths@seattlechildrens.org. They will complete a survey taking no more than 60 minutes. Parents will then be randomized to either take the class immediately or be in the control group which can take the class in 12 months. At the end of 6 and 12 months all the participants again take the survey.

Classes are 7 weeks in length, 2 hours each and are offered at various locations throughout the Greater Seattle area.

Eligibility criteria: Inclusion Criteria:

* Child 2-11 years of age, with diagnosed chronic illness
* Parent at least 18 years of age, able to speak and read English at 4th grade level and able to attend a 7 week two-hour class program

Exclusion Criteria:

* Child in active hospice treatment

Primary outcomes:
measure: depressive symptoms
timeFrame: 6, and 12 months
Secondary outcomes:
measure: self-efficacy
timeFrame: 6 and 12 months
measure: parent-child shared management
timeFrame: 6, and 12 months
measure: coping
timeFrame: 6, and 12 months
measure: quality of life
timeFrame: 6, and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Gail M Kieckhefer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01252784: Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation
Official title: Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndrome
Keywords: higher risk MDS
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2010-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with higher risk MDS

Brief summary: The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.

Detailed description: Conditioning therapy

* Busulfan 3.2 mg/kg/d on d-7 to -6
* Fludarabine 30 mg/m2 on d-7 to -2
* ATG 1.5-3.0 mg/kg/d on d-3 to -1
* Methylpred 2 mg/kg/d on d-4 to -1

Mobilization and harvest

* Donor
* G-CSF 10 mcg/kg/d s.c. on d-3 to 0
* Harvest of PBMCs on d 0 to +1

Infuse G-PBMCs on d 0 to d+1.

* Donor G-PBMC infusion

GVHD prophylaxis

* Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
* Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Prophylactic dose-escalating DLIs

* Begin at d+120 or at least 2 wks after IST discontinuation.
* No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels

Eligibility criteria: Inclusion Criteria:

1. Patients with higher risk MDS including chronic myelomonocytic leukemia

   * RAEB-1 or RAEB-2
   * IPSS Intermediate-2 or High risk category
   * Chronic myelomonocytic leukemia
2. Patients with appropriate hematopoietic cell donor

   * HLA-matched sibling
   * HLA-matched unrelated donor
   * HLA-mismatched familial donor 3.16 years old or older

Exclusion Criteria:

* • Presence of significant active infection

  * Presence of uncontrolled bleeding
  * Any coexisting major illness or organ failure
  * Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Primary outcomes:
measure: relapse incidence,duration of remission
timeFrame: 4years
Secondary outcomes:
measure: engraftment, donor chimerism, secondary graft failure,GVHD
timeFrame: 4 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Asanbyeongwon-gil, songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Je-Hwan Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00899184: DNA Changes in Patients With Prostate Cancer
Official title: Assessment of SNP Genotypes in Men With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage IV prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 646
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE

Brief summary: RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.

Detailed description: OBJECTIVES:

* Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
* Determine the age of onset of prostate cancer in affected probands and affected siblings.
* Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
* Determine the odds ratio of developing prostate cancer in the presence of SNPs.
* Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.

Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.

PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Patient or sibling diagnosed with prostate cancer
  * Cancer-free participant (healthy control)
* Whole blood sample available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Frequency of single nucleotide polymorphism (SNP) genotypes
timeFrame: 1 month
measure: Age of onset of prostate cancer in patients and their affected siblings
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Kim M. Hirshfield, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00568984: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
Official title: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 3 months
* No previous treatment for diabetes
* HbA1c between 7.0-12.0%
* Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes
* Known unstable/untreated proliferative retinopathy
* Uncontrolled treated/untreated hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

Primary outcomes:
measure: HbA1c
timeFrame: after 16 weeks of treatment
Secondary outcomes:
measure: Glucose profiles
measure: Quality of life assessment
measure: Treatment satisfaction
measure: Hypoglycaemic events
measure: Adverse events
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
state: Tianjin
city: Cheras
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Ipoh
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Cebu City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Manila
country: Philippines
facility: Novo Nordisk Investigational Site
city: Marikina City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Pampanga
country: Philippines
facility: Novo Nordisk Investigational Site
city: Quezon City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Quezon
country: Philippines
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04598984: The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer
Official title: The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer Stage III
Keywords: rectal cancer
neoadjuvant
serum adipokines
leptin
adiponectin
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with locally advanced rectal cancer

Brief summary: It has been shown that adipokines (resistin, leptin, adiponectin) secreted from adipose tissue and proinflammatory cytokines such as IL-6, TNF-a are associated with the risk of developing colorectal cancer. However, the role of these factors in predicting clinical response to neoadjuvant therapy in rectal cancers is unknown. In this study, the role of serum adipokine levels before neoadjuvant therapy in predicting clinical response in patients with rectal cancer is investigated. For this purpose, blood will be drawn from patients with rectal cancer who will receive neoadjuvant therapy, serum adipokines will be studied and clinical response to neoadjuvant therapy will be compared.


Eligibility criteria: Inclusion Criteria:

* All patients with locally advanced rectal cancer

Exclusion Criteria:

* below 18 years old
* patients who did not received neoadjuvant therapyAll

Primary outcomes:
measure: The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
References:
Clinical trial NCT02503384: Clinical and Basic Study for Pediatric Liver Transplantation
Official title: Clinical and Basic Study for Pediatric Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Atresia
Metabolic Disorders
Fulminant Liver Failure
Hepatic Tumors
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric liver transplantation cases

Brief summary: Background: In mainland China, the development of pediatric liver transplantation (LT) has lagged behind that of adult LT during the past two decades, but it has been progressing immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric transplant center in mainland China.

Aim and method: This study is performed for establishment of key techniques for pediatric LT in mainland China, including the indications and timing for pediatric LT, the criteria for donor selections, living donor LT planning, prevention and treatment for posttransplant complications, long-term follow-up management et al.

Detailed description: Outcome measures:

* Annual caseloads of pediatric liver transplantation
* Patient survival: 1-, 3- and 5-year patient survival after liver transplantation
* Graft survival: 1-, 3- and 5-year graft survival after liver transplantation
* Posttransplant complications, such as biliary complications, vascular complications, acute rejections, infections et al.
* Perioperative data, such as duration of operations, postoperative hospital stay et al.
* Clinical data for living donors.

Eligibility criteria: Inclusion Criteria:

* Children with end-stage liver diseases
* Children with metabolic disorders for whom liver transplantation are required
* Children with fulminant liver failure
* Children with unresectable hepatic tumors
* Other miscellaneous conditions which need liver transplantation

Exclusion Criteria:

* Recipient age ≥ 18 years
* Patients with metastatic liver tumors
* Severe systmatic infections
* Acquired Immune Deficiency Syndrome

Primary outcomes:
measure: Patient survival
timeFrame: up to 36 months
measure: Graft survival
timeFrame: up to 36 months
measure: Annual caseload for pediatric liver transplantation
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Qiang Xia, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02222584: The Effects of Physical Activity on Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: inflammatory bowel disease
physical activity
disease activity
quality of life
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to Feburary 2015

Brief summary: Physical activity (PA) is beneficial in the prevention and management of chronic disease. However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the effect of PA on quality of life of patients with IBD.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 19
* patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis, intestinal behcet's disease)

Exclusion Criteria:

* Age \<19
* Patient who denied to response the survey questions
* Patient who denied to enroll the survey research

Primary outcomes:
measure: level of physical activity (PA)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: