louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00518037: Quality of Life in Patients With Nonmelanoma Skin Cancer
Official title: Quality of Life in Patients With Nonmelanoma Skin Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonmelanoma Skin Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nonmelanoma skin cancer patients

Brief summary: The goal of this study is to learn more about the physical discomfort, sensory impairment, depression, anxiety, and interference with relationships, family, and work associated with NMSC via survey questions.

Detailed description: The purpose of this study is to learn more about the physical discomfort, sensory impairment, depression, anxiety, and interference with relationships, family, and work associated with NMSC via survey questions.

Eligibility criteria: Inclusion Criteria:

* patients with nonmelanoma skin cancer
* 18 years of age

Exclusion Criteria:

* non-English speakers
* minors

Primary outcomes:
measure: statistics from results of Skindex survey
timeFrame: 1 hour to complete survey
Secondary outcomes:
measure: statistics from time-tradeoff utility survey
timeFrame: 1 hour to complete survey
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759837: Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
Official title: An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Bosutinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Leukemia, Myeloid, Chronic
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.


Eligibility criteria: Inclusion criteria (for both study populations):

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.

   WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone \[FSH\] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration.
2. Have a high probability for compliance with and completion of the study.

Exclusion criteria (for both study populations):

1. History of clinically important cardiovascular disease.
2. Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death.
3. Presence or history of any disorder that may prevent the successful completion of the study.

Other inclusion and exclusion criteria apply.

Primary outcomes:
measure: Blood samples
timeFrame: 5 weeks
Secondary outcomes:
measure: Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01004237: Additive Effects of Pravastatin and Valsartan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
High Cholesterol
Keywords: insulin resistance
hypertensive
hypercholesterolemic patients
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.


Eligibility criteria: Inclusion Criteria:

* Hypertension and low-density lipoprotein cholesterol levels \>100

Exclusion Criteria:

* Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Primary outcomes:
measure: flow-mediated dilation
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: insulin resistance
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
citation: Koh KK, Lim S, Choi H, Lee Y, Han SH, Lee K, Oh PC, Sakuma I, Shin EK, Quon MJ. Combination pravastatin and valsartan treatment has additive beneficial effects to simultaneously improve both metabolic and cardiovascular phenotypes beyond that of monotherapy with either drug in patients with primary hypercholesterolemia. Diabetes. 2013 Oct;62(10):3547-52. doi: 10.2337/db13-0566. Epub 2013 Jul 17.
Clinical trial NCT00258037: Effect of Pelvic Floor Muscle Training in Stroke
Official title: Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Urinary Incontinence
Keywords: Physiotherapy
Stroke
Urinary Incontinence
quality of Life
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2005-11-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.


Eligibility criteria: Inclusion Criteria:

* Female stroke patients
* one month since stroke
* UI in close relation to the stroke
* normal cognitive level
* independent walking indoor ability \> 100 m
* independence in toilet visit

Exclusion Criteria:

* urinary ineffections
* vaginal prolabs
* qronical lung disease
* psychiatric diseases
* other neurological diseases
* do not speak Danish

Primary outcomes:
measure: Quality of Life parameters (SF-36, IIQ)
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Copenhagen University Hospital, Glostrup
Study officials:
affiliation: Copenhagen University Hospital, Glostrup
name: Sigrid G Tibaek, MSc., Pt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31.
citation: Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134.
citation: Tibaek S, Gard G, Jensen R. Is there a long-lasting effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A 6-month follow-up study. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):281-7. doi: 10.1007/s00192-006-0137-3. Epub 2006 Jun 28.
Clinical trial NCT04654637: Multiple Interactive With Nutrition and Exercise Strategies in Frailty Cancer Patients
Official title: Department of Nursing, Tzu Chi University, Hualien, Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Tzu Chi University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Arm A: fix model of cycle exercise(online supervise) and routine nutrition consult Arm B: fix model of cycle exercise(online supervise) and online nutrition consult Arm C: individualize cycle exercise(online supervise) and routine nutrition consult Arm D: individualize cycle exercise(online supervise) and online nutrition consult
Primary purpose: PREVENTION

Brief summary: Due to the changes in lifestyle caused by the COVID-19, it is a priority to provide multi-interactive digital platforms and social media for nutrition and exercise programs for cancer patients. A two-year serial program uses mixed study methods of longitudinal combined experimental study. We will investigate cancer frailty's current situation and track the frailty trends after cancer patients received different treatments. We will also invite experts to develop multi-interactive digital platforms of nutrition and performance-based tailored circuit training programs according to the cancer frailty survey. We will recruit 20-85 years of newly diagnosed or first-time recurrence cancer patients and stratified randomization assigned to evaluate nutrition and physical exercise intervention effectiveness. The measure indicators were treatment-related adverse events, nutritional status, frailty status, survival rate, and life quality.


Eligibility criteria: Inclusion Criteria:

* Aged from 20-85 years with histological confirmation malignancy.
* Requiring treatment by surgery, chemotherapy, hormonotherapy, radiotherapy, or targeted therapy with a curative intention as estimated by oncologists.
* First diagnosed or recurrence of head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma.

Exclusion Criteria:

* Non-head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma with first diagnosis or recurrence patients.
* Eastern Cooperative Oncology Group test score\>2.
* Serious psychiatric or cognitive problems, and functional disability leading to a total inability to walk.

Primary outcomes:
measure: Frailty trend
timeFrame: After treatment three-month
Secondary outcomes:
measure: Treatment-related adverse events
timeFrame: After treatment one month
Other outcomes:
measure: Survival
timeFrame: The OS was calculated from the date of diagnosis to the date of death or was censored at the date of the last follow-up (3 years from diagnosed) for surviving patients.
Locations:
city: Hualien City
country: Taiwan
facility: Tzu Chi University
Study officials:
References:
Clinical trial NCT05864937: C677T Methylenetetrahydrofolate Reductase Mutation
Official title: Comparison of Two Preventive Treatments for Patients With Recurrent Miscarriages Carrying a C677T Methylenetetrahydrofolate Reductase Mutation: 5-year Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mutation
Keywords: recurrent miscarriages
aspirin
folic acid
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 363
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with three or more consecutive first-trimester miscarriages who were carrying the C677T MTHFR gene mutation and were treated and followed-up by the Department of Obstetrics, Gynaecology and Reproductive Medicine, Amiens University Medical Centre, Amiens, France between January 2006 and December 2011.

Brief summary: To investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (RM) who carry a methylenetetrahydrofolate reductase (MTHFR) gene mutation.

In this longitudinal retrospective study, patients with RM were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). An age-matched group of triparous women without RM or thrombophilia was used as the control group (group 3).

Detailed description: Recurrent miscarriage (RM) is defined as three or more consecutive spontaneous fetal losses and it affects 0.3% to 1% of pregnancies.To investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (RM) who carry a methylenetetrahydrofolate reductase (MTHFR) gene mutation.

In this longitudinal retrospective study, patients with RM were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). An age-matched group of triparous women without RM or thrombophilia was used as the control group (group 3).

Eligibility criteria: Inclusion Criteria:

* patients with three or more consecutive first-trimester miscarriage
* Three or more consecutive first-trimester miscatrriages
* C677T MTHFR gene mutation

Exclusion Criteria:

* Patients with the A1298C polymorphism

Primary outcomes:
measure: number of miscarriages
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Moncef Ben Khlifa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01129037: Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
Official title: Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Oncology
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients.

Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Signed informed consent

Exclusion Criteria:

* History CHF
* Severe valvular heart defects, intra cardiac shunts
* Irregular heart rhythm
* Allergy to hydroxyethyl starch solutions
* Coagulation abnormalities (INR\>1.5, aPTT\>40s, platelet count\<100x10 9/L
* History of severe bleeding disorders
* Renal insufficiency with creatinine \>200Umol/L
* Pregnant of nursing women
* History of skin disorders that are accompanied by chronic puritis

Primary outcomes:
measure: The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
timeFrame: Initiation of surgery to end of surgery on average 8-10 hours
Secondary outcomes:
measure: Incidence of major complication and LOS
timeFrame: Post operative day 0 to hospital discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, UHN
state: Ontario
Study officials:
affiliation: Toronto General Hospital, UHN
name: Leonid Minkovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02145637: Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NSCLC
Keywords: Cancer, Lung cancer, Head and neck squamous cell carcinoma, Afatinib, Ruxolitinib, EGFR, JAK, STAT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.


Eligibility criteria: Inclusion Criteria:

1. Stage 4 NSCLC patients
2. disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
3. Men and women aged 20 years or older
4. Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
5. ECOG 0 or 1
6. able to orally take and retain drug
7. have a measurable or unmeasurable lesion under RECIST 1.1 Criteria
8. have proper hematological, renal, and hepatic functions
9. intention to use an acceptable contraception
10. able to read and understand the informed consent form

Exclusion Criteria:

1. previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
2. Clinically significant gastrointestinal disorder or malabsorption syndrome
3. Acute digestive disorder
4. major organ failure
5. Significant cardiac disorders
6. major operation of a main organ in 4 weeks
7. Untreated symptomatic brain metastasis
8. pregnant or nursing
9. previously diagnosed Interstitial lung disease(ILD)
10. previously treated with irreversible pan-HER inhibitor including Afatinib or Ruxolitinib
11. previously experienced hypersensitivity to an ingredient of the study drug
12. must receive CYP3A4 inducer or inhibitor persistently during the study period.
13. HIV positive or active hepatitis
14. threatening patient's safety is predicted

Primary outcomes:
measure: To set a recommended phase II dose (RP2D)
timeFrame: 36 days
Secondary outcomes:
measure: Safety and tolerability (dose relating toxicity; DLT)
timeFrame: 1year
measure: Overall response rate (ORR)
timeFrame: 1year
measure: Progression free survival (PFS)
timeFrame: 1year
measure: Overall survival (OS)
timeFrame: 1year
measure: Pharmacodynamic biomarker
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
References:
citation: Park JS, Hong MH, Chun YJ, Kim HR, Cho BC. A phase Ib study of the combination of afatinib and ruxolitinib in EGFR mutant NSCLC with progression on EGFR-TKIs. Lung Cancer. 2019 Aug;134:46-51. doi: 10.1016/j.lungcan.2019.05.030. Epub 2019 May 28.
Clinical trial NCT03552237: Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients
Official title: The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Central Obesity
Lead sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background There has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. It has been reported that the proportions of Firmicutes and Bacteroidetes differ between obese and normal weight human subjects. Human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. However, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. Importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. Human intestinal microbiota compositions related with obesity may impact the heath of this population. Therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity.

Method We will investigate in a 4-week intervention whether consumption of dietary fiber supplement(Inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. Fecal samples from participants before and after the intervention will be processed for the microbiota analysis.


Eligibility criteria: Inclusion Criteria:

1. Schizophrenia inpatients
2. Overweight and with central obesity
3. agree to sign informed consent

Exclusion Criteria:

1. Diagnosis of IBS
2. Systemic antibiotic use during the past 4 weeks
3. Excessive water intake

Primary outcomes:
measure: Changes from baseline in microbiota composition at week 4
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: