louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03233971: How do Older Adults and Caregivers Feel About Their Medications?
Official title: Patients' and Caregivers' Attitudes Towards Deprescribing in the Asian Community Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deprescribing
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Guardian
name: NTUC Unity
name: Watsons
name: Kwong Wai Shiu Hospital
name: Ang Mo Kio - Thye Hua Kwan Hospital
name: Khoo Teck Puat Hospital
name: National University Hospital, Singapore
name: Singapore General Hospital
name: Tan Tock Seng Hospital
name: National Healthcare Group Pharmacy
First posted: 2017-07-31
Enrollment: 1057
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be selected by convenient sampling from walk-in patients/caregivers who present at the participating pharmacies seeking advice or medication.

Brief summary: The aim of this study is to study patients' and caregivers' perspectives towards deprescribing using the Revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.


Eligibility criteria: Inclusion Criteria:

* Older adults' inclusion criteria:

  * age at least 65 years;
  * taking one or more long-term prescription medication;
  * have not participated in this anonymous questionnaire previously
* Caregivers' inclusion criteria:

  * currently an informal caregiver for an older adult (defined as having any role in a family member or friend's management of health and/or medications);
  * care recipient must be at least 65 years of age and taking one or more long-term prescription medication;
  * have not participated in this anonymous questionnaire previously

Exclusion Criteria:

* Older adults' exclusion criteria:

  * inability to complete a questionnaire in English.
* Caregivers' exclusion criteria:

  * caregiver's age less than 21 years;
  * caregiver's inability to complete a questionnaire in English.

Primary outcomes:
measure: rPATD questionnaire scorings
timeFrame: up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Multi-centres
Study officials:
References:
Clinical trial NCT03721471: Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
Official title: Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Surgery--Complications
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 144
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 80 years admitted for elective major abdominal surgery at Haukeland University Hospital, Bergen, Norway.

Brief summary: The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.

Detailed description: Patients ≥ 80 years admitted for elective major abdominal surgery will be asked to participate in this study where frailty will be scored using the Clinical Frailty Scale and by measuring hand-grip-strength.

Primary outcome is mortality at 30 days, 90 days and 1 year.

Eligibility criteria: Inclusion Criteria:

* age 80 years or above
* elective abdominal surgery
* informed consent

Exclusion Criteria:

* age less than 80 years
* emergency surgery
* palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)

Primary outcomes:
measure: Time to death
timeFrame: Up to one year
Secondary outcomes:
measure: Postoperative complications
timeFrame: Up to 90 days after surgery
measure: Discharge to institution
timeFrame: Up to 90 days after surgery
measure: Worsening functional status
timeFrame: 1 year postoperatively.
measure: Mortality at 30 days
timeFrame: 30 days after surgery
measure: Mortality at 90 days
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Ib Jammer, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088971: Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Lead sponsor: Cell Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.


Eligibility criteria: Inclusion Criteria:

* age: 18\~65 years
* diarrhea type irritable bowel syndrome (by ROME III criteria)
* no organic bowel disease (by colonoscopy or barium enema)

Exclusion Criteria:

* pregnant women or nursing mothers
* hypersensitivity to probiotics
* congestive heart failure or ischemic heart disease
* systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
* uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
* abdominal surgery (exception: appendectomy, hernia surgery)
* more than moderate alcohol drinking

Primary outcomes:
measure: The improvement of IBS symptoms
timeFrame: 6 weeks (symptom diary and weekly questionnaire)
Secondary outcomes:
measure: Changes in fecal microflora
timeFrame: baseline and after 6weeks
measure: Changes of biochemical marker
timeFrame: baseline and after 6weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT04090671: Evaluation of the Multidimensional Dyspnea Profile (MDP)
Official title: Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD Exacerbation
CHF
OSA
COPD
Keywords: Dyspnoea
MDP
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter prospective cohort study
Primary purpose: DIAGNOSTIC

Brief summary: Aim of this multicenter prospective cohort study is the evaluation of the multidimensional qualities of dyspnea in a number of diseases using the Multidimensional Dyspnea Profile (Banzett et al, ERJ 2015).

Detailed description: The study sites will examine patients with COPD (Chronic obstructive pulmonary disease) in state of acute exacerbation and in stable state, patients with congestive heart failure (CHF) in state of acute decompensated cardiac insufficiency, and patients newly diagnosed with obstructive sleep apnea (OSA) as a control group.

In the acute setting of COPD and CHF, the questionnaire will be given at the day of hospital admission and at the day of discharge. The patients will additionally fill the Severe Respiratory Insufficiency (SRI) Questionnaire (in COPD) or the Physical Activity Questionnaire 50+ (in CHF).

In stable state of COPD, the questionnaires will be given once during a routine control visit at the hospital or the medical practice.

In OSA, the questionnaire will be given once during the first visit in the sleep laboratory.

Eligibility criteria: Inclusion Criteria:

* COPD patients with acute exacerbation (Group I)
* CHF patients with acute decompensation (group II)
* stable COPD patients (group III)
* OSA patients with AHI\>15 (group IV)

Exclusion Criteria:

* Other severe acute diseases that contradict the participation in a clinical trial
* Simultaneous participation in another clinical trial
* Not capable of giving consent
* Language abilities and other disabilities that contradicts the understanding or completing of a clinical questionnaire

Primary outcomes:
measure: MDP scores during hospital stay
timeFrame: day 1 to day 5
Secondary outcomes:
measure: comparison of MDP scores with clinical data
timeFrame: 1 to 5 (+- 3) days
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
state: NRW
city: Hagen
country: Germany
facility: Helios Klinik Hagen Ambrock
state: NRW
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid
state: NRW
city: Menden
country: Germany
facility: Praxis Dr. med V. Jansen
state: NRW
Study officials:
affiliation: KEM Kliniken Essen-Mitte
name: Georg Nilius, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02281071: Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
Official title: Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Mucogingival Surgery
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects.

Six months results of this study showed that LMCAF with microsurgical approach offered better complete and mean root coverage results over macrosurgical LMCAF technique. The superior effect of microsurgical approach on post-operative morbidity can make this technique more preferable for the patients who expected comfortable postoperative period.

This study supports that using the microsurgical aproach with LMCAF procedure significantly affects the clinical and patient-centered success of treating Miller Class III isolated typed defects.


Eligibility criteria: Inclusion Criteria:

* Presence of Miller Class III isolated gingival recessions located at upper and lower incisors and canines (Miller 1985)
* Presence of identifiable cementoenamel junction (CEJ)
* Presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ
* Lateral keratinized tissue width at least 6 mm greater than the width of the recession measured at the level of the cemento-enamel junction (CEJ)
* Lateral keratinized tissue height at least 2 mm greater than the buccal probing depth of the adjacent tooth/teeth
* Full-mouth plaque score and full-mouth bleeding score of \< 15% (four sites/tooth) -No occlusal interferences; all patients were nonsmokers

Exclusion Criteria:

* Tooth with a prosthetic crown or restoration involving CEJ
* Patients with a history of destructive periodontal disease (o zaman class 3 nasıl oluştu demiş adam) or repeated abscess formation
* Presence of systemic disease or taking medications known to interfere with periodontal tissue health or healing (patients with insulin-dependent diabetes
* History of malignancy, radiotherapy, or chemotherapy for malignancy
* Disease affecting connective tissue metabolism)
* Patient pregnant or nursing during the past 5 months
* Patients who participated in a clinical trial within the past 6 months

Primary outcomes:
measure: the percentage of root coverage
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT03045471: The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
Official title: The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2017-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AIDS associated CD20+ diffuse large B lymphoma

Brief summary: 1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma.


Eligibility criteria: Inclusion Criteria:

1. male or female aged 18-60 years old;
2. Confirmed as AIDS patients and treated with HAART;
3. Confirmed as CD20+ diffuse large B lymphoma;
4. Serum test; negative for HBV, HCV and syphilis;
5. Hematology: Absolute neutrophil count greater than or equal to 1000/mm(3); Platelet count greater than or equal to 50,000/mm(3); Hemoglobin greater than 8.0 g/dl; Lymphocyte count less than or equal to 4,000/mm(3);
6. Chemistry: Serum ALT/AST less or equal to 5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl;
7. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram;
8. Negative pregnancy test for female;
9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment;
10. To be able to understand and sign the Informed Consent Document with legal force.

Exclusion Criteria:

1. With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;
2. Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;
3. Women with pregnant or breastfeeding;
4. Any form of primary immunodeficiency;
5. Concurrent Systemic steroid therapy;
6. History of severe immediate hypersensitivity reaction to any of the agents used in this study;
7. History of allogeneic stem cell transplantation.

Primary outcomes:
measure: progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: complete response rate
timeFrame: 3 years
measure: partial response partial response rate
timeFrame: 3 years
measure: overall response
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01300871: Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer
Official title: Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that attend Medical Oncology Breast Clinics at Princess Margaret Hospital.

Brief summary: This is a study to determine the prevalence and severity of alopecia (hair loss) experienced by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen, Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Diagnosed with hormone-receptor positive breast cancer
* Commenced adjuvant endocrine therapy ≥ 3 months ago, specifically Tamoxifen, Anastrozole, Exemestane, and/or Letrozole
* Good command of the English language
* Under the care of a medical oncologist at Princess Margaret Hospital

Exclusion Criteria:

* Previously received chemotherapy
* Recurrent and/or metastatic disease
* History of endocrine, dermatology, or immune system disorders known to alter hair growth (ie. Hypothyroidism and iron deficiency)

Primary outcomes:
measure: Severity of Alopecia Tool (SALT)
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of Tamoxifen, AI or Tamoxifen plus AI
timeFrame: 1 year
measure: Severity of Alopecia Tool (SALT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network-Princess Margaret Hospital
name: Lindsay Carlsson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00028171: Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing
Official title: Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-12-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Tacrolimus is a medication given to transplant patients to help prevent rejection. The purpose of this study is to see if tacrolimus can be taken once a day instead of twice a day in kidney transplant patients.

Transplant patients are required to take several medications to prevent rejection and to treat complications after their transplantation. Because of the complicated dosing schedule, it can be difficult for patients to follow their medication schedule. Taking fewer medications less frequently may help transplant patients to better manage their drug therapy.

Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken in the evening. This suggests that tacrolimus can be taken once every morning instead of twice daily in order to produce appropriate drug exposure to prevent organ rejection without increased side effects.


Eligibility criteria: Inclusion Criteria: 1) Kidney transplant recipients (18 years or older) at Washington University/Barnes Hospital taking tacrolimus-based immunosuppression; 2) Stable kidney transplant recipients (\>6 months post-transplantation, serum creatinine \< 2 ml/dL, no history of rejection); 3) Stable immunosuppression (therapeutic tacrolimus concentrations, no change in tacrolimus dose within one month prior to the study); 4) Subjects must agree to abstain from alcohol and caffeine for 48 hours prior to the pharmacokinetics studies.

Exclusion Criteria: 1) Pregnant women or nursing mothers; 2) Patients unwilling or unable to comply with the protocol; 3) Significant liver impairment (AST or ALT \> 2 x upper limit of normal, or total bilirubin \> upper limit of normal); 4) Anemia: Hematocrit \< 30%; 5) Use of concomitant P450 3A4/p-glycoprotein inducers or inhibitors; 6) Current smoking; 7) Patients with diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University/Barnes Jewish Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT03079271: An Open Label Comparing the Short Term Efficacy of Lacrisert
Official title: An Open Label Comparing the Short Term Efficacy of Lacrisert
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Virginia Eye Consultants
Sponsor class: OTHER
First posted: 2017-03-14
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: SUPPORTIVE_CARE

Brief summary: To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

-Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of \>6

Exclusion Criteria:

* Concurrent involvement in any other clinical trial
* Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
* Active ocular infection, uveitis or non-KCS inflammation
* History of recurrent herpes keratitis or active disease within the last six months
* Topical ophthalmic medications during the study
* Temporary collagen punctal plugs within one week prior to study.

Primary outcomes:
measure: Dry Eye disease measured by OSDI questionnaire
timeFrame: 10 days
measure: Dry eye disease measured by Corneal Staining
timeFrame: 10 days
measure: Dry eye disease measured by topographic results
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: