louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01312337: Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
Official title: A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nonsmall Cell Lung Cancer
Keywords: gefitinib
EGFR mutation negative
NSCLC
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.


Eligibility criteria: Inclusion Criteria:

* Pathologically proven NSCLC
* Ineligibile for curative treatment (namely, stage IIIb or IV)
* History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
* At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
* 18 years old or older
* Performance status ECOG 0-2
* Adequate organ function as evidenced by the following:

  * Absolute neutrophil count \> 1.0 x 109/L
  * Platelets \> 75 x 109/L
  * Total bilirubin ≤ 1.5 UNL
  * AST and/or ALT \< 5 UNL
  * Creatinine clearance ≥ 45mL/min

Exclusion Criteria:

* Previous EGFR TKI therapy history
* Systemic anticancer therapy within the previous 3 weeks
* Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
* Other concurrent illness that would preclude study participation (severe heart disease)
* Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
* Pregnant or nursing

Primary outcomes:
measure: To determine disease control rate at 8 weeks will be 35% or higher in the the study group
timeFrame: 6 months after the enrollment of the last patients
Secondary outcomes:
measure: The number of patients who live longer than 6 months after enrollment
timeFrame: 6 months after the enrollment of the last patients
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05131737: Exercise Endurance Time on the 2nd Day at 2500 m High Altitude
Official title: The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension

Detailed description: Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed

Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: cycle constant work-rate exercise test
timeFrame: 30 hours
Secondary outcomes:
measure: Heart rate
timeFrame: 30 hours
measure: Ventilation in liters per minute
timeFrame: 30 hours
measure: Oxygen uptake
timeFrame: 30 hours
measure: Oxygen saturation
timeFrame: 30 hours
measure: Partial pressure or oxygen
timeFrame: 30 hours
measure: Tricuspid pressure gradient
timeFrame: 30 hours
measure: Borg dyspnoea scale
timeFrame: 30 hours
measure: Visual analogue scale
timeFrame: 30 hours
measure: sit-to-stand test frequency
timeFrame: 30 hours
measure: 6 minute walk test
timeFrame: 30 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
References:
Clinical trial NCT05149937: Development and Testing of an Interprofessional, Person-centered Care Concept for People Living at Home With Care Needs.
Official title: Development and Testing of an Interprofessional, Person-centered Care Concept for People Living at Home With Care Needs.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs
Keywords: interprofessional collaboration
reduction of hospitalisation
people living at home with care needs
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 0
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: The aim of the project is to develop and pilot measures to optimize the person-centered cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs, so that hospital admissions and the use of unplanned medical and rescue services are avoided, the quality of life is improved and a deterioration in the need for long-term care can be stopped.

This is done by developing an interprofessional person-centered collaboration-concept, perform an explorative mixed-methods-study: interviews, focus groups, expert workshops, survey of best practices, shadowing, questionnaires.

Detailed description: Description of mixed-methods-study:

1. Interviews with

   * 20 patients,
   * 20 relatives,
   * 5 experts of health insurance professionals,
   * and 3 focus groups à 8 persons with general practioniers, nurses, therapists.
2. investigation of best practice cases
3. explorative survey of 100 cases in each group:

   * general practitioner
   * nursing services
   * therapists
   * persons in need of care
   * family members of persons in need of care

The mixed-methods-study is analysed in different ways:

* structured content analysis
* case-based qualitative analysis of interviews
* descriptive analysis

The mixed-methods-study has been approved by the ethics committee and is recruiting.

Eligibility criteria: Inclusion Criteria:

* years of age \>18
* receipt of benefits in the form of outpatient care according to SGB XI,
* preliminary / final classification of care ≥level 2
* expected life expectancy \>6 months
* informed consent
* sufficient opportunity to answer answering questions about patient-reported outcomes

Exclusion Criteria:

* Living in nursing home / planned move-in within the following 6 months
* claim acceptance of SAPV
* participation in scientific study

Primary outcomes:
measure: cumulative number of hospitalisation
timeFrame: 40 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01871337: Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS)
Official title: A Clinical Trial for the Efficacy of Paula Method ( Circular Muscle Exercise) in Women With Multiple Sclerosis Who Suffer From Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence;
Multiple Sclerosis
Keywords: Multiple Sclerosis
urinary incontinence
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 12
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 will examine whether the Paula method is an effective treatment for UI and the correlating LUTD symptoms. We assume that the Paula method, a simple, non-aerobic exercise method that significantly decreased urinary incontinence in women with MIX in two randomized controlled trials, would also be effective in Multiple Sclerosis (MS) patients with UI. The secondary aim is to evaluate the effectiveness in terms of MS general physical functioning, quality of life and sexual function and to detect adherence and continuity six months post intervention.

Detailed description: The patient will be examined by the neurologist at the MS clinic, at the Hadassah University Medical Center. Patients who meet the inclusion criteria will receive an explanation, and will sign informed consent. She will be asked to complete the baseline questionnaires. Than the patient will be assigned to an exercise group. After 12 weeks the patient will be asked to complete post intervention questionnaire. Apart from the weekly lesson, women will be asked to exercise at home for 15 minutes a day. After six months she will be invited again for a neurological examination and filling an additional questionnaire.

Eligibility criteria: Inclusion Criteria:

women ≥18 years old; who have complained of urine leakage in the past four weeks; MS diagnosed with an Expanded Disability Status Scale (EDSS)≤7.5; literate in Hebrew and/or English; suffering from UI at least in the 4 last weeks prior to recruitment

Exclusion Criteria:

pregnant or breastfeeding women, those within 12 weeks of delivery; 6 weeks of abortion; six months of pelvic surgery; symptomatic urinary tract infection (UTI); more than grade 2 genital prolapse, permanent catheterization for urination; women taking medications for UI less then 3 months and women who exercise on regular basis in Paula method.

Primary outcomes:
measure: Urinary Incontinence ,measured by The ICIQ-SF Short Form questionnaire
timeFrame: two years
Secondary outcomes:
measure: quality of life, sexual function and mobility
timeFrame: two years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Jerusalem
country: Israel
facility: Hadassah Hospital
Study officials:
affiliation: Hadassah University Hospital
name: Adi Vaknin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05048537: 18F-FACBC PET/CT and the PSA Kinetics for PCa Patients With Biochemical Recurrence.
Official title: The Correlation Between the Detection Rate of 18F-FACBC PET/CT and the PSA Kinetics for Prostate Cancer Patients With Biochemical Recurrence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biochemical Relapse Fo Malignant Neoplasm of Prostate
Keywords: Prostate cancer
18F-FACBC
Biochemical recurrence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate cancer (PCa) is the fifth-most common cancer for male with a seventh highest cancer-related death in Taiwan. Currently, the incidence and mortality rate are still increasing rapidly. The treatment decision planning is made up by clinical charts like Gleason score (GS), TNM stage and serum prostate-specific antigen (PSA) level. However, after definitive therapy for PCa with either external beam radiotherapy (EBRT) or radical prostatectomy (RP), up to half patients experience biochemical recurrence (BCR). Although not all patients with BCR proceed to develop disease progression, it is important to identify early lesion to initiate salvage treatment.

Anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (18F-FACBC) positron emission tomography (PET) is a imaging marker for L-amino acid transport evaluation. Many cancers including PCa have up-regulated amino acid transport tied to their proliferative potential. Recently, 18F-FACBC was included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of recurrent PCa patients. As we know, PSA level and PSA kinetics are valuable for the prediction of recurrence. The objective of this study is to investigate the correlation between the detection rate of 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.


Eligibility criteria: Inclusion criteria:

* PCa patients with BCR
* Serum PSA data and pathologic report
* Agreement consent

Exclusion criteria:

* Claustrophobia and unstable vital signs
* Disagreement

Primary outcomes:
measure: The detection rate of 18F-FACBC PET/CT
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Hsien Chou, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02677337: NCCN Renal Cell Registry
Official title: Novel Educational Interventions for Community Oncologists & Patients: Optimizing Renal Cell Carcinoma Outcomes Through Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will consist of three parts: 1) a retrospective chart review of patients treated for mRCC from July 2013 until the start of the educational intervention; 2) an educational program for DCN community oncology providers and DCN community patients with mRCC, lasting 8 - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting at the time of the educational intervention until the intervention is completed.

Detailed description: The initial retrospective cohort will serve as the pre-education control, and the second cohort will be the experimental group to assess the efficacy of the educational intervention to change care of patients with mRCC.

Chart Reviews. This study will begin with a multi-site chart review conducted at the Duke Cancer Network affiliated sites. The chart review will begin in late fall, 2015. The Duke Cancer Network team will perform chart abstraction for this study, with a goal of reviewing at least 60 charts of patients treated between July 2013 and October 2015.

The second data collection period will collect data on patients with mRCC seen at DCN sites after the date in fall 2015 when the educational intervention is rolled out. The target will again be at least 60 charts of patients treated during the time the educational intervention is actively available.

Eligibility criteria: Inclusion Criteria:

* Oncology providers (physicians, nurse practitioners, physicians' assistants) at DCN affiliated sites will be invited to use the performance support system and participate in the online virtual tumor boards for CME credit.

Exclusion Criteria:

* Non DCN affiliated sites providers

Primary outcomes:
measure: Assignment of patient to appropriate firstline treatment based on Heng Risk criterion
timeFrame: eight to ten months
Secondary outcomes:
measure: Percentage of increase in duration of treatment with appropriate first line therapy
timeFrame: eight to ten months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa Criscione-Schreiber
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948337: A Study With Health Educational Material on Health Promotion in Cancer Survivors
Official title: A Randomized Controlled Trial on the Effect of Intervention With Health Educational Material on Knowledge, Attitude, and Behavior in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Cancer
Colon Cancer
Thyroid Cancer
Breast Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2009-07-29
Enrollment: 326
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to provide educational material to promote screening for second primary cancer for the intervention group, or educational material to instruct appropriate use of dietary supplement for the control group.


Eligibility criteria: Inclusion Criteria:

* Age \>=18, \<80
* Cancer survivors (pathologically confirmed)
* Finished primary treatment (surgery, radiotherapy, chemotherapy)
* \>= 1 year from cancer diagnosis
* No evidence of recurrence, metastasis, and second primary cancer
* No evidence of hereditary cancer
* ECOG 0,1,2
* Ability in reading Korean educational material

Exclusion Criteria:

* ECOG 3,4
* Disagree with the investigators study purpose

Primary outcomes:
measure: Screening behavior for second primary cancer
timeFrame: After 1 yr
Secondary outcomes:
measure: Knowledge and attitudes of Secondary cancer screening and dietary supplement
timeFrame: In 2 weeks
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Shin DW, Cho J, Kim YW, Oh JH, Kim SW, Chung KW, Lee WY, Lee JE, Guallar E, Lee WC. Efficacy of an educational material on second primary cancer screening practice for cancer survivors: a randomized controlled trial. PLoS One. 2012;7(3):e33238. doi: 10.1371/journal.pone.0033238. Epub 2012 Mar 29.
Clinical trial NCT01669837: An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias
Official title: Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
Laparoscopy
Surgical tissue glue
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a primary inguinal hernia

Brief summary: Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.


Eligibility criteria: Inclusion Criteria:

* Patient is older than 18 years.
* Written informed consent is obtained from patient.
* Patient is able to complete the EQ-5D questionnaire.
* Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).

Exclusion Criteria:

* Patient has a recurrent inguinal hernia.
* Patient is treated using the Lichtenstein technique.
* Mesh fixation with sutures, tacks, absorbable tacks or clips.
* Patient is allergic to components of surgical tissue glue (Ifbond™).
* Patient has a life expectancy of less than 1 year.

Primary outcomes:
measure: Postoperative pain
timeFrame: up to 1 year
Secondary outcomes:
measure: Intraoperative complications
timeFrame: 1 day
measure: Postoperative complications
timeFrame: Up to 30 days after index-procedure
measure: Analgesic intake
timeFrame: Discharge, 5 weeks
measure: Quality of life (QOL)
timeFrame: Preoperative, 5 weeks, 1 year
measure: Freedom from hernia-related reinterventions
timeFrame: 1 year
measure: Late complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Kurt Van der Speeten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056637: Choice of Modality of Follow up for Medication Abortion
Official title: Choice of Modality of Follow up for Medication Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abortion in First Trimester
Keywords: MLPT
multi-level pregnancy test
medication abortion
first trimester abortion
abortion follow-up
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Gynuity Health Projects
First posted: 2019-08-14
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.

This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.


Eligibility criteria: Inclusion Criteria:

* Eligible for medication abortion \<63 days gestational age
* In general good health
* English or Spanish speaking competency
* Willing and able to sign consent forms

Exclusion Criteria:

* Clients less than 18 years of age.
* Any client not meeting the inclusion criteria listed above will be excluded from participating in the trial.

Primary outcomes:
measure: Percent follow-up after medication abortion by group
timeFrame: 5-14 days following mifepristone administration
Secondary outcomes:
measure: Percent follow-up after medication abortion by follow-up type
timeFrame: 5-14 days following mifepristone administration
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT04969237: Vitamine D in Post-COVID Patients
Official title: Vitamine D in Post-COVID Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post COVID
Lead sponsor: Klinikum Emden
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects and patients with post-COVID

Brief summary: In this study routineously collected vitamine D values will compared to healthy cohorts from this year and previous years.


Eligibility criteria: Inclusion Criteria:

* patients with or without post-COVID-Syndrome

Exclusion Criteria:

* substitution of vitamine D
* diseases influencing vitamine D level

Primary outcomes:
measure: vitamin D values between the groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Emden
country: Germany
facility: Klinikum Emden
Study officials:
References: