louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03029416: Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
Official title: A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Neoplasm Metastasis
Cancer
Radiation Therapy Complication
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 Gy single fraction SBRT 18 Gy x three fractions
Primary purpose: TREATMENT

Brief summary: 30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED \</-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.

Detailed description: Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.

Eligibility criteria: Inclusion Criteria:

* Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
* Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
* Age ≥18 years
* ECOG performance status \>/= 2 (Karnofsky≥60%)).
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with more than \>/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
* Patients who are receiving any other investigational agents.
* Patients with active systemic, pulmonary, or pericardial infection.
* Pregnant or lactating women
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Chemotherapy concurrent with SBRT is not allowed

Primary outcomes:
measure: Local Disease Control Rates
timeFrame: 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ronald McGarry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382316: Making Alcoholics Anonymous Easier
Official title: Making Alcoholics Anonymous Easier: A Group TSF Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Drug Dependence
Keywords: 12-step facilitation
Alcoholics Anonymous
Narcotics Anonymous
AA
Self-help
Lead sponsor: Alcohol Research Group
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was determined by comparing abstinence rates of participants recruited during ON (MAAEZ intervention) and OFF (usual care) conditions and by studying the effect of the number of MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12 months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ session received. MAAEZ appeared especially effective for those with more prior AA exposure, severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an evidence-based intervention that is easily implemented in existing treatment programs.


Eligibility criteria: Inclusion Criteria:

* current alcohol or drug dependence diagnosis

Exclusion Criteria:

* incapacitating mental or physical health; under age 18

Primary outcomes:
measure: Alcohol and drug abstinence
timeFrame: Past 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: Alcohol Research Group
state: California
Study officials:
affiliation: Alcohol Research Group, Public Health Institute
name: Lee A Kaskutas, Dr.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaskutas LA, Subbaraman MS, Witbrodt J, Zemore SE. Effectiveness of Making Alcoholics Anonymous Easier: a group format 12-step facilitation approach. J Subst Abuse Treat. 2009 Oct;37(3):228-39. doi: 10.1016/j.jsat.2009.01.004. Epub 2009 Apr 1.
citation: Subbaraman MS, Kaskutas LA, Zemore S. Sponsorship and service as mediators of the effects of Making Alcoholics Anonymous Easier (MAAEZ), a 12-step facilitation intervention. Drug Alcohol Depend. 2011 Jul 1;116(1-3):117-24. doi: 10.1016/j.drugalcdep.2010.12.008. Epub 2011 Feb 2.
citation: Zemore SE, Kaskutas LA. Development and validation of the Alcoholics Anonymous Intention Measure (AAIM). Drug Alcohol Depend. 2009 Oct 1;104(3):204-11. doi: 10.1016/j.drugalcdep.2009.04.019. Epub 2009 Jul 5.
Clinical trial NCT00892216: Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?
Official title: Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pectus Excavatum
Keywords: PONV
NUSS procedure
Acupressure
Pectus Excavatum
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2009-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can delay hospital discharge and increase cost of stay. In some cases, when severe vomiting occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is considered to be a procedure with a high risk for the outcome of nausea and vomiting.

Detailed description: The rationale is to do a prospective study in patients who have been diagnosed with Pectus Excavatum and who are undergoing a NUSS procedure (pectus excavatum correction) and to evaluate the effect of Acupressure on the post-operative outcome of PONV in these patients. Also, to determine whether there are any secondary outcomes related to pain scores and length of hospital stay.

Eligibility criteria: Inclusion Criteria:

* age 8-40 years old
* ASA 1-3
* males \& females

Exclusion Criteria:

* local infection of the site - P6
* acupuncture treatment within 8 weeks of the preoperative period
* coagulopathy is a contraindication for Acupuncture but not Acupressure

Primary outcomes:
measure: Relief of PONV. This effect will be evaluated in the PACU and then twice a day until discharge which is usually 5 days post-operative. Hospital score for nausea and vomiting will be used.
timeFrame: Twice a day for 5 days
Secondary outcomes:
measure: Possibility of decrease in VAS score and hospital stay when compared to control group.
timeFrame: Day 5
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Hospital, HHSC/Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509716: Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis Chronic Kidney Disease (CKD) Patients
Official title: Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis CKD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease Stage 3
Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 5
Keywords: Predialysis
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Predialysis patients with stage 3-5 chronic kidney disease patients seen in outpatient renal clinic in National University Hospital, Singapore

Brief summary: Aims: The investigators' primary objective is to assess both perceived and actual disease knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators hypothesize that actual disease knowledge is poorer than perceived. As the secondary objectives, the investigators will also assess the HRQoL and examine the association between level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize that HRQoL of pre-dialysis CKD patients is poorer than that of the general population while pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with poorer knowledge.

Methodology: A survey was developed to assess both perceived and actual knowledge on five aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL, the following questionnaires will be used - Kidney Disease Quality of Life-Short Form (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main languages - English, Chinese and Malay. A standardized data collection form was developed to retrospectively collect demographic and clinical information from the patients' electronic medical records and patient charts. Descriptive statistics will be used to report all results.


Eligibility criteria: Inclusion Criteria:

* patients at least 21 years of age,
* able to read English, Chinese or Malay,
* have stage 3 to 5 CKD as identified from their medical records, but are not receiving dialysis.

Exclusion Criteria:

* patients who do not consent,
* have already been started on dialysis,
* are cognitively impaired as assessed by the recruiter or unable to fill up questionnaires on their own.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT01413516: Varenicline In-Patient Study
Official title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Varenicline
Placebo
Inpatient
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-08-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).

Detailed description: The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization.

Eligibility criteria: Inclusion Criteria:

* The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.

Exclusion Criteria:

- Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance \<30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.

Primary outcomes:
measure: 7 Day Point Prevalence Abstinence From All Forms of Tobacco
timeFrame: 4 weeks after beginning study
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Judith J Prochaska, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235116: Predictors of Patient Attitudes and Barriers to Skin Cancer Screening
Official title: Predictors of Patient Attitudes and Barriers to Skin Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Keywords: Number of patients
full body skin exam
Survey
preferences
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English-speaking patients 18yrs old and older attending the UCLA Dermatology clinics in Santa Monica, California or Westwood, California from June 14 to July 1, 2011

Brief summary: This is a cross-sectional survey distributed to a convenience sample of patients in a waiting room of an academic dermatology clinic. The survey assesses patient experiences with full body skin exams and attitudes towards full body skin exams. The survey is designed to help investigators better understand how many patients are not getting full body skin exams, why this may be occurring, and what types of interventions may be enacted to increase the number of patients getting full body skin exams.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* English-speaking

Exclusion Criteria:

* previously completed the survey

Primary outcomes:
measure: Number of patients reporting ever having had a full body skin examination
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Dermatology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Melvin Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06634316: Sarcopenia in Patients With Heart Failure
Official title: Nutritional Management of Sarcopenia in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 60
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: Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure


Eligibility criteria: Inclusion Criteria:

* Patients with a previous admission due to HF in the previous 12 months
* Moderate or severe LVEF
* Both sexs
* Age \>18 years old.

Exclusion Criteria:

* MDRD \<15 ml/min
* End-stage liver disease.

Primary outcomes:
measure: Muscle mass
timeFrame: 6 months
measure: Functionality
timeFrame: 6 months
Secondary outcomes:
measure: Albumin
timeFrame: 6 months
measure: C-RP
timeFrame: 6 months
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: IMIBIC
Study officials:
References:
Clinical trial NCT00504816: A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
Official title: An Open Label, Single-sequence, Repeat-dose Study to Investigate the Effects of GSK189075 on the Pharmacokinetics of an Oral Contraceptive Pill When Coadministered to Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords: healthy female,
pharmacokinetics,
pharmacodynamics
drug interaction,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.


Eligibility criteria: Inclusion Criteria:

* healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
* able to take a specific oral contraceptive \& KG2107494.
* female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
* female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.

Exclusion Criteria:

* pregnant or a nursing female.
* female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
* Have suffered with certain infection within 4 weeks prior to the first dose of study drug

Primary outcomes:
measure: Oral contraceptive pill (OC) drug levels
timeFrame: over 24h starting on Day 14
measure: blood hormone levels
timeFrame: on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone.
Secondary outcomes:
measure: Adverse events
timeFrame: all visits after study drug
measure: ECGs, Clinical laboratory tests
timeFrame: screening & follow-up
measure: vital signs
timeFrame: screening;Day 13, Period 1 & 3; Follow-up
Other outcomes:
Locations:
city: Miramar
country: United States
facility: GSK Investigational Site
state: Florida
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: