louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00169182: Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Official title: Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Larynx Cancer
Hypopharynx Cancer
Keywords: Larynx cancer
Hypopharynx cancer
Chemotherapy
Randomized trial
Larynx preservation
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.

Detailed description: The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.

Eligibility criteria: Inclusion Criteria:

* T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy
* Biopsy proven carcinoma
* Adequate biology
* Performance status 0 or 1

Exclusion Criteria:

* Larynx or hypopharynx tumors that could be treated with partial laryngectomy
* Distant metastasis
* Prior surgery, chemotherapy or radiation
* Intercurrent disease that is a contra indication to chemotherapy

Primary outcomes:
measure: 3-years larynx preservation rate
Secondary outcomes:
measure: 5-years survival rate
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
affiliation: CHU Bretonneau
name: Gilles Calais, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01062282: Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
Official title: VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary hypertension in Korea

Brief summary: The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.


Eligibility criteria: Inclusion Criteria:

* The treating physician has chosen Ventavis as a suitable treatment for the patient
* Patient with PH and classified as NYHA functional class III or IV and WHO group 1

Exclusion Criteria:

* Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).

Primary outcomes:
measure: The primary efficacy variable is 6-minute walking distance
timeFrame: At baseline and month 1,3,6 for an observational period of 6 months
Secondary outcomes:
measure: New York Heart Association functional class
timeFrame: Baseline, month 1,3,6
measure: PH-related symptoms and change of concomitant medication
timeFrame: Baseline, month 1,3,6
measure: Hemodynamic parameters
timeFrame: If applicable ( at any time during Ventavis treatment)
measure: Adverse Event collection
timeFrame: If applicable (during the study period)
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04050982: Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
Official title: Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Text Messaging
Patient Education
Psychometric
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: PatientBond
First posted: 2019-08-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).

The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.


Eligibility criteria: Inclusion Criteria:

1. BMI \> 28 kg/m2 AND one additional CVRF using LS7
2. Access and willingness to engage in digital technology
3. Has a valid email address and a cell phone number
4. Able to ambulate
5. Able to speak/read English

Exclusion Criteria:

1. Class III/IV heart failure
2. MI or cardiac surgery in prior 3 months
3. Severe renal/hepatic disease
4. Active malignancy
5. Current/recent (within 6 months) enrollment in weight loss program

Primary outcomes:
measure: Percentage of Text Messages That Were Reviewed
timeFrame: Baseline through month 6
measure: Percentage of Emails Opened and Clicked Through
timeFrame: Baseline through month 6
measure: Cardiovascular Risk Factor Score
timeFrame: Baseline, month 3, month 6, and month 12
Secondary outcomes:
measure: Change From Baseline in Knowledge Related to Atrial Fibrillation
timeFrame: Baseline, month 3, month 6, and month 12
measure: Change From Baseline in AF Quality of Life Score
timeFrame: Baseline, month 3, month 6, and month 12
measure: Change From Baseline in AF Symptom Severity
timeFrame: Baseline, month 3, month 6, and month 12
measure: Change From Baseline in AF Symptom Burden
timeFrame: Baseline, month 3, month 6, and month 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Clinician and research scientist
name: Linda Ottoboni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994082: Treating Smokeless Tobacco Use in Rural Veterans
Official title: Treating Smokeless Tobacco Use in Rural Veterans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smokeless Tobacco
Nicotine Dependence
Keywords: Rural health
Veterans
Smokeless tobacco cessation
Lead sponsor: Iowa City Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Iowa City VA Health Care System
First posted: 2016-12-15
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to:

1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.


Eligibility criteria: Inclusion Criteria:

1. Use smokeless tobacco on a daily basis
2. Be willing to make a quit attempt in the next 30 days
3. Reside in a rural location
4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
5. Able to provide informed consent
6. Telephone access
7. Stable residence

Exclusion Criteria:

1. Planning to move in the next 12 months
2. Terminal illness
3. Unstable psychiatric disorder
4. Incarcerated
5. Institutionalized

Primary outcomes:
measure: Treatment satisfaction
timeFrame: Three month follow-up
Secondary outcomes:
measure: Tobacco use
timeFrame: Three-and six-month follow-up
measure: Alcohol use
timeFrame: Three- and six-month follow-up
measure: Depressive symptoms
timeFrame: Three- and six-month follow-up
measure: Body weight
timeFrame: Three- and six-month follow-up
measure: Enrollment rate
timeFrame: Six months after study initiation
measure: Retention
timeFrame: Six months after study initiation
measure: Treatment attendance
timeFrame: Three-month follow-up
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Healthcare System
state: Iowa
Study officials:
affiliation: Iowa City VA Health Care System
name: Mark W. Vander Weg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747482: Omentectomy vs Omental Preservation in Resectable Cancer
Official title: Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer of Stomach
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 569
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: European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).

Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.

The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* Resectable gastric cancer
* Gastric cancer T3-4 N+/- M0

Exclusion Criteria:

* M1
* Non surgical patients for medical status
* Non resectable gastric cancer during surgery
* Endoscopic resectable gastric cancer

Primary outcomes:
measure: disease free interval
timeFrame: 5 years
Secondary outcomes:
measure: global survival
timeFrame: 5 years
measure: survival at 5 years
timeFrame: 5 years
measure: complications - CCI
timeFrame: 30 days after surgery
measure: postoperatory mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00971282: Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
Official title: Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Skin
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.

The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.

Detailed description: The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.

Eligibility criteria: Inclusion Criteria:

* male or female subjects of Chinese origins
* aged 21 years or older
* with healthy skin;

Exclusion Criteria:

* skin pigmentation which interferes with the reading of skin reactions
* with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated
* with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids
* with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids

Primary outcomes:
measure: Erythema Rating Scale
timeFrame: at 4 weeks
measure: Scaling
timeFrame: at 4 weeks
measure: Dryness
timeFrame: at 4 weeks
measure: Stinging/Burning
timeFrame: at 4 weeks
measure: Pruritus
timeFrame: at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: national Skin Center
Study officials:
affiliation: National Skin Center
name: Dr LEOW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00225082: SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
Official title: SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Lipoatrophy
Mitochondrial function
Nucleoside analogue switch
Treatment Experienced
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-09-23
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected subjects receiving antiretroviral treatment (lopinavir/ritonavir, stavudine, and lamivudine) for greater than 6 years through the Abbott M97-720 protocol with be evaluated for clinical lipoatrophy and mitochondrial function prior to switching nucleoside analogues from stavudine (d4T) to tenofovir and after 48 weeks or tenofovir treatment. Subjects with or without lipoatrophy are eligible for the study.

Brief summary: HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside analogues from stavudine (d4T) to tenofovir treatment and after 4.

Hypothesis: Tenofovir therapy will increase peripheral fat content as assessed by DEXA and mitochondrial function at 48 weeks.

Detailed description: HIV infected subjects receiving antiretroviral treatment (lopinavir/ritonavir, stavudine, and lamivudine) for greater than 6 years through the Abbott M97-720 protocol with be evaluated for clinical lipoatrophy and mitochondrial function prior to switching nucleoside analogues from stavudine (d4T) to tenofovir and after 48 weeks or tenofovir treatment.

Subjects with or without lipoatrophy are eligible for the study. Adipose tissue biopsies to measure mitochondrial function, metabolic laboratory tests, and DAXA scans and clinical evaluations of lipodystrophy will be performed at Entry and after 48 weeks of tenofovir treatment.

Eligibility criteria: Inclusion Criteria:

* HIV infection
* Receiving Kaletra, stavudine, and lamivudine for greater than 6 years (through Abbott M97-720 study)
* Planning to switch from stavudine to tenofovir

Exclusion Criteria:

* Will continue to receive stavudine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert L Murphy, MD
role: STUDY_CHAIR
affiliation: University of Hawaii
name: Mariana Gerschenson, Ph.D.
role: STUDY_CHAIR
References:
citation: Gerschenson M, Kim C, Berzins B, Taiwo B, Libutti DE, Choi J, Chen D, Weinstein J, Shore J, da Silva B, Belsey E, McComsey GA, Murphy RL. Mitochondrial function, morphology and metabolic parameters improve after switching from stavudine to a tenofovir-containing regimen. J Antimicrob Chemother. 2009 Jun;63(6):1244-50. doi: 10.1093/jac/dkp100. Epub 2009 Mar 25.
Clinical trial NCT05507320: Neural Circuits for Action Perception
Official title: Neural Circuits for Action Perception
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pharmacologically intractable epilepsy undergoing invasive implantation of electrodes

Brief summary: Study the mechanisms underlying action recognition and execution

Detailed description: Subjects will participate in a task where they have to either

1. Perform a movement
2. Observe an actor performing a movement There are three types of actions including different kinematics and grip types The goal is to compare the neural circuits activated by action execution versus action observation.

Eligibility criteria: Inclusion Criteria:

* Patients with pharmacologically intractable epilepsy

Exclusion Criteria:

* Any situation that may put the patient at risk

Primary outcomes:
measure: Selectivity for kinematics and movement type in neurophysiological responses
timeFrame: Through study completion, an average of 2 years.
measure: Evoked responses by action execution
timeFrame: Through study completion, an average of 2 years.
measure: Evoked responses by action observation
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: CHB
name: Gabriel Kreiman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04924582: Learning From Our Patients, Learning From Our Practice: Implementing an Intervention to Support Patients on Dialysis
Official title: Learning From Our Patients, Learning From Our Practice: Implementing an Intervention to Support Patients on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-06-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to gather preliminary estimates of the impact of using Capacity Coaching as an intervention for patients receiving dialysis.


Eligibility criteria: Inclusion Criteria:

Clinician Participants:

* Clinicians employed at Mayo Clinic who provide care to patients visiting the Mayo Clinic - Department of Nephrology and Hypertension Dialysis Services.

Patient Participants:

* Adult patients (18 years of age and older).
* Receive long-term dialysis treatment and services at Mayo Clinic.

Exclusion Criteria:

* Minors (under the age of 18 years).
* Non-English speaking.
* Lack the ability to provide informed consent.

Primary outcomes:
measure: Change in Illness Intrusiveness Score at Baseline, 3 Months, 6 Months
timeFrame: Baseline, 3 Months, 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kasey R Boehmer, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343482: Maternal Non-Stress Testing
Official title: Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring


Eligibility criteria: Inclusion Criteria:

* Maternal age \>18 years old
* Pregnant mothers \>26 weeks undergoing nonstress testing or delivering
* Singleton pregnancy
* No fetal abnormality or chromosomal abnormality
* Subjects willing and able to comply with requirements of the protocol
* Nurses and clinicians who will be administering the non-stress test to the pregnant subject

Exclusion Criteria:

* Women who refuse to signed the informed consent form
* Maternal age under 18 years old
* Multiple pregnancy
* Known major fetal malformation or chromosomal abnormality
* Medical or obstetric problem that would preclude the use of abdominal electrodes
* Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
* Women using pacemakers

Primary outcomes:
measure: Device comparison to standard monitoring
timeFrame: 3 years
Secondary outcomes:
measure: Qualitative analyses of sensor output
timeFrame: 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Prentice Women's Hospital
state: Illinois
Study officials:
References: