louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02968615: Simple Changes Weight Loss Intervention
Official title: Simple Changes Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: fiber
lean protein
loss weight
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators examined feasibility and acceptability of a non-restrictive diet focused on increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a 12-week assessment which included 6 bi-weekly individual dietary counseling sessions to attain a daily goal of higher fiber (\>35 g/day) and lean protein (0.8 g per kilogram/day of individual's ideal body weight).

Detailed description: Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Loss of 5% of their body weight are considered to achieve the weight-loss goal. The intervention included 6 bi-weekly, 30-minute individual dietary counseling sessions over 12-weeks. Behavioral strategies including self-monitoring, problem solving, goal setting, stimulus control, food substitution, and relapse prevention were taught to assist participants in meeting their fiber and protein goals.

Eligibility criteria: Inclusion Criteria:

1. interested in losing weight and have a body mass index (BMI) 30-45 kg/m2;
2. ages 21 to 70;
3. able to provide informed consent;
4. physician's approval of his/her patients to participate;
5. non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect on weight

Exclusion Criteria:

1. clinically diagnosed diabetes, or an HbA1c ≥ 6.5%;
2. an acute coronary event within the previous 6 months;
3. pregnant or lactating;
4. plans to move out of the area within the 12-week study period;
5. diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease);
6. following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or participating in a weight loss program;
7. previously had bariatric surgery;
8. currently using weight loss medication;
9. diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating);
10. unable to provide consent.

Primary outcomes:
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: Total energy
timeFrame: 12 weeks
measure: Fiber
timeFrame: 12 weeks
measure: Protein
timeFrame: 12 weeks
measure: Saturated fat
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Yunsheng Ma, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07011615: Feasibility/Acceptability of a Brief Motivational Intervention for Frequent/High-Intensity Cannabis Use
Official title: Feasibility/Acceptability of a Brief Motivational Intervention Integrating Online Personalized Feedback & Tailored Text Messages for Frequent/High-Intensity Cannabis Use in Post-Legalization Landscape
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cannabis Use
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to develop a novel brief motivational mobile health (mHealth) intervention for high-risk and high-intensity cannabis use for non-collegiate young adults. A total of 120 young adults (ages 18-29, not enrolled at or attending a 4-year college or university) will be randomized to receive a mHealth intervention with text messages for five weeks or to an online resource/program with psychoeducation information about cannabis. The mHealth intervention will focus on prompting the young adult to reflect on their journey with cannabis and to reflect on their personal goals and how cannabis is reflected in these goals. Personalized feedback about their patterns of use, motivations, emotions, and social connections will be integrated throughout the program. Participants will come back to the program each week to reflect on the prior week and reflect on goals for the upcoming week. All participants will complete a program satisfaction survey and complete follow-up assessments at 3- and 6-months post-program.


Eligibility criteria: Inclusion Criteria:

* 18-29 years old
* reside in Washington State
* have valid email address
* report using cannabis on 15 or more days in the past month, using 2 or more times a day (when use) in the past month, and/or using high THC concentration products in the past month (\>60% THC)
* have a mobile phone and agree to receive text messages and has an internet browser
* not attending or enrolled at a 4-year college or university.

Exclusion Criteria:

* females who are pregnant or trying to become pregnant
* those who are in substance abuse treatment at screening
* those attending or enrolled at a 4-year college or university.

Primary outcomes:
measure: Cannabis use - typical hours high in a week
timeFrame: Baseline, 3-month follow-up, 6-month follow-up
measure: Negative cannabis-related consequences
timeFrame: Baseline, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Cannabis use - Number of sessions
timeFrame: Baseline, 3-month follow-up, 6-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: leecm@uw.edu
name: Christine M Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06149715: Water Filter Study in Ciudad Victoria
Official title: Evaluating Comparative Efficacy of Sawyer PointOne Filter Types in Ciudad Victoria, Mexico
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Waterborne Diseases
Diarrhea
Lead sponsor: Aquora Research & Consulting, LLC
Sponsor class: INDUSTRY
Collaborators: name: Sawyer Products, Inc
name: The Bucket Ministry
name: Sparrow Data Solutions
First posted: 2023-11-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study measures effects of water filters and filter types on household health in Ciudad Victoria, Mexico.

Detailed description: A project to assess the water quality in Ciudad Victoria, Mexico and the effectiveness of different Sawyer PointOne Filter types (Bucket, Tap, Squeeze) . The project is designed to 1) assess the impact of filters on health and well-being of families, 2) assess the impact of filters on the economic status of families and 3) compare different filter formats for use/adoption on the above metrics. The project will provide information about how well the different filters are working in urban households in a middle-income Latin American country, make recommendations for future deployment of filter types in similar settings, and determine the potential for scaling the use of filter systems to provide clean drinking water for people in need in future projects.

Eligibility criteria: Inclusion Criteria:

* Recruiting will occur in Ciudad Victoria, Mexico at any household in the areas surveyed

Exclusion Criteria:

* None, except those who decline the survey and/or filter

Primary outcomes:
measure: Change in self-reported diarrhea rates from initial filter distribution to end of follow up
timeFrame: 3 months follow up
Secondary outcomes:
measure: Change in other self-reported health outcomes from distribution to end of follow up
timeFrame: 3 months follow up
measure: Change in household economic outcomes from distribution to end of follow up
timeFrame: 3 months of follow up
Other outcomes:
Locations:
city: Ciudad Victoria
country: Mexico
facility: Ciudad Victoria
Study officials:
References:
Clinical trial NCT06638515: Effects of Walking Apnea At Low Lung Volume on Hypoalgesia
Official title: Effects of Walking Apnea At Low Lung Volume on Hypoalgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Hypoxemia
Hypercapnia
Apneas
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
timeFrame: before and after intervention (up 30 minutes)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: before intervention (up 5 minutes)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: before intervention (up 5 minutes)
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Oxygen saturation
timeFrame: during intervention (up 6 minutes)
measure: Blood pressure
timeFrame: before and after intervention (up 10 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)
measure: Heart rate
timeFrame: during intervention (up 6 minutes)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT04449315: Outpatient Oncology Aromatherapy for Symptom Management
Official title: Outpatient Oncology Aromatherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Nausea
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 40
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 purpose of this research study is to determine whether using aromatherapy during chemotherapy infusion treatments in the outpatient Oncology setting promote relief of nausea and anxiety.

The objectives of this study are: 1. To promote relief of nausea using peppermint aromatherapy oil in an outpatient oncology setting. 2. To promote relief of anxiety using lavender aromatherapy oil in an outpatient oncology setting.

Detailed description: Subject Selection: Every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital-approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. Informed consent will then be obtained by co-investigators or principal investigator of the study. The consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.

Method of Subject Identification and Recruitment: Every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital- approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. Informed consent will then be obtained by co-investigators or principal investigator of the study. The consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.

Eligibility criteria: Inclusion Criteria:

All outpatient Oncology patients \> 18 years of age Non pregnant Not cognitively impaired English speaking only Patients who report nausea and/or anxiety

Exclusion Criteria:

All outpatient oncology patients \<18 years of age Pregnant Cognitively impaired Non-English Speaking Patients who do not report nausea and/or anxiety Patients with a known allergy to peppermint and/or lavender aromatherapy oil

Primary outcomes:
measure: Post Intervention Interview From
timeFrame: Immediately upon Completion of the patient's infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Central DuPage
state: Illinois
Study officials:
affiliation: Central DuPage Hospital
name: Lorraine Mack, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598515: Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Official title: Single Arm Prospective Trial of Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fanconi Anemia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main reason for this research study is to determine whether time-restricted eating will reduce inflammation in the bodies of persons with Fanconi anemia (FA) and whether time-restricted eating will improve function in people with FA and neurological changes. Participants will be asked to eat for only 8 hours out of 24 hours in a day.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of FA with neuroinflammation
* Age ≥ 12 years old

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with neuroinflammation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stella Davies, MBBS, PhD, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152515: A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients
Official title: A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tracheal Extubation
Keywords: safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20
2. Short term ventilator care after surgery in intensive care unit

Exclusion Criteria:

1. pneumonia
2. chronic obstructive lung disease
3. asthma
4. end stage renal disease
5. risk factors for aspiration

Primary outcomes:
measure: Mean Arterial Pressure Changes During Extubation
timeFrame: 10 min
measure: HR Changes During Extubation
timeFrame: 10 min
measure: The Grade of Coughing During Extubation
timeFrame: 2 min
Secondary outcomes:
measure: Time of Awake
timeFrame: 1 hour
measure: Time of Extubation
timeFrame: 1 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00458315: Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
Official title: Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Unknown Primary Tumors
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.

Detailed description: Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

Arm A: Cisplatin, Paclitaxel and Gemcitabine

* Cisplatin 75 mg/m2 IV infusion, Day 1
* Paclitaxel 175 mg/m2 IV infusion, Day 1
* Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8

Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab)

* Cisplatin 75 mg/m2 IV infusion, Day 1
* Paclitaxel 175 mg/m2 IV infusion, Day 1
* Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
* Bevacizumab 7,5 mg/m2 IV infusion, Day 1

Patients will be stratified by number of metastatic sites (one versus two or more) and the level of Lactate Dehydrogenase (normal versus high).

The regimens will be repeated every 21 days.

Eligibility criteria: Inclusion Criteria:

1. Unknown primary tumors
2. ECOG performance status 0-1
3. Adequate kidney, liver and bone marrow function
4. No prior chemotherapy
5. Life expectancy \> 3 months

Exclusion Criteria:

1. The following specific syndromes:

   * Squamous carcinoma limited to cervical glands
   * Women with adenocarcinoma isolated to axillary nodes
   * Women with adenocarcinoma isolated to peritoneal involvements
   * Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected
   * Neuroendocrine carcinomas
2. Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
3. Any significant cardiac disease
4. Clinically significant peripheral vascular disease
5. History of myocardial infarction or stroke within 6 months
6. Evidence of coagulopathy
7. Use of ASA, NSAIDs or clopidogrel
8. Pregnancy or breast feeding
9. Ongoing therapeutic anti-coagulation
10. Hypertension with blood pressure \> 150/100 mmHg
11. Brain metastases

Primary outcomes:
measure: Progression Free Survival
measure: Response
Secondary outcomes:
measure: Toxicity
measure: Response Duration
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Dept of Oncology
Study officials:
affiliation: Rigshospitalet, Dept of Oncology
name: Gedske Daugaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084915: The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC)
Official title: The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Keywords: Weight loss after SAGB VC band placement
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2010-03-11
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received a SAGB-VC band from 2004-2008

Brief summary: Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement.

This is the first retrospective clinical study of a large study population of \>800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.


Eligibility criteria: Inclusion Criteria:

* SAGB band placed from 2004-2008

Exclusion Criteria:

* None

Primary outcomes:
measure: Weight loss
timeFrame: 2 months
Secondary outcomes:
measure: Bariatric Analysis and Reporting Outcome System (BAROS) score
timeFrame: 2 months
measure: Operating time
timeFrame: 2 months
measure: Complications
timeFrame: 2 months
measure: Co-morbidities
timeFrame: 2 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital The Netherlands
name: F.J. Berends, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02966015: Product Evaluation of a Newly Developed Intermittent Catheter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urinary
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 153
Sex: MALE
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 study is to investigate the navigation of a newly developed catheter.


Eligibility criteria: Inclusion Criteria:

1. Male and at least 18 years
2. Has used Intermittent self-catheterization at least 3 months
3. Has normal to slightly reduced hand mobility
4. Use catheter size CH12 or CH14 (must use same size during product evaluation)

Exclusion Criteria:

1. Currently receiving treatment for urinary tract infection
2. Currently receiving chemotherapy

Primary outcomes:
measure: Number of Participants Successfully Able to Insert Catheter
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Head of clinical operation
name: Camilla F Vibjerg, Msc
role: STUDY_CHAIR
References: