louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01640730: Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer
Official title: An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stage IV NSCLC
Lead sponsor: KangLaiTe USA
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 1
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: This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.


Eligibility criteria: Inclusion Criteria:

* confirmed (within last 3 months)progressive Stage IV NSCLC
* estimated life span of 3 months
* phase angle of at least 5 as measured by bioimpedance

Exclusion Criteria:

* currently taking a lipid lowering medications
* has an imminently life threatening condition
* has pre-existing liver disease
* known allergy to soybeans
* uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
* pregnant or lactating
* has a pacemaker or other implantable electronic medical device

Primary outcomes:
measure: Overall Survival
timeFrame: from date of enrollment until date of death from any cause assessed up to 12 months
Secondary outcomes:
measure: Bioimpedance Phase Angle
timeFrame: measured each month up to one year
measure: Palliation Response Measure
timeFrame: each month up to one year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
References:
Clinical trial NCT01915030: Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass
Official title: Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Muscle
Physical performance
Protein
Diet
Caloric restriction
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Top Institute Food and Nutrition
First posted: 2013-08-02
Enrollment: 61
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.


Eligibility criteria: Inclusion Criteria:

* Overweight and obese subjects (BMI 27-40 kg/m2)
* Waist circumference male:≥ 102 cm, female: ≥ 88 cm
* Willingness and ability to comply with the protocol

Exclusion Criteria:

* Renal insufficiency
* Co-morbidities
* Type 1 \& 2 diabetics (Fasting glucose level ≥ 7 mmol/L)
* Cancer
* COPD
* Participation in weight loss program 3 months before the intervention
* Participation of any heavy resistance-type exercise training (\>1 wk) the last 2 y.
* Intentional or unintentional weight loss (\> 3 kg in the last 3 months)
* Severe loss appetite
* Diagnosed allergy to milk products
* Gastric bypass
* Supplements or medication use for weight loss
* Participation in any other intervention trial
* Women can only participate if they are postmenopausal (last period ≥ a year ago)

Primary outcomes:
measure: Change in Body composition
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Physical performance
timeFrame: baseline and 12 weeks
measure: Blood related parameters
timeFrame: baseline and 12 weeks
measure: Muscle related parameters
timeFrame: baseline and 12 weeks
measure: Physical activity
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
affiliation: Prof. Wageningen University
name: Lisette de Groot, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01102530: Diabetes Prevention in Women With a Recent History of Gestational Diabetes (Focus Groups)
Official title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women with a diagnosis of gestational diabetes during a pregnancy within the past 5 years

Brief summary: The objective of this research is to conduct focus groups in order to adapt the Diabetes Prevention Program (DPP) so that it may successfully target women diagnosed with gestational diabetes (GDM) who are at high risk for developing Type 2 diabetes in the post-partum period. As this research seeks to gather formative data for a future intervention, the focus groups will: 1) provide information to maximize participation in the future intervention and 2) inform the location, content and format of the intervention.

We will be conducting focus groups and informant interviews to determine the DPP modifications necessary for adapting to the post-partum lifestyles of women with a recent history of GDM. Subjects will attend a 1 hour focus group or phone interview where they will be encouraged to respond to the facilitators' questions and to each other's comments on topics such as: gestational diabetes, healthy eating, exercise, and other type 2 diabetes prevention related activities. Working with a variety of health care providers, including endocrinologists, obstetricians and nurse-practitioners, we will identify and enroll up to 60 women total who are either current GDM patients at BWH or have a recent history of GDM who have delivered at Brigham and Women's Hospital in the last 5 years.


Eligibility criteria: Inclusion Criteria:

* Healthy women ages 18-45
* Diagnosis of gestational diabetes within the past 5 years (Carpenter-Coustan criteria)
* English-speaking
* Currently not diagnosed with type 2 diabetes

Exclusion Criteria:

* Diagnosis of type 2 diabetes
* Non-English-speaking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Sue E Levkoff, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicklas JM, Zera CA, Seely EW, Abdul-Rahim ZS, Rudloff ND, Levkoff SE. Identifying postpartum intervention approaches to prevent type 2 diabetes in women with a history of gestational diabetes. BMC Pregnancy Childbirth. 2011 Mar 24;11:23. doi: 10.1186/1471-2393-11-23.
Clinical trial NCT05478330: Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris
Official title: Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: From the obtained results, topical Flutamide 1% gel can be a promising, effective, and safe alternative in treating patients with acne vulgaris with minimal side effects.

Detailed description: Flutamide is a non-steroidal anti-androgen, which is used to treat patients with prostate cancer. Due to its anti-androgenic properties can be used in cases of acne, hirsutism, and androgenic alopecia with successful outcomes. To minimize the unnecessary systemic side effects associated with the oral administration of Flutamide. It has been shown that the topical delivery of Flutamide can allow high drug levels at the site of action, decreasing the systemic side effects and improving patient compliance.

The Flutamide group received topical Flutamide 1% gel twice daily on the face for 8 weeks and the control group received the same gel components, without flutamide, twice daily on the face for 8 weeks

Eligibility criteria: Inclusion Criteria:

* Fifty adult patients with acne having inflammatory (papules and pustules) and non-inflammatory (comedones) of different sizes, distribution, and durations were included in this study.

Exclusion Criteria:

* Patients with a history of acne treatment with systemic or topical antibiotics, retinoids, or hormonal therapy within the last 3 months.
* Patients with a history of chronic renal failure, hepatic insufficiency

Primary outcomes:
measure: changes in the number of comedones, papules, and pustules
timeFrame: up to 8 weeks
Secondary outcomes:
measure: side effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Reham Essam
state: Al Sharqia
Study officials:
References:
Clinical trial NCT00934830: Antibiotics Versus Therapeutic Ultrasound for Sinusitis
Official title: Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sinusitis
Keywords: Antibiotic
Ultrasound
Efficacy
Treatment
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sør-Trøndelag chapter of the Norwegian Physiotherapist Association
First posted: 2009-07-08
Enrollment: 48
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Question: Is the effect of therapeutic ultrasound equally effective to antibiotic for treatment of sinusitis? Design: A randomized clinical trial with concealed allocation, self-assessment by the subjects and intention-to-treat analysis.

Detailed description: Subjects (n=48) with clinically diagnosed acute bacterial rhinosinusitis (ABRS)will included. The antibiotic group will receive amoxicillin (500 mg) 3 times per day for 10 days. The ultrasound group will receive therapeutic ultrasound over sinuses at 1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days. Improvement of symptoms (pain and congestion; numeric rating scale; 0-10) from day 1 to days 4 and 21 will be recorded. Relapses, side-effects and satisfaction with treatment will be assessed at one-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Pain when bending forward, headache, pain in the teeth, purulent nasal secretion, "double worsening" and white blood cell count (WBC).
* Patients eligible for the study had to meet one of the first three criteria (pain when bending forward, headache, pain in the teeth) and all of the other indicators (purulent nasal secretion, double worsening, a left handed displacement of lymphocytes and a right handed displacement of granulocytes on the WBC as indication of bacterial infection).
* Subjects over 15 years of age were included.

Exclusion Criteria:

* Subjects with any kind of antibiotic or allergic treatment within the last three weeks.
* Antibiotic intolerance.
* Pregnant women.

Primary outcomes:
measure: Pain and congestion over in forehead, around nose and pain in the teeth
timeFrame: Day 1, 4 and 21, and one-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Røros
country: Norway
facility: Røros Medical Center
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ottar Vasseljen, PhD
role: STUDY_CHAIR
References:
citation: Hosoien E, Lund AB, Vasseljen O. Similar effect of therapeutic ultrasound and antibiotics for acute bacterial rhinosinusitis: a randomised trial. J Physiother. 2010;56(1):29-32.
Clinical trial NCT04101630: Activity Monitoring in Pulmonary Hypertension
Official title: Activity Monitoring in Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be those enrolled in the Longitudinal Pulmonary Vascular Disease Phenomics Program (L-PVDOMICS) and any patient with pulmonary hypertension.

Brief summary: This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

Detailed description: A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.

Eligibility criteria: Inclusion Criteria:

* Enrolled in L-PVDOMICS or
* Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis

Exclusion Criteria:

* Pregnancy
* Hospitalization within the prior 3 months
* Orthopedic limitations that preclude 6MWD testing

Primary outcomes:
measure: Activity Monitoring
timeFrame: Baseline
measure: Activity Monitoring
timeFrame: 1 year
measure: Activity Monitoring
timeFrame: 2 year
measure: Activity Monitoring
timeFrame: 3 year
Secondary outcomes:
measure: Six Minute Walk Distance (6MWD) Test
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Intensity of Activity
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Quality of Life 36-Item Short Form Survey (SF-36)
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: emPHasis-10
timeFrame: Baseline, 1 year, 2 year, 3 year
measure: Minnesota Living with Heart Failure (MLHF)
timeFrame: Baseline, 1 year, 2 year, 3 year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Evan L Brittain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00955630: Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Official title: Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ocular Histoplasmosis Syndrome
Keywords: Histoplasmosis
Lucentis
Ranibizumab
OHS
Lead sponsor: Retina Associates of Kentucky
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2009-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.

Detailed description: Patients will be evaluated monthly for one year.

Participants will be assigned to one of two groups:

Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study

You cannot take part in this study if:

1. You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
2. You are under the age of 18

Eligibility criteria: Inclusion Criteria:

* age 18 or over
* active choroidal neovascularization secondary to ocular histoplasmosis
* Visual acuity between 20/25 and 20/400

Exclusion Criteria:

* pregnancy or intent to become pregnant within the next 12 months
* nursing an infant
* premenopausal women not using contraception
* prior treatment with subfoveal thermal laser
* allergy to sodium fluorescein simultaneous participation in another investigation or trial

Primary outcomes:
measure: incidence and severity of ocular adverse events as identified by eye examination
timeFrame: 1 year
measure: incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
timeFrame: 12 mos
Secondary outcomes:
measure: mean change in visual acuity
timeFrame: 1 year
measure: mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
timeFrame: 6 and 12 months
measure: change in fluorescein angiographic outcomes
timeFrame: 12 months
measure: mean number of injections
timeFrame: 12 mos
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
Study officials:
affiliation: Retina Associates of Kentucky
name: John Kitchens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04768530: Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis
Official title: Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis: Clinical and Biochemical Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the effect of nitazoxanide delivered subgingivally as thermosensitive hydrogel on the clinical and biochemical outcomes of SRP in patients with moderate periodontitis.

Detailed description: A randomized, controlled clinical trial in a split-mouth design was conducted on forty patients equally divided between two groups: a control group treated with full mouth scaling and root planing (SRP) and a test group treated with SRP combined with subgingivally delivered 0.01% NTZ sustained release Poloxamer 407/hyaluronic acid thermosensitive hydrogel.

Eligibility criteria: Inclusion Criteria:

* Patients having probing depth (PD) ≥5 mm.
* Patients having bleeding on probing (BOP) in proximal tooth surface.
* Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study.

Exclusion Criteria:

* Patients having any systemic disease that may affect the treatment outcomes.
* Smokers.
* Pregnant females.
* Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.

Primary outcomes:
measure: Probing depth
timeFrame: up to 6 months
measure: Clinical attachment loss
timeFrame: up to 6 months
measure: Bleeding on probing
timeFrame: up to 6 months
measure: Gingival index
timeFrame: up to 6 months
measure: Biochemical assessment of inflammation
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha R. Taalab, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Sylvia Farid, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt
name: Shaimaa Maklad, PhD
role: STUDY_DIRECTOR
affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt
name: Labiba El-Khordagui, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha El Tantawi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01480830: The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy
Official title: The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Quality
indicators
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 633
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: Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient.

This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen.

We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.


Eligibility criteria: Inclusion Criteria:

* Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.

Exclusion Criteria:

* Inability or unwillingness to provide written informed consent.
* Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
* Colonoscopist not participating in trial.
* Current pregnancy.
* Cardiac pacemaker or any other type of implantable stimulator.
* Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.

Primary outcomes:
measure: Cecal intubation rate
timeFrame: baseline
Secondary outcomes:
measure: Patient comfort
timeFrame: baseline
measure: Amount of sedation required
timeFrame: baseline
measure: Polyp detection rate
timeFrame: baseline
measure: Use of abdominal compression
timeFrame: baseline
measure: Insertion time
timeFrame: baseline
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Donald MacIntosh, MD
role: PRINCIPAL_INVESTIGATOR
References: