louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03615508: Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Official title: Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Horner Syndrome
Keywords: Alpha blockers
Tamsulosin
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2018-08-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, intervention trial.
Primary purpose: OTHER

Brief summary: This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye examination, but their pupil dilation measurements will be recorded.

Detailed description: This study will enroll 10 participants who have a unilateral Horner's Syndrome AND have a history of taking an alpha blocker such as Tamsulosin. Participants will be recruited based on those two enrollment criteria, and after consenting they will undergo pupil dilation with 10% phenylephrine. Once fully dilated the pupil size will be measured. Pupil dilation size of the eye affected by the Horner's Syndrome will be compared to the eye not affected by Horner's. Primary study outcome is the comparative dilation size of the Horner's affected eye to the non affected eye in all subjects.

Eligibility criteria: Inclusion Criteria:

1. Horner's Syndrome
2. History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication

Exclusion Criteria:

1. Subjects with untreated hypertension
2. Subjects with thyrotoxicosis
3. Pregnant women
4. Prisoners
5. Inability to consent
6. Subjects with anatomical narrow angles who have never had a dilated exam

Primary outcomes:
measure: Pupil Size Measurements
timeFrame: 20-30 minutes after 10% phenylephrine has been placed in each eye.
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital, Rocky Mountain Lions Eye Institute
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Denver Health
name: Cristos Ifantides, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06716008: Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis
Official title: Effect of Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatic Arthritis
Lung Function
Lead sponsor: Middle East University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of manual diaphragmatic release on ventilatory functions in women with rheumatoid arthritis

Detailed description: Sixty women with rheumatoid arthritis will be sourced from the rheumatology outpatient clinic at Tanta University hospitals in Egypt, with referrals from rheumatologists. Patients will be randomly assigned into two groups.

The study group will include 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks while the control group will include 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes will be assessed:

1. Ventilatory functions (Forced vital capacity and total lung capacity).
2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
3. Quality of life (Short form health survey).

Eligibility criteria: Inclusion Criteria:

* All women will have rheumatoid arthritis for more than 2 years with low-to-moderate disease activity.
* Normal to mildly restrictive lung pattern.
* Their ages will be ranged from 40 to 60 years old.
* Their body mass index will be less than 30 Kg/m2.

Exclusion Criteria:

* Chronic chest diseases.
* Recent parenteral steroid administration.
* Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
* Smokers.
* Joint surgery (in the preceding 6 months).
* Musculoskeletal/ neurological limitations to exercise.
* Pregnancy.

Primary outcomes:
measure: Ventilatory function
timeFrame: At baseline and 12 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: At baseline and after 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National institute for Gerontology
name: Mohammed Sayed Saif, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03242408: Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
Official title: Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism, Male
Lead sponsor: Lipocine Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.


Eligibility criteria: Inclusion Criteria:

1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
3. Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.

Exclusion Criteria:

1. History of significant sensitivity or allergy to androgens, or product excipients.
2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
5. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
9. History of stroke or myocardial infarction within the past 5 years.
10. History of or current or suspected prostate or breast cancer.
11. History of untreated and severe obstructive sleep apnea.
12. History of long QT syndrome (QTc \> 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).

Primary outcomes:
measure: Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
timeFrame: Following 24 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lipocine Inc.
name: Anthony DelConte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04224623: Raising Well at Home
Official title: Raising Well at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Envolve, Inc., a wholly owned subsidiary of Centene Corporation
First posted: 2020-01-13
Enrollment: 195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study was to test the feasibility and efficacy of a balanced lifestyle intervention for caregivers and their children with obesity, conducted in partnership with Envolve, Inc., a family of comprehensive health solutions and wholly owned subsidiary of Centene Corporation.

Detailed description: This pilot study employed a pretest-posttest design to assess the feasibility and efficacy of the Raising Well at Home pilot intervention delivered by peer coaches on weight (caregiver/child), behaviors (eating, walking), and the home environment. The Raising Well at Home intervention was delivered via home visits with additional support via text or phone over 6 months, beginning after completion of the baseline assessment. This study was implemented in partnership with the parent Raising Well programs located in three states: Florida, Louisiana, and Missouri. The caregiver and the child's height and weight were measured by trained staff in the home with the same scale and stadiometer at the pre- and post-intervention time points. Measures were completed on a paper survey with the same caregiver pre and post intervention delivery.

Eligibility criteria: Inclusion Criteria:

* Caregivers had to be at least 18 years old, live in one of the states offering the Raising Well program, and be the primary caregiver to at least one child 2-17 years old served by an Envolve Medicaid Health Plan with International Classification of Diseases, Ninth Revision (ICD-9) coding for overweight or obesity. Caregivers had to be able to give informed consent. If more than one child within a household was eligible to participate, all children were invited to participate.

Exclusion Criteria:

* Unable to speak English or Spanish

Primary outcomes:
measure: Change in Weight
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Debra Haire-Joshu
state: Missouri
Study officials:
References:
citation: Haire-Joshu D, Schwarz C, Jacob R, Kristen P, Johnston S, Quinn K, Tabak R. Raising Well at Home: a pre-post feasibility study of a lifestyle intervention for caregivers and their child with obesity. Pilot Feasibility Stud. 2020 Oct 6;6:149. doi: 10.1186/s40814-020-00692-0. eCollection 2020.
Clinical trial NCT04675723: The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
Official title: The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridioides Difficile Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without known underlying inflammatory GI conditions with recent diagnosis and treatment of C. difficile infection, for whom the recent diagnosis was not that of recurrent disease already

Brief summary: The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.

Detailed description: Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.

Eligibility criteria: Inclusion criteria:

* Adults aged 18 and over
* Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea

Exclusion criteria:

* Known pregnancy
* Prior diagnosis of C. difficile infection within 2 months of this diagnosis
* Other known active gastrointestinal infectious process
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

Primary outcomes:
measure: Mucosal presence
timeFrame: 1-14 days post C. Difficile treatment
measure: Disease recurrence
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Purna Kashyap, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737723: Electroencephalograph for Detection of Acute Ischemic Stroke
Official title: Collecting Data for an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Neurokeeper Technologies
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients

Brief summary: The purpose of this study is Collecting data for an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.

Detailed description: Inclusion criteria study population Age \> 18 years old. Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.

Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

Exclusion criteria study population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Inclusion criteria Control Population

Age \> 18 years old.

Exclusion criteria Control Population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Migraine Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.
* Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

Exclusion Criteria:

* Primary intracranial hemorrhage on admission by CT.
* Significant movement disorder.
* Previous major hemispheric stroke.
* Local skull or skin affliction which prevents electrodes application.
* Any known condition which in the opinion of the investigator may interfere with the protocol implementation

Primary outcomes:
measure: Detection of stroke
Secondary outcomes:
measure: Correlation to severity of stroke
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT00860223: Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin
Official title: An Open-Label, Nonrandomized, Crossover Study to Evaluate the Potential Effect of Multiple Doses of Neratinib on the Pharmacokinetics of a Single Dose of Digoxin When Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.


Eligibility criteria: Inclusion criteria:

* Healthy men and women of non-childbearing potential, age 18-50

Primary outcomes:
measure: Pharmacokinetic parameters: concentration of digoxin in blood and urine
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT06221423: Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
Official title: A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Metastatic Colorectal Cancer
Refractory Colorectal Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.

Brief summary: Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.


Eligibility criteria: Inclusion Criteria:

* Histology-confirmed metastatic CRC (mCRC)
* Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab
* Fruquintinib administered as salvage treatment
* Age: 18-75 years old
* Informed consent

Exclusion Criteria:

* Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
* Fruquintinib and/or TAS-102 administration as second-line treatment
* Drug administration stopped after less than two cycles

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 3 years
measure: Overall Survival (OS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Colorectal Surgery, Zhongshan Hospital, Fudan University
name: Jianmin Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02125123: Oral Nutritional Supplementation in Children
Official title: Oral Nutritional Supplementation in Children With Picky Eating Behaviors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Children
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 26
Sex: ALL
Minimum age (years): 36
Maximum age (years): 109
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.


Eligibility criteria: Inclusion Criteria:

1. ≥ 36 months and \< 109 months of age.
2. Healthy and not suffering from any physical disability.
3. Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
4. Capable of oral feeding.
5. Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
6. Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

Exclusion Criteria:

1. History of an acute or chronic condition that may affect feeding habits or nutritional status.
2. Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
3. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
4. Any acute/chronic condition requiring medical treatment which may include hospitalization.
5. Allergy or intolerance to any ingredient in the study product.
6. Gastrointestinal infection, acute constipation or acute diarrhea.
7. Hepatitis B or C, or HIV, or malignancy.
8. Congenital cardiac defects.
9. Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
10. Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.

Primary outcomes:
measure: Vitamin D Intake
timeFrame: Change from Baseline to Week 4
Secondary outcomes:
measure: Macronutrient Intake
timeFrame: Change from Baseline to Week 4
measure: Micronutrient Intake
timeFrame: Change from Baseline to Week 4
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References: