louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01107041: Mobile Phone Sensing and Outreach as Adjuncts to Internet-Based Behavioral Intervention for Depression
Official title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Technology Assisted
Mobile Phone
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 2010
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is collecting phone sensor data and ecological momentary assessment data to try to develop algorithms that can passively detect behavioral patterns in participants
Primary purpose: OTHER

Brief summary: Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.

Detailed description: Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety. Participants will include people who are high on depression, high on anxiety, hight on both depression and anxiety, and health controls. Particpants will load software on their phones that collects phone sensor data, and obtains self report on sleep, mood, and social contacts. Data will be collected for at least 6 weeks.

Eligibility criteria: Inclusion Criteria:

* PHQ-9 score 10 or higher
* Has an e-mail account, computer, and broadband access to the Internet
* Familiarity with mobile phones and is within a cellular network range the majority of the day.
* Is able to speak and read English.
* Is at least 19 years of age.

Exclusion Criteria:

* Hearing or voice impairment preventing participation in psychotherapy.
* Visual impairment that would prevent use of the website, mobile phone application, and assessment materials.
* Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, etc.).
* Planning to be out of town or unavailable for intervention for 1 or more weeks during the scheduled study participation.
* Exhibits severe suicidality, including ideation, plan, and intent.

Primary outcomes:
measure: Depression, as assessed the Patient Health Questionnaire-9
timeFrame: Baseline, Weeks 2-6
Secondary outcomes:
measure: Positive Affect (PANAS - Positive Affect Scale)
timeFrame: Baseline, Weeks 2-6
measure: Anxiety (GAD-7)
timeFrame: Baseline, Weeks 2-6
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: Burns MN, Begale M, Duffecy J, Gergle D, Karr CJ, Giangrande E, Mohr DC. Harnessing context sensing to develop a mobile intervention for depression. J Med Internet Res. 2011 Aug 12;13(3):e55. doi: 10.2196/jmir.1838.
Clinical trial NCT01269541: MESS-study MRSA Eradication Study Skåne
Official title: MESS- MRSA Eradication Study Skåne. A Comparison Between Systemic Antibiotic Treatment in Combination With Topical Mupirocintreatment With Only Topical Mupiroicintreatment to Eradicate MRSA in Throat Carriers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Throatcarriers of MRSA
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 69
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers


Eligibility criteria: Inclusion Criteria:

Colonized with MRSA in the throat Older than 5 years MRSA-bacteria sensitive for Rifampicin and Clindamycine or Trimethoprimsulfa -

Exclusion Criteria:

Allergy to the studymedication Healthcareworkers Pregnancy Active infection with MRSA Immunosuppression Treatment with other antibiotic during the studyperiod

Primary outcomes:
measure: Culture for MRSA
timeFrame: after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg hospital
state: Skåne
city: Kristianstad
country: Sweden
facility: Kristianstad hospital
state: Skåne
city: Lund
country: Sweden
facility: Infectious department SUS Lund
state: Skåne
city: Malmö
country: Sweden
facility: SUS Malmö
state: Skåne
city: Stockholm
country: Sweden
facility: Karolinska university hospital
city: Örebro
country: Sweden
facility: Örebro university hospital
Study officials:
affiliation: Labmedicin Skåne Malmö
name: Eva Melander, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06079541: Phase 1 Clinical Study of JMKX003142 Tablets
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Tablets Administered Randomly, Double-blind, Placebo-controlled Single and Multiple Times in Healthy Adult Subjects, as Well as the Effects of Randomized, Open, and Two Cycle Crossover Foods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Safety and Tolerability
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Hangyu Pharmaceutical Co., Ltd.
First posted: 2023-10-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged 18-45 years (including boundary values)
2. Able to sign a written informed consent form
3. Physical examination, clinical laboratory examination value, Virology examination, vital signs and 12 lead ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
4. The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

Exclusion Criteria:

1. Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
2. Participants in any other clinical study within 3 months prior to the first administration of this study
3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment
4. Pregnant or lactating women

Primary outcomes:
measure: Number of the Adverse Events that are related to the single dose treatment
timeFrame: from baseline to Day 18
measure: Number of the Adverse Events that are related to the multiple dose treatment from
timeFrame: from baseline to Day 24
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xuening li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05174741: Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.
Official title: Effects of Pulmonary Rehabilitation Therapy on Pulmonary Function and Health Related Quality of Life in Non-chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Pulmonary Fibrosis
Tuberculosis
Bronchiectasis
Asthma
Keywords: non-COPD
quality of life
pulmonary function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.

Detailed description: A review state that "Interstitial lung disease presents clinical features of exertional desaturation and a nonproductive cough. Patients with ILD have significantly reduced exercise capacity as manifested by a reduced maximum work load achieved during exercise, as well as a reduced maximal oxygen uptake VO2max." in previous studies Pulmonary rehabilitation is the use of exercise, education and behavioral interventions for diseases such as non-ILD restrictive lung disease, asthma, lung cancer, bronchiectasis , and pulmonary hypertension, pre and post op thoracic surgery patients.

Quality of life (QOL) as an individual's perception of contentment or satisfaction with life in areas he or she considers important, and we define health-related quality of life (HRQL) as an individual's perception of the impact of health (in all its many facets) on his or her quality of life. a study on pulmonary rehabilitation outcomes between individuals with chronic obstructive lung disease (COPD) and non-COPD disease and its impact on gender.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of non-COPD disease interstitial lung disease (pulmonary fibrosis), restrictive lung disease (TB, pneumonia), Bronchiectasis, and Asthma with FEV1 below 50%, FVC\<80%, and FEV1/FVC\>70%

Exclusion Criteria:

* Clinically/vitally unstable or having Uncontrolled DM/HTN, Current smokers or ex-smokers of less than 1 year.

Primary outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 3 weeks, 6 weeks
measure: Forced vital Capacity (FVC)
timeFrame: 3 weeks,6 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 3 weeks,6 weeks
Secondary outcomes:
measure: Health related Quality of life
timeFrame: 3 weeks,6 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan railway hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01204541: A Single-Center Pilot Study to Assess Macular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Non-exudative age-related macular degeneration
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups of subjects will be enrolled:

1. Normal healthy subjects aged 20-29 years
2. Normal healthy subjects aged 60-90 years
3. Subjects with early dry AMD

Brief summary: This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.


Eligibility criteria: Inclusion Criteria:

* Subjects in good health aged 20-29 or 60-90 years (normal cohorts)
* Subjects with early non-exudative age-related macular degeneration (AMD cohort)

Exclusion Criteria:

* Enrollment in a investigational drug or device study and have used an investigational drug or device within 7 days of enrollment into this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
state: Massachusetts
Study officials:
References:
Clinical trial NCT05749341: A Liquid Biopsy Diagnostic Techniques for Endometriosis
Official title: A Pilot Study of Liquid Biopsy Diagnostic Techniques for Endometriosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liquid Biopsy
Endometriosis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Planned number of sample for each group: 20 with endometriosis and 20 without endometriosis

Brief summary: To evaluate the diagnostic efficiency of circulating endometrial cell detection method using microfluidic chip as an non-invasive method for diagnosis in endometriosis.

Detailed description: Endometriosis is a chronic condition, characterized by the presence of functional endometrial glands and interstitium in extrauterine ectopia. Ectopic endometrial tissue responds to estradiol and other hormones similar to normal endometrium. Endometriosis is one of the most common benign gynaecological conditions, affecting up to 5 to 10 percent of women of reproductive age. In addition to severe dysmenorrhea or pelvic pain, decreased fertility is a common clinical manifestation of internal heterogeneity, with up to 40 percent of patients associated with infertility . Currently, laparoscopy is the gold standard for diagnosis. However, the actual time to diagnosis in patients with internal dysmorphia is delayed by an average of 4 to 11 years, resulting in a large number of patients with moderate to severe (stage III to IV) at diagnosis. Recently, the exploration of efficient and cost-effective non-invasive diagnostic solutions has been a hot button issue.

Eligibility criteria: Inclusion Criteria:

• Surgically and pathologically verified patients with or without endometriosis

Exclusion Criteria:

* suspicion of malignancy
* pregnancy
* acute infection
* Lack of ability to sign informed consent forms on their own

Primary outcomes:
measure: Percentage of cases with identified circulating endometrial cells.
timeFrame: within one week after blood sample collecting
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wenwen Wang
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: WENWEN WANG, DOCTOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT04143841: Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
Official title: A Pilot Study to Evaluate the Safety and Effectiveness of the Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndromes
ATD
Sjogren's Syndrome
Lead sponsor: Epitech Mag Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease.


Eligibility criteria: Inclusion Criteria:

1. Males and females, 18-80 years old
2. Subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted):

   1. SPEED questionnaire score ≥ 10 AND
   2. Fluorescein Corneal Staining Score (FCSS) ≥ 5 NEI score in at least in one eye AND
   3. Schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment)
3. No contact lens wear for at least seven days prior to the Screening Visit and willingness to forego contact lens wear for the duration of the study;
4. Literacy, able to speak English or Hebrew, and able to complete questionnaires independently;
5. Willing and able to sign the informed consent form and deemed capable of complying with the requirements of the study protocol (tests and follow-up visits).

Exclusion Criteria:

1. Significant anterior blepharitis including signs of Demodex eyelid infection;
2. If the subject is using prescription dry eye ophthalmic drug such as Restasis (Cyclosporine A 0.05% ophthalmic emulsion), Xiidra (Lifitegrast), Cequa (Cyclosporine 0.09% ophthalmic solution), and the medication has not been used regularly for the past 3 months prior to screening visit;
3. Change in eye lubricant type usage in the last 1 month prior enrollment. Use of any device to manage DED within 1 month of Screening Visit;
4. Punctal plugs are present at screening that were inserted in the last 30 days prior enrollment, or intracanalicular plug that were inserted in the last 6 months in any eyelid;
5. Corneal transplant in either or both eyes;

Primary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 12 weeks
measure: Intraocular Pressure (IOP)
timeFrame: 12 weeks
measure: Slit lamp biomicroscopy
timeFrame: 12 weeks
measure: Rate of device/treatment related adverse events
timeFrame: 12 weeks
measure: Fluorescein corneal staining
timeFrame: 12 weeks
measure: Ocular discomfort questionnaires
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E.Wolfson MC
city: Jerusalem
country: Israel
facility: SZMC
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
References:
Clinical trial NCT03974841: Cornual Wedge Resection Outcome
Official title: Cornual Wedge Resection for Interstitial Pregnancy and Postoperative Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Laparoscopic
Cornual Pregnancy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: postoperative results of patients who underwent laparoscopic cornual resection for cornual ectopic pregnancy, Patients forming the study group will be operated in the center for the last 3 years.

Brief summary: Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. However, nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial resection.

Although this technique can potentially protect the fertility of the patient, it carries a serious risk of bleeding and requires a surgical experience.


Eligibility criteria: Inclusion Criteria:

* cornual ectopic pregnancy
* Patients undergoing laparoscopic cornual wedge resection

Exclusion Criteria:

* medical treatment area due to cornual pregnancy
* laparotomy
* conservatively managed patients

Primary outcomes:
measure: Operation time
timeFrame: surgery from start to end
measure: amount of bleeding
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00585741: Pilot Study of 18F-FLT PET
Official title: Pilot Study of 18F-FLT Pet Imaging in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: CNS Brain Metastasis
Head and Neck Cancer
Lung Cancer
Prostate Cancer
Esophageal Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission


Eligibility criteria: Inclusion Criteria:

* Able to tolerate a PET/CT scan
* Age of 18 or older
* signed informed consent
* being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer

Exclusion Criteria:

* Prior XRT to site being studied
* severe claustrophobia or inability to tolerate PET/CT
* unable to provide written consent
* pregnant or breastfeeding women

Primary outcomes:
measure: To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging
timeFrame: end of study
Secondary outcomes:
measure: To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients
timeFrame: end of study
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and clinis
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Jeraj, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: