louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04124406: Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
Official title: Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colon Cancer
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2019-10-11
Enrollment: 150000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.

Brief summary: The purpose of this study is to gather information about the long term health of people who have been prescribed the Cologuard test, which is used for colorectal cancer (CRC) screening.

Detailed description: Participates will be consented for prospective follow-up for health outcomes, which will be ascertained through periodic contacts. Participants will complete a baseline health questionnaire survey (T0) and a 1-year follow-up questionnaire survey (T1), allow access to medical records, when available, and allow future contacts for additional surveys.

Eligibility criteria: Inclusion Criteria:

* Resident of the United States
* Age 18 years or older
* Able to provide informed consent
* Able to complete surveys in English or Spanish
* Valid order for Cologuard screening

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Enrollment of Subjects
timeFrame: 3 years
Secondary outcomes:
measure: Diagnostic colonoscopy
timeFrame: 4.5 years
measure: CRC Frequency
timeFrame: 10 years
measure: National Rates Comparison
timeFrame: 10 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Olson JE, Kirsch EJ, Edwards V DK, Kirt CR, Kneedler B, Laffin JJ, Weaver AL, St Sauver JL, Yost KJ, Finney Rutten LJ. Colorectal cancer outcomes after screening with the multi-target stool DNA assay: protocol for a large-scale, prospective cohort study (the Voyage study). BMJ Open Gastroenterol. 2020 Feb 19;7(1):e000353. doi: 10.1136/bmjgast-2019-000353. eCollection 2020.
Clinical trial NCT00490906: Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis
Official title: Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Low Bone Density
Keywords: MS (Multiple Sclerosis)
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Kansas City Area Life Sciences Institute, Inc.
First posted: 2007-06-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants must be female with clinical diagnosis of multiple sclerosis and have been using either Copaxone or interferon injections for the past 1 or more years.

Brief summary: The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.

Detailed description: There will be 60 female patients with MS at University of Kansas Medical Center (KUMC). They will be split into two groups: a Copaxone group and an Interferon (Avonex, Rebif, or Betaseron) group. Each group will be composed of 30 women matched for menopausal status. Each subject will be given a questionnaire assessing risk factors for low bone density. All patients will have a determination of an Expanded Disability Status Scale (EDSS), height and weight, medical history, and fracture history. All patients will undergo hip and spine dual x-ray absorptiometry (DEXA) and will have labs drawn to determine serum 25 hydroxyvitamin D, parathyroid hormone, ionized calcium, estradiol, bone-specific acetyl phosphatase, osteocalcin, and C-peptides.

Eligibility criteria: Inclusion Criteria:

* Female, age \> 18
* Able to understand and give informed consent
* Relapsing remitting multiple sclerosis (RRMS)
* Treatment with interferons or Copaxone for at least one year prior to study entry

Exclusion Criteria:

* Known osteoporosis
* History of hypercalcemia
* Currently pregnant
* History of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism
* Unstable medical condition
* Ongoing use of bisphosphonates

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: General Clinical Research Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Nancy Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03538106: Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Official title: Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Diabetes Type 1
Cesrean Delivery
Keywords: Cesrean delivery
Risks factors
Diabetes Type 1
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women with diabetes type 1

Brief summary: Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.

Methods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with diabetes type 1
* Pregnancy initiated between 2009 and 2015
* Pregnancy followed up in the universitary hospital center of Montpellier

Exclusion Criteria:

* Women who deliver in an other center
* women with intraperitoneal injections of insulin
* twin gestation
* termination of pregnancy

Primary outcomes:
measure: Risk factors associated with a cesarean delivery in patients with diabetes type 1
timeFrame: 6 years
Secondary outcomes:
measure: Risk factors associated with a planned cesarean delivery in patients with diabetes type 1
timeFrame: 6 years
measure: Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1
timeFrame: 6 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
References:
Clinical trial NCT05906706: Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid
Official title: An Open-Label, Expanded Access Program of Dupilumab in Adult Patients With Bullous Pemphigoid
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Bullous Pemphigoid
Keywords: Skin Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Diseases
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2023-06-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.

Detailed description: Expanded Access requests are only being considered in response to intermediate size patient population applications. Availability will depend on location.

Eligibility criteria: Key Inclusion Criteria:

1. Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553)

Key Exclusion Criteria:

1. Patients who, during the parent dupilumab study, R668-BP-1902 (NCT04206553), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to program drug and which led to discontinuation of investigational product
2. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
3. Treatment with BP-directed biologics, as defined in the protocol
4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
5. Planned or anticipated use of any prohibited medications or procedures during program treatment
6. Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program

NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06659406: Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome
Official title: The Effect of Coenzyme Q10 Supplementation on Oxidative Stress, Inflammation and Hyperandrogenism in Women with Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovarian Syndrome (PCOS)
Keywords: PCOS
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
Collaborators: name: College of Physicians and Surgeons Pakistan
First posted: 2024-10-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are:

Does Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome.

Participants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.


Eligibility criteria: Inclusion Criteria:

* Married Patients that presented with anovulatory infertility due to PCOS.
* Unmarried Patients that presented with symptoms due to PCOS
* All patients should fulfill Rotterdam criteria for PCOS

Exclusion Criteria:

* Male factor infertility ( oligospermia or aspermia)
* Tubal factor infertility (abnormal hysterosalpingography)
* Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function
* Autoimmune and Inflammatory disorders
* Abnormal serum prolactin level
* Smokers
* Alcoholic beverage use
* Use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements

Primary outcomes:
measure: effect of coenzyme q10 administration on polycystic ovary syndrome
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: The effect of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome
timeFrame: from enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Madinah Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Faisalabad
name: Sana Akram, MBBS, FCPS
role: STUDY_DIRECTOR
References:
citation: Hu X, Wang W, Su X, Peng H, Tan Z, Li Y, Huang Y. Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis. PeerJ. 2023 Nov 13;11:e16410. doi: 10.7717/peerj.16410. eCollection 2023.
Clinical trial NCT06793306: A Study Comparing the Differences Between Young and Non-young Breast Cancer
Official title: A Study Comparing the Differences Between Young and Non-young Breast Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During the period from January 2000 to December 2024, the first breast cancer diagnosed and treated in several hospitals in China was in the age range of 18-75 years. Young patients with breast cancer were defined as ≤35 years old, and non-young patients were defined as patients over 35 years old.

Brief summary: To collect data on diagnosis, treatment, survival prognosis, and intrinsic molecular detection of breast cancer in China from January 2000 to December 2024.Compare the difference between young and non-young breast cancer.


Eligibility criteria: Inclusion Criteria:

* During the period from January 2000 to December 2024, the first breast cancer diagnosed and treated in several hospitals in China was in the age range of 18-75 years.

Exclusion Criteria:

* Breast cancer patients under 18 years of age or over 75 years of age; Combined with other malignant tumors; Patients with chronic infectious diseases or chronic infectious diseases; Patients with severe comorbidities, with serious dysfunction of vital organs (heart, liver, kidney); Known history of human immunodeficiency virus; The investigator concluded that patients should not be included in other conditions of this trial.

Primary outcomes:
measure: Overall survival rate
timeFrame: 10-year
Secondary outcomes:
measure: invasive disease-free survival rate
timeFrame: 10-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT01785706: COPD Research Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: COPD Foundation
Sponsor class: OTHER
Collaborators: name: National Jewish Health
First posted: 2013-02-07
Enrollment: 50000
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: Individuals with COPD or at-risk of developing COPD.

Brief summary: The COPD Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. The COPD Foundation is working with National Jewish Health in Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest confidentiality of participant information.


Eligibility criteria: Inclusion Criteria:

-Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD.

Exclusion Criteria:

-Individuals under the age of 18

Primary outcomes:
measure: The COPD Foundation expects to assist at least 8 researchers (with patient recruitment) annually.
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: COPD Foundation
state: Florida
Study officials:
affiliation: National Jewish Health
name: James Crapo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494206: Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Official title: Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Upper Extremity Lymphedema
Keywords: QBX258
human monoclonal antibodies
VAK694
QAX576
15-085
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2015-07-10
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of QBX258, a compound developed by Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with stage I-II breast cancer related lymphedema.


Eligibility criteria: Inclusion Criteria:

* Women 18-70 with unilateral stage I or II BCRL
* Volume difference of at least 300 mL between the normal and lymphedematous limb based on perometry evaluation
* BMI of 18-30
* No current evidence of breast cancer
* At least 6 months postop from axillary lymph node dissection

Exclusion Criteria:

* Bilateral lymphedema or history of bilateral axillary lymph node dissection
* Recent history of cellulitis in the affected extremity (within last 3 months)
* Recurrent breast cancer or other malignancy
* Current (within last month) use of chemotherapy for breast or other malignancy
* Current (within last 3 months) use of radiation for breast or other malignancy
* Recent (within last month) or current intensive MLD and/or short stretch bandage use
* Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
* Pregnant or nursing (lactating) women
* Stage III lymphedema
* Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).

Primary outcomes:
measure: Volume Changes as Measured by Perometry
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Babak Mehara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05216406: Effects of Daily Supplementation of 5-HTP on Body Composition
Official title: Effects of Daily Supplementation of 5-HTP on Body Composition, a Randomized Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Keywords: Body Composition
5-HTP
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
Primary purpose: OTHER

Brief summary: The purpose of this investigation was to compare supplementation with 5-HTP to placebo on indices of body composition. A randomized trial compared a sample of 48 resistance-trained individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo.

The investigators tested anthropometric measurements using a multi-frequency bioelectrical impedance device (InBody® 270). The primary outcome (i.e., changes in anthropometric measurements) was assessed at the first visit (pre-test-) and post-test (8 weeks). Secondary outcomes include resting heart rate, blood pressure, and dietary intake.


Eligibility criteria: Inclusion Criteria:

* Healthy or free of disease
* Minimum of 1 year of regular physical activity. Regular physical activity is defined by a minimum of 150 minutes of aerobic activity or performing muscle-strengthening exercises at least 2 days a week.

Exclusion Criteria:

* Physically inactive
* Regularly used sleep aids of any kind
* Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.

Primary outcomes:
measure: Body Composition
timeFrame: 8 weeks
Secondary outcomes:
measure: Dietary Habits
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 8 weeks
measure: Resting Heart Rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: IHP
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Jose Antonio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maffei ME. 5-Hydroxytryptophan (5-HTP): Natural Occurrence, Analysis, Biosynthesis, Biotechnology, Physiology and Toxicology. Int J Mol Sci. 2020 Dec 26;22(1):181. doi: 10.3390/ijms22010181.
citation: Stamatakis E, Straker L, Hamer M, Gebel K. The 2018 Physical Activity Guidelines for Americans: What's New? Implications for Clinicians and the Public. J Orthop Sports Phys Ther. 2019 Jul;49(7):487-490. doi: 10.2519/jospt.2019.0609.
citation: Cangiano C, Ceci F, Cairella M, Cascino A, Del Ben M, Laviano A, Muscaritoli M, Rossi-Fanelli F. Effects of 5-hydroxytryptophan on eating behavior and adherence to dietary prescriptions in obese adult subjects. Adv Exp Med Biol. 1991;294:591-3. doi: 10.1007/978-1-4684-5952-4_73. No abstract available.
Clinical trial NCT04270006: Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis
Official title: Effect of Adipose Derived Stem Cells Exosomes as an Adjunctive Therapy to Scaling and Root Planning in the Treatment of Periodontitis: A Human Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Periodontitis
Keywords: Periodontitis
SRP
ADSCs
Exosomes
treatment
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.


Eligibility criteria: Inclusion Criteria:

* Advanced periodontitis (Stage III or IV)
* Healthy patients.

Exclusion Criteria:

* Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.

Primary outcomes:
measure: change in gingival inflammation
timeFrame: 0, 3 and 6 months
measure: change in pocket depth
timeFrame: 0, 3 and 6 months
measure: change in attachment level
timeFrame: 0, 3 and 6 months
measure: change in Bone level
timeFrame: 0 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Lecturer of Oral Medicine , Oral diagnosis and Periodontology , Faculty of Dentistry, Beni- Suef University.
name: Ebtehal Mohammed, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University
name: Nesrine Mohammed Khairy, Associated Professor
role: STUDY_DIRECTOR
affiliation: Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.
name: Noha Saleh Mohammed, Associated
role: STUDY_DIRECTOR
affiliation: Biochemistry, Faculty of Medicine, Cairo University
name: Dina Sabry, Professor
role: STUDY_DIRECTOR
References: