louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04847882: Case-control Study of Sleep Disorders in Children With Cystic Fibrosis
Official title: Sleep Disorders in Patients Aged From 6 to 17 With Cystic Fibrosis: a Single-center Case-control Study at Strasbourg University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Sleep Disorder
Keywords: Children
Case control study
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 6 to 17 years with cystic fibrosis for the case group and children with an emergency surgical consultation for the control group

Brief summary: Our primary purpose is to compare the prevalence of sleep disorders in children aged 6 to 17 with cystic fibrosis versus controls with a Sleep disorder screening score, the SDSC. Our hypothesis is that patients aged 6 to 17 with cystic fibrosis have a higher prevalence of sleep disturbances than the general population of the same age group.

Our secondary hypothesis is that these sleep disorders are mixed and that there are non-respiratory causes, sometimes modifiable by simple non-medical treatment and that's why our secondary purpose is to identify the responsible factors, in particular non-respiratory factors in the 2 groups and to compare them.


Eligibility criteria: Inclusion criteria for the case group :

* Cystic fibrosis followed at the pediatric (Centre de Ressources et de Compétences de la Mucoviscidose) in Strasbourg
* Aged from 6 to 17 years old
* Non hospitalized
* Able to read and understand French language
* Accompanied by at least one of his parents

Inclusion criteria for the control group :

* Emergency surgical consultation
* Aged from 6 to 17 years old
* Non hospitalized
* Able to read and understand French langage
* Accompanied by at least one of his parents

Exclusion criteria:

* Children under 6 years old
* Children over 17 years old
* Children and parents who don't understand or can't read French language
* Hospitalized children
* Children unaccompanied by their parents

Primary outcomes:
measure: Questionnaire SDSC
timeFrame: 15 minutes
Secondary outcomes:
measure: Questionnaire SDSC
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaire de Strasbourg
Study officials:
References:
Clinical trial NCT00156182: A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.
Official title: A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leiomyoma
Keywords: Fibroid Uterus
Leiomyoma
Uterine Fibroids
asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

Detailed description: No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Eligibility criteria: Inclusion Criteria:

* Completed dosing and Day 84 procedures at sites in study M99-144
* No interruption of dosing
* Otherwise continued good health

Exclusion Criteria:

* Any abnormal lab result the study-doctor considers significant
* History of severe reaction to or current use of hormone therapy
* History of alcohol or drug abuse

Primary outcomes:
measure: Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
timeFrame: Treatment months 3 and 6 and Post-treatment months 3 and 6
measure: Percentage of subjects that achieved amenorrhea.
timeFrame: Treatment months 1-6
Secondary outcomes:
measure: Improvement in hematologic parameters.
timeFrame: Treatment months 2,4,and 6
measure: Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale
timeFrame: Treatment Months 1-6
measure: Change from baseline in uterine size in gestational weeks.
timeFrame: Months 3 and 6
measure: Duration of amenorrhea.
timeFrame: Start of previous study to first post-treatment menses.
measure: Response to global efficacy question regarding improvement of fibroid symptoms.
timeFrame: Month 6
measure: Mean change from baseline for endocrine determinations.
timeFrame: Months 2,4 and 6
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References:
Clinical trial NCT04494282: The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
Official title: The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pseudocyst Pancreas
Pancreatic Duct Disorder
Keywords: Pancreatic Pseudocyst
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random control trial
Primary purpose: DIAGNOSTIC

Brief summary: Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.

Detailed description: METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent will be explained and signed. In those patients who ERP fails, a second attempt will be performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance cholangiopancreatography will be performed (Group 2).

Eligibility criteria: Inclusion Criteria:

1. Pancreatic pseudocyst that fulfilled the Atlanta Classification
2. Symptomatic pancreatic pseudocyst
3. Informed consent obtained

Exclusion Criteria:

1. Patient unwilling to participate
2. Absence of duration time of the pancreatography procedure in the record
3. Absence of the number of weeks between the drainage and the pancreatography

Primary outcomes:
measure: The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01756482: Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)
Official title: Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory
Syncytial
Virus
Infections
RSV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-12-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female
* Between 18 to 45 years old
* Body Mass Index of 18 to 33 kg/m2

Exclusion Criteria:

* Acute or chronic medical illness
* Positive for Human Immunodeficiency Virus, Hepatitis B or C
* Nose or nasopharynx abnormalities
* Abnormal lung function

Primary outcomes:
measure: Change in viral load measurements.
timeFrame: Post initial dose of GS-5806/placebo to Day 12
Secondary outcomes:
measure: Change of baseline symptoms
timeFrame: Innoculation through Day 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Retroscreen Virology
Study officials:
affiliation: Retroscreen Virology
name: Adeyi Adeyemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, Ramanathan S, O'Riordan T, Lewis SA, Li X, Toback SL, Lin SL, Chien JW. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014 Aug 21;371(8):711-22. doi: 10.1056/NEJMoa1401184.
Clinical trial NCT05980182: Engaging Black Men in Colorectal Cancer Screening
Official title: SUCCEED: Engaging Black Men in Colorectal Cancer Screening (CRC) Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
CRC
Behavior
Keywords: Colorectal Screening behaviors
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-08-07
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/ Black men use of colorectal cancer screening and describe how community leaders such as barbers may act as Community Champions to educate and facilitate screening participation.


Eligibility criteria: Inclusion Criteria:

* Adult men
* Identify as Black or African American
* Work or live in Petersburg, VA or surrounding counties
* Eligible for colorectal cancer (CRC) screening at time of study enrollment

Exclusion Criteria:

* Inability to speak or read English
* Currently up-to-date with CRC screening

Primary outcomes:
measure: Colorectal Screening Status
timeFrame: 3 Months
Secondary outcomes:
measure: Determine feasibility of Mobile Health (mHealth) Application -Enrollment
timeFrame: Week 1
measure: Determine the feasibility of the mHealth Application-Videos
timeFrame: Week 1
measure: Determine the feasibility of the mHealth Application- Retention
timeFrame: Baseline (Day 1), Week 2, and Week 12
measure: Determine the feasibility of the mHealth Application- Clinic/ Screening Request
timeFrame: Week 12
measure: Determine the feasibility of the mHealth Application - Sharing Content
timeFrame: Week 12
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealt University
name: Maria Thomson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06392282: MV-140 Efficacy in Recurrent Urinary Tract Infections in a Cohort of Portuguese Adult Patients
Official title: MV-140 Efficacy in Recurrent Urinary Tract Infections
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urinary Tract Infections
Keywords: Urinary tract infections
immunotherapy
MV-140
Lead sponsor: Unidade Local de Saúde Santa Maria
Sponsor class: OTHER_GOV
First posted: 2024-04-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients consulted at Urology clinic with recurrent UTIs

Brief summary: We will access the efficacy of MV-140 immunotherapy in the prevention of recurrent urinary tract infections in a cohort of Portuguese patients.

Detailed description: Urinary tract infections represent a highly frequent and debilitating disease, responsible for an extensive use of antibiotics for treatment and prophylaxis. Non-antibiotic therapies, such as oral vaccines, have been developed, in order to avoid antibiotic use. MV-140 is a sublingual vaccine comprised of 4 inactivated bacteria - E. coli, K. pneumoniae, E. faecalis and Proteus vulgaris. It is approved for the prevention of recurrent UTIs, with promising results in the few published results to date. The efficacy of this tool in the Portuguese population is, however, still unknown. Since the prevalence of pathogens responsible for infections and overall antibiotic use are highly variable worldwide, the results of studies conducted so far are not directly applicable in other regions. Therefore, we designed the present study which aims at assessing the efficacy of immunotherapy with MV-140 In the Portuguese population. It is a prospective observational study, in which patients will be asked to report their condition before and 1 year after therapy.

Eligibility criteria: Inclusion Criteria:

* At least 3 positive urine culture UTIs in the preceding 12 months
* Ability to understand and fill the informed consent

Exclusion Criteria:

I. History of genitourinary tumours II. Urinary lithiasis III. Immunodeficiency IV. Pregnancy V. Simultaneous use of any other urinary tract prevention vaccines or prophylactic antibiotics

Primary outcomes:
measure: UTI episodes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
Study officials:
References:
Clinical trial NCT02312882: Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Official title: Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

Detailed description: This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old
* Diagnosis of alopecia areata with \>50% scalp involvement, alopecia totalis, or alopecia universalis
* Hair loss present for at least 6 months
* No treatment for alopecia areata in past 2 months
* No evidence of hair regrowth
* Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
* Fluent in spoken and written English

Exclusion Criteria:

* Age \<18 years old
* Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
* Patients known to be HIV or hepatitis B or C positive
* Patients with positive tuberculin skin test or positive QuantiFERON TB test
* Patients with leukopenia or anemia
* Patients with renal or hepatic impairment
* Patients with peptic ulcer disease
* Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
* Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
* Women who are pregnant or nursing

Primary outcomes:
measure: Percent Change in Severity of Alopecia Tool (SALT) Score
timeFrame: 0 and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anthony E Oro, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kennedy Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge MC, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776.
Clinical trial NCT00433082: Metabolic Syndrome and Inflammatory Markers
Official title: Effect of Fasting With Two Meals on Inflammatory Markers of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome,Ramadan,Fasting,Inflammatory markers,
Iran
Lead sponsor: Free Islamic University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-02-09
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The metabolic syndrome has been recognized as a proinflammatory state. It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, may be effective in improving the metabolic syndrome. Our objective was to evaluate the effect of Ramadan fasting on High-sensitive C-reactive protein (hs-CRP) and fibrinogen levels in metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Males with metabolic syndrome

Exclusion Criteria:

* Conditions with insulin resistance including;
* Type 2 diabetes mellitus,
* Infections,
* Stresses,
* Uremia,
* Acromegaly,
* Glucocorticoid excess,
* Hypertension ,
* Cirrhosis and
* Any addiction or drug therapy and conditions witch cause changes in hs-CRP and fibrinogen levels including infection, trauma, infarction, inflammatory arthritis, various neoplasm and liver diseases.

Primary outcomes:
measure: Measuring inflammatory markers in metabolic syndrome
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Islamic Free University of Medical Science
name: Zahra Vahdat Shariatpanahi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803582: Effectiveness of Acupuncture for Phonotraumatic Injuries
Official title: Effectiveness of Acupuncture for Phonotraumatic Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Phonotraumatic Injuries
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-12-05
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of acupuncture for the treatment of phonotraumatic lesions of the vocal folds, using the International Classification of Functioning Disability and Health (World Health Organization, 2001) as the conceptual framework to guide the selection of outcome measures.

Detailed description: The experimental hypothesis for this study is that needling at the designated treatment acupoints will bring about greater improvement in structural and functional impairment in the vocal folds and its sequelae, as compared to placebo treatment. However, it is further hypothesized that treatment benefits from acupuncture will be outweighed by continued phonotrauma following termination of treatment, and thus will not be maintained at long-term follow-up. Further, it is expected that voice-related quality-of-life improvements may be equal for genuine acupuncture as compared to placebo. Finally, it is hypothesized that the acupuncture protocol should have comparable effects for male and female subjects.

Eligibility criteria: Inclusion Criteria:

1. Otolaryngological diagnosis within the preceding 15 days of swelling or thickening of at least one vocal fold, or nodules, fibrous mass, cyst, polyp, or chronic (non-infectious) laryngitis, which by history are traceable to phonotrauma and by history appear stable or worsening;
2. age 20-55 yr

Exclusion Criteria:

1. no prior voice therapy;
2. no medication or therapy that may affect voice during the period of participation;
3. no acupuncture treatment for any condition within the preceding 10 year;
4. no diagnosed or suspected neurological conditions, hearing loss (i.e. hearing threshold of the better ear not exceeding 35dB HL at 250 Hz, 500 Hz, 1000 Hz, 4000 Hz and 8000 Hz), history of asthma, and no upper respiratory infection at the time of recruitment.

Primary outcomes:
measure: Maximum fundamental frequency of the voice range profile
timeFrame: Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment
Secondary outcomes:
measure: Voice Activity and Participation Profile
timeFrame: Pre-treatment, Mid-treatment, Post-treatment, 2 weeks post-treatment, 4 weeks post-treatment, 3 months post-treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Voice Research Laboratory, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Edwin Yiu, Prof
role: PRINCIPAL_INVESTIGATOR
References: