louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01556698: Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
Official title: Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Acne
Keywords: Acne Vulgaris
Acne
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.

Detailed description: The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.

Eligibility criteria: Inclusion Criteria:

* Baseline IGA score of moderate (3) or severe (4)
* Minimum of 20 but no more than 40 facial inflammatory lesions
* Minimum of 20 but not more than 60 facial non-inflammatory lesions
* No more than 2 facial nodules

Exclusion Criteria:

* Dermatological conditions on the face that could interfere with clinical evaluations
* Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
* History of experiencing significant burning or stinging when applying any facial treatment
* Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
* Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
* Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
* Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
* Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatologico
Study officials:
affiliation: Instituto Dermatológico
name: Daisy Blanco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03320798: Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients
Official title: Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Pemphigoid
Keywords: Bullous pemphigoid
neurologic disorders
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting bullous pemphigoid and consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011.

Brief summary: Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic disorders, which represent a major risk factor of the disease

Detailed description: The aim was to determine whether neurologic disorders, especially dementia, influences outcome and mortality of patients with bullous pemphigoid.

Eligibility criteria: Inclusion Criteria:

* patients presenting bullous pemphigoid using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria of Vaillant et al., subepidermal blister on skin biopsy and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF
* patients consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011

Primary outcomes:
measure: neurological disease
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT03203798: Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence
Official title: Effects of Pelvic Floor Muscle Training or Hipopressive Abdominal Gymnastics in the Treatment of Women's Stress Urinary Incontinence: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the current scientific literature, it is clear that SUI can cause several social, hygienic and personal relationship problems. It has also been proven that this condition affects many more menopausal women than menacme, and this is believed to be due to the hypoestrogenism characteristic of this phase.

On the other hand, weakness of the pelvic floor muscles (PFM) is also related to the genesis of SUI. The role of these muscles would be to keep the bladder neck elevated (above the pubic symphysis) during increases in abdominal pressure, and its weakness would lead to excessive lowering of the bladder neck at these times, leading to SUI due to bladder neck hypermobility.

The conservative treatment of this condition, therefore, encompasses the strengthening of PFMs, which would avoid excessive descent of the bladder neck during increases in abdominal pressure, thereby reducing urinary loss.

In the current literature there are studies proving the effectiveness of pelvic floor muscle training; however, in relation to the literature on abdominal hipopressive gymnastics, it is observed that the scientific evidence is still poor, however, the technique is still Widely spread through extension courses offered throughout Latin America, France and Spain; With regard to the comparison of these methods with respect to their clinical efficacy and the quality of life and patient satisfaction, there are no consistent studies, and this fact motivated us to carry out this study.


Eligibility criteria: Inclusion Criteria:

* Women with IUE and with a modified Oxford scale of at least 1.

Exclusion Criteria:

* Presence of neuromuscular diseases
* Uncontrolled diabetes

Primary outcomes:
measure: Check for modification on modified oxford scale
timeFrame: two months
measure: Check for modification on Perineometry
timeFrame: two months
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire Short Form
timeFrame: two months
measure: Pelvic Floor Impact Questionnaire (PFIQ-7) Floor Impact Questionnaire (PFIQ-7)
timeFrame: two months
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: two months
measure: Void diary
timeFrame: two months
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Luciene Aparecida José Vaz
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Luciene Aparecida Vaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734798: Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Official title: Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Locally Advanced Bladder Cancer
Keywords: locally advanced bladder cancer
Postoperative radiotherapy
Adjuvant chemotherapy
Radical Cystectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.


Eligibility criteria: Inclusion Criteria:

* Patients not more than 70 years old.
* Radical cystectomy performed within 42 days with no microscopic or macroscopic residual after surgery (negative surgical safety margins)
* Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN)
* ECOG Performance Scale (0-2).
* Adequate liver functions.
* Adequate renal function serum (creatinine \< 1.5 mg).
* No evidence of distant metastasis or other malignancy.

Exclusion Criteria:

* patients who received radiotherapy or chemotherapy prior to radical cystectomy

Primary outcomes:
measure: Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy
timeFrame: Five-year overall and disease-free survival.
Secondary outcomes:
measure: comparison of the Local recurrence rate in the three Arms
timeFrame: Five year local pelvic control rate
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer Institute-Cairo University
Study officials:
References:
citation: Zaghloul MS, Christodouleas JP, Smith A, Abdallah A, William H, Khaled HM, Hwang WT, Baumann BC. Adjuvant Sandwich Chemotherapy Plus Radiotherapy vs Adjuvant Chemotherapy Alone for Locally Advanced Bladder Cancer After Radical Cystectomy: A Randomized Phase 2 Trial. JAMA Surg. 2018 Jan 17;153(1):e174591. doi: 10.1001/jamasurg.2017.4591. Epub 2018 Jan 17.
Clinical trial NCT02851498: Use of Novel High-protein Food Products To Reduce Insulin Resistance
Official title: Use of Novel High-protein Food Products to Reduce Insulin Resistance in Adults With an Elevated Triglyceride/HDL Ratio
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Inflammation Research Foundation
First posted: 2016-08-01
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This controlled weight loss trial in adults at cardiometabolic risk (elevated triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel, high-protein pasta and cereal to examine the physiological impact of stealth substitution of dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal) was matched with conventional flaked cereal. Participants were instructed to follow an energy restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a 24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well as changes in in insulin sensitivity and common blood biomarkers.


Eligibility criteria: Inclusion Criteria:

* 20-75 years of age
* BMI 23-42 kg/m2

Exclusion Criteria:

* food allergies
* diet restrictions (e.g., vegetarian, gluten or lactose intolerant)
* insulin use
* cigarette use
* active disease states including diagnosed diabetes
* anticipated changes to diet or physical activity levels
* recent weight gain or loss (±10 pounds)
* current or recent pregnancy or lactation
* prescription medication use by participants was allowed if use had been consistent

Primary outcomes:
measure: Insulin resistance
timeFrame: 6 weeks
measure: Body composition
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05992298: Feasibility Testing of 7-Tesla Magnetic Resonance Imaging
Official title: Explorative Technical Feasibility Testing of 7-Tesla Magnetic Resonance Imaging of the Musculoskeletal System and of the Head
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of the current project is to explore and develop the technical feasibility of non-invasive imaging of the human musculoskeletal system and head with the first 7T MR scanner with a CE mark to identify areas where the higher field promises significant benefits in qualitative image quality. For a subset of the planned exams, state-of-the art 7T or 3T images will be used as standard of reference to comparatively gauge the qualitative image quality of the investigational 7T images.


Eligibility criteria: Inclusion Criteria:

* Consent to undergo a 7T (and, if appropriate a comparative 3T) MRI exam.
* For some of the consistent small series: presence of a specific condition of the musculoskeletal system or of the head. This can include traumatic or degenerative changes, e.g., of tendons, cartilage, muscle, peripheral nerves, ligaments, and bones, or in the brain, as well as focal lesions, e.g., tumors.

Exclusion Criteria:

* Contraindications to undergo a MRI examination at a field strength of 7 Tesla or at 3 Tesla.
* Irregular anatomy and/or tissue properties
* Inability to consent - for any reason.
* Body mass above 200 kg.
* Body mass below 30 kg.
* Women: pregnancy.
* Age below 18.
* Known or suspected non-compliance, drug or alcohol abuse.
* Inability to follow the procedures of the study.

Primary outcomes:
measure: Qualitative image quality of 7 T MRI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Reto Sutter, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01885598: Eliquis Regulatory Post Marketing Surveillance
Official title: Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NonValvular Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 3335
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting outpatient department of hospital

Brief summary: The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients ≥19 years of age
* Adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating Eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism
* Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

* Receiving Eliquis treatment for an indication that is not approved in Korea
* Contraindicated for the use of Eliquis as described in the Korean label

Primary outcomes:
measure: Adverse events (AE) occurrence based on Incidence of serious adverse events, unexpected adverse drug reactions, Identification of AE profile in usual practice Nonserious adverse events, major bleeding
timeFrame: within 30 days after end of the treatment
Secondary outcomes:
measure: Final identification of major events and no event based on Incidence of stroke, systemic embolism, death, Effectiveness or death at 24 months after discontinuation of therapy or at the end of the observation period (whatever is later)
timeFrame: At 3, 6, 12, and 24 months after enrollment
measure: Final evaluation of clinical significance of Eliquis is provided by the physician's subjective decision (Excellent, Good, Moderate, Insufficient)
timeFrame: At 3, 6, 12, and 24 months after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Kim JS, Koo J, Shin DI, Kim BS, Kim J, Kim EG, Hong KS, Yi H. Apixaban for Secondary Stroke Prevention: Coexistant Cerebral Atherosclerosis May Increase Recurrent Strokes. J Stroke. 2022 Jan;24(1):118-127. doi: 10.5853/jos.2021.02355. Epub 2022 Jan 31.
Clinical trial NCT01203098: A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Official title: A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Thromboembolism
Thrombosis
Embolism and Thrombosis
Deep Vein Thrombosis
Arthroplasty, Replacement, Hip
Keywords: prevention
venous thromboembolism
edoxaban
anticoagulants
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 264
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing unilateral total hip arthroplasty
2. Patients who are 20-84 years olds

Exclusion Criteria:

1. Subjects with risks of hemorrhage
2. Subjects with thromboembolic risks
3. Subjects who weigh less than 40 kg
4. Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Primary outcomes:
measure: Percentage of Subjects With Venous Thromboembolism Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
city: Kaohsiung
country: Taiwan
Study officials:
affiliation: Osaka Koseinenkin Hospital
name: Takeshi Fuji
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. J Arthroplasty. 2014 Dec;29(12):2439-46. doi: 10.1016/j.arth.2014.05.029. Epub 2014 Jun 9.
Clinical trial NCT02497898: Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma
Official title: A Randomized Controlled Clinical Trial of Cytokine-induced Killer (CIK) Cells Treatment in Patients With Refractory Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 1000
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 purpose of this study is to study the safety and efficacy of chemotherapy usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.

Detailed description: Autologous cytokine-induced killer (CIK) cells transfusion(\>2\*10\^9 cells count) within 2 weeks after regular chemotherapy every 3 months.

Eligibility criteria: Inclusion Criteria:

* diagnosed as non-Hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy

Exclusion Criteria:

* patients refuse the therapy or have no tolerance for the therapy

Primary outcomes:
measure: Progression-Free-Survival (PFS)
timeFrame: 1 month
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 1 month
Other outcomes:
measure: Lactic Dehydrogenase (LDH)
timeFrame: 1 month
Locations:
Study officials:
References: