louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02749786: Genetic Basis of Rosacea Study (Control)
Official title: Expansion Arm of Papulopustular Rosacea Gene Expression Profiling to Include Normal Individuals as Anatomic Site Specific Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 10
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: Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigator hopes to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.


Eligibility criteria: Inclusion criteria include:

1. Fitzpatrick skin type II or III
2. Age greater than or equal to 18 years
3. Individuals without a history of rosacea

Exclusion criteria include:

1. Women who are pregnant or lactating
2. Use of topical prescription medications or procedures to the face within one month of enrollment
3. Skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)

Primary outcomes:
measure: Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea.
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Dermatology
state: California
Study officials:
affiliation: Stanford University
name: Anne Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380886: Growth and Tolerance of Young Infants Fed Infant Formulas
Official title: Growth and Tolerance of Young Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant Newborn
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 209
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.


Eligibility criteria: Inclusion Criteria:

* healthy infant
* full term
* birth weight \> 2490 g
* 0 to 8 days of age
* parent/physician agree to not use medications affecting tolerance/growth
* parent agrees to sole source feeding of study formula
* parent agrees to not use vitamin/mineral supplements
* parent has signed consent/HIPAA authorization

Exclusion Criteria:

* any maternal, fetal, or infant history affecting growth and tolerance
* participation in any other study not preapproved by Abbott

Primary outcomes:
measure: Weight gain
timeFrame: 119 days
Secondary outcomes:
measure: gastrointestinal tolerance
timeFrame: 119 days
measure: Anthropometric variables
timeFrame: 119 days
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance, LLC
state: Florida
city: Indianapolis
country: United States
facility: Northpoint Pedicatrics, LLC
state: Indiana
city: Owensboro
country: United States
facility: Springs Medical Research, LLC
state: Kentucky
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Cary
country: United States
facility: Cary Pediatric Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association, INC.
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Parma
country: United States
facility: The Cleveland Pediatric Research Center
state: Ohio
city: Sioux Falls
country: United States
facility: Sanford Clinic Family Medicine
state: South Dakota
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03570086: Multiparametric Diagnostic Model of Thick-section Clinical-quality MRI Data in Detecting Migraine Without Aura
Official title: Multiparametric Diagnostic Model of Thick-section Clinical-quality MRI Data in Detecting Migraine Without Aura
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine Without Aura
Lead sponsor: Xidian University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 migraineurs without aura 200 age- and gender-matched health controls (HCs)

Brief summary: Recently, radiomics combined with machine learning method has been widely used in clinical practice. Compared with traditional imaging studies that explore the underlying mechanisms, the machine learning method focuses on classification and prediction to propose personalized diagnosis and treatment strategies. However, these studies were based on thin-section research-quality brain MR imaging with section thickness of \< 2 mm. Clinical, the usage of thick-section clinical setting instead of thin-section research setting is especially important to shorten the acquisition time to reduce the patient's suffering. Here investigators want to build multiparametric diagnostic model of migraineurs without aura using radiomics features extracted from thick-section clinical-quality brain MR images.


Eligibility criteria: Inclusion Criteria:

* right-handed
* International Headache Society criteria for episodic migraine without aura

Exclusion Criteria:

* addition (including alcohol, nicotine, or drug)
* physical illness

Primary outcomes:
measure: accuracy
timeFrame: 2018.7-2019.12
measure: sensitivity
timeFrame: 2018.7-2019.12
measure: specificity
timeFrame: 2018.7-2019.12
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT03611686: Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies
Official title: Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Prostate Adenocarcinoma
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 219
Sex: MALE
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 with metastatic prostate adenocarcinoma resistant to castration

Brief summary: Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration


Eligibility criteria: Inclusion Criteria:

* Patient monitored for castration-resistant metastatic prostate
* Patients starting a first or second line treatment as part of castration resistance
* Patient not objecting to the study after reading the information letter
* Patient aged over 18 years

Exclusion Criteria:

* Patient monitored for non-metastatic prostate cancer
* Patient monitored for castration-nonresistant prostate cancer
* Patient not able to understand the information letter

Primary outcomes:
measure: Number of alive patient
timeFrame: 3 years
Secondary outcomes:
measure: Number of alive patient disease free
timeFrame: 3 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Christian PFISTER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391386: Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique
Official title: Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Tube Bonding
Keywords: molar tube
failure rate
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparing between the failure rates of molar tubes bonded with conventional bonding technique using resin adhesive and the alternative bonding technique using compomer (containing glass ionomer) adhesive by adding a layer of compomer adhesive at the molar/tube interface.


Eligibility criteria: Inclusion Criteria:

1. Patients requiring fixed appliance orthodontic treatment (with no previous orthodontic treatment).
2. Patients aged \>12 years with full permanent dentition (excluding third molars).
3. Intact buccal enamel surface of the molars without any of the following:

   * Caries, abrasion, or any other crown defect (like hypoplasia).
   * Pretreatment chemical agents.
   * Restorations or fractures.
   * Morphological modifications or other crown alterations.
4. Patients who have the desire and ability to comply with the trial protocol.

Exclusion Criteria:

1. Treatments with planned extraction of first permanent molars.
2. Occlusal interference that prevents correct position of molar tube.
3. Patients with a craniofacial anomaly (like cleft lip and palate) and/or require orthognathic surgery.
4. Patients that require extra-oral or intra-oral anchorage device (headgear, palatal arch, lingual arch) or expander (quad-helix, hyrax).
5. Lack of consent to participate in the trial.

Primary outcomes:
measure: failure rate of molar tubes
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karbala
country: Iraq
facility: Almina Dental Clinic
Study officials:
affiliation: MSc student
name: nawar m hasan, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vale E Nascimento AE, Bramante FS, Pinzan-Vercelino CR, Pinzan A, Gurgel JA. Resin reinforcement: an alternative approach for direct bonding of molar tubes. J Clin Orthod. 2014 Jul;48(7):436-40. No abstract available.
citation: Pinzan-Vercelino CR, Pinzan A, Gurgel Jde A, Bramante FS, Pinzan LM. In vitro evaluation of an alternative method to bond molar tubes. J Appl Oral Sci. 2011 Jan-Feb;19(1):41-6. doi: 10.1590/s1678-77572011000100009.
Clinical trial NCT04537286: First-line Nab-paclitaxel Plus Cisplatin Plus Carilizumab in mTNBC Patients
Official title: A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 90
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: To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Female patients aged 18-70 years who had
2. Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
5. At least one measurable lesion according to RECIST 1.1,
6. ECOG performance status ≤ 1
7. Life expectancy of more than 12 weeks
8. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Patient of childbearing potential but unwilling to receive contraception.
2. Radiation therapy of axial bone within 4 weeks before enrollment.
3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
4. Patients have active autoimmune diseases.
5. Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
8. Uncontrolled infection.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03185286: 3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Official title: 3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Diseases
Keywords: 3D printing, metal implant, bone defect
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.

Detailed description: Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.

The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.

Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.

Eligibility criteria: Inclusion Criteria:

* Receive ankle or subtalar arthrodesis;
* Refuse to use autologous bone graft or allogeneic bone graft.

Exclusion Criteria:

* The local defect area is small;
* Refuse to use permanent metal metal implant.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Postoperative 24 months
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
timeFrame: Postoperative 24 months
measure: Lower limb alignment
timeFrame: Postoperative 24 months
measure: Osteotylus growth
timeFrame: Postoperative 24 months
measure: Implant displacement
timeFrame: Postoperative 24 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Xiaojun Duan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595686: Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
Official title: A Phase 1, Open-label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Neoplasms
Keywords: Hematologic Malignancies Hsp90 Hematologic Malignancy
Lead sponsor: Esanex Inc.
Sponsor class: INDUSTRY
Collaborators: name: Serenex, Inc.
First posted: 2008-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Karnofsky performance status \> 60
* confirmed hematological malignancy
* refractory to available therapy or for which no therapy is available
* adequate hepatic, renal and hematological function

Exclusion Criteria:

* CNS malignancy
* at risk for prolonged QT interval
* significant GI/liver disease
* other serious concurrent illness or medical condition

Primary outcomes:
measure: adverse events and other safety assessments
timeFrame: continuous
Secondary outcomes:
measure: disease response specific to the hematological malignancy
timeFrame: after every 2 cycles
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03963986: Impacts of Remote Digital Support on Physical Activity for Patients in Bariatric Surgery
Official title: Impacts of Remote Digital Support on Adapted Physical Activity for Patients in Pre-bariatric Surgery Care Pathways
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Keywords: Regular physical activity
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to the STANDARD group for which management will be standard or to the STIMUL group with digital coaching program
Primary purpose: PREVENTION

Brief summary: Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months

Detailed description: Regular physical activity (PA) is a key element in the success of bariatric surgery and the prevention of complications associated with frequent co-morbidities. However, the levels of PA observed in patients who will benefit from bariatric surgery are generally low, and many patients do not comply with the recommendations of their course in terms of PA. It is envisaged that coaching interventions and adapted programs can improve the level of PA. The objective of this pilot study is to evaluate the effectiveness and adherence to digital tools on the level of PA in preparation for bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Patient aged 30 to 50 years.
* Candidate for bariatric surgery within 4 to 6 months of inclusion: BMI \>40 kg/m² or BMI 35-40 kg/m² with obesity-related comorbidity
* Ability to follow the STIMUL education program focused on adapted physical activity
* Has and knows how to use a computer connected to the Internet or mobile phone
* Ability to understand, read and write French

Exclusion Criteria:

* • Contra-indication to the practice of sport

  * refusal to participate in the study
  * refusal to participate in the study

Primary outcomes:
measure: Ricci-Gagnon score (9-45)
timeFrame: month 4
Secondary outcomes:
measure: Ricci-Gagnon score (9-45)
timeFrame: 10 and 16 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 4, 10 and 16 months
measure: Body masse Index (BMI) (kg/m²)
timeFrame: 4, 10 and 16 months
measure: Waist circumference (cm)
timeFrame: 4, 10 and 16 months
measure: Hip circumference (cm)
timeFrame: 4, 10 and 16 months
measure: Lipid balance (g/l)
timeFrame: 4, 10 and 16 months
measure: Blood pressure (mmHg)
timeFrame: 4, 10 and 16 months
measure: Quality of Life, Obesity and Dietetics Scale(EQVOD)
timeFrame: 4, 10 and 16 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Créteil
Study officials:
References: