louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01376284: Drug Use Investigation for AVOLVE(BPH)
Official title: Drug Use Investigation for AVOLVE(BPH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 1000
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese male adult subjects with benign prostatic hyperplasia (BPH) who start the treatment with dutasteride capsules

Brief summary: The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.


Eligibility criteria: Inclusion Criteria:

* Must be male subjects
* Use dutasteride capsules for the first time

Exclusion Criteria:

* Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
* Subjects with severe hepatic function disorder
* Dutasteride capsules shall not be used to female or child

Primary outcomes:
measure: The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04455984: Multimodality Treatment Including Curative Resection of Advanced NSCLC
Official title: Multimodality Treatment Including Curative Resection of Advanced Stage Non-small Cell Lung Cancer - an Explorative, Retrospective Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Non-small-cell Lung Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic Surgery, Medical University.

Brief summary: This study retrospectively evaluates clinical parameters and outcome of patients with advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by curative-intent surgery at the Divison of Thoracic Surgery at the Medical University of Vienna

Detailed description: This study will be undertaken as a retrospective cohort study at Devision of Thoracic Surgery, Medical University of Vienna. All patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic Surgery, Medical University, will be included. The aim of this study is to evaluate peri- and postoperative clinical parameters and short- and long-term outcomes in patients.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced NSCLC and multimodality treatment including curative-intent resection

Exclusion Criteria:

* Patients with early stage NSCLC
* Patients with advanced NSCLC without multimodality treatment
* Patients without curative resection

Primary outcomes:
measure: Overall survival
timeFrame: 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT00809484: Arimidex Bone Mass Index and Oral Bisphosphonates
Official title: A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Bone Density
Keywords: Arimidex
Bone Mineral density
Bisphosphonates
Aromatase Inhibitors
Lead sponsor: Hellenic Breast Surgeons Society
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Posmenopusal women with endocrine responsive breast cancer who are treated with the aromatase inhibitor anastrozole

Brief summary: To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score \<-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score \<-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* ER and or PgR positive breast cancer
* Completed Surgery and =/- chemotherapy

Exclusion Criteria:

* metastases
* history of fractures
* HRT or SERMs
* Liver or kidney disfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Breast Surgeons Society
Study officials:
References:
citation: Markopoulos C, Tzoracoleftherakis E, Polychronis A, Venizelos B, Dafni U, Xepapadakis G, Papadiamantis J, Zobolas V, Misitzis J, Kalogerakos K, Sarantopoulou A, Siasos N, Koukouras D, Antonopoulou Z, Lazarou S, Gogas H. Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial. Breast Cancer Res. 2010;12(2):R24. doi: 10.1186/bcr2565. Epub 2010 Apr 16.
Clinical trial NCT01915784: Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Patients With COPD
Official title: Study Evaluating Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2013-08-05
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD


Eligibility criteria: Inclusion Criteria:

* Adult male or female patients aged ≥40 years with stable moderate-to-severe COPD according to the GOLD Guidelines classification (grades II and III): forced expiratory volume in 1 second (measured between 10 to 15 minutes post-inhalation of 400 μg of salbutamol) is 30%≤FEV1\<80% of the predicted normal value
* Patients naïve to both study inhaler devices, Genuair® and Breezhaler®, for at least 2 years
* Agreement to participate and voluntarily sign the informed consent form

Exclusion Criteria:

* Patients with other clinically significant uncontrolled chronic diseases, particularly body malformations or diseases affecting coordination and/or motor system
* Patients unable to read product package instructions and answer patient reported questionnaires (PASAPQ)
* Patients with any other serious or uncontrolled mental health problems
* Patients currently participating in other randomised clinical studies
* Patients with COPD exacerbation within 6 weeks before Visit 1 and patient hospitalised for COPD exacerbation within 3 months prior to Visit 1
* Patients with any other conditions that, in the investigator's opinion, might indicate the patient to be inappropriate for the study
* Patient likely to be uncooperative

Primary outcomes:
measure: Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2
timeFrame: 14 Days
Secondary outcomes:
measure: Mean for the overall satisfaction score with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2
timeFrame: 14 Days
measure: Percentage of patients making at least 1 critical error with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2
timeFrame: 14 Days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Almirall investigative site 2
city: Munich
country: Germany
facility: Almirall investigative site 1
city: Barcelona
country: Spain
facility: Almirall investigative site 3
city: Palma de Mallorca
country: Spain
facility: Almirall investigative site 4
city: Glasgow
country: United Kingdom
facility: Almirall investigative site 5
city: Newcastle upon Tyne
country: United Kingdom
facility: Almirall investigative site 6
Study officials:
affiliation: Almirall, S.A.
name: Jordi Estruch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06896084: Comparison of Surgeons' Object Discernment Via Their Hands Versus Using a Robotic Surgical System That Does Not Incorporate Haptics
Official title: Comparison of Surgeons' Object Discernment Via Their Hands Versus Using a Robotic Surgical System That Does Not Incorporate Haptics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Services Research
Lead sponsor: Valley Health System
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Targeted population are board certifed surgeons and those who are robotic certified surgeons

Brief summary: The purpose of this study is to compare surgeons' discernment of 4 balloons filled with different materials when using their eyes and hands versus using the da Vinci robot.

Detailed description: The study design is a non-randomized parallel group study in which a group of surgeons (Group A) will make determinations as to the material within each of four visually identical balloons that contain air, water, petroleum jelly or a firm substance similar to the consistency of a non-ripe banana using their hands and eyes while another group of experienced robotic surgeons (Group B) will do so using the da Vinci Xi System (Intuitive Surgical, Sunnyvale, CA).

Before making their "hands on" determinations as to balloon contents, each participant will be asked to first determine whether they can visually determine the balloon contents without any manipulation. For the purposes of outcome measurement, only two possible outcomes are considered - namely that the 4 balloons are ordered correctly or not.

Investigators will also record each "guess" for all participants in order to report any trends of mis-assortment that may occur.

Eligibility criteria: Inclusion Criteria:

* Board Certified Surgeon
* Robotic Board Certified Surgeon

Exclusion Criteria:

• Non Board Certified Surgeon

Primary outcomes:
measure: Number of participants with Farrington-Manning test of Binary Non-Inferiority
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT03950284: Assessment of the Stability of Immediately Loaded All-on-four Dental Implants in FFF Used for Reconstruction of the Jaws
Official title: Assessment of the Stability of Immediately Loaded Dental Implants With the All-on-four Technique in Free Vascularized Fibular Grafts Used for Reconstruction of the Jaws
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reconstructed Jaws
Free Fibula Flaps
All on Four Technique
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of free vascularized fibula flaps for bony reconstruction has proved its success as a substitution for the resected bone and in some instances, the surrounding soft tissues

The aim of this case series study is to evaluate the stability of the dental implants placed in free fibula flaps substituting a resected mandible and/or maxilla when they are immediately loaded with the All-On-Four technique along with the patient satisfaction.

Detailed description: • Preoperative phase :

Patients will be subjected to:

* Case history including personal data, medical, surgical and family history.
* Clinical examination
* Radiographic examination using computed tomography (C.T) bony and soft tissue window.
* Diagnostic studying casts.
* Operative phase :

All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.

• Postoperative care Proper postoperative instructions will be given to the patient such as strict oral hygiene measures and soft diet for 1 month, in addition to the postoperative medications including antibiotics (amoxicillin 1g capsules b.d.s ) and analgesics (diclofenac potassium 50mg as needed). Adherence to follow ups will be also instructed

Eligibility criteria: Inclusion Criteria

* Patients with reconstructed jaws with free fibula flaps in either or both jaws.
* Age group : from 15 to 60 years old
* No sex predilection
* Patients with no contraindications to surgical intervention Exclusion Criteria
* Patients with systemic condition counteracting with the surgical procedure.

Primary outcomes:
measure: Primary Stability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Assistant lecturer. OMFS. Cairo University
name: Mohamed Shawky, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03791684: Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
Official title: Accelerated Versus Standard Corneal Cross Linking in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty: A Long Term Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Surgery
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: WHAT WAS KNOWN

\*Standard CXL is the common procedure for treating progressive corneal ectasia. Modifications of the standard protocol were introduces to reduce its complications especially long exposure to ultraviolet rays. The Accelerated protocol, while believed to overcome this issue with comparable outcomes, has not been studied fully in patients with ectasia following corneal refractive surgery and penetrating keratoplasty.

WHAT THIS PAPER ADDS Accelerated CXL is as safe and effective as the Standard CXL in halting the progression of ectasia post refractive surgery and penetrating keratoplasty with the benefit of: reduced ultraviolet exposure, reduced operation time, and reduced patient discomfort.

Detailed description: Purpose:

The aim of this study is to compare the clinical outcomes of the Standard CXL and the AC CXL in patients with progressive corneal ectasia post refractive surgery and penetrating keratoplasty.

Setting:

Menoufia University Hospital, Egypt

Design:

Prospective, randomised comparison.

Methods:

Patients scheduled to receive either Standard CXL (3mW/cm2 for a period of 30 min) or Accelerated CXL (18mW/cm2 for a period of 5 min).The main outcomes for comparison were the change in; Maximum-K reading (K-max), manifest refractive spherical equivalent (SE), central corneal thickness (CCT), and the best corrected distance visual acuity (CDVA).

Eligibility criteria: Inclusion Criteria:

* Eligible patients were:
* adults aged above 18 years.
* They have been diagnosed clinically with progressive corneal ectasia following refractive surgery procedure (LASIK, PRK, ReLex smile), or penetrating keratoplasty
* CCT above 400µ.

Exclusion Criteria:

* The exclusion criteria involved:
* history of herpetic ocular diseases (including herpes simplex virus and varicella zoster virus) in the study eye
* active or recurrent ocular disease in either eye (e.g., uveitis, chronic moderate to severe blepharitis or severe dry eye) or sight-threatening diseases (e.g., previous retinal or optic nerve diseases) that would interfere with the interpretation of the study data.

Primary outcomes:
measure: K-max changes
timeFrame: 12 post treatment
Secondary outcomes:
measure: manifest refractive spherical equivalent (SE) in Diopter power
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04445584: High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals
Official title: High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals - Development of Reference Standards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Cervical Spine Anatomy
Reference Standard
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asymptomatic individuals

Brief summary: High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good differentiation between nerve and surrounding tissues within foramen und allows to reliably quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery and its relation to neural structures / foramina can be assessed.


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* \>18 years old
* no cervical back pain

Exclusion Criteria:

* previous surgery
* tumor patients
* pregnancy or breast feeding
* any MRI contra-indications

Primary outcomes:
measure: standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment
timeFrame: 1 year
Secondary outcomes:
measure: relation of vertebral artery to neural structures - assessment of contact between ganglion/spinal nerve and vertebral artery by assessing the presence of fat tissue between these structures.
timeFrame: 1 year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References:
Clinical trial NCT03505684: Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Official title: Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Manifestations
Skin Wrinkling
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants

Detailed description: The aim is to investigate the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants by a randomized, double-blind, and control-group study.

Eligibility criteria: Inclusion Criteria:

- \> = 4 of Tewameter

Exclusion Criteria:

* Within the last 6 months, took skin surgery including cosmetic purpose
* Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
* Creatinine levels: more than twice the normal upper limit
* AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
* Uncontrolled hypertension
* sun allergy or sensitive skin
* functional cosmetics that affect dermal moistures and wrinkles within the last 3 months.
* If you have participated or are planning to participate in another clinical trial within the past month
* Alcohol abuser
* If they are pregnant or lactating or have a pregnancy plan during the clinical trial Those with allergic reactions to the constituent food
* Any person deemed inappropriate by the researcher for other reasons

Primary outcomes:
measure: changes in Transepidermal Waterloss by Tewameter
timeFrame: baseline, after 6 weeks, and after 12 weeks
Secondary outcomes:
measure: changes in skin wrinkling indices by Visiometer
timeFrame: baseline, after 6 weeks, and after 12 weeks
measure: skin elasticity by Cutometer
timeFrame: baseline, after 6 weeks, and after 12 weeks
measure: changes in hydration level of the skin surface by Corneometer
timeFrame: baseline, after 6 weeks, and after 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Integrated Research Institute for Natural Ingredients and Functional Foods
Study officials:
affiliation: Integrated Research Institute for Natural Ingredients and Functional Foods
name: Sang Yeoup Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tak YJ, Shin DK, Kim AH, Kim JI, Lee YL, Ko HC, Kim YW, Lee SY. Effect of Collagen Tripeptide and Adjusting for Climate Change on Skin Hydration in Middle-Aged Women: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jan 11;7:608903. doi: 10.3389/fmed.2020.608903. eCollection 2020.