louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00563511: A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction
Official title: A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2007-11-26
Enrollment: 1210
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit rate.


Eligibility criteria: Inclusion Criteria:

* Male ethnic Chinese aged 18 or above
* Smokes at least 1 cigarette per day
* Is not following other forms of smoking cessation interventions
* Intends to quit smoking within the next 7 days of the first contact and would use NRT
* Free from illness that contraindicate to the use of NRT
* Has signed an informed consent form, or has given verbal consent (for those contacted by telephone)

Exclusion Criteria:

* Patients who are psychologically or physically unable to communicate
* Children and teenagers (aged below 18)
* Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions

Primary outcomes:
measure: quit rate
timeFrame: 6-month
measure: adherence rate
timeFrame: 4-weeks after the first use of NRT
Secondary outcomes:
measure: erectile function
timeFrame: 6-month
measure: use of NRT
timeFrame: 3-month
measure: quit rate
timeFrame: 3-month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: HKFPA
city: Hong Kong
country: China
facility: Kwong Wah Hospital
city: Hong Kong
country: China
facility: The University of Hong Kong
city: Hong Kong
country: China
facility: WHO
Study officials:
affiliation: Department of Community Medicine, The University of Hong Kong
name: TH Lam, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03609411: Splenectomy During Whole Liver Transplantation
Official title: Splenectomy During Whole Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Liver Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 141
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the 906 liver transplantations performed between 1994 and 2013 at the Liver Transplant Department of the Croix-Rousse University Hospital, Lyon-France, all 47 liver transplantations with simultaneous splenectomy were included and compared to 94 transplant recipients without splenectomy after a 1:2 matching for gender, age at transplantation, year of liver transplantation, MELD score, platelet level and presence of hepatocellular carcinoma.

Brief summary: Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.

Detailed description: Data on patients who underwent splenectomy during liver transplantation were retrospectively analyzed . Participants underwent splenectomy as part of routine medical care. Patients undergoing simultaneous liver transplantation and splenectomy were matched to a non-splenectomy group.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing liver transplantation between 1994 and 2013

Exclusion Criteria:

* Data from living donor patients, split liver transplantation, patients with pre- or post-operative splenectomy in medical history, and patients under 16 years were excluded from analysis

Primary outcomes:
measure: 3-month post-operative mortality
timeFrame: At 3 months post surgery
Secondary outcomes:
measure: Post-operative morbidity
timeFrame: 3 months post surgery
measure: One-year mortality
timeFrame: One year after surgery
measure: Mortality at 5 years
timeFrame: Five years after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT06481111: Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital
Official title: Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypovitaminosis D
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient clinics who will access of the Endocrinology Unit of the IRCCS San Raffaele Hospital for endocrine-metabolic diseases and who are on supplementary treatment with vitamin D until December 2029

Brief summary: The Endocrinology Unit of the IRCCS San Raffaele Hospital is dedicated to establishing a prospective single-center registry with data from patients undergoing vitamin D supplementation, initiating their first visit to the outpatient unit until December 2029. 1000 patients will be enrolled, aligning with the unit's recent patient influx for hypovitaminosis D.

The registry's goal is to assess the epidemiological trend, identify risk factors, and evaluate the diagnostic and therapeutic clinical management strategies for hypovitaminosis D. It will involve collecting clinical, laboratory, and historical data during outpatient visits, adhering to the standard diagnostic and therapeutic protocols for endocrine-metabolic diseases. This data collection is expected to continue for a duration of ten years.


Eligibility criteria: Inclusion Criteria:

* Adult men and women (age ≥ 18 years) regardless of fertility status and pregnancy/breastfeeding conditions
* Vitamin D supplementation, with any formulation and dosage
* Signing of informed consent

Exclusion Criteria:

* Patients unable to understand and sign informed consent.

Primary outcomes:
measure: Change from baseline of data in outpatient accessing Endocrinology Unit of the IRCCS San Raffaele Hospital for endocrine-metabolic diseases who are on supplementary treatment with vitamin D.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01096511: Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
Official title: Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Peritonitis
Abscess, Intra-Abdominal
Keywords: Moxifloxacin,
cIAI
non-interventional
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 1001
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: Adult female and male patients with cIAI, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin infusion, can be documented after the therapy decision has been made.

Brief summary: This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered.

Exclusion Criteria:

* Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.

Primary outcomes:
measure: Types of cIAI infections
timeFrame: Day 1
Secondary outcomes:
measure: Cure rate
timeFrame: 5-14 days
measure: Clinical signs and symptoms
timeFrame: 5-14 days
measure: Duration until improvement and cure
timeFrame: 5-14 days
measure: Adverse event collection
timeFrame: 5-14 days
Other outcomes:
Locations:
city: Many locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02460328: Resolution of Primary Immune Defect in 22q11.2 Deletion Syndrome
Official title: Resolution of Primary Immune Defect in 22q11.2 Deletion Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Defect
22q11.2 Deletion Syndrome
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 43
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: 22q11.2 deletion syndrome diagnosed from Fluorescence in situ hybridization (FISH) for 22q11

Brief summary: * Evaluate about age of resolution in immune defect in 22q11.2 Deletion Syndrome
* Incidence of immunodeficiencies in 22q11.2 Deletion Syndrome

Detailed description: 22q11.2 Deletion Syndrome is the most common for microdeletion syndrome. The incidence is about 1:4000 of live birth. Clinical features in this syndrome are vary which consist of conotruncal cardiac anomalies, developmental disabilities, palatal anomalies, speech delay, hypocalcemia, characteristic facial features and immunodeficiencies. The most common type of immunodeficiencies is T cell defect that associated with thymic hypoplasia. In the present time, the investigators don't know about the resolution of immune defect in this syndrome.

Eligibility criteria: Inclusion Criteria:

* 22q11.2 deletion syndrome patients in allergy and immunology clinic, genetic clinic, cardio clinic, genetic clinic and development clinic

Exclusion Criteria:

* loss follow up in 22q11.2 deletion syndrome patients or incomplete medical record

Primary outcomes:
measure: age of resolution in immune defect in 22q11.2 Deletion Syndrome
timeFrame: 18 months
Secondary outcomes:
measure: incidence of immunodeficiencies in 22q11.2 Deletion Syndrome
timeFrame: 18 months
measure: type of infectious disease in 22q11.2 Deletion Syndrome
timeFrame: 18 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Punchama Pacharn, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McLean-Tooke A, Barge D, Spickett GP, Gennery AR. Immunologic defects in 22q11.2 deletion syndrome. J Allergy Clin Immunol. 2008 Aug;122(2):362-7, 367.e1-4. doi: 10.1016/j.jaci.2008.03.033. Epub 2008 May 16.
citation: Chinen J, Rosenblatt HM, Smith EO, Shearer WT, Noroski LM. Long-term assessment of T-cell populations in DiGeorge syndrome. J Allergy Clin Immunol. 2003 Mar;111(3):573-9. doi: 10.1067/mai.2003.165.
Clinical trial NCT00958828: Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
Official title: Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment.
* Currently wearing contact lenses at least 8 hours/day and 5 days/week.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in any clinical trial.
* Prior history of corneal or refractive surgery.
* Monovision correction.
* Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Lens Satisfaction
timeFrame: After 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00715728: Efficacy of Warming Device During Surgery
Official title: Efficacy of a New Intraoperative Resistive Warming Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Plastic surgery
Warming
Core temperature
Bair Hugger
Hot Dog heating system
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 28
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 undergoing major plastic surgery lasting approximately 5 hours.

Brief summary: This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.

Detailed description: Subjects undergoing major plastic surgery lasting approximately 5 hours will be randomized to either the Hot Dog resistive heating system or the Bair Hugger forced air heating system. Core temperature will be measured using a distal esophagus and mean skin temperature. Warming will continue until the subjects' core temperature reaches 37°C. Subsequent temperature will be adjusted as clinically necessary. Data will be recorded at 15 minute intervals. Core temperature will be first measured after intubation when the esophageal temperature probe is inserted. The primary outcome will be the rate of core rewarming over the range of 35°C to 37°C.

Eligibility criteria: Inclusion Criteria:

* Plastic surgery lasting approximately 5 hours
* Subjects over the age of 18 years
* Patient signed Informed Consent

Exclusion Criteria:

* Plastic surgery lasting less than 5 hours
* Individuals under the age of 18 years

Primary outcomes:
measure: The Rate of Core Rewarming Over the Range From 35°C to 37°C.
timeFrame: Until the end of surgery, up to 5 hour
measure: Intraoperative Time Weighted Average Core Temperature
timeFrame: Until the end of surgery, up to 5 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital/University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Olga Plattner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626728: A Prospective Feasibility Study for TAMIS
Official title: A Prospective Quality Assurance Feasibility Study of Laparoscopic Assisted Transanal Minimally Invasive Surgery (TAMIS) for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and distant metastasis, will be offered the operative procedure with TAMIS technique.

Brief summary: Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.


Eligibility criteria: Inclusion criteria:

* rectal cancer with histological diagnosis
* tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope.
* suitable for elective resection

exclusion criteria:

* preoperative magnetic resonance imaging (MRI) showing diameter of tumor size \>6 cm
* American Society of Anesthesiologists (ASA) class IV and V
* anticipated need of intensive care unit (ICU)
* history of previous major abdominal surgery
* computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs
* obese patient with body mass index \>35kg/m2
* those, who do not understand the requirements of the protocol
* pregnancy
* more than one colorectal tumor

Primary outcomes:
measure: morbidity
timeFrame: 30-days
Secondary outcomes:
measure: mortality
timeFrame: 30-days
measure: short-term oncological result
timeFrame: 30-days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital University of Copenhagen
Study officials:
affiliation: Hvidovre Hospital University of Copenhagen
name: Mette W Christoffersen, M.D, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00795028: Preventing Falls and Disability in Older Adults After Hip Fracture
Official title: Preventing Falls and Disability in Older Adults After Hip Fracture
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Fracture
Keywords: older women
hip fracture
exercise intervention
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.


Eligibility criteria: Inclusion Criteria:

* Older community dwelling women who have sustained a first hip fracture

Primary outcomes:
measure: Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by an independent investigator
timeFrame: Monthly
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: M C Ashe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04017728: Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
Official title: Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastasis
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous vertebroplasty has been applied widely to treat bone metastases. The injected cement may strengthen the affected bone to prevent pathological fractures and relieve the pain. Moreover, the thermal reaction (70°C) due to polymerisation of cement also contributes to tumour destruction. The cement dose and diffusion pattern may be significant factors for the treatment efficacy, which can be affected by the inner pressure of the metastases. The investigators will apply a rotary cutter to destroy the structure of metastases to alleviate the pressure in the metastases. Then, more cement will be injected, which may effectively interdigitates with the surrounding bone and generate more thermo to kill the tumor cells.


Eligibility criteria: Inclusion Criteria:

1. Imaging-proven and pathology-proven metastases
2. Intractable pain with neurologic dysfunction

Exclusion Criteria:

1. Poor general condition without tolerance of surgery

Primary outcomes:
measure: Back pain: Visual analogue scales system
timeFrame: 3 months
Secondary outcomes:
measure: The patterns of cement opacification
timeFrame: during the procedure of vertebroplasty
measure: Cement leakage
timeFrame: during the procedure of vertebroplasty
measure: Cement volume
timeFrame: during the procedure of vertebroplasty
Other outcomes:
Locations:
city: Jinan
country: China
facility: 960 Hospital of PLA
state: Shandong
Study officials:
References: