louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02058173: "Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C Virus
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.


Eligibility criteria: Inclusion Criteria:

* patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment
* who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks

Exclusion Criteria:

* Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study
* coinfection with Hepatitis A,C,D viruses or HIV
* Severe dysfunction of liver and kidney
* pregnancy
* breast feeding
* refusing to give informed consent
* active Alcohol user
* presence of decompensate cirrhosis

Primary outcomes:
measure: Loss of HCV RNA at end of treatment which is 8 weeks
timeFrame: march 2014
Secondary outcomes:
measure: Two log decrease in HCV RNA at the end of treatment
timeFrame: july 2014
Other outcomes:
measure: ALT response which is significant decrease in ALT-(biochemical response during Treatment)
timeFrame: july 2014
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Health Policy Research Center
state: Fars
Study officials:
affiliation: Health policy research center
name: Kamran B Lankarani, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT00391573: Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial
Official title: Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2006-10-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft suturing in pterygium surgery.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria included patients with primary nasal pterygium, aged 18 years or older, and able to cooperate surgery under local anaesthesia.

Exclusion Criteria:

* Patients with recurrent pterygium, scarred superior conjunctiva, previous surgery involving the superior bulbar conjunctiva, history of glaucoma, and cicatricial ocular surface disease were excluded

Primary outcomes:
measure: The difference in VAS score between the two groups
Secondary outcomes:
measure: Graft hyperemia, oedema and tarsal conjunctival papillary hypertrophy
measure: Surgical complications
measure: Pterygium recurrence
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Eye Hospital
Study officials:
affiliation: Hong Kong Eye Hospital
name: Victoria Wong, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297673: Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
Official title: Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vesico-ureteral Reflux
Spinal Cord Injury
Keywords: vesico-ureteral reflux
neurogenic bladder dysfunction
spinal cord injury
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages Eligibility: minimum 18 years Genders Eligibility: female and male

Brief summary: The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management

Detailed description: Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury
* Neurogenic lower urinary tract dysfunction
* Written informed consent

Exclusion Criteria:

* Lower urinary tract dysfunction due to other causes than spinal cord injury

Primary outcomes:
measure: Incidence and degree of vesico ureter renal reflux
timeFrame: average: yearly scheduled control
Secondary outcomes:
measure: pdet (cmH2O)
timeFrame: average: yearly scheduled control
measure: Medication
timeFrame: average: yearly scheduled examination
measure: possible complications
timeFrame: average: yearly scheduled examination
measure: maximum cystometric capacity
timeFrame: average: yearly scheduled control
measure: compliance mL/cmH2O
timeFrame: average: yearly scheduled control
measure: bladder management
timeFrame: average: yearly scheduled control
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Study officials:
References:
Clinical trial NCT04001673: Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.
Official title: Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthritis
Treatment Adherence
Keywords: treatment knowledge
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.

The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.

Detailed description: This is an interventional, controlled, open-label and monocentric study. 80 patients are planned to be included.

After written informed consent will be obtained, the patients will be randomized in two arms:

* Intervention arm: intervention of a pharmacist who will explain bDMARDs management.
* Control arm, without intervention.

Two primary end-points are defined:

1. the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management
2. the changes from baseline to M6 in Medication Possession Ratio (MPR)

As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.

Eligibility criteria: Inclusion Criteria:

* Outpatients from Rheumatology Department at Cochin Hospital
* Diagnosis of Spondyloarthritis
* Under treatment with subcutaneous bDMARDs for at least 6 months
* Disease activity stable for at least 6 months
* No treatment modification 3 months before or after inclusion in the study
* Informed consent signed and dated
* Older than 18 years
* Patients who speak french

Exclusion Criteria:

* Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion
* History of psychological problems
* Patients who need other persons to manage their treatment.

Primary outcomes:
measure: Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
timeFrame: 6 months of follow-up
measure: Improvement in knowledge about bDMARDs management.
timeFrame: 6 months of follow-up
Secondary outcomes:
measure: Changes in disease activity
timeFrame: 6 months of follow-up
measure: Satisfaction of patients after receiving pharmacist's intervention
timeFrame: 6 months of follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
state: Ille De France
Study officials:
References:
Clinical trial NCT01354873: Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging
Official title: Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyps
Keywords: Colonoscopy
Colon Polyps
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Olympic Medical
First posted: 2011-05-17
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women(not pregnant) presenting to the GI lab for colonoscopy. Child bearing potential not excluded.

Brief summary: The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Detailed description: Information will be collected. Images will be taken.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Presenting for surveillance, screening or diagnostic colonoscopy
* Willingness to provide informed consent

Exclusion Criteria:

* Inability to provided informed consent
* Pregnancy
* Known inflammatory bowel disease
* Personal or family history of polyposis or nonpolyposis syndrome
* Emergency colonoscopy/endoscopy
* Coagulopathy or thrombocytopenia preventing polypectomy
* Procedure indication for acute bleeding or active colitis

Primary outcomes:
measure: Accuracy of In Vivo determination of colorectal polyps histopathology
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes.
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B Wallace, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04915573: Antimicrobial Resistance in Cirrhotic Patients
Official title: Antimicrobial Resistance Among Sputum Pathogens in Post Hepatitis Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2021-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis

Brief summary: Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.

Detailed description: Cirrhotic patients are more vulnerable to bacterial infection which is a common cause of acute liver disease decompensation. The aim of this study will characterize the antimicrobial resistance and distribution of bacteria isolated from chronic hepatic patients with pulmonary infections, as well as to evaluate the antimicrobial susceptibility of bacteria isolated from sputum.

Eligibility criteria: Inclusion Criteria:

1. Adults' older than 18 years with clinical evidence of liver disease

Exclusion Criteria:

1. Pregnancy
2. Intensive care unite stay of more than 24 hours
3. Malignancy
4. Organ transplantation
5. Acquired immune deficiency syndrome

Primary outcomes:
measure: Isolate Identification
timeFrame: One day
measure: Antimicrobial resistance
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
Study officials:
affiliation: Mansoura University
name: Noha Mansour, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06602973: Relationships Between Exercise and Appetite in Women With Loss of Control Eating
Official title: Relationships Between Exercise and Appetite in Women With Loss of Control Eating
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Keywords: exercise
eating disorders
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.


Eligibility criteria: Inclusion Criteria:

* Engage in loss of control eating at least 12 times in the last three months
* Clinically significant eating disorder-related impairment (CIA \&gt; 15)
* Taking hormonal contraception
* Minimum VO2max of 50th percentile for age and sex assigned at birth
* Be willing to eat study-provided foods
* Likes chocolate (at least 6/10 on 10 point scale)

Exclusion Criteria:

* BMI \&amp;lt; 18.5 kgm/2
* Medical conditions that affect appetite or weight (e.g., diabetes mellitus, thyroid disease)
* Recent pregnancy or breastfeeding (prior 6 months)
* Relevant food allergies (e.g., wheat, chocolate)
* Specific phobia, blood-injection-injury type
* Medical condition that precludes safe participation in exercise (e.g., stress fracture)
* Medications that acutely affect appetite (e.g., GLP-1 agonists; psychiatric medications allowed)

Primary outcomes:
measure: Relative Energy Intake
timeFrame: Food intake from 8 am to 8 am; Energy expenditure from approximately 9 am to 9:05 am and 9:25 to 9:30 am, coinciding with study condition (rest or exercise)
Secondary outcomes:
measure: Lactate
timeFrame: 30 minutes, pre-post exercise (or rest)
measure: Acylated ghrelin
timeFrame: Immediately prior to lunch
measure: Self-reported binge eating
timeFrame: 24 and 48 hours after exercise/rest study visit
measure: Food reward value
timeFrame: Approximately 3:30 pm day of study visit
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
References:
Clinical trial NCT00459173: Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation
Official title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Maintenance of Smoking Cessation
Keywords: abstinence
maintenance
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-11
Enrollment: 4850
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: The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking.

Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.


Eligibility criteria: Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* non tobacco cigarettes consumption
* chronic use of marijuana
* pregnancy, breastfeeding
* any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

Primary outcomes:
measure: Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
measure: Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day
Secondary outcomes:
measure: Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
measure: Safety data
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Cove
country: Australia
facility: Sanofi-Aventis
state: New South Wales
city: Laval
country: Canada
facility: Sanofi-Aventis
state: Quebec
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02063373: Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bilateral Knee Osteoarthritis
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Treatment: five intro-articular Hyaluronic Acid injection

Assessment has two parts, that are as follow:

1. Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
2. Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.

For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.

Detailed description: This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA).

Participants were individuals with knee OA (control and treatment) and healthy people.

Eligibility criteria: Inclusion Criteria:

* Mild and moderate bilateral knee osteoarthritis
* Age between 50 and 70 years

Exclusion Criteria:

* Recent Lower limb injury
* Diabetic
* Knee or hip replacement
* Knees HA injection in last 6 months
* Any neuromuscular disease such as stroke and Parkinson

Primary outcomes:
measure: Change in Postural stability after treatment
timeFrame: baseline and 6 weeks
measure: Changes in Biomechanics of gait after treatment
timeFrame: baseline and 6 weeks
measure: Changes in biomechanics of stair climbing after treatment
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change in Pain after treatment
timeFrame: baseline and 6 weeks
measure: Changes in WOMAC scores after treatment
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
Clinical trial NCT00230373: Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
Official title: Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Morphea
Keywords: Localized scleroderma
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2005-09-30
Enrollment: 0
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: Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A screening and baseline clinic visit will be required for each patient enrolled in the study. Each visit will involve completing a medical history, skin examination, digital pictures, histologic examination if the patient consents and an ultrasonographic score. One morphea plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with vehicle cream. Patients will be asked about side effects (local and systemic). Patients will be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of treatment period (month 12).


Eligibility criteria: Inclusion Criteria:

* Adults and children \> 6 years with plaque-type morphea
* Subject has not participated in previous study involving imiquimod for three months
* In the investigator's judgement, imiquimod treatment may benefit the patient over conventional treatment
* Subject has provided informed written consent
* Female subjects of childbearing potential have a pregnancy urine test that is negative prior to treatment
* Sexually active subjects agree to practice effective birth control throughout the duration of the study

Exclusion Criteria:

* Patients with a non-morphea skin disorder in the region of interest
* Subjects previously undergoing morphea therapy within four weeks of the study
* Subjects have a known hypersensitivity to imiquimod or component of the cream preparation
* Subjects who are pregnant or nursing

Primary outcomes:
measure: The main outcome of this study is to evaluate the efficacy of imiquimod cream in improving morphea plaques. Improvement of skin induration will be measured by percent improvement in the skin induration as assessed radiologically by ultrasonography score.
Secondary outcomes:
measure: Any adverse outcome is recorded.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Dr. Marlene Dytoc's clinic
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Red Deer
country: Canada
facility: Dr. Loretta Fiorillo's clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: Marlene T Dytoc, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: