louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01010659: The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
Official title: Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epiphora
Keywords: Dacryocystorhinostomy
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 30
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 purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.

Detailed description: Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.

30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.

Syringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.

Eligibility criteria: Inclusion Criteria:

* Subjects having epiphora
* Canalicular blockade ascertained with probing
* Chronic dacryocystitis
* Mucocele

Exclusion Criteria:

* Absent puncta
* Acute on chronic dacryocystitis
* Noticeable lid laxity
* Previous lacrimal surgery
* Patients younger than 15 years
* Suspicion of malignancy
* Post traumatic lids
* Bony deformity

Primary outcomes:
measure: Resolution of epiphora
timeFrame: 15th Day, 1st Month, 6th Month and 12th month
Secondary outcomes:
measure: Post operative complications
timeFrame: 15th Day, 1st Month, 6th Month and 12th Month
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital
name: Dr. Usha Kim, MBBS, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00096759: Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis
Official title: Efficacy of CAM Interventions in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis
Tai Chi
Meditation
Relaxation Techniques
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi in treating the symptoms of rheumatoid arthritis (RA).

Detailed description: RA is a debilitating disease characterized by inflammation of the joints, leading to chronic pain, loss of function, and disability. Complementary and alternative medicine (CAM) treatments are being used with increased frequency by patients with chronic pain and rheumatic diseases to relieve their symptoms. While patients find these treatments helpful, there is limited scientific evidence of the effectiveness of these interventions. This study will compare relaxation therapy (a commonly used treatment for RA) to tai chi chih (a combination of slow, deliberate movements and meditation) in treating the symptoms of RA.

Participants will be randomly assigned to receive 12 weeks of either relaxation therapy or tai chi chih. At study entry and Weeks 6 and 12, participants will complete questionnaires about their RA symptoms, health functioning, overall quality of life, and complete a brief medical exam.

Eligibility criteria: Inclusion Criteria:

* Active adult onset rheumatoid arthritis
* Stable on disease-modifying antirheumatic drugs (DMARDs) or biologic medications
* Able to walk without use of an assistive device
* Resides in greater Los Angeles area
* Willing and able to comply with study requirements

Exclusion Criteria:

* Uncontrolled or untreated medical conditions
* Frequent or uncontrolled disease flares
* Use of certain medications any medical condition deemed by the investigators to interfere with either the patient's safe participation or interpretation of the study data

Primary outcomes:
measure: RA-related disability
measure: Health functioning
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jennifer Pike, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05655559: Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise
Official title: Comparison of Oxygenation of the Vastus Lateralis Muscle During Cycling and Treadmill Exercises
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Oxygenation
Treadmill
Keywords: muscle oxygenation
treadmill
cycle
moxy
exercise
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The study will be conducted on healthy young adults. Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), including muscle oxygenation, will be compared in treadmill and bicycle exercises.

Detailed description: In recent studies, sensor systems that measure the oxygen level in muscle tissue at the microvascular level have been developed. These devices working with Near Infrared Spectroscopy (NIRS, 630-850 nm) method; It provides measurements of muscle oxygenation level at rest and during exercise. It is known that significant changes in vastus lateralis oxygenation levels measured by the NIRS method are associated with various factors such as exercise intensity, exercise profile and training. The aim of this study is to measure the oxygenation level of the vastus lateralis muscle during the exercises performed on the treadmill and bicycle ergometer, and thus to reveal the effect of using different ergometers on fatigue and sportive performance.

Muscle oxygen levels will be measured and evaluated before, during and after exertion. In addition, blood pressure (BP), oxygen saturation (SpO2), dyspnea and fatigue parameters will be recorded and evaluated. If undesirable symptoms are observed during our study, the exercise will be terminated. Within the scope of the project, the acute effect will be examined with the measurements made with the Moxy device on the vastus lateralis muscle during the treadmill and bicycle ergonometer.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* No known disease
* Be between the ages of 18-25

Exclusion Criteria:

* Having cardiopulmonary disease,
* Have had lower extremity muscle or joint injuries
* Having an orthopedic/neurological disorder
* Smoking and alcohol use,
* Have suffered a lower extremity muscle or joint injury,
* Having an orthopedic/neurological disorder,
* Uncontrollable asthma,
* PaO2\< 50 mmHg,
* PaCO2\> 70mmHg,
* Individuals with a resting systolic blood pressure of 200 mmHg

Primary outcomes:
measure: Measurement of Patient-Reported Dyspnea and Fatigue
timeFrame: Baseline
measure: Measurement of Muscle Oxygenation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Esra PEHLİVAN, Assoc. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03151759: MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients
Official title: Effect of Long and Short Radiotherapy on MMP-7 Levels in Rectal Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy

Brief summary: To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.


Eligibility criteria: Inclusion Criteria:

Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.

Exclusion Criteria:

Colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.

Primary outcomes:
measure: Matrilysin levels
timeFrame: 1 - 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00092859: A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 1500
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: This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.


Eligibility criteria: Inclusion Criteria:

* Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study

Exclusion Criteria:

* Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

Primary outcomes:
measure: Body weight after 1 year of treatment. Safety and tolerability for 2 years.
timeFrame: After 1 & 2 years of treatment
Secondary outcomes:
measure: Durability of weight loss over two years.
timeFrame: Over two years.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00870259: Investigating Physiological Adaptations to Weight Loss
Official title: An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
Weight maintenance
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.


Eligibility criteria: Inclusion Criteria:

* males and post-menopausal females
* aged over 18 years
* BMI 27-40kg/m2
* weight-stable

Exclusion Criteria:

* major comorbid medial condition (including diabetes)
* taking medications known to affect weight
* smoking

Primary outcomes:
measure: Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline
timeFrame: 2, 6 and 12 months
Secondary outcomes:
measure: Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
timeFrame: week 8 vs week 10
measure: Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
timeFrame: 0, 2, 6 and 12 months
measure: Association of psychosocial factors with successful weight maintenance
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Heidelberg Repatriation Hospital
state: Victoria
Study officials:
References:
citation: Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
Clinical trial NCT05264259: New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
Official title: New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: BK Virus Infection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adult patient with a posititive serology BK confirmed

Brief summary: BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.


Eligibility criteria: Inclusion Criteria:

* BK positive
* adult
* ok to participed to research

Exclusion Criteria:

* under guardianship
* under curatorship
* opposed to research
* deprived of liberty

Primary outcomes:
measure: Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Virologie - CHU Strasbourg - France
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Samira FAFI-KREMER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04988659: Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
Official title: Total Exon Association Analysis of Femoroacetabular Impingement (FAI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoroacetabular Impingement
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both patients were from Peking University Third Hospital and were diagnosed as Femoroacetabular impingement syndrome.

Brief summary: Femoral acetabular impingement (FAI) is a common disease of the hip joint. In this study, whole-genome sequencing was used to further explore the pathogenesis of this disease.

Detailed description: Femoral acetabular impingement (FAI) is a group of chronic hip pain caused by the impact between the proximal femur and the edge of the acetabulum due to the anatomical abnormality of the hip joint, which damages the labrum and adjacent cartilage, and causes limited hip movement, especially limited flexion and internal rotation. However, the specific etiology of FAI is still unknown at present. The application of genome-wide, exon and transcription research methods to the study of hip impaction syndrome can uncover key differentially expressed genes and provide a theoretical basis for the study of FAI.

Eligibility criteria: Inclusion Criteria:

* The patient underwent preoperative imaging and was diagnosed with FAI. The patient complained of pain in the hip, hip, or thigh, and had a positive hip flexion impact test.

Exclusion Criteria:

* Patients with hip surgery history, hip osteoarthritis, necrosis of the femoral head, hip infection, hip dysplasia and other hip diseases.

Primary outcomes:
measure: The patients were clinically diagnosed with FAI (femoral acetabular impingement) and underwent arthroscopic surgery, then clinical samples were collected.
timeFrame: The patient was diagnosed with FAI, and conservative treatment was ineffective for an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: yan xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017859: High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Official title: High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.

Detailed description: A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI\>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
* Apnea Hypopnea Index (AHI)≥15
* Patient has difficulties to adjust or comply with CPAP treatment
* Signed Informed Consent Form

Exclusion Criteria:

* Patients who need bilevel positive airway pressure (BIPAP)
* Known carbon dioxide (CO2) retainers
* Weight change\>10% compared to time of OSA diagnosis
* Clinically unstable patients
* Pregnant women or special populations (e.g. children or patients unable to give informed consent)

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: During at least 2 hours of sleep time
Secondary outcomes:
measure: Percent of hypoxemia time
timeFrame: During at least 2 hours of sleep time
measure: Minimal SO2%
timeFrame: During at least 2 hours of sleep time
measure: Adverse events reported while using HFNC
timeFrame: During at least 2 hours of sleep time
measure: Sleep efficiency
timeFrame: During at least 2 hours of sleep time
measure: Total sleep time
timeFrame: During at least 2 hours of sleep time
Other outcomes:
measure: Percent rapid eye movement (REM) sleep
timeFrame: During at least 2 hours of sleep time
measure: Percent Deep sleep
timeFrame: During at least 2 hours of sleep time
measure: User experience with HFNC
timeFrame: During at least 2 hours of sleep time
Locations:
Study officials:
affiliation: Pulmonary Institute, Rabin Medical Center, Israel
name: Mordechai R Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699659: The Efficacy & Safety of the UAS Immunotherapy Protocol
Official title: The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perennial Allergic Rhinitis With Seasonal Variation
Keywords: Allergic Rhinitis
Allergen Immunotherapy
Lead sponsor: United Allergy Services
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).

Brief summary: Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.

Detailed description: Patients will be assessed for efficacy of the immunotherapy protocol by completing Consented-IRB approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.

Eligibility criteria: Inclusion Criteria:

* Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy.

Exclusion Criteria:

* No beta blocker use,
* no pregnancy,
* no systemic steroids,
* no severe asthma/copd,
* no severe collagen vascular disorders,
* no neoplastic or uncontrolled seizure activity,
* no previous anaphylaxis, no significant cardiovsacular disease.

Primary outcomes:
measure: change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).
timeFrame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
Secondary outcomes:
measure: Changes in medication plus symptom aggregate score.
timeFrame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
Other outcomes:
measure: Quality of Life (QOL) scores
timeFrame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy
Locations:
city: San Antonio
country: United States
facility: UAS
state: Texas
Study officials:
affiliation: United Allergy Services
name: Frederick M Schaffer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: