louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01844154: Fracture and Fall Prevention in Elderly With Osteoporosis
Official title: Fracture and Fall Prevention in Elderly With Osteoporosis: Long-term Follow up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis, Osteopenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: osteopenia (-2.5 \< t-score \< -1.0) or osteoporosis (t-score \<-2.5)

Brief summary: Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.


Eligibility criteria: osteopenia or osteoporosis group:

Inclusion Criteria:

* able to stand and walk for 5 minutes independently
* having normal or corrected to normal vision
* having age between \> 50 years
* already have DEXA and X-ray exam with osteopenia (-2.5 \< t-score \< -1.0) or osteoporosis (t-score \<-2.5)

Exclusion Criteria:

* being pregnant
* sensory-motor deficits
* inability of communication
* lack of access to a telephone
* t-score \<-2.5 combine with existing fracture

control age-matched group:

Inclusion Criteria:

* able to stand and walk for 5 minutes independently
* having normal or corrected to normal vision
* having age between \> 50 years
* already have DEXA and X-ray exam without osteopenia or osteoporosis (t-score \> -1.0)

Exclusion Criteria:

* being pregnant
* sensory-motor deficits
* inability of communication
* lack of access to a telephone
* t-score \<-2.5 combine with existing fracture

Primary outcomes:
measure: Muscle activation during balance recovery
timeFrame: every 3 month, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University
city: Taipei
country: Taiwan
facility: School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Study officials:
affiliation: School of physical therapy, National Taiwan University
name: Wei-Li Hsu, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00126854: High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation
Official title: High Field (3 Tesla) Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Permanent Iodine 125 Brachytherapy Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Keywords: brachytherapy
magnetic resonance spectroscopy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2005-08-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish the correct scanning parameters for obtaining good quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a valuable additional diagnostic and follow-up investigation for prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* Suitable candidate for prostate brachytherapy to treat prostate cancer
* Patient signs a study consent form

Exclusion Criteria:

* Have received other radiotherapy for prostate cancer or hormone treatments
* Has contraindication to MRSI scanning
* Does not sign study consent form

Primary outcomes:
measure: pilot study meant to establish scanning parameters on 3T MRSI
Secondary outcomes:
measure: safety/toxicity
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Don Yee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723354: Clinical Efficacy of Axillary Block in Cervical Radiculopathy
Official title: Comparison of Clinical Efficacy of Axillary Block in Patients of Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary endpoint of this study was to compare the clinical efficacy of axillary block in patients of cervical radiculopathy using 2 volumes of local anesthetics.

Detailed description: The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.

Recent study deomonstrated good pain relief when ultrasound guided interfascial plane injection was performed in patients with cervical radiuculopathy.

There is no study showing clinical efficacy of interfascial plane injection of axillary block in patients of cervical radiculopathy.

Eligibility criteria: Inclusion Criteria:

* Cervical foraminal stenosis
* Cervical central stenosis
* Cervical disc herniation
* Cervical spondylolisthesis
* Prominent arm pain rather than neck pain

Exclusion Criteria:

* Infection
* Pregnancy
* allergy to local anesthetic agents
* previous cervical spine surgery
* Prominent neck pain rather than arm pain

Primary outcomes:
measure: Numerical rating scale changes among 4 time periods
timeFrame: baseline, 2 weeks after injection, 4 weeks after injection, 8 weeks after injection
measure: Neck disability injex changes between 2 time periods
timeFrame: baseline, 8 weeks after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
References:
Clinical trial NCT00005654: Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperinsulinism
Polycystic Ovary Syndrome
Keywords: endocrine disorders
hyperinsulinism
polycystic ovarian syndrome
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Virginia
First posted: 2000-05-03
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.

Patients receive oral metformin (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS)

Must have oligoamenorrhea and hyperandrogenemia

--Prior/Concurrent Therapy--

At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents

--Patient Characteristics--

Hematopoietic: Hematocrit greater than 38%

Hepatic: Liver function normal No clinically significant hepatic disease

Renal: No clinically significant renal disease Creatinine less than 1.4 mg/dL No proteinuria

Cardiovascular: No clinically significant cardiac disease

Pulmonary: No clinically significant pulmonary disease

Hormonal: Thyroid function normal Prolactin normal Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency

Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No diabetes mellitus No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease No clinically significant malignant disease except nonmelanomatous skin cancer At least 1 year since any prior drug abuse or alcoholism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: William S. Evans
role: STUDY_CHAIR
References:
Clinical trial NCT04111354: Early Mobilization After Pacemaker Implantation.
Official title: Early Mobilization After Pacemaker Implantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker Complication
Mobilization
Keywords: pacemaker
implantation
mobilization
complication
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours. The optimal duration of patient´s immobilization is not determined. There is also no recommendation from individual manufacturers of pacemakers for the duration of immobilization after pacemaker implantation. The length of immobilization is based rather on the tradition established at the time of using electrodes with passive fixation. The aim of our prospective, randomized study (EMAPI) is to compare the safety of short-term (4-hours) immobilization with long-term (16-24 hours) immobilization after primary pacemaker implantation. Septal position will be used for right ventricular electrode.


Eligibility criteria: Inclusion Criteria:

1. 18 years and older.
2. Indication for permanent pacemaker implantation.
3. Mobile and compliant patient.
4. Willing and able to give written informed consent.

Exclusion Criteria:

1. Imobile and noncompliant patient.
2. Indication of CRT implantation.
3. Upgrade or revision of implanted devise.
4. Contraindications to pacemaker implantation.
5. Gravidity.

Primary outcomes:
measure: Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late).
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of atrial lead dislodgement.
timeFrame: 6 months
measure: Incidence of ventricular lead dislodgement.
timeFrame: 6 months
measure: Incidence of hematoma (surgically treated or requiring blood transfusions.)
timeFrame: 6 months
measure: Incidence of pneumothorax.
timeFrame: 24 hours
measure: Incidence of pocket infection.
timeFrame: 6 months
measure: Incidence of others complications.
timeFrame: 6 months
Other outcomes:
Locations:
city: Plzen
country: Czechia
facility: Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic
Study officials:
References:
Clinical trial NCT00411554: A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
Official title: Sitagliptin (MK0431) Phase III Double-blind Comparative Study - Type 2 Diabetes Mellitus -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 319
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.


Eligibility criteria: Inclusion Criteria:

* Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion Criteria:

* Patients have type 1 diabetes mellitus

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 2 Hour Postprandial Glucose at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Iwamoto Y, Tajima N, Kadowaki T, Nonaka K, Taniguchi T, Nishii M, Arjona Ferreira JC, Amatruda JM. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010 Jul;12(7):613-22. doi: 10.1111/j.1463-1326.2010.01197.x.
Clinical trial NCT01686854: Effectiveness of Cognitive Behavioral Therapy vs. Prescriptive Diet in Short and Medium-term Control of Body Weight
Official title: "Terapia Dell'obesità: Studio Randomizzato Per la Valutazione Dell'Efficacia Della Terapia Cognitivo-comportamentale Versus Dietoterapia Prescrittiva Nel Controllo a Breve e Medio Termine Del Peso Corporeo e Del Rischio Cardiovascolare."
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: cognitive-behavioral approach
obesity treatment
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial.

According to the Italian guidelines on obesity, the target to reach is the weight loss of 10% compared to the initial weight, obtained in six months and maintained for the next 5 years.

The guideline considers six months as the time required to lose weight, but many patients are not able to achieve this result. Since in clinical practice many patients fail to achieve this weight loss in six months, it was decided to extend to 12 months the time to reach the target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5% on respect of the basal weight in six months.

Detailed description: The hypotheses to be tested is that the addition of a short CBT, as it can be applied in a public outpatients, is able to improve the percentage of responders and to raise the proportion of subjects able to maintain the result over time.

Eligibility criteria: Inclusion Criteria:

Subjects with severe overweight (BMI 27-29.9) or obesity of first step (BMI 30-34.9kg/h2 and obesity of second step (BMI 35-39.9 9kg/h2). Patients with dyslipidemia, hypertension, slight organ damage were eligible in the study; Exclusion Criteria:

patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.

Primary outcomes:
measure: body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight
timeFrame: 12 months
Secondary outcomes:
measure: body weight reduction by 5% compared to the initial weight
timeFrame: 6 months
measure: cardiovascular risk
timeFrame: 6, 12, 24 months
measure: Attrition in the two groups
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Clinica Medica 2A
state: PV
Study officials:
affiliation: Clinica Medica 2a
name: Chiara Muggia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01685554: Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery
Official title: Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: perfusion
cardiopulmonary bypass
hypothermia
cerebral oxygenation
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.

Detailed description: Our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery

Eligibility criteria: Inclusion Criteria:

* requirement of surgical correction of two or more valves

Primary outcomes:
measure: Cerebral oxygen saturation
timeFrame: perioperatively
Secondary outcomes:
measure: time until "fit for ICU discharge" fulfillment
timeFrame: 5 days postoperatively
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Dep. of Anesthesiology, Northern SMU
Study officials:
affiliation: Northern State Medical Univercity
name: Mikhail Y Kirov, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lenkin AI, Zaharov VI, Lenkin PI, Smetkin AA, Bjertnaes LJ, Kirov MY. Normothermic cardiopulmonary bypass increases cerebral tissue oxygenation during combined valve surgery: a single-centre, randomized trial. Interact Cardiovasc Thorac Surg. 2013 May;16(5):595-601. doi: 10.1093/icvts/ivt016. Epub 2013 Feb 13.
Clinical trial NCT00953654: Exercise Training for the Treatment of Generalized Anxiety Disorder
Official title: Exercise Training for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial Comparing Endurance and Strength Training Among Sedentary Women With Generalized Anxiety Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Exercise Training
Strength Training
Mental Health
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of 6 weeks of endurance or strength training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder (GAD).


Eligibility criteria: Inclusion Criteria:

* Women aged 18-39 years
* Principal diagnosis of Generalized Anxiety Disorder according to DSM-IV diagnostic criteria (comorbidities will be acceptable as long as Generalized Anxiety Disorder is the principal diagnosis)

Exclusion Criteria:

* A score of less than 45 on the Penn State Worry Questionnaire
* A score of less than 7 on the Generalized Anxiety Disorder section of the Psychiatric Diagnostic Screening Questionnaire
* Expending greater than 250 kilocalories per kilogram body weight per week as measured by a 7-day physical activity recall questionnaire
* Engaging in greater than 6 exercise bouts in the month prior to recruitment
* Pregnancy
* Any medical contraindications (cardiovascular or musculoskeletal) to exercise training according to American College of Sports Medicine guidelines

Primary outcomes:
measure: Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings
timeFrame: Pre- and post- 6 week training intervention
measure: Worry Symptoms
timeFrame: Baseline, Week 2, Week 4, Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: The University of Georgia
state: Georgia
Study officials:
affiliation: The University of Georgia
name: Matthew P Herring, MS, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Georgia
name: Patrick J O'Connor, PhD
role: STUDY_DIRECTOR
References: