louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03100097: A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers (The ARREST Study)
Official title: A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain
Low Back Pain
Lead sponsor: Aspen Medical Products
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.

Detailed description: The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.

Eligibility criteria: * Inclusion Criteria:

  o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
* Exclusion Criteria:

  * Pregnant patients
  * Patients considering pregnancy
  * Patients in any other investigational device or drug study
  * Patients unwilling to return for follow up
  * Patients unwilling to provide access to medical claims associated with pain management.

Primary outcomes:
measure: 40% change in Oswestry Disability Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Opioid utilization
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Number of participants with treatment-related adverse events as assessed by questionnaire
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: General Health Survey
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05692297: Denosumab Treatment in CKD Patients at High Risk of Fracture
Official title: Denosumab Treatment in Patients With Chronic Kidney Disease (CKD) at High Risk of Fracture: A Prospective, Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Fracture
Bone Density, Low
End Stage Renal Disease
Keywords: Denosumab
Chronic Kidney Diseases
Treatment
Fracture
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture.

Methods: A cohort of CKD patients with high risk of fracture was established and followed up for long periods (≥24 months). Patients with CKD3b-5D stage and fracture risk assessment tool (FRAX) scores at high risk or very high risk of fracture were enrolled. A multicenter, prospective, open-label, randomised controlled, interventional study was conducted. The patients were divided into two groups. The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months, and the patients in the non-denosumab group received conventional treatment. Bone metabolic markers (serum calcium, phosphorus, vitamin D, parathyroid hormone, alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteocalcin, total N-terminal propeptide of type I collagen, etc.), bone mineral density (dual-energy X-ray, quantitative CT), and vascular calcification score were regularly monitored. All adverse events (all-cause death, cardiovascular death, cardiac events, fracture, hospitalization, emergency department visits, etc.) were recorded during the follow-up period. Bone mineral density and clinical parameters were compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old;
* Stage 3b-5D chronic kidney disease;
* The 10-year probability of hip fracture assessed by fracture risk assessment tool (FRAX) was \>5%;
* Voluntarily signed informed consent.

Exclusion Criteria:

* Age \< 18 or ≥100 years;
* Premenopausal women;
* Denosumab was absolutely contraindicated;
* Had received denosumab or bisphosphonates therapy;
* Tertiary hyperparathyroidism;
* Patients with malignant tumor;
* Patients at risk for osteonecrosis of the jaw;
* Estimated follow-up time ≤12 months.

Primary outcomes:
measure: Rate of bone mineral density (BMD) decline at the lumbar spine
timeFrame: 24 months
Secondary outcomes:
measure: Rate of fresh fractures, cardiovascular cerebrovascular adverse events and all-cause mortality
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Nephrology Department of Beijing Jishuitan Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04805697: Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory
Official title: Fermented Grape Drinks Made of Fermented Grapes With Fruit and Vegetable Powder to Explore Whether it Can Improve the Skin's Condition and Achieve Anti-inflammatory Effects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 subjects were recruited and divided into placebo group and fermented grape drinks group.

Detailed description: In this study, using a fermented grape drinks made of fermented grapes with fruit and vegetable powder to explore whether it can improve the skin's condition and achieve anti-inflammatory effects. Sixty subjects were recruited and divided into placebo group and fermented grape drinks group. After drinking for 8 weeks, skin test and blood biochemical analysis were performed.

Eligibility criteria: Inclusion Criteria:

1. Dry skin.
2. Rough skin
3. Large pores
4. Dark yellow complexion
5. Sagging skin

Exclusion Criteria:

1. Skin disorders
2. Liver diseases
3. Kidney diseases
4. Allergy to cosmetics, drugs, or foods
5. Pregnant and lactating women
6. People who had any cosmetic procedures before 4 weeks of the study
7. Area of facial spot over 3 cm2
8. Vegan
9. People who took collagen supplements in the past 3 months.

Primary outcomes:
measure: skin brightness
timeFrame: 8 week
measure: skin elasticity
timeFrame: 8 week
measure: skin moisture
timeFrame: 8 week
measure: skin spot
timeFrame: 8 week
measure: skin wrinkle
timeFrame: 8 week
measure: inflammatory cytokines
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Research & Design Center, TCI CO., Ltd
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04171297: Ultrasound Evaluation of the Pelvis in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery
Official title: Ultrasound Evaluation of the Pelvis Using the International Deep Endometriosis Analysis (IDEA) Terminology in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery - IDEA 1 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Endometriosis
Endometriosis, Rectum
Endometriosis of Colon
Endometriosis of Vagina
Endometriosis Rectovaginal Septum
Endometriosis of Bladder
Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: University of Cagliari
First posted: 2019-11-20
Enrollment: 1866
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with suspected endometriosis scheduled for laparoscopic surgery.

Brief summary: An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for radical laparoscopic endometriosis surgery

Exclusion Criteria:

* \<18 years
* \>45 years
* (suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy
* Premenarche
* Menopause
* Pregnancy
* Patients refusal for radical surgery (for example refusal for bowel resection/temporary stoma)
* Surgery performed more than 1 year after ultrasound scan
* Patients refusal to participate to the study

Primary outcomes:
measure: Presence of deep endometriosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Medical School Nepean
city: Leuven
country: Belgium
facility: UZLeuven
city: Cagliari
country: Italy
facility: University of Cagliari
Study officials:
affiliation: UZ Leuven
name: Dirk Timmerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723497: Elderberries and Obesity
Official title: Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuel Management
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Previous studies in humans indicate that anthocyanin-rich berries can positively alter fat oxidation and insulin sensitivity. This study will determine if this is also true with elderberries, which are a more concentrated source of anthocyanins compared to other commonly consumed berries.


Eligibility criteria: Inclusion Criteria:

Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.

Exclusion Criteria:

* Are not fully vaccinated against COVID-19 (at least 2-weeks out from final dose at time of staff meeting)
* Have a body mass index less than 25 kg/m2
* Are younger than 22 years of age, or older than 75 years of age
* Pregnant, lactating, or intending to become pregnant during the study period, or have given birth in the past year
* Known allergy or intolerance to elderberries
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study
* Adherence to restrictive (vegetarian or vegan) or extreme (fad \[ex. Ketogenic or Atkins\] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight
* Habitual use of tobacco or marijuana (including vaping) products in the last 6 months
* Diagnosis or treatment of cancer in the past 3 years
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
* Type 2 diabetes requiring the use of medication
* Fasting blood glucose \> 125 mg/dL
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Primary outcomes:
measure: Substrate oxidation
timeFrame: 3.5 hours
measure: Glucose tolerance/insulin sensitivity
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Nutrition and Exercise Physiology
state: Washington
Study officials:
References:
Clinical trial NCT00397397: Comparative Treatment Study in Patients With Lower Ureteral Stones
Official title: Comparative Study in Patients With Lower Ureteral Stones Treated With 10 MG Alfuzosin,10 MG Alfuzosin With Rowatinex, and Rowatinex Alone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Calculi
Keywords: Urinary Calculi
Rowatinex
Alfuzosin
Drug Therapy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?

Detailed description: The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of lower ureter (urinary calculi) up to 8mm
* Must be able to swallow tablets

Exclusion Criteria:

* Sensitivity to Alfuzosin and Rowatinex
* Pregnant and breastfeeding women
* Single kidney
* Obstructing stone
* Renal failure creatinine up to 1.8 mg/dl
* Patients using various alpha blockers
* Liver failure
* Fever higher than 38 C
* UTI
* Syncope or hypotension
* Patients treated with PDE5
* Patients treated with inhibitor CYP3A4
* Patients refusing participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Urology Department, Hillel Yaffe Medical Center
name: Gabriel Faragi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01516697: Non-invasive Cardiac Output Monitoring in Obstetric Patients
Official title: Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Complications; Cesarean Section
Anesthesia; Adverse Effect, Spinal and Epidural
Keywords: thoracic electric bioimpedance
cardiac output monitoring
cesarean section
spinal anesthesia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician promptly, 2) provide information for the physician to make the differential diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient outcome.

-determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic profile of the patient under spinal anesthesia for cesarean section. To determine if using instantaneous measurements of SV and CO to guide patient management improves hemodynamic stability.


Eligibility criteria: Inclusion Criteria:

* age 18-45;
* receiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section

Exclusion Criteria:

* Patients who have major cardiovascular disease,preexisting of hypertension or gestational hypertension, preeclampsia and body mass index greater than 35kg/m2;
* Patients who have skin lesion at the place where the electrode is supposed to be applied;
* Emergency cesarean section patients.

Primary outcomes:
measure: Maximum percentage changes in mean blood pressure after spinal anesthesia
timeFrame: baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yandong Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06717997: The Placental Thickness and Pregnancy Outcomes in Placenta Previa Women
Official title: The Third-trimester Placental Thickness and Pregnancy Outcomes in Placenta Previa Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Placenta previa is the placenta overlying the cervical os. Placenta previa is about 1 in 200 pregnancies. The risk factors are the increasing rate of cesarean section and previous uterine surgery. Placenta previa is associated with many adverse complications; the most serious one is related to maternal hemorrhage. The diagnosis of placenta previa is done by trans-abdominal and trans-vaginal ultrasonography, which can document the placental edge's relationship to the internal os. Placenta accreta spectrum disorder is defined when trophoblastic invades the myometrium. The Placenta accreta spectrum can be categorized as: placenta accreta, placenta increta, and placenta percreta.

The clinical utility of placental thickness is an area of ongoing research in placenta previa. Prior studies have demonstrated an association between mid-trimester placental thickness and placenta accreta spectrum. Despite the presence of many studies in characterizing placental thickness, most studies have focused primarily on the placental accreta spectrum lacking information about other fetal and maternal complications. Symptomatic (bleeding) placenta previa is associated with increased maternal and neonatal morbidity and mortality. In addition; the mechanism that involves bleeding is unclear. It is usually related to uterine contractions, cervical effacement, and dilation leading to separation of the placenta from the underlying decidua.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women from 32-34 weeks.
2. Pregnant women with singleton pregnancy.
3. Women with placenta previa.
4. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
5. Women without any medical disorders.
6. Women should be living in a nearby area to make follow-up and early transportation is reasonably possible.

Exclusion Criteria:

1. Women with severe bleeding necessitate immediate delivery.
2. Women with confirmed fetal malformation.
3. If associated with abruptio placentae.
4. Women who will refuse to participate.

Primary outcomes:
measure: number of women with placenta accreta
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT05412797: Use of a DeskCycle to Reduce Sedentary Behavior During the Workday
Official title: Use of a DeskCycle to Reduce Sedentary Behavior During the Workday
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Reduction, Weight
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: DeskCycle
First posted: 2022-06-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this research was to evaluate the effectiveness of a DeskCycle intervention in reducing sedentary behavior by increasing the time spent participating in light to moderate physical activity in a randomly selected group of desk job employees at Kent State University main campus. The study also assessed the feasibility of using the DeskCycle in the working environment, as well as the effect on weight and mood. The primary outcome of interest was the 'mean minutes of light to moderate physical activity'. Secondary outcomes include weight, mood score, and feasibility of using the DeskCycle. The study was a randomized controlled trial (RCT) with a cross-over design where differences between the intervention and control group were evaluated over an eight-week period, after which there was a switch and the DeskCycles were given to the control group to use for the eight-week period that followed. The allocation during the first eight-week period intervention will be done through random process.


Eligibility criteria: Inclusion Criteria:

* females 18 years and above
* full-time Kent State university administrative employees at the Kent main campus
* sedentary for 75% of their workday
* height under 5'10"
* desk height of at least 27"

Exclusion Criteria:

* any uncontrolled cardiovascular diseases
* back, knee or other joint pains

Primary outcomes:
measure: Minutes of Exercise
timeFrame: Daily (M-F) for 8 weeks time period 1 and 2
measure: Feasibility of using the deskcycle during work
timeFrame: Week 2 period 1 and 2
measure: Feasibility of using the deskcycle during work
timeFrame: Week 8 period 1 and 2
measure: Mood
timeFrame: Baseline period 1 and 2
measure: Mood
timeFrame: Week 4 period 1 and 2
measure: Mood
timeFrame: Week 8 period 1 and 2
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline to end of study period 1 and 2
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
References: