louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01553344: Serum Sclerostin Level & Treatment of Vitamin D Deficiency
Official title: Serum Sclerostin Level in Patients With Vitamin D Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine System Diseases
Vitamin D Deficiency
Keywords: sclerostin
osteomalacia
vitamin D deficiency
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-03-14
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vitamin D deficiency

Brief summary: The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.

Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.

Detailed description: This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.

This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.

Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.

Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically \<0.012 ng/ml. Intra-assay precision is less than 8%.

Eligibility criteria: Inclusion Criteria:

* Premenopausal
* Serum 25(OH)D \< 10 ng/mL

Exclusion Criteria:

* Anemia
* Tumor-induced osteomalacia (hypophosphatemia)
* Hypothyroidism
* Hepatic / renal disease
* Primary hyperparathyroidism
* Fibromyalgia
* Polymyalgia rheumatica
* Serum 25(OH)D \> 10 ng/mL
* Vitamin D and calcium treatment commenced prior to study participation

Primary outcomes:
measure: Serum sclerostin level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training & Research Hospital
Study officials:
affiliation: Bagcilar Training & Research Hospital Istanbul, Turkey
name: MUHARREM CIDEM, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00980044: Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Official title: Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Substance Withdrawal Syndrome
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-09-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.


Eligibility criteria: Inclusion Criteria:

* Addicted to opioids

Exclusion Criteria:

* Any major medical or psychiatric disorder that would be contraindicated for participation

Primary outcomes:
measure: Subjective Opioid Withdrawal Total Adjective Score
timeFrame: Days 1-7
measure: Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
timeFrame: Days 1-7
measure: Subjective Opioid Withdrawal Adjective Total Score Week 2
timeFrame: days 8-13
measure: Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
timeFrame: Days 8-13 (all groups now on placebo)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Michelle Lofwall, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lofwall MR, Babalonis S, Nuzzo PA, Siegel A, Campbell C, Walsh SL. Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):188-97. doi: 10.1016/j.drugalcdep.2013.05.010. Epub 2013 Jun 4.
Clinical trial NCT03777644: Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
Official title: Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.

The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Primary outcomes:
measure: the postoperative recovery quality on postoperative day 7
timeFrame: at the 7th postoperative day
Secondary outcomes:
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 8, 24,48 hours after the surgery
measure: cumulated morphine consumption
timeFrame: At 8, 24,48 hours after the surgery
measure: post operative length of stay
timeFrame: Up to 2 weeks
measure: time to out-of bed activity/ambutation
timeFrame: Up to 2 weeks
measure: time to resumption of bowel movement
timeFrame: Up to 2 weeks after surgery
measure: the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire
timeFrame: at the 3th postoperative day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT02293044: A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
Official title: A Pilot Clinical Study to Evaluate the Safety and Efficacy of a Self-Applied Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale in response to the cold water challenge.

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed facial orthodontic appliances
* self-reported pregnancy or nursing
* a history of kidney stones
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.

Primary outcomes:
measure: Change From Baseline Cold Water Challenge
timeFrame: 1 Day
Secondary outcomes:
measure: Change From Baseline Visual Analog Scale
timeFrame: 1 Day
Other outcomes:
Locations:
city: Mason
country: United States
facility: Oral Health Science Center
state: Ohio
Study officials:
affiliation: Procter and Gamble
name: Robert W Gerlach, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02065544: Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
Official title: Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
behavioral weight loss
exercise training
hemoglobin A1c
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of \< 6.5%.

Detailed description: This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of \< 6.5%.

The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. \> 50%) for individuals in the study.

Eligibility criteria: Inclusion Criteria:

* new diagnosis of type 2 diabetes since 12 months
* BMI\>27
* HBA1c \> 6.5, , 8.0

Exclusion Criteria:

* HBA1c \>8.0
* BMI\< 27

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6-months
Secondary outcomes:
measure: lipid profile
timeFrame: 6 months
measure: HS-C Reactive Protein
timeFrame: 6 months
measure: Aerobic Fitness
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: Philip A Ades, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06557044: The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:
Official title: The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty: a Prospective, Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prospective
Randomized
Double-blind
Keywords: Pericapsular Nerve Group Block
hip endoprostheses
Lead sponsor: Diakonie-Klinikum Stuttgart
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2024-08-16
Enrollment: 110
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 aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.


Eligibility criteria: Inclusion Criteria:

* planned cementless hip TEP operation for primary coxarthrosis via minimally invasive anterolateral approach using the identical implant system (Taperloc stem, Plamafit cup)
* Patient capable of giving consent
* Informed consent has been obtained
* age \> 18 years

Exclusion Criteria:

* Refusal to participate in the study
* Regular use of opioids
* Known chronic pain symptoms
* Infections in the area of the puncture site
* Presence of a contraindication to ropivacaine
* Presence of a contraindication to metamizole
* Presence of a contraindication to postoperative analgesia with diclofenac
* Secondary forms of osteoarthritis with deformities (i.e. high-grade dysplasia, secondary conditions after trauma, secondary conditions after childtrauma, secondary conditions after childhood hip joint diseases
* Spinopelvic dysbalance, spinal canal stenosis
* Previous operations on the hip/pelvis

Primary outcomes:
measure: Rate of postoperative opioid administration
timeFrame: 60 minutes after arrival in the recovery room
Secondary outcomes:
measure: Quantity of total opioid consumption
timeFrame: until the evening of the second postoperative day
measure: Intensity of postoperative pain
timeFrame: until the evening of the second postoperative day
measure: Intensity of postoperative nausea and vomiting
timeFrame: until the evening of the second postoperative day
measure: Postoperative recovery
timeFrame: until the evening of the second postoperative day
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT05251844: The Effectiveness of Email Alerting on Reducing Employees' Unauthorized Access to Protected Health Information
Official title: Effectiveness of Email Alerting on Reducing Hospital Employees' Unauthorized Access to Protected Health Information: A Nonrandomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unauthorized Data Access
Lead sponsor: Protenus, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 444
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group received email notice while the group didn't
Primary purpose: OTHER

Brief summary: To assess the effectiveness of email warnings on reducing repeated unauthorized access to Protected Health Information (PHI), a randomized trial was conducted in a large academic medical center to understand the effectiveness of email warning on reducing repeated unauthorized access to PHI.

Detailed description: From January 1, 2018, to July 31, 2018, a large academic medical center's PHI access monitoring system flagged all unauthorized accesses to patient electronic medical records from 444 employees (all professional medical staff), who were not part of the patient's intervention team and did not have access permission. 219 employees (49%) were randomly selected to receive an email warning on the night of their access, while the remaining employees (225, 51%) served as controls. The email informed that the employee has had been identified as having accessed a patient's electronic medical record without a known work-related purpose and that unauthorized access is a privacy violation. A sample email was attached at the end of the protocol.

The system tracked all these individuals' violations within the sample period. Later on, all cases with the violators' ID and patients' ID fully de-identified (see the following excerpt as examples) were shared with researchers at John Hopkins and Michigan State for data analyses. Because researchers do not have the ability to link the data with an identifier, the study was exempted from Michigan State University's IRB review.

Violator ID Patient ID Date Intervention 01B1NSYX3CEXZ86UZXU7R9JQ4VEK R7Z8RTZQL4B9IAC13F6EXQJVWAI7 1/2/2018 No Email

01B1NSYX3CEXZ86UZXU7R9JQ4VEK R7Z8RTZQL4B9IAC13F6EXQJVWAI7 1/3/2018 No Email

Eligibility criteria: Inclusion Criteria:

* violators of patients' privacy rights

Exclusion Criteria:

-

Primary outcomes:
measure: the number of subsequent unauthorizated access violations
timeFrame: 12 weeks starting from the first time a violation was flagged
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Protenus, Inc.
state: Maryland
Study officials:
affiliation: Protenus, Inc.
name: Nick Culbertson, BS
role: STUDY_CHAIR
References:
Clinical trial NCT06827444: The Role of Attention in Modulating the Placebo Effect
Official title: Effects of Attention and Placebo Modulation on Cycling Performance: an Experimental Study on Stationary Bikes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placebo Effect
Attention
Keywords: Placebo
Bayesiana approach
Mindfulness
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to examine whether these forms of attention to sensory information can modulate the mind-body interaction. This will be demonstrated through a study focused on the placebo effect with attention manipulation. Specifically, the project will focus on the construct of mindful attention to increase the precision of the likelihood and reduce the effects of priors, and on directed attention to modify the position and precision of the likelihood, hypothetically modulating the placebo effect.

The study involves recruiting 128 healthy individuals, who will be asked to cycle on an ergometer for approximately 60 minutes, with alternating phases in which attention will be manipulated. After an initial warm-up phase, they will receive a placebo drink, presented as "highly stimulating." An additional group of 32 participants will not receive either the placebo drink or the attentional stimuli, but will undergo the same training cycles. All participants will receive a pre-intervention assessment, and heart rate, emotions, and perceived fatigue will be monitored.


Eligibility criteria: Inclusion Criteria:

* Persons (18+) in good health, verified by presenting a medical certificate (sporting, competitive or non-competitive, or of good health).
* Be available to go to a gym. If not enrolled, the cost of admission is borne by the project.

Exclusion Criteria:

* known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
* allergy and/or intolerance to caffeine.

Primary outcomes:
measure: Fatigue
timeFrame: 30 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: 30 minutes
measure: Perceived efficacy of the energy drink
timeFrame: 30 minutes
Other outcomes:
measure: Mindfulness
timeFrame: Once, at the baseline (pre-experiment)
measure: Anxiety
timeFrame: Once, at the baseline (pre-experiment)
measure: Stress
timeFrame: Once, at the baseline (pre-experiment)
measure: Optimism
timeFrame: Once, at the baseline (pre-experiment)
measure: Cognitive flexibility
timeFrame: Once, at the baseline (pre-experiment)
measure: Personality traits
timeFrame: Once, at the baseline (pre-experiment)
Locations:
city: Milan
country: Italy
facility: Università Cattolica del Sacro Cuore
state: Milano
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Francesca NA Grosso, MD
role: STUDY_DIRECTOR
References: