louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01393860: Real-world Aliskiren Use in Diabetic Patients
Official title: Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypertension
Keywords: Diabetes
aliskiren
hypertension
renal impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 200
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: Diabetic patients with hypertension who were initiated on aliskiren

Brief summary: The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Patients ages 18 yeras and older
* Hypertension Diagnosis
* Currently on at least 1 hypertensive medication
* At least 2 lab measure before and after aliskiren initiation

Exclusion Criteria:

* Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren
* Pregnancy
* Development of secondary renal disease unrelated to diabetes (such as nephritis)
* Terminal illness
* AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: Change in blood pressure
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Measure: Change in urine microalbumin
timeFrame: baseline and 1 year
measure: Measure: Change in creatinine
timeFrame: baseline and 1 year
measure: Measure: Change in potassium levels
timeFrame: baseline and 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North
state: Maryland
Study officials:
affiliation: Novartis Phamaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06879860: The Impact of 3D Patch One-Suture Fixation vs No Fixation on Chronic Pain and Recurrence in Ⅲ Inguinal Hernia
Official title: The Effects of 3D Patch Fixation With One Suture Versus no Fixation on Chronic Pain and Recurrence in Patients With Ⅲ Type Inguinal Hernia: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 150
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: This study aims to compare the effects of one-stitch fixation and non-fixation of 3D patches on chronic pain and recurrence in type III inguinal hernia. The primary outcome measures include hernia recurrence, chronic pain, etc.


Eligibility criteria: Inclusion Criteria:

1. primary inguinal hernia
2. Type III inguinal hernia (internal annulus \>3cm)

Exclusion Criteria:

1. Age below 18 years or older than 80. recurrent hernia, incarcerated hernia,strangulated hernia, and other types of hernias.
2. Patients not suitable for general anesthesia.
3. Patients requiring open surgery.
4. patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.

Primary outcomes:
measure: Rate of recurrence
timeFrame: 1 month,3 months,6 months and 12 months after surgery
measure: Rate of postoperative pain
timeFrame: 6 month
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: 6 month
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04204460: Electromyographic Evaluation of Quadriceps During Eccentric Decline Squat
Official title: Electromyographic Evaluation of Quadriceps During Eccentric Decline Squat: An Investigation of the Effect of Decline Angle and Arc of Motion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patellar Tendinopathy
Keywords: eccentric squatting
electromyografic activation
exercise
patellar tendinopathy
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asymptomathic older than 18 years, voluntary subjects who are students in a high school of physical education and sports.

Brief summary: Previous studies have generally investigated patellar tendon stiffness, cross-sectional area of patellar tendon, patellar tendon length, patellar force and patellafemoral forces during decline squat. However, there is just a few study about electromyographic (EMG) activity during the eccentric squating, which is about rectus femoris (RF) recruitment. In the present study the investigators primarly aimed to quantify the activation of RF, vastus lateralis (VL), and vastus medialis obliqus (VMO) during eccentric squat on different decline angle (0, 5°, 10°, 15°, 20°). An additional purpose of our study was to compare the changes in muscle activation at various arc of knee flexion motion (degrees of 0-30, 30-60, 60-90, 0-60, 30-90, 0-90).The investigators hypothesised that the recruitment of RF, VL, and VMO during eccentric squat would differ according to decline angle and arc of motion.

Detailed description: The squat procedure in each condition will be repeated 10 times on a treadmill. The treadmill will be used to adjust the degree of decline in a standard manner. There will be a metronome to keep the speed of exercise in the same rhythm. All squats will be performed with a weighted barbell. The weight of it will be set as in ratio 30% of the participant's body weight

Eligibility criteria: Inclusion Criteria:

* had exercised regularly (\>3 days in a week) for at least six months.
* older than 18 years old.

Exclusion Criteria:

* had patellofemoral pain, knee pain otherwise unrelated to the knee extensor mechanism and other injuries that would restrict performance of the tasks (e.g. ankle pathology).

Primary outcomes:
measure: Electromyographic measurement of muscle activation
timeFrame: 50 minutes
measure: Maximal voluntary isometric contractions (MVICs)
timeFrame: 5 minutes
measure: Normalized EMG values
timeFrame: 5 minutes
Secondary outcomes:
measure: Weight
timeFrame: 1 minute
measure: Height
timeFrame: 1 minute
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Sevim Acaröz Candan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04669860: Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma
Official title: Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Calcium Oxalate Urolithiasis
Renal Cell Carcinoma
Keywords: calcium oxalate stones
renal cell carcinoma
microbiome
urinary microbiome
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 90
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: 1. Healthy participants
2. Participants with CO urolithiasis scheduled for endoscopic kidney stone removal surgery.
3. Participants with RCC who are scheduled for kidney removal surgery.

Brief summary: The purpose of the study is to identify bacterial and fungal microbiome associated with calcium oxalate (CO) urolithiasis and renal cell carcinoma (RCC).


Eligibility criteria: Inclusion Criteria:

* Adults that are able to consent (≥ 18 years of age)
* No history of asymptomatic bacteriuria or Urinary Tract Infection within the past 1 month
* No history of coagulopathy and not on anticoagulant or antiplatelet medication at the time of surgery.
* For patients with urolithiasis, must not have a history of RCC
* For patients with RCC, must not have a history of urolithiasis
* Controls must have no history of stones, RCC, or urinary tract infection (within 1 month).
* For all participants, no antimicrobial treatment within the past month

Exclusion Criteria:

* Adults unable to consent
* For patients with urolithiasis, technical difficulty in taking renal papillae biopsy.
* History of urinary tract infection within the past 1 month
* History of coagulopathy and on anticoagulants or antiplatelets that could not be stopped perioperatively.
* Patients with nephrolithiasis and renal tumors with positive preoperative urine cultures- suggesting asymptomatic bacteriuria.
* For patients with urolithiasis, a history of RCC
* For patients with RCC, a history of urolithiasis
* Controls who have a history of stones, RCC, or urinary tract infection.
* For all participants, antimicrobial treatment within the past month.

Primary outcomes:
measure: Microbial community structure in patients with CO urolithiasis
timeFrame: Day 1
measure: Microbial community structure in patients with RCC
timeFrame: Day 1
measure: Microbial community structure in healthy participants
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hemendra N Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05548660: Pharmacogenetic-guided Choice of Post-surgery Analgesics
Official title: Pharmacogenetic-guided Choice of Post-surgery Analgesics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Post Operative Pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia
Primary purpose: OTHER

Brief summary: Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects or therapeutic failure from analgesics. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing surgeons with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide analgesic choice and improve patient outcomes.

This is a prospective, two-arm randomized implementation study. Eligible participants will be randomly assigned to receive genotype-guided analgesic selection (intervention arm) or usual care (control arm). Both cohorts will undergo pharmacogenetic testing at the time of consenting. The investigators will primarily measure the feasibility of using this test to guide analgesic selection.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide informed consent
2. Assigned female at birth and aged 18 years or older at the time of study initiation
3. Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery
4. Willing to provide a buccal swab for PGx testing and comply with all study-related procedures

Exclusion Criteria:

1. Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
2. Pregnancy
3. Breastfeeding
4. Treating physician does not want subject to participate

Primary outcomes:
measure: Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient
timeFrame: 14 days
measure: Fidelity to genotype-guided pharmacotherapy recommendations
timeFrame: 14 days
Secondary outcomes:
measure: Acute pain - Self-reported numeric pain score
timeFrame: 14 days
measure: Total opioid consumption in morphine milligram equivalents (MME)
timeFrame: 14 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03358160: Motor Representations in Orthopedic Patients
Official title: Motor Representations in Orthopedic Patients: Pilot Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Disorder
Motor Disorder
Perceptual Disorders
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic patients and age-matched healthy controls.

Brief summary: The aim of this study is to investigate the possible effects that a motor limitation at the peripheral level might have on the ability to visually discriminate others' actions.

Previous literature has shown that specific motor skills (motor expertise) facilitate the visual discrimination of domain-specific actions, and that these motor experts' superior abilities might be mediated by areas not only responsible for the visual recognition of movements (as it happens in non-expert subjects) but also involved in motor planning. Similarly, impairment in the motor system due to neurological damage modulates not only the ability to perform movements but also the ability to discriminate and predict the temporal course of observed actions.

Based on these findings, it has been hypothesized that the motor representations of gait, despite being a hyper-learned motor pattern, might be subjected to modification as a result of an impairment of walking caused by a peripheral functional limitation in the lower limbs as the one characterizing orthopaedic patients who underwent a surgical operation for total knee arthroprosthesis. In this protocol, patients are thus required to perform visual discrimination tasks based on the observation of movements performed with either the upper or lower limbs, and their performance is expected to correlated with their functional impairments in movement execution.

These results would indicate that the (in)ability to perform a movement might have an impact on its representation at the central level and on internal motion simulation capabilities, which also influence the ability to visual discriminate others' actions through action-perception transfer: this would suggest that rehabilitation in orthopaedic patients should take into account (and restore) such a central impairment in motor representations.


Eligibility criteria: Inclusion Criteria:

* Participants must be able to understand instructions and have no history of neurological or psychiatric disorders.

Exclusion Criteria:

* History of neurological or psychiatric disorders.

Primary outcomes:
measure: Group Differences in action discrimination performance.
timeFrame: End 2018.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
References:
Clinical trial NCT02128360: Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve
Official title: Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Low ovarian reserve
Poor responder
Infertility
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-05-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

Detailed description: A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of poor responder to ovarian stimulation

Exclusion Criteria:

* Patients undergoing pregestational diagnosis (PGD)
* Patients using donor eggs

Primary outcomes:
measure: Clinical pregnancy rates
timeFrame: 1 Year
Secondary outcomes:
measure: Number of High quality embryos
timeFrame: 1 year
measure: Number of eggs retrieved
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Shir Dar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190760: Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.
Official title: Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of the Interscalene Brachial Plexus Block.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-07-15
Enrollment: 90
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: The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.


Eligibility criteria: Inclusion Criteria:

* Pre-surgical patients for arthroscopic or open shoulder surgery

Exclusion Criteria:

* Skin infection near block site
* Allergy to local anesthetics
* Peripheral neuropathy
* Proven opioid dependency
* Coagulopathy
* Dementia

Primary outcomes:
measure: Efficacy DxaM Perineural
timeFrame: One day
Secondary outcomes:
measure: Efficacy of Systemic DxaM
timeFrame: One day
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Anatoly Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.
Clinical trial NCT01152060: Treatment for HBV-MN Patients in Chinese: An Open Parallel Controlled Trial
Official title: an Open Parallel Clinical Trial in HBV-GN Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proteinuria
HBVe-antigen
Keywords: remission of proteinuria
HBVe-antigen
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HBV-MN patients with heavy proteinuria in adults; HBsAg or HBeAg positive; HBV-DNA negative

Brief summary: Lamivudine treatment for HBV-DNA negative HBV-GN patients.

Detailed description: lamivudine and predinisone treatment for HBV-DNA negative HBV-GN patients.

Eligibility criteria: Inclusion Criteria:

* Adult HBV-GN patients with biopsy-proven MN, heavy protinuria, HBsAg or HBeAg positive, HBV-DNA negative

Exclusion Criteria:

* Primary MN patients, HBV-DNA positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: second affiliated hospital to nanchang university
name: Gaosi XU, MD & PhD
role: STUDY_DIRECTOR
References:
citation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
citation: Xu G, Duang Z, Wu X, Zou H, Fang X, Tu W. Treatment of hepatitis B virus-associated membranous nephritis patients in Chinese: an open parallel controlled trial. Clin Chem Lab Med. 2011 Jun;49(6):1077-8. doi: 10.1515/CCLM.2011.168. Epub 2011 Mar 17. No abstract available.