louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04834180: Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
Official title: Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Abdominal Obesity
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample.

Detailed description: Methods: After a pre-study, a prospective experimental randomized, controlled and single-blinded study was conducted. The sample included 31 adult women with ages ranging from 20 to 51 years old. The groups had a frequency of physical activity ≥ 2 and ≤ 4 times per week. Individuals with BMI ≤ 24.9 Kg/m2 and pregnant women excluded from the study. All participants were then randomized into one of three groups: group 1 was treated with Vaccaria seeds plus diet therapy, group 2 with ASP needles plus diet therapy and finally, group 3 received only diet therapy. A licensed nutritionist prescribed the hypocaloric diet plan. Baseline evaluation included anthropometric measures collected according to standardized procedures. They received two treatments per week for a total of 6 weeks. After one month of follow-up, all the anthropometric measures were reevaluated. Main Parameters: Weight/body composition by bioelectrical impedance analysis. Secondary parameters: Waist to height ratio (WHtR), weight and Body Mass Index (BMI).

Eligibility criteria: Inclusion Criteria:

* Adults
* Unfamiliar to acupuncture

Exclusion Criteria:

* Psychotropic medication
* Psychiatric or thyroid disorders
* Pregnancy

Primary outcomes:
measure: Weight (kg)
timeFrame: 1 month
measure: Waist Perimeter (cm)
timeFrame: 1 month
measure: height (cm)
timeFrame: 1 month
measure: body fat (%)
timeFrame: 1 month
measure: Body mass index (kg/m2)
timeFrame: 1 month
measure: Waist-to-height ratio (cm2)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06476080: Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster
Official title: Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Herpes Zoster Neuropathy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role


Eligibility criteria: Inclusion Criteria:

* Adult population between 30 and 75 years old.
* Unilateral painful thoracic herpetic eruption of less than one week duration.
* VAS more than or equal 4, persistent pain in spite of proper antiviral and analgesic therapy, (800 mg oral acyclovir, 5 times per day, for one week), pregabalin 300 mg per day, acetaminophen 1000 mg per day, topical calamine lotion).

Exclusion Criteria:

* Diabetic patients.
* Painful herpetic eruptive vesicles more than one week.
* Abdominal herpetic eruptions.
* Non-compliant on anti-viral (bulbar palsy for example).
* Co-malignancy or radiotherapy.
* Steroid therapy \> 5 mg prednisolone or its equivalent.
* Infections or hematoma at site of injection.
* Coagulopathy (chronic kidney or liver disease, clopidogrel use).

Primary outcomes:
measure: pain score
timeFrame: immediate after injection, 1 week, 1, 3 months
Secondary outcomes:
measure: Number of patients with pain recurrence
timeFrame: 1 week, 1, and 3 months
measure: analgesic consumption
timeFrame: 1 week, 1, and 3 months
measure: Incidence of treatment related adverse events
timeFrame: immediately after injection
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05325580: Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Official title: Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Head Pain
Keywords: intavenous
magnesium sulfate
nontraumatic
acute headaches
placebo
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

Detailed description: Rate of Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

Eligibility criteria: Inclusion Criteria:

* informed consent
* age \>18 years
* Acute non-traumatic acute headaches
* patients treated in ED
* Magnesium sulfate and aspirin administered intravenously (IV)

Exclusion Criteria:

* Current regular use of analgesics, anticonvulsants or antidepressants
* Renal disorder with a low glomerular filtration rate (\<60 ml/min)
* Neuromuscular disorder
* Pregnant woman
* Contrindication
* Allergy to NSAID
* Traumatic Headache
* Chronic headache ( headache occurring at least 15 days per month for at least 3 months)
* Hemodynamic instability

Primary outcomes:
measure: Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department
timeFrame: 1day
Secondary outcomes:
measure: Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
timeFrame: 1 day
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University of Monasrtir
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00138580: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Official title: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Only patients successfully completing study CLAF237A2305 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2305
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety of vildagliptin in combination with glimepiride during 52 weeks of treatment
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Change in HbA1c between 24 weeks and 52 weeks
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Change in fasting plasma glucose between 24 weeks and 52 weeks
measure: Change from baseline in HOMA B at 52 weeks
measure: Change from baseline in HOMA IR at 52 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab. 2010 Jun;12(6):495-509. doi: 10.1111/j.1463-1326.2010.01214.x.
Clinical trial NCT05963880: Concordance Between Central Blood PRessure dEvices In Nephrology Patients
Official title: Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Chronic Kidney Disease
Blood Pressure
Keywords: central blood pressure
Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular catheterization, which is not possible to perform routinely during the regular follow-up of patients. However, in recent years, devices used to estimate central BP have been designed and approved for clinical use. These devices can determine aortic BP in a non-invasive way using various techniques and algorithms and offer a high degree of precision when compared to invasive measurements of intraaortic BP. On the other hand, certain characteristics specific to the different devices mean that the central BP values obtained may not be interchangeable. It is therefore important to determine the degree of agreement of central BP values obtained using commercially available devices.

This study aims to determine the degree of agreement between central BP measurements obtained using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM, Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA) and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and then derive the central BP using an algorithm. The main differences between these devices lie in this algorithm, or "transfer function,", which is unique to each and the calibration used. All use a brachial cuff to capture the pulse waveform and can easily be used in clinical practice.


Eligibility criteria: Inclusion Criteria:

- Age 18-80 years old

Exclusion Criteria:

* Ongoing atrial fibrillation
* Arm circumference incompatible with the blood pressure cuffs for all devices (\<18 cm or \> 50 cm)
* Incapacity to give consent

Primary outcomes:
measure: Central SBP difference
timeFrame: at enrollment (time 0)
Secondary outcomes:
measure: Brachial SBP difference
timeFrame: at enrollment (time 0)
measure: Central DBP difference
timeFrame: at enrollment (time 0)
measure: Brachial DBP difference
timeFrame: at enrollment (time 0)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT02591680: The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs
Official title: The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening.


Eligibility criteria: Inclusion Criteria:

* Sedentary women,
* previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping

Exclusion Criteria:

* Lower limb surgery,
* patella displacement
* knee instability
* Heart or locomotor disorders which might influence the evaluation

Primary outcomes:
measure: 3D kinematic range of motion of hip adduction during ascending and descending stairs
timeFrame: 4 weeks
measure: 3D kinematic range of motion of hip internal rotation during ascending and descending stairs
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Scores on the Numerical Pain Rating Scale
timeFrame: 4 weeks
measure: Strength of hip and knee extensor muscles measured through hand-held dynamometer
timeFrame: 4 weeks
measure: Lower Limb Function measured through the questionnaires Anterior Knee Pain Scale -AKPS and Functional Index Questionnaire- FIQ .
timeFrame: 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
References:
Clinical trial NCT06031480: Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors
Official title: Study of Combination Treatment Using Anlotinib and TQB2450 in Patients With Advanced Hepatocellular Carcinoma Who Failed Prior Immune Checkpoint Inhibitor Therapies: a Single Arm, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2023-09-11
Enrollment: 55
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: This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who failed prior immune checkpoint inhibitor therapies.


Eligibility criteria: Inclusion Criteria:

* The participants must be required to sign an informed consent
* Hepatocellular carcinoma patients confirmed by pathological or cytological examination, or who meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of primary hepatocellular carcinoma" (2022)
* At least one measurable lesion (RECIST 1.1)
* Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after local treatment
* The previous treatment plan for patients before enrollment was a standard treatment plan containing immune checkpoint inhibitors, and patients with progression or intolerance were evaluated based on the RECIST v1.1 standard
* Child-Pugh Score, Class A or better B
* ECOG performance status 0 or 1
* Adequate organ function
* Life expectancy of at least 3 months

Exclusion Criteria:

* Patients who have received local treatment (including TACE, ablation, HAIC, radiotherapy) and are less than 1 month after enrollment
* Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens
* Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe immune-related AEs requiring permanent cessation of immunotherapy
* Pregnant or lactating wome

Primary outcomes:
measure: Objective response rate (ORR, RECIST v1.1)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jia Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04593680: Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men
Official title: Institute of HIV Research and Innovation (IHRI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drug Interaction
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are currently no published studies addressing drug-drug interactions (DDI) between masculinizing hormone therapy (MHT) and pre-exposure prophylaxis (PrEP) among transgender men (TGM). This could lead to concerns and subsequent prioritizing MHT over PrEP among TGM. Because tenofovir alafenamide (TAF) can achieve higher intracellular tenofovir diphosphate (TFV-DP) levels with lower tenofovir plasma concentrations, it is promising that both plasma tenofovir (TFV) and intracellular TFV-DP levels might not be significantly affected by MHT. The current study aims to determine the pharmacokinetics (PK) DDI between MHT and daily PrEP among TGM.


Eligibility criteria: Inclusion Criteria:

1. Thai nationality
2. Age 18-40 years old
3. Female-to-Male transgender individual
4. HIV-negative
5. Body mass index 18.5-24.9 kg/m2
6. Negative urine pregnancy test
7. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft-Gault equation
8. Alanine aminotransferase (ALT) ≤2.5 x ULN
9. Signed the informed consent form

Exclusion Criteria:

1. Known history of allergy to hormonal component to be used in the study
2. Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
3. Use of injectable MHT in the past 3 months
4. Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen \[HBsAg\] positive
5. Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive
6. History of myocardial infarction or coronary artery disease
7. Current use of any of the following:

   * Anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, or phenobarbital
   * Herbs: gingko biloba, St John's wort or milk thistle
   * Anti-infective agents: protease inhibitors, rifampicin or rifabutin
8. History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
9. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures

Primary outcomes:
measure: Changes in plasma TFV level
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Institute of HIV Research and Innovation (IHRI)
state: Pathumwan
Study officials:
References:
Clinical trial NCT02941380: Exploration of Cerebral Pathophysiology During and After CABG Using CPB
Official title: Cerebral Oxidative and Inflammatory Stress and Cerebral Hemodynamics During and After Coronary Artery Bypass Grafting With Use of Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: coronary artery bypass grafting
cardiopulmonary bypass
Cerebral oxidative stress
Cerebral inflammatory stress
Cerebral hemodynamics
Postoperative cognitive dysfunction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass

Brief summary: Purpose:

The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function.

Detailed description: Postoperative cognitive decline is a well-known and well-described complication following coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but the majority of patients with postoperative cognitive decline following coronary artery bypass grafting have decline in recent and remote memory in particular.

The reason for the cognitive decline is still not fully understood though many reasons have been proposed.

Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction which may also be in combination with a reduced cerebral autoregulation.

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass

Exclusion Criteria:

* Cerebrovascular disease

Primary outcomes:
measure: Cerebral autoregulation
timeFrame: 6 hours post operation
Secondary outcomes:
measure: Postoperative cognitive function
timeFrame: One day prior to operation and three days after operation
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kirsten Møller, MD PhD DMSc
role: STUDY_DIRECTOR
References: