louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01792908: Kinesio Tape Effects on Ankle Proprioception
Official title: Has Kinesio Tape Effects on Ankle Proprioception? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sprains and Strains
Keywords: ankle lateral ligament
athletic tape
position sense
Proprioception
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy volunteers immediately after its application and 48 hours later.

Detailed description: The investigators assessed Joint Position Sense (JPS) through the difference of error (DoE) and the deviation of the target angle (DTA). JPS was assessed before the Kinesio Tape (KT) was placed, immediately after and 48 hours later.

Eligibility criteria: Inclusion Criteria:

* Must be signed the informed consent
* Aged between 18 and 35 years
* Did not suffered from ankle or foot skin diseases
* Active dorsal/plantarflexion ARoM equal to or above 15º and inversion/eversion
* ARoM equal to or above 5º.

Exclusion Criteria:

* Traumatic, neurological or circulatory diseases diagnosed
* Joint laxity
* More than three ankle sprains in their lives or one in the last 12 months that required treatment and ankle or foot pain at the time of study enrolment in the non-dominant lower limb.

Primary outcomes:
measure: Joint position sense on the Difference of Error from the target angle
timeFrame: Change from baseline in proprioception at 48h
Secondary outcomes:
measure: Deviation of the target angle
timeFrame: Change from baseline in proprioception at 48h
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili.
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: Iris Miralles
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miralles I, Monterde S, Montull S, Salvat I, Fernandez-Ballart J, Beceiro J. Ankle taping can improve proprioception in healthy volunteers. Foot Ankle Int. 2010 Dec;31(12):1099-106. doi: 10.3113/FAI.2010.1099.
Clinical trial NCT01799408: Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis
Official title: The Effect of Intra-articular Injection of Betamethasone Acetate/Betamethasone Sodium Phosphate at the Knee Joint on the Hypothalamic-pituitary-adrenal Axis: a Case Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Suppression
Lead sponsor: The Nazareth Hospital, Israel
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with osteoarthritis of the knee and had not been onsteroids for at least 3 months

Brief summary: To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients with osteoarthritis of the knee

Detailed description: Consecutive patients attending the rheumatology or orthopedic clinic with osteoarthritic knee pain, not responding satisfactorily to medical or physical therapy were allocated to group-1 after consent and given IACI of 6 mg of betamethasone acetate/betamethasone sodium phosphate. Following completion of this part, consecutive age- and sex-matched patients were allocated to group-2 and given intra-articular injection of 60 mg of sodium hyaluronate. Just prior to the knee injection and 1, 2, 3, 4 and 8 weeks later, patients had 1 µg adrenocorticotropin hormone (ACTH) stimulation test. Secondary adrenal insufficiency (SAI) was defined as levels of less than 18 ng/ml or a rise of \< than 7 ng/ml of serum cortisol, 30 minutes following the ACTH stimulation test.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee

Exclusion Criteria:

* Had steroids in the last 3 months. Allergic to steroids

Primary outcomes:
measure: Adrenal Suppression
timeFrame: 2 months
Secondary outcomes:
measure: favorable clinical response
timeFrame: 2 months
measure: Favorable clinical response
timeFrame: 2 months following the steroid injection
Other outcomes:
measure: Nadir serum cortisol level
timeFrame: 2 months
Locations:
Study officials:
affiliation: Nazareth Hospital
name: George Habib, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02186808: T-116_Procera-Bridge Zirconia - A Clinical Study
Official title: Procera-Bridge Zirconia - A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 80
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: The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.

Detailed description: The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
* Indication: same indication as for metal supported bridges
* Obtained informed consent from the patient

Exclusion criteria

* Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
* Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
* Mobility of the abutment teeth exceeding grade I
* Patients with pathologic pocket formation at abutment teeth
* Patients with complete dentures in the opposing jaw
* Patients with a removable partial denture in the same jaw

Primary outcomes:
measure: Success Rate of Bridge Procera Bridge Zirconia
timeFrame: prosthesis delivery, 1 year
Secondary outcomes:
measure: Success Rate of Bridge Procera Bridge Zirconia
timeFrame: prosthesis delivery, 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
Clinical trial NCT04688008: Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations
Official title: An Open-label, Randomized, Single-dose, Two -Period, Crossover Study to Investigate the Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations in Healthy Chinese Adult Subjects Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability Study
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. History of deep vein thrombosis, or any other thromboembolic event;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

Primary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: 0-120 hours post dose
measure: Area Under the plasma concentration vs time curve (AUC0-120).
timeFrame: 0-120 hours post dose
measure: area under the blood concentration vs time curve (AUC0-inf).
timeFrame: 0-infinity
Secondary outcomes:
measure: Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
timeFrame: 0-120 hours post dose
measure: Half-life Associated With the Terminal Slope (t½)
timeFrame: 0-120 hours post dose
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
References:
Clinical trial NCT00749138: Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Official title: Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: hepatitis C, tamoxifen
Lead sponsor: Bader, Ted, M.D.
Sponsor class: INDIV
First posted: 2008-09-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.

Detailed description: Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.

Eligibility criteria: Inclusion Criteria:

1. HCV RNA positive.
2. failed standard therapy

Exclusion Criteria:

1. Cirrhosis on biopsy
2. Severe medical or psychiatric conditions that would make the evaluation difficult
3. Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
4. Patients with coumadin cannot be used from a drug interaction.
5. Active use of alcohol or illegal substances -

Primary outcomes:
measure: No significant changes in ALT or total bilirubin
timeFrame: 14 days
Secondary outcomes:
measure: HCV RNA reduction
timeFrame: 14 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: VA Hospital
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Ted Bader
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212338: Effect of Music Intervention on Intravitreal Injection
Official title: Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Intervention
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.


Eligibility criteria: Inclusion Criteria:

* The participants were patients aged 18 or above,
* Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.

Exclusion Criteria:

* The participants were patients aged under 18 years
* Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.

Primary outcomes:
measure: Visual Analog Scale for Anxiety (VAS-A)
timeFrame: 1 day
Secondary outcomes:
measure: Visual Analog Scale for Pain (VAS)
timeFrame: 1 day
Other outcomes:
measure: Surgeon-patient cooperation
timeFrame: 1 day
measure: Patient Satisfaction
timeFrame: 1 day
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
state: Centre
Study officials:
affiliation: +90 272 444 0304
name: Yeliz Ciğerci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03666338: Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization
Official title: Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Rehabilitation
Keywords: early mobilization
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Università degli Studi di Brescia
name: Beth Israel Deaconess Medical Center
First posted: 2018-09-11
Enrollment: 200
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: Analysis of the randomized controlled SOMS trial of early, goal-directed mobilization to investigate if the treatment effect is consistent and independent of the initial conscious state without evidence of moderation or modification.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* mechanically ventilated for less than 48 h and expected to require mechanical ventilation for at least another 24 h at the time of screening
* functionally independent at baseline with a Barthel Index Score of at least 70 at 2 weeks before admission to the ICU based on patient or proxy completion of the measure

Exclusion Criteria:

* admitted to hospital for more than 5 days before screening
* a motor component of Glasgow Coma Scale (GCS) lower than 5
* irreversible disorder with a 6-month mortality of greater than 50%,
* raised intracranial pressure
* cardiopulmonary arrest
* unstable fractures contributing to probable immobility
* inclusion in another trial at the same time
* acute myocardial infarction
* do not have lower part of their legs
* have a rapidly developing neuromuscluar disease
* pregnant
* ruptured or leaking aortic aneurysm

Primary outcomes:
measure: Functional independence at hospital discharge
timeFrame: At the day of hospital discharge, on average up to 1 month
Secondary outcomes:
measure: average achieved mobility level during the ICU stay
timeFrame: from ICU admission to ICU discharge, on average up to 2 weeks
measure: Functional status at hospital discharge
timeFrame: At the day of hospital discharge, on average up to 1 month
measure: Start to mobilization (SOMS > 0)
timeFrame: Days from ICU admission till first mobilization, approximately up to 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Matthias Eikermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
Clinical trial NCT01704638: Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the MDR1-gene. The hypothesis is that one group will have higher exposure than the other.


Eligibility criteria: Inclusion Criteria:

* - Healthy volunteer ≥ 18 years of age
* Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min)
* Normal P-potassiumvalue (3,6-4,6 mmol/L)
* HF\>50 and no AV-block on resting ECG. No other significant abnormalities as judged by the investigator.
* Subject giving written informed consent
* Subject capable of understanding instructions

Exclusion Criteria:

* - Pregnancy
* Ongoing infection
* Intake of medication, including natural remedies (for example St John´s wort), within one month prior to starting study except for paracetamol.
* Active drug or alcohol abuse

Primary outcomes:
measure: Cmax of fluvoxamine and of digoxin
timeFrame: 2 days for fluvoxamine and 2 days for digoxin. Washout period of at least 1 week between the both parts. Total study time maximum 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: CPTU
Study officials:
References:
Clinical trial NCT06993038: Adenosine vs Diltiazem for Treatment of SVT in the ED
Official title: COMparison of Adenosine Versus Diltiazem FOR Supraventricular Tachycardia in the ED (COMFORT-ED) - Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Supraventricular Tachycardia (SVT)
Keywords: diltiazem
adenosine
emergency medicine
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a small, pilot study with a primary goal of assessing patient perceptions of two medication treatments for supraventricular tachycardia in adult patients treated in the Emergency Department.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (18 years and older)
2. Diagnosis of acute, stable SVT in the emergency department

Exclusion Criteria:

1. Receipt of IV AV-nodal blocking agents prior to study enrollment (includes adenosine, non-dihydropyridine calcium channel blockers, beta-antagonists in pre-hospital and/or hospital setting).
2. Reported or confirmed personal history of Wolff-Parkinson-White (WPW) syndrome
3. History of heart failure with reduce ejection fraction (HFrEF) (LVEF\</= 40%)
4. Severe bronchoconstrictive lung disease
5. Prior hypersensitivity to study medication
6. Previously enrolled in pilot study
7. Pregnant
8. Incarcerated

Primary outcomes:
measure: Feasibility outcome
timeFrame: From enrollment to the end of ED encounter (up to 24 hours).
measure: Feasibility outcome
timeFrame: From enrollment to the end of ED encounter (up to 24 hours).
measure: Feasibility outcome
timeFrame: From enrollment to the end of ED encounter (up to 24 hours).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Anne Zepeski, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05226338: Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects
Official title: A Phase 1, Open-Label, Randomized, Single Dose, 3-Period, 3-Treatment Study to Evaluate the Relative Bioavailability of D-0502 Tablet Formulations in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Female Volunteer
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects

Detailed description: Phase 1, Open Label, Randomized, Single dose, 3 Period, 3 treatment study to evaluation the relative Bioavailability of D-0502 tablet formulation in healthy female subjects

Eligibility criteria: Inclusion Criteria:

* Healthy female subjects between the ages of 18-55
* Required evaluation by Investigator for screening and enrollment
* Agreement and compliance with the study and follow-up procedures

Exclusion Criteria:

* Significant medical history or current comorbidly determined by the Investigator.
* Pregnant or nursing women

Primary outcomes:
measure: Access the oral bioavailability of D-0502 100mg and 200mg tablets
timeFrame: Single Dose, 3 period, 3 treatment study separated by 14 day washout periods to evaluate safety and bioavailability. Overall time in study is approximately 42 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Labcorp Clinical Research Unit
state: Florida
Study officials:
References: