louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05654766: Assesment of the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies
Official title: Development of a Method for Assessing the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies Using Flow Cytometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Thrombocytopenia
Thrombocytopathy
Acute Leukemia
Hemorrhagic Disorders
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
First posted: 2022-12-16
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pediatric volunteers aged 1 to 17. Pediatric volunteers aged 1 to 17 with any manifestation of hemorrhagic syndrome.

Brief summary: The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets for use in the differential diagnosis of thrombocytopenia and platelet defects.

Detailed description: The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets using flow cytometry and turbidimetric and impedance aggregometry for use in the differential diagnosis of thrombocytopenia and platelet defects

Eligibility criteria: Inclusion Criteria:

* Pediatric participants with hemorrhagic syndrome (hemorrhagic rash, bruising, bleeding, increased bleeding of the skin and mucous membranes, spontaneous hemorrhages in soft tissues and joints)
* Pediatric participants with acute leukemia
* Parameters of the plasma level of blood coagulation correspond to the age normal levels

Exclusion Criteria:

* Anticoagulation drug therapy
* Antiaggregation drug therapy
* Biologically active additives

Primary outcomes:
measure: Expression of CD42b by platelets
timeFrame: baseline
measure: Expression of CD41 by platelets
timeFrame: baseline
measure: Expression of PAC-1 by platelets
timeFrame: baseline
measure: Expression of CD63 by platelets
timeFrame: baseline
measure: Expression of CD62p by platelets
timeFrame: baseline
measure: Expression of Annexin V by platelets
timeFrame: baseline
measure: Level of platelet aggregation
timeFrame: baseline
measure: Impedance of platelet aggregates
timeFrame: baseline
measure: Fibrinogen level
timeFrame: baseline
measure: Prothrombin test
timeFrame: baseline
measure: Thrombin time
timeFrame: baseline
measure: aPTT
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: rrchypp@gmail.com Shamova, Dr
role: STUDY_DIRECTOR
affiliation: Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
name: Viacheslav Dmitriev, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01494766: Efficacy of Tyrosine in Restless Legs Syndrome
Official title: Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome (RLS)
Keywords: RLS
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter, dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is subsequently and avidly converted into dopamine. It is well known that dopamine deficiency leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine agonists and L-dopa to be effective in controlling symptoms. No studies to date have been done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in treating RLS in addition to adding another possible agent to the investigators arsenal of treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated, in increments of 750 mg every week in patients who meet the inclusion criteria for RLS. Patients' symptoms will be monitored on a weekly basis for six weeks.


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18 to 80 years and
2. Newly diagnosed (medication-naïve) as having restless legs syndrome (using the International Restless Legs Syndrome Study Group (IRLSSG20) diagnostic criteria with a score of greater than or equal to 15, see Appendix A) and
3. That interfered with sleep onset and/or maintenance for greater than four nights/week for a minimum of six months
4. Currently not receiving treatment for RLS

Exclusion Criteria:

1. Patients suffering from secondary RLS (other movement and/or primary sleep disorders, chronic renal insufficiency - calculated from the creatinine clearance, and/or iron deficiency - baseline serum ferritin level less than 10 ng/ml)
2. Patients currently on pharmacotherapy for RLS (not medication-naïve) or previous use of pharmacotherapy for RLS in the past
3. Patients that are pregnant and/or breastfeeding
4. Patients that are on levothyroxine or monoamine oxidase inhibitors

Primary outcomes:
measure: International RLS Survey Group (IRLSSG20) Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical global impression-global improvement (CGI-I) scale
timeFrame: 6 weeks
measure: Medical Outcomes Study - Sleep Scale (MOS-SS)
timeFrame: 6 weeks
measure: Case Report Form
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Seton Family of Hospitals
state: Texas
Study officials:
References:
Clinical trial NCT05377866: Holo CTO Proctoring Study
Official title: Holo CTO Proctoring Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Chronic Total Occlusion of Coronary Artery
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
name: HoloCare AS
First posted: 2022-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease and total chronic occlusion of one or more coronary arteries.

Brief summary: Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures

Detailed description: Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging.

This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.

Eligibility criteria: Inclusion Criteria:

Clinical inclusion criteria:

* Stable angina pectoris, or dyspnoea as an angina equivalent
* Age ≥18 yrs.
* Able to provide written informed consent

Angiographic inclusion criteria:

* One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow 0. An estimated occlusion duration of at least 3 months
* Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography

Procedural inclusion criteria:

* Clinical indication for CTO PCI regardless of operative technique

Exclusion Criteria:

* STEMI within 72 hours
* Cardiogenic shock
* Active bleeding or coagulopathy
* Life expectancy \< 2 years
* Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
* Severe peripheral artery disease
* Clinical unstable angina

Primary outcomes:
measure: Standard Usability Score on a Likert Scale
timeFrame: Procedure duration( aprox 120 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
state: Agder
Study officials:
affiliation: Sorlandet Hospital
name: Slobodan Calic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508466: Mechanism of Hypersensitivity Reactions to Iron Nanomedicines
Official title: Investigation of the Underlying Mechanism of Hypersensitivity Reactions to Intravenous Iron Nanomedicines in Patients With Previous Hypersensitivity Reaction Compared to Controls - a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Keywords: hypersensitivity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants with a previous hypersensitivity reaction to an iron nanomedicine application and participants without a hypersensitivity reaction to a previous iron nanomedicine application

Brief summary: Iron deficiency is common and when oral treatment is not sufficient intravenous application is indicated. Hypersensitivity to intravenous iron nanomedicines is rare but does occur and little is known about the underlying mechanism but complement activation has been suggested.

This is a purely exploratory study as it is not yet known whether in vitro complement activation can be stimulated by titration with iron preparations. These data will provide first empirical evidence of whether and to what extent complement activation occurs in this population.


Eligibility criteria: Inclusion Criteria:Group 1)

* adult participants from 18-65 years of age
* previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) Group 2)
* adult participants from 18-65 years of age
* previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction Group 3)
* adult participants from 18-65 years of age
* previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer) Group 4)
* adult participants from 18-65 years of age
* previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction

Exclusion Criteria:

* Group 1)-4) • Autoimmune disorder or immune deficiency

Primary outcomes:
measure: Complement activation
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Esther H Steveling-Klein, Dr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205866: Incidence of Non Receptive Endometrium in Obese Women
Official title: Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.


Eligibility criteria: Inclusion Criteria:

* Infertile women: \> 1 year of regular unprotected intercourse without evidence of pregnancy.
* Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
* No endometriosis
* Presence of both ovaries
* \< 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).

Exclusion Criteria:

* Hydrosalpinx
* Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
* Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
* Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)

Primary outcomes:
measure: Non Receptive Endometrium
timeFrame: 25 days
Secondary outcomes:
measure: Distribution of fat and risk factors
timeFrame: 4 months
measure: Look for specific endometrial gene patterns.
timeFrame: 25 days
measure: Evaluate the result of assisted reproduction treatment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stamford University
state: California
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Jose Bellver, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB. Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis. Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.
Clinical trial NCT05423366: Comparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.
Official title: Comparative Effects of Large Focused and Controlled Unfocused (Radial) Extracorporeal Shock Wave Therapies in the Treatment of Patellar Tendinopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinitis
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 75
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: There is no scientific study in the literature regarding the use of different extracorporeal shock wave therapies (ESWT) in the treatment of patellar tendinopathy. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in the treatment of patellar tendinopathy.


Eligibility criteria: Inclusion Criteria:

* Engaging in active sports, being 18 years or older, history of activity-related knee pain in the patellar tendon or patellar insertion, symptoms lasting longer than 8 weeks (non-acute), VISA-P score less than 80 before treatment, pain during knee loading on tendon or tendon it remains isolated in the limited part of the bone junction and does not spread to the entire patellar region (to differentiate patellar tendinopathy and patellofemoral pain).

Exclusion Criteria:

* Being under the age of 18, acute knee or acute patellar tendon injury, chronic inflammatory joint diseases (rheumatoid arthritis, etc.), using immunosuppressive or corticosteroid medication in the last 6 months, previous knee surgery (in the anterior cruciate ligament or patellar tendon), knee in the last 1 month local (corticosteroid) injection, contraindications for ESWT treatment (eg pregnancy, malignancy, coagulopathy), previous ESWT treatment

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: at baseline.
measure: Visual Analogue Scale (VAS)
timeFrame: 3 weeks after baseline.
measure: Visual Analogue Scale (VAS)
timeFrame: 7 weeks after baseline.
measure: Visual Analogue Scale (VAS)
timeFrame: 15 weeks after baseline.
measure: Victorian Institute of Sports Assessment-Patella (VISA-P)
timeFrame: at baseline.
measure: Victorian Institute of Sports Assessment-Patella (VISA-P)
timeFrame: 3 weeks after baseline.
measure: Victorian Institute of Sports Assessment-Patella (VISA-P)
timeFrame: 7 weeks after baseline.
measure: Victorian Institute of Sports Assessment-Patella (VISA-P)
timeFrame: 15 weeks after baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Volkan Şah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05331066: Understanding immunE-related toXicities by multifACeT Profiling
Official title: EXACT - Understanding immunE-related toXicities by multifACeT Profiling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to enroll and obtain samples of investigational interest from 200 patients with a confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy.

Brief summary: A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.

Detailed description: The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.

Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.

IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18 years or older
* Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy

Exclusion Criteria:

* Medical or psychological condition that would preclude informed consent
* Planned participation in a drug trial receiving investigational agents
* Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.
* Subjects unable to comply with the study or sample schedule.

Primary outcomes:
measure: Patients who experience irAEs
timeFrame: 36 months
Secondary outcomes:
measure: Biological and clinical characteristics
timeFrame: 60 months
measure: Time to development of irAEs
timeFrame: 36 months
measure: Proportion of patients experiencing irAEs
timeFrame: 60 months
Other outcomes:
measure: Impact on patients quality of life using patient questionnaires
timeFrame: 60 months
Locations:
city: Chelsea
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: London
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Samra Turajlic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171366: A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
Official title: A Multicenter, Group Study to Evaluate the Safety and Efficacy of Amlodipine and Benazepril Administered in Combination Compared to Amlodipine Monotherapy in Hypertensive Patients Not Adequately Controlled With Amlodipine Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: amlodipine
benazepril
hypertension
diastolic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-09-15
Enrollment: 1422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.


Eligibility criteria: Inclusion Criteria:

* Outpatients 18 years of age or older.
* Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device.
* Patients with essential hypertension as measured by a validated device

Exclusion Criteria:

* Severe hypertension (DBP \> 115 mmHg diastolic and/or SBP \> 180 mmHg systolic).

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure at week 6
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure at week 6
measure: Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6
measure: Diastolic response rate at week 6. Patients were considered responders if they had a mean sitting diastolic blood pressure of < 90 mmHg or a >= 10 mm Hg decrease compared to baseline.
measure: Change from baseline in 24 hour diastolic and systolic blood pressure at week 6
measure: Change from baseline in 24 hour diastolic and systolic blood pressure at peak which is defined as the lowest hourly blood pressure mean and the average of the hourly means from 4 to 6 hours post dose at week 6
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: