cyrilzakka/clinical-trials huggingface dataset:
Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization

In coronary pathology, persistent platelet hyperresponsiveness under antiplatelet therapy, which is often referred to as "antiplatelet resistance," is predictive of increased risk of thrombotic recurrence as well as hyper-Inhibition of this aggregation may be predictive of a hemorrhagic risk. But no study has shown that the adaptation of treatment based on platelet aggregation tests has a benefit: the management of antiplatelet treatments through the search for antiplatelet resistance (APR) is not recommended by the European Society of Cardiology (ESC) in the context of coronary angioplasty (IIIA), while this is a common practice in neurovascular pathology.

In peripheral arterial disease, several studies have shown that the existence of an APR is predictive of the occurrence of thrombotic events but not all. The investigators can therefore ask the question of the benefit of adaptation of antiplatelet therapy by biological monitoring to prevent the recurrence of thrombotic events. The platelet aggregation tests used mainly concern aspirin, via stimulation with arachidonic acid, or anti-P2Y12 (clopidogrel, ticagrelor, prasugrel), via stimulation with adenosine diphosphate (ADP). For the latter, a test via the measurement of the phosphorylation of a cytoplasmic protein called "VASP" is also used routinely, making it possible to further clarify the existence of platelet resistance to anti-P2Y12. Within the vascular medicine department, any discovery of a potential resistance to the anti-platelet treatment of a patient requires a therapeutic adaptation to overcome this phenomenon of "resistance", and to improve the phenomenon of anti-aggregation

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* All patients who were hospitalized in the vascular medicine department and who received a search for antiplatelet resistance between April 2014 and November 2017.

Exclusion Criteria:

* Opposition to participation in the study
* Absence of follow-up after antiplatelet resistance testing
The Prevalence of Sympathetic Overactivity in Primary Hypertensive Patients.

The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients with newly diagnosed essential hypertension.

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed essential hypertension patients will be eligible for the study.
* Average of two or more systolic BP readings ≥ 140mmHg or diastolic BP readings ≥ 90mmHg

Exclusion Criteria:

* History of coronary artery disease
* History of diabetes
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer

This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by participating providers from Cardinal Health's Oncology Provider Extended Network (OPEN).

This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US.

The primary population for this study includes:

-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HER2-negative ABC
* gBRCA1/2 mutation(s)
* Treatment with talazoparib monotherapy initiated on or after October 16, 2018

  -≥18 years of age at initiation of talazoparib
* A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period

Exclusion Criteria:

* Participation in any BC clinical trial after initiation of talazoparib
* Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy
* gBRCA1/2 or HER2 status unknown
* Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection
Evaluation of Patients With Refractory Dermatomyositis Using [18F] FAPI-74 PET/MRI Imaging

This study proposes the use of a PET isotope, \[18F\]-Fibroblast Activation Protein Inhibitor-74, for a prospective single-center, single-arm study using MRI imaging for participants with Refractory Dermatomyostitis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected dermatomyositis.
2. Patient must be \> 18 years old.
3. Be willing and able to provide written informed consent for the trial.

Exclusion Criteria:

1. Women who are pregnant or potentially pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.
2. Contraindication to MRI or inability to lie flat for 30 min
3. Any serious medical condition that in the opinion of principal investigator could pose significant risk of harm or injury to the patient if they participate in the study
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals

This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

The study had the following objectives:

1. Verify that the CoVa Monitoring System does not interfere with implanted devices.
2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
3. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
* Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
* Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria:

* Subject is participating in another clinical study that may affect the results of either study.
* Subject is unable or not willing to wear electrode patches as required.
* Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
* Subject is considered by the PI to be medically unsuitable for study participation.
Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male subjects
* Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive
* Body weight max. 100 kg

Exclusion Criteria:

* A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
* Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies
* Positive result of test for HIV (Human Immunodeficiency Virus) antibodies
* Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician
* Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician
* A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)
* Habitual smoking, i.e daily smoking or more than 7 cigarettes/week
* Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial
* Surgery or trauma with significant blood loss within the last 2 months prior to dosing
Auricular Stimulation for Relief of Stress and Anxiety

The aim of the study is to evaluate whether auricular stimulation (percutaneous sensory stimulation of cranial nerves) as compared vs. no intervention (waiting list) reduces stress and anxiety in health care providers, working at the time of COVID-19 pandemic at the University Medicine of Greifswald.


Eligibility Criteria:
Inclusion Criteria:

1. Medical care workers at the University Medicine of Greifswald
2. Experiencing stress and anxiety in connection with COVID-19 pandemic
3. Participants without previous anxiolytic medication
4. Ability to understand and fill in the structured questionnaire (Appendix D \& E)
5. Written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Pregnant or lactating women
4. Participants with prosthetic or damaged cardiac valves and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
5. Participants who are unable to understand the consent form
6. History of psychiatric disease
Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>60 years or older
* Visually significant cataract
* Mild to moderate primary open angle glaucoma controlled on medications
* undergoing cataract surgery with lens implantation and concurrent microstent placement
* IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s)
* CCT 480 to 620μm
* No prior ocular surgery including corneal refractive surgery
* No SLT within 6 months of baseline visit, no history of intracameral glaucoma drug eluting implants
* Visual field mean deviation ≤ -12 dB
* Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8

Exclusion Criteria:

* Prior intraocular surgery
* Visual field MD ≥ -12 dB
* secondary glaucoma including uveitis, traumatic, malignant, neovascular, and congenital glaucoma.
* Glaucoma related to elevated episcleral venous pressure including Sturge-Weber syndrome, thyroid eye disease, orbital tumor, and etc.
* Uncontrolled intraocular pressure on maximum tolerated medical therapy;
* Unable to perform wash-out IOP
* Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities including angle closure glaucoma
* Corneal disease or dystrophy
* Pathological myopia with degeneration that affects diagnostic imaging
* Clinically significant ocular pathology or degenerative diseases that affect vision, visual field, or optical coherence tomography of optic nerve.
* Inability to perform reliable Visual Field and optical coherence tomography.
Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel

The goal of this clinical trial is to learn the effect of Nano-fortified Bleaching on whitening and sensitivity of teeth.The main questions it aims to answer are:

Does Nano-fortified Bleaching gel is more effective in enhancing the whitening in comparison to conventional bleaching gel ? Does Nano-fortified Bleaching gel is more effective in declining the sensitivity in comparison to conventional bleaching gel ?

Participants will be divided into 2 groups i.e Group A where Nano-fortified Bleaching agent will be employed and Group B where Conventional Bleaching agent without nanoparticles will be used. One application of bleaching for thirty minutes will be carried out . Tooth sensitivity will be measured by VAS Scale having "No Pain" at one-end and "Worst Pain" at opposite-end .Color change will be measured with spectrophotometer.

This triple blinded randomized clinical trial will be performed where Participants without any caries, restorations or periodontal disease in anterior teeth having shade A3 or darker will be included in this trial. Those having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth will be excluded. Consecutive non probability sampling technique will be used where total participants (n=60) will be randomly allocated into two groups 'A' and 'B' (n= 30). After informed consent, bleaching protocol will be carried out in both the groups 'A' and 'B'with conventional and novel bleaching gel. The color change (ΔE) and post bleaching hypersensitivity scores will be recorded by Visual analogue scale (VAS). In group A; Nano-fortified Novel TiHP gel (Titanium Dioxide nanoparticles and 35 % Hydrogen Peroxide ) will be used for the participants of Group-A and Conventional bleaching gel (35 % Hydrogen Peroxide) will be utilized for participants of Group-B. The color change (ΔE) will be investigated via spectrophotometer and VAS score will be calculated by participants who will be instructed to rate their hypersensitivity scores after 1st session, 2nd session, 3rd session and post-bleaching after 1 week and 1 month

Eligibility Criteria:
Inclusion Criteria:Patients enrolled in the current trial ranged between 20- 40 years old with good general and oral health. Participants selected without any caries, restorations or periodontal disease in anterior teeth. The selected participants possessed maxillary incisors having shade A3 or darker after checking with Vita Classical Shade Guide

Exclusion Criteria:The patients having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth shall be excluded from this study. Moreover, pregnant, lactating women, smokers, patients taking medications, those having fixed orthodontic appliances and undergone tooth whitening will be also excluded
A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

A study of the pharmacokinetics of ustekinumab in Chinese male subjects.

This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of ustekinumab (Stelara). The study population will consist of 24 healthy male participants in China. Participants will receive a single dose of either 45mg or 90 mg ustekinumab. Participants will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.

Eligibility Criteria:
Inclusion Criteria:

* Have no clinically relevant abnormalities
* Non smoker

Exclusion Criteria:

* Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any underlying physical or psychological medical condition
* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy

To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.

Diabetic painful neuropathy a prevalent, disabling disorder. Currently, the only effective treatments are glucose control and pain management. Diabetic neuropathy is characterized by reduction of vascularity in peripheral nerves and deficiency in neurotrophic and angiogenic factors. Recent studies have shown that bone marrow (BM)-derived stem or progenitor cells have favorable effects on the repair of cardiovascular diseases. Since these BM-derived stem or progenitor cells contain various angiogenic and neurotrophic factors, these cells have been attempted for treating experimental diabetic neuropathy, and turned out to be effective for reversing various manifestations of experimental diabetic neuropathy.

However, stem-cell therapy was not proven in human study. Therefore, we will investigate the efficacy and safety of autologous peripheral blood stem cell injection in diabetic neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic diabetic neuropathy moderate pain more than 3 months Michigan Neuropathy Screening Instrument (MNSI) \>3 3/day mean pain scale \> NRS 4 Body weight \>50 kg systolic blood pressure: 90-150 mmHg, Diastolic blood pressure \<100 mmHg, Body temperature \<37.5℃, Pulse rate: 50-100/min

Exclusion Criteria:

* other cause of neuropathy symptomatic peripheral vessel disease skin lesion or arthritis central neuronal disease drug addiction or abuse Aspartate aminotransferase or Alanine aminotransferase \>1.5 times than upper normal limit range Creatinine clearance rate \<60ml/min or dialysis Myocardial infarction, unstable angina or heart failure diagnosed in 3 months psychologic disorder pregnancy or lactation
Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells. It is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone in treating patients with stage II or stage III ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage II or stage III ovarian cancer.

OBJECTIVES: I. Determine the impact of interval debulking surgery, in terms of survival, disease-free survival, and quality of life, in patients with newly diagnosed stage II or III ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery.

OUTLINE: This is a randomized study of debulking surgery with concurrent chemotherapy. Patients are randomized to receive chemotherapy alone (arm I) or chemotherapy and interval debulking surgery (arm II). Arm I: Patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks. Arm II: Patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks. In the absence of disease progression, patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy. Surgery is then immediately followed by three additional courses of platinum-based chemotherapy. Patients are followed at 6 months after randomization, then every 3 months for the remainder of the first 2 years, then every 6 months for the following 3 years, and then annually thereafter. Quality of life is assessed prior to randomization and before the fourth course of chemotherapy, and then at follow-up visits at 6 months and 1, 2, and 3 years.

PROJECTED ACCRUAL: There will be 1,000 patients accrued into this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage II or III ovarian epithelial cancer Must be planning to receive platinum-based chemotherapy Must be fit for interval debulking surgery Residual macroscopic disease with longest dimension of largest tumor mass greater than 1 cm in diameter documented at primary surgery or postoperatively by imaging

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent or prior malignancy likely to interfere with protocol treatments or comparison

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Immediate Versus Early Endovenous Ablation In Venous Ulcer

The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). Patients in control group will receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. The primary outcome for this study is the reduction of venous ulcer area at four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Venous ulcer \> 1 month
* Ulcer area \> 1cm2
* Palpable distal pulses / Ankle-brachial index \> 0,8 / Toe-brachial index \> 70mmhg (at least one criteria must be met)

Exclusion Criteria:

* Leg ulcers other than venous etiology
* Pregnancy
* General contraindications for foam sclerotherapy
* Ulcers requiring operation theater revision
A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.

Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.

Eligibility Criteria:
Inclusion Criteria:

* The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
* Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..

Exclusion Criteria:

* Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
* Patients were not allowed to take forbidden medications or not comply the study requirements.
* Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
* Pregnant or breast-feeding women were also excluded.
* Women of childbearing potential had a pregnancy test done