cyrilzakka/clinical-trials huggingface dataset:
Paradigm Shift in the Treatment of Patients With ACS

This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Men or non-pregnant women \>18 years of age and \< 75 years of age
* Patients undergo cardiac catheterization for ACS. Patients with STEMI, NSTEMI, and UAP will be included. STEMI will be defined as continuous chest pain for \>30 minutes, arrival at the hospital within 12 hours from chest pain onset, ST-segment elevation \>0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB). NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. UAP will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest.
* Culprit lesion located in a native coronary artery
* TIMI flow grade 3 and diameter stenosis \< 70% on angiogram
* Definite erosion defined by OCT
* Patients able to provide written informed consent

Exclusion Criteria:

Left ventricular ejection fraction \< 30%.

* Life expectancy \< 1 year.
* Contraindication to the contrast media.
* Creatinine level \> 2.0 mg/dL or end-stage kidney disease.
* Serious liver dysfunction.
* Patients with hemodynamic or electrical instability (including shock).
* Any contraindication against the use of ticagrelor.
* Investigator considers the patient is not suitable.
Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease

In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease
* German speaking men and women
* Recent coronary angiogram (\<= 3 months old)
* Depression score (HADS-D) \>= 8
* Written informed consent

Exclusion Criteria:

* Severe heart failure
* Other acutely life- threatening conditions
* Severe chronic inflammatory disease
* Current suicidal tendency
* Severe depressive episode
* Other severe mental illness.
Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus

Accelerated atherosclerosis in patients with systemic lupus erythematosus (SLE) is not fully explained by Framingham risk factors. The detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (CHIP) - predisposes to cardiovascular events (CVE) in general population. We aimed to determine whether CHIP is associated with CVE in SLE.

SLE patients indeed display an accelerated atherosclerosis that strongly contributes to the excess mortality observed but is poorly explained by the traditional cardiovascular risk factors. Clonal hematopoiesis defines the clonal expansion of hematopoietic cells driven by a selective advantage given by leukemia-associated somatic mutations. Clonal hematopoiesis is said of indeterminate potential (CHIP) when found in asymptomatic patient. CHIP strongly correlated with age and logically predispose to haematological malignancy, but is also causally associated with cardiovascular events (CVE) in the general population. The main objective of our study was to determine whether CHIP is associated with CVE in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a systemic lupus erythematosus

Exclusion Criteria:

* Inadequate follow-up period (\< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study
Clinical Application of 68Ga-PSMA PET in Prostate Cancer

Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.

Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer

Exclusion Criteria:

* Patients with known malignancy in other organs.
* Patients with severe claustrophobia or unstable vital sigh
* Other serious comorbidities evaluated by primary investigator
Effects of Water-Based Exercise in Women With Metabolic Syndrome

The objective of the present study was to compare the neuromuscular, cardiorespiratory and metabolic effects of 12 weeks of aerobic training, strength training and combined training in the aquatic environment in women with MS. For this purpose, 51 postmenopausal, sedentary and MS women were randomly divided into three intervention groups: hydro-aerobic (HA, n = 18, 63.77 ± 5.03 years), hydro-power (HF, n = 16, 61.01 ± 4.93 years) and hydro-combined (HC; n = 17; 60.52 ± 6.91). A subsample participated in eight weeks without physical exercise to characterize a control period. The three intervention groups performed two weekly sessions of 60 minutes for 12 weeks. Before and after the training period, blood tests, muscle strength tests, cardiorespiratory evaluation, functional tests and a questionnaire were performed. For statistical analysis, the Generalized Estimates Equations (GEE) model was used, using the "group" and the "time" as factors. The Bonferroni post hoc was used to locate the differences and the significance index adopted was α = 0.05.

Water-based exercise as a mode of aquatic exercise has been highlighted in the scientific literature. Research on different models of training, aerobic, muscle strength and combined (aerobic and muscle strength), have already demonstrated their beneficial effects on different physical abilities. Recent studies indicate benefits of water-based exercise for the population with metabolic diseases such as hypertension, type 2 diabetes, dyslipidemias and obesity. However, for subjects with metabolic syndrome (MS) there are few studies that investigated which training model in the aquatic environment could generate physical and metabolic improvements.

This study is characterized as a randomized clinical trial, which treated three intervention groups with physical exercise programs. A subsample participated in a period of eight weeks without physical exercise to characterize a control period. The subjects in this subsample were later randomized into the intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal;
* Sedentary;
* Presented at least three positive components within the five possible to characterize the metabolic syndrome.

Exclusion Criteria:

* Smokers.
The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.

Due to cancer is a leading cause of death world wide , we will coduct the study to evaluate the diagnostic accuracy of using salivary miRNAs (412,512) from the salivary extracellular vesicles (index test) in detection of the malignant transformation of the premalignant lesions using the qualitative real time polymerase chain reaction (qRT-PCR) analysis in comparison to taking biopsy .

our study is a case control study,we will coduct our study to evaluate specificity and sensitivity of using salivary extracellular vesicles miRNAs (412,512) in detection of malignant transformation in potientially malignant oral lesions by using qRT-PCR analysis ,participants will be selected and arranged in 3 groups the control group, potentially malignant group and malignant group ,the salivary samples from the participants will be collected and then microRNA extraction steps will be done through the laboratory steps ,that include extracellular vesicles isolation, PCR Analysis for miRNA-412 and miRNA-512 expression ,also the histopathologic diagnosis and examination of all specimens were confirmed by pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Clinically evident lesions as morphologically altered tissue noted at conventional visual tactile examination
* Clinically evident suspicious lesions which are morphologically altered tissue noted at comprehensive visual ductile examination ( CVTE) with a definitive diagnosis of a potentially malignant disorders (PMD) or even a malignant disorder to be a distinct possibly.
* Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors will recruited as controls.

Exclusion Criteria:

.\<18 years of age.

* pregnant or breast feeding. .psychiatrically or mentally unstable.
An Epidemiological Study to Investigate the Characteristics of RSV Infection in Adult Hematopoietic Cell Transplant Recipients or Hematological Malignancies Patients in Tianjin HI (Hematology Institute)

This primary objective of this study is to describe the incidence of RSV infection in adult hematopoietic cell transplant recipients OR hematological malignancies patients in Tianjin HI.


Eligibility Criteria:
Inclusion Criteria:

* 1) Aged ≥ 18 years old. 2) Receiving hematopoietic stem cell transplantation; OR being diagnosed with hematological malignancies (including but not limited to leukemia, lymphoma, and multiple myeloma) and receiving chemotherapy.

  3) New onset of respiratory symptoms; OR exacerbation of existing chronic respiratory symptoms (such as previously diagnosed chronic runny nose, seasonal allergies, chronic lung disease, etc.).

  4) Willing to sign an informed consent form, able to understand and willing to follow the study protocol.

Exclusion Criteria:

* Unwillingness to sign an informed consent form.
Observational Registry on the HARPOON Device

To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.

Exclusion Criteria:

* N/A
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).

Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Renal stones ≥2 cm.
3. Patients are candidate to PCNL.
4. Patient with ECOG performance score of 2 and less.
5. Able to give informed consent
6. Able to discharges home at the same day.

Exclusion Criteria:

1. Renal stones \< 2cm and can managed by another technique.
2. Known with psychological disease.
Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery

The use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative and post-operative period to reduce or potentially eliminate narcotic usage following scrotal surgery. Research study results have shown that the use of anti-inflammatories in the peri-operative period reduces both pain and narcotic use. The hypothesis is that adding another agent in the multi-modal pathway will further reduce pain and potentially reduce narcotic usage.

This is a double-blinded, placebo-controlled, randomized trial that will recruit patients categorized into two study arms. Patients in the gabapentin arm will receive gabapentin 600mg taken pre-operatively and 300mg taken three times a day for 3 days, while patients in the placebo arm will receive a placebo drug taken pre-operatively three times a day for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Participants undergoing microsurgical testicular sperm extraction.
* Participants over 18 years of age who can provide informed consent
* Participants with no contraindication to the consumption gabapentin or documented allergy/intolerance
* Participants not currently using opiates for another reason

Exclusion Criteria:

* Contraindication to the consumption of celecoxib or gabapentin
* History of substance abuse (including prior opiate abuse)
* Narcotic use within last 3 months
* Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
* Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
* Participant is ≤12 months postpartum at screening and Day 1.

Exclusion Criteria:

* Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
* Participant has active psychosis per investigator assessment.
* Participant has a medical history of nonfebrile seizures.
* Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
* Participant has a history of sleep apnea.

Note: Other protocol-defined inclusion/exclusion criteria applied.
AGE - Functional Reserve

Renal functional reserve is defined as the glomerular hyper filtration induced by a protein load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a protein load. Renal functional reserve loss is associated with a persistent hyper filtration state, seen in first stages of diabetic nephropathy, leading to progression of Chronic Kidney Disease (CKD). This observation has lead to larger clinical studies that demonstrated the positive effects of protein restriction on kidney function, and allowed the scientific community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat), were in fact responsible for an AGEs load, based on recent published data.

The aim of this study is to determine whether AGEs alone or proteins in general are responsible for the mobilization of renal functional reserve, leading to the progression of CKD.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males subjects
* age between 18 and 30 years old

Exclusion Criteria:

* Kidney disease
* Diabetes
* Obesity
* Hypertension
* Non Steroidal Anti Inflammatory Drug treatment (NSAIDS)
* MRI Contra indications
* Myeloma
* High basal Radiation exposure : more than 1 milliSievert (mSv) in the last 6 months
Study of the Prevalence of Osteo-metabolic Complications in Patients With Thyroid Cancer

This is a multicenter retrospective observational study aimed to evaluate the prevalence of osteo-metabolic complications in patients with thyroid cancer.

Approximately 150-200 outpatients evaluated in the Endocrinology Unit of the IRCCS San Raffaele Hospital and the Nuclear Medicine Unit of the Spedali Civili of Brescia will be included in the study.

During the follow-up visits, patients who meet the inclusion criteria will be offered inclusion in the study. After signing the informed consent, the patient's anamnestic and clinical (biochemical, radiological, anamnestic) data will be retrospectively collected in an electronic database. Sensitive data will be anonymized.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Histological diagnosis of Thyroid Carcinoma
* radiological data from chest x-ray in lateral projection in the preoperative evaluation on which the vertebral morphometry
* Signing of the informed consent

Exclusion Criteria:

* Subjects not falling within the previously described criteria are excluded
Influence of an Endometrioma on Oocyte Quality

The purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma.

There is no consensus for whether an endometrioma influences oocyte quality, as well as the possible mechanisms that induce them.

In this study, the oocyte maturation will proof oocyte quality: This mean, the percentage of oocytes in metaphase II obtained after stimulation, as well as the rate of oocytes fertilized in direct contact with an endometrioma.

Eligibility Criteria:
Inclusion Criteria:

* Patients \<40 years, BMI \<30kg / m2,

Exclusion Criteria:

-