cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal patients
* Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
* Estrogen receptor positive breast cancer patients
* Patients who remain free from disease following treatment with tamoxifen

Exclusion Criteria:

* Patients taking other drugs for the adjuvant treatment of breast cancer
* Patients taking hormone replacement therapy
* Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
Retrospective Study of COVID-19 on Reproductive Function

This multi-center, retrospective cohort study aimed to determine which factors are associated with ongoing pregnancy rates in infertile patients received ART treatments during the current outbreak of COVID-19 infection.Couples who underwent IVF-ET/ICSI-ET/FET due to infertility in the department of Reproductive Medicine from 2022-11-23 to 2023-01-07 were included. Patients who were infected with Coronavirus were observation groups; the infection status and clinical outcome were tracked. Patients who were not infected with Coronavirus were control groups.

In this multi-center, retrospective cohort study, we included patients who underwent IVF-ET/ICSI-ET/FET due to infertility in the department of Reproductive Medicine from 2022-11-23 to 2023-01-07. Patients who were infected with Coronavirus were observation groups; the infection status and clinical outcome were tracked. Patients who were not infected with Coronavirus were control groups. We compared different parameters between two groups. The primary outcome was ongoing pregnancy rate. Basic information about patients' menstruation, sexual desire, and sexual function were collected from Medical record system. Other information about patients' vaccination status, symptoms related to viral infection were collected by telephone follow ups. Susceptibility indicators to COVID-19 infection including fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone were obtained . Reproductive function indices AMH, INHB, sex hormones, follicle retrieval rate, Gn days, total Gn, endometrial thickness, the incidence of OHSS, semen quality, oocyte maturation rate, fertilization rate, qualified embryo rate, blastocyst formation rate, and other laboratory indices of both men and women were also collected . Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators were analyzed to determine whether there is deference in clinical outcomes between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with infertility
* Patients with IVF-ET/ICSI-ET/FET from 2022/11/23 to 2023/01/07

Exclusion Criteria:

* Patients with contraindications to pregnancy or assisted reproductive technology
Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis

The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are:

1. How many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital?
2. What is the actual number of patients undergoing endovascular interventions for deep vein thrombosis?

Participants received endovascular treatment according to the clinical protocol of the treatment.

Tertiary hospital database was analyzed. All the records of patients referred for deep vein thrombosis were extracted. The collected data included general patient information, medical history, results of physical examination, duplex ultrasound, laboratory analysis, etc. Indications and contraindications for mechanical thrombectomy and catheter-directed thrombolysis were assessed, considering possible benefits and risks. Patients who could be eligible for this technique were identified

Eligibility Criteria:
Inclusion Criteria:

* lower limb, pelvic, or inferior vena cava deep vein thrombosis

Exclusion Criteria:

-
Treatment of Peyronie's Disease with Platelet-Rich Plasma

The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.

The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. Subsequently, participants will attend weekly injection sessions for 6 weeks, during which they will receive 3 PRP injections and 3 saline injections (placebo) in a randomized order. Three months after the final injection, participants will attend a follow-up visit, where the final data will be collected. Analysis will then be conducted.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Be able to provide written informed consent
* Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).
* Penile curvature of 30-95 degrees

Exclusion Criteria:

* Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
* Hourglass malformation
* Severely calcified plaques where injection is considered unfeasible
* History of priapism.
* History of penile fracture.
* Previous treatment for PD with injections and/or surgery.
The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy

A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited.

The correlation between endometrial pattern and ectopic pregnancy will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* First trimester of pregnancy
* No visualization of gestational sac

Exclusion Criteria:

* Hemodynamic instability
Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic cholecystectomy surgery
* Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

Exclusion Criteria:

* Uncontrolled Arterial Hypertension
* Uncontrolled Diabetes Mellitus,
* Mental retardation ,
* Antidepressant use
* Metabolic disorders,
* Bleeding diathesis
* Patients with a body mass index above 30.
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.


Eligibility Criteria:
INCLUSION CRITERIA

* Current primary diagnosis of bipolar I disorder, mania or mixed type
* Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score \>= 18
* Hospitalized no more than 7 days at time of Screening or in process of being admitted
* History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement

EXCLUSION CRITERIA

* History of schizophrenia or schizoaffective disorder
* Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
* Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
* Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
* Had first manic episode after age 60
* Has ever taken clozapine
* Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of active alcohol or substance dependence within past 3 months.
* History of failed treatment on adequate valproate therapy for bipolar disorder
* Has taken Depakote (DR or ER) regularly over the last 30 days
* Has serious violent, homicidal, or suicidal ideation
Virtual Reality Based Rehabilitation After Ischemic Stroke

Use the template below as a guide to write a brief study description in plain language. Tailor the text that appears in brackets and yellow to your research study. To finalize, delete the text in italics.

The goal of this single-arm study is to explore the use of early virtual reality-based rehabilitation as an adjunct to conventional physical/occupational therapy in adult patients with acute ischemic stroke. The main question it aims to answer is:

Feasibility and tolerability of using immersive Virtual Reality technology-based therapy for patients suffering from acute ischemic stroke in an inpatient hospital setting Participants will receive 1 or 2 virtual reality therapy sessions and complete surveys at the end of each session.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* MRI or CT imaging confirmed ischemic stroke
* Able to follow multistep commands

Exclusion Criteria:

* Plegia in both arms
* Previous reported history of vertigo or inner ear dysfunction
* Patients with epilepsy
* Patients who cannot begin therapy during admission
* Patients who are pregnant
* Patients with a pre-existing condition that interferes with virtual reality usage (e.g., visual impairment, limitation of either upper extremity or neck).
Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant (HPI2022)

HPI monitoring and the adoption of therapeutic interventions before hypotension occurs should be ensure a shorter time of intra-operative hypotension (MAP \< 65 mmHg) during deceased-donor kidney transplant surgery. The control group is represented by patients undergoing the same surgical procedure with hemodynamic monitoring with invasive blood pressure monitoring which represents the gold standard for this surgery. HPI monitoring has not yet been investigated during this surgery.


Eligibility Criteria:
Inclusion Criteria:

* First single or double kidney transplant from a cadaveric donor;
* ASA Class III-IV;
* Signature of informed consent.

Exclusion Criteria:

* Patient with atrial fibrillation rhythm or high frequency tachyarrhythmias;
* Severe valvulopathies;
* Combined single/double kidney-liver-transplant;
* Patients in whom the need for monitoring would still be expected advanced, invasive or minimally invasive hemodynamic, regardless of the allocation to the study group;
* Inclusion in another study.
The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients

The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult patients may shorten the duration, and reduce the severity of the disease.

Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may shorten the duration, and reduce the severity of the disease.

Study design A prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in patients with AP.

The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv Medical Center. Signed informed consent will be required from all patients before inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed

Exclusion Criteria:

* Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10 days prior to inclusion
RGD With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect

Periodontal regeneration is a complex process that involves coordinated activities and interactions of many cell types, extracellular matrix, cytokines, and specific growth factors to restore tissue integrity. The most important challenge facing periodontal regeneration is cellular insufficiency. Periodontal defects usually have a limited regenerative capacity due to their bounded surface area which is supposed to provide the wound area with a limited number of viable cells and a limited amount of biologic mediators. Cell recruitment and adhesion into the defect area are essential for cells to survive and secrete collagen.

Apoptosis is initiated when failure in adhesion in many different cell types occurs. Some periodontal treatment options failed in the reconstruction of the defect due to failure in wound stabilization and subsequent cell adhesion. Many treatment options have been developed to enhance defect stability and cellular recruitment including the use of GTM and different biologics. However, the treatment outcomes vary considerably depending on the level of the defect cellularity and the degree of cell recruitment into the defect area. For maximum outcomes, enhanced stability, vascularity, and biologics-sustained delivery were suggested. The minimally invasive surgical technique (MIST) suggested by Cortellini et al. offers a suitable level of tissue preservation that could help in defect stability and cellular adhesion. It was suggested to promote flap stability, maintain space, and maintain a greater amount of blood supply at the alveolar crest and papillary levels.

Periodontitis is an inflammatory multifactorial disease initiated by pathogenic bacteria accumulated as a biofilm on the tooth surface leading to clinical attachment loss (CAL), pocket formation (PD), bleeding on probing (BOP), and bone loss which if neglected may lead to increased tooth mobility and final tooth loss. Pathological tooth mobility may arise from extensive alveolar bone loss, traumatic occlusion, acute periodontal inflammation, and apical tooth displacement. Treating tooth mobility can be a challenging process, particularly for patients with severe periodontitis, including those in stage III or IV, who often experience a range of these symptoms. ue to compromised periodontal support. Therefore, effective treatment not only relies on periodontal therapy but also on occlusal stability and tooth splinting

Eligibility Criteria:
Inclusion Criteria:

* • All patients included will have moderate to advanced periodontitis.

  * Patients included in this study will be free from any systemic diseases according to criteria of Modified Cornell Medical Index(10).
  * Patients who had not undergone any type of regenerative periodontal therapy six months prior to the initial examination.

Exclusion Criteria:

* • Patients with systemic diseases, smokers, pregnant (female).

  * Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.
Pet Your Stress Away Study

The purpose of this study is to determine whether an animal visitation programs on college campuses are effective in the treatment of college student stress reduction during preparation for final examinations.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate status

Exclusion Criteria:

* None
Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients

Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.

The aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal adenocarcinoma stage IV patients.
* ECOG= 0-1
* Age \> 18 years.
* Fit to receive chemotherapy treatment
* Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.
* Adequate renal (Cr \< 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)

Exclusion Criteria:

* Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
* Previous Chemotherapy treatment
IRF-PAI Functional Outcomes Data(With FIM Instrument Variables)

IRF-PAI Functional Outcomes Data, including FIM instrument variables

United States IRF functional outcomes, medical and socio-demographic data for years 2002-2015

Eligibility Criteria:
Inclusion Criteria:

* Admission to an inpatient rehabilitation facility

Exclusion Criteria:

* Admission to acute, SNF setting, etc.
Yoga in an Urban School for Children With Emotional Behavioral Disorders

Yoga is becoming a part of therapies for children with emotional behavioral disorders. The goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school.

Participants: children in 4th and 5th grade at an urban elementary school, identified by the special education director and the teaching staff, as having emotional behavioral disorders including anxiety, depression, aggression, conduct disorder, hyperactivity and attention difficulties. These grades have a combined student population of 160 students. Enrolled over two years.

Inclusion/Exclusion criteria:

Eligible if identified by the teaching staff or special education director as having an emotional behavioral disorder. Exclusion criteria: inability to comprehend English sufficiently to complete written assessments and follow the yoga intervention.

Pre- and post-intervention assessments (teachers)

1. Behavior Assessment Scale for Children (BASC).
2. The Swanson, Kotkin, Agler, M-Flynn \& Pelham Rating Scale (SKAMP)

Eligibility Criteria:
Inclusion Criteria:

* identified by the teaching staff or special education director as having an emotional -behavioral disorder

Exclusion Criteria:

* inability to comprehendread in English sufficiently to complete written assessments and follow the yoga interventionintervention protocols
Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.

OBJECTIVES:

* Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia.
* Determine the significance of the absence of IgV_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients.
* Correlate IgV_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients.
* Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS.
* Determine if clonal evolution occurs in these biological markers at partial response or disease relapse.

OUTLINE: This is a multicenter study.

Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia

  * Previously untreated disease
* Registered to receive treatment on a Cancer and Leukemia Group B protocol

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics