cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) between 2011 and 2016.

The primary end points are overall survival (OS) and progression free survival (PFS) with Kaplan Meier.

This study was approved by Ethical Committee in Dharmais National Cancer Hospital.

Eligibility Criteria:
Inclusion Criteria:

* IIIB/C and IV stage of breast cancer
* received neoadjuvant hormonal therapy or neoadjuvant chemotherapy
* had first and second biopsy (surgery) within 6 months

Exclusion Criteria:

* had mastectomy before treatment
* pregnant
* disagree to enter the study
* had been given hormonal therapy or chemotherapy before study
* had contra-indication of SOB for pre-menopausal patients
Mobile CHESS Research on Emergency Medical Services for Children

The primary aims are to test whether an asthma care management system (M-CHESS) delivered via a smartphone (cellular phone with internet access) can support low income teenagers (ages 12-18) with significant asthma and can improve asthma control and reduce asthma-related emergency or urgent care visits and hospitalizations. Secondary aims include whether M-CHESS increases adherence to asthma control medication and reduces absenteeism from school, work or an event they wanted to attend.

Four hundred Milwaukee Medicaid recipients (ages 12-18), with an asthma-related emergency care visit or hospitalization in the last twelve months, will be recruited through their managed care organization (MCO). They will be randomly assigned to one of two study arms and will participate in a 12-month intervention plus a 12-month follow-up period. Subjects in the control group will receive a smartphone with internet access \& text messaging service. These devices will provide the ability to collect smartphone use data electronically. The experimental group will also receive the same smartphone devices (with internet access and text messaging service and ability to collect usedata. In addition the experimental group will have access to the Mobile CHESS (M-CHESS) interface. The M-CHESS smartphone interface features an interactive, internet based asthma education program, peer support mechanisms and automated reminders for asthma control medicines and data collection.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents ranging in age from 12-18:

  * These study candidates will have had an asthma related emergency care visit or hospitalization in the last 12 months and fit the following characteristics: an ICD-9 code 493.XX and have filled one or more prescription(s) for an asthma medication (short acting beta agonist, oral corticosteroid, inhaled or nebulized corticosteroid, long-acting beta agonist, xanthine, or leukotriene modifier).
  * They also must receive medical care from one of the two participating managed care organizations involved in our study.

Exclusion Criteria:

* Other chronic pulmonary disorders such as cystic fibrosis, ABPA, or bronchopulmonary dysplasia.
* Developmental/cognitive/sensory disabilities.
Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay

Purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.


Eligibility Criteria:
Inclusion Criteria:

1. Military health care beneficiary between the ages of 21-55.
2. Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of tear collection.
3. Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by principal investigator or sub-investigator.
4. Ability and willingness to understand and provide informed consent to participate in this study.

Exclusion Criteria:

1. Irritated eye reflected by patient statements or finding of "red" eye.
2. Individuals with any infections or inflammatory ocular condition (e.g. have "pink eye" or uveitis).
3. Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotrophic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
4. Individuals who are on any topical eye medications.
5. Anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.
Assessment of Dissociative Traumatic Disorders

More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed.

The goal of this research is :

1. to assess the prevalence of dissociative disorders using specific tools in patients suffering from PTSD.
2. to validate the French version of the DDIS interview (Ross, 1997) that the investigators have translated.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with PTSD according to DSM 5 criteria
* Over 18 years of age
* Informed consent signed

Exclusion Criteria:

* Neurological disorders
* Serious and/or unstable somatic pathologies
* Patient not affiliated with social security
* Patient hospitalized under restraint in psychiatric care by decision of the state representative or in psychiatric care at the request of a third party
* Patient under guardianship
* Patient participating in parallel in another biomedical research
* Change of antidepressant in the last three months
* Patient not mastering the French language
INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register

The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective (for patients operated and data recorded before 2018) and prospective (for data collected after 2018) in nature.Patients' medical data contained in the register will be analysed to determine the efficacy of the treatments they received during their follow-up at the investigation centre.

This study involves the creation and analysis of a large-scale register including all patients suffering from glaucoma, currently and previously followed-up and treated at a single tertiary centre in Lausanne, Switzerland. The design of the study is longitudinal, observational and comparative. Patients are recruited retrospectively if they attended the research centre before September 2018, and prospectively if they attend the centre from this month onwards. Their inclusion does not affect their care, treatment choice or follow-up. All data of recruited patients is be kept in their medical notes until a specific analysis is launched. Data is then exported from their medical notes into a coded database for analysis. At the end of each analysis session (defined as the publication of the related article), all exported data is fully anonymised.

Data analysis will aim to assess the long-term efficacy, safety profile, and factors predictive of success/failure of treatments performed.

To ensure the quality of all included data, health-related information will be extracted directly from the medical notes and coded into the register by a Clinical Research Associate. Conformity of the process and recorded data will be confirmed by regular internal auditing. For quality assurance the Ethics Committee may visit the research sites. Direct access to the source data and all project related files and documents must be granted on such occasions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (IOP \> 24 mmHg, medicated or not)
* Patients who received treatment (medical, laser or surgical) at the Glaucoma Centre, Montchoisi Clinic
* Able and willing to provide informed written or verbal consent

Exclusion Criteria:

* Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.

A prospective, randomized, double blinded clinical trial. Patients will undergo standard clinical and hormonal investigation as usual for IVF. Patients that will be given the standard GnRH antagonist IVF protocol will be prospectively randomized into two groups: 1. hCG group- will be triggered for final follicular maturation with hCG (Pregnyl 10,000IU) as is usual and placebo (normal saline) - 36 hours prior to oocyte aspiration. 2. The Double trigger group- will receive GnRH agonist (Suprefact 0.5 mg) and hCG (Pregnyl 10,000IU) 36 hours prior to the oocyte aspiration. All patients will be supplemented with the usual progesterone preparation (vaginal progesterone suppositories) for luteal support.

In order to increase the rate of MII from to 65% to 80% with an alpha error of 5% and beta error of 80% the sample size needed is 276 total patients in both groups or 138 patients in each group.

Eligibility Criteria:
Inclusion Criteria:

* Women during one of their first 3 IVF cycle attempts
* Women between the ages of 18-42.
* BMI (body mass index) of 18-35.
* AMH (Anti mullerian hormone) \> 1 ng/ml
* FSH˂ 20 IU/L.
* Informed consent.

Exclusion Criteria:

* Women with low ovarian response
* Previous enrollment in this study.
* AFC\>20
* E2 above 15,000 pmol/l at the trigger day.
* hypersensitive to Suprefact/Pregny/gonal F/Purigon/Menopur/progesterone, and/or their ingredients/components of the formulation
* primary ovarian failure
* pregnancy and breast-feeding
* active blood clots
* undiagnosed uterine or genital bleeding
* endometriosis
* uncontrolled hypertension;
* uncontrolled diabetes
* abnormal liver and kidney functions
* abnormal ECG, e.g. QT prolongation and torsades de pointes
* cancers/tumors, e.g. pituitary adenomas, ovarian cysts, etc.
* HIV, HBV and HCV infections
* low bone mineral density (BMD) and an increased risk of bone fracture, such as chronic alcohol and/or tobacco use, presumed or strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids
* suicidal tendency, history or disposition to seizures, state of confusion, clinically relevant psychiatric disorders, and brain lesions
* Use of an investigational drug or participation in an investigational study within 30 days prior to this study.
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Hepatocellular carcinoma of BCLC (Barcelona Clinic Liver Cancer) stage B
* Also for BCLC stage A patients, in whom ablative therapy has technical limitations.
* Downsizing tumor for resection or transplantation.

Exclusion Criteria:

* Factors related to liver cirrhosis:

  * Decompensated cirrhosis (Child-Pugh B and C, score \>8), including jaundice, clinical hepatic encephalopathy, and refractory ascites and/ or hepatorenal syndrome
  * Impaired portal-vein blood flow (portal-vein thrombus, hepatofugal blood flow)
* Factors related to HCC:

  * Extensive tumor involving the entirety of both lobes of the liver
  * Malignant portal vein thrombosis
  * Extra-hepatic metastases
* Impaired renal function:

  * Creatinine ≥2 mg/dl or creatinine clearance \<30 ml/min
* Factors related to procedure (Radial artery access):

  * Existing AV (arteriovenous) fistula or graft
  * Pervious major surgery to forearm or wrist
  * Vasculitis
  * Pervious access failure
  * Skin infection or compromised integrity
  * Artery size \<2mm
  * Intolerance of hyperextended wrist positioning
  * Severe vasospasm
  * Vessel tortuosity
  * Radial loops
  * Absent or occluded radial artery
  * Atherosclerotic or calcific PAD (peripheral artery disease)
  * Coagulopathy INR\>1.5 platelets count \<50.000/mmc
Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate


Eligibility Criteria:
Inclusion Criteria:

* hypertriglyceridemia

Exclusion Criteria:

* moderate or severe hypertension, uncontrolled diabetes (HbA1c \> 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan

Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

Selection test for assessing aortic aneurysm is CT angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. This test exposes the patient to ionizing radiation and the injection of iodine contrast medium. Repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. Ultrasound is another test that enables the detection and evaluation of aortic aneurysm. Patients with a known diagnosis of aortic aneurysm detected on CT are required to continuous monitoring in light of its growth over time and the risk of rupture.

Using Co-registration over the US device will enable to conduct a US directed aorta examination, which uses the information produced from the CT as a "roadmap" for detection and localization of the aneurysm. That can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

Eligibility Criteria:
Inclusion Criteria:

•Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.

Exclusion Criteria:

* Inability to perform Ultrasound
* Pace maker
* Hemodynamic instability
* Inability to cooperate in US examination
* Pregnant Women - does not undergo CT
Effectiveness of Individual Physical Activity Programs to Prevent Sarcopenia and Frailty Among Older Adults

Sarcopenia and frailty could be prevented and rehabilitated through individual physical activities in the form of combined exercise that could be practiced at home in daily life.

The volunteers were randomly assigned to either the intervention or control group using sealed envelopes containing documents marked with either IG (intervention group) or CG (control group). The intervention group received training, after which they demonstrated and practiced the physical activities. They were provided with an exercise leaflet for self-practice at home and were followed up by phone, LINE application, and leaders of social club for older adults at least once a week to ensure regular practice. The older adults' relatives and caregivers were also trained and encouraged to practice with them in a 1:1 match. Support techniques and warning signs for stopping or taking a break during exercise were added to each posture, along with suggestions for suitable environmental management, such as flat plains, sufficient light, and no barriers within 2 meters, to reduce the risks of accidents. However, the control group did not receive any intervention apart from general suggestions and continued with their usual daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 60 and 80 years.
* Those who are able to walk independently or with the aid of walking devices.

Exclusion Criteria:

* Participants with leg or foot amputations.
* Participants who had been admitted to hospitals in the past 6 months.
* Those with underlying medical conditions such as heart disease, bone and muscle injuries, and infectious diseases.
* Individuals who did not pass the Physical Activity Readiness Questionnaire (PAR-Q).
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).


Eligibility Criteria:
Inclusion Criteria:

* Healthy, postmenopausal women, aged 35 to 70 years
* Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
* BMI in the range of 18 to 35 kg/m2

Exclusion Criteria:

* History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic)
* History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
* Use of prescription or investigatioanl drugs within 30 days before test article administration
Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema

During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.

Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone breast surgery at least 3 months ago
* Had stage 1-2 lymphedema
* Had upper extremity lymphedema associated with breast cancer

Exclusion Criteria:

* Signs of infection such as lymphangitis, cellulitis, fungal infections
* Those with documented lymph node metastases
* Those with bilateral lymphedema
* Those with other diseases affecting upper extremity functions
* Those with a history of previous surgery related to the upper extremity
Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects

Primary objective:

* Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects

Secondary Objectives:

* Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval

The total study duration per subjects is 8-9 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Period clopidogrel/placebo: 7 days including 5 days treatment
* Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
* Washout between periods: at least 14 days period after last dosing respect to clopidogrel treatment
* End of study: at 7 to 10 days after the last dosing

Eligibility Criteria:
Inclusion Criteria:

Healthy subject,

* as determined by medical history, physical examination including vital signs and clinical laboratory tests.
* with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
* Any contraindication to clopidogrel and/or omeprazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

The objective of this study is to determine whether protocol guided resuscitation of brain dead organ donors using Pulse Pressure Variation (PPV) will increase the number of organs transplanted per donor.

Specifically the study aims to:

1. improve resuscitation of potential organ donors.
2. improve organ function in donors.
3. increase organ recovery per donor.

The investigators will randomize 960 subjects to either protocolized resuscitation (n=480) using a consensus-based PPV-guided algorithm or usual care using a 1:1 randomization scheme. The primary outcome is the mean number of organs transplanted per donor. Secondary outcomes include 6mHFS (six-month hospital-free survival) in the recipients, and mean number of organs procured per donor that are suitable for transplantation (intention to transplant). The study is powered to detect a 0.5 organ increase for transplantation per donor.


Eligibility Criteria:
Inclusion Criteria:

* Donors who were declared brain dead per local hospital brain death criteria.
* Donors who are deemed suitable for organ donation by the local OPO whether they meet the standard criteria or the extended criteria for donation.
* Presence of functioning arterial catheter.

Exclusion criteria:

* Inability to obtain informed consent from donor next of kin or legal representative.
* Donors less than 16 years of age, no maximum age limit.
* Inability to perform hemodynamic monitoring.
* Patients on lithium therapy prior to brain death.
* Known severe aortic regurgitation, intra-cardiac shunts, or on intra-aortic balloon pump.
* Donors previously enrolled in experimental protocol in which cytokines are the therapeutic targets (e.g. anti-TNF antibodies).
* Donors receiving chemotherapy or with any disease state (e.g. AIDS) that renders the subject leukopenic (WBC count \< 2).
* Donors receiving anti-leukocyte drugs (e.g. OKT3) regardless of their WBC counts.
* Pregnant donors.
* Donor is on ECMO machine