cyrilzakka/clinical-trials huggingface dataset:
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis

This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Chronic kidney disease stage III-IV or V
* Probable start of dialysis within 18 months (pre-dialysis group)
* Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)
* Adequate iron status
* Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug

Exclusion Criteria:

* Failing renal allograft in place
* Acute or chronic bleeding within 8 weeks prior to screening
* Transfusion of red blood cells within 8 weeks prior to screening
* Poorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control
* History of seizures, hemoglobinopathies and/or severe liver disease
* Active malignant disease, except for non-melanoma skin cancer
* Immunosuppressive therapy in the 12 weeks prior to screening
* Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment
* Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients
* Pregnant or lactating women
A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese subjects.This study data will be used to support CAZ-AVI NDA in China.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Healthy male and female (of non-child bearing potential) Chinese subjects, with suitable veins for cannulation or repeated venipuncture
* BMI 19 to 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Key Exclusion Criteria:

* Any clinical condition requiring the regular use of any medication.
* Consumption of alcohol, drug, tobacco (cigarettes).
* Sensitive to any food, or any serious reaction to carbapenem, cephalosporin, or other β-lactam antibiotics.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12 lead ECG abnormal.
TVMR With the Innovalve System Trial - Pilot Study in Italy

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system


Eligibility Criteria:
Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF \<30%
Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

The COVID-19 pandemic bears a burden on medical care and economies worldwide, however immunization at the population level provides a way for to reduce future morbidity and mortality. Vaccine hesitancy and reluctance in getting the COVID-19 vaccine and apprehensions about them have been present along the course of vaccination programs and mass immunizations across the world. Factors such as the quick, large-scale production of vaccines, lack of information, and uncertainty about adverse reactions in the public's eye as well about myths spreading through media channels have given rise to suspicion and fear in the Latin American population. Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Ecuadorian nationality
* Active practice in the medical field
* Received the Pfizer-BioNTech COVID-19 vaccine

Exclusion Criteria:

* Patients who voluntarily refused to participate.
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis

Low back pain is a leading cause of medical consultations in France and in other industrialized countries. Although spinal surgery is a recognized treatment, to date, its impact has only been assessed using subjective or declarative criteria. Yet, in many orthopaedic diseases, it has been shown that the evaluation of functional capacities, including walking speed, is particularly useful to study the impact of these diseases and their treatment. To date, no study has attempted to assess the impact of spinal surgery by evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable locomotion parameters, and in particular walking speed. Walking speed is a quantitative measurement, which could reflect the degree of functional impairment of the patient before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

Patient:

* more than 18 years old
* who has provided verbal consent
* with acquired arthritic lumbar spinal stenosis
* eligible for surgery (pain \> 3 months, resistant to medical treatment)
* for whom the neurosurgeon has scheduled nerve decompression without osteosynthesis or instrumentation
* able to walk ≥ 10 metres without help

Exclusion Criteria:

Patient:

* Adult under guardianship
* Absence of health insurance cover
* Pregnant or breast-feeding women
* History of lumbar spinal surgery involving posterior or anterior arthrodesis
* History of lumbar spinal surgery involving arthroplasty
* History of lumbar spinal surgery within the previous 12 months
* Locomotor disorders due to causes other than spine disease (orthopaedic, neurological, vascular, cardiac...) that could significantly affect walking speed
* patients in whom the surgery could not be done or deferred (intolerance to the ventral decubitus position, infection...)
* patients who had revisit surgery before M6 (with the exception of early revisit surgery during the first month post-intervention)
* patients in whom osteosynthesis or the implantation of instruments was decided and done during the surgery
Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.

The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.

This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein \[CRP\] and Procalcitonin \[PCT\]).


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥ 18 years)
2. Requiring ICU management
3. At high risk of sepsis (septic patients are excluded)
4. Expected ICU stay for more than 4 days
5. Have provided written informed consent or consent is given by the patient's legally designated representative.

Exclusion Criteria:

1. Patient expected to die within 48 hours of admission to ICU
2. Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the IUC stay he/she will remain in the study.
Molecular Imaging of Brain Inflammation in Depressive Disorders

In a number of neuropsychiatric disorders such as depression, both brain inflammation and glutamate mediated excitotoxicity (cell death through over-activated stimulation) are suspected to play a key role. It is difficult, if not impossible, to determine the potential destructiveness of the inflammatory response seen in disease states by studying the brain's inflammatory cells (microglia) activity in isolation. The investigators are proposing to develop the means to concurrently study inflammatory response (i.e., microglial activity) and its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire brain in order to establish the importance of inflammation. In this study the investigators propose a phased clinical study whereby the early-phase involves the development of our capacity to study inflammation-mediated damage to brain cells, followed by a feasibility study in patients with clinical depression that tests whether concurrent inflammation and glutamate excess could be measured in key brain regions associated with a depressed mood state.


Eligibility Criteria:
Inclusion Criteria:

* screening form for MRI/PET is satisfactory after being reviewed by a radiologist
* diagnosed with depression or healthy control participants with no present mental health disorder
* Good general health with no diseases expected to interfere with the study
* Subject is not pregnant, lactating, or of childbearing potential (must be practicing effective form of birth control)
* Patient and healthy controls must not have an infection or an autoimmune disorder or persistent inflammation.

Exclusion Criteria:

* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
* use of Investigational agents within last month
Urdu Version of Menopause-specific Quality of Life Scale

Menopause is accompanied by a spectrum of symptoms that are frequently related to hormonal changes. Menopause and its symptoms frequently have an impact on postmenopausal women's Quality of Life. There is a need for culturally adapted screening tool to aid healthcare professionals or clinicians to screen the symptoms of menopausal women, so the aim of this study is to translate the Menopause specific quality of life (MENQOL) into Urdu and to find the reliability and validity of the translated version Menopause specific quality of life in menopausal women.

Menopause is accompanied by a variety of physiological changes and symptoms, including hot flashes, nightly sweating, anxiety, headaches, vaginal dryness, lethargy, irritability, and sleep disturbance. Menopause and its symptoms frequently have an impact on postmenopausal women's quality of life, a metric that is influenced by a variety of societal and personal circumstances. The Menopause-Specific Quality of Life Questionnaire(MENQOL) evaluates the prevalence and severity of bothersome physical and psychological concerns that women could experience during the menopausal transition.

As cross-border and cross-cultural studies continue to increase, there is a greater need for linguistic validation of tools in various societies. Until now no translation or adaptation of the MENQOL questionnaire has been made for the population with different languages in Pakistan. There is a need for culturally adapted screening tools to aid healthcare professionals or clinicians to screen the symptoms of menopausal women in the Pakistani population. As the Urdu language is Pakistan's national language so commonly used all over Pakistan, so it is required to translate and culturally adapt the MENQOL scale into Urdu language for the Pakistani population.

Eligibility Criteria:
Inclusion Criteria:

* Natural Menopause
* Females who are able to speak and read Urdu
* Volunteer to participate in the study

Exclusion Criteria:

* Mental in capacity to complete a self-administered questionnaire
* Communication problem
* Taking treatment for menopausal symptoms
* History of hysterectomy or ovariectomy
* Any systemic Chronic diseases affecting quality of life
Comparison of Ultrasound-determined and Intraoperative #Enzian-classification in Patients With Deep Endometriosis

The Enzian classification, which was developed in order to describe deep endometriotic (DE) lesions, is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered as the first-line imaging technique for endometriosis. The aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination to the definitive intraoperative Enzian classification using the latest revision of the Enzian classification (#Enzian).

Endometriosis is a common disease with endometriotic lesions being found in the ovaries, peritoneum, or as deep endometriosis (DE) involving different pelvic organs and structures. In order to describe DE lesions, the Enzian classification was developed. In the last revision of this Enzian classification, the so-called #Enzian, presence and severity grades of ovarian and peritoneal endometriosis as well as adhesions involving tubes and ovaries are also described in addition to DE lesions.

The Enzian classification is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered to be the first-line imaging technique for this disease. Therefore, the aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination (in the form of an US-#Enzian classification) to the definitive intraoperative Enzian classification (OP-#Enzian) using the latest revision of the Enzian classification (#Enzian).

Eligibility Criteria:
Inclusion Criteria:

* All women who are scheduled for a radical surgical treatment of deep endometriosis (DE) and who undergo preoperative evaluation by transvaginal sonography (TVS)

Exclusion Criteria:

* Diagnosed or suspected malignancy
* Previous colorectal surgery or previous surgery for DE including full thickness bowel resection, vaginal resection or excision of a DE lesion involving the urinary bladder
* Virgo intacta women
Intraoral Scanner With and Without Orthodontic Brackets

this study aim to evaluate the effect of two different intraoral scanners on the scanning Quality and Time in Patients With/Without Orthodontic Brackets

aim of study : evaluate two types of Intra-oral scanner in patients with/without orthodontics brackets

methodology:

* patient preparation diagnosis, photos, x-rays
* starting scanning in 3 techniques bucco-palatal , palato-buccal ,s shape
* brackets bonding by indirect technique
* scanning after brackets placement also by same 3 techniques
* data measurements by linear and angular measurements.

outcome:2 scanners will be evaluated

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes.
2. Full permanent dentition cases.
3. Class I/II/III molar relationship.
4. Mild to moderate crowding cases

Exclusion Criteria:

1. Dental anomalies.
2. Congenital missing teeth.
3. Impaction.
4. Orthognathic surgery
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels. Expansion of the T cell population during early HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus. This study will determine if a 6-month HAART regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune response against drug-resistant virus.

This study will last 48 weeks. All participants will receive T-20 as part of a HAART intensification regimen; HAART other than T-20 will not be provided by the study. There will be 17 study visits. Prior to beginning treatment intensification, participants will have weekly study visits for three weeks. Once treatment intensification has started, participants will be followed weekly for four weeks, then weekly for four weeks after treatment intensification, then monthly thereafter. Blood collection will occur at each visit.

Eligibility Criteria:
Inclusion Criteria:

* HIV viral load of more than 1000 copies/ml
* On stable antiretroviral therapy
* Have multidrug resistance

Exclusion Criteria:

* Require immunomodulatory drugs
Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer

This study evaluates what influences treatment decision-making in African American women with triple negative breast cancer. The study also aims to learn about the influence of information sources that support this decision-making process.

PRIMARY OBJECTIVE:

I. Evaluate the acceptance of treatment recommendations by African American women diagnosed with triple negative breast cancer (TNBC).

SECONDARY OBJECTIVES:

I. Evaluate the association of beliefs about chemotherapy, self-efficacy, and cancer-specific psychological distress with intention to follow through with treatment.

II. Evaluate the association of intention, Reliance on Formal or Informal Resources, and decisional conflict as predictors of final treatment decision.

III. Evaluate the association of Reliance on Formal or Informal Resources as a moderator of the relationship between intention and final treatment decision.

OUTLINE:

Patients participate in a standard of care treatment planning meeting over 3 hours with members of the multidisciplinary treatment team including, the oncologist, radiologist, oncology surgeon, and social worker. Patients then complete surveys over 20 minutes and within 30 days later. Some patients may participate in interviews over 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* New patient in the MD Anderson Cancer Center Nellie B. Connally Breast Center or Houston Area Locations (HALs) (presenting to the surgery clinic, medical oncology clinic, or multiteam clinic)
* Women 18 years and older treated at MD Anderson Cancer Center between 1/1/2019 and 12/31/2021
* Diagnosis of triple negative invasive breast cancer on percutaneous needle biopsy within 60 days of first clinic appointment demonstrated by estrogen receptor (ER) 0% (absence or very low presence of estrogen uptake), progesterone receptor (PR) 0% (absence or very low presence of progesterone uptake), and HER2 negative (immunohistochemistry \[IHC\] score of 0 or 1 or fluorescence in situ hybridization \[FISH\] non-amplified score 2.0 or less)
* Tumor size \>= 1 cm (chemotherapy is not recommended for tumors \< 1 cm)
* Breast cancer stage I, II, or III
* Self-identify as of African descent (African American, African, Black, Afro-Caribbean, etc.)
* Completion of treatment planning team meeting and receipt of treatment at MD Anderson or local oncologist under the guidance of MD Anderson medical oncologist; no time window for treatment completion
* Ability to read, write, and speak in English, and provide consent

Exclusion Criteria:

* Patients with previous history of breast cancer diagnosis
* Patients with newly diagnosed bilateral breast cancer
* Patients with psychiatric disorders that exceed moderate severity documented within patient medical record
Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids

The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge


Eligibility Criteria:
Inclusion Criteria:

* Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
* Patients infused Fentanyl or Hydromorphone for more than 72 hours
* Patients with evidence of reversal of process that caused respiratory failure, adequate oxygenation (PaO2/fraction of inspired oxygen (FiO2)\>200; Positive end expiratory pressure (PEEP)≤8 and Ph≥7.2
* Patients hemodynamically stable
* Patients with a failed single or multiple attempts at spontaneous breathing trials

Exclusion Criteria:

* Patients with history of opioid drug abuse
* Patients receiving schedule II narcotics on a chronic basis for longer than 6 months prior to ICU admission or on other analgesic infusions other than Fentanyl or Hydromorphone
* Patients with cervical spinal cord injury or neuromuscular disease
* Patients with end stage liver disease at ICU admission (ie, International normalized ratio ≥2and not taking warfarin and/or a total serum bilirubin ≥1.5 times above normal limits
* Patients with prolonged QTc interval ≥500
* Patients with prior history of cardiac conduction defects or sudden death
* Patients with QTc increase of ≥60 milliseconds above the value of prior EKGs measured during current ICU admission
* Patients with more than 5 days on IV analgesia
* Patients intubated for more than 3 days
* Patients without feeding tubes
* Patients not receiving enteral feeding