cyrilzakka/clinical-trials huggingface dataset:
TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)

The purpose of this study is to determine if implementing a policy of widespread INH (Isoniazid) prophylaxis therapy in HIV-infected patients with access to antiretroviral therapy reduces the incidence of active TB disease in the HIV clinic population.

Tuberculosis remains a major public health problem in Brazil. Approximately 35% of HIV-infected adults in Rio de Janeiro are co-infected with latent TB. The Brazilian policies for the provision of treatment to HIV-infected people are among the most progressive in the world. Brazil provides combination antiretroviral therapy free of charge to all patients who meet clinical criteria and maintains an extensive clinic and laboratory system for the appropriate prescription and monitoring of therapy. The use of IPT, however, has been very limited in Brazil and TB remains a prominent disease in AIDS patients.

A clustered randomized trial (CRT) will determine if the routine detection of latent TB in HIV-infected patients identified at HIV clinics in Rio de Janeiro, followed by treatment with isoniazid, will reduce TB incidence in this population. The CRT will take a phased-implementation approach to ensure that all clinics will eventually have full coverage.

This study will determine if implementing a policy of widespread IPT use in HIV-infected patients with access to ARV therapy reduces the incidence of active TB disease in the HIV clinic population. The study population will be comprised of HIV-infected individuals who attend any of the 29 government HIV clinics in Rio de Janeiro, Brazil. We expect that IPT use in addition to ARVs will result in a 40-60% reduction in TB incidence, and that approximately 50% of the prevented TB cases will be in patients not yet eligible for HAART.

Eligibility Criteria:
Inclusion Criteria:

* Attending 1 of 29 participating HIV clinics
* Confirmed HIV infection
* Age \> 15 years

Exclusion Criteria:

* Current active TB disease
* TB infection within 2 years
* Hepatitis
Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE)

The purpose of this study is to determine

1. whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity
2. whether quality improvement interventions implemented at the University of Michigan and at Washington University:

   1. decrease the extent and duration of intraoperative hypotension and hypertension.
   2. are associated with decreased postoperative mortality and morbidity.

Recent epidemiological data from an European study suggests that the 30-day postoperative mortality rate reaches a rate of about 1 in 50. A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials. Many factors are associated strongly and independently with postoperative morbidity and mortality; including patient age, functional status, comorbid medical conditions, and duration and invasiveness of the surgery. It is imperative to identify modifiable factors for possible intervention.

With the advent of electronic intraoperative medical record, intraoperative hemodynamic factors can be assessed as a potential contributor to postoperative morbidity and mortality. Recent studies have shown that intraoperative hypotension occurs commonly and is associated with both early and late postoperative mortality. The investigators goal is to conduct a study that might help to clarify whether intraoperative blood pressure management might be interdependently associated with postoperative morbidity and mortality. There are two phases in this trial: pre-quality improvement phase and post quality improvement phase. Pre-quality improvement phase data will be used as a baseline control group. Data from this phase will also be used to establish whether there appears to be an independent association between intraoperative blood pressure management and postoperative morbidity and mortality. The Anesthesiology Departments at Washington University in St. Louis and at the University of Michigan are implementing quality improvement initiatives in relation to intraoperative blood pressure management. Following implementation of the quality improvement initiatives, the investigators plan to determine whether: a) there is an improvement in intraoperative blood pressure management; b) whether there is a decrease in postoperative morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012

Exclusion Criteria:

* Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6)
* Patients without a Social Security Number
Early Prediction of Placenta Accreta by Ultrasound and Color Doppler

Placenta accreta is a substantially life threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta previa. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of placenta accreta was 3.7 per 1000 deliveries.


Eligibility Criteria:
Inclusion Criteria:

1. Low implantation of the gestational sac (\<4 cm from external os) by transvaginal ultrasound
2. Presence of placental lakes by transvaginal ultrasound
3. Disruption of placental-myometrial interface by transvaginal ultrasound
4. Trophoblast overlapping a uterine scar (Cesarean section, myomectomy) by transvaginal ultrasound
5. Intraplacental dilated vessels by Doppler ultrasound
6. Turbulent blood flows by Doppler ultrasound
7. Greatly increased periplacental vascularity by Doppler ultrasound

Exclusion Criteria:

a) Cases far away from our hospital and expected to be lost to be followed. b) Pregnant women who will refuse to Participate

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Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection

Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.
2. Participants of any gender between the ages of 18 and 85 are eligible.
3. Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.

Exclusion Criteria:

1. Patients who have previously undergone lung surgery;
2. Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;
3. Patients who did not receive Chest computed tomography (CT) at admission or within 7 days before surgery, or whose Chest CT at admission suggests pneumonia or current infection with SARS-CoV-2 (confirmed by routine laboratory tests as positive nucleic acid in admission or on the day of surgery);
4. The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;
5. Local unresectable lesions or distant metastases are found intraoperatively.
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route

The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.

The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users; to assess the cognitive and behavioral effects of CL-108 tablets following oral administration relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered CL-108 tablets relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.

Eligibility Criteria:
Inclusion Criteria:

* BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
* Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
* Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

* Drug or alcohol dependence within the last 12 months (except nicotine)
* Subjects who had ever been in treatment for substance use disorders (except smoking cessation
* History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
* History or presence of hypotension, judged to be clinically significant based on investigator judgement
Biomarkers of Processed Meat Intake

The intake of processed meat products has been linked to several adverse health outcomes. However, estimation of their intake proves difficult. This study aims at identifying biomarkers of intake for processed meat products in blood and urine. For this, participants of a randomized cross-over dietary intervention will consume highly controlled diets containing non-processed pork, different processed meat products or no meat. Urine and plasma will be collected and analysed to identify sets of metabolites that are specific for the intake of the processed meat products.

The intake of processed meat has been linked to several adverse health outcomes such as cancer. However, little is known about the respective effects of the single products in this diverse group.

Most epidemiological studies rely on self-reported questionnaires to assess the intake of different foods. Even though this method is relatively easy to perform, it is prone to errors such as memory biases of subjects or difficulties in estimating portion size. The use of food specific biomarkers may overcome this limitation by offering an objective quantification of dietary exposure. No biomarkers for the consumption of processed meat products have been established yet.

Twelve human healthy adults will participate in a randomized cross-over dietary intervention study and will consume three different processed meat products, fresh meat or no meat, each during 3 successive days followed by a 10-day washout period. The metabolite profile in urine and plasma samples will be analysed to find metabolites that are specific for the intake of the processed meat products.

The identification of these biomarkers in blood and urine will allow a more precise estimation of intake of different processed meat products. This will enable a more robust estimation of the risk linked to the intake of processed meat products.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30
* Healthy

Exclusion Criteria:

* Vegetarians
* Smokers
Diabetes Medical Nutrition Therapy in Southeastern African American Women

A two-arm randomized controlled trial design will be used. Participants will include 291 African American women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. Both arms, diabetes medical nutrition therapy (MNT) and diabetes MNT plus motivational interviewing (MI), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods.


Eligibility Criteria:
Inclusion Criteria:

* African American
* Female
* Clinical diagnosis of type 2 diabetes for at least 6 months
* At risk for development and/or progression of diabetes complications (HbA1c ≥ 7.0% AND either systolic blood pressure ≥130, LDL cholesterol ≥ 100, or BMI ≥ 30).

Exclusion Criteria:

--Observed or diagnosed psychotic disorders
Comparative Effects of Weight Bearing and Non-weight Bearing Exercises in Patients With Total Hip Replacement

to compare the effects of weight bearing and non-weight bearing exercises on pain, range of motion and disability in patients with total hip replacement


Eligibility Criteria:
Inclusion Criteria:

* unilateral total hip arthroplasty
* posterolateral approach of hip replacement
* patients that were willing to participate
* patients with 2 weeks post-operative history of total hip replacement

Exclusion Criteria:

* History of any systemic pathology
* Individual suffering from congenital hip disease.
* Bilateral total hip arthroplasty
* Evidence of CNS involvement and any other neurological involvement
* Any red flag (malignancies or any kind of tumor
* History of lower extremity fracture.
* Patient having any local or systemic infection of hip joint
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy

This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.

Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. Approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. A total of four to six injections are administered one week apart. Response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inoperable lung carcinoma and/or recurrent disease.
* Patients with symptomatic obstruction.
* Occlusion or partial occlusion of bronchi.
* Disease verified via bronchoscopy.
* Patients with a least one endobronchial tumor, measuring at least 0.5 cm.
* Patients between ages of 20 and 80 years.
* Documented informed consent must be obtained.

Exclusion Criteria:

* Patients without diagnosis confirmed by bronchoscopy.
* Patients with endobronchial tumors measuring less than 0.5 cm.
* Patients younger than 20 or older than 80 years.
* Patients who do not sign informed consent form.
Effects of Cerebellar tACS-iTBS in Ataxia

Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings.
2. Stable medication regimen for at least four weeks prior to the study.
3. Sufficient cognitive ability to understand and comply with study instructions.

Exclusion Criteria:

1. History of seizures.
2. Severe general impairment or concomitant diseases.
3. Intracranial metal implants.
4. Cardiac pacemaker.
5. Pregnancy status.
Non-invasive Neurally Adjusted Ventilatory Assist

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.

To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 years
* History of chronic obstructive lung disease
* Invasive mechanical ventilation for more than 12 hours
* Planned extubation according to the weaning protocol of our clinic
* Informed consent obtained from a next of kin
* Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient

Exclusion Criteria:

* Tracheostomy
* Facial or cranial trauma or surgery
* Oral, esophageal, diaphragmatic or gastric trauma or surgery
* Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
* Uncooperative state and combativeness not responding to low levels of sedatives
* Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
* Next of kin refuses informed consent
* Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.
A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer

To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV.
* No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC.
* ECOG Performance Status of 2 .
* Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.
* Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.

Exclusion Criteria:

* Any prior radiation therapy to the thoracic area.
* Active and ongoing systemic infection.
* Prior radiation to greater than 25% of the bone marrow.
* ECOG PS other than 2
* Patients with a known hypersensitivity to gemcitabine and carboplatin.
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)

A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular function


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or above
* Congestive Heart Failure with symptoms for more than 4 weeks before starting study
* Provision of informed consent

Exclusion Criteria:

* Current low blood pressure with symptoms
* Liver disease considered significant by the study doctor
* Pregnant or lactating females
Liposomal Bupivacaine Versus Interscalene Nerve Block

The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* patients who are older than 18 years
* patients undergoing reverse total shoulder arthroplasty

Exclusion Criteria:

* pregnancy
* inability to provide informed consent
* deemed unreliable for follow-up survey completion
* individuals who do not speak English
* those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease
Epidemiologic Assessment of SARS-CoV-2 (COVID-19) Prevalence in Minnesota

The purpose of this epidemiologic study is to estimate the prevalence and incidence of anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also estimate the risk of SARS-CoV-2 exposure in target population.

This study is not for real-time diagnostic purposes, guidance for patient care, or the development of a diagnostic test. The research tests performed for this study will not be prioritized over clinical care samples, that research samples will be batched and tested after clinical care samples. This study is a population-based epidemiologic analysis of prevalence of various groups of persons.

Group (1) general healthy population. People 18 years of age and older that have not tested positive for SARS-CoV-2 and who have not sought medical help in the previous 4 months.

Group (2) Medical School Residents , 18 years of age and older that have not tested positive for SARS-CoV-2 Group (3) Individuals who are HIV positive. People 18 years of age and older that have not tested positive for SARS-CoV-2

Eligibility Criteria:
Inclusion Criteria:

* Participants in Group 1 (General Healthy Population) must have no known exposure to SARS-CoV-2 and have not sought medical help in the previous 4 months for SARS-CoV-2-related symptoms
* Participants in Group 2 must be currently enrolled in a medical residency program
* Participants in Group 3 must currently test positive for HIV infection

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., someone not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe).
* Contraindication for routine blood draws (e.g., severe anemia, hemophilia, etc)