cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test

Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.


Eligibility Criteria:
Inclusion Criteria:

Case Detection Group:

* Age 18 years or above
* Clinical suspicion of pulmonary TB (including cough ≥2 week and at least 1 other symptom typical of TB);
* Willingness to provide 3-4 sputum specimens at enrolment;
* Willingness to have a trial follow-up visit approximately 2 months after enrolment;
* Provision of informed consent.

Drug Resistant TB Group:

In addition to the criteria of the Case Detection Group, participants should also meet the following conditions:

* Non-converting pulmonary TB cases (category I and category II failures)

Exclusion Criteria:

Case Detection Group:

* Receipt of any dose of TB treatment within 60 days prior to enrolment (even if within last two days only).

Drug Resistant TB Group:

* Receipt of any dose of MDR-TB treatment within 60 days prior to enrolment (even if within last two days only).
Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.

The objective of this study is to determine the influence of an increase of meat in complementary food on iron status and the effect of an exchange of vegetable oil in the same food on the status of omega-3 fatty acids in infants in the second six months of life.

Because of rapid growth in the first year of life, infants are at a high risk to develop iron deficiency (ID) or even iron deficiency anaemia (IDA). Iron metabolism in infancy seems to be immature and to be affected by developmental changes and is not yet fully understood. Therefore studies with both, detailed dietary intake and a full set of biomarkers to characterize iron status or the risk of IDA are welcome.

LC-PUFA, especially docosahexaenoic acid (DHA, n-3), are of important meaning in infants´ neural development because neural tissues have a unique pattern of FA. DHA is predominantly found in brain and retina. LC-PUFA can be either supplied preformed by diet or converted from their essential precursors the polyunsaturated fatty acids (PUFA) linoleic acid (LA, n-6) and α-linolenic acid (ALA, n-3) by the organism dependent on the ratio of n-6/n-3 FA in the diet.

In the case of iron as well as of PUFA and LC-PUFA very little is known about the nutritional supply and its effect on status in the second half of the first year of life. Therefore the objective of DINO is to examine the feasibility of increasing meat and of exchanging n-6 rich corn oil vs. n-3 rich rapeseed oil in common commercial menus and to examine the effects on iron status and on blood FA pattern respectively as primary outcome variables in a double-blinded randomized controlled intervention trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* a term healthy newborn infant (birth weight \> 2500 g, gestational age \> 37 weeks);
* inclusion during the first two months of life.
* German speaking mother;
* the intention of the mother to breast-feed the child and to feed study menus 5 to 7 times per week beginning in the fifth to seventh month of life.

Exclusion Criteria:

* preterm infants
Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated immunity can be used to determine whether patients who complete a course of therapy for CMV viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their prophylaxis stopped.

Cytomegalovirus (CMV) is the most important infection in transplant patients and it is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver; when CMV infection becomes serious enough to cause symptoms, it is called CMV disease. Some patients require treatment while others will clear the virus on their own.

QuantiFERON-CMV (QFT-CMV) is a blood test that measures CMV-specific cell-mediated immunity. This test was able to predict that patients with low cell-mediated immunity are at greater risk for developing CMV disease. In this study, QFT-CMV will be used to make a decision regarding CMV treatment. The QFT-CMV test will be performed at the first detection of CMV, at end of antiviral therapy and one month post-therapy. The end-of-therapy results will be available to clinicians and study investigators within one week of collection. Based on the result, a decision will be made to continue with prolonged antiviral therapy. Patients that show weak cell-mediated immunity against CMV will be given secondary antiviral prophylaxis, while patients with good cell-mediated immunity will have their therapy stopped. Patients will continue to be monitored three months after the last QFT-CMV test for recurrent CMV viremia.

This study will also attempt to evaluate the predictive value of the QuantiFERON-Monitor (QFT-Monitor) assay. QFT-Monitor is a recently developed non-pathogen specific immune assay: it is based on immune activation of both innate and adaptive immunity. The investigators hypothesize that stimulation of both the innate and adaptive immunity may predict global immune function and also be predictive of CMV reactivation. The investigators plan to perform the QFT-Monitor assay in parallel to the QFT-CMV test to determine the test characteristics and cut-off values in predicting global immune function. This test will be collected and tested in batches. Therefore, the results will not influence clinical decisions.

Eligibility Criteria:
Inclusion Criteria:

* Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication
* Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease
* CMV viral load ≥ 1000 IU/mL

Exclusion Criteria:

* Known ganciclovir-resistant CMV
* Known intolerance to valganciclovir or ganciclovir
* Unable to comply with protocol
Proprioceptive Neuromuscular Facilitation Exercises in Temporomandibular Dysfunction

Individuals who were diagnosed with reduction disc displacement by Research Diagnostic criteria for Temporomandibular Disorder (TMD / RDC) were included in the study. Proprioceptive neuromuscular facilitation exercises were performed for 30 minutes using neck jaw and tongue patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques by physiotherapist. Maximal mouth openings were measured with caliper, pain intensities were measured with visual analogue scale and pressure pain thresholds with hand algometer.

TMD patients who are diagnosed by TMD/RDC are firstly assessed by physiotherapist for maximal mouth opening(MMO), pain intensity and pressure pain threshold. Then they will taught exercises with rhythmic initiation which includes repetation of the patern and 15 repetitions are applied as warm-up period. Proprioceptive neuromuscular facilitation (PNF) exercises are performed in the neck and jaw patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques. In the neck, right rotation-right lateral flexion, left rotation-left lateral flexion pattern, and the opening and closing pattern according to the working mechanics of the masseter and temporal muscle in the chin, RS and CI techniques are used. By providing maximum resistance in accordance with the needs of each individual, the RS protocol consist of isometric contractions that would not involve changing movements for 10 seconds. The combination of isotonics technique include combined concentric, isometric, and eccentric contraction of the agonist muscle for 5 seconds of each contraction without rest. CI exercises consist of 15 repetitions per set. A 30-second rest given between sets to include recovery. After exercises immediate MMO, pain intensity and pain treshold assessment will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers between 18-25 years female, admitted to the study with clenching, grinding, clicking, jaw pain when eating hard foods, and limited and painful mouth movements.

Exclusion Criteria:

* Having orthopedic, neurological or rheumatological cervical disorders which affect the jaw motions; receiving occlusal therapy as a companion to treatment, those who have an operation in the area of jaw, head and neck and those with vertigo that prevents head movements during exercises.
The Impact of Polynuclear Neutrophils' Intra-tumoral Rate and the Mutational Status in Pulmonary Adenocarcinomas on Survival

Lung cancer is one of the most frequent cancer concerning human beings and it represents, worldwide, one of the first cause of death. Most of patients with this cancer are males and 85% of lung cancers are non-small cells type (NSCLC) with adenocarcinoma being the most common histologic subtype.

Patients with pulmonary cancer have a poor long-term prognosis with an overall 5 years of survival which is less than 25% for all stages.

The natural immune system, with polynuclear neutrophils (PNN) is involved in carcinogenesis. The impact of PNN localized within the tumor as a prognostic biomarker has not been really studied in non-small cells lung cancers.

According to some studies, an increase in the number of PNN (labelled by the CD66b antibody) within the tumor is associated to a greater risk of relapse and a poor overall survival rate.

The intra-tumoral ratio PNN over Lymphocytes T CD8 + (iNTR) is an independent factor of the poor prognosis concerning the overall survival rate and concerning risk of relapse with patients who went through a first surgery for a non-small cells lung cancer.

With this study we will initially concentrate on lung adenocarcinoma and attempt to evaluate the PNN's rate within the tumor and its impact on an overall survival rate and progression-free survival.

Secondly, we will explore the role of iNTR and the mutational profile of tumors concerning this survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stages I to III lung adenocarcinoma (TNM UICC 8ème édition)
* Patients who went through a first surgery with a lymph node dissection at the CHRU of Nancy between 01/01/2010 and 01/01/2012
* Patients included in the CRB CHRU-INSERM bronchial collection

Exclusion Criteria:

* patients who received neoadjuvant therapy.
* Stage IV patients (TNM UICC 8ème édition)
* Patients whose surgical resection was incomplete
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South

The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP prescription to train family medicine physician trainees to take a thorough sexual history and discuss HIV/STI prevention and PrEP options with adolescent patients in Alabama. The primary outcomes of the study are:

* Feasibility of the PrEP Pro training intervention
* Acceptability of the PrEP Pro training intervention

Secondary outcomes include:

* Behavioral changes in sexual history taking performed by physician trainees
* PrEP knowledge and prescribing practices
* HIV and STI screening practices

Participants will receive training on sexual history taking and HIV prevention options, including PrEP prescription and management. They will complete a pre-training survey (enrollment) and post-training survey (6 months post enrollment) to understand differences in knowledge and practice before and after receiving the training intervention. The post training survey will also assess acceptability and feasibility of the intervention. A subset of participants will complete qualitative in-depth interviews to further discuss their experiences with the program and suggestions for future adaptations.


Eligibility Criteria:
Inclusion Criteria:

1. licensed HCP (MD, DO) trainee
2. providing medical care to AGYW in AL
3. working in a clinic setting where at least 20% of the population is Black
4. able/willing to provide informed consent

Exclusion Criteria:

(a) unable or unwilling to provide informed consent
REBYOTA™ Prospective Registry

This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form (ICF)
* Age ≥ 18 years
* Diagnosis of rCDI as determined by the treating physician
* Completed antibiotic treatment for the presenting rCDI episode
* Prescription for REBYOTA™ to prevent rCDI according to the approved indication

Exclusion Criteria:

* Currently enrolled in an interventional clinical trial
Evaluation of the Effect of Musical Listening on Hypnotic Savings During the Induction of General Anesthesia

Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of accelerated postoperative rehabilitation. Music has shown its effectiveness in reducing the doses of hypnotics administered during sedation procedures.

Objective :

We propose a study of this anesthetic period evaluating the effectiveness of music as an adjuvant agent for anesthetic drugs allowing hypnotic savings.

Materials and methods :

Randomized, prospective, monocentric study

2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.

The primary endpoint is the amount of hypnotic (propofol®) used during anesthesia induction. The main secondary criteria are the duration of induction, the cost of induction, and the postoperative pain score and the proportion of patients with postoperative nausea and vomiting.

This study should include 104 subjects (52 in each group) requiring general anesthesia.

Hypothesis tested:

Listening to music reduces the amount of hypnotic product used in the induction of anesthesia by 0.5 mg/kg.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting for surgery under general anesthesia in ophthalmic surgery, ENT, CMF and neurosurgery (lumbar and cervical disc hernia, neurostimulator insertion, vertebral cementoplasty)
* Score ASA 1, 2, 3.
* Intervention time \< 3 hours.

Exclusion Criteria:

* Patients under 18 years of age
* Patient under guardianship or curatorship
* Refusal of the patient
* Deaf patient
* Non-cooperating patient
* Anesthetic protocol different from that standardised
The CIA Score: a Learner's Tool

The goal of this project is to use a previously described scoring system - the CIA system - as a teaching tool to help learners assess the bleeding risk of peripheral nerve blocks. We will teach the CIA system to residents, then they will complete a survey in which they apply the system to various peripheral nerve blocks. We hypothesize that the CIA system will allow learners to reach the same consensus about bleeding risk as expert opinions.

Prior survey of Stanford and Palo Alto VA regional anesthesiologists showed diverging assessments of whether various blocks are considered superficial or deep. Investigators hope to have a simple systematic approach to "scoring" regional anesthesia procedures which can be used as a basis for discussion and comparison of regional expert's opinions.

A scoring system using three categories of consideration to classify any regional procedure is proposed. The following three categories, Critical, Intervention, and Assess (CIA) can be used to analyze any procedure to determine bleeding risk. A score of 0 or 1, was given to each parameter depending on whether it was absent or present. A total score can be range from 0 to 3. From this, the risk can be categorized based on the total score as low-risk (0), intermediate-risk (1) or high-risk (2 or 3).

Eligibility Criteria:
Inclusion Criteria:

* Regional Anesthesiologist and interested staff from Stanford

Exclusion Criteria:

* Non-regional anesthesiologists and non-interested staff at Stanford
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, \>=18 years of age with HIV-1 infection;
* previously treated with antiretroviral agents.

Exclusion Criteria:

* prior use of Fuzeon or T-1249;
* inability to self-inject;
* active, untreated opportunistic infection.
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

The primary objective of this study is to evaluate the generic health status outcomes and efficacy and safety outcomes following use of the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with PAD seen in routine clinical practice.

The main testable hypothesis is that the use of IVL is associated with a health status improvement that is equal or higher than the threshold of a minimally clinically important difference on the EQ5D. Preliminarily data will be derived for the primary endpoint target lesion revascularization to enable future planning of larger comparative effectiveness research.

Secondary objectives of the study are to document procedural success following the use of IVL in common femoral lesions, disease stage change, as well as disease-specific health status in the real-world.

Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
* Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines
* Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.

Angiographic Inclusion Criteria

* Target lesion that is located in a native, de novo common femoral artery
* Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
* Target lesion is ≥70% stenosis by investigator via visual estimate.
* Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.
* Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
* Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.

Exclusion Criteria:

* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
* Cognitive impairment as documented in medical records
* Not speaking English or Spanish
* Currently a prisoner
* Pregnancy or nursing
* Estimated survival less than 12 months at the time of screening
* Prior history of CFA endarterectomy
The Anemia Control Program: High or Low Iron Supplementation

The purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron status in infancy and on development longitudinally.

For a detailed description of the clinical trial setting and procedures in infancy, please refer to the following:

Walter T, Pino P, Pizarro F and Lozoff B. Prevention of iron-deficiency anemia: Comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pedr 1998:132:635-40.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \>= 3.0 kg
* single birth
* no major congenital anomalies
* no major birth or neonatal complications
* no emergency c-section
* no jaundice requiring phototherapy
* no hospitalization for more than 5 days
* no chronic illness
* no iron therapy
* already started to received some bottle feedings by 6 months of age

Exclusion Criteria:

* residence outside identified neighborhoods
* another infant \<12 months in household
* infant in daycare
* unstable, illiterate, or psychotic caregiver
TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age.
* Pathological evidence of ICC
* Tumors can be completely resected.
* Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
* Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

* Tumors can not be resected .
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
* Patients with a medical history of other malignant tumors.
* Subjects participating in other clinical trials.
* Liver function:Child C.