cyrilzakka/clinical-trials huggingface dataset:
Clinical Metagenomic of Post-traumatic Infections

Treatment of fracture related infection is challenging and often lead to failure in such situation that carry a high health cost burden.

These infections are often polymicrobial, making the identification of all involved microorganisms a major concern to provide tailored antibiotic treatment. Culture-independent methods are needed to better represent the microbial diversity of infected wounds. Metagenomic sequencing might lead to an accurate microbiome characterization in infected trauma-related wound.

Preliminary studies have reported results of metagenomic sequencing in diabetic foot infection but data focusing on non-diabetic infected patients are scarce.

The impact of post-traumatic infected wound microbiome needs to be assessed, with regards to bacterial abundance, diversity including at the strain level and functional genes, along with their longitudinal evolution and association with clinical outcomes.

DNA will be extracted from samples carried out during surgical procedures. Different extraction protocols will be assessed to determine the best to be used for this type of tissue samples.

Purified DNA will be quantified using the Qubit dsDNA High-Sensitivity Assay Kit (Invitrogen). The quality of the fragment length will be estimated with the DNA high-sensitivity kit in the 2100 Bioanalyzer (Agilent Technologies). DNA sequencing will be performed with Oxford Nanopore Technologie devices: MinIONTM and GridIONTM.

Another sequencing of the same samples will be performed on the MiSeq after libraries preparation using the NexteraXT DNA Library Preparation Kit (Illumina).

Sequenced OTU from both sequencing methods will be confronted at different taxonomic ranks and compared with conventional routine method results (bacterial culture). A functional analysis of sequences will be done to identify potential genes associated with clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of trauma-related infection

Exclusion Criteria:

* Participation in an interventional research during the study
* Patient opposition
* Absence of bone or soft tissue samples stored at -80°C
Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control

The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. However, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (T\&A) procedures. The goal of this study is to determine whether the SZMN block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing T\&A. An additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the SZMN block to cover the entire duration of pain experienced.

Patients between 6 months and 18 years undergoing T\&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into one of the three groups:

* the suprazygomatic maxillary nerve (SZMN) block treatment cohort
* the SZMN block with Dexmedetomidine treatment cohort
* the control cohort (standard of care).

After anesthesia induction, patients randomized into the SZMN-treatment group or SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room.

Participants enrolled into the control group will receive the standard of care with no changes to their anesthetic or surgical care. This group will not receive the SZMN block.

Postoperative pain scores and opioid consumption for all three groups will be collected in the PACU and for each postoperative day for a total of 14 postoperative days. We will also collect the following data: time to discharge readiness, postoperative nausea/vomiting, emergence delirium, oxygen desaturation and respiratory events, ability to tolerate oral intake, bleeding, hospital readmission, and adverse events related to the nerve block.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 months - 18 years
* Give consent/parental consent to participate in study
* Patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria:

* Participants who do not consent or have parental consent
* Patients who require urgent/emergent intervention
* Patients who undergo additional combined surgical procedures with separate incisions (in addition to the adenotonsillectomy)
* Patients with known difficult airway, clinical hemodynamic instability, coagulopathy, chronic pain history, chronic pain medication use, and unrepaired congenital heart disease
* Patients under age 6 months
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS.

This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants.

All participants completing the 24-month treatment of the Core Part of the study are eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female 40 years of age or older
* Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
* Treated with ocrelizumab according to routine clinical practice and at standard dose
* Neurologically stable within 30 days
* Suitable to be switched to remibrutinib based on physician judgement or patient preference

Key Exclusion Criteria:

* Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
* History of clinically significant Central Nervous System disease or neurological disorders
* History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
* Active clinically significant systemic bacterial, viral, parasitic or fungal infections
* Active, chronic disease of the immune system other than MS
* Severe cardiac disease or significant findings on the ECG
* Participant who is unable to undergo MRI scans
* History of life-threatening infusion or injection reaction related to ocrelizumab

Other inclusion and exclusion criteria may apply
Effectiveness Trial for Project SafeCare for Child Neglect

The study is a field trial comparing the SafeCare family preservation model to a comparable usual care model for parents in child welfare. The study also compares two levels of service quality control.

The study is a cluster-randomized field trial of the SafeCare(SC) home-based family preservation model for families in the child welfare system. The trial is conducted in collaboration with the state child welfare agency and their contracted in-home service system. The service system is regionalized and provides in home services to families referred by child welfare. Regions of the state are assigned by the study to either the SC model or to services as usual. Provider teams, nested within regions, are assigned to either a monitored or unmonitored model implementation quality control condition. The aims of the project are to test client level child welfare reentry outcomes between SC and standard conditions, across the two implementation and quality control conditions.

Eligibility Criteria:
Inclusion Criteria:

* Parents in the child welfare system for neglect with or without physical abuse

Exclusion Criteria:

* Parents in the child welfare system for sexual abuse
Maternal Well-being in the Perinatal Period

The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.

The primary goal of this observational study si to investigate the mental health status of women experiencing their first pregnancy, with particular attention to manifestations of anxiety and depression, feelings of loneliness, and the quality of defense mechanisms employed, during the last trimester of gestation (28th-35th week of gestation) and over the course of the 18 months following the child's birth.

Furthermore, the study aims to conduct an in-depth analysis of the variables associated with the psychological adaptation of women during the perinatal period, with particular reference to the following exploratory objectives:

* To explore the association between the investigated psychological dimensions and the quality of the bond with the child in the prenatal and postnatal periods.
* To identify any significant differences in the variables of interest between women who conceived naturally and those who underwent assisted reproductive technology (ART).
* To detect, through qualitative methods (semi-structured interviews and focus groups), the unmet needs of women during the perinatal period, as well as their preferences and expectations regarding the nature of desirable support interventions during this period. This would enable the construction and provision of an intervention model that closely aligns with the specific needs of this patient population.

The collected data will allow for the identification of individuals at higher risk of psychological distress and adaptation problems during the perinatal period, as well as potential impairment in the quality of the attachment bond with the child.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Adequate understanding of the Italian language
* Willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
* Women experiencing their first pregnancy
* Women in the last trimester of gestation (28th-35th week of gestation) who will be followed for 18 months after childbirth

Exclusion Criteria:

* Age under 18 years old
* Women who are not able to understand the Italian language
* Absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
* Women who are not experiencing their first pregnancy
* Women who are not in the last trimester of gestation (28th-35th week of gestation)
Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians

The physical examination before an abortion is usually performed by a physician. However, in many countries access to physicians is limited. To increase access to safe abortion this study wishes to examine if midlevel providers such as specially trained midwives can provide safe abortion services. Midwives in study were specially trained to perform early pregnancy ultrasound and if needed to consult a physician. The midwife then provided the abortion service as well as the contraceptive advice. Women were randomized to receive the service from a midwife or a physician.


Eligibility Criteria:
Inclusion Criteria:

* healthy women aged 18-45 with no contraindication to medical abortion

Exclusion Criteria:

* any medical condition which contraindicates medical abortion
Social Media-based Bundle Care of AECOPD Patients.

Chronic obstructive pulmonary disease(COPD) is an incompletely reversible and progressive pulmonary disease characterized by airflow restriction, which is the third leading cause of death worldwide, accounting for 6% of all deaths worldwide. Acute exacerbation (AE) of COPD can accelerate the decline of lung function, worsening pulmonary symptoms, and increase the risk of death in patients. Health education, inhaled technical guidance training, individual self-management, psychological counseling, home oxygen therapy, nutritional support, and other comprehensive interventions can help improve the lung function of COPD patients, alleviate clinical symptoms, improve the quality of life. While a number of COPD applications have been developed, few provide comprehensive assessment and guidance for these kinds of patients. Therefore, the investigators aim to establish a bundle care mode based on the mode of "hospital-home-community-patient", clarify the impact of the management on prognosis, and evaluate the effect of mobile medical-assisted bundle management mode. In this randomized controlled trial(RCT), AECOPD patients will be divided into interventional or control groups randomly. Patients in the interventional group will receive mobile medication and standard of care at the same time (bundle care mode). While patients in the control group will receive standard of care only (traditional management mode). This study will be conducted to compare the effects of traditional and bundle care modes, and to formulate the implementation path and specifications of bundle care for AECOPD patients after discharge in China.


Eligibility Criteria:
Inclusion Criteria:

* AECOPD Patients with pulmonary function grade GOLD2-4;
* Aged between 45 and 70 years old;
* Have a smartphone, and can skillfully use mobile Wechat official account;
* Willing to use Wechat official accounts to manage COPD;
* Willing to accept outpatient follow-up;
* Signed informed consent.

Exclusion Criteria:

* Patients with asthma, bronchiectasis, tuberculosis, or other diseases;
* Patients with malignant tumors, liver and kidney failure, limb dyskinesia, and other diseases;
* Unstable angina pectoris in recent one month, myocardial infarction within a half year, severe arrhythmia, uncontrollable congestive heart failure, or poor blood pressure control (systolic blood pressure \> 140mmHg and/or diastolic blood pressure \> 90mmHg);
* Cognitive impairment;
* Combined with respiratory failure;
* With a life expectancy of less than one year;
* Plan to or participating in a COPD management project or mobile Wechat official account project;
* Completed another trial within 30 days.
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
* Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and \<32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
* Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
* Able to understand and sign Informed Consent Document;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
* Any form of glaucoma other than open angle glaucoma or ocular hypertension;
* Severe central visual field loss;
* Chronic, recurrent, or severe inflammatory eye disease;
* Ocular trauma within the past 6 months;
* Ocular infection or ocular inflammation within the past 3 months;
* Best-corrected visual acuity score worse than approximately 20/80 Snellen;
* Eye surgery within the past 6 months;
* Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
* Use of any additional topical or systemic ocular hypertensive medication during the study;
* Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
* Other protocol-defined exclusion criteria may apply.
Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

Involves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish normal values for the Dx-pH Measurement System.

The specific aim of this study is to establish the normal range of values in an adult population with no symptoms of laryngopharyngeal reflux disease or gastroesophageal reflux disease using the Dx-pH Measurement System.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* no symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease
* score less than 10 on Reflux Symptom Index

Exclusion Criteria:

* age less than 18
* known lidocaine allergy
* history of heartburn, regurgitation, chronic cough, voice changes, globus pharyngeus, excessive throat clearing, or swallowing problems
* score 10 or greater on Reflux Symptom Index
* current or past antacid use or other antireflux therapy
* history of antireflux surgery
* pregnancy
* current anticoagulation therapy (warfarin, heparin, aspirin, clopidogrel bisulfate)
* special/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage)
An Eye Tracking Study of Affective Disorder Patients With Suicide Risk

This research tries to investigate the validity and reliability of eye-tracking technologies by using different paradigms (eg. free-view, pro-saccade and anti-saccade) which served as a novel way of evaluating suicide risk among affective disorder patients including bipolar and unipolar depression. All the participants including health control will be assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual,DSM-IV diagnosis of depression or Bipolar disorder
* BDI-II\>20(Suicide and disorder control group); BDI-II\<13，no history of depression(Health control)
* Informed consent
* suicide attempt in the past 6 months(suicide risk group)

Exclusion Criteria:

* Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
* History of epilepsy or head trauma
* Eye disorders
* History of electroconvulsive therapy in the past 4 weeks.
Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance and/or uncontrolled systolic hypertension.

This Phase 3 study patients will be randomized in a 1:1 ratio to treatment with relacorilant (active drug) or placebo. Patients will receive relacorilant or placebo for 22 weeks. Patients who complete the study may also be eligible to roll over into an extension study.

Eligibility Criteria:
Inclusion Criteria:

* Shows lack of cortisol suppression
* Suppressed or low early-morning ACTH levels
* A radiologically confirmed adrenal lesion
* Has IGT or DM
* Has uncontrolled hypertension

Exclusion Criteria:

* Has severe, uncontrolled hypertension
* Has poorly controlled DM
* Has DM Type 1
* Has significantly abnormal liver test results or severe renal insufficiency
* Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)

The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

Maternal depression can have a significant harmful influence on both mothers and children. Considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (PUFAs) supplementation in reducing depressive symptoms, omega-3 PUFAs may provide a safe strategy. The investigators evaluate efficacy and safety of omega-3 PUFAs for pregnant women with depressive symptoms. (Participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women aged 20 years or older
2. between 12-24 weeks gestation
3. a Japanese conversational ability in Japan site or a Mandarin conversational ability in Taiwan site to understand the scope of the present trial and to provide written consent for study participation
4. planned to take assessments after childbirth
5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
6. to have good physical health judged by obstetricians.

Exclusion Criteria:

1. history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
2. Serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
3. difficult to expect a normal birth (ex: fetal malformation etc.)
4. having a history of bleeding disorder such as von Willebrand's Disease
5. regular treatment with aspirin or warfarin within the last 3 months
6. a smoking habit of ≥40 cigarettes per day
7. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
8. a habit of eating fish as a main dish ≥4 times per week.
Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
* Agreement to maintain the same dose of metformin from screening to the end of the study
* Age in the range of 18-80 years
* Body mass index (BMI) in the range of 22-40 kg/m2
* HbA1c in the range of 7.0 to 10%
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Liver disease
* Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply