cyrilzakka/clinical-trials huggingface dataset:
18F-NaF-PET for Identification of TCFA

Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.

In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).

It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Until now, evaluation of vulnerable plaque have been mainly performed with invasive imaging modalities such as optical coherence tomography or intravascular ultrasound.

Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.

In this study, we will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
* 2. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by coronary CT angiography.
* 3. Patients who are anticipated coronary artery disease.(Probability \> 90 %)
* 4. Acute coronary syndrome.

Exclusion Criteria:

* 1. Stenosis at distal coronary or small vessel.
* 2. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
* 3. Inadequate quality of 18F-NaF PET-CT
* 4. Inadequate quality of Optical Coherence Tomography (OCT), IVUS, Coronary CT angiography
Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection

Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).

In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food .

Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).

In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food. The pathogenicity of Blastocystis is controversial because most patients carrying this parasite are asymptomatic. Several studies have considered Blastocystis sp. as a commensal micro-organism, while other results have showed the pathogenicity of the parasite.

Calprotectin (CP), a calcium-binding protein, comprises 60% of cytosolic protein found in neutrophils. Fecal calprotectin (F-CP) concentration is an indicator of neutrophil migration into the intestinal lumen and is associated with intestinal inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients from outpatient clinics, Sohag hospitals.

Exclusion Criteria:

* Patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.
Longitudinal Study of Cell Free DNA in Lung Transplant

Lung transplant is a viable treatment strategy for many with end-stage lung diseases. Despite advances in both the surgical and medical management, lung transplant recipients experience episodes of allograft insult and injury that lead to dysfunction and ultimately contribute to graft failure. The primary noninvasive tool for monitoring the lung allograft, pulmonary function testing, is neither sensitive nor specific for lung allograft injury which makes the management of lung transplant recipients particularly challenging. A decline in pulmonary function tests prompts invasive procedures such as bronchoscopy with transbronchial lung biopsy to diagnose the cause of allograft injury, although this, too, is not 100% sensitive, and oftentimes patients are treated empirically for rejection when no other etiology for lung function decline is identified. Empiric treatment prompted by extrapulmonary drivers of decline in lung function may result in inappropriate exposure to risks of augmented immunosuppression. The purpose of this study is to determine to what extent monitoring of donor-derived cell free DNA in lung transplant recipients can be used as a marker of lung injury and stability.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Actively listed or have recently had a double lung transplant
* Participant is willing and able to provide informed consent

Exclusion Criteria:

* Prior organ transplantation
* Transplantation performed in the setting of hospitalization for acute illness or decompensation
* Unable or unwilling to consent for enrolment
* Single lung transplant recipient
* Consideration for multi-organ transplantation
* Pregnant women
Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)

Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.

A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening
2. Score ≥ 2 on at least 6 of 9 items in the inattentive subscale of the CAARS-INV at Baseline (Day 1)
3. Score of \< 2 on at least 4 of 9 items in the hyperactive/impulsivity subscale of the CAARS-INV at Baseline (Day 1)
4. Score ≥ 4 (at least moderate) on the CGI-S
5. Tobacco non-users as indicated by lack of tobacco use within the last 6 months prior to Screening, and by negative urinary cotinine level of \< 50 ng/mL after quantification

Exclusion Criteria:

1. Current DSM-IV Axis I psychiatric disorder other than ADHD;
2. Use of tobacco cessation agents within 4 weeks prior to Screening
3. Known or suspected drug abuse within the last 6 months prior to Screening
4. Urine drug screen positive for illegal or non-prescribed drugs at Screening
5. Patients at imminent risk of suicide or of danger to themselves or others as judged by the investigator
6. Use of drugs affecting cognitive function within 4 weeks prior to Day 1. This includes use of any concomitant medications for treatment of ADHD.
7. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (CV), gastrointestinal (GI), or urological disorder; or diagnosis of major depressive disorder
8. Myocardial infarction within past year
9. Seizure disorder within past year
10. Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed)
11. HbA1C \> 7.4 at Screening
12. BMI \< 15 or \> 35; male weight \< 100 lbs; female weight \< 80 lbs.
13. Current tuberculosis (TB) or known systemic infection \[Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)\]
14. Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control
15. Participation in another Central Nervous System (CNS)-related clinical trial in the last 3 months and any other clinical trial in last 30 days prior to Screening, or participation in a previous TC-5619 clinical trial
Femoral Nerve Block Versus Adductor Canal Nerve Block for Peri-Operative Analgesia Following Anterior Cruciate Ligament (ACL) Reconstruction: Evaluation of Post-operative Pain and Strength

All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). Post-operatively, the primary outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic analgesic requirements will be measured.

Currently, because of its good track record, femoral nerve block is the modality of choice for post-operative pain control following elective anterior cruciate ligament reconstruction at our institution. It has been proven in the literature to provide good post-operative pain analgesia following this procedure (1). However, femoral nerve block is not without its concerns, including the concern for long-term quadriceps weakness (2). Benefits of decreased use of Femoral Nerve Block include the decreased incidence of side effects and/or complications, and use of quadriceps for immediate rehabilitation. Benefits of Adductor canal nerve block include possible equivalent pain control with the avoidance of motor de-innervation and its deleterious adverse effect of quadriceps weakness postoperatively. Adductor canal nerve block has proven to be effective in other orthopaedic procedures involving the knee including total knee arthroplasty (3). This results of this study will give more information on how to better control pain in the post-op period while minimizing the deleterious side effects for patients undergoing ACLreconstruction.

All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). A single dose of 30 mL of 0.25% marcaine is injected for femoral nerve block and 20 mL of 0.25% marcaine for Adductor Canal nerve block. These procedures will be performed by the attending anesthesiologist prior to surgery. After surgery the patient will record their pain levels using visual analog scale (VAS) score in a daily diary for the first 5 post-operative days. They will also record all medication requirements, both narcotic and non-narcotic analgesic medications. The patient will be tested on their ability to perform a straight leg raise in the post-anesthesia care unit (PACU) and at their first post-operative visit.

Eligibility Criteria:
Inclusion Criteria:

* Primary ACL Reconstruction with use of Bone-Patellar-Bone Autograft
* Age 16 or older

Exclusion Criteria:

* Patients under 16
* The use of Allograft,
* The use of hamstring autograft
* The use quadriceps autograft
* Patients allergic to active ingredients in the injection.
Olfactory Dysfunction of Rhinosinusitis - Cyclic Adenosine Monophosphate (cAMP)/Calcium Signaling Study

The study examines the biochemistry underlying human olfaction in both normal and diseased states.

The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using calcium imaging and 4. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using "smell-chip" technology.

Subject will be recruited from those scheduled to have endoscopic sinus surgery and similar procedures. This study uses the tissue that would normally be discarded during the surgical process. The tissue is cultured and frozen for purposes of the following testing:

odor detection and signal transduction, cyclic adenosine monophosphate and odor detection, the role of cAMP in olfactory dysfunction, and pheromone detection.

Only tissue that would normally be discarded during the course of the surgery will be used. The study does not interfere with or change any clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be 18 years old and over and scheduled for one of the following:

  * endoscopic sinus surgery for chronic sinusitis
  * endoscopic transnasal approach to the pituitary for pituitary tumor removal
  * endoscopic inferior turbinectomy or septoplasty for nasal congestion
  * endoscopic repair of cerebrospinal fluid (CSF) leaks

Exclusion Criteria:

* Subjects are excluded if they are unable to give informed consent or unable to complete self-administered questionnaires due to English language barrier, cognitive impairment, or severe medical conditions
Effect of Tetrabenazine on Stroop Interference in HD

Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in Huntington disease (HD) patients as measured by computerized dynamic posturography testing. This study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the Stroop interference test.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Huntington disease by movement disorders expert
* Patients currently taking tetrabenazine.
* Patients should not have taken dopamine receptor blocking medication for at least three days

Exclusion Criteria:

-
Patients with Stage III-IVa Nasopharyngeal Carcinoma with or Without a Mobile Medical Platform Full-course Nutritional Intervention

To study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional rehabilitation management.


Eligibility Criteria:
Inclusion Criteria:

* 1.Voluntarily participate and sign the informed consent in writing.
* 2.Stage III-IVa (AJCC 8th edition staging) .
* 3.Received induction chemotherapy + concurrent chemoradiotherapy .
* 4.18-70 years old.
* 5.Pathologically diagnosed with non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, WHO type II or III).
* 6.No previous anti-tumor therapy .
* 7.ECOG score 0-1.
* 8.Ensure contraception during the study period.
* 9.Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
* 10. Liver function: ALT, AST \< 2.5 times the upper limit of normal (ULN), total bilirubin \< 2.0 × ULN.
* 11. Renal function: serum creatinine \<1.5×ULN.
* 12.Able and willing to use a mobile phone or tablet to fill in the electronic scale.

Exclusion Criteria:

* 1.Received antitumor therapy in the past.
* 2. The pathology was keratinizing squamous cell carcinoma (WHO type I).
* 3.Pregnant women who are in the reproductive period and have not taken effective contraceptive measures.
* 4. Has suffered from other malignant tumors (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
* 5.Patients with significantly low heart, liver, lung, kidney and bone marrow functions.
* 6.Serious, uncontrolled medical diseases and infections.
* 7.Concurrent use of other experimental drugs or other clinical trials.
* 8. Refused or unable to sign the informed consent to participate in the trial.
* 9.Those who have other contraindications to treatment.
* 10.Persons with personality or mental disorders, no capacity for civil conduct or limited capacity for civil conduct.
Progestrone and Doppler Indices

The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices

A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the ﬁrst administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age: 18-33 weeks
* Willing and able to give informed consent
* History of preterm labor (\<34 weeks)
* At risk for preterm labor ( increased amniotic fluid volume)
* Short cervical length (\<25mm) as incidental finding
* Presenting with actual cervical changes ( dilatation and\\or effacement) in current pregnancy

Exclusion Criteria:

* PPROM
* Contraindication to progesterone use
* Diabetic patients, have glucose intolerance
* Multiple pregnancies
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making

The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults.

Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Consume alcohol at least weekly
* A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
* Some interest in cutting back on drinking or quitting
* Read and understand English

Exclusion Criteria:

* A score of 31 or greater on the Alcohol Use Disorder Identification Test (AUDIT) at baseline
* Reporting schizophrenia and/or other psychiatric diagnoses other than depression or anxiety at baseline
* Already being in treatment for alcohol use disorder at baseline
* Past month substance use other than cannabis or tobacco
Patients With Alzheimer's Disease or Related Youth Disease

This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.


Eligibility Criteria:
Inclusion Criteria:

As part of this study, patients will be considered:

* Residing in the departments of Nord (59) and Pas-de-Calais (62),
* whose diagnosis of Alzheimer's disease or related illness (DLFT, DCL) was made and announced,
* Whose diagnosis of illness was made after 2007
* whose first symptoms appeared before the age of 60 Patients included in the COMAJ cohort and those who completed the Pathways medical and social booklet will have to meet these criteria to be selected for this study.

As part of the survey, caregivers of patients meeting the above criteria and the following two will be recruited:

* Having consulted or being followed by liberal neurologists or in hospital memory consultations (excluding CMRR-CNR-MAJ Lille) of the departments of Nord and Pas-de-Calais,
* Not monitored at the CMRR-CNR-MAJ Lille (ad hoc notice possible). The caregiver is defined as a family member or friend who helps regularly by doing the necessary tasks so that the sick person can keep as much autonomy as possible.

Exclusion Criteria:

* aged under 18
* no social coverage
* refusal to sign informed consent form
A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer

The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
* Measurable disease: At least 1 measurable metastatic lesion that has not been irradiated; The lesion will be measured according to RECIST and be evaluated radiologically within 28 days prior to study entry
* ECOG performance status of 0 or 1 at study entry
* Adequate bone marrow, liver and renal function
* Women of childbearing potential:Negative serum pregnancy test within 7 days and must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and 28 days after the last study drug dosing

Exclusion Criteria:

* Previous chemotherapy for locally advanced or metastatic gastric cancer:prior neoadjuvant or adjuvant chemotherapy completed at least 6 months prior to study entry is allowed
* Previous anti-angiogenic therapy: Anti VEGF or VEGFR tyrosine kinase inhibitor such as bevacizumab, sorafenib, sunitinib, AZD2171
* Previous total platinum dose \>300 mg/m2: total prior platinum dose of ≤300 mg/m2 will be allowed in the adjuvant or neo-adjuvant setting
* Candidates for curative therapy
* Clinical or radiographic evidence of brain metastasis
* Cardiac disease; uncontrolled hypertension; hemorrhage/bleeding events
* Known or suspected allergy to any component of telatinib, cisplatin or capecitabine
* Known dihydropyrimidine dehydrogenase (DPD) deficiency
* Unable to take oral medications that could affect oral intake of capecitabine and telatinib
Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder

The study aims to evaluate:

* the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
* the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).

Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with a diagnosis of bipolar disorder according to DSM-IV criteria currently followed up by the investigator in hospital or open-care practice and informed of his/her disease.
* For whom the previous episode was a bipolar depression assessed clinically stabilized for at least 4 weeks by the investigator.
* Able to complete the self-assessment diary weekly

Exclusion Criteria:

* Pregnant women.
* Patient included in a clinical trial on an investigational drug or having received an investigational drug in the preceding 30 days.
* Person deprived of freedom or subject to a guardianship (or ward) order or unable to undergo medical monitoring for geographical, social or psychological reasons.