cyrilzakka/clinical-trials huggingface dataset:
Lung Ultrasound for COVID-19 Initial Triage and Monitoring

The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.

Initial triage assessment is the cornerstone of first-line medical management for COVID-19 patients. Only an accurate and fast evaluation of COVID-19 patients respiratory system integrity, can allow optimal treatment care and medical resources attribution. Despite its very large deployment, the use of thoracic Computed Tomography (CT scan) for COVID-19 patients severity assessment is currently debated. Actually CT-scan use in this setting: i) it is associated with risky in/out hospital patient's transport, both in terms of medical management of patient's critical conditions and risk of COVID-19 nosocomial transmission, ii) risks related to x-ray exposure iii) CT-scan is a snapshot of respiratory system integrity and does not provide data that might be used for patient's monitoring. LUS is a non-invasive, non-ionizing, fully bedside imaging tool. Investigators team has previously contributed to the development and validation of LUS for critically ill patient's management. To the extent of our knowledge, there is neither data regarding COVID-19 patient's LUS patterns, nor about the potential link between LUS data, patient's severity and outcome.

The investigators hypothesize that the combined use of LUS and clinical data (Q-SOFA score, SpiO2/FiO2) recorded at COVID-19 patients hospital admission, will allow to accurately predict short-term outcome. The investigators expect to predict at patient's hospital admission, the patient's clinical status at 24h: favorable (spontaneous ventilation with O2 \< 6 l/min) or unfavorable (spontaneous ventilation with O2 \> 6 l/min or under mechanical ventilation).

Eligibility Criteria:
Inclusion criteria:

* Adult (\> 18 years).
* Proven COVID-19 (specific PCR from respiratory track sample)
* CT scan prescribed by physician in charge, independently of research.
* Patients consent (or surrogate decision maker's consent in case of need).

Exclusion criteria:

* Reduction or cessation of active treatment.
* Patient under guardianship, tutelage measure or judicial protection
* Patient deprived of liberty by judicial order
* No French health insurance.
* Pregnancy or nursing woman.
* Enrolled in another trial evaluating thoracic imaging.
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma

Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diagnosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.

This is an open-label, phase 1, dose escalation trial that followed a 3x3 design. Three doses will be evaluated in the resectable cohorts: Cohort 1: 0.5x10\^8 NSCs loading 6.25x10\^10 vp; Cohort 2: 1.0x10\^8 NSCs loading 1.25x10\^11 vp; and Cohort 3: 1.5x10\^8 NSCs loading 1.875x10\^11 vp. Subjects enrolled have newly diagnosed high-grade glioma based on clinical and radiologic criteria; pathology will be confirmed at the time of surgical resection. Direct intra-tumoral injection of study product (NSC-CRAd-S-p7) will be done after resection but prior to closure. Subjects will then receive concomitant radiotherapy (RT) at a dose of 60Gy and chemotherapy with temozolomide (TMZ), 75 mg/m2, daily during RT. This will be followed by adjuvant TMZ dosed at 200 mg/m2 for 6 cycles. Subjects will be followed until disease progression with serial brain MRIs, and for survival up to 5 years. The non-resectable cohort will not opened due to limited product availability.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have presumed malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of stereotactic biopsy or resection prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
* Tumor must be accessible for injection and must not be located in the brainstem, or contained within the ventricular system.
* Planning to undergo standard radiation/chemotherapy
* 18 years of age or older.
* Performance status must be KPS ≥ 70
* SGOT (AST) \< 3x upper limit of normal
* Serum creatinine \< 2mg/dl
* Platelets \> 100,000/mm3 and WBC \> 3000/mm3

Exclusion Criteria:

* Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection.
* Immunosuppressive drugs (with exception of corticosteroid).
* Known HIV+ patients.
* Acute infections (viral, bacterial or fungal infections requiring therapy).
* Pregnant or breast-feeding patients.
* Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
* Prior radiation therapy to the brain or prior treatment for brain tumor Other serious co-morbid illness or compromised organ function.
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning

The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.5-25 kg/m2 (lean)
* Gender: Male
* Age: subjects has to be older than 18 and including 35 years old
* Caucasian

Exclusion Criteria:

* Metabolic abnormalities such as:

  1. Lactose intolerant
  2. Diabetes Mellitus
  3. Hypertension
  4. Hypotension
  5. Cardiovascular diseases
  6. Asthma and other obstructive pulmonary diseases
  7. Elevated fasting blood glucose level
Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer

The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).


Eligibility Criteria:
Inclusion Criteria:

* Participants who have an Eastern Cooperative Oncology Group Performance Status less than or equals to (\<=) 1
* Participants who have histologically confirmed and localized resectable rectal cancer (Stage 3)
* Participants who received induction chemotherapy are allowed to be enrolled to this study except this induction is resulting in clinical complete response (cCR) or tumor progression
* Participants who have lower edge of the tumor located in rectum
* Adequate hematological, hepatic and renal function as defined in the protocol
* Male participants if they agree to the following during the study intervention period and for at least 12 weeks after the last dose of study intervention
* Female participants are eligible if not pregnant or breastfeeding
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with history of any other significant medical disease or psychiatric conditions that might in the assessment of the Investigator preclude safe participation in the study
* Participants with history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study intervention
* Unstable cardiovascular function within 6 months prior to enrollment
* Hypertension uncontrolled by medication (ie, systolic blood pressure \>= 150 millimeter of mercury (mmHg) and diastolic blood pressure \>= 90 mmHg)
* Participants with history of other malignant disease within the past 5 years, other than successfully treated basal carcinoma of the skin or carcinoma in situ of the cervix
* Participants with known human immunodeficiency virus positivity, known active hepatitis (for example, hepatitis B virus or hepatitis C virus), current alcohol abuse, or cirrhosis
* Participants with ongoing active infection or treatment with a live attenuated vaccine within 4 weeks of dosing
* Participants with concomitant use of H2-blocker or proton pump inhibitors (PPIs) (or unable to stop at least 5 days prior to the first treatment). Note that calcium carbonate is acceptable
* Participation in any interventional clinical study within 28 days prior to Screening or during participation in this study
* Other protocol defined exclusion criteria could apply.
Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)

Different medications are often used in combination for the condition COPD (chronic obstructive pulmonary disease). Some medicines act by opening the airways (bronchodilators) and some act as anti-inflammatories (steroids). More recently an approach of using a combination inhaler (containing a steroid and a long-acting bronchodilator) at the same time as a long acting bronchodilator of a different group of medicines (anti-cholinergics inhalers) has been used. This approach is sometimes called 'triple therapy'. Studies which have looked at these combinations usually use only standard blowing tests (spirometry) to test these medicines and focus on the effects of the medicines at their highest (peak) levels. It is some ways more relevant to study these medicines towards to end of the dose period (trough)- just before the next dose. This is when there is less medicine in the system, and differences in drug effects are more obvious. There are also more detailed breathing tests than spirometry which get a more detailed picture of the way the lungs respond to bronchodilator medicines. The investigators have studied 'triple therapy' in COPD, by measuring the effects at the end of the dosing interval (trough) using a range of detailed respiratory tests.


Eligibility Criteria:
Inclusion Criteria:

* Current or ex-smokers
* aged over 50years
* FEV1/FVC ratio less than 0.7
* FEV1 less than 60% predicted

Exclusion Criteria:

* Diagnosis of asthma, ABPA or bronchiectasis
* Recent RTI or steroid use
* Inability to perform study procedures or to give informed consent
* Known sensitivity to trial medications
Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Our aim was to compare the ultrasound-guided infraclavicular and costoclavicular approach in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients
* Patients who will undergo hand or forearm surgery

Exclusion Criteria:

* Infection in the area to be injected
* Coagulopathy,
* Previously known neurological damage
Study Investigating Rapamune For Post-Marketing Surveillance

To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors in the Korean population, such as:

1. Unknown adverse reactions, especially serious adverse reactions
2. To assess the incidence of adverse reactions under the routine drug uses
3. Factors that may affect the safety of the drug (e.g., proteinuria)
4. Factors that may affect the effectiveness of the drug

All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 13 years or older receiving renal transplants, who are newly administered Rapamune after a contract is made between Pfizer Korea and an investigator and/or an institution for conducting this study.

Exclusion Criteria:

* Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information.
* Patients who have known hypersensitivity to Rapamune or its derivatives or any excipients in the formulation.
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection

The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.

Despite technological advancements, the rate of anastomotic leak after left colon and rectal resection remains high. In most cases, these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes. The device C-REX, developed by CarpoNovum, may help the anastomosis construction, providing at the same time a system to monitor the anastomosis until complete healing. This may lead to reduced anastomotic leak rate and severity. This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial. The objective of the study is to provide preliminary data to determine whether the C-REX device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection, providing new insights on the feasibility and effectiveness of the C-REX device in a real-word setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old, men or women.
* Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice.
* Patient indicated to elective minimally invasive sigmoid or high rectal resection.

Exclusion Criteria:

* Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
* Patients with preoperative evidence of distal metastasis.
* Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis.
* Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.
* Patients indicated to defunctioning ileostomy (intention to treat).
* Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.
Cannabinoid Supplementation on Vascular and Cognitive Function

Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC. Available evidence suggests that there are marked therapeutic CBD effects for diverse disease processes including inflammation, cancers, psychosis, and epileptic seizures. The purpose of this study, in both younger and older healthy humans, is to improve our understanding of how CBD might control and regulate blood vessel health as well as cognitive and exercise performance.


Eligibility Criteria:
Inclusion Criteria:

* non-smoking
* non-obese
* between the ages of 18-30 \& 60-75 years
* have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.

Exclusion Criteria:

* are obese
* are taking prescription drugs or over-the-counter supplements that influence cardiovascular or nitric oxide metabolism
* have a history of smoking
* have history of cardiovascular, respiratory (including asthma) or neurological disease
* have known intolerance to ginseng or ginkgo herbals
* have kidney, gastrointestinal or liver disease
* have epilepsy
* have diabetes
* are pregnant or breast feeding
* do not speak English as first language
* a student in the University of British Columbia (UBC) Okanagan Centre for Heart, Lung and Vascular Health
* medical or recreational use of cannabis
* clinically diagnosed anxiety or depression
* history of opioid use
* unwilling or unable to execute the informed consent documentation
Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.

Background：Intrauterine adhesion (IUA) can cause infertility. Hysteroscopic surgery can effectively treat most IUA. In order to prevent adhesion reformation after surgery, most gynecologists will prescribe high-dose estrogen to stimulate endometrial growth, and leave an IUD or a Foley catheter in uterus for 1-3 months. But neither IUD nor Foley catheter conform to the uterine cavity. The Cook balloon uterine stent was designed to fit into the uterine cavity. But it was designed to tamponade the uterus to prevent post-operative uterine bleeding. It's not known if it can be left in the uterus for 30 days.

Study Design：Uterine culture was done before hysteroscopic surgery, and 30 days later. The study group comprise patients with uterine stent; the control group comprise patients who undergo hysteroscopic surgeries but without uterine stent.

Method：Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity. The removed uterine stent was sent for bacterial culture too. The same procedures are done for patients with and without uterine stent. The bacterial counts will be compared before and after hysterosocpic surgeries, and between the two groups of patients.

Effect：If leaving the uterine stent in the uterus up to 30 days does not cause bacteria to grow, we can be confident to leave the stent for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* intrauterine adhesion women

Exclusion Criteria:

* allergic to Cook balloon uterine stent
DLBS1449 in Diabetic Patients With Low HDL

This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in elevating high density lipoprotein (HDL) cholesterol in diabetic patients. The hypothesis of interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level from baseline to the end of study significantly higher than the elevation resulted by placebo. In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide a significantly better response than that of the lower dose (DLBS1449 75 mg daily).

There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1449 at a dose of 1 x 75 mg daily, or 2) DLBS1449 at a dose of 1 x 150 mg (two capsules of DLBS1449 75 mg) daily; or 3) placebo, once daily. Study medication should be administered once daily, in the evening with meal, for eight weeks. Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at interval of four weeks over 8-week course of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 21 - 70 years.
* Have been diagnosed diabetes mellitus and being treated with lifestyle intervention for at least 1 month prior to screening, with or without antidiabetic agents.
* HDL-cholesterol level of \< 35 mg/dL.
* Triglycerides level of \< 200 mg/dL.
* Adequate liver and renal function.
* Statin and/or fenofibrate therapy should have been being regularly taken for \>=3 months at stable dose (ONLY for subjects currently under statin and/or fenofibrate therapy).
* Able to take oral medication.

Exclusion Criteria:

* Pregnant or breast-feeding women or willing to be pregnant.
* Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg).
* Any other disease state, including chronic/acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
* Concurrent treatment with systemic corticosteroids or herbal (alternative) medicines.
* Known allergic or hypersensitive to drugs contain similar active substance with the study medication.
* Participation in any other clinical studies within 30 days prior to screening.
Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.

Temporomandibular Joint Disorders (TJD) represent a set of conditions that involve pain and dysfunction of the temporomandibular joint. TJD are a frequent disability affection in the worldwide population and the 35% of affected present at least a symptom such as orofacial pain, mouth movement limitations and snapping or crying temporo-mandibular. Due to the increase of the incidence of the TJD the investigators propose to complete this study.

A randomized controlled trial with parallel groups have been designed and blind evaluation of the response variable.

The hypothesis is that dry needling produces a positive effect in the involved variables of this study in comparison with manual therapy.

The aim of this RCT is to compare the effectiviness of the application of manual therapy in comparison with dry needling in the perceived pain, mouth opening, the degree of cervical disability and the pressure-pain threshold (PPT) of myofascial trigger points (MTrP) in patiens with TJD.


Eligibility Criteria:
Inclusion Criteria:

Female and male subjects with an age of 18-65 years old with a TJD who meet at least two of the following inclusion criteria:

* Pain on palpation of the myofascial trigger points of the masseter, anterior temporal, posterior temporal, external pterygoid and sternocleidomastoid muscles (minimum 3 active trigger points).
* Pain in the temporomandibular joint.
* Limitation of mouth opening.
* Clicking of the temporomandibular joint.

Exclusion Criteria:

Subjects who present any of the following characteristics:

* fibromyalgia, orthodontia, systemic disease, syndrome or pathology with possible joint repercussions, patients undergoing treatment with NSAIDs, jaw fracture, mandibular surgery, non-collaborative patients or patients with phobia needles.
Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause

Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss

Study population: Women 50 - 60 years, 1-5 years after menopause

Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II" clinical trial.

Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer

Study Treatment Group: Daily supplementation with Vitamin K2, "NATTO"

Study Control Group: Identically-looking placebo medication

Duration of treatment: 12 months

Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response: Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the minimum clinically significant difference between the groups is 0.3 percentage points. The trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage points in the treatment group.

Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334


Eligibility Criteria:
Inclusion Criteria:

* Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.

Exclusion Criteria:

* History of hip fracture
* Bone disease affecting bone mineral density
* Use of vitamin K antagonists
* Significant co-morbidity that makes it difficult to obtain BMD measurements
* Use of hormone replacement therapy or other therapy that influence bone remodeling