cyrilzakka/clinical-trials huggingface dataset:
Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.


Eligibility Criteria:
Inclusion Criteria:

* Children 24-60 months old
* Undernourished or at risk of undernutrition according to the WHO Growth Standards.
* Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
* Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
* Child's parent(s)/LG is not planning to relocate during the study period.
* Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

Exclusion Criteria:

* Participant participates in another study that has not been approved as a concomitant study.
* Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product.
* Child is currently drinking an Abbott product(s).
* Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG.
* Child had birth weight \< 2500 g or \> 4000 g.
* Child whose either parent has BMI ≥ 27.5 kg/m2
* Child has continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
* Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis.
* Child has been diagnosed with the following according to medical records or report by parent(s)/LG or the clinician's judgment:

  1. Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)
  2. Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia
  3. Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
  4. Disorders of hemoglobin structure, function or synthesis
  5. Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
  6. Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
Comparison of Bupivacaine and Exparel for Carpal Tunnel Release

Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain through the use of a long-acting local anesthetic, the use of narcotic pain medications may be decreased and patient satisfaction scores may increase.

The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine with respect to post-operative pain control, narcotic usage, and patient satisfaction after carpal tunnel release.


Eligibility Criteria:
Inclusion Criteria:

* Patients with carpal tunnel syndrome undergoing surgery

Exclusion Criteria:

* Non english speaking
* Allergy to bupivacaine or exparel
Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer

Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.

Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer

Exclusion Criteria:

* Histology showing other than adenocarcinoma
Effect of OSA on RV Heamodynamics and Function

Correlation of severity of obstructive sleep apnea and function of the right ventricle by means of 2D echocardiography and cardiac MRI

Obstructive sleep apnea (OSA) is a frequently under diagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension , myocardial infarction or stroke.

Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive collapse of the upper airway during sleep .The obstructive apneic event is associated with considerable breathing efforts against a totally or partially occluded upper airway, and apnea is terminated by an arousal and heavy snoring as airflow is restored. Severity of OSAS is described according to total number of apneas and hyperpneas per hour of sleep, which is named as the apnea-hypopnea index (AHI).

Cardiovascular disturbances are the most serious complications of OSAS. These complications include heart failure, acute myocardial infarction, nocturnal arrhythmias, stroke, systemic and pulmonary hypertension. All these cardiovascular complications increase morbidity and mortality of OSAS.

Currently, sleep apnea is accepted as one of the identifiable causes of hypertension. Also, OSAS is closely associated with obesity and ageing.

There is conclusive evidence that OSAS influences right heart function (the pathophysiological consequences of sleep apnea-hypopnea might result in an imbalance in myocardial oxygen delivery/consumption ratio, activation of sympathetic and other neurohormonal systems, and increased right and left ventricular after load )

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed as OSA with age range from 18 to 70 years
* Glomerular filtration rate (MDRD formula-based) \> 60 ml/min
* Arterial hypertension diagnosed according to the European Society of Hypertension 2013 Guidelines.

Exclusion Criteria:

* Mental illness
* Acute and chronic inflammation
* Heart failure III or IV grade
* Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics
* Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.

This is a prospective, multicenter, all-comers observational study. Primary endpoint was procedural success (defined as a combination of successful primary target lesion crossing, residual stenosis of ≤30% following vessel preparation and before definite treatment) and absence of procedural complications (defined as target vessel perforation or rupture, acute occlusion, and distal embolization).

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥18 years old
2. Subject has provided written informed consent
3. Subject has Rutherford classification 2 to 6
4. Reference vessel diameter ≥2 and ≤7 mm
5. Target lesion(s) has stenosis \>70% by visual assessment
6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between will be considered one lesion.

   Above the knee (ATK) group:
7. Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
8. At least one below-knee artery patent to the ankle
9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care. The inflow lesion(s) must be treated first, prior to consideration of treatment of the target lesion. Subject can be enrolled if the inflow lesion(s) are treated and result in ≤30% residual stenosis and no evidence of embolization or significant complications.

   Below the knee (BTK) group:
10. Target lesions involve arteries below the tibial plateau
11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications

Exclusion Criteria:

1. Subject has a single target lesion that involves both ATK and BTK segments.
2. Subject not suitable for receiving endovascular procedures of lower limb arteries.
3. Prior planned major amputation in the target limb (i.e., above the ankle).
4. Subject with previous bypass surgery of target vessel.
5. History of any open surgical procedure within the past 30 days.
6. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb.

   Note: The inflow vessels can be treated on the day of the procedure.
7. Subject has Oscar IFU listed contraindication (such as uncorrected bleeding disorders, sepsis).
8. Subject under dialysis.
9. Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached.
10. Subject lacking capacity to provide informed consent.
11. Subject under judicial protection, tutorship, or curatorship (for France only).
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.

Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion Criteria:

* Pregnant
* Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
The Economic Consequences of Loneliness Among the Elderly

Elderly individuals across the world are increasingly living alone. However, little is known about the effects of loneliness on economic and health outcomes. The elderly living alone (i.e., in a household of size 1) will be randomized into one of two cross-randomized intervention arms or a control condition to improve older individuals' mental wellbeing as well as ability to cover basic needs, particularly in times of COVID (including health). The first intervention will focus on improving the elderly's outlook on life and relationships through problem-solving therapy (PST) delivered over the phone. The second will deliver to them a one-time cash transfer of Rs.1000, equivalent to the emergency help amount distributed to ration card holder by the government of Tamil Nadu. Each intervention will be offered on its own in each of two treatment arms, and in combination in a third. A control group will receive no intervention. Investigators will track outcomes of the elderly at 3 weeks and 3 months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least 55 years of age
* Individuals living alone

Exclusion Criteria:

-
Assessment of Sleep Quality in Patients Treated for Cancer Between 15 and 24 Years of Age

Medical professionals now take into account the specificities of the care and support of Adolescents and Young Adults (AYAs). Cancer aftermaths in patients diagnosed during the AYA period are also known: the consequences of chemotherapy and radiotherapy treatments on a growing organism, the difficulty of some follow-ups, the longevity, and the delayed occurrence of certain complications.

In the general population, sleep disorders affect 40% of adolescents. About 30% of pediatric cancer survivors experience fatigue they attribute to their cancer, even years after the end of their treatment. The sleep quality of patients treated for cancer when they were AYAs, and the eventual care of sleeping disorders, are poorly studied. The investigators suppose that the oncologic treatment during this particular life stage, when sleeping disorders are already present and multifactorial, could have long-term impacts on sleep. The investigators offer to evaluate, through a questionnaire filled out by patients treated for cancer in the AYA period, the frequency of moderate to severe insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Patient treated for a cancer
* Patient aged between 15 and 24 years old at the time of the diagnosis
* Patients whom intensive treatment ended at least 3 months ago
* Patient followed in a PACAAURA cancerology center
* Life expectancy ≥ 6 months
* Karnosky index \> 60%
* Patient who agrees to participate in the program and benefits from social security
* Patient able to understand, speak and read French.
* No major cognitive impairment (assessed by the patient's referees)
* No sensory disability

Exclusion Criteria:

* Patient unable to use informatic tools
* Known superior cognitive function disorders
* Progressive psychiatric pathology
* Drug user or alcohol abuse
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery

The objective of this research project is to develop, evaluate, and disseminate an Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be based on the four point cognitive-behavioral program for SMART Recovery (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and behavioral skills to abstain from drinking, drug use, and problem gambling.

The investigators will evaluate the effectiveness of the OA web application for heavy drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.

The study design has three conditions: 1) participation in face-to-face SMART Recovery meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3) combining the OA web application with participation in face-to-face SMART Recovery meetings.

Study Hypotheses:

1. All three groups will reduce their alcohol consumption, drug use (if any), and alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month post-baseline assessments.
2. The OA only group (Experimental group 1) will show a greater reductions in drinking, drug use (if any), and alcohol/drug-related problems relative to the face-to-face only (Control) group.
3. The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking and drug use variables compared to the Control group.


Eligibility Criteria:
Inclusion Criteria:

1. Minimum age 18.
2. Positive response to quantity/frequency screening questions regarding heavy drinking in the previous 90 days.
3. An Alcohol Use Disorders Identification Test (AUDIT) score of 8+.
4. Is a new member of SMART Recovery(i.e., just joining or joined within the last 4 weeks).
5. Has a computer at home with Internet access.
6. Has a primary focus on abstaining from drinking.

Exclusion Criteria:

1. Court mandated 1st time DWI offenders.
2. Current diagnosis of drug dependence or consider themselves to be drug dependent.
3. Current evidence of uncontrolled psychosis or bipolar disorder.
4. Evidence of significant cognitive impairment from brain dysfunction.
5. English reading level below the 8th grade.
6. Unwilling or unable to be available for 3 and 6 month post-baseline assessments.
7. Unwilling or unable to provide one Significant Other (SO) for corroboration of participant's self-report of drinking and drug use (if any).
Analytical and Clinical Performance Testing Plan

Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.

Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:

* Precision
* Sample Matrix Comparison
* Method comparison study and flagging analysis
* Reference interval range

Eligibility Criteria:
Inclusion Criteria:

For Residual Samples:

* Specimen obtained by venipuncture or finger prick and collected into tubes normally used by the site
* Patient is at least 3 months of age
* Samples within 8 hours from phlebotomy

For Prospectively collected samples:

* Subject is at least 22 years of age
* Non-diseased individuals or, for specific studies, individuals with blood count ranges to cover indicated medical decision points and ranges
* Samples within 8 hours from phlebotomy

Exclusion Criteria:

Exclusion criteria post blood draw and pre sample scan - For whole blood samples:

* Visibly hemolyzed or clotted specimens
* Specimens with insufficient blood volume to complete the procedure
* Samples older than eight hours

Exclusion criteria post sample scan:

* Instrument failure or sample rejected by the instrument due to system error or sample mishandling
* The daily quality control sample measurements indicate that the assay run is outside the specifications for the instrument
* Operator related error documented in the study records
* Failure to adhere to study specifics or protocols
Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Positive result for HIV, Hepatitis B or Hepatitis C virus.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Known hypersensitivity or history of allergy to sulfonamides.
Mobile Phone Messaging to Improve Women's and Children's Health (Mobile WACh) in Kenya

With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Access to a mobile phone
* Able to read SMS messages
* Willing to receive SMS messages

Exclusion Criteria:

* Unwilling or unable to meet inclusion criteria
Surgery for Masaoka-Koga I-II Thymoma

The purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for Masaoka-Koga I-II thymoma.

It is a multi-center, open, prospective randomized phase II\&III clinical trial sponsored by Shanghai Zhongshan Hospital with other four hospitals in China participating in. 100 patients with thymoma (Masaoka-Koga I-II ) diagnosed by enhanced computed tomography were recruited and randomly assigned into the subxiphoid approach thoracoscopic thymectomy (SATT group) and the lateral intercostal approach thoracoscopic thymectomy (LATT group) according to the proportion of 1:1. The safety and perioperative outcomes are compared between the two surgical regimens.

Eligibility Criteria:
Inclusion Criteria:

1. Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
2. The patients whose tumor diameter was \<6 cm;
3. The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months;
4. ASA grade：1-2;
5. The patients should have no functional disorders in main organs.;
6. The patients should be able to understand our research and sign the informed consent.

Exclusion Criteria:

1. Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis;
2. Patients with myasthenia gravis;
3. Patients had undergone a sternotomy;
4. The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control;
5. The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy;
6. Female who is positive for serum pregnancy test or during lactation period;
7. The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation;
8. The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders;
9. The patients attend other clinical trials.