cyrilzakka/clinical-trials huggingface dataset:
Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula

The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections. A total of 176 patients will be enrolled


Eligibility Criteria:
Inclusion Criteria:

Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality.

A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).


Eligibility Criteria:
Inclusion Criteria:

* preterm infant born between 25+0 and 32+0 weeks of gestation
* preterm infant included in the study before 24 +/- 12 hours of life
* preterm infant nursed in a closed incubator
* written informed consent from his parents

Exclusion Criteria:

* newborn infant with polymalformative syndrome
* life threatening events or serious heart disease
Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression

Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.


Eligibility Criteria:
* Men/Women in good health 65 years or older
* Ability to read, understand and sign study informed consent
* Major depression- mild to severe based on rating scale
Strong Heart Study Analyses Obesity and Lipoproteins

To examine the relationship of obesity and body fat distribution to lipoprotein concentrations in members of the Strong Heart Study.

BACKGROUND:

The Strong Heart Study is a longitudinal cohort study of several American Indian groups in three participating centers. The overall aim of the main study is to determine the role of various risk factors in the development of cardiovascular disease in this native American population.

DESIGN NARRATIVE:

Data from the first and second clinical exams of the Strong Heart Study were analyzed to determine if body fat distribution as measured by waist-to-hip circumference was a better correlate of lipoproteins than was body mass index. In addition, change in body mass index (BMI) and waist-to-hip ratio (WHR) were correlated with change in lipoproteins.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma

Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (PDAC). In this prospective study, we aimed to evaluate the performance and value of 68Ga-FAPI-04 PET/CT in the patients with PDAC.

With an incidence rate of 10 cases per 100,000 people per year, cancer of the pancreas is the third most common malignancy of the gastrointestinal tract. The overall survival for patients with pancreatic cancer is very poor, with a 5-year survival of 1% to 4%. Successful therapy depends on early diagnosis. The discrimination between benign and malignancies of the pancreas and the assessment of local resectability and distant metastases of the pancreatic cancer remains challenging with different imaging modalities such as ultrasound (US), endoscopic US (EUS), multidetector row computed tomography (MDCT), magnetic resonance imaging (MRI), and 18F-FDG positron emission tomography (PET). PDAC is characterized by a distinct and exuberant desmoplastic stroma, with stromal components outnumbering the pancreatic cancer cells. In PDAC, more than 90% of the tumour volume consists of cancer-associated fibroblasts (CAF). Fibroblast activation protein (FAP) is highly and selectively expressed in CAFs but is weakly expressed or not detected in normal tissues. The aim of this study was to evaluate the impact of FAPI-PET/CT on the clinical management of patients with suspected pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected pancreatic lesions
2. Signed written consent.

Exclusion Criteria:

1. pregnancy;
2. breastfeeding;
3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Preemptive Pregabalin in Myringoplasty

The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.

Patient were randomly assigned to one of two groups with 30 participants each by lottery method. Pregabalin group received capsule Pregabalin 150mg and Placebo group were given Vitamin B capsule 1 hour prior to surgery.

All patients underwent endoscopic myringoplasty with tragal cartilage and perichondrium graft. Surgical procedure was done under local anesthesia. 5ml of 2% xylocaine with 1:2,00,000 adrenalin was infiltrated in the four quadrants of external ear canal and on tragus. Around 2cm incision was given on canal surface of tragus and around 2cm x 1.5cm cartilage- perichondrium graft was obtained. The skin was closed with 4/0 prolene interrupted suture. Using rigid Hopkins II 0-degree endoscope (Karl Storz) with 4-millimeter diameter and 18 centimeters in length, margin of perforation was refreshed. Gelatin sponge was kept in the middle ear and cartilage perichondrium graft placed. Canal was then packed with gelatin soaked in ciprofloxacin ear drops followed by ribbon pack medicated with soframycin. Small dressing was applied over it.

Post-operative pain severity was assessed with VAS scale at 6, 12, 24, 48 hours. Rescue analgesia is given with Injection Ketorolac (30mg IV) or Tab Flexon (Ibuprofen 400mg + Paracetamol 500mg) whenever the patient required.

Eligibility Criteria:
Inclusion Criteria:

* Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
* Age \>= 18 years
* either sex.

Exclusion Criteria:

* Revision cases,
* Pregnancy or breastfeeding,
* Known or suspected sensitivity or contraindication to pregabalin,
* Patient using medication for chronic pain,
* History of seizure disorder,
* Mental retardation.
Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill

Compared with AN69 hemofilter, AN69 ST hemofilter may prolong the time of hemofilter and decrease the quantity of heparin during continuous renal replacement therapy in critically ill.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years old
* admitted to ICU and need CRRT
* anticipated survival time \>72h

Exclusion Criteria:

* allergy to hemofilter or heparin
* heparin associated thrombocytopenia
* pregnancy or lactation
* using other anticoagulate drugs
Value of Sonographic Diagnosis of Toddler's Fracture of the Tibia

This fracture of the distal tibia occurs in 1 to 4 year-old-children. Timely diagnosis is important, because it obviates the need for investigations to archive adequate treatment as well as to prevent unnecessary immobilization. The value of sonographic diagnosis of toddler's fracture has been demonstrated. The aim of the present study is to investigate the reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.

This fracture of the distal tibia occurs in 1 to 4 year-old-children. The child usually presents with an acute onset of limp or refusal to bear weight on one leg. Toddlers and young children may present with guarding, but may not have swelling or noticeable deformity.

Radiologic signs can be subtle too. In some cases initial radiographs is negative and fractures are diagnosed on follow-up studies by periosteal reaction.

However, timely diagnosis is important, because it obviates the need for investigations to archive adequate treatment as well as to prevent unnecessary immobilization. The value of sonographic diagnosis of toddler's fracture has been demonstrated. In children it is of particular value as it is comfortable and does not involve the use of ionizing radiation.

The aim of the present study is to investigate the reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Suspicion of Toddlers fractures

Exclusion Criteria:

1. Major delay in treatment
COMMIT Depression Trial Nepal

Community health workers (CHWs) have successfully used Motivational Interviewing (MI) to improve treatment adherence (i.e. taking medications and attending clinic appointments) for patients with depression in the US and globally. Mobile health (mHealth) tools can address challenges in implementing MI by providing real-time support in the community and facilitating ongoing coaching and supervision for CHWs, as these two challenges currently impede CHWs' ability to use MI. The investigators will develop then test a new mHealth app, which can potentially be used in the US and abroad, to help CHWs receive decision-support for MI and capture consented audio recordings of patient interactions for review and feedback by facility-based nurses with MI expertise.


Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for patient population: a. Adult patients aged 18 or older; AND b. Must have with active diagnosis of moderate to severe depression (last PHQ-9 ≥10) in the electronic health record system at the research performance site in Nepal; AND c. Have poor adherence (did not refill medications 1 week past the expected date and/or missed a scheduled clinic visit by at least 2 weeks; AND d. Must reside in Dolakha, Nepal
2. Inclusion criteria for community health worker or a community health worker supervisor: a. community health workers and their supervisors currently employed by and working at the research performance site, serving communities in Dolakha; AND b. have received training in motivational interviewing and use of the COMMIT mobile application.

Exclusion Criteria:

1. Exclusion criteria for patient population: patients with bipolar disorder (their treatment will be different from standard antidepressants) and those with substance use or psychotic disorders (their motivational factors will be substantially different from those of other depressed patients).
2. Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.
Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

This study investigates whether there is an immune response directed against gut microbes or food and parts of the body in severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients.

Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients will be identified by Epsom and St Helier CFS Service and the Clinical Research Network Eastern. Information sheets will be posted by health professionals to eligible patients. Interested patients are asked to arrange a telephone call with the research team to receive more information about the study. Volunteers still interested after the 72 hour consideration period arrange a home visit to be taken through the consenting process.

Household controls will be recruited through patients participating in the study. Patients invited will be provided with information about household controls. The patient identifies and informs potential household controls of the study using information sheets provided by their health professional. Household controls willing to participate in the study will be taken through an eligibility questionnaire with GCP trained researchers.

Six stool and blood samples will be collected over the three year study period. Stool and blood samples need to be collected within 24 hours of each other, during home visits. 48 hour food diaries will be completed prior to each stool sample collection.

The study is based at the Quadram Institute and the University of East Anglia (UEA). The research is funded by the UEA and Invest in ME Research UK.

Eligibility Criteria:
Inclusion Criteria:

* severe ME/CFS patients: men or women aged 18 to 70 years with a clinical diagnosis of severe ME/CFS patients
* household controls: men or women aged 18 to 70 years, no current or on-going medical conditions. Has to be either related/non-related, living in the same household or in close proximity to, or providing care to the severe ME/CFS patient they are paired with.

Exclusion Criteria:

* severe ME/CFS patients: the presence of significant anxiety or depression. Have received probiotics or antibiotics up to six weeks before joining the study.
* Household controls: The presence of long term medical conditions, in particular, affecting the stomach or bowel. Previously diagnosed with autoimmune diseases, for example, systemic lupus erythematous or rheumatoid arthritis. Suffer from significant anxiety or depression. In recipient of immunomodulatory drugs, statins, beta blocker or steroids. Have received probiotics or antibiotics up to six weeks before joining the study.
Effect of Observation Plus Imagination of Gait on Stride Variability in Young and Older Adults

The aim of study is to examine the combined effect of observation and imagination of gait on stride time variability of stride time among in healthy young and older adults.

JUSTIFICATION :

* In geriatric rehabilitation, gait reeducation, especially after a fall, is often encountered at the very beginning, to the inability to walk again. The main reasons are poorly controlled pain, immobilisations of a segment or the entire lower limb and adaptation to certain prostheses after fracture. This delay in walking recovery leads briefly to acute postural disadaptation that exposes to multiple decubitus complications such as infections, bedsores and muscular atrophy. Conventional rehabilitation techniques are then difficult to implement because they are poorly adapted to the geriatric patients.
* Today, many experimental data suggest a functional equivalence between making a movement, imagining and observing it. These data can be used to support the development of new rehabilitation techniques. For example, mental imagery is used in the learning of complex movements in order to improve motor performance.
* Stride variability, and more specifically stride time variability was identified as the best marker of the automatic walking, a low variability corresponding to an automatic and safety gait.
* We hypothesize that the combined effect of observation and imagination of a gait using an imposed cadency cadency may reduce stride time variability of stride time in healthy young and older adults.

The secondary objectives of the study are as follows:

* To examine the combined effect of observation and imagination of a gait on mean value of spatio-temporal parameters in healthy young and older adults.
* To study the influence of age on the combined effect of observation and imagination of gait on mean value and coefficient of variation of spatio-temporal parameters in healthy young and older adults

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years
* Able to walk without walking aid on 15 metres
* Written informed consent to participate in the study (or trustworthy person)
* Being affiliated to a social security regime

Exclusion Criteria:

* Osteoarticular pathologies of the lower limbs and / or spine altering the biomechanical characteristics of the body members.
* Ataxia
* History and / or progressive neuropsychiatric disorders.
* Score in the 4-items Geriatric Depression Scale \> 1.
* Enrolment in another simultaneous clinical trial (Participation in a concomitant clinical trial.)
* Civil defense measures underway (Measures civil protection type trusteeship / guardianship / safeguarding justice in progress.)
* Refusal to participate
FluSAFE: Flu SMS Alerts to Freeze Exposure

Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else has influenza is the major risk factor for contracting influenza. The household secondary attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms. Non-pharmaceutical preventive measures, including education, may play a role in decreasing transmission, but are only effective if started within 36 hours of symptom onset in index cases. Yet, most interventions are delayed because they are not initiated until care is sought. The investigators have demonstrated in one primarily Latino, urban community sample, that text messaging can be used to rapidly identify community members with influenza-like illness (ILI) early in an illness. This early identification would enable implementation of an educational intervention in the optimal time frame to reduce influenza transmission. Providing education within a text message is a proven successful strategy to influence behavior. Text messaging itself is scalable, low-cost, and can be used in low literacy populations. However, using text-message based surveillance to trigger a real-time text-message behavioral educational intervention to decrease household influenza transmission has not been assessed.

The study will enroll approximately 400 households with ≥1 child recruited from four contiguous communities in New York City. Households will be randomized, stratified by community 1:1 to receive surveillance-only (no text message education) vs. surveillance plus text message educational intervention. For symptom surveillance, households in both arms will receive text messages 3x/week during each influenza season and report if someone in the household has ILI symptoms. For those in the educational intervention arm, when an ILI/acute respiratory infections (ARI) is reported, a series of educational text messages will be sent with information to decrease household transmission.

Eligibility Criteria:
Inclusion Criteria:

* ≥3 persons per household
* At least one person who is less than 18 years old
* English or Spanish speaking
* Household reporter has cell phone with text messaging capabilities
* Household reporter willing to use text messages to report
* Reside within study neighborhoods in New York City

Exclusion Criteria

* Intention to move away from New York City area in \<12 months
* Language other than English or Spanish
Palpation and ACCURO for Placing Spinal in C-section

The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.

We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone.

Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace.

Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine navigation: A clinical validation study RM002" where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.


Eligibility Criteria:
Inclusion Criteria:

* • Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section

  * ASA-1, ASA-2, and ASA-3
  * Patients with no known back deformities
  * Ability to sit upright for spinal placement
  * No prior lumbar surgery
  * No allergies to ultrasound gel

Exclusion Criteria:

* • Unable or unwilling to give informed consent
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)

Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain for previous 3 months and majority of days in last month
* Regular use of acetaminophen or NSAID to treat low back pain in past month
* Judged to be in otherwise good health

Exclusion Criteria:

* Low back pain that is due to secondary causes
* Radicular/myelopathic pain
* Surgery for low back pain within the past 6 months
* Active lawsuit or claim pertaining to their low back pain
* Disease that may confound the results of the study or pose risk to the patients
* Corticosteroid use in past month
* Previous participation in an MK0663 study
Effect of Garlic Extracts on Changes in Blood Flow Velocity in the Carotid Artery

The purpose of this study is to assess the safety and efficacy of Garlic extracts for improving of blood flow velocity in the carotid artery.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 19 years of age or older as of the screening date
2. Those with no history of treatment for hypertension within the last 3 months
3. A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this study

Exclusion Criteria:

1. Those with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher
2. Those who have had a stroke, myocardial infarction, percutaneous coronary angioplasty or surgery for coronary angioplasty within the past 6 months
3. Persons with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke
4. Those with acute/chronic inflammation such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease, etc.
5. Those who have a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the product for human application testing
6. Persons who have taken prohibited concomitant drugs within the last 3 months
7. Persons with a history of clinically significant hypersensitivity reactions to drugs and health functional foods
8. Those who have received antipsychotic drug treatment within 2 months before the screening test
9. Persons with a history of drug or alcohol abuse
10. Pregnant or lactating women
11. When women of childbearing potential of childbearing potential do not accept the implementation of appropriate contraceptive methods (except for women who have undergone sterilization)
12. Subjects who have participated in health functional food related research or clinical trials within the last 3 months
13. In case the principal investigator judges that it is not appropriate to participate in this study