cyrilzakka/clinical-trials huggingface dataset:
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates delivered between 24 0/7 and 32 6/7
* Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
* Written parental consent

Exclusion Criteria:

* Multiple gestation pregnancies (twins or higher order multiples)
* Rh or other antibody sensitization
* Hydrops fetalis
* Known major congenital abnormality
* Suspected abruptio placentae
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.


Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .

Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .

Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .

Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.

Radiotherapy also have cardio toxic effect through different mechanisms


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-75 years old 2. histopathology diagnosed 3. Left sided breast cancer 4. Receiving 3D hypofractionated radiotherapy 5. Patients should be non metastatic 6. performance status 0-2

Exclusion Criteria:

* • Patient \> 75 years old

  * Non histological diagnosed
  * Metastatic patient
  * Patient with cardiac or other co morbidity.
  * ECoG performance status \>2
  * pregnant or lactating patients
Diathermy Compared With Sham Diathermy in Doms Management

To investigate the effect of hand massage, switched on diathermy or sham/switched off diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.

This study examine DOMS in athletes following a ski mountaineering race, pain measured with numbering pain rating scale NPRS and perceived global improvement (PGIC) after treatment have been measured after a massage treatment, a diathermy treatment and a sham diathermy treatment.

Eligibility Criteria:
Inclusion Criteria:

- Healthy patients who complaints about D.O.M.S. after a skimountaneering race

Exclusion Criteria:

- Patient who complain of pathology such trauma or declaring consuming drugs for pain management where excluded from the study.
Teachers and Parents as Partners During Middle School

There are two aims of this study (a) to examine the effect of Teachers and Parents as Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers and facilitators to implementing Teachers and Parents as Partners in middle school for students with behavior concerns.

Teachers and Parents as Partners will occur in a series of stages comprised of approximately four structured meetings over approximately 8 weeks. A Teachers and Parents as Partners consultant will meet together with a student's parent(s), teachers, other school personnel (as appropriate), and the student (as appropriate). The Teachers and Parents as Partners team will collaboratively address behavior problem solving objectives. Specific CBC objectives include: identifying strengths and specific behaviors of concern, specifying alternative prosocial behaviors, creating measurable behavior goals, co-constructing behavior intervention/support plans to address the target concerns, creating sustainable conditions to support plan implementation at home and school, and evaluating the plan to assess progress toward goals.

Treatment integrity in multiple dimensions (e.g., engagement, dosage, adherence) will be assessed at the two tiers of implementation (i.e., Teachers and Parents as Partners procedural integrity and behavior support plan implementation) to determine the extent to which procedures are implemented as designed.

During each structured meeting, Teachers and Parents as Partners consultants will inquire with parents, teachers, other school personnel, and students about barriers and facilitators to implementation.

Eligibility Criteria:
Inclusion Criteria:

* Students will be eligible if they have scores in the "elevated" or "extremely elevated" risk categories on the parent and teacher version of the Behavior Assessment Scale for Children (BASC) 3 Behavioral and Emotional Screening System (BESS). Parents, and primary teachers and school staff associated with an eligible student will be included.

Exclusion Criteria:

* Students who do not meet the inclusion criteria will be excluded from participation, which includes their parent(s), teachers, and other school personnel. Students also may not be eligible if they have mental health concerns that may not be appropriate for Teachers and Parents as Partners or a research project (e.g., some internalizing problems, students who pose an risk of harming themselves).
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with Type 2 diabetes mellitus.

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with Type 2 diabetes mellitus (T2DM) based on subject incidence of adverse events.

The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes medications.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed type 2 diabetes mellitus
* Must have a body mass index ≥25 and \<45 kg/m2, but if body mass index is ≥25 and \<28 kg/m2, then waist circumference must be \>94 cm for men and \>80 cm for women
* Must be on a stable dose of metformin for at least 8 weeks prior to randomization
* Hemoglobin A1c (HbA1c) of 6.5 to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at Screening

Key Exclusion Criteria:

* Type 1 diabetes mellitus or history of diabetic ketoacidosis
* Received insulin treatment within 12 weeks of randomization
* Received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomization
* Received sulfonylurea, thiazolidinedione, exenatide, or any other glucose lowering treatment (other than metformin) within 8 weeks of randomization
* Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral edema, poorly-controlled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>100), history of unstable angina, myocardial infarction or stroke within 6 months of randomization, or chronic renal failure
* History or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopenia (WBC count \<3.5 x 10(9)/L)
* History or presence of any form of cancer within the 5 years prior to randomization, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis
* Fasting serum triglyceride \>400 mg/dL
Smartphone Application for the Management of Gestational Diabetes Mellitus

The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing. It is important to recognize and treat GDM to minimize the risk of maternal and neonatal complications. Multifaceted professional interventions are effective in the management of GDM and mobile healthcare can be an effective approach. The purpose of the current study was to develop and evaluate a model for prevention and management of GDM using mobile healthcare. Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks of gestation, were randomly divided into a conventional management group and a mobile management group. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received mobile healthcare services including tailored mobile coaching. The effectiveness of the management using the application were evaluated through the result values of the laboratory tests, anthropometric measurement performed during the study period and perinatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnant women diagnosed as GDM at 24 to 28 weeks of gestation were included.

Exclusion Criteria:

* Patients after 30th week of gestation and patients with pregestational diabetes were excluded from participating in the study. Patients who were unable to understand Korean, were unfamiliar with mobile phones, who did not have access to a mobile phone, or who were already receiving services from another mobile healthcare agency were also excluded.
Adaptive Treatment for Adolescent Cannabis Use Disorders

The purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.

The study will address the current contrasts in youth response to treatment, the problem of poor response to treatment and the prevention of relapse. Results from the study may support Adaptive Treatment as an efficacious approach for youth with Cannabis Use Disorder who are poor responders to treatment.

Poor responders fall into two categories, those who failed to achieve a negative drug urinalysis during the last session of the initial MET/CBT-7 treatment they attended, and those who either dropped out or were administratively discharged at any time during the initial MET/CBT-7 treatment.

Eligibility Criteria:
Inclusion Criteria:

* 13-18 years of age at the time of intake assessment
* Current diagnosis of DSM-IV Cannabis Abuse or Dependence
* Able to read and comprehend English at a 5th grade level
* Residence within 45 minutes drive from the UCHC Farmington treatment site
* Participant and a parent/legal guardian responsible for providing collateral information agree to sign an IRB approved consent form
* Participant and a parent/legal guardian responsible for providing collateral information agree to provide locator information
* The family is not planning to move from the area during the next six months

Exclusion Criteria:

* Meet criteria for dependence of any other substance of abuse other than nicotine or alcohol
* Report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days
* Meet a lifetime diagnosis of schizophrenia
* Has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment
* Demonstrate an inability or unwillingness to provide locator information
Demographics, Clinical and Paraclinical Characteristics of Multiple Sclerosis in Egypt

The primary study aim is to depict the demographics, clinical and para clinical features of patients attending five tertiary referral multiple sclerosis (MS) centers in Egypt.

This requires effective and unified pooled registries to extract data from with a standardized, sufficient and high quality clinical, magnetic resonance imaging (MRI) data, neurophysiological data and body fluids.

Investigators want to shed light on the challenges that face both physicians and patients in the area of "diagnosis and treatment"


Eligibility Criteria:
Inclusion Criteria:

* Patients with MS/NMOSD or their mimics who sought advice in one of our centers even once

Exclusion Criteria:

* Patients with missing data in their records that couldn't be completed
Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program.

This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH.
* Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable
* Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible.
* Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis.
* Patient has taken at least 1 week of treatment

Exclusion Criteria:

* Patient included in a crizotinib clinical trial
* Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS

Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.

Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.

Exclusion Criteria:

* None
Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.

The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female Patients \> 50 years of age.
2. Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
3. Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
4. If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.
5. Patients must be able and willing to provide written informed consent.

Exclusion Criteria:

1. Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
2. Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
3. Choroidal neovascular membrane greater than 9 disc diameters in size.
4. Previous posterior vitrectomy in the study eye.
5. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
6. Pregnant women or premenopausal women not using adequate contraception.
7. History of allergy to fluorescein, Visudyne, Lucentis.
8. Inability to comply with study or follow up procedures.
Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with resectable cancer head pancreas.
* Soft Pancreas.
* Small pancreatic duct diameter.

Exclusion Criteria:

* Unresectable cancer pancreas.
* Non soft pancreas.
* Dilated pancreatic duct.