cyrilzakka/clinical-trials huggingface dataset:
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Eligibility Criteria:
Inclusion Criteria:

* Males or females \> or = 12 years of age
* NDD-CKD subjects
* Baseline hemoglobin \< or = 11g/dl
* Stable erythropoietin (EPO) status

Exclusion Criteria:

* Known hypersensitivity to ferrous sulfate or IV iron
* Unstable EPO status
* Anemia not related to CKD
* Chronic, serious infection
* Recent IV iron
* Recent blood transfusion
* Recent blood loss
* Need for surgery
* Received investigational drug within 30 days
* Female subjects who are pregnant or lactating
Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 18 years old
* Non-traumatic HSA
* Hyponatremia defined by a natremia less than 135 mmol / L and a high natriuresis, greater than 250 mmol / L despite well-managed saline intakes

Exclusion Criteria:

* Severe cardiac decompensation (LVEF \<30%)
* Severe hepatic cirrhosis (PT \<30%, ascites), known severe renal failure (GFR \<30mL / min / 1.73m²)
* Blood urea\> 25 mmol / L in the basal state
* Osmotherapy and diuretics in the last 48 hours
* Ongoing treatment with systemic corticosteroids
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.
* Patient not affiliated to a social security scheme
* Known hypersensitivity to any of the components of ergytonyl
* Contraindications to ergytonyl: taking curative anticoagulants, previously known and treated diabetic patients
W-PPMA for Postpartum Mothers

To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.

This randomized waitlist-controlled trial evaluates the feasibility and acceptability of the W-PPMA digital health tool.

Participants will be recruited from the IRB-approved PowerMom research study of Scripps Research and, if interested, will complete screening for the sub-study. Eligible participants will be asked to provide informed consent and complete the baseline assessments. Those that do not meet eligibility criteria may resume their PowerMom experience.

Eligible participants will be randomized to one of two groups, W-PPMA or Waitlist, and will receive instructions on when and how they can access the digital health tool. Primary endpoints will be measured at 8-weeks (end of treatment) with additional measures being collected at 1- 4-, 8-, 12-, and 16-weeks (end of study). Screening, consenting, and outcome measures will be completed online through the MyDataHelps app.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 16 years of age
* Be ≤ 3 month postpartum
* Currently enrolled in Scripps Research PowerMom study
* Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
* Available and committed to engage with the program and complete assessments for a 16-week duration.
* Ability to read and understand English

Exclusion Criteria:

* Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
* Lifetime diagnosis of bipolar disorder
* Current suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
* History of (a) drug and/or alcohol abuse within the past 12 months
* Fetal demise within the past 18 months
* Previous use of the Woebot app
Acute KIDnEy Injury in CoviD-19

This is a prospective observational parallel group cohort study that will aim to recruit 220 participants who were admitted to the hospital with COVID-19 between 1st March 2020 and 30th June 2020 (Group A - 110 participants who had COVID-19 with AKI; Group B - 110 participants who had COVID-19 without AKI). Data from groups A and B will be compared with AKI and non-AKI groups from an existing study database (ARID study, n=1125) who were recruited before the outbreak of the COVID-19 pandemic (recruitment 2013-2016) and who have all completed at least three years of follow up. Participants who have recovered from COVID-19 will be matched for analysis to participants from the ARID study for AKI status, baseline estimated glomerular filtration rate (eGFR) stage, age (± 5 years) and presence of diabetes. Potential participants will receive a letter of invitation along with a comprehensive participant information sheet (PIS).

After the participants have read and understand the PIS, and had sufficient time (at least 24 hours) to consider their participation in this study, the investigators will ask them to sign a consent form, which shows their willingness to take part. The investigators will then collect information from their medical records about their hospital admission with COVID-19, including their age, ethnicity, medical conditions, length of hospital stay, tablets or any other treatments they received, as well as details of their stay in the intensive care unit.

For the two groups - COVID AKI and COVID non-AKI, telephone follow-up with a study questionnaire will be performed at recruitment, 6-9 months and 12-15 months after hospital discharge. The study questionnaire will include the following:

1. Details of any medical event and date of medical event since last study follow-up.
2. Details of any hospital re-admission.
3. Details of current medication.

In addition, at the same time points, participants will be asked to attend their general practitioner surgery or other clinic to have simple clinical measurements (height, weight and blood pressure), blood and urine tests.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients greater or equal to 18 years of age.
2. Swab results positive for SARS-CoV-2.
3. Patients admitted to the hospital for ≥24hrs.

Exclusion Criteria:

1. Paediatric patients as defined by age of \<18 years of age.
2. Patients \>90 years of age.
3. Swab results negative for SARS-CoV-2.
4. Patients on haemodialysis or peritoneal dialysis, pre-existing CKD stage 5 (eGFR \<15ml/min/1.73m2), solid organ transplant.
5. Inability/refusal to give informed consent to participate.
6. Death during the same hospital admission that AKI occurred.
End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer

The aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.

Colorectal cancer has been reported to be the 3rd most common and the second most deadly cancer world wide.

Anterior resection is the gold standard operation for both rectal and recto-sigmoid cancer with considering oncological safety maintenance to be the most important goal which can be achieved by keeping abundant resection margin and ensuring anastomotic safety, despite the technical difficulties of working in a narrow deep pelvis.

Understanding the characteristics of each anastomotic technique and establishing a stable anastomotic procedure both are pillars in anastomotic leakage prevention.

The intersection of the linear staple line and circular staple line in conventional anastomotic way is considered a risk factor for anastomotic leakage by creating stapled corners (called "dog-ears") which considered potentially ischemic and represent the area with high incidence of anastomotic leakage. Single stapled technique using ether end to end with omega suture or end to side stapled anastomosis allows avoidance of the formation of this intersection.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years.
* Both sexes.
* Recto sigmoidal carcinoma.
* Upper rectal cancer.

Exclusion Criteria:

* Patients younger than 18 years
* Recurrent or non-resectable cancer
* Complicated cancer (e.g., obstructed or perforated)
* Previous left-sided colorectal surgery or anorectal surgeries
* Lower rectal cancer
Study of Stereotactic Radiotherapy for Breast Cancer

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age \> or = to 50 years of age
* Invasive ductal carcinoma
* Clinically and radiographically T1 tumor
* Clinically node negative
* Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
* Planning breast conserving surgery including sentinel node biopsy
* ≥10% expression of ER and/or PR
* HER2- using the current College of American Pathologists guidelines
* Post-menopausal
* Willing and able to provide informed consent

Exclusion Criteria:

* Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
* Pure DCIS without invasive cancer
* Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
* Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
* Positive pregnancy test
* Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
* Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
* Planning mastectomy
* Unable to tolerate prone positioning
High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.

Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab, polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS patients. Patients will be divided into two groups by block randomization method. The study was planned as double-blind. Patients will not know what treatment they are receiving, the doctor does not know what treatment the patient is receiving, and technicians who take and analyze polysomnography will not know what treatment the patients are receiving.

Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high intensity) to the second group with expiratory muscle training device, 7 days / week, 25 breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP measurements will be repeated every 2 weeks in the hospital and the new training workload will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.
2. General health condition is stable

Exclusion Criteria:

1. Passed stroke,
2. Neurological disease and psychological disease
3. Cardiac disease
4. Hypothyroidism
5. Serious obstructive nasal disease,
6. A history of infection in the past month.
7. Previous oroferengeal surgery history
8. With a BMI of 40 kg / m2 or more,
9. Using substance, alcohol, sedative and hypnotic drugs
Prevalence of Diastasis m. Rectus Abdominis in Postpartum Women

This study will evaluate the prevalence of diastasis m. rectus abdominis after delivery.

Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.

Evaluation of the width of the linea alba within the evaluation of diastasis of the rectus abdominis by 2D USG relation to pelvic floor muscle function (strength and endurance of pelvic floor muscles) and pelvic floor muscle morphometry by 3D/4D USG .

Eligibility Criteria:
Inclusion Criteria:

* Women from six weeks to up to 6 months after birth, age over 18 years old.

Exclusion Criteria:

* Psychiatric illness, postpartum depression, non-cooperation. Neurological diseases conditions after a stroke, a history of brain injury, significant visual and hearing damage, confirmed by neurological examination. Serious internal, orthopedic and oncological diseases. Disagreement with inclusion in the study.
Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group

The primary goal of this study is to assess in vivo the efficacy of the insoles, in improving venous return in subjects affected by this problem after 14 days of the initial measurements, by self-assessment, filling-in questions regarding Quality of Life, in comparison with a control group.

The secondary goal of this study is to assess in vivo the acceptability of the subjects regarding the same medical device, after 14 days of using the medical device, by selfassessment, filling-in subjective evaluation questions.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Female/Male;
* Age: with 18 years old and older;
* Having signed an Informed Consent Form (ICF);
* Willingness, ability and likeliness to comply with all the study procedures and restrictions;
* Ability to give informed consent;
* Available during the entire study period;
* Understanding Portuguese language: Portuguese-speaking subjects capable of reading the documents;
* Affected by a symptomatic venous return problem;
* With a score \>14 from the question 1 to 11 of the adapted CIVIQ questionnaire;
* With shoes suitable for insoles (with heel \<2.5cm);
* Having a size of 36 to 44;
* Is taking a venotonic as a regular therapy with a daily dosage;

Exclusion Criteria:

* Known allergy or known history of hypersensitivity to the components of the investigational device and related compounds;
* Currently participating in another clinical study that may interfere with the study;
* Diagnosed skin diseases and/or cutaneous alterations on the test region (under the feet) that may impair the study (for example tattoos, marks, burns, scars, etc.);
* Diagnosed diseases that may impair the study (including but not limited to: Diabetes, Arteritis, Phlebitis, etc);
* Under pharmacological treatments on the 30 days previous to the beginning of the study and during the entire period of the study that may impair it (including but not limited to: inflammatory drugs, any drug that might cover the signs and symptoms, drugs with arterial or venous indications, etc.);
* Having applied any type of topical product (pharmaceutical, cosmetic or other) with similar effect of the medical device under study, on the test region (feet) during the study, besides the investigational device;
* Having a stage of CVD C3 on the CEAP classification;
* Having had a traumatic or neurological history in the last 6 months;
* Wearing an orthopaedic insole made by a health professional;
* Having a significant and disabling lower limb pain;
* Having a significant and disabling back pain;
* Having a contraindication to wearing insoles;
* Pregnancy or intention to conceive during the study;
* Breast-feeding.
Empirically-Based Couple Interventions on the Web: Serving the Underserved

Although several empirically-supported interventions to prevent and treat relationship distress have been developed, the majority of couples - especially high-risk couples - do not seek these face-to-face interventions. However, our pilot data indicate that large numbers of couples will seek self-administered assistance for their relationship. Additionally, unlike many in-person interventions, couples seeking self-help resources tend to have higher levels of relationship distress. Thus, to improve the reach of couple interventions, this project will translate a leading empirically-supported intervention targeting early signs of relationship distress into a Web-based format. This intervention will consist of individualized feedback and professionally-filmed video clips tailored to a couple's specific needs. By intervening effectively with a large number of couples, the resulting Web-based intervention has the potential to have a population-level impact on relationship distress, divorce, and resulting child difficulties.

In the proposed project, building off our previous pilot studies, effective translation of this in-person intervention into a Web-based format will be ensured by conducting two additional intensive pilot studies. Once final changes have been made to the website and Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or an online intervention. All couples will be assessed for the initial two months; intervention couples will be assessed for one year. This project will: 1) demonstrate that couples randomly assigned to the online intervention will report higher levels of individual, child, and relationship functioning than those in the wait-list control group; 2) document the mechanisms of both active conditions; and 3) show that initial gains in those assigned to the intervention are largely maintained through one-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Currently in a heterosexual relationship
* Currently married, engaged, or cohabiting for at least 6 months
* At least one partner scoring in distressed range of relationship satisfaction (or both partners \> 0.5 SD of population mean of distress).
* Living in the United States
* Both partners ages 21-64 (inclusive)

Exclusion Criteria:

* Severe Intimate Partner Violence in last 3 months
* Moderate to severe suicidal ideation in last 3 months
* Concrete plans to divorce
* Ongoing affair
* Ongoing couple therapy (or refusal to seek couple therapy for 3 months)
The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time

The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.

The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years and \<80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.

Exclusion Criteria:

* Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure.
* Patients, who have proven or suspected obstruction of the bowel.
* Patients, who have had prior small bowel and/or gastric surgery.
* Patients, who have a dysphagia prohibiting.
* Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.
Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma

The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of diffuse large B cell lymphoma or follicular lymphoma, according to the WHO 2016 classification, requiring a first line of treatment with a RCHOP 21 regimen
* Agreement to participate after receiving oral and written information on the study

Exclusion Criteria:

* History of previous treatment for lymphoma (excluding localized low dose radiotherapy in the case of follicular lymphoma)
* Treatment with a chemotherapy regimen different from RCHOP21
Early Detection of Breast Cancer and Cervical Cancer in Women in India

RATIONALE: Health education programs and screening methods, such as clinical breast examination and examination of the cervix, may help reduce the number of women who develop breast cancer and cervical cancer.

PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.

OBJECTIVES:

* To investigate the effectiveness of well planned health education programs (HEP) and low-cost screening methods (e.g., clinical breast examination \[CBE\] and visual inspection of the cervix painted with 4% acetic acid \[VIA\]) in down-staging and reducing the incidence of and mortality due to breast and cervical cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

* Arm I (intervention): Participants undergo intervention comprising health education programs (HEP), clinical breast examination (CBE), and visual inspection of the cervix painted with 4% acetic acid (VIA) every 2 years for up to 8 years. Participants also undergo active surveillance over 8 years.
* Arm II (control): Participants receive one HEP. Participants also undergo active surveillance over 8 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified