cyrilzakka/clinical-trials huggingface dataset:
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health

The prevalence rate of maternal depression in Pakistani women and its effect on the growth and development of young children and child mortality is very high.

The main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months, consistent with her values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled trail. Depressed mothers will be randomized either to intervention arm or control arm. Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).

Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There are a number of efficient treatments for postnatal depression including antidepressant medication, psychotherapy and psychosocial interventions. Tele-health and mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance.

The proposed study will test the efficacy of an innovative, affordable mobile based intervention program that can help mothers with postnatal depression in low resource countries such as Pakistan.

Participants will be recruited from maternal and child care centres in Karachi, Pakistan and those participants (n = 204) meeting inclusion criteria of the study will be randomized into one of the 2 treatment arms, i.e., intervention or control, after completion of baseline assessment. Intervention will be comprised of LTP Plus and will be delivered through text messages. Momentary Sampling assessment and Momentary Psychological intervention will be part of this study. Participants will be assessed again after completion of intervention (i.e., after 12 weeks) and then 3 months post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with mild to moderate depression will be included
* Mother of children age 0-30months
* The age range in the study is 18 to 44 years
* Participants having mobile phones will be included

Exclusion Criteria:

* Subjects will not be included if they had a diagnosed medical condition or significant physical or learning disability
* Any form of psychosis, or are currently under psychiatric care.
* Mothers with severe depression or suicidal ideation will not be included
* Mothers who will be receiving any psychological intervention will be excluded
* Mothers of children with any serious medical or psychiatric illness will also be excluded.
The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections

The purpose of this study was to determine if the use of daily chlorhexidine bathing would decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream Infections (BSI) among Intensive Care Unit (ICU) patients.

Infections due to Staphylococci including MRSA are the predominant nosocomially acquired complication in the intensive care unit. The increasing incidence of MRSA colonization and infection among ICU patients has been attributed to many factors including increased admission of patients already colonized with MRSA to the ICU, poor compliance with handwashing and barrier precautions, delayed identification of MRSA colonized patients, and understaffing. Measures that have proven to limit horizontal transmission between patients and staff and staff to patients include strict attention to barrier precautions and handwashing. Unfortunately both of these strategies require levels of compliance that are often not achieved.

Nosocomial blood stream infections are a leading source of morbidity and mortality among intensive care unit patients. Several modifiable factors have been shown to increase the risk of bloodstream infections. These include lapses in the use of strict sterile technique in the insertion of central venous catheters and improper site preparation. New CDC guidelines on the prevention of catheter related bloodstream infections recommend that the preferential use of chlorhexidine containing skin disinfectants be used for site preparation prior to insertion. The use of chlorhexidine reduces residual skin organisms as well as inhibits their rebound growth and has been demonstrated to reduce catheter-associated bloodstream infections in comparison to other skin disinfectant products such as povidone-iodine.

As a result of guidelines promoting the use of chlorhexidine, a number of intensive care units have implemented quality improvement projects examining the potential role of chlorhexidine based bathing of intensive care unit patients in reducing nosocomial transmission of multiresisitant organisms such as MRSA and vancomycin-resistant enterocooci (VRE). The goal of the currently proposed study is to analyse existing data from participating intensive care units that have adopted the use of chlorhexidine antisepsis to determine the impact of chlorhexidine on bacterial colonization and nosocomial infections Participating hospitals who have completed quality improvement projects that included the use of chlorhexidine in bathing of ICU patients will submit de-identified data on nosocomial bacteremias and MRSA and VRE colonization during defined time periods where chlorhexidine bathing was used in comparison to time periods where regular bathing procedures were utilized.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to study units

Exclusion Criteria:

* Children under the age of 18
* Previous adverse reaction or documented allergy to chlorhexidine based products
Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage

Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.

To search for a biomarker, which might be able to predict rectal anastomotic leakage before its clinical presentation. Serum procalcitonin, C-reactive protein, and drain fluid culture, IL-6 and TNF-α levels were evaluated in 50 consecutive patients with rectal cancer who underwent low anterior resection with colorectal anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient underwent to colonic resection and had drain

Exclusion Criteria:

* other patients
Probing the Cannabinoid System in Individuals With a Family History of Psychosis

The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.


Eligibility Criteria:
Inclusion Criteria FHP:

* Exposure to cannabis at least once in their lifetime
* Medically and psychiatrically healthy based on screening
* Having one relative with a confirmed psychotic disorder

Exclusion Criteria FHP:

* Current or lifetime major DSM-IV Axis I disorder
* Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
* Major or unstable medical illness that might impact safety of the subject in the study
* Cannabis naive
* IQ less than 85
* Less than a high school diploma or its educational equivalent
* Pregnancy or lactation
* Major current or recent (\<6 weeks) psychosocial stressors.

Inclusion Criteria FHN :

* Exposure to cannabis at least once in their lifetime
* Medically and psychiatrically healthy based on screening

Exclusion Criteria FHN:

* Having a family member with psychosis
* Current or lifetime major DSM-IV Axis I disorder
* Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
* Major or unstable medical illness that might impact safety of the subject in the study
* Cannabis naive
* IQ less than 85
* Less than a high school diploma or its educational equivalent
* Pregnancy or lactation
* Major current or recent (\<6 weeks) psychosocial stressors.
Combined Diagnosis of CT and Exosome in Early Lung Cancer

This experiment has now collected 50 cases, all through CT chest scans and blood exosome detection. Twenty-two patients underwent surgical treatment and 14 tissue specimens were examined for cancer and paracancerous tissue exosomesWe found that exosomal micor-A was highly expressed in early stage lung cancer tissues and was significantly higher than paracancerous tissues. The micor-A in the adjacent tissues was significantly higher than that in peripheral blood exosomes


Eligibility Criteria:
Inclusion Criteria:1. At least 18 years of age, male or female; 2. No patients with acute disease; 3. Chest or LDCT examination for the first time found 5-30mm pulmonary nodule patients, and ruled out disseminated tuberculosis; 4. Past pulmonary nodes Festival failed to diagnose. 5. Have not received a history of surgical treatment of the lungs; 6. Patients who have not received targeted drugs, biological treatments, immunosuppressive agents, and modulators; 7. No organ transplants; 8. Signed informed consent before undergoing clinical studies Consent and adherence to the research protocol.

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Exclusion Criteria:1. Pulmonary nodules have been treated surgically (considering that surgery has been performed to interfere with the study); 2. History of organ transplants such as lung transplantation (consider the use of allogeneic genes and immunosuppressive agents); 3. Pregnancy or lactation (consider Failure to perform regular CT follow-up and fetal component effects. 4. Known HIV-positive or only AIDS-related diseases (taking into account interference with the use of immune drugs); 5. Being targeted drugs, immunosuppressive agents, immunomodulators, biotherapies Patients; 6. Active pulmonary tuberculosis (consider infectious and referral missing factors); 7. RNA-like viral infections: such as SARS, HIV, hepatitis virus (except for hepatitis B, the other four are all RNA viruses), influenza virus, Bird flu virus, H5N1, Ebola, measles, etc. 8. Various blood system diseases such as leukemia, lymphoma, aplastic anemia, myelodysplastic syndrome, anemia, hemolysis, hemophilia, DIC, etc. 9. Recent history of blood transfusion (within 3\~6 years) and potential for blood transfusion; 10. Patients with neurological disorders and mental disorders unable to cooperate; 11. Emergency treatment for acute and severe diseases; 12. No Willing to sign a written informed consent and follow the study protocol before they are willing to conduct clinical research; 13. The presence of the patient may interfere with any psychological, family, social or geography conditions that obey the requirements of the research protocol or the follow-up procedure. Discuss these conditions with the patient before entering the study.

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Intraoperative Evaluation of Axillary Lymphatics

This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.

Lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal of only the lymphatics of the breast and protection of the lymphatic channels draining the upper extremity during axillary dissection (AD) or sentinel lymph node (SLN) biopsy, thereby reducing the risk of arm lymphedema.

In this prospective study, breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.

The standard of care (blue dye) will be used for clinical care while the OnLume Imaging System is being used to determine feasibility of the product.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node biopsy or axillary lymph node dissection
* Surgery at University of Wisconsin Hospital and Clinic

Exclusion Criteria:

* Pregnant or breast feeding
* Unable to provide informed consent
* Allergy to indocyanine green
* Patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or without axillary lymph node dissection, after neoadjuvant chemotherapy
Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 to 65 years of age
* EASI score ≤ 21 at baseline
* Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
* BSA affected by AD: 5% to 20% at start of treatment
* Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
* Willing and able to provide informed consent
* Use of adequate birth control, if of reproductive potential and sexually active

Exclusion Criteria:

* Widespread AD requiring systemic therapy
* Use of any of the following treatments within the specified time periods prior to Day 1
* Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
* Systemic agents (cyclosporine, systemic corticosteroids \[oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study\], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs \[e.g., methotrexate, cyclophosphamide, azathioprine\], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
* Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
* Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1
* Antihistamines within 5 days prior to Day 1 \[stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed\]
* Active or potentially recurrent dermatologic condition other than AD that may confound evaluation
* Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)
* Known allergy to any ingredients of the investigational product formulation
* Significant confounding conditions as assessed by Investigator
* Any condition that could interfere with any evaluation in the study
* Pregnancy or breast feeding
* Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial
Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase in the Treatment of Classical Infantile Pompe Disease

Pompe disease is caused by a deficiency of a critical enzyme in the body called acid alpha glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In infants with severe cases of Pompe disease (called Classical Infantile Pompe disease), an excessive amount of glycogen accumulates and is stored in various tissues, especially heart, skeletal muscle, and liver, which prevents their normal function. This study being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for Pompe disease. Patients diagnosed with Classical Infantile Pompe disease who have a small, but inactive, amount of natural GAA enzyme present in their bodies (called Cross-Reacting Immunologic Material-Positive or "CRIM (+)" patients), will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Classical Infantile Pompe Disease
* endogenous GAA activity \< 1.0%
* cardiomegaly
* cardiomyopathy
* CRIM (+)
* ability to comply with the clinical protocol which will require extensive clinical evaluations

Exclusion Criteria:

* respiratory insufficiency
* cardiac failure
* major congenital abnormality
* any other medical condition that could potentially decrease survival
* CRIM (-)
The Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity

Our aim in this study is to translate the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors that facilitate and prevent individuals for physical activity for patients with inflammatory arthritis into Turkish language. Also, our aim is to evaluate the validity and reliability of the IFAB Questionnaire in the Turkish population, and to perform a cultural adaptation if necessary at the same time. Determining the factors that facilitate and prevent individuals for physical activity interventions with rheumatic diseases and then designing physical activity programs considering these factors may play an important role in reducing the symptoms caused by the disease and increasing their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist
* To have the neurological competence and cognitive level to answer the scale questions.

Exclusion Criteria:

* Having a rheumatological disease other than Axial Spondyloarthritis ,
* Using an assistive device for walking.
* Any verbal or written communication problems in Turkish,
Results of the Treatment of Patients With Elbow Osteoarthritis

The study is a prospective case controlled clinical trial. The purpose of the study is to investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow when compared to conservative treatment.

Patients will be recruited at departments of hand surgery and orthopedic surgery outpatient clinics. The control group will be patients to whom the conservative treatment continues. Patients who meet the inclusion criteria will be asked to participate and sign the informed consent. Therefore the investigators have two treatment groups: group 1 who receives an elbow joint debridement arthroscopically without physiotherapy and group 2 who receives only conservative treatment with physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic post-traumatic or primary osteoarthritis - mechanical locking and/or decreased range of motion ( \>30°)
* Radiographic evidence of at least mild primary or post-traumatic osteoarthritis according to Broberg - Morrey classification symptoms lasting at least 6 months
* Patients willingness to participate the study
* All patients 18-80 ages

Exclusion Criteria:

* Patients with previous severe soft tissue trauma at elbow region ( crush, burns etc - the elbow joint problems are not joint specific)
* Patients with crystal arthropathy or inflammatory arthritis
* Patient refuses to participate the study
* Patients with dementia or are institutionalized
* Patients with severe substance addiction
* Patient does not understand written and spoken guidance
Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

Acute pancreatitis is a complex gastrointestinal disease with a variable course that is often difficult to predict early in its development. The majority of cases are mild, self-limited, and follow an uncomplicated course. However, 10-20% of cases can be associated with pancreatic or peripancreatic fluid collections, or both. Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with a mortality of 15-20%. Current guidelines for necrotizing pancreatitis recommend to postpone drainage until 4 or more weeks after initial presentation to allow collections to "walled-off". However, evidence of infection with clinical deterioration despite maximum support may mandate earlier intervention. It is unclear whether such delay is needed for drainage or whether earlier endoscopic intervention could actually be beneficial in the current approach. The aims of this randomized, controlled, multicenter study is to evaluate whether early endoscopic drainage in patients with peripancreatic fluid collection is superior to postponed intervention in the current practice.

EUS guided drainage is now the preferred route for peripancreatic fluid collections (PFC). It belongs to transmural drainage and is accomplished by creating a fistula and placing a stent between the gastric or duodenal lumen and the PFC. The size of the PFC and percentage of solid debris were noted prior to puncture, and the optimal site of transluminal puncture was identified using EUS. Participants will be randomly allocated to either the intervention or the control group. Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. The follow-up duration is 6 months from randomization. All patients undergo imaging (contrast enhanced computed tomography) at 3- and 6-months post randomization.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with PFC;
* All patients with PFC will be screened for eligibility including a protocolized approach;
* Patients admitted within 72 hours of onset

Exclusion Criteria:

* More than 30 days after onset of acute pancreatitis
* Pregnant women
* Documented chronic pancreatitis
* Inability to gave informed consent