cyrilzakka/clinical-trials huggingface dataset:
SMS Reminders for Positive FOBT Follow-up

A randomized controlled trial to examine the effect of 3 mobile telephone text message reminders on followup colonoscopy 120 days after a positive fecal occult blood test among Meuhedet members aged 50-74 who tested positive in 2016.

Background: Fecal occult blood tests are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer, but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation.

Objective: To examine the effectiveness of a short message service in increasing adherence to colonoscopy follow-up after a positive fecal occult blood test.

Methods: This randomized controlled trial was conducted with patients who had positive colorectal cancer screening results. Randomization was stratified by residential district and socioeconomic status. Subjects in the control group (n = 238) received routine care that included an alert to the physician regarding the positive Fecal occult blood test result. The intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their computerized medical records. Physicians of the study patients completed an attitude survey regarding FOBT as a screening test for colorectal cancer. The intervention and control groups were compared using chi-squared for discrete variables. Logistic regression was used to calculate odds ratios and 95% confidence intervals for performing colonoscopy within 120 days, adjusting for potential confounders of age, gender, socioeconomic status, district, ethnicity, intervention group and physician's attitude.

Eligibility Criteria:
Inclusion Criteria:

* positive fecal occult blood test (FOBT) in 2016
* agreed to receive SMS from healthcare provider

Exclusion Criteria:

* Existing oncology diagnosis
* personal or family history of colorectal cancer
* colonoscopy up to 10 years prior to FOBT
Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Stroke Survivors

The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

* Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors?
* Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 21 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

Stroke is happening increasingly more. The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:

* Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors?
* Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 21 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium.

This is a prospective, multi-center, single-arm, open-label, interventional Phase 4 clinical study and will be conducted across several sites in India.

The study consists of:

* Open-label treatment period: The open-label treatment period will be of 270 days during which 3 single doses of inclisiran sodium will be administered subcutaneously (SC) on Day 1, Day 90, and Day 270, respectively. On Day 1/Dose 1 visit, the patients will be assessed by the Investigator for their eligibility to receive inclisiran sodium based on their medical history and previous lipid test reports. The study treatment i.e., inclisiran sodium will be prescribed as per the latest India Prescribing Information (PI). The assignment of the participant to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the participant in the study.
* Safety follow-up period: The safety follow-up will be performed 30 days after each dose administration of the study treatment i.e., Day 30, Day 120, and Day 300. The follow-up on Day 30 and Day 120 visits will be conducted telephonically while Day 300 visit will be an onsite follow-up visit.

This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and New Drugs and Clinical Trials (NDCT) Rules, 2019 requirements.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female Indian participants aged ≥18 years or older.
2. Participants for whom the treating physician prescribes treatment with inclisiran sodium in adherence with the India PI i.e., patients who are diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:

   1. in combination with a statin or statin with other LLTs in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
   2. alone or in combination with other LLTs in patients who are intolerant to statins or for whom a statin is contraindicated.
3. Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.

Exclusion Criteria:

1. Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
2. Participants who have previous exposure to inclisiran sodium.
3. Pregnant or nursing (lactating) women.
Post-licensure Safety Study of IMOJEV® in Thailand

The aim of this study is to further characterize the safety profile of IMOJEV®.

Primary Objective:

* To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®.

Secondary Objective:

* To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.

Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Children requiring vaccination against Japanese encephalitis
* Children aged 9 months to less than 5 years on the day of inclusion
* In good general health at the time of inclusion
* Informed consent form has been signed and dated by the parent(s)/legal guardian(s)
* Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any additional visits that may need to be done in case of an SAE (including AESI), and are able to comply with all trial procedures
* The subject's parent(s)/legal guardian(s) have a telephone number at which they can be contacted throughout the study

Exclusion Criteria:

* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the vaccination
* Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination
* Planned participation in another clinical trial during the present trial period
* Children previously vaccinated with the live attenuated Japanese encephalitis vaccine CD-JEVAX® (SA14-14-2 LAV)
* Contraindications to vaccination according to the IMOJEV® Summary of Product Characteristics (SmPC)
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
* Children who received IMOJEV® as primary vaccination in this study.
Tezosentan in Patients With Pulmonary Arterial Hypertension

Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.


Eligibility Criteria:
Inclusion Criteria :

1. Signed informed consent prior to initiation of any study-mandated procedure
2. Male and female patients 18 years of age or older
3. Patients with PAH according to one of the following subgroups of the Dana Point Classification Group 1:

   * Idiopathic, or
   * Heritable, or
   * Associated with connective tissue disease
4. Documented hemodynamic diagnosis of PAH by right heart catheterization (not part of study mandated procedures):

   * Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
   * Resting mean pulmonary vascular resistance (PVR) ≥ 240 dyn•s•cm 5 and
   * Pulmonary capillary wedge pressure ≤ 15 mmHg
5. Modified NYHA functional class II-III
6. Patients on treatment with ERAs, PDE-5 inhibitors or a combination of both, if used for at least 3 months prior to Visit 1 and dosing kept stable for at least 28 days prior to Visit 1.

Exclusion Criteria :

1. Patients with PAH in Dana Point Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion No. 3
2. Patients with sitting SBP \< 100 mmHg
3. Patients with sitting DBP \< 60 mmHg
4. Patients with body weight \< 50 kg (110 lbs)
5. Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase \> 3 times upper limit)
6. Patients with clinically significant chronic renal insufficiency (serum creatinine \>2.5mg/dL / 221 µmol/L)
7. Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
8. Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of Visit 1
9. Patients who have received any investigational drugs within 28 days of Visit 1
10. Patients who have received cyclosporine A (CsA) or tacrolimus within 28 days of Visit 1
11. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
12. Life expectancy less than 12 months
13. Females who are lactating or pregnant (positive pre-treatment pregnancy tests) (serum test at Screening and urine test on Visit 1 and 2) or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after last administration of study drug
14. Known hypersensitivity to any of the excipients of the drug formulation.
A Study to Develop a Strategy to Increase Lung Cancer Screening in Women Who May Be at Risk for Lung Cancer

The purpose of this study is to develop a digital strategy to increase awareness about lung cancer screening among women who are eligible to receive it. The digital strategy involves email communications and LungTalk, a web-based (accessed through the Internet) health communication tool that uses text, audio, video, and animation to increase awareness and knowledge about lung cancer screening. This study will focus on women who have recently received a screening mammogram.


Eligibility Criteria:
Inclusion Criteria:

* LDCT screening-eligible women who received a BiRADS 1 (negative) or 2 (benign/non-cancerous finding) result from a screening mammogram in the last 7 days
* Age 50-80 years
* ≥ 20-pack-year smoking history of combustible cigarettes as per self report
* Women who currently smoke or quit within past 15 years as per self report
* Lung screening naïve as per self-report

Exclusion Criteria:

* Lung cancer diagnosis
* Chest CT within the last 12 months
Hormonal Sensitivity in Patients With Noonan and LEOPARD Syndromes

Noonan and LEOPARD syndromes share, with variable severity, different clinical traits, notably craniofacial manifestations, cardiopathies, short stature, and juvenile cancers.

The main genetic cause of these syndromes is missense mutation of the gene encoding the ubiquitous tyrosine phosphatase Shp2, found in more than half the patients with NS and in 80% of LS cases. Shp2 plays pivotal roles in development, growth, and metabolism by regulating key signalling pathways (Ras/Mitogen activated protein kinase (MAPK), Phosphoinositide-3 Kinases (PI3K)/Akt) in response to growth factors/hormones. Deregulation of these signalling pathways has been causally linked to NS and LS pathophysiology.

This project aims at better understanding hormonal sensitivity abnormalities in patients with Noonan syndrome (NS) or LEOPARD syndrome (LS) caused by mutations of the tyrosine phosphatase Shp2.

To reach this goal, the investigators will take advantage of different tissues (fibroblasts ± adipocytes) from patients with NS / LS compared to healthy controls.

All patients will have a skin biopsy and only patients about to undergo surgery will have a adipose tissue biopsy.

The activation of different signaling pathways (Ras/MAPK, PI3K/Akt) in response to growth factors/hormones (growth hormone, insulin) in fibroblasts and/or in adipocytes from patients with NS or LS will be compared to those of healthy subjects.

These data will be correlated to clinical, hormonal, and biochemical characteristics of patients

Eligibility Criteria:
Inclusion Criteria:

Patients with Noonan syndrome (NS) or LEOPARD syndrome (LS):

* female or male
* age between 5 to 15 years
* clinical diagnosis of NS or LS according to published criteria
* signed informed consent of parents

Healthy controls:

* female or male
* age between 5 to 15 years
* no personal history of syndrome or chronic disease
* planned surgical procedure
* signed informed consent of parents

Exclusion Criteria:

* age below 5 or above 15 years
* pregnancy

In healthy controls: syndromic or chronic disease
Study to Investigate the Influence of Compression Treatment in Patients With Pelvic Congestion Syndrome (PCS)

Pelvic vein embolization (PVE) is the current treatment procedure used to treat women with Pelvic Congestion Syndrome (PCS). This treatment is not widely available, and many women when diagnosed with PCS cannot afford treatment.

The purpose of this study is to assess whether compression therapy is an effective alternative treatment to PVE for women who are unwilling or unable to undergo treatment by PVE. Compression therapy would provide a cost-effective alternative to coil embolization.

Women that book a consultation and have a trans-vaginal ultrasound scan at The Whiteley Clinic which confirms a diagnosis of Pelvic Congestion Syndrome (PCS) will be informed about the opportunity to participate in this study by their consultant (provided they also fulfil the inclusion/exclusion criteria). Potential participants will be given an information sheet and time to consider the study before giving written informed consent.

These women will be given a personalised pelvic vein embolization (PVE) treatment plan. Women that opt for PVE will form the control group for this study. Women that do not wish to have PVE and opt compression therapy will form the intervention group for this study. Alternatively, women may wish to not have any treatment and will not be enrolled in the study.

Each patient will be directly involved in the study for three months (Month 1, Month 2, Month 3). A quality of life and symptom questionnaire will be completed by all patients at the start of Month 1 (baseline), at the end of Month 2 (1-month post PVE or compression therapy), and at the end of Month 3.

Eligibility Criteria:
Inclusion Criteria

* Females aged 18 - 65 years
* Having one or more symptoms of PCS
* Symptoms: Aching / dragging in pelvis on sitting and/or standing, aching/tender /painful vulval varicose veins, irritable bowel, irritable bladder, deep dyspareunia, low back pain, hip pain with no or very mild changes on hip x-ray.
* Able to understand study and give written consent.
* Able to have trans-vaginal ultrasound scan and attend for follow-up.

Exclusion Criteria

* Under 18 years of age or over 65 years of age
* Currently pregnant, actively trying to get pregnant, planning pregnancy within next 12 months or within 3 months of child-birth
* Current symptoms due to diagnosed gynaecological conditions
* Current or previous malignancy
* Unable or refuse to consent to trans-vaginal ultrasound scan or any other aspect of the study
* Previous abdominal or pelvic surgery (excluding diagnostic laparoscopy)
* Previous embolization of pelvic veins
* Previous deep vein thrombosis, pelvic embolisation, venous intervention in abdomen or pelvis (stent, filter)
* Any vascular malformation of the pelvis or the legs apart from that diagnosed as venous reflux disease.
* Any medical condition likely to cause death or serious ill health within the next five years.
* Any deep venous obstruction or reflux on duplex ultrasound.
* Unable to wear compression garments on lower abdomen / pelvis
* Unable to wear leg compression garments
Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer

The purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).

The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: Greene climacteric scale score, quality of life (MenQol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer
* thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day
* climateric simptoms
* age from 18 to 65 years
* spontaneous or caused by chemotherapy amenorrea
* hormone therapy for breast cancer
* Green climateric scale score = or \> of 15
* performance status Eastern Cooperative Oncology Group (ECOG) \< or = to 1
* the patient agrees to follow physical exercice
* diet and self-help groups

Exclusion Criteria:

* Hormone substitutive Therapy (TOS) during the last month
* other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy)
* chemotherapy or radiotherapy
* patients who refuses acupuncture
Lifestyle Modification Using an App in OSA

This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Adults aged \> 20 years with witnessed snoring or sleep apnea from a sleep clinic of a tertiary center were prospectively enrolled, and the participats were randomized into app user and control groups. The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. In the control group, the lifestyle modification performed as the usual practice. All participants underwent Watch PAT and body mass index (BMI) measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters of sleep related breathing were analyzed.


Eligibility Criteria:
Inclusion Criteria:

ᆞ patients must agree to participate in our clinical study ᆞ patients without severe cardiopulmonary disease ᆞ patients must be with BMI \> 23 Kg/m2

Exclusion Criteria:

ᆞ patients who did not agree ᆞ patients with severe cardiopulmonary disease ᆞpatients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ᆞ patients who were pregnant
Trial of Safety Nets In Hospitalized Patients

This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfaction of MD, nurse, and relatives of patients.


Eligibility Criteria:
Inclusion Criteria:

1. age more than 18
2. hospitalized
3. acute confusion or agitation

Exclusion Criteria:

1. Patients who require acute respiratory or cardiac support such as patients requiring ventilator support or patients in cardiac or septic shock
2. Patients who have a documented history of claustrophobia
3. Patients or family members who refuse to consent for safety net treatment under any circumstances. Failure to obtain consent due to absence of or inability to reach a family member or to give consent to participate in the study
4. Failure to obtain consent due to absence of or inability to reach a family member within reasonable time or to give consent to participate in the study.
5. Acutely ill patients requiring intravenous vasopressors, intubation or ventilatory support
6. Other conditions deemed terminal within 24 hours as determined by the patient's attending physician
7. Patients who stay less than 24 hours in the hospital
8. If patient is already on restrains for more than 48 hours preceding enrollment.
9. If two or more limbs are already on restraint to protect IV lines.
10. Extreme degree of agitation requiring continuous IV sedation or anesthesia. Such patients may pose a danger to staff or themselves if their restraints were to be discontinued in order to put them on study restraints.
11. When the intent of single wrist restraint is only to hold the IV line and patient is not agitated or in delirium.