cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.

Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment.

Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.

Eligibility Criteria:
Inclusion Criteria (Patients):

* history of taking arsenic contaminated water (\>50 ppb) for more than 6 months
* patients having mild to moderate arsenical keratosis present on palm of the hand
* patients those voluntarily agree to participate

Inclusion Criteria (Arsenic exposed controls):

* family member of the patient
* drinking arsenic contaminated water from the same source as patient
* those voluntarily agree to participate
* no sign/symptom of palmer keratosis

Inclusion Criteria (Healthy volunteers):

* drinking arsenic safe water (\<50 ppb)
* those voluntarily agree to participate

Exclusion Criteria:

* pregnancy
* lactating mother
* patient receiving treatment of arsenicosis
* any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla

This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age on the day of signing informed consent.
* Karnofsky performance \>70%
* Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.
* Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.
* Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
* Be within 28 days post-HSCT at the time of enrollment.
* Be able to comply with medical recommendations or follow-up.
* Has adequate organ functions determined by

  1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
  2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
  3. ALT or AST ≤200 IU/ml for adults.
  4. Conjugated (direct) bilirubin \< 2x upper limit of normal.
  5. Left ventricular ejection fraction ≥40%.
  6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.

Exclusion Criteria:

* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
* Received within 7 days prior to screening or plans to receive during the study any of the following:

  1. Ganciclovir
  2. Valganciclovir
  3. Foscarnet
  4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day)
  5. Valacyclovir (\> 3000 mg/day)
  6. Famciclovir (\> 1500 mg/day)
* Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
* Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
* Has an uncontrolled infection on the day of randomization.
* Requires mechanical ventilation or is hemodynamically unstable at the time of randomization.
Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest.

Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.

This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \< 18 years of age on admission to the cardiac intensive care unit following cardiac surgery with a predicted probability of supraventricular tachycardia \>10%

Exclusion Criteria:

* Patients following orthotopic heart transplant, ventricular assist device implantation, primary extracorporeal membrane oxygenation cannulation, pacemaker or implantable cardioverter-defibrillator implantation or sympathectomy
* Patients on antiarrhythmic medication at the time of surgery
* Patients with atrioventricular conduction disease (1st degree atrioventricular block with PR interval greater than 200 ms, 2nd degree atrioventricular block or complete heart block)
* Patients with severe ventricular dysfunction in whom therapy with beta-blocker or sotalol is deemed contra-indicated by the primary team
* Patients with absent or non-functioning atrial pacing wires
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.

The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older, that signed informed consent
* Proliferative diabetic retinopathy with indication for panretinal photocoagulation

Exclusion Criteria:

* Previous retinal photocoagulation
* Previous ocular surgical procedures
* Ocular media opacities
* History of trigeminal neuralgia
* Chronic ocular pain
* Depression under conductual or medical treatment
A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients

Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 to 1.
* Life expectancy of more than 12 weeks.
* Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
* Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
* Subjects who have overall good overall general condition.
* Signed informed consent.

Exclusion Criteria:

* Subjects who received any previous treatment with any PARP inhibitors.
* Subjects who received any previous treatment with any taxanes.
* More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
* Less than 4 weeks from the last clinical trial.
* Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
* Unstable hypertension.
* Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
* Subjects with brain metastases.
* Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
* Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of the excipients of the product.
* Ongoing infection (determined by investigator).
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
* Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
* Pregnant or breast-feeding women.
PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia

The study investigates the safety of discharge from the Post-Anesthesia Care Unit (PACU) without assessment of motorfunction after spinal anesthesia for total hip- or knee replacement. This is an randomized controlled trial between two groups with assessment of normal (Aldrete) PACU discharge criteria with or without assessment of the motorfunction. The study hypothesis is that it is safe to be discharged from the PACU to a ward without assessment of motor function.

The main outcome is length of hospial stay (LOS) in days and re-admission within the first 30 days after surgery .

Secondary outcomes include adverse events up to 24 hours after surgery, and minuttes spent in the PACU after surgery.

Participants will be monitores for adverse events for the first 24 hours after surgery and reported. The total number of minuttes spent in the PACU will be recorded and reported.

A novel analysis of the latest database version was performed 06.04.2015, showing that 86.7% of patients have LOS of less than 5 days and no re-admission within the first 30 days after discharge.

The study is designed as a non-inferiority study with a two-sided 5% significance level, 80% power and a non-inferiority level of 5%, resulting in 2 x 725 patients (1500 in total including drop-outs).

A 30-day re-admission period was chosen to detect complications that could be assumed to have occurred as a consequence of the potential earlier PACU discharge The study will also investigate Length of stay, incidence of failed anesthesia, and reason for stay in PACU after THA and TKA 24.11.2016 A substudy based upon the un-published data from the time in PACU will be performed to analyse factors related to adverse events occuring during the PACU stay, and description of specific organdysfunction based upon the recordings from the modifed Aldrete discharge criteria.

Preoperative demographic data are collected from charts and the Lundbeck Centre for Fast-track Hip and Knee Replacement database, (LCDB), intraoperative data from anesthesia charts.

A logistic regression analysis will be performed with the YES/NO outcome of moderate/severe adverse PACU events at any time during PACU stay, and pre- and intr operatie variables.

Eligibility Criteria:
Inclusion Criteria:

* age 18 yr or more
* primary unilateral total hip or knee arthroplasty
* spinal anesthesia

Exclusion Criteria:

* intraoperative conversion to general anesthesia
* intraoperative bleeding exceeding 750 ml.
Inflammatory Mediators in Obstructive Sleep Apnoea Syndrome; Mechanisms of Production and the Effect of Long Term Antioxidants Administration

Obstructive Sleep Apnea Syndrome (OSAS) is associated with elevated plasma levels of IL-6 and TNF-α, which cannot be accounted for by obesity (Vgontzas et al Sleep Med Rev 2005;9:211-24, Ciftci et al Cytokine 2004;28:87-91\].

Obstructive apneas-hypopneas are accompanied by strenuous diaphragmatic contractions before the ensuing arousals and re-establishment of airway patency. We have shown that strenuous diaphragmatic contractions induced by resistive loading lead to elevated plasma levels of IL-6, TNF-α, and IL-1β (Vassi-lakopoulos et al AJRCCM 2002;166:1572-8) with concomitant up-regulation of the cytokines within the diaphragmatic myofibers (Vassilakopoulos et al AJRCCM 2004;170:154-61).

OSAS patients exhibit frequent episodes of hypoxemia during the night. Loaded breathing is a form exercise for the respiratory muscles, and both acute and chronic hypoxia lead to an augmented plasma IL-6 response to exercise compared to normoxia (Lundby et al Eur J Appl Physiol 2004;91:88-93).

In OSAS, monocytes have oxidative stress (Dyugovskaya et al AJRCCM 2002;165:934-9) and produce more cytokines (TNF-α) in vitro (Minoguchi et al Chest 204;126:1473-9).

Hypothesis #1: plasma levels of IL-6 and TNF-α are increased during the night in OSAS patients secondary to the intermittent strenuous diaphragmatic contractions and the episodes of hypoxia-reoxygenation associated with the obstructive apneas-hypopneas.

Hypothesis #2: monocytes from sleep apnea patients, exhibit augmented intracellular expression of IL-6 and TNF-α during the night.

Hypothesis #3: Oxidative stress is a stimulus for cytokine upregulation in OSAS.


Eligibility Criteria:
Inclusion Criteria:

* Obstructive Sleep Apnea Syndrome diagnosis

Exclusion Criteria:

* narcolepsy or idiopathic hypersomnia
* chronic obstructive disease,
* neuromuscular or endocrinological disease,
* autoimmune systemic disease,
* psychological disorders,
* use of non steroids antinflammatory drugs,
* use of cortisone drugs,
* recent or concomitant systemic infections
* upper or lower airway infections
Facial Hair, PPE and COVID-19

An observational cross sectional questionnaire study looking into facial hair of hospital doctors during the COVID-19 pandemic, and how personal protective equipment guidance has affected this.

COVID-19 is a highly contagious virus which has caused a global pandemic. There have been significant health consequences for healthcare workers, which may be related to the provision of personal protective equipment (PPE). Following PPE guidance is a significant health and safety concern, under which facial hair guidance for tight fitting masks falls.

This has implications as FFP3 masks are not the only form of PPE for the face, and this study may highlight a need for employers to diversify which PPE they supply to their employees, such as full hoods if staff need to maintain facial hair for cultural or religious reasons.

As such, facial hair has potential implications for patient safety, but also these have to be balanced with personal or religious reasons for maintaining facial hair. Our study aimed to determine the facial hair styles of hospital doctors, and reasons for maintaining them during the COVID-19 pandemic. We also looked at whether these styles adhered to the PPE guidance set about by Public Health England (PHE)

Eligibility Criteria:
Inclusion Criteria:

All hospital doctors working at the main site at Royal Cornwall Hospital between January and April 2020 were included in the study population. This includes all genders and ethnicities.

Exclusion Criteria:

The principle exclusion criteria were those who did not work at the Royal Cornwall Hospital main site. Also, while not forming part of the exclusion criteria, those who are unable to grow facial hair were excluded from the statistical analyses.
Nurse-Led BBTi for Post-stroke Insomnia

The current study aims to compare face-to-face and internet-based nurse-led BBTI compare to a wait-list conditions in the stroke population. This study is a parallel, three-arm, randomized controlled trial (RCT). Each participant will be randomized into one of the treatment arms; face-to-face BBTI, internet-based BBTI, and waiting-list. The BBTI, emphasizes behavioral aspects of insomnia care, arises from techniques of sleep restriction and stimulus control. The face-to-face and internet-based BBTI have equivalent content based on the standard portion. All participants will be asked to fill the online questionnaires at weeks 0 (baseline), 1 (mid-treatment), 2 (post-treatment), 4, and 12 (follow up). After the final follow-up, the waiting-list participants will be allowed to join the internet-based BBTI treatment. Our hypotheses are that patients with stroke who receive face-to-face or internet-based BBTI, compared to a wait-list condition, will experience fewer insomnia complaints.

Post-stroke insomnia is a common complaint with prevalence rates remain high. Patients suffering from insomnia following stroke could impair their health-related quality of life and negative rehabilitation outcomes. Identifying effective treatment in managing post-stroke insomnia has become clinically relevant.

Brief behavioral therapy for insomnia (BBTI), a 4-section of treatment for insomnia, has similar treatment components with CBTI, with the exception of cognitive therapy. Previous evidence found that both BBTI and CBTI have comparable effects on improving sleep quality and consolidation. Existing literature has suggested that BBTI was effective on mitigating primary and comorbid insomnia. Nonetheless, thus far, no study has explored its effects in stroke population. Of note, BBTI still requires certain contact with therapists. To enhance the widespread dissemination of BBTI, it is important to establish the internet-based BBTI treatment model (more flexible time schedule) to target more populations with insomnia. The recent study of the online tailored BBTI has proven the comparable effects to reduce insomnia severity in the general population. However, no study investigates the efficacy of internet-based nurse-led BBTI in the stroke population.

Eligibility Criteria:
Inclusion Criteria:

* Had diagnosed with stroke for at least 3 months (chronic phase)
* Had NIHSS score \< 6
* Complain insomnia symptom based on the score of ISI\> 7
* Having sufficient cognitive function to complete tasks,
* Able to access to internet

Exclusion Criteria:

* The people receiving BBTI and other psychological treatment for insomnia
* Doing shift work
* Having psychiatric disorders
* Being pregnant or breastfeeding
* Having other sleep disorders (e.g., sleep apnea)
* Drugs or alcohol abuse,
* Serious or unstable medical condition prior to the study
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.

The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from April 2018 to March 2020. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). Experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the inform consent
* Sufficiently communicate in the Chinese language
* Be able to follow instructions
* Newly diagnosed oral cancer
* Spinal accessory shoulder dysfunction

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Cognitively impaired
* Central nervous disease
* Distant metastasis or recurrence
* A history of shoulder pain or known shoulder pathology
* Unable to communicate or comprehend the questionnaires
Anlotinib Combined With PD-1 Inhibitors for Advanced/Metastatic Esophageal Cancer

Efficacy and Safety of Anlotinib combined with PD-1 inhibitors as 2 or more lines treatment for Heavily Pretreated Patients With Advanced, Metastatic Squamous Cell Carcinoma of the Esophagus.

The APEC study is a multi-center, retrospective ,real-world study of anlotinib combined with PD-1 inhibitors for patients with histologically confirmed advanced and metastatic esophageal squamous cell carcinoma (ESCC) that progressed after 1or more lines of therapy, conducted at 8 sites in China. Patients received anlotinib combined with PD-1 inhibitors , every 3 weeks for up to 2 years, until progression of disease, unacceptable toxic effects occurred, or withdrawal of consent. The primary end point was the progression-free survival (PFS)among all patients. Secondary end points included Adverse events (AEs),objective response rate (ORR) ,duration of response (DOR), , and overall survival (OS). Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged more than 18 years old;
2. ECOG PS：0-2;
3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced esophageal squamous cell carcinoma(ESCC);
4. For local advanced or advanced ESCC, disease progression occurred after 1 or more lines systemic treatment previously;
5. Have received anlotinib combined with PD-1 inhibitor treatment.

Exclusion Criteria:

1. have used Anlotinib before;
2. mixed with small cell cancer and/or other kinds of cancer ;
3. Previously (within 5 years) or presently suffering from other malignancies;
4. Symptomatic or uncontrolled brain metastases;
5. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
6. Pregnancy or lactation. -
Evaluating an eHealth Breastfeeding Resource

This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers and their co-parents. Couples will be randomized to study groups and the intervention group will receive information about this resource or the control group will receive usual care. The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum.

This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers and their co-parents. Couples will be randomized to study groups and the intervention group will receive information about this resource with an online demonstration and weekly emails for 6 weeks reminding them about the resource. The control group will receive usual care and 6 weekly emails reminding them that they are in the study. The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum. Additional outcomes will include: breastfeeding initiation, duration, challenges, attitude, knowledge, confidence, anxiety, partners support and co-parenting.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, over 25 weeks pregnant, planning to breastfeed, lives with co-parent who is willing to participate, first time mother or mother who has not previously breastfed,

Exclusion Criteria:

* does not have access to the internet and telephone, does not reads and speaks English, does not lives in Ontario, Canada, is expecting more than one child with this pregnancy