cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Patients with PAH who completed study AC-055-401
* Women of childbearing potential must:
* Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
* Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Exclusion Criteria:

* Patients who prematurely discontinued study drug in study AC-055-401
* Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
* Known hypersensitivity to macitentan or its excipients or drugs of the same class
A Study of Gaboxadol in Primary Insomnia

To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia.

To compare hypnotic efficacy of gaboxadol with placebo in elderly outpatients with primary insomnia

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of primary insomnia
Trainee Involvement in ERCP Risk Score

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.

Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.

data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.

Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ERCP in the participating centers
* informed consent signed prior to the procedure

Exclusion Criteria:

* refusal to participate / sign the informed consent
Children's Deep Neck Infections at the Montpellier Hospital

To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage


Eligibility Criteria:
Inclusion criteria:

* under 18 years old
* hospitalized for acute pharyngeal infection ( cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses)

Exclusion criteria:

* neck infection in the context of immune deficiency
* malignancy or post-traumatic disease
* others deep neck infections: angina, otitis, sinusitis, ethmoiditis, mastoiditis.
Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Eligibility Criteria:
Inclusion Criteria:

* 35-75 hospitalized patients
* Patients with acute stroke ≤24h
* NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
* For the first time or always without obvious sequelae of stroke disease(mRS≤1）
* Informed consent

Exclusion Criteria:

* The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
* Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
* TIA
* Symptoms of disease rapidly improving during the randomized
* Severe hypertension(SBP \> 200 mmHg or DBP \>110 mmHg)
* Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance \<60ml/min）
* Severe system or viscera organic disease
* Have used other neuroprotectant or other experimental drugs
* Patient who are unlikely to complete the study that due to a severe clinical condition
* Pregnant or breast-feeding
* Participation in a previous clinical study within 30 days
* Meets all other exclusion criteria
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast

This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients.

The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively.

Pruritus score and satisfaction will be monitor along the entire course of cast retention.


Eligibility Criteria:
Inclusion Criteria:

* Fracture distal end radius treated conservatively

Exclusion Criteria:

* open fracture
* skin disease and wound under cast area
* Fracture distal end radius needed surgical management
* Allergy to baby talcum
Is Lipid Mapping an Effective Early Detection Tool for Breast Cancer in High-risk Populations?

This study aims to investigate if lipid composition mapping using magnetic resonance imaging could improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer. It is hypothesised that there is a significant difference in the extent of spatial variation in lipid composition in breast from MRI between genetic mutation carriers and patients with breast cancer.

Breast cancer is a major and expanding societal challenge despite the significant improvement in survival rate. The current screening method has been shown to lead to overtreatment, prompting the development of accurate early detection approaches targeting underlying clinical features. Patients with BRCA1/2 and TP53 genes are at risk of breast cancer and receive annual surveillance. However, the current diagnostic approach relies on detecting the changes to the growth of tumour only once cancer is well under development. Detecting earlier changes to breast fatty tissue may detect patients earlier and more accurately.

Breast fatty tissue is composed of different fatty acids and a difference in the fatty acid composition has been shown in BRCA1/2 gene carriers. Measurement of lipid composition can be achieved using a specialist magnetic resonance spectroscopy method, but is limited to sampling a small area and is unable to provide the full picture of lipid composition distribution during early cancer growth. Recently, magnetic resonance chemical shift imaging, through combining magnetic resonance spectroscopy and imaging approaches, has been developed to provide lipid composition maps of the entire breast.

The investigators propose to perform lipid mapping in the breasts of 20 genetic mutation carriers at high risk of breast cancer and 20 patients with newly diagnosed breast cancer to examine the sensitivity of the method. The overarching aim is to improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer through the assessment of whole breast lipid composition.

Eligibility Criteria:
Inclusion Criteria:

* female over 18 years old
* BRCA1/2 or TP53 gene carriers (high-risk group)
* invasive ductal carcinoma of the breast (patient group)
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)

Exclusion Criteria:

* female under 18 years old
* male
* affected by metabolic disorders (e.g., diabetes)
* on long term medications that affect lipid metabolism (e.g., statins)
* contraindicated for MR investigations (poor renal function and metal implants)
* concurrent cancer in other sites
* concurrent hormone treatment, chemotherapy or underwent surgery
* non-English speakers
Wired Mothers - Use of Mobile Phones to Improve Maternal and Neonatal Health in Zanzibar

Reducing maternal and newborn mortality remains a global challenge. Because obstetric complications cannot be predicted, skilled attendance at the time of delivery and access to emergency obstetric care remain the most effective strategies to reduce mortality. Antenatal care has the potential to reduce maternal morbidity and improve newborns survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. There is a rapidly expanding number of mobile phone users in developing countries and due to the potential to strengthen health system the use of mobile phones is health care is emerging. The investigators assessed a mobile phone intervention named "wired mothers" aimed to improve maternal and newborn health.

The hypothesis of the study was that the wired mothers mobile phone intervention would increase attendance to essential reproductive health services such as antenatal care and skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and newborn.

The objective of the study was to examine the effect of the wired mothers intervention on antenatal care, skilled delivery attendance, access to emergency obstetric care and perinatal mortality.

The study was a pragmatic cluster randomized controlled trial with the primary health care facility as the unit of randomization. The study took place in 2009-2010 on the island of Unguja in Zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected facilities were included at their first visit and followed until 42 days after delivery. Facilities were allocated by simple randomization to either mobile phone intervention (n=12) or standard care (n=12). The intervention consisted of a SMS and mobile phone voucher component.

The perspectives of the study are that mobile phones may contribute to saving the lives of women and their newborns and achievement of MDGs 4 and 5. Evidence is needed to guide maternal and child health policy makers in developing countries.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending antenatal care at one of 24 selected primary healthcare facilities

Exclusion Criteria:

* Missing end-of-study questionnaire
ONO-7913 Phase I Study (ONO-7913)

To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
2. ECOG Performance Status of 0-1
3. Patients with life expectancy of at least 3 months

Exclusion Criteria:

1. Patients with multiple cancers
2. Patients with history of serious allergy
Prospective Evaluation of a Fast-track Treatment Pathway for Patients With Chronic Hepatitis B Under Primary Care

This is a retrospective-prospective longitudinal cohort study, with analyses performed before and after introduction of the pathway, and comparisons made to unexposed controls. We will launch a protocol-driven management for CHB patients, and provide the appropriate assessment tools (transient elastography, HBV DNA assay) to general outpatient clinics (GOPC) in Hong Kong. Patients who fulfil treatment criteria will be referred to specialist outpatient clinics (SOPC) in a fast-track manner. We will also evaluate the linkage-to-care rate 3 years before the launch of this care pathway retrospectively.

Chronic viral hepatitis is the seventh leading cause of mortality globally, responsible for 1.45 million deaths in 2013. The consequences of chronic hepatitis B and C infection - cirrhosis and liver cancer - account for 94% of deaths associated with hepatitis.1 Liver cancer is the second most common cause of cancer death in the Asia-Pacific region. Approximately 78% of liver cancer cases are a result of chronic viral hepatitis.1,2 In Hong Kong, the positive rate of hepatitis B surface antigen (HBsAg) remains high among adults of productive ages of 31-40 and 41-50 years (5.2% and 7.2% respectively) in 2015.3 World Health Organization (WHO) published the first global health sector strategy on viral hepatitis in June 2016, a strategy that contributes to the proposed targets for the reduction of chronic viral hepatitis incidence and mortality of 90% and 65% respectively by 2030.4 The Chief Executive's 2017 Policy Address in Hong Kong asked to set up the Steering Committee to formulate strategies to effectively prevent and control viral hepatitis.5 The Steering Committee is currently reviewing local and international trends and developments in the prevention and control of viral hepatitis; advising the Government on policies and cost-effective targeted strategies for prevention and control of viral hepatitis; and conducting and coordinating the surveillance and evaluation of viral hepatitis control and recommending appropriate response.5 One of the key gaps in CHB management is the suboptimal treatment in patients who fulfil treatment criteria but not started on antiviral treatment because of linkage-to-care issue, namely very long waiting time (up to 2.5 years) from primary care setting like general outpatient clinics (GOPC). There are limited resources for specialized assessments (e.g. HBV DNA assays, transient elastography for liver fibrosis assessment).

Therefore a novel fast-track treatment pathway for patients with chronic hepatitis B under primary care would fill this gap and provide pivotal data to the Government and the Steering Committee to guide the strategies for achieving the goals set by WHO.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with positive hepatitis B surface antigen (HBsAg) for 6 months
* Under the care of GOPC

Exclusion Criteria:

* Age under 18
* Refusal to consent
Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure

The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be \> 18 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Facial pain or pressure for \> 3 months of symptom duration.
* Pain/pressure VAS (Visual Analogue Scale) Score of \> 5.

Exclusion Criteria:

* Upper respiratory illness within the last 2 weeks.
* History of severe epistaxis.
* Known pregnancy.
* Allergic sensitivity to silicone or any other component of device.
* Sinonasal surgery in the last 3 months.
* Topical decongestant use in the last week.
* Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
* Sinusitis on imaging.
* Nasal crusting or ulceration on exam.
* Inability to read or understand English.
Continuation Study for Latozinemab

Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

This is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study.

All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
* Has successfully completed participation in their parent latozinemab study.
* Female participants must be nonpregnant and nonlactating.
* Male participants must agree to acceptable contraception use.

Exclusion Criteria:

* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata

Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. The two agents have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. Topical prostaglandins like latanoprost have also been used for this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. However, the two agents i.e. topical corticosteroids and topical latanoprost have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

Eligibility Criteria:
Inclusion Criteria:

* • Cases of AA involving scalp and beard area, having 5 or less patches in all, involving less than 40% area

  * Stable disease without appearance of new patch or increase in size of existing patch for at least 15 days

Exclusion Criteria:

* • Pregnant and lactating women

  * Patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for alopecia in the past one month
  * Presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy) or latanoprost (pregnancy, lactation and dermatitis)
  * Any other coexisting hair disorder (viz., trichotillomania, androgenetic alopecia, telogen effluvium)
  * Extensive disease i.e. \>5 patches of AA or area involving \>40% area / alopecia totalis/ alopecia universalis/ ophiasis
Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate

The objective of the present study was to compare the effects of a commercially available dentifrice containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate versus a negative control dentifrice on removal of extrinsic stains.

There is great concern on the tooth esthetics and color among people, especially young adults. Great efforts have been made in order to improve patients' smile. Epidemiological studies have reported that dissatisfaction with tooth color ranged from 19.6% to 65.9%, depending on different population. An oral health related quality of life questionnaire for use among young adults reported that tooth color was the most important concern. This dissatisfaction with tooth color has been shown to be associated with increased desire for treatments that improve dental aesthetics including tooth whitening dentifrices. Tooth whitening products generally help to improve the overall whiteness of teeth, by removing and controlling the formation of extrinsic stains. In recent years the interest on the treatment of tooth stain with various tooth whitening agents, among which dentifrice containing high cleaning silica is widely used.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-70 years old
* Good general health
* Could attend the clinical examinations during the 8 week study period
* Possessing \>20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars
* Having a whole-mouth mean tooth stain score of more than 1.5 according to the Lobene index.

Exclusion Criteria:

* Severe oral diseases, chronic disease or allergic to the trial products
* Advanced periodontal diseases
* Females who are pregnant or lactating
* Taking part in other clinical trials
* Taking part in orthodontic treatment or wearing removable denture
* Fluorosis or tetracycline teeth
* Receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.
NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes

This study evaluates the intervention of Nut Fish based food, micro nutrients supplementation and pregnancy class to improve maternal and birth outcome. This is cluster randomized trial with two arms. The intervention group will receive Nut Fish based supplementation, multiple micro nutrients, and pregnancy class. The control group will receive government food supplementation, iron folic acid supplementation, and pregnancy class.

Objectives: To investigate whether a nut fish based food and dietary supplementation delivered to pregnant mothers with health education would benefit maternal and birth outcomes compared with the government standard of care.

Design. A randomized control trial will be implemented in rural community in Indonesia.

Intervention. The 2 trial arms will be control group (government standard of care) and intervention group with nut fish based food and dietary supplementation and health education series in the pregnancy class. A control group will receive government food supplementation package, Iron Folic acid pills and pregnancy class. An intervention group will receive NutFish based food supplementation, multiple micro nutrients, and pregnancy class. As a pilot study, all the intervention packages will be delivered by research team members.

Subjects. A total 72 first trimester of pregnant mothers will be enrolled with 36 pregnant mothers each group.

Outcome measures. Maternal outcome at 1 and 2 month after intervention namely weight increment, energy and protein intake, mid upper arm circumference, and complications. Birth outcomes include APGAR score, birth weight and length, preterm birth.

Analysis. Linear, logistic and multinomial logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* First trimester of pregnancy
* Anemic or Mid Upper Arm Circumference \< 23.5cm or no weight gain
* Plan to deliver at village midwives
* residence in the study area

Exclusion Criteria:

* severe anemia \< 7.0g/dl