cyrilzakka/clinical-trials huggingface dataset:
Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers

The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.

The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent obtained prior to study entry
* healthy adults aged between 18 and 65 years
* no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
* In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception

Exclusion Criteria:

* History of autoimmune diseases and malignancies
* Active or passive vaccination 4 weeks before and during the entire study protocol
* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* History of severe hypersensitivity reactions and anaphylaxis
* Known hypersensitivity or allergic reactions to one of the components of the vaccine
* Clinically significant diseases as judged by the investigator
* Immunodeficiency due to immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Dry eyes is multi-factorial disease which inflammation play etiological role. Diacerein is drug which has anti-inflammatory effect by antagonist Interleukin-1, decrease Interleukin-1 receptor, increase Interleukin-1 Receptor antagonist. This observational study enrolled participants who going to take diacerein for osteoarthritis, measure corneal staining score, Ocular surface disease index score, Tear Osmolarity, Tear break up time, Schirmer 1 test, Interleukin-1 Receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear at the time of enrollment and after 2 months.


Eligibility Criteria:
Inclusion Criteria:

1. Osteoarthritis with
2. Ocular surface index score ≥ 13 with
3. Corneal staining score ≥ 3

Exclusion Criteria:

1. Allergic to diacerein
2. Use Cyclosporin within 30 days
3. Eyelid problem
4. Change artificial tear while in the study
5. Pregnancy or breast feeding
The PCOS Challenge Study

The primary purpose of The PCOS Challenge Study will be to conduct high-quality research where patients are included in the design, and answering the questions that patients identify as important to their lived experience with PCOS. In partnership with clinical investigators, patients will work on the development and management of data collection, the research agenda, and the sharing of research findings. The PCOSC Study will promote the advancement of research that provides reliable, useful, and meaningful information to patients with PCOS and their clinicians.

The population for The PCOS Challenge Study will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PCOS by a health professional, self-diagnosed with PCOS or individuals with PCOS symptoms
* Willing to sign the consent form
* Able to understand the registry surveys or what is being asked

Exclusion Criteria:

* Unable to understand the surveys or what is being asked
* Unwilling to sign the consent form
Impedance Threshold Device Tilt Study

This study will see if a special piece of equipment can help burn patients who have been in bed for a long time to get out of bed without feeling dizzy or faint.

To measure stroke volume, cardiac output, arterial blood pressure and cerebral blood flow velocity in human patients while they undergo exposure to head-up tilt that is designed to test their tolerance to an orthostatic challenge.

Eligibility Criteria:
Inclusion Criteria:

* Military or civilian males or females between the ages of 18-65 years
* Burn injury with at least one unburned finger for Portapres measurement
* Minimum of 96 hours bedrest or physician directive to tilt

Exclusion Criteria:

* Age \< 18 and \> 65 years
* Facial burns when application of ITD device would cause further trauma
* Medical monitoring devices that preclude the use of the ITD
* Signs of cardiac abnormalities, autonomic dysfunction
* Chronic obstructive pulmonary disease (COPD), or any other respiratory limitations (ventilator dependent, intubated, tracheostomy) limiting use of ITD
* History of pre-syncopal/syncopal episodes or orthostatic hypotension
* History of atherosclerotic coronary heart disease
* Patients taking any kind of cardiovascular pressor medications
* Inability to obtain a Portapres pulse wave validated by blood pressure cuff with +/- 5mmHg diastolic blood pressure
* Unable to provide informed consent for self
Vitamin D Absorbance Study - Clinical Trial of the Absorbance of Nano Liquid D3

Vitamin D is a commonly available essential prohormone humans need to regulate blood calcium and has recently emerged as potentially helpful in combating severe COVID-19. Despite its importance, some studies estimate as much as 40% of the US population is deficient in vitamin D. Most available vitamin D supplements have little absorption data and are nearly all softgels or capsules. This clinical trial is designed as a preliminary pharmacokinetics study to assess the absorbance of a nano liquid D3 supplement that can be taken as an oral spray once daily. Preliminary evidence suggests that this nano liquid D3 may be absorbed more readily than commercially available softgel dosage forms of D3. This randomized, double-blind, placebo-controlled trial will compare nano liquid D3 to commonly available D3 oral softgels and a placebo control group over the course of a thirty-one (31) day study period.


Eligibility Criteria:
Inclusion Criteria:

* Adults, ages 18-70 years old
* Either male or female
* Taking less than 2,000 IU of vitamin D daily as a supplement during the 30 days before starting the study
* Ability to swallow a pill of typical size or a liquid less than 1 mL daily for 30 days
* Ability to speak, read, and understand English
* Access to smart phone or smart device with internet access for study-related communications
* Ability to do 3 at-home vitamin D finger prick blood tests on 3 separate days. The kits and supplies will be given to you.
* Ability to drop off finished blood tests at a UPS store or UPS drop box, or schedule a UPS pickup at your home, on each of the same days as you do the blood tests

Exclusion Criteria:

* Females who are pregnant
* Taking, on average, more than 2,000 IU of vitamin D daily within 30 days before the study
* Currently have COVID-19 infection
* History of COVID-19 infection or positive COVID-19 test in last 60 days
* People with a diagnosis of Cystic Fibrosis
* People with a diagnosis of Crohn's Disease
* People diagnosed with Celiac Disease
* People with known diagnosis or history of any kidney related disease Including, but not limited to: Chronic kidney disease; End stage renal disease; Polycystic kidney disease; Lupus nephritis; Kidney cancer, Alport syndrome; Amyloidosis; Goodpasture syndrome; and Wegener's granulomatosis
* People with known diagnosis or history of any liver related disease Including, but not limited to: Hepatitis A; Hepatitis B; Hepatitis C; Fatty liver disease; Cirrhosis of the liver; Liver cancer; Hemochromatosis; Wilson disease
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion

The aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.


Eligibility Criteria:
Inclusion Criteria:

* children with otitis media with effusion
* children with adenoid hypertrophy

Exclusion Criteria:

* no patients with trisomy 21
Differences in Postprandial Glucose Changes

Following a meal, in nondiabetic individuals, blood glucose rises to peak at 1hr and returns to baseline in 2 - 3 hours. In T2DM, this peak is higher and prolonged. Meal plans for persons with T2DM should comprise evenly spaced, complex carbohydrate portions in order to avoid post-prandial glucose spikes. Researchers have developed an expanded line of Caribbean-flavoured, low-calorie meal-replacement shakes which have been formulated to match the macronutrient and caloric content of a commercially available brand. In this trial investigators aim to (1) examine the change in glucose levels post intake of Caribbean vs the commercially available brand and (2) to conduct a comparative sensory analysis of the two shakes.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of T2DM for any length of time,
2. last HbA1C (within the last 6 months) of \< / = 8%

Exclusion Criteria:

1. On insulin for any length of time
Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery

As postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. This statement is associated with prolonged hospital stays by increasing morbidity. We wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Undergoing elective pituitery tumor removal surgery

Exclusion Criteria:

* \>II ASA scores
* Using antidepressant agents
* Patient refusal
* Mental diseases
Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease

This is a phase II open-label study of the activity and safety of trastuzumab in patients with vulvar Paget's disease with overexpression of HER2 on biopsy.

The primary objective will be to estimate the anti-tumor activity of trastuzumab by evaluating the response to trastuzumab therapy in patients with recurrent or persistent vulvar Paget's disease demonstrating HER2/neu overexpression by immunohistochemistry and/ or FISH ((fluorescence in situ hybridization).

The secondary objectives:

* To evaluate the quality of life, based on the severity of the patients' vulvar itching on a 4-point verbal rating scale from 0 to 3 (0=no itching, 1=mild itching/ bothersome, 2=moderate itching/ troublesome, 3=severe itching/ extremely troublesome) as well as on the severity of the patients' vulvar pain on a numeric pain scale from 0-10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain).
* To assess the frequency and severity of observed adverse effects
* To assess the frequency/ incidence of HER2 in Paget's disease of the vulva

Eligibility Criteria:
Inclusion Criteria:

* recurrent or persistent vulvar Paget's disease with overexpression of HER2 by immunohistochemistry and or fluorescence in situ hybridization (FISH)
* Biopsy for histologic confirmation
* Measurable disease
* Karnofsky score of 50-100
* recovered from effects of recent surgery, radiotherapy, or chemotherapy
* free of active infection requiring antibiotics
* adequate bone marrow function,renal function,hepatic function,cardiac function,WOCBP-neg.serum pregnancy,meet requirements in section 7.0

Exclusion Criteria:

* no measurable disease
* tumors not HER2 positive by immunohistochemistry FISH
* prior therapy with any anti-HER2 monoclonal antibody preparation
* Karnofsky score of 0-40
* other invasive malignancies, with the exception of non-melanoma skin cancer
* Patients requiring supplemental oxygen
* unstable medical conditions in the opinion of the treating physician place them at unacceptably increased risk from trastuzumab therapy
* Patients with active or unstable cardiac disease, or myocardial infarction within 6 months
Evaluation of Eflornithine on Facial and Forearm Skin

The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms


Eligibility Criteria:
Inclusion Criteria:

* Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair
* Women of childbearing potential must agree to use an effective form of birth control for the duration of the study
* Skin type I-IV
* Customary frequency of removal of facial hair two or more times per week

Exclusion Criteria:

* Pregnant or lactating women
* Severe inflammatory acne or presence of significant scarring on the face
* History of skin malignancy
* Connective tissue disorders
Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup

Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. At present, no validated instrument is available for the assessment of the symptom responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have previously conducted focus group sessions and cognitive interviews in PDS patients to identify all relevant symptom items that characterize PDS. In this study we aim to validate the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its consistency, reliability and ability to detect change in the framework of a controlled treatment trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see appendix 1B)
* Patients must provide witnessed written informed consent prior to any study procedures being performed
* Patients aged between 18 and 70 years inclusive
* Male or female patients
* Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements

Exclusion Criteria:

* Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
* Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). Patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline) during the last 3 months are eligible.
* Females who are pregnant or lactating.
* Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months.
* Patients suffering from diabetes type 1 or type 2.
* Patients taking medication for functional dyspepsia will need a wash-out period of 2 weeks before they can be screened
* Patients with known hypersensitivity to gastroprokinetic drugs.
* Patients with confirmed gastro-intestinal disease.
* Patients with former digestive surgery affecting upper gut motility.
* Patients affected by concomitant disease responsible for digestive symptoms
* Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
* Patients presenting symptoms of EPS several times a week according to Rome III questionnaire
* Patients presenting daily symptoms of CIN on Rome III questionnaire
* Patients presenting vomiting more than one day a month.
* Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire
* Patients presenting predominant GERD according to GERD questionnaire
Mechanisms and Management of Infant Dysphagia

The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known. In this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the stomach and that help protect an infants airway.

Infants with chronic feeding difficulties exhibit inadequacy of suck-swallow and breathe coordination, regurgitation or vomiting, gastroesophageal reflux disease, and airway aspiration. Often these infants must rely on feeding tubes, either inserted through the nose or surgically placed, to meet their nutrition and hydration needs until they are able to orally feed safely, effectively, and efficiently. The process of assessment and treatment of swallowing disorders is often stressful for the infants and their providers, including parents. The goal of this study is to combine two commonly used diagnostic techniques (video fluoroscopy swallow studies and esophageal manometry) to more comprehensively evaluate feeding from the mouth to the stomach in infants. The hope is that by doing so treatment strategies can be improved.

: Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. The data is from single center prospective observational study. The controls are those who had VFSS alone with provider recommendations from the same single center.

In addition, we are also embarking on alternate strategies to achieve the original stated aims: 1) Mechanisms of dysphagia is ascertained by studying concurrent recordings of VFSS and manometry. 2) Feeding outcomes of Dysphagic infants are ascertained by evaluating the discharge outcomes and 1-year feeding outcomes among those that had evaluation of dysphagia using VFSS. 3) Dysphagic infants that had sequential VFSS and manometry studies are evaluated to test which method is a better predictor of stated outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Infants with feeding-related aero-digestive symptoms
* ≤60 weeks PMA (both pre-term and full term)
* History of orally feeding ≥ 25% of least 50% of prescribed feeding volume
* Room air or supplemental oxygen of ≤1liter/minute (LPM)

Exclusion Criteria:

* Direct breast feeding exclusively
* Known genetic, metabolic or syndromic disease
* Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), moderate to severe perinatal asphyxia or stroke
* Craniofacial, airway or foregut malformations
* History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery
Infant Feeding Study.09-68

Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.

The long range purpose of this pilot study is to inform the development of an NIH-funded randomized intervention trial designed to improve early breastfeeding outcomes for mothers planning to breastfeed. The purpose of the pilot study is to 1) described the prenatal infant feeding attitudes and intentions of population-based sample of expectant mothers from the same recruitment base as the future intervention trial, 2) characterize the metabolic health profiles of the sample and 3) estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* First-time expectant mother, speaks English, receiving OB care at designated practice group

Exclusion Criteria:

* 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery
Promoting Cervical Cancer Screening Through the Advocacy of Screened Women

This study pilots a 7-session group intervention among 40 screened women, 20 of whom will be randomly assigned to take part in the intervention, and 20 to the wait-list control. Assessments will be administered at baseline and month 6 to index participants as well as up to three unscreened female social network members of each index participant (up to 120 total). The primary outcome is CC screening among participating social network members.

Cervical cancer (CC) is the most common cancer and accounts for \~25% of all cancer related deaths among women in Uganda, which has one of the highest incidence rates in the world. Adding to the burden is the general lack of knowledge about, and social stigma towards CC and its screening in Uganda, where lifetime CC screening is estimated to be as low as 5%. There is a dire need to increase CC screening in Uganda to ensure timely and lifesaving treatment, as well as the need to enhance the capacity to conduct behavioral and health services research related to CC and other stigmatizing conditions among local researchers and service providers. Accordingly, the proposed intervention pilot study seeks to (1) empower women who have been screened for CC, to advocate for CC screening and early treatment among women in their social networks, and (2) engage and train local public health researchers and programmers. The proposed intervention draws on theories of social diffusion, cognitive consistency, and social influence, and the investigator's recently developed and tested group intervention that mobilized people living with HIV in Uganda to successfully act as change agents for HIV prevention within their social networks. The intervention actively targets internalized stigma, disclosure decision making, healthy living, and advocacy communication skills. This study will pilot the intervention among 40 screened women, 20 of whom will be randomly assigned to take part in the intervention, and 20 to the wait-list control. Assessments will be administered at baseline and month 6 to index participants as well as up to three unscreened female social network members of each index participant (up to 120 total). The primary outcome is CC screening among participating social network members. The primary aims of the study are to assess the feasibility, acceptability and preliminary efficacy of the group intervention to promote CC screening and treatment; identify characteristics associated with successful advocacy; and increase local capacity for conducting public health research on CC control and use of social network-based intervention and measurement methods.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* has been previously screened for cervical cancer
* has told at least one woman in her social network about her cervical cancer screening experience

Exclusion Criteria:

* unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study)