cyrilzakka/clinical-trials huggingface dataset:
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults

The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.

The study is seeking for participants who:

* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.

The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.

In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.

During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.


Eligibility Criteria:
Key Eligibility criteria for this study include, but are not limited to the following:

Inclusion Criteria:

* Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

* Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome \[IBS\] or lactose intolerance).
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
* Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients

Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This research will admit a wide range of data on the clinical study experience of metastatic prostate cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of metastatic prostate cancer
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Enrolled in another research study
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Inability to provide written informed consent
Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus.

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for Gastroesophageal Reflux Disease.
* Age between 18 and 65 years.
* Confirmed tongue-pharyngeal nerve injury by electromyography.
* Esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia.
* Normal higher brain function, able to cooperate with treatment.

Exclusion Criteria:

* Brain vascular disease diagnosed.
* Clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders.
* Concurrent presence of other neurological disorders such as Alzheimer's disease, traumatic brain injury, Parkinson's disease.
* Esophageal obstruction and severe liver or kidney dysfunction
* Subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.
Efficacy of Artemisia Pollen Specific Allergen Immunotherapy

Allergic rhinitis (AR) is a noninfectious inflammatory disease of the nasal mucosa mediated by immunoglobulin E (IgE) after exposure to allergens. Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.

The trial is a randomized, Open label, multicentred trial. A total of 150 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and conversation drugs group.


Eligibility Criteria:
Inclusion Criteria:

* presence of seasonal rhinitis symptoms.
* the TNSS was higher than 6 scores in last autumn pollen season.
* artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) at least class 3, and higher than both of ragweed and Humulus IgE levels.
* patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
* patients who are able to understand the information given and the consent and complete the daily record card.

Exclusion Criteria:

* ulcers, inflammation or trauma in the sublingual part;
* oral diseases / oral allergies;
* had surgery within four weeks before screening evaluation;
* Continuous use of systemic glucocorticoids within four weeks before screening evaluation;
* Any history of severe systemic allergic reaction and eosinophilic esophagitis before screening evaluation;
* Suffering from perennial allergic rhinitis;
* Complicated with chronic rhinitis or sinusitis, nasal polyps;
* In the recent pollen season, rhinitis can be relieved without symptomatic treatment;
* Within 2 years before enrollment, diagnosed with a history of moderate and severe asthma or FEV1 less than 70% of the estimated value;
* Applying β Treatment with receptor blockers (including systemic and local drugs) or angiotensin converting enzyme (ACE) inhibitors;
* Participated in clinical trials of other drugs within one month; Receiving other pollen allergen specific immunotherapy;
* Pregnant and lactating women or those who have pregnancy planning within the past year;
* history of immunosuppressive disease (such as HIV infection history), history of malignancy, history of autoimmune diseases, history of pulmonary tuberculosis, cardiovascular dysfunction, or other serious diseases of other organ systems judged by researchers.
* received pollen allergen specific immunotherapy or are receiving allergen specific immunotherapy within three years.
Immunogenicity of Rotavirus Vaccine

Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:

1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.


Eligibility Criteria:
Inclusion Criteria:

* 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
* Written informed consent obtained from the parents or guardians.

Exclusion Criteria:

* Hypersensitivity to any of the vaccine components.
* Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
* Use of any immunosuppressive drugs.
* Previous intussusception or abdominal surgery.
* Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
* Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
* Immunoglobulin and/or blood products use since birth or during the study period.
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Neuropathic pain and allodynia after a peripheral nerve injury (VAS \>= 4)

Exclusion Criteria:

* Patients who cannot cooperate and do no understand Danish
* Fertile women
* Clinically significant abnormality or disease
* Drug and alcohol abuse
* Clinically abnormal ECG
* Hypersensitivity to any of the treatments
* Patients in treatment with cimetedin, antidepressants, antipsychotics, antiepileptics except gabapentin, anticoagulants, Na channel blockers and beta blockers
* Patients who have previously been treated in a NS1209 study
* Patients treated with an investigational drug
Secular Trends in the Prevalence of Diabetes in India

Series of epidemiological studies have been carried out by the research team since 1988 studying the changes in the prevalence of type 2 diabetes, prediabetes and associated risk factors. These studies have shown that the determinants to rising prevalence of diabetes vary among populations and with time. Comparative studies from the same region can help to understand the secular changes occurring in a specific population. In this proposal we intend to conduct a cross-sectional survey with varied levels of urbanisation and compare the findings with our earlier reported data to assess the degree of changes in dysglycaemic prevalences. The primary aim of the proposal is to study the secular changes and the prevalence of diabetes, prediabetes and associated cardio-metabolic risk factors with varying levels of urbanization.

A multi-stage random selection method will be used. Field workers will conduct an enumeration of the individuals above 20 years of age. In each location, streets will be randomly selected to have an equal representativeness from different socio-economic strata. All eligible family members of the selected households are invited for the survey. The study outcomes will be of relevance in public health research in modeling effective national healthcare policies.


Eligibility Criteria:
Inclusion Criteria:

Willing to participate and provide informed consent form.

Exclusion Criteria:

Age less than 20 years,cognitive impairment, unwilling to participate
Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques

Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way.

The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may cause important potential complications, and on the other hand, the surgery does not improve the parameters of the fertility.

Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these fibroids by medical treatment is then a good option.

When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate the surgery.

Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II studies, the first indication in France was a pre-surgical treatment for 3 months at a dose of 5 mg per day.

The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent repeated treatment, giving to it a prominent position for the long-term management of symptomatic fibroids.

Furthermore, cases of pregnancy before surgery are frequently described in women with fibroids treated by UPA for a pre-IVF surgery.

5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this unique cause of infertility.

Then, some of patients followed in ART centers have been treated by UPA to reduce the fibroids size and/or to decrease the associate symptoms.

The aim of this study is to evaluate in the different French ART centers, the impact on fertilization of UPA administration for infertile women with fibroids and to describe the modalities of its prescriptions and to collect information regarding safety tolerance profile of Esmya® in this patient population.

A retrospective, national, multicenter study

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 43 years 'old at the time of the beginning of ulipristal acetate intake
2. Women with fibroid at the time of ulipristal acetate prescription
3. Women with desire to have children and managed for infertility in an ART center (whatever the type of infertility treatment)
4. Women having received a treatment by ulipristal acetate
5. Data collected between 2013/12/01 and 2018/06/30 ; data collected between ulipristal acetate prescription until the term of pregnancy or embryo transfer failure (up to 4) or death/lost to follow up or ART treatment discontinuation

Exclusion Criteria:

none
Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.

Participants will undergo prostate MRI using a range of b-values and echo times. 40 participants will be invited to complete two such scans within 30 days of each other to evaluate reliability across time. Several advanced MRI models will be applied to the data, and the models will be assessed for accurate prediction of grade group ≥2 prostate cancer on histopathology, obtained through routine clinical care. We hypothesize that advanced, multi-compartment dMRI will yield a reliable, quantitative metric that is superior to standard ADC for detection of csPCa.

RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion). The relative contributions of each compartment are estimated for each voxel in the imaging field of view. RSI cellularity index is a normalized parameter reflecting the contribution of very slow diffusion that is associated with tumor cellularity.

Eligibility Criteria:
Inclusion Criteria:

* Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate
* Has already undergone prostate MRI and/or scheduled to undergo clinically indicated radical prostatectomy (to permit whole-mount histopathology correlation).
* Intended treatment and follow-up according to standard of care for prostate cancer
* In good general health as evidenced by medical history and ECOG performance status 0-2
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
* Hip prosthesis
* Contraindication to MRI, per institutional requirements
* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients

It was well known that long term intubation caused a various kind of abnormal presentations of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal pathology, the airway stenosis and so on. It was thought that the freezing and impaired proprioception to be developed as a result of dis-use around the pharynx and the larynx while intubation was one of the reason.

Preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious cycle of dis-use was reported to improve dysphagia after extubation.

Neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of multiple causes of neuro-muscular disorder.

Supposing that preemptive transcutaneous neuromuscular electrical stimulation to be delivered to the muscles of being involved in swallowing could decrease the degree of dis-use during intubation so that it could reduce the occurence and severity of dysphagia developed after extubation, the investigators plan to perform randomized prospective double blind placebo controlled clinical interventional study.


Eligibility Criteria:
Inclusion Criteria:

* patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours

Exclusion Criteria:

* Past history of intubation
* Past history or current status of traumatic brain injury
* Past history or current status of symptomatic stroke
* Past history or current status of injury of cranial nerves
* Past history or current status of neuromuscular disorder
* Patient not to be expected to be extubated
* Patient to reject the participation
* current usage of neuro-muscular blockers
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.

It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16 to 85
* Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions

Exclusion Criteria:

* Unwilling to consent
* Had surgery of colorectal tumors
* Using NSAIDS
* Diagnosed or suspected IBD
* Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease
Prevention and Treatment of Hemodialysis Vascular Access Malfunction

Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.

It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week
2. Have an arteriovenous (polytetrafluoroethylene) graft as vascular access
3. Have a venous stenosis between 30% and 70% as determined by angiogram

Exclusion Criteria:

1. Native arteriovenous fistula
2. Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries \>4
3. Unwilling to participate
4. Allergy to iodine
5. Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
6. Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization
7. Known hypercoagulable state