cyrilzakka/clinical-trials huggingface dataset:
Phone-based Intervention Under Nurse Guidance After Stroke 2

The overall objective of Phone-based Intervention under Nurse Guidance after Stroke II (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to substantially improve longer term BP control among 500 recent stroke patients encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation strategy for routine integration and policy adoption of mhealth for post-stroke BP control in a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain Disorders funded R21 pilot study (NS094033) to test efficacy of a refined, culturally-tailored, and potentially implementable intervention aimed at addressing the premier modifiable risk for stroke \& other key variables in an under-resourced system burdened by suboptimal care \& outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years (stroke is commoner above this age cut-off)
* male or females (sex is a biologic variable of interest)
* recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible
* uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives \<60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control
* patients or family carers should own a basic mobile phone that can receive text/audio messages.

Exclusion Criteria:

- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).
Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.

Patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their COVID19 vaccination, and in a subset also before vaccination. Immune responses of antibodies and SARS-CoV2-specific T-cells to the vaccination will be quantified and the rituximab effect on COVID19 vaccine-induced immune responses is analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were treated with anti-CD20 treatment since 01.01.2010
2. Patients who received a COVID19 vaccination (completion of all required doses) until target date (initial target: 30.05.21, but can be delayed to 30.06.21, 30.07.21 or 30.08.21 in case of insufficient enrollment)
3. Volunteers without a history of anti-CD20 treatment exposure
4. All: written informed consent.

Exclusion Criteria:

Exclusion criteria for patients (any of the following)

1. Patients aged 18 years and younger at time of study enrollment and/or
2. Pregnant or lactating women at time of study enrollment and/or
3. Patients who do not provide written informed consent and/or
4. Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
5. Patients who are in a dependency relationship with the study personnel (hierarchical, social)

Exclusion criteria for volunteers (any of the following)

1. Volunteers aged 18 years and younger at time of study enrollment and/or
2. Pregnant or lactating women at time of study enrollment and/or
3. Volunteers who do not provide informed consent and/or
4. Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
5. Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
6. Volunteers who did not complete their COVID19 vaccination
7. Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)
Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World

To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.


Eligibility Criteria:
Inclusion Criteria:

* (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;
* (2)Aged between 18 and 80.

Exclusion Criteria:

* Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.
A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.

This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
* Healthy adult male subjects aged 19 to 45 years
* The subject has a Body weight ≥ 60 kg and \< 90 kg and Body Mass Index(BMI) ≥ 18.5 kg/m2 and \< 27.0 kg/m2
* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)

Exclusion Criteria:

* A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
* A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
* A subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) or received a blood transfusion within last 1 month
* Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial)
* Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers

Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
* Healthy male subjects aged ≥ 18 years and ≤ 65 years;
* Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
* The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
* Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.

Exclusion Criteria:

* History of hypertension or abnormal blood pressure at screening/baseline measurement;
* A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
* Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
* Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
* Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
* History of digestive tract perforation or digestive tract fistula;
* Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion;
* Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use;
* Positive virology test;
* Known allergy to trastuzumab;
* Known history of allergic diseases or allergic constitution;
* Study the history of blood donation 3 months before drug infusion;
* Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening
* A history of alcohol or drug abuse in the 12 months prior to screening;
* A history of mental illness;
* Subjects whose spouses plan to become pregnant;
* The study cannot be completed according to protocol requirements during the study period;
* Conditions considered unsuitable for inclusion by other researchers.
Measurement of Soluble Factors and Particulate Matter in Induced Sputum and EBC in Inflammatory Diseases of the Lung

In the present study inflammatory mediators will be isolated in induced sputum and exhaled breath condensate and will be correlated with particulate matter measured in these samples.Particulate matter will be assessed by partcle size distribution method and shape analysis.

The aim of the study is to perform biological monitoring in environmental and occupational diseases in a non invassive fashion.


Eligibility Criteria:
Inclusion Criteria:

* Ages 7-80

Exclusion Criteria:

* FEV1 \< 75% predicted pO2 \< 75
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.

This study aims to determine if a short course of oral prednisone helps to improve the operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery.

This study will be conducted as a double blinded randomized control trial and aims to recruit about 34 patients (17 patients per arm). Patients will be randomized to receive either prednisone 50 mg po x10 days or an identical looking placebo x10 days. Photographs of the polyps will be taken prior to the intervention, on the day of surgery and in the follow-up visit. Symptom survey (SNOT22) will also be administered at these same time points. Blood loss will be determined volumetrically from the suction canister and by using the Wormald Surgical field grading scale. Surgeons will also complete a survey postoperatively evaluating visibility, difficulty and ease of surgery. At 2 weeks, 1 month, 3 months and 6 months, patients will again fill out the Sino-nasal Outcome Test - 22 (SNOT-22) and the surgeon will do an endoscopic assessment by using the Peri-Operative Sinus Endoscopy (POSE) scoring system .

Eligibility Criteria:
Inclusion Criteria:

* All patients with severe obstructing nasal polyps scheduled for surgery.

Exclusion Criteria:

* Patient unable to tolerate side effects of prednisone
* Uncontrolled diabetes mellitus
* Hypertension
* Previous congestive heart failure
* Acute/chronic systemic infection
* History of hypersensitivity to prednisone
* History of cataracts or glaucoma
Biomarkers of Trained Immunity Following MMR Vaccination

This is a substudy of NCT04333732. The goal of this sub-study is to identify and characterize biomarkers of trained immunity by measuring, in vitro, immune responses to heterologous products, especially viral associated products, in the MMR vaccinated compared placebo groups.

All participants are randomly assigned to MMR or placebo injection at baseline, followed by SARS-CoV-2 specific vaccination. Blood is drawn around 60 to 90 days after the last SARS-CoV-2 specific vaccine injection.

A sub-study of the CROWN CORONATION Trial (COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION; NCT04333732). The goal of this sub-study is to identify and characterize biomarkers of trained immunity by measuring, in vitro, immune responses to heterologous products, especially virally associated products, in those exposed to MMR vaccine injection compared to those exposed to 0.9% sodium chloride ('normal saline') placebo injection.

A secondary objective is comparison of SARS-CoV-2 neutralization assays between MMR and placebo comparison groups around 60 to 90 days after the last SARS-CoV-2 specific vaccine injection.

All participants are randomly assigned to MMR or placebo injection at baseline, followed by SARS-CoV-2 specific vaccination. Blood is drawn around 60 to 90 days after the last SARS-CoV-2 specific vaccine injection. Peripheral blood mononuclear cells (PMBC) will be isolated from samples and stimulated with heterologous products (for example; Roswell Park Memorial Institute medium \[RPMI; negative control\], MMR \[the vaccine itself as specific stimulus\], severe acute respiratory syndrome coronavirus-2 \[SARS-CoV-2; heat inactivated\], influenza virus \[heat inactivated\], toll-like receptor 3 ligand \[TLR3 ligand; poly I:C\], toll-like receptor 7/8 ligand \[TLR7/8 ligand; R848\], toll-like receptor 4 ligand \[TLR4 ligand; lipopolysaccharide (LPS)\]). Supernatants will be assayed by multiplex luminex protein assay at 24 hr (for example; type I interferons \[IFN\], interleukin \[IL\]-1β , IL-6, tumor necrosis factor \[TNF\]-α) and after 5 days (for example; IFN-γ, IL-17, IL-22, IL-10). This process of testing stimulus-response will be conducted on both the baseline and day 30 samples, collected from both the MMR and Placebo groups.

Neutralization assay will be conducted on all samples using wild-type SARS-CoV-2.

Measles IgG titres will be measured on all samples. Measles IgG titres will be used for sensitivity analysis.

Eligibility Criteria:
Inclusion/ Exclusion Criteria:

Prospective participant must already be enrolled into the CROWN CORONATION trial at the sub-study location. Refer to NCT04333732 for list of inclusion / exclusion criteria for the study population.
Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive inotropic effects in vitro and in vivo without altering myocardial oxygen consumption. Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated. Thus, it might be possible to save catecholamines in patients with severe heart failure or cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation in patients with severe heart failure or in patients with acute myocardial infarction and cardiogenic shock after having performed percutaneous coronary intervention. A pronounced improvement in hemodynamics is expected to occur.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients male/female
* Age: 18 - 85 years
* Weight: 45 - 110 kg
* Height 150 - 195 cm
* Clinically signs of heart failure (NYHA III-IV) refractary to therapy or cardiogenic shock in acute myocardial infarction
* written informed consent or witnessed verbal consent or presumed will (compassionate use)

Exclusion Criteria:

* Malignoma
* Clinically significant cardiac valve stenosis
* Participation in another clinical trial with relevant or probable drug-interactions
* Pregnancy or lactation
* Addiction
* Poor compliance
Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)

This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.

Eligibility Criteria:
Inclusion Criteria: must have:

* be between the ages of 30 and 80
* have a clinical diagnosis of Gold stage 2 to 4 COPD
* have a diagnosis of pulmonary hypertension established by a historic right heart catheterization
* a minimum weight of 45 Kg
* minimum systolic blood pressure of \>90 mmHg
* be able to perform a six minute walk test
* be able to maintain a oxygen saturation \>88% at rest (with or without oxygen)
* be treated with background therapy for COPD for a minimum of 1 month prior to consideration of enrollment.
* be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedure.

Exclusion Criteria. Cannot have or be:

* The presence of pulmonary venous hypertension defined by a historical right heart catheterization
* Gold Stage I COPD
* documented left ventricular dysfunction as measured by echocardiography
* pregnant or breastfeeding
* Recipient of a lung transplant
* received chronic prostanoid therapy for pulmonary hypertension within 4 weeks prior to the screening appointment
* A requirement of greater than 9 l/min of O2 to maintain oxygen saturations greater than 88% at rest
* No other serious medical conditions
Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours

The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of gastrointestinal endocrine tumour.
* Patient able to read and understand the study questionnaires.
* Patient who has given informed consent in writing to take part in the study.

Exclusion Criteria:

* Patient who is taking part in another clinical study during the study.
* Patients with another serious malignancy.
* Patients unable to meet the requirements of the protocol (non-compliant patients or those unfit to answer the questionnaires).
RCT Comparing 21 and 22 G Needle in the Diagnosis of Sarcoidosis by EBUS TBNA

Randomized controlled trial to determine the efficacy of different needles sizes (22G and 21G) used in endobronchial ultrasound guided transbronchial needle aspiration

Among the bronchoscopic techniques in diagnosis of sarcoidosis, transbronchial needle aspiration (TBNA) of lymph nodes has emerged as a particularly useful supplement to the previously known endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA is well established. With improvements in technology, the last decade has seen the use of convex probe endobronchial ultrasonography (EBUS) to guide TBNA under direct vision. This technique is a minimally invasive alternative to mediastinoscopy, further it offers additional advantage of choosing the appropriate node for sampling on the basis of their echogenicity. Studies subsequently have demonstrated the superiority of EBUS TBNA over conventional TBNA.

Once the role of TBNA in diagnostic bronchoscopy was established, technical aspects of the procedure became the topic of research. Needle size used in TBNA is one such important factor. Apparently, larger the needle, better the tissue yield and hence improved diagnostic capability. Conventional TBNA is usually performed with a 19G needle, though varying sizes have been used in different studies (18, 21, 22, 26G). On the other hand, EBUS-TBNA is performed with a 22G needle. More recently 21G needles are being used for the same purpose. There have been conflicting reports in literature, when these two needle sizes have been compared with regards to the adequacy of the sample, accuracy of diagnosis and the rate of complications. Moreover, the above studies undertaken so far were done from centers where malignancy was the predominant diagnosis. Whether the needle size used during EBUS TBNA has any impact on diagnosing benign diseases like sarcoidosis is still not clear, hence this study was planned. The investigators hypothesize that performing EBUS-TBNA using 21G needles may enable identification of intact compact granulomas in sarcoidosis, and hence a better diagnostic yield than using a 22G needle.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Clinicoradiological suspicion of sarcoidosis where endobronchial ultrasound guided transbronchial needle aspiration is contemplated
* Enlarged hilar and mediastinal lymph nodes \>10 mm (any axis) on computed tomography of the chest

Exclusion Criteria:

* Hypoxemia (SpO2 \<92%) on inspired fraction of oxygen 0.3
* Treatment with systemic glucocorticoids for more than 2 weeks in the preceding three months
* Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
* Failure to provide informed consent