cyrilzakka/clinical-trials huggingface dataset:
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics

Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.

1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
2. Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen.
3. The human antigen presenting cells (APCs) can take up and process COVID-19 target antigen protein into small peptide fragments, and then COVID-19 virus can be killed by APCs directly.

* Conducting an initial small, controlled trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.
* 20 Moderate COVID-19 patients
* Moderate COVID-19
* Positive testing by standard RT-PCR assay or equivalent testing
* Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
* Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute
* No clinical signs indicative of Severe or Critical Illness Severity
* Our trial duration will be 4-week duration.
* 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
* Intradermic Injection, ID
* Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 2 weeks.

Eligibility Criteria:
* Conducting an initial small, controlled trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.
* 20 Moderate COVID-19 patients

Inclusion Criteria:

* Moderate COVID-19
* Positive testing by standard RT-PCR assay or equivalent testing
* Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
* Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute
* No clinical signs indicative of Severe or Critical Illness Severity

Exclusion Criteria:

* 1. Severe or Critical Illness Severity
* 2. Pregnancy
* 3. Breast-feeding
* 4. The patients with other serious inter-current illness
* 5. Serious Allergy
* 6. Serious Bleed Tendency
* 7. The prohibition of the biological product
Whole Breast RT on Prone Position in Korean Women

It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position in RT is not studied in the Korean women have relatively small breast. The investigators planned this study to evaluate the real efficacy of prone position in Korean breast cancer treated with RT.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed left breast cancer
* 20 or older age
* less than 70 years old
* after curative resection
* Eastern Cooperative Oncology Group performance status 0 to 1
* Informed consent to this study
* Consent to contraception for 6 months after RT completion

Exclusion Criteria:

* Male breast cancer
* Combined distant metastasis
* Status of pregnant or brest feeding
* Previous RT history of chest or neck area
* Indication of supraclavicular RT
* Not indicated postoperative whole breast RT
Establishment of Normal Muscle Strength for French Population

Normal values for muscle strength using hand held dynamometer and muscle mass using echography are largely unknown. The objective of the present study is to establish normal values of these measurements in population living in France.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-90 years

Exclusion Criteria:

* Patients \< 20 years and \> 90 years,
* Athletes involved in international sport competition
* Rheumatic or neuromuscular disease
* Other decompensated pathological conditions
* Pregnancy
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.

This study will alter the intestinal microbiota in healthy adults using antibiotics and subsequently measure immune reactions to the rotavirus vaccine (Rotarix), the tetanus vaccine and the pneumococcal vaccine (Pneumo23).

Eligibility Criteria:
Inclusion Criteria:

* Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to starting antibiotics (day -98). A subject with a clinical abnormality or laboratory parameter outside the reference range may be included if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
* Male between 18 and 35 years of age, inclusive at the time of signing the informed consent
* Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
* Normal defecation pattern (defined as ≤3x/ day and ≥3x/week)

Exclusion Criteria:

* Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrollment, including inflammatory diseases.
* Subject with any history of immunodeficiency
* Subjects with a history of any type of malignancy
* Subject with a history of thrombocytopenia or bleeding disorder
* Subject has a past or current gastrointestinal disease which may influence the gut microbiota
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* History of alcoholism and/or drinking more than an average of 5 units of alcohol per day
* The subject has received an investigational product within three months of day 0 of the current study
Gender, Obesity, C-Reactive Protein, and Oxidative Stress

This randomized placebo-controlled trial will test whether supplementing with vitamins C and E can lower markers of inflammation and oxidative stress in healthy adults. We will examine whether one antioxidant vitamin is more effective than another, and whether gender or body fat influence the treatment effects. We will also determine whether gender, body fat, or menopausal status are associated with baseline concentrations of inflammation and oxidative stress markers.

Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.

Eligibility Criteria:
Inclusion criteria:

* Nonsmoker and not passively exposed
* Males and females 18 year and older
* Able to take vitamin supplements
* Able to take acetominophen instead of aspirin or NSAIDs during the study

Exclusion criteria:

* Pregnancy or lactation
* History of ever smoking or passive smoke exposure in the last year
* Active liver disease; history of HIV/AIDS, diabetes, kidney stones, hemochromatosis, or autoimmune diseases; heart disease, stroke, or cancer in the last 5 years
* User of prescribed anti-inflammatory or lipid-lowering medications, oral contraceptives, hormone replacement therapy, or blood-thinning drugs
* User of iron supplements or vitamin E at 600 IU per day or more
* Consumption of more than 2 alcoholic beverages per day
Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease. Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients. Novel imaging techniques called MRCP+ and Liver Multiscan (LMS) hold the prospect of adequate depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, these features must be tested first.

The purpose of this study is to assess the (i) ability of MRCP+ to detect change in biliary volume, (ii) reproducibility of MRCP+ and LMS, and (iii) correlation of MRCP+ with ERC findings as gold standard.

After informed consent, patients will undergo standard care with blood tests and MRI/MRCP. While performing the MRI, additional sequences called LMS are performed. Thereafter, an ERCP will be performed. Approximately 8 weeks after ERCP, another MRI/MRCP and LMS will be performed. Also, blood tests will be performed and a clinician will evaluate the clinical condition and complaints of patients

Images will be coded and analysed by Perspectum to retrieve MRCP+ and LMS results.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis according to the IPSCSG Definitions (22)
* Age ≥ 18
* Able to give informed consent
* Clinically suspicious for a dominant stricture

Exclusion Criteria:

* insufficient image quality
* known allergy for MRI contrast agents
EFFECT OF NEUROMUSCULAR TRAINING ON SHOULDER FUNCTION

This study will be conducted to compare the effect of neuromuscular training versus traditional strength training in terms of shoulder joint function, proprioception accuracy and isometric external and internal rotator muscles strength in patients with SIS, it will be conducted at the out-patient clinic of physical therapy in Pharos University in Alexandria, Egypt

Double-blinded randomized controlled trial (patient and research assistant (the examiner of all patients) will be blinded).

Participants:

Thirty-four patients of both genders will be selected through non-probability sampling diagnosed as Neer's stage II SIS and their age range from 25-45 years will be randomly assigned to 1 of 2 groups. Each patient will sign an informed consent before starting the study (Appendix III).

Eligible patients will be recruited by physical therapist via referral from the treating orthopedic surgeon who will diagnose SIS based on clinical and radiological examination.

Group I (control): it includes 17 patients who will receive traditional strength training program.

Group II (experimental): it includes 17 patients who will receive upper extremity neuromuscular training exercises

Eligibility Criteria:
Inclusion Criteria:

* Patient age from 25-40 with a clinical diagnosis of Neer's stage II SIS (Consigliere et al., 2018).

Shoulder pain for at least three months (Heron et al., 2017) Painful arc of movement during flexion or abduction (Heron et al., 2017). Positive Neer's or Kennedy- Hawkins Test (Heron et al., 2017). Pain on resisted external rotation, abduction or Empty Can Test (Ager et al., 2019).

Exclusion Criteria:

Symptoms of cervical radiculopathy. Diagnosed inflammatory disorder. Neurological disorder. Widespread pain condition. Evidence of complete RC tear (positive drop arm test). Previous surgery to the affected shoulder.

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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI) bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.

Patients with iron deficiency anemia from suspected occult GI bleeding will be randomized to receive CE or usual standard care following a negative gastroscopy and colonoscopy. Our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. Patients with have a minimum of one year of clinical followup. Direct health care costs in each arm of the study will be determined after a minimum of two years of followup.

An economic evaluation based on the results of the clinical trial is also planned.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients age over 18years with iron deficiency anemia (IDA). IDA is defined as hemoglobin \<137g/L in men or \<120g/L in women with serum ferritin level \<22ug/L in men and \<10ug/L in women.
2. Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study.
3. Negative celiac screen and /or negative small bowel biopsies

Exclusion Criteria:

1. Overt gastrointestinal bleeding
2. Premenopausal women with menorrhagia
3. Known or suspected small bowel obstruction
4. Serious medical co-morbidities precluding surgery given the risk of capsule impaction
5. Pregnancy
6. Inability to provide informed consent
Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery

The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.

Cardiac output (CO) is a major physiological variable that should be monitored closely during cardiac surgery in order to assess and guide therapeutic interventions so as to decrease postoperative morbidity. The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery. After Internal review board approval and written informed consent, 19 patients were included in this study. Before cardiopulmonary bypass (CPB), CO was measured simultaneously using both the esCCO and the Volume View device before and after 3 CO-modifying maneuvers \[passive leg raise (PLR), end expiratory occlusion test (EEOT) and positive end expiratory pressure (PEEP) at 10 cm H2O. Five CO values for esCCO and three for volume view were averaged and compared during a one minute period of time before and after each maneuver. The precision error and its 95% confidence interval (CI) that corresponds to the least significant change (LSC) were calculated within this period of time. The Bland-Altman analysis was used to compare bias, precision and limits of agreement (LOA) of both devices. Trending ability of CO changes was assessed by a modified 4 quadrant plot analysis, within angular limits of agreement considered as acceptable when the mean angle between both delta CO was less than 30°.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective cardiac surgery

Exclusion Criteria:

* age less than 18 years
* known or potential pregnancy
* arrhythmias
* known significant tricuspid or aortic valve insufficiency
* left or right ventricular dysfunction
* peripheral arteriopathy
* low perfusion index.
Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs

drug-drug interaction between DWP14012 and three different kinds of NSAIDs

to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
* Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 2 to 16 years and 11 months of age
* Clinical diagnosis of stable mild to moderate plaque psoriasis

Exclusion Criteria:

* Other forms of psoriasis
* Hypercalcemia
* Past history of kidney stones
* Vitamin D deficiency
* Other concomitant dermatological disease
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)

This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
* No prior chemotherapy or any other systemic therapy for metastatic NSCLC
* Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred \>12 months from end of last therapy
* Known tumor PD-L1 status
* Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
* WHO/ECOG status at 0 or 1 at enrollment
* Life expectancy of at least 12 weeks
* Troponin I or T ≤ ULN (per institutional guidelines)

Exclusion Criteria:

* Active or prior documented autoimmune or inflammatory disorders
* History of active primary immunodeficiency
* Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
* Untreated CNS metastases
A Study of TRV130 for the Treatment of Pain After Abdominoplasty

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 and \<=65 years of age.
* Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
* Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse.
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.
Efficacy of Gralise® for Chronic Pelvic Pain

This study is done to investigate the pain relieving effects of the study drug Gralise (a novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be recruited. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been reported to be well tolerated and effective in the treatment of various chronic pain conditions, particularly in neuropathic pain. About 36 subjects will take part in this study.

As a participant in this study, you will be asked to come to the Rehabilitation Institute of Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611). Your part in this study will last for 15 weeks and will involve 4 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.

If you are in this study, you will be placed in one of two study groups: one group will receive the study drug followed by a placebo and the second group will receive a placebo followed by the study drug. The amount of weeks on placebo versus the study drug will not be equal. You will be assigned a study group by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. However, if you have a medical emergency, we can get this information. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* English speaking
* able to give consent
* willing to use electronic diary during entire length of the study
* has 'chronic' pelvic pain
* Meets one of the following diagnostic criteria for one of the following: Irritable Bowel Syndrome (IBS) Ulcerative Colitis (UC), Interstitial Cystitis (IC), and Prostatitis

Exclusion Criteria:

* allergic to gabapentin or inactive ingredients
* taking gabapentinoids (i.e. gabapentin or pre-gabalin)
* with severe or unmanaged psychiatric disturbance (at PI discretion)
* with severe ongoing or unaddressed medical conditions (esp. Renal or Hepatic disease, uncontrolled hypertension), rheumatologic disease, narrow angle glaucoma, hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention.
* who plan to change their therapeutic regimen during the course of the trial (e.g. start physical therapy, massage, medications, injections, etc.)
* with acute pain

Female subjects:

* pregnant or plan to become pregnant
* gave birth within the last 6 months
* breastfeeding
* episodic visceral pain (e.g. endometriosis)