cyrilzakka/clinical-trials huggingface dataset:
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

The goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. The main questions it aims to answer are:

1. How does consuming the fermented foods impact the gut microbiome?
2. Does this interaction between the fermented foods and the gut microbiome affect inflammation?

Participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses.

Researchers will compare the gut microbiome and inflammation between these two diets.

The rationale for the research is that fermentation of pulses can reduce the concentration of compounds that suppress butyrate producing bacteria and butyrate production. This will in turn boost butyrate production during consumption of these fermented pulses relative to that in unfermented pulses. This in turn will lead to lower inflammation in people consuming fermented pulses. To best study this question the investigators will utilize a cross-over design trial where participants will consume daily meals containing either fermented or unfermented pulses (chickpeas), followed by a washout period and then a period of consuming the other type of pulse. The investigators hypothesize that those consuming the fermented pulses will experience a significant decrease in inflammatory markers driven by increased butyrate production by gut bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Taken antibiotics within the past month
* Taking any medication for the management of diabetes or obesity
* Are pregnant
* BMI \> 24.9
* Allergies to pulses or any other meal components
Fructooligosaccharide and Calcium Absorption in Adolescent Girls

Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and bone accrual during growth. This study aims to see whether the addition of fiber in the form of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical visits, participants will receive a beverage containing a small amount of calcium, supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone density and geometry, calcium absorption, and physical fitness will be measured. The effects of this fiber intervention may provide support for improving bone health with minimal fiber supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Calcium intake of 900-1300 mg/d
* Generally healthy

Exclusion Criteria:

* Male
* BMI \> 90th percentile for age
* Takes medication that influences calcium metabolism
* Any disorder of calcium or bone homeostasis (hypercalcemia, Paget's Disease)
* Smoking, illegal drug consumption
* Any gastrointestinal disease (Crohn's Disease, Celiac Disease, Inflammatory Bowel Disease)
Bioequivalence Study of CJ-30059

This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 19 and 55 years old(inclusive)
* Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
* Available for the entire study period
* Understand the requirements of the study and voluntarily consent to participate in the study

Exclusion Criteria:

* Subjects with a history of gastrointestinal diseases which might significantly change absorption, distribution, metabolism and excretion (ADME) of medicines
* Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 70 to 1000 mmHg for male subjects during screening
* Subject with symptoms of acute disease within 14days prior to study drug administration
* Subjects with a history of clinically significant allergies
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, aspartate aminotransferase (AST) or alamin aminotransferase (ALT) \>1.5 times of the Upper Normal Limit or total bilirubin \> 1.5 times of the Upper Normal Limit)
* History of drug abuse
* History of caffeine, alcohol, smoking abuse

  * caffeine(coffee, tea, coke) or grapefruit juice \> 4 cups/day
  * smoking \> 20 cigarettes/day
  * alcohol \> 140 g/week
* Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
* Participation in any clinical investigation within 30 days prior to study drug administration
* Subjects with whole blood donation within 60 days, component blood donation within 30days and blood transfusion within 30 days prior to study drug administration
* Subjects who are judged unsuitable by investigators
Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection

The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.

A prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. Patients presenting to the Emergency Department (ED) with signs and symptoms of acute heart failure will be approached for enrollment.

Clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. Approximately 1800 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.

Sample collection and testing of clinical samples with the Access Natriuretic Peptide assay will be performed under two separate protocols

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent obtained
* Adult aged 21 years or older
* Presenting with a clinical suspicion of acute HF
* Subject clinical history available for review by Sponsor or delegates and FDA or other regulatory agencies

Exclusion Criteria:

* Dyspnea clearly not secondary to HF (e.g. primary lung disease or chest trauma)
* Stage 4 or 5 Chronic Kidney Disease (CKD)
* Chronic dialysis
* Participation in a clinical study that may interfere with participation in this study
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

* Skin disorder other than plaque psoriasis in the areas to be treated.
* Disease on only elbows, knees, and scalp
Contrast Enhanced SWI for Carotid Plaque Imaging

This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.

Atherosclerosis of craniocervical arteries are one of most important causes of stroke. Carotid artery is the most frequent site of atherosclerosis. Recent research in carotid artery covers not only morphology of lumen but also direct visualization of carotid plaque or vessel wall. Vulnerable carotid plaques share pathologic features of intra-plaque inflammation and hemorrhage. There have been reports about post-contrast SWI in the field of vascular imaging. We hypothesized SWI is so sensitive to gadolinium based contrast agent and hemorrhage that contrast-enhanced SWI can visualize vulnerable carotid plaque. The purpose of this study is to investigate gadolinium-enhanced SWI in detection of vulnerable carotid plaque and compare it with MP-RAGE and DANTE T1-SPACE. This can be used to guide proper treatment for stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute or recent (within 3months) stroke or TIA
* 50-99% stenosis of internal carotid artery by NASCET criteria
* Written informed consent, prior to registration

Exclusion Criteria:

* Hemorrhagic stroke
* Previous history of carotid endarterectomy (CEA), angioplasty, or stenting
* Contraindication for MR imaging
* Hypersensitivity to gadolinium based contrast media
* Pregnant or lactating women
* Patients under age of 19-year-old
* Renal condition : eGFR \< 60
* Patients unable and/or unwilling to comply with treatment or study instructions.
Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy

The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed metastatic colorectal cancer
* Documented disease progression after first-line chemotherapy containing oxaliplatin
* Both genders, age 18 years
* ECOG performance status 0 or 1
* Adequate organ and marrow function
* Written informed consent to participate in the study

Exclusion Criteria:

* Have received irinotecan treatment
* With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
* With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea \> grade 1)
* With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
* With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment.
* Prior chemotherapy within 3 weeks
* Major surgery or radiotherapy within 4 weeks
* Prior participation in any investigational drug study within 3 weeks
* History of allergic reaction to liposome product
* Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?


Eligibility Criteria:
Inclusion Criteria

All subjects accepted for this study must:

* Be 18 years of age
* Be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass
* Have evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team in addition to a PT \>16.6 sec or INR \>1.6 sec.

Exclusion Criteria

Subjects who have one or more of the following will be excluded from the study:

* Are unable to grant informed consent or comply with study procedure
* History of hypercoagulable condition (e.g. Factor V Leiden, AT-3 deficiency, Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc) or previous unprovoked thromboembolic complications
* Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery
* Thromboembolic event within past 3 months
* Received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within the past 5 days
* Patients taking chronic warfarin therapy who have not discontinued treatment and demonstrated an INR \<1.3 prior to surgery
* Fibrinogen level \<150 mg/dL on initial post cardiopulmonary bypass labs
* Antithrombin 3 level \< 80% control (preoperative)
* Are undergoing emergency open heart-surgery
* Cardiopulmonary bypass time is expected to be \< 30 minutes
* Age \< 18 years of age
* Are pregnant
Treatment of Depression in Parkinson's Disease Trial

The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.

Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden.

Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.

A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.

Eligibility Criteria:
inclusion criteria:

* Parkinson's disease without dementia.
* Depression.
* Males or females.

exclusion criteria:

* Psychosis
* Heart block
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis

The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.


Eligibility Criteria:
Inclusion Criteria:

* Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
* Normal kidney function.

Exclusion Criteria:

* Bleeding diatheses
* Uncontrolled UTIs
* Severe skeletal malformations
Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B

It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years
2. HBsAg positive for more than 6 months before enrollment
3. Serum HBVDNA \>2×104IU/ml and serum ALT \>80U/L or TBIL \< 34 umol/L for chronic hepatitis B
4. Serum ALT \< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
5. Serum HBVDNA \>40 IU/ml for cirrhosis regardless of ALT and TBIL

Exclusion Criteria:

1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
2. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
3. Renal function: creatinine \>1.5 ULN or eGFR\< 50ml/min/1.73m2 before therapy
4. Combined with hepatocarcinoma before therapy
5. suspend therapy voluntarily
6. use other nephrotoxic drugs
Interactive Sections Of An Internet-Based Intervention Increase Patient Empowerment: A Study With Chronic Back Pain Patients

The aim of the study is to study how to improve patients' management of chronic back pain, particularly their management of prescription medication, through increasing health literacy and patient empowerment through an internet based intervention. We do this by designing both patient education materials and physician communication strategies to increase literacy and volitional components of patients. We will test two conditions using a website called Oneself: one providing only information (literacy-only control) and a second providing relational communications designed to increase both literacy and volitional empowerment. To test the self-management enhancing effects of empowerment and health literacy, we will conduct a longitudinal experiment with 51 chronich back pain patients over two months. This span of time is the minimum necessary to achieve a systematic change in self-management and literacy skills, increasing also the range of possible decisions to be made and actions to be real-ized by the patients.


Eligibility Criteria:
Inclusion Criteria:

1. aged \> 18 years,
2. having suffered from back pain for at least 3 months,
3. no concurrent involvement in other studies.

Exclusion Criteria:

1. No access/limited access to computer and internet
2. concurrent diseases
PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC

Concurrent chemoradiotherapy is now considered to be the standard treatment modality for esophageal cancer patients who are medically unfit for surgery. However, elderly patients have limitations in their ability to tolerate concurrent chemoradiotherapy in comparison to nonelderly patients because of medical comorbidities and reduced functional reserve of organs. Immune checkpoint inhibitors, including PD-1 inhibitor, have been used in a large number of clinical studies on esophageal cancer and have achieved certain results. PD-1 inhibitor combined with radiotherapy may be a new strategy for elderly patients with esophageal cancer. This study aims to explore the efficacy and safety of PD-1 inhibitor combined with radiotherapy in the treatment of elderly patients with esophageal cancer. PD-1 inhibitor was delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.

Study Design Primary Purpose: To investigate the safety and efficacy of PD-1 inhibitor combined with radiotherapy for elderly patients with esophageal squamous cell carcinoma.

Study Phase: Phase II Intervention Model: PD-1 inhibitor combined with radiotherapy Number of Arms: One Masking: No Allocation: 68 patients for one single group Enrollment: 68 patients Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Esophageal squamous cell carcinoma with stage II to IVA, 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS ≥ 70, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.

Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Severe autoimmune disease, 4. Joining other clinical trial prior this study.

Intervention: PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year. Radiotherapy:56-60Gy/28-30 fraction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 70 years or above
2. Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy
3. Stage II-IVa according to the AJCC TNM staging system
4. Estimated survival time ≥ 3 months
5. Karnofsky performance score ≥70
6. Normal blood routine, liver and kidney function less than 2 times of the normal upper limit
7. Without mental disorders, cooperate with treatment and follow-up
8. Have fully understood this study and voluntarily signed the informed consent

Exclusion Criteria:

1. Esophageal bronchial fistula or esophageal mediastinal fistula
2. Patients who have participated in other clinical trials before this treatment
3. Severe heart, liver and/or kidney dysfunction
4. Serious infectious diseases
5. EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy
6. Severe autoimmune disease
7. Relapse disease or distant metastasis
8. Combined with other malignant tumors.
Safety & PK of Single Doses of MT1980

MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat.

This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with good physical and mental health
* Body Mass Index 18 to 30 kg/m2
* Men \& women of child-bearing potential must agree to use adequate contraception
* Willing \& able to provide written informed consent and to communicate and participate in the study

Exclusion Criteria:

* Clinically significant abnormal biochemistry, haematology, urinalysis results
* Results of screening liver function or kidney function tests outside of normal ranges
* Heavy daily smoking or use of nicotine containing substances