cyrilzakka/clinical-trials huggingface dataset:
Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

The goal of this project is to determine if task-activated fMRI is sensitive to the central cholinergic deficit associated with Mild Cognitive Impairment.

Clinical studies suggest that cholinesterase inhibitors (ChEIs) exert a cognitive benefit with chronic use among MCI and AD patients. Some studies also demonstrate a slight treatment benefit for persons who are APOE 4 positive. We propose to conduct a 24-week, randomized, double-blind, placebo-controlled, parallel group study of the Exelon® \[rivastigmine\] transdermal patch in 120 aMCI patients who have one or both APOE 4 alleles. Our preliminary analyses indicate that aMCI patients, even those who convert to AD, exhibit increased fMRI activation on our semantic memory activation task relative to not at-risk healthy participants and that increasing activation over time correlates with declines on neuropsychological testing. In addition, our preliminary data indicate that ChEI treated aMCI patients demonstrate normalization (i.e. reduction) in the magnitude of task-related neural activation over time relative to an untreated group. Furthermore, changes in fMRI magnitude demonstrated greater sensitivity to cholinergic modulation than changes on neuropsychological testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of amnestic MCI
* In good general health with no diseases expected to interfere with the study
* Ability to undergo MRI
* Fluent in English
* Stable prescription dosages 1 month prior to testing
* Carrier of the APOE e4 allele (determined by blood draw at screening visit)

Exclusion Criteria:

* Neurological illness/conditions
* Medical illnesses/conditions that may affect brain function
* Prior history of use of any cholinesterase inhibitor
* Instable or severe cardiovascular disease or asthmatic condition
Brain Metabolism in Polycystic Ovary Syndrome

The purpose of this study is to investigate whether higher insulin resistance in young women with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained.

MRI and FDG PET scan for each participant were obtained within an average time frame of 3 weeks. Isulin resistance were assessed with the updated homeostasis model assessment (HOMA2-IR).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS
* Age ≤ 35 y
* BMI ≤ 35

Exclusion Criteria:

* Taking medications for diabetes or insulin-sensitizing drugs
* Drug addictions
* Psychiatric illness
* Smoking
* Overt evidence of heart, liver or renal disease
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis.
* Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
* Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
* Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
* Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery

The method of arranging and restoring the position of the small intestine under laparoscopy is used to determine whether it can promote the recovery of intestinal function after colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed colorectal cancer, patients undergoing colon cancer or radical resection of high rectal cancer；
* Tumor Stage (TNM): I-III；
* Age: \>18 years old; \<80 years old;
* ASA: I-III;
* Agree and sign the informed consent form.

Exclusion Criteria:

* Stoma patients；
* Patients with preoperative intestinal obstruction；
* Constipation patients (More than three days before the last bowel movement)；
* Combined other organ resection patients；
* Stroke or spinal cord injury patients；
* Long-term opioid use patients；
* Patients with a history of previous abdominal surgery；
* Patients refused entry into the trial；
Survey of the Anxiety Associated With the COVID-19 Pandemic

The study aims to systematically examine various aspects of the anxiety associated with the COVID-19 pandemic in Germany. The data collection is carried out online with longitudinal repeated measurements.

The COVID-19 pandemic is currently one of the greatest challenges for numerous countries - also for Germany. In addition to its somatic and economic consequences, the psychological dimension of the Coronavirus pandemic is discussed increasingly and is visible in public life - e.g. in the "pandemic-caused experience of threat", "loss of control" and "panic" of multiple people. The study examines the phenomenon of this "corona-related anxiety" in terms of epidemiological, clinical and psychosocial characteristics. It is investigated how "corona anxiety" affects people who already have an anxiety disorder or other mental illnesses as well as formerly mentally healthy people. It is also examined how media reporting and personal consequences of COVID-19 are connected with corona-related anxiety and if there is a need for therapeutic support regarding corona-related anxiety.

To answer these questions a longitudinal online survey targeting the general population in Germany is carried out. The survey takes place all three weeks as long as the pandemic lasts and ends with one follow-up one year later.

Eligibility Criteria:
Inclusion Criteria:

* informed consent was given
* age ≥ 18
* able to complete the questionnaire in German
* country of residence: Germany

Exclusion Criteria:

* if at least one of the inclusion criteria is not met
Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance

Data suggest that alanine may facilitate the intestinal absorption of fructose in patients with DFI and thereby may decrease GI symptoms.

We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks that contain foods with free fructose or high fructose content will decrease GI symptoms in subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose.

Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a randomized, double blind, cross over study.

Methods: We propose to investigate the effects of co-administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose intolerance, in a randomized, double blind, cross over study.

Data Analysis: The primary outcome measure will be a comparison of baseline breath sample values and study visit breath sample values. Additionally, we will assess subject-reported occurence and severity of nine gastrointestinal symptoms during the test on a visual analog scale (VAS).

Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve with ingestion of supplemental L-alanine (along with foods containing free fructose or high fructose content). We additionally expect treatment of DFI with administration of L-alanine powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-99 years
2. Diagnosis of fructose malabsorption (positive breath test after ingestion of 25 grams of fructose defined as either (a) ≥ 20 ppm rise of breath H2/CH4/both over baseline values or a successive rise of ≥ 5 ppm over baseline and in 3 consecutive breath samples)

Exclusion Criteria:

1. Cognitive impairment or any other inability to provide informed consent
2. Prisoners
3. GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy
4. Antibiotics in the previous 6 weeks
5. History of bacterial overgrowth or lactose intolerance
6. Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc.
7. Known food allergies
8. Medication use: opioids, Tegaserod, laxatives, enemas
9. An allergy or intolerance to any fiber supplements or other dietary nutritional supplements such as: psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel).
10. Difficulty swallowing
Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors

This study includes two parts, different part has different administration frequencies of SSGJ-706.

This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-706 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.


Eligibility Criteria:
Inclusion Criteria:

* PE high-risk population aged 18-50 years with gut microbiota dysbiosis
* No severe cardiopulmonary diseases
* No severe hepatic and renal insufficiency
* No severe active infection
* Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism
* No diseases affecting intestinal microecology
* No history of smoking and drinking
* The researchers evaluated those pregnant women expected to deliver more than 20 weeks
* Voluntarily participate in this clinical study and sign the informed consent form

Exclusion Criteria:

* With severe cardiopulmonary, hepatic and renal insufficiency
* With uncontrolled active infections 2 weeks before enrollment
* Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism
* with diseases affecting intestinal microecology
* Smoking and drinking history
* With acute gastrointestinal ulcer
* Hemorrhagic constitution
* Other discomfort assessed by the investigato
An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD.

In addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged over 18 years (including borderline values), of either sex.
2. Subjects consistented with the Chinese consensus on the diagnosis and treatment of IBD;
3. Subjects able to cooperate with follow-up, participate in this study and sign the informed consent.

Exclusion Criteria:

1. Subjects with incomplete clinical data;
2. Subjects can not to cooperate with follow-up, and refuse to sign the informed consent;
3. Subjects can not to cooperate with the completion of relevant examinations; 4 Pregnant women;

5.Subjects with severe heart, lung, kidney and other organ diseases or cancer, and expected survival time less than 6 months.
The Molecular Pathogenesis Study of Cataract

To study the molecular pathogenesis of cataract and explore possible treatments，anterior lens capsules were collected from cataract patients

Anterior lens capsules were collected from the patients with DC and ARC, and transparent crystals of cadaveric eyes. M6A epitranscriptomic microarray was performed to investigate the altered m6A modifications and determine the differentially expressed mRNAs. The potential role of dysregulated m6A modification levels was predicted through Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses. Real-time polymerase chain reaction was performed to identify the dysregulated expression of RNA methyltransferases, demethylases, and readers.

Eligibility Criteria:
Inclusion Criteria:

* diabetic cataract
* underwent cataract surgery

Exclusion Criteria:

* Combined with other eye diseases
* underwent other eye surgery
O2 Transport and Utilization in Health and Lung Disease

Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore, the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide synthase uncoupling induced by chronic oxidative stress on metabolic and vascular abnormalities in skeletal muscle of patients suffering from COPD.

The purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must be between the age of 18 and 85 years;
* For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (FEV1 \<80% predicted, FEV/FVC\<0.70);
* Ability to perform motor tests;
* Ability to provide informed consent

Exclusion Criteria:

* uncontrolled hypertension;
* hyperlipidemia;
* recent exacerbation;
* Major cardiovascular event procedure (\<3 months);
* Pregnancy
* known significant hepatic, renal disease, active substance abuse
* contraindication to MRI, claustrophobia
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old.
* Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:

Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (\<0.26 or \>1.65).

* The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
* No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
* Patient has read, understood and signed informed consent.

Exclusion Criteria:

* Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
* Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
* Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.
Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg

To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, age 20\~55 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.
Development of a Novel Methodology Using BMVC Staining as an Assistance to Cancer Cytological Diagnosis

3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different. Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained cells was established to instantly differentiate cancer cells from normal cells. The investigators want to quantitatively measure the fluorescence expression of BMVC in normal and cancer cells and explore the usefulness of this staining in head and neck lumps.


Eligibility Criteria:
Inclusion Criteria:

* patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.

Exclusion Criteria:

* No cytology data
Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE

This study will evaluate the performance of biologically assisted core decompression with the PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study will explore the potential impact of patient demographics and baseline characteristics on post-operative outcomes.

This study will evaluate the performance of biologically assisted core decompression with the PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study will explore the potential impact of patient demographics and baseline characteristics on post-operative outcomes. The study will evaluate change in Harris Hip Score (HHS) at 12 months after treatment. The change in AVN lesion size will also be measured at 12 months after index treatment via MRI. Change in quality of life and pain measures will be measured at each follow-up. Adverse events will also be recorded throughout the study.

This study will follow patients for 5 years after initial treatment.

Data will be recorded in a online database that will be entered by the site or patient, depending on the report form. This database includes data checks to compare entered data against predefined rules for range.

A risk-based monitoring plan will be put in place for source data verification.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with the study procedures
* Signed informed consent
* Untreated unilateral or bilateral bone lesion(s) of the femoral head associated with AVN in need of biologically assisted core decompression. Note:If bilateral untreated bone lesions of the femoral head associated with AVN,both hips eligible and willing to undergo study treatment and follow-up
* ≥ 3 months after arthroplasty (e.g., total, hemi) in the contralateral hip

Exclusion Criteria:

* Pregnant or lactating
* Participating in another device or drug study
* ARCO stage ≥ III
* Unable to undergo MRI of the study hip(s)
* Active, local or systemic infection