cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection

A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI)


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of 30 - 75 years of age.
2. A qualifying episode of CDI as defined by:

   1. ≥ 3 abnormal stools as assessed by BSFS score of 6 \& 7 in the last 24 hours.
   2. A positive C. difficile stool toxin assay as assessed by C. difficile toxins A \& B - CARD\*.
   3. The requirement of CDI Standard of Care (SOC) antibiotic therapy (as per PI's discretion). 3) Individuals willing to give voluntary, written informed consent to participate in the study.

4) Individuals without/with antibiotic-associated diarrhea (indicated by use of antibiotics any time in last one week) will also be considered for the testing of C. difficile toxins

Exclusion Criteria:

1. History or presence of terminal/end-stage renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders (which might confound the interpretation of the study results, or put the individual at undue risk).
2. History of peptic ulcer.
3. History of abdominal surgery within the previous 3 months.
4. Presence of colostomy, gastric-tube, or naso-gastric-tube.
5. Individuals requiring any gastrointestinal surgery planned during the next 3 months.
6. HIV, AIDS, primarily immunodeficiency, cancer
7. Individuals with a very recent (\< 1 year) solid organ or bone marrow transplant.
8. Individuals requiring blood transfusion or renal dialysis planned during the next 3 months.
9. Unwilling to abstain using kombucha, sauerkraut, pickles and kimchi
10. Individuals with the following food intolerance - gluten, lactose, and/or histamine.
11. Heavy alcohol drinkers are defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/week.
12. Smokers.
13. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
14. Individuals who have participated in another clinical study(ies) with an investigational product within 90 days before screening, or who plan to participate in another study during the study period.
15. Use of any supplements (may include probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplementation the last 30 days.
Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).

Colonoscopy is the gold standard screening test for colorectal cancer (CRC). Removal of adenomas can reduce the incidence and mortality of CRC. However, there is evidence that some patients may develop interval cancers-cancers developed within 3-5 years following colonoscopy and polypectomy. The overall rate of interval cancer was 1.1-2.7 per 1000 person-years. Several studies have suggested that patients who develop interval cancers are more likely to have proximal compared than distal cancers.

One hypothesis is that adenomas may be more likely to be missed in the proximal colon compared with the distal colon. Serrated polyps and some adenomas in the proximal colon may be difficult to detect if they are flat, covered with mucus, or behind folds. A second hypothesis is that neoplastic lesions of the proximal colon may biologically differ from distal lesions and progress to malignancy with a short dwell time.

Several tandem back to back colonoscopy studies have demonstrated that up to 27% adenomas in the proximal colon are missed during routine screening colonoscopy. Hover, examining the colon twice as that in the back to back studies is difficult to be performed in clinical practice. Thus, we developed a novel colonoscopy technique, segmental examination twice of the proximal colon, that is simple and easy to be performed. The current study aims to examine the efficacy of segmental examination twice of the proximal colon on adenoma detection rate (ADR) during routine screening and surveillance colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Asia-Pacific Colorectal Screening score ≥2, such as patients ≥ 50 years, patients with a family history of colorectal cancer in a first-degree relative or male patients with current or past smoking.

Exclusion Criteria:

* Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
* The cecum could not be intubated.
* Inadequate bowel preparation (Boston Bowel Preparation Scale score \<2 in any segment of the colon).
* Biopsies were not available.
* Unable to provide informed consent.
A Study Evaluating the Bioavailability of Oral Insulin (N11005)

The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.


Eligibility Criteria:
Inclusion Criteria:

* 1) Volunteer to participate in the trial and sign an informed consent form; 2) 18-45 years old (including 18 and 45 years old) healthy male subjects (without heart, liver, kidney, digestive tract, neurological diseases, and metabolic abnormalities in the 4 weeks before screening; No abnormal clinically significant vital signs results, physical examination results, laboratory examination results and electrocardiogram examination results judged by the investigator at the time of screening); 3) BMI (body mass index): between 19-24 Kg/m2, including 19 and 24 Kg/m2; 4) Normal glucose tolerance (fasting plasma glucose \[FPG\] \<6.1 mmol/L, and oral glucose tolerance test \[OGTT\] 2-hour postprandial blood glucose \<7.8 mmol/L); 5) No family history of diabetes, obesity, etc.; 6) Insulin secretion function is normal (confirmed by insulin release test (IRT) judged by the investigator); 7) There is no planned parenthood during the study period, and it is agreed to use reliable contraceptive measures during the study period until 4 weeks after the last administration of the study drug; 8) Be able to communicate well with researchers and complete research in accordance with research regulations.

Exclusion Criteria:

* 1). Those who have serious systemic diseases, infectious diseases or mental disorders; 2). The results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, syphilis test are positive; 3). Those who have used any prescription drugs, Chinese herbal medicines and/or over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol) and health products (except routine vitamin supplements) within 2 weeks before screening; 4). Those who donated more than 400 mL of blood within 3 months before screening; 5). Severe smokers (25 or more cigarettes per day); 6). Alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who have a positive alcohol breath test result; 7). Those who have a history of drug abuse or have a positive urine test for illegal drugs; 8). Those who are known or suspected to be allergic to insulin and/or its excipients; 9). Those who have participated in other clinical trials within 3 months before screening, or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial; 10). Those who have any food allergies or have special dietary requirements and cannot follow a unified diet; 11). Those who have undergone gastrointestinal surgery before screening, or have a history of gastric obstruction or impaired gastrointestinal motility; 12). Those who are using gastric mucosal protective agents during screening; 13). Those who are deemed unsuitable to participate in this trial after the researcher's evaluation;
Awareness and Compliance Among Health Professionals of the Preoperative Fasting Period

Preoperative fasting is mandatory for anesthetic induction. This period of fasting is probably greater due to delays in the surgical theater and changes in daily operation schedules.Investigators want to resarch between the prescribed and the actual preoperative fasting time.

Before surgery, the patients will be asked to liquid, solid fasting times.and whether information is given about the fasting period.In addition, the appropriateness of health personnel to new guidelines for preoperative fasting will be evaluated.At the end of the study, the desired duration of fasting, clinical practice and trends of health personnel will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Between 1 day and 80 years
* Elective surgery
* Oral fed
* American Society of Anesthesiologists score of 1 or 3

Exclusion Criteria:

* Intensive care patient
* Parenteral nutrition
* Emergency surgery
Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined.

This study will test the hypothesis that continuous positive airway pressure (CPAP) has an acute lowering-BP effect in autonomic failure patients with supine hypertension. CPAP is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. It involves using a CPAP machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. For these studies, a commercial CPAP device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm H2O for 1-20 minute each. Depending on the BP response and tolerability to CPAP, CPAP may be applied during the night using a CPAP level that was tolerable and showed a BP-lowering effect during the acute test.

Eligibility Criteria:
Inclusion Criteria:

* Patients with autonomic failure and with supine hypertension from all races

Exclusion Criteria:

* All medical students
* Pregnant women
* High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
* History of serious allergies or asthma.
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have severe kidney disease
* Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
* All women must be post-menopausal (no longer menstruating) or surgically sterile

Exclusion Criteria:

* Patients requiring dialysis
* History of allergy to aspirin or clopidogrel
* Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
* Recent history of fainting or light-headedness
Feasibility of Permacol Use in Infected Fields

This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh


Eligibility Criteria:
Inclusion Criteria:

* Have given written Informed Consent
* Be 18-85 years of age (inclusive)
* Have prosthetic mesh that is in proximity to an infected wound that has failed conservative management for at least 3 months, with mesh exposure and a draining wound, or that is in proximity to an abscess that requires operative intervention.
* Have a wound characterized by purulent discharge, positive gram stain or positive culture to document infection
* Be a candidate for surgical removal of infected mesh placed for repair of ventral/incisional hernias and concomitant abdominal wall reconstruction
* Have an ASA Score ≤3
* Have a body mass index (BMI) between 16.5 and 40 inclusive
* Be a candidate for anticipated primary approximation of skin/wound
* Have a life expectancy of at least 18 months
* Be willing to allow biopsy of implant if secondary wound opening is performed or spontaneous implant exposure occurs

Exclusion Criteria:

* Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree
* Have an enterocutaneous fistula in proximity to wound/mesh
* Be a candidate for emergency surgery that would make giving valid Informed Consent impractical
* Be currently taking part in another clinical study that conflicts with the current study
* Have known allergy to porcine collagen products
* Have active generalized peritonitis or intraperitoneal sepsis
* Have active necrotizing fasciitis
* Have active abdominal compartment syndrome
* Have active untreated metabolic or systemic illness
* Report unintentional weight loss \>10% of body weight in the previous 90 days
* Have known collagen metabolism disorder.(e.g., Ehlers-Danlos syndrome)
* Have known altered immune response (e.g., HIV or other immunodeficiency disorder))
* Have chronic renal failure
* Have known active malignancy present
* Have history of systemic chemotherapy within previous 1 year
* Have lifetime history of radiation to the abdomen, pelvis or thorax
* Have inguinal or groin hernia as primary diagnosis
* Be currently pregnant or planning to become pregnant during study period
* Be unable to give valid informed consent or comply with required follow- up schedule
* Suffer from mental capacity sufficiently severe to make informed consent unobtainable
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).


Eligibility Criteria:
Inclusion Criteria:

Phase 0 study

* Advanced MTC with elevated levels of calcitonin (\> 100 pg/ml) and/or calcitonin-doubling time \< 24 months before or after total thyroidectomy or
* Patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
* Age \> 18 years
* Informed consent

Phase I study

* Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
* Advanced MTC with elevated levels of calcitonin (\> 100 pg/ml) and/or calcitonin-doubling time \< 24 months before or after total thyroidectomy- Age \> 18 Years
* Informed consent
* Curative surgical therapy not possible

Exclusion Criteria:

Phase 0 study

* Medication with Vandetanib 3 weeks before the study and during the study
* Renal failure (calculated glomerular filtration rate (GFR) \< 60 ml/min per 1.73 m2 body surface).
* Bone marrow failure (thrombocytes \< 70 000/μl, leucocytes \< 2 500/μl, hemoglobin \< 8 g/dl).
* Pregnancy and breast feeding
* Knows allergic reaction on Physiogel or other gelatine products
* Known, serious side reaction in the case of a former application of pentagastrin
* Active, second malignancy oder remission after second malignancy \< 5 years

Phase I study

* Medication with Vandetanib 3 weeks before the study and during the study
* Renal failure (calculated GFR \< 50 ml/min per 1.73 m2 body surface).
* Bone marrow failure (thrombocytes \< 100 000/μl, leucocytes \< 3 000/μl, hemoglobin \< 10 g/dl).
* Pregnancy and breast feeding
* Known, serious side reaction in the case of a former application of pentagastrin
* Active, second malignancy oder remission after second malignancy \< 5 years
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15

This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody
* Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin
* Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
* Subjects who have been positive for CCR4 by CCR4 expression analysis
* Subjects who have never been treated for adult T-cell leukemia-lymphoma
* Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
* Subjects with a performance status of 0 to 2
* Subjects who have been negative for HBs antigen and anti-HCV antibody
* Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

* Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
* Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
* Subjects who have been positive for anti-HIV antibody
* Subjects with active multiple cancer
* Subjects with a history of allergic reactions to therapeutic antibodies
* Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses or who may require such radiotherapy after the start of the study
* Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children
Evaluating a Website for Parents of Injured Children

The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills.

The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. Secondary objective is to compare conditions as above with regard to child and parent PTS symptoms at 6 wks.

Eligibility Criteria:
Inclusion Criteria:

1. Children age 6 through 17 who sustained an injury within the past 2 months and their parents.
2. Have access to the Internet at home (for Stage 3 only)

Exclusion Criteria:

1. Parent does not read or understand English
2. Child's injury is due to participation in organized sports
3. Child's injury is due to suspected abuse or family violence
A Study on Behavioral and Psychological Symptoms of Dementia

The purpose of this observational study is to obtain the current status of patients with Behavioral and Psychological Symptoms of Dementia. This study is also expected to further provide insight into the evolution of behavioral and psychotic symptoms and its relationship with treatment as well as severity of cognitive declines in a naturalistic setting.

This is an observational, prospective, multi-center study to obtain information about the symptoms and treatment received for patients with behavioral and psychological symptoms of dementia (BPSD). Patients must first meet eligibility criteria and sign informed consent. Patient treatment will be based upon investigator opinion. The following parameters will be assessed: patient's characteristics, Clinical Global Impression (CGI) score, Neuropsychiatric Inventory (NPI), and Minimal Mental Status Examination (MMSE). Each patient will be observed for 12 weeks. Medication dosing regimen will be flexible throughout the study and is based on patient response and investigator judgment. During the study observation period, all patients will attend clinic visits for the subsequent 12 weeks (visit 2 to 3) as is the usual clinical practice. Patients can visit clinics on additional dates as needed or by request. At the pre-planned clinic visits, CGI score, NPI, vital signs, reports of adverse events, drug information, and MMSE score (visit 3) will be recorded. This is an observational study and no study drug is administered.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of dementia according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria
* Patients meet one of the following types of Dementia: Dementia of the Alzheimer's Type (AD), Vascular Dementia (VaD), Dementia of Lewy Body (DLB), Parkinson's Disease Dementia (PDD)
* Patients have one or more active symptoms of Behavioral and Psychological Symptoms of Dementia (BPSD) on Neuropsychiatric Inventory (NPI) and have not received treatment with antipsychotics, mood stabilizers, or antidepressants within 1 month prior to study entry
* Patients are with caregiver(s) who can give appropriate information about the patients and can assist with the assessment during the study
* Patients (or a legally acceptable representative) have signed the informed consent form

Exclusion Criteria:

* Patients with concurrent other primary major psychiatric disorders (such as Schizophrenia or Bipolar disorder)
* Patients with history of severe allergies or multiple adverse drug reactions
* Patients with history or current symptoms of tardive dyskinesia
* Patients with history of neuroleptic malignant syndrome (NMS)
* Patients who participated in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry