cyrilzakka/clinical-trials huggingface dataset:
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152).


Eligibility Criteria:
Inclusion Criteria:

* Able/willing to provide informed consent
* Between 18-75 years of age
* Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not predicted based on pre-operative National Comprehensive Cancer Network guidelines to meet criteria for adjuvant chemotherapy, or a history of diverticulitis.
* Able to provide fecal samples.
* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence

Exclusion Criteria:

* Any history of inflammatory bowel disease
* Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential on the proposed day of MTP-101P (prior to its administration). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTP-101P.
* Life expectancy of \< 6 months
* Presence of ileostomy or colostomy
* Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
* Patients with neutropenia (an absolute neutrophil count \<0.5 x 10\^9 cells/L) obtained on a complete blood count with differential at screening.
* History of solid organ or bone marrow transplant.
* Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).
* History of severe anaphylactic food allergy.
* History of celiac disease.
* Patients receiving cancer chemotherapy, immunotherapy, or radiation.
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group

Background:

Adenoma detection rate is one of the most quality indicator: an accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality1,2. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5.

Equipment and technique to improve ADR: To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10.

Application of 3D endoscopy on GI disease: 3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination.

Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 40 years of older
* Subjects who have positive fecal immunochemical test

Exclusion Criteria:

* Contraindication for colonoscopy
* Subjects with familiar or hereditary polyposis
* Subjects with history of colectomy
* Inadequate bowel cleansing level
* Subjects with inflammatory bowel disease
Effects and Safety of Metronidazole in Patients With Gastrectomy

Recent study showed that SIBO is common among postgastrectomy patients and It appears to be associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO could be a new therapeutic target for managing intestinal symptoms in postgastrectomy patients.The purpose of this study is to determine whether antiboitic (metronidazole) is effective in patients with postgasrectomy syndrome


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70
* gastrectomy for early gastric cancer with complete resection
* no reccurrence after follow up more than 6 months
* identified small bowel bacterial overgrowth by hydrogen breath test
* symptoms of postgastrectomy syndrome

Exclusion Criteria:

* hypersensive to metronidazole
* systemic chemotherapy history
* other organic gastrointestinal disease (inflammatory bowel disease, carcinoid syndrome, amyloidosis, intestinal obstruction)
* other gastrointestinal operation history except appendectomy, cholecystectomy)
* recent colonoscopic examination (within 30 days)
* uncontrolled psychopathy
* drug or alcohol abuser
* pregnant or breast feeding woman
* recent history of antibiotics treatment (within 90 days)
* recent history of PPI or H2 blocker treatment (within 30 dyas)
* recent history of probiotics treatment (within 30 dyas)
* recent history of prokinetics or antispasmotic treatment (within 15 days)
* severe systemic illness
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, based on the screening visit and medical history,
* BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27;
* Able to understand and sign informed consent form.

Exclusion Criteria:

* Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis),
* Any medication impacting dietary fat absorption and metabolism,
* Pregnancy (on anamnesis) and/or lactation,
* Known food allergy and food intolerance,
* Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional,
* Individuals under ketogenic diets, or taking regular ketones products,
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier,
* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study,
* Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland,
* Volunteer who cannot be expected to comply with the protocol,
* Smokers unable to stop for the day of the visit.
Efficacy of Platelet- and Extracellular Vesicle-rich Plasma in Chronic Postsurgical Temporal Bone Inflammations

This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma (PVRP) for the treatment of chronically inflamed post-surgical temporal bone cavities. Half of the participants will be treated with platelet- and extracellular vesicle-rich plasma and another half with standard nonsurgical measures.

The hypothesis of this study is that platelet- and extracellular vesicle-rich plasma (PVRP) may be efficient in the treatment of chronically inflamed post-surgical temporal bone cavities.

Platelet-rich plasma (PRP) is a well-known autologous blood-derived product with favourable immune, haemostatic and regenerative effects. It has been used in various medical fields including otorhinolaryngology.

In fact, PRP contains important concentrations of extracellular vesicles (EV) which are the main contributors to PRP effects. For that reason, PRP can be identified as platelet- and extracellular vesicle-rich plasma (PVRP). In this study, PVRP will be prepared by a unique non-commercial 2-step centrifugation protocol developed by this study researchers.

A radical cavity is a large post-surgical temporal bone cavity due to removal of the posterior external ear canal wall in open-technique cholesteatoma surgery. This technique is performed in approximately 40 per cent of cholesteatoma surgery.

Radical cavities become inflamed in 3-20 per cent, which leads to the formation of granulation tissue and multiple suppurative periods. The large spectrum of surgical and nonsurgical treatment options have been applied to reduce patient discomfort. This significantly worsens the patients' quality of life and puts a significant burden on health care.

Due to the knowledge of local immune response mechanisms in moist radical cavities and exhausted treatment options, new conservative treatment options have been researched. PVRP could present a promising treatment option for chronically inflamed radical cavities based on published preclinical and clinical studies.

PVRP will be administered to chronically inflamed radical cavities via PVRP-soaked ear wicks.

Eligibility Criteria:
Inclusion Criteria:

* chronic otitis media, defined as a presence of at least 1 of the following: visible ear discharge, indirect signs of ear discharge (e.g. on a pillow, clothes), ear itching, the sensation of ear fullness, clinical signs of acute exacerbation of chronic otitis media during an otomicroscopic examination.
* non-cholesteatomatous chronic otitis media despite prior standard conservative treatment
* non-cholesteatomatous chronic otitis media despite prior surgical treatment

Exclusion Criteria:

* the presence or suspicion of cholesteatoma
* infection of venepuncture site
* pregnancy
* breastfeeding
* long-term treatment with antimicrobial drugs
* long-term treatment with immunosuppressant drugs
* the presence of systemic infectious disease
* the presence of an autoimmune disease
* the presence of cancer
* receiving other types of experimental treatment for chronic otitis media
PAP Therapy Sleep Apnea and Exercise

Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators sought to verify this by assessing cardiac and pulmonary function during exercise.


Eligibility Criteria:
Inclusion Criteria:

* obstructive sleep apnea diagnosed by polysomnography
* CPAP therapy indicated

Exclusion Criteria:

* obstructive or restrictive lung disease
* cardiac failure
* acute coronary syndrome
* inability to cycle
Explore the Mechanisms of Pruritus in Bullous Pemphigoid Patients During Remission

The following is the investigators hypothesis regarding the pruritus of BP patients during remission. Anti-BP 180 IgE binds to dermal mast cells, inducing their activation and secretion of mediators after being cross-linked by antigens. Among mediators, histamine directly induces itching and vessel changes, whereas tryptase potentiates itching and vessel changes in an indirect way through the actions of neuropeptides. Tryptase stimulates neurons which in turn secrete neuropeptides.

Bullous pemphigoid(BP) is a cutaneous autoimmune blister disease. In addition to blisters formation which disrupt skin barrier and result in high mortality, erythematous edematous plaques often develop on skin of bullous pemphigoid patients accompanied with intensive pruritus. As regard with the pathogenesis of BP, it is generally accepted that anti-BP180 IgG is the most important pathogenic factor for blister formation, whereas anti-BP180 IgE which binds to mast cells and induces their activation results in erythematous edematous plaques. Quite a few bullous pemphigoid patients suffer from intensive pruritus even during clinical remission period that means blisters or plaques are no longer on their skin. The reasons why pruritus persists during this period are still obscure.

Pruritus is the most common symptom of cutaneous diseases. Our understanding regarding pathophysiology of "pruritus" has made a remarkable progress in the past decade. Now, it is known that there are various kinds of substances that induce pruritus (pruritus mediators) and different combinations of these mediators are involved in different itching diseases. Moreover, neuropeptides secreted by stimulated neurons can in turn induce neurogenic inflammation.

The following is our hypothesis regarding the pruritus of BP patients during remission. Anti-BP 180 IgE binds to dermal mast cells, inducing their activation and secretion of mediators after being cross-linked by antigens. Among mediators, histamine directly induces itching and vessel changes, whereas tryptase potentiates itching and vessel changes in an indirect way through the actions of neuropeptides. Tryptase stimulates neurons which in turn secrete neuropeptides.

Thus, in order to test our hypothesis, the strategy of this study is to compare parameters between two groups of patients, bullous pemphigoid patients in remission with pruritus and without pruritus. The following parameters in serum and skin will be measured: total IgE, anti-BP 180 IgE, the number and activated status of mast cells, the amount of some mediators and neuropeptides produced by mast cells and neurons, respectively. In addition, these parameters in active stage will also be measured for reference and with a hope to find useful parameters for predicting the persistence of pruritus in remission.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bullous pemphigoid

Exclusion Criteria:

* Patients have other disorders which can lead to itching sensation
Determination of Factors Related With Daily Living Activities in Severe COPD

The main purpose of chronic obstructive pulmonary disease (COPD) rehabilitation applications is to increase the functional capacity of the patients and improve the quality of life in daily living activities (ADL). Therefore, the investigators planned the study to determine the influence of ADL and related factors in severe COPD.

GOLD C and D COPD patients admitted to Bezmialem Vakif University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Pulmonary Rehabilitation Application and Research Laboratory will be included in this study on a voluntary basis. Individuals who have experienced exacerbations of COPD in the last 6 weeks, have comorbidities affecting ambulation and have cognitive impairment will be excluded. Physical and sociodemographic characteristics of all participants will be recorded. Spirometric measurement will used to evaluate pulmonary functions, London Chest Activities Scale (LCADL) will used to evaluate daily living activities, six minute walking test (6MWT) will used to evaluate functional capacity, and mouth pressure will measured to evaluate respiratory muscle strength. (MIP: maximal inspiratory pressure, MEP: maximal expiratory pressure). Saint George Respiratory Questionnaire (SGRQ) for assessing quality of life, International Physical Activity Questionnaire (IPAQ) for assessing physical activity, COPD Assessment Test (CAT) for symptom assessment, and Hospital Anxiety and Depression Scale (HAD) for anxiety and depression assessment will be applied. SPSS 22.0 package program will be used in statistical analysis. For descriptive statistics, mean ± standard deviation values will be calculated and Pearson correlation test will be used in correlation analysis. p \<0.05 will be the level of significance.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary function tests (PFT) value of FEV₁ / FVC \<70%,
* Being in GOLD III-IV groups,
* Being over 18 years old,
* Being able to read and to understand the spoken language.

Exclusion Criteria:

* subjects have had COPD exacerbation in the last six weeks,
* having comorbidities affecting ambulation and
* cognitive disorders.
Cold Snare Endoscopic Mucosal Resection Trial

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. The concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. This may lengthen procedure time and increase the risk of incomplete resection.

Furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. Normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. Eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. It is unclear how these two solutions compare with respect to resection efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
* Patients with a ≥20mm non-pedunculated colorectal polyp

Exclusion Criteria:

* Pedunculated polyps (as defined by Paris Classification type Ip)
* Suspected adenocarcinoma with deep submucosal invasion
* Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma
* Patients with inflammatory bowel disease
* Patients who are receiving an emergency colonoscopy
* Poor general health (ASA class\>3)
* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
* Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
* Pregnancy
Fast-track Surgery for Perforated Peptic Ulcers

The concept of "enhanced recovery after surgery" has become increasingly popular in elective abdominal surgeries. Yet, the role of this concept has not been described in emergency procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery in patients with perforated peptic ulcer.

The study is designed as a randomized, controlled clinical study. The patients with a preoperative diagnosis of perforated peptic ulcer will be recruited for the study. Among those, the patients with a definitive diagnosis of perforated peptic ulcer confirmed by surgical exploration will be included.

The patients will be randomized according to their protocol number given automatically by the registration system of the hospital during admission. The patients who have an odd protocol number will have conventional surgical protocol, and those who have an even protocol number will have fast-track surgery protocol.

The conventional surgical protocol for perforated peptic ulcers is composed of regular general anesthesia, postoperative pain control by intravenous analgesics, removal of nasogastric tube by the end of 48th postoperative hour, initiation of oral intake after clinical signs of active bowel movement is observed. Fast-track surgery protocol, however, is composed of general anesthesia with short-acting agents and the use of regional anesthesia if possible, removal of nasogastric tube during recovery from anesthesia, aggressive pain control, initiation of oral intake by the end of 48th postoperative hour.

All of the patients will be scheduled for control gastroscopy in the end of six weeks after surgery.

Primary end-point is the morbidity and mortality rate. Secondary end-points are length of hospital stay, readmission rate, endoscopic findings in control gastroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Perforated peptic ulcer located in the stomach or the duodenum

Exclusion Criteria:

* The patients who refuse to join the study or to sign the informed consent form
* The patients who are unable to understand and sign the informed consent form
* Age younger than 18
* The patients with a possibility of having trouble in communicating with or reaching the investigators during the first 6 weeks after surgery
* The patients who are considered as ASA class 4
* Shock on admission
* The patients who have serious negative factors for wound healing such as steroid usage, autoimmune diseases
* Pregnant
* Previous upper abdominal surgery
* The patients who are found to have a pathology other than perforated peptic ulcer during surgical exploration
* The patients who are found to have malignant ulcer during surgery or in postoperative period
* Concomitant bleeding peptic ulcers
* Peptic ulcer perforations with a diameter greater than 5 mm, which are not suitable for simple repair techniques
* Multiple perforated peptic ulcers