cyrilzakka/clinical-trials huggingface dataset:
Mucosal and Microbiota Changes During Acute Campylobacteriosis

Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are doing this study to understand if changes in gut bacteria and gut mucosal lining during an acute infection can help identify individuals who might be at risk for developing problems in the future.

Gastrointestinal (GI) infections involving a variety of bacterial, viral, and parasitic pathogens predispose patients to post-infectious irritable bowel syndrome (PI-IBS) and other functional GI disorders1. Campylobacter is one of the top five organisms responsible for food-borne illnesses causing approximately 0.8 million cases annually2. Isolated C. jejuni infection has been associated with a PI-IBS risk of 9% to 13%3. Epidemiological studies have identified female gender, age \<60 years, smoking, enteritis severity, and pre-enteritis psychological stress as risk-factors for development of PI-IBS4. In a single study, variants in host genes TLR9, IL6, and CDH1 were identified as independent risk factors for development of PI-IBS after controlling for previously identified clinical risk factors5. In another study, host cytokines were looked at in relation to development of reactive arthritis and IBS following Campylobacter enteritis. The risk of acquiring clinical gastroenteritis with Campylobacter jejuni/coli was related to the INFG (+ 874A\>T) of intron 1. Polymorphisms in IL-18 and INFG were linked to the risk of post-infectious reactive arthritis, but not to PI-IBS6. However, this study was limited by assessment of only serum cytokine profile and not mucosal. A recent study has shown that fecal microbiota of patients with PI-IBS differs from that of healthy controls and resembles that of patients with IBS with diarrhea (IBS-D)7. The microbiota is altered during acute enteritis, but it is unclear if there are any signatures in acute microbiota alterations that can help predict development of PI-IBS following Campylobacter enteritis. Our overall goal with this study is to identify non-invasive and invasive host factors that can help predict the development of PI-IBS following Campylobacter enteritis.

Eligibility Criteria:
Inclusion Criteria:

* No abdominal surgery (except appendectomy and cholecystectomy)
* Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter

Exclusion Criteria:

* History of IBS, Irritable Bowel Disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.
* History of gastroenteritis in six months prior to Campylobacter enteritis
* Pregnancy
Study of the Metabolism of Danicopan in Healthy Adults

This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.

For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

1. No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
2. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
3. Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
4. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

1. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
2. History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period 1.
3. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
4. History of procedures that could alter absorption or excretion of orally administered drugs.
5. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
6. Body temperature ≥ 38.0°Celcius at screening or prior to first dosing or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
7. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
8. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, receipt of blood products within 6 months prior to first dosing, or receipt of a vaccine within 30 days prior to first dosing.
9. Is a female with a positive pregnancy test or who is lactating.
Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer

To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer.

RAndomized pilot study of supplemental Iscar in combination with Gemcitabine vs. Gemcitabine alone as second line treatment for advanced non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed IIIB and IV NSCLC who have failed one prior line of chemo
* Karnofsky score 60% or greater
* patients who will be treated with Gemcitabine
International REACH Forgiveness Intervention

Six sites spanning five regions (Hong Kong, Colombia, Indonesia, Ukraine, South Africa) will administer a forgiveness workbook intervention in a randomized design with a stepped, waitlist intervention deployment.

Intervention deployment:

ODO1 X O2 O3 (immediate-treatment \[IT \] group) ODO1 O2 X O3 (delayed-treatment \[DT \] group)

where OD denotes measurement of baseline demographic and personality measures, X denotes deployment of the intervention, and O1, O2, and O3 denote measurements of outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to read and comprehend the materials in the workbook
* Must be 18 years old or above
* Have someone in mind they want to forgive

Exclusion Criteria:

* No
Stem Cell Factor, a Potential Biological Marker of Skin Involvement in Systemic Sclerosis?

This project aims to study systemic sclerosis and find a serum marker of its cutaneous involvement.

Systemic sclerosis (SSc) is a rare immune disease that is part of connectivitis and is characterized by fibrosis and vasculopathy. Multiple visceral lesions involving these two processes make up the severity of this disease. Its dermatological involvement is a fundamental clinical element.

Systemic sclerosis is mainly divided into two subtypes, depending on the extent of dermatological involvement: limited and diffuse systemic sclerosis. These also differ in certain autoantibody profiles and clinical features. Nevertheless, it is still necessary to determine certain criteria, markers, making it possible to distinguish at an early stage the presence of limited or diffuse systemic sclerosis. The latter being characterized by more severe organic and cutaneous involvement and excess mortality. This would allow for more aggressive management from the outset at an early onset of the disease.

In general, it is known that this pathology is characterized by dysfunction of endothelial cells (EC) and fibroblasts as well as autoimmunity. Many mediators contribute to the fibroblast activation observed in SSc. However, transforming growth factor beta (TGFβ) is considered to be the central regulatory factor of fibrosis processes.

It is also known that endothelial cells interact with mast cells through the production of Stem Cell Factor (SCF) to induce their proliferation and differentiation. The damaged skin tissues in systemic sclerosis are infiltrated in particular by mast cell cells which produce TGFβ.

The team of Kihira et al (1998) demonstrated the presence of a high level of SCF in the serum of patients with systemic sclerosis.

Few studies explore this possible production pathway of TGFβ in systemic sclerosis via SCF assay.

This study will allow the investigators to:

* study this possible route of fibrosis through the dosage of SCF in the serum of patients suffering from systemic sclerosis
* describe SCF as a possible biomarker of skin involvement by hypothesizing that the dosage of SCF will be higher in patients with diffuse scleroderma compared to those with limited scleroderma


Eligibility Criteria:
Inclusion Criteria:

* Patients followed regularly at CHU Brugmann in Rheumatology/Dermatology for limited or diffuse systemic sclerosis in accordance with the ACR/EULAR 2013 criteria.
* Control patients recruited among patients followed for mechanical pathology in rheumatology

Exclusion Criteria:

* Patients with comorbidities of hematological diseases, asthma or severe chronic renal failure (GFR \< 30)
Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.

Eligibility Criteria:
Inclusion Criteria:

* Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
* Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
* Prior regular use of any of the investigational products.
Cheese Intake and Hypercholesterolemia

In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.


Eligibility Criteria:
Inclusion Criteria:

* 42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL),
* 30-60 years of age

Exclusion Criteria:

* Pregnant (or those planning to become pregnant during the study period) and lactating women were excluded;
* also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit.
* In addition, those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening, were not enrolled.
* Volunteers with the following characteristics were also excluded:

  * total cholesterol ≥ 300 mg/dL,
  * serum triglycerides ≥ 250 mg/dL or ≤ 200 mg/dL,
  * HDL ≥ 70mg/dL,
  * BMI ≥ 30, or
  * uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or
  * diastolic blood pressure ≥ 100 mm Hg) at screening.
Italian Registry Chronic Pancreatitis

ITARECIPE is a multicenter national registry designed to study the diagnosis and evolution of Chronic Pancreatitis

Chronic pancreatitis (PC) is a relatively rare disease (45/100,000 population) in Italy, with heterogeneous aetiology, clinical history and treatment.

Patients need to be treated by different specialists, but almost always the gastroenterologist is central in diagnosis and treatment.

The study will be the first National Registry, prospective and will collect data on the history of the disease and its outcomes.

Data will be collected through an electronic data collection form (e-CRF) that the Sponsor (AISP) will make available to the Participating Centres.

Patients enrolled will be both new diagnoses or follow-up visits of patients with a diagnosis already made no more than 1 year before the signing of informed consent for the study in question: only data on the diagnosis and follow-up visits prior to the signing of the informed consent will be collected retrospectively (no more than one year).

Data from patients visited in the Centres included in the study will be collected prospectively.

In addition to the first visits, data will also be collected on follow-up visits that are scheduled according to the clinical need of each patient, which differ according to the stage of the disease

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 12 years;
* Diagnosis "definite" or "probable" according to the "M-ANNHEIM" criteria;
* First evidence of diagnosis within 12 months of enrolment.

Exclusion Criteria:

* Age \< 12 years;
* History of known disease with certainty for \> 12 months.
Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU

The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU.

This is a monocentric interventional study (RIPH 2).


Eligibility Criteria:
Inclusion Criteria:

* Patient \> or =18 years
* Hospitalization in intensive care
* PCR COVID 19+ or compatible clinical signs (fever, cough, myalgia, asthenia, loss of taste, anosmia) associated with compatible radiological signs

Exclusion Criteria:

* Pregnancy in progress
* Patient \<18 years
* Patients deprived of freedoms or under guardianship
* Patient or family opponent of protocol participation
* patient on curative anticoagulant for more than 48H00
* impossible Venous Doppler Echo
Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes

The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor outcome (\<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve higher cure rates have more side effects. Hence the investigators propose to use Interim PET CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is known that those with interim PET positive disease have a cure rate of less than 10-15% if continued with ABVD alone) and to use EB selectively in this population in an attempt to improve treatment outcomes - at the same time to limit side effects of therapy.

Thus, this study is an attempt to improve the outcome in the small subset of poor responders to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Age 12-65 years old
* Newly diagnosed histology proven patients of advanced HL (stage IIb, III and IV)
* Patients' performance status ECOG 0-2
* Normal hematopoetic parameters except if due to marrow involvement by disease (WBC \> 4000/cmm, Platelet count \> 100,000/cmm)
* No uncontrolled hepatitis B/C infection; and normal LFT values with s -Bilirubin, SGOT and SGPT not more than 2.5 times upper limit of normal (unless initially due to liver involvement by disease)
* Serum Creatinine ≤ 2mg/dL unless elevated due to involvement by disease
* Cardiovascular/ Metabolic: No severe cardiac disease that would limit normal life expectancy or preclude study. LVEF at least 50%; Controlled blood glucose if diabetic; controlled Blood pressure if hypertensive
* Pulmonary: No severe pulmonary disease that would limit normal life expectancy or preclude study
* Others: HIV negative status; No prior haematological cancers or chemotherapy or radiation therapy in the past

Exclusion Criteria:

* Pregnancy
* Nursing mothers
Treating Depression with Text Messaging

The purpose of the research study is to investigate whether CBT-txt, a counseling program delivered by text messages is effective in stopping or reducing depressive symptoms. CBT-txt is based on a counseling program that has been proven to reduce depression when delivered in-person and on the web, but has not yet been tested or shown to be effective when delivered by text.

After being informed about the study and potential risks, participants will complete online screening assessments. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the waitlist-control group. Those who are randomized to the intervention group will receive the 8-week text intervention via smartphone and complete assessments at baseline, 1 month, 2 months, and 3 months. Those who are randomized to the waitlist-control group will only complete the assessments at baseline, 1 month, 2 months, and 3 months. Participants who are initially assigned to the waitlist-control group can choose to receive the text intervention once their 3-month participation is complete.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 25 years old
* a score of at least 5 on the PHQ-9 (indicating elevated depression symptoms

Exclusion Criteria:

* treatment for depression during the past three months
* endorse suicide ideation on the PHQ-9\*
* lack of access to a text-capable phone
* unable or unwilling to commit to two months of follow-up
* not fluent in English.
Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

MedlinePlus related topics: Blood Sugar

Primary Outcome Measures:

* Fast glucose and HbA1c change between the baseline and end of study \[ Time Frame: From baseline to 30 and 100 days\]
* \[ Designated as safety issue: No \]
* Successful rate of blood glucose control (the proportion of patients with HbA1c \<7%) \[ Time Frame: From baseline to 30 days and 100 days\] \[ Designated as safety issue: No \]

Secondary Outcome Measures:

• To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36 \[ Time Frame: From baseline to month 1 \] \[ Designated as safety issue: No \]

This study is aimed to evaluate the safety and efficacy of Sangrow Decotion, diet and exercise for the treatment of type 2 diabetes. Previous study has shown that this therapeutic regimen is safe and effective.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus patients who have received medical treatment for more than 3 months
* Patients willing to sign written informed consent form

Exclusion Criteria:

* Patients unable or unwilling to comply with the requirements of the protocol
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage fluids of Breast Cancer patients.

Breast cancer is the leading cause of cancer incidence and the second leading cause of cancer mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of developing breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have a history of breast cancer.
* Patient must be scheduled to receive standard treatment with Arimidex for adjuvant hormonal management.
* Patient must be willing to undergo a duct lavage.
* Patient must sign an Informed Consent.

Exclusion Criteria:

* None.
Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis

The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).

Exclusion Criteria:

* Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed
A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants

Objectives:

To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma, after a single intravenous (IV) dose and after a single oral dose of Genz-112638 (unlabeled).

To determine the PK, total recovery, routes and rates of excretion, and the metabolic profile of Genz-99067 after 5 days of BID oral dosing with unlabeled Genz-112638 followed by a single dose of \[14C\]-Genz-112638.

The maximum study duration for an individual subject was approximately 65 days from the beginning of Screening through the Safety Follow-up visit.

Eligibility Criteria:
Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure The subject has a body weight of 50 to 100 kg \[110 to 220 pounds (lb)\] with a body mass index (BMI) less than 30 kilograms per square meter (kg/m2) at Screening.

The subject's physical examination results, vital signs, laboratory assessments, and cardiac assessments are within normal limits or, if abnormal, are not clinically significant at Screening and Day -1. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

Prolonged QTc interval (eg, repeated demonstration of a QTc interval ≥450 msec), family history of long QT or Brugada Syndrome, and/or history of sudden death in a first-degree relative.

The subject receives an immunization within 30 days of providing informed consent.

The subject has a history of drug allergies (eg, significant rash, hives, etc in response to antibiotics).

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.