cyrilzakka/clinical-trials huggingface dataset:
COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

Early and adequate fluid resuscitation (\< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Improving fluid balance is considered crucial in the management of patients in septic shock, but the efficacy of the measures currently proposed (diuretics associated or not with albumin and/or dialysis) is controversial. The investigators hypothesize that a whole-body compression using a body bandage could reduce capillary leakage and thus lead to faster restoration of a normal transmural pressure gradient in postcapillary venules and improve venous return.

This is the first study to evaluate mechanical compression using a body bandage to reduce oedema in septic shock.

To do this, a whole-body compression will be set up within the 12 hours following admission. Water balance will be monitored daily throughout the duration of the compression and vital status of patients will be search at 7 days, 28 days and 90 days.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from a person of trust,
* Patients aged 18 years or over,
* Admitted to a Medical ICU for less than 24 hours,
* For severe sepsis or septic shock and requiring fluid resuscitation because of hypotension and/or persistent signs of circulatory shock,
* On mechanical ventilation with orotracheal intubation,

Exclusion Criteria:

* Person not covered by national health insurance
* Recent abdominal or pelvic surgery,
* Contra-indication for a body bandage (PAD, Compartment Syndrome, acute rhabdomyolysis, wounds),
* Pregnant women,
* Patients with severe sepsis or septic shock for more than 24 hours,
* Patients who are moribund or in whom death is probably imminent (within 24h),
* Patients who have given instructions not to be resuscitated,
* Patients under ward of court.
Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis

This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases.

Early diagnosis of oral lesions, particularly oral cancer, is crucial for enhancing prognosis, facilitating early intervention and care with the intention of lowering disease-related mortality.

Since conventional oral examination (COE) is the most used method in identifying oral lesions, the average dental practitioner's experience is a decisive factor in early diagnosis.

Visual examination lacks specificity and sensitivity since its highly subjective. Unfortunately, Studies show that the majority of dentists lack expertise in early detection of the disease, resulting in false negative diagnosis of oral lesions.

General practitioners are found to either delay the referral of a suspected oral lesion to an Oral Medicine specialist, or referring numerous false positive cases, unnecessarily pushing the patients into a state of anxiousness and cancer phobia. False positive referrals overburden the specialists, which will eventually cause delayed diagnosis of true positive cases due to the oversaturation with false positive ones.

diagnostic research scope shifts towards noninvasive, easy chair side methods with higher accuracy for early detection of oral lesions. Recent approaches towards using machine based programs indicate that this machine-learning method may be useful in the detection and diagnosis of oral cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old
* Candidates with normal oral cavity findings
* Candidates with variations of oral cavity findings
* Candidates with different oral lesions

Exclusion Criteria:

• Patients less than 18 years old
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
2. Male or female subjects ≥ 18 years.
3. A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment

Exclusion Criteria:

1. Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Active irritable bowel syndrome with diarrhea within the previous 12 months.
4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery.
5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months.
6. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
7. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 may be enrolled.
8. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
9. Absolute neutrophil count \< 500 cells/mm3
Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC)

This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.

This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.

In the context of clinical practice of general surgery and apparatus digestive services, patients entering with mild acute pancreatitis will be asked to participate in the study and if so, they will sign the informed consent.

On admission, demographic and anthropometric data of the patient will be recorded, as well as medical history, patient's admission data and vital signs. Patient's blood will be drawn for analysys and the risk of organ failure will be measured by modified Marshall and Apache II scales. The assessments and procedures performed are the standard practice at the center.

At 24 hours (± 3 hours) and at 7 days (or nine days to avoid weekends) after admisison, vital signs will be recorded, laboratory tests will be performed and the risk of organ failure will be measured by modified Marshall and Apache II scales.

At discharge of the patient (regardless of when it occurs), the outcome of the acute pancreatitis will be recorded.

. Those patients discharged within the first month after admission will be visited or called (according to standard practice at the center) one month after arrival, to record follow-up data, including health condition, readmissions and abdominal pain evaluation by visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mild acute pancreatitis according to seriousness criteria established by Banks et al, 2013.
* Patients of either sex aged ≥ 18 years .
* Patients who have given their written informed consent

Exclusion Criteria:

* Patients with exacerbated chronic pancreatitis.
* Patients with coagulation disorders (congenital and acquired antithrombin deficiency) .
* Patients with liver cirrhosis.
* Pregnant patients
Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study

There are controversies about the best sites -biopsy based -tests for H pylori associated gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia. 400 patients with dyspepsia are planned to be enrolled in this study. in addition to the routine antral biospy, corpus biospies are taken to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in this study are those with peptic ulcer disease, previous upper gastrointestinal surgery, a known or a suspected past history of H.pylori eradication therapy, a personal or first-degree family history of gastric cancer

Exclusion Criteria:

* those having received antibiotic or proton pump inhibitor treatment one month beforehand
Coloplast DialogueStudy

The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Eligibility Criteria:
Inclusion criteria

* Signed informed consent before any study related activities
* Subjects with a colostomy, ileostomy or urostomy
* Subjects must have had their ostomy for at least 6 months
* Subjects must have mental capacity to understand the study and questionnaires
* Subjects must be at least 18 years of age.

Exclusion criteria

* Women who are pregnant or breast-feeding
* Subjects who have more than one ostomy
* Subjects with an ostomy who use plug
* Participation in other studies at the same time
* Previous participation in this study
Anxiety Disorders, Depression and Related Factors in PCOS

Polycystic ovary syndrome (PCOS) is a systemic neuro-endocrine-metabolic-reproductive disorder, common in women of reproductive age, affecting 21.27% of women worldwide and the rate of PCOS has been increasing over the past decade.

Women with PCOS have many health problems, including insulin resistance, hyperandrogenemia, and ovulation disorders. Moreover, PCOS is also associated with significant consequences such as increased risk of cardiovascular disease, glucose intolerance and diabetes mellitus (both type 2 and gestational), increased risk of endometrial hyperplasia and endometrial cancer and mental health disorders.

A meta-analysis of 57 studies has been reported that women with PCOS are more likely to have an increased risk of diagnosis of depression, anxiety, bipolar disorder, and obsessive-compulsive disorder.

These psychological disorders may be related to biometric and biochemical characteristics in women with PCOS, such as body image, hirsutism or acne. Furthermore, researches showed that waist-to-hip ratio and plasmatic levels of testosterone is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress. Psychological consequences may also be related to other factors, including stigmatization and isolation, the lack of empathy from family and friends, the feeling of guilt and the diminished sense of self-worth, the costs of treatment and treatment outcomes.

However, there has been no data on the psychological disorders in infertile women with PCOS. Therefore, the study aimed to determine the prevalence of anxiety disorders, depression in infertile women with PCOS and associated factors.

* This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
* Women who are potentially eligible will be provided information about the study purposes, procedures, related risk and benefits
* Screening for eligibility will be performed on the day of the first visit when diagnosis about PCOS is established.
* Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
* All patients selected for this study will answer the questionares and complete the GAD-7 GAD-7 (General Anxiety Disorder-7) and PHQ-9 (Patient Health Questionnaire-9) following careful instruction on how to complete the instrument by investigator in a private room without the presence of their husband.
* The survey will last about 15 minutes. If the result of the GAD-7 and PHQ-9 suggested anxiety disorders, depression, the patient will refer to specialists for further assessment and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Infertile Vietnamese women
* Reporting PCOS according to Rotterdam 2003
* Agreement to participate in the study

Exclusion Criteria:

* Having a family history of neuropsychiatric disease
* Patients who are deaf, blind, or born dumb
* Patents cannot understand Vietnamese
Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children

The clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.

A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated infected school children.

Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection.

Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before inclusion, and at W9 and W21 during the follow-up.

Blood samples for immune response analysis at D0, W12 and W21.

Eligibility Criteria:
Inclusion Criteria:

* School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion.
* Residence in the area during the period of the study.
* Free of obvious/severe health problems except schistosomiasis, as established by clinical examination.
* Written informed consent to participate obtained from subject's parents or legal guardian.
* Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests.
* Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
* Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission.
* Children Groups 2 \& 3: infected with mansoni or/and haematobium schistosomiasis.

Exclusion Criteria:

* School child who does not respond to one of the inclusion criteria
* Child under 20kg of body weight
* Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period.
* Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
* Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
* Knowledge of non-infectious chronic disease
* Known acute disease.
* Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.
The Potential Role of Testosterone on Target Organ Damage in Postmenopausal Hypertensive Women

The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. And the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension
* Women are all postmenopausal
* Men are matched with women.

Exclusion Criteria:

* Secondary hypertension
* Coronary disease
* Heart failure
* Arterial fibrillation
* Previous myocardial infarction
* Previous stroke
* Malignant disease
* Kidney failure
* Liver failure
* Neoplastic disease
* Severe neurological diseases
* Severe metabolic or organic decompensation
* Refuse to sign the informed consent form
Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain

The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or older.
* Subjects suffering from moderate to severe localized chronic PoNP (post operative neuropathic pain) pain following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
* Localized PoNP present for at least 3 months.
* Size of the affected painful skin area is not larger than the size of 3 plasters.
* Intact skin besides the scar of surgery in the area of plasters application
* Baseline average pain intensity of 4 or greater on the 11 point pain intensity Numeric Rating Scale.

Exclusion Criteria:

* Participation in another trial (with medicine or a device under investigation) in parallel or less than 30 days prior to enrollment in this trial.
* Previous enrollment in this trial.
* History of dependency or active drug abuse (alcohol, medication) during the 1 year prior to enrollment.
* Evidence or history (during the 3 years prior to enrollment) of neurotic personality or psychiatric illness that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subjects safety during trial participation.
* Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
* Any surgery performed in the 3 months prior to enrollment, which may affect efficacy or safety assessment.
* Any surgery scheduled or expected during the trial.
* Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator's opinion, may preclude the subject's participation in the trial.
* History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to enrollment.
* Subject with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.
* Pending litigation due to chronic pain or disability.
* Total anesthesia in the cutaneous area neurologically related to the location of the surgical intervention.
* Hypersensitivity to the lidocaine 5% medicated plaster, its excipients, or anesthetics of the amide type.
* Any former use of topical lidocaine in the area of localized chronic PoNP.
* Severe renal, hepatic or heart disorder.
Effects of Dark Chocolate on the Risk Factors of Cardiovascular Diseases

Cardiovascular disease (CVD) is the number one cause of death in the US. Epidemiologic evidence supports that antioxidant-rich diets promote health and attenuate or delay the onset of CVD. Cocoa and chocolate products have among the highest antioxidant concentrations compared to other antioxidant food sources. The objective of this study is to examine the effects of regular dark chocolate, bloomed dark chocolate, and white chocolate on cardiovascular health markers.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy subjects

Exclusion Criteria:

* Smoker
* Pregnant woman
* Lactose intolerance
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to cacao