cyrilzakka/clinical-trials huggingface dataset:
Intrapartum Ultrasonography in Evaluation of the Progress of Labor

The optimal management of the second stage of labor is a subject of an ongoing debate. It is well established that prolonged second stage of labor is associated with increased maternal and neonatal morbidity.

Diagnosing the onset of labour is one of the most critical and complex judgments made by care providers in the delivery room. Measurement of cervical dilatation is considered the most crucial parameter for labour progress during childbirth and the main reason for doing digital vaginal examination (DVE) in women with signs of labour onset.

DVE was the most common method for measuring cervical dilatation in the past and has been the gold standard for assessing labour progress. However, it can be subjective, inaccurate, and uncomfortable for women. Also, only 50% of assessments are accurate, and there is an increased risk of infection with frequent DVE. Therefore, vaginal examination cannot be a correct scale for measuring cervical dilatation, mainly when done by different examiners. Because of the poor reliability and pain associated with DVE, the use of intrapartum ultrasound to measure cervical dilation has been suggested as an alternative method. Abdominal, vaginal, trans-labial, and trans-perineal 2D and 3D ultrasounds have been used to measure cervical dilatation during labour.


Eligibility Criteria:
Inclusion Criteria:

* Primigravida patients
* At the onset of active phase
* Cephalic vertex presentation
* Estimated Fetal Weight 3Kg - 4Kg
* Gestational Age ≥37 weeks

Exclusion Criteria:

* Multiple Pregnancy
* Patients refused to participate in our study
* Induced labor
* Any Obstetrical Complication or Disease
* Malpresentation
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age?

In this randomised controlled trial the investigators will determine whether taking iron supplements compared to placebo for 21 days alters the bacteria (microbiome) in the large intestine of non-pregnant female participants.

BACKGROUND: Many women take iron-containing supplements during pregnancy. Indeed, the World Health Organization recommends that all pregnant women in low-income countries take an iron supplement containing 60 mg/day of elemental iron to reduce iron deficiency and iron-deficiency anaemia. However, oral iron has poor bioavailability, less than 10% absorbed with the remainder passing into the large intestine unbound, potentially providing a competitive advantage to iron-dependent opportunistic pathogens in the large intestine.

In a large randomized control trial in children, iron supplementation was shown to promote the growth of pathogenic species (E. coli, S. aureus, and L. monocytogenes) and inhibited the growth of commensal species (Lactobacillus and Bifidobacterium). These pathogens are associated with enteric infections, while the commensals act on the host's immune system to prevent colonization and invasion by pathogens.

It is NOT known if iron supplementation during pregnancy impacts the maternal and infant microbiome and, by extension, how this affects the neonatal risk of infection and immune dysregulation. Vertical transmission of the maternal microbiome to the newborn is a major determinant of infant health. If maternal iron supplementation affects the infant's health, strategies would be required to mitigate this risk.

The investigators require preliminary data to show how oral iron supplementation alters the intestinal microbiome in women. The Investigators will recruit non-pregnant female participants as there is no risk of vertical transmission to an infant in non-pregnant women. The investigators will conduct the study in Australia because there is not a natural abundance of pathogens that could potentially cause harm to the women. Nevertheless, the investigators would expect a shift in the microbiome from non-iron to iron, requiring bacterial species to return to baseline after women stop taking the iron.

HYPOTHESIS: Daily iron supplementation versus placebo for 21 days will alter the stool microbiome composition compared to placebo in non-pregnant female participants of reproductive age.

METHODS: 80 female participants (18-45 y) will be randomized to receive capsules containing iron (65.7 mg of elemental iron as ferrous fumarate) or placebo to take daily for 21 days. Stool samples will be collected at baseline, 21 days, and 42 days (washout).

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent

Exclusion Criteria:

* Pregnant or breastfeeding.
* Planning on becoming pregnant
* Diagnosed with iron deficiency and/or anaemia in the previous three months
* Taken antibiotics in the past three months
* Taken iron containing supplements in the past three months
Resuscitation and Capillary Reperfusion

Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are associated with poor survival. To our knowledge, no human studies evaluating microperfusion during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have been published. Capillary refill time (CRT) and skin-mottling-score (SMS) are parameters for microperfusion and evaluated in septic and cardiogenic shock. In animal studies, microperfusion was impaired during cardiac arrest, although not correlating with systemic blood pressure.

The aim of this study is to investigate the correlation between impaired microcirculation (as measured with CRT and SMS) during resuscitation and ROSC resp. neurological outcome. Our clinical impression in daily routine is, that the appearance of a patient undergoing CPR is often linked to the outcome. We hypothesize, that this is due to changes in microperfusion of the skin.


Eligibility Criteria:
Inclusion Criteria:

* All patients ≥18 years during cardiopulmonary resuscitation
* witnessed cardiac arrest

Exclusion Criteria:

* insufficient manpower (e.g. study team has to provide CPR)
* hypovolemia (exsanguination, anaphylaxis, sepsis as underlying cause)
* presumed or known COVID-19 disease
* hypo-/hyperthermia (\<36.0°, \>37.5°C)
* Raynaud's disease
* Peripheral arterial disease
Glycosylation Analysis of Lupus Anti-DNA Antibodies (GALA)

Systemic lupus erythematosus (SLE) is a severe autoimmune disease in which patients often develop numerous autoantibodies (Abs). Unfortunately, none of the SLE specific Abs described so far (anti-DNA, -C1q, -nucleosome) are correlated enough to the disease activity to be used as a useful biomarker and reliably help in the therapeutic decision.

Abs effector functions, including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and antibody-mediated complement activation, are conditioned by the structure of the crystallizable fragment (Fc) and especially the N-linked oligosaccharide structures attached to the asparagine-297 in the CH2 domain of the Fc region. It has been shown that the decrease in galactosylation, sialylation and fucolylation is generally associated with inflammatory function of circulating IgG whereas Abs with sialic acid, fucose and/or galactose in Asn-297 are anti-inflammatory. This major role of Ab glycosylation in the regulation of the effector and pathogenic functions of Abs have been well documented in rheumatoid arthritis and ANCA associated vasculitis with a good correlation between Ab sialylation and disease activity. In lupus, it has been shown that glycosylation of total IgG is also altered and correlated with disease activity but glycosylation analysis of the LES specific Abs is still lacking.

The aim of this study is to analyse by mass spectrometry (MS) the different glycoforms of anti-DNA Abs in lupus patients and find a correlation with disease activity.

140 adult patients with lupus and anti-DNA Abs will be prospectively recruited in the University Hospital of Montpellier and Nîmes (department of rheumatology, internal medicine and nephrology) and followed during 1 year.

Blood samples will be drawn at inclusion, at 1 year and during any flare of the disease. After centrifugation (2000g x 10 minutes) serum will be aliquoted and frozen at -80°C.

At the end of the study, total IgG will be isolated using protein G and anti-DNA Abs will be purified from total IgG with DNA affinity columns. Glycosylation status of the anti-DNA Abs will be extensively determined by mass spectrometry and correlated to disease activity (SLEDAI).

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with LED according to the ACR/EULAR 2019 criteria, all clinical forms combined, quiescent or in flare with positive native anti-DNA antibodies, providing oral informed consent.

Exclusion Criteria:

* Patients under protection of justice or unable to receive a clear information.
* High probability of non-compliance with the protocol or withdrawal during the study
* Already involved in another interventional clinical study
Expanded Access to Elezanumab

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

- The participant must not be eligible for an elezanumab clinical trial.
Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients

Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. Usually severity is determined by the class of CF mutations, but even among patients with the same severity of mutations there is a variation of the severity of CF.

Haptoglobin has several types (phenotypes), one of them was found to be related to infectious complications.

In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications.

To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.

Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. The severity of the disease is determined by genetic factors (type of mutation), environmental factors (exposure to bacteria) and behavioral (adherence with therapy). Even among patients with the same severity of mutations there is a variation of the severity of CF.

Haptoglobin is a protein responsible for collecting Iron from senescent Red Blood Cells. There are two genes of Haptoglobin, numbered 1 and 2, and combinations between the two genes create three forms of proteins: 1-1, 1-2, and 2-2. The 1-1 Phenotype was found to be associated with a predisposition to infection.

In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications.

To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype by gel- electrophoresis. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.

FEV1- Forced Expiratory Volume in 1 second.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with CF according to diagnostic criteria , between the ages of 0 and 50, who are themselves, or their parents or guardians, able to give informed consent.

Two known severe (class I , II and III) mutations

Exclusion Criteria:

none
Effect of Waterpipe Smoking on Periodontal Health

The main objective of the study is to assess the effect of waterpipe smoking on periodontal health, which will be done using a well constructed validated questionnaire. Then a full periodontal examination and x-ray evaluation will be done for all of the participants.

The primary outcome of the study is to assess the effect of waterpipe smoking on periodontal health, it will be assessed by questions about smoking habits, including smoking mode as well as duration (heads smoked per day) and extent of use (age of initiation and number of sessions per week) of waterpipe smoking.

A full periodontal examination using UNC-15 periodontal probe will be done for all of the participants measuring the CAL, Probing Depth (PD), plaque index (PI), bleeding on probing (BOP) and gingival recession depth (GD). In subjects where attachment loss will be clinically detected, radiographic examination will be performed by digital periapical radiograph to detect the amount of bone loss, then staging will be done according to the new classification by the aid of radiographic examination.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age is between 18-60 years old.
2. Patient consulting in the outpatient clinic.
3. Provide informed consent.

Exclusion Criteria:

1. Individuals with chronic systemic diseases such as diabetes, endocrine and hematological Pathologies.
2. Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
3. Pregnant women.
4. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
5. Patients with orthodontic appliances.
Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis

Aim of the current study was to evaluate the effect of Aloe vera gel as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.

The effect of Aloe vera on treatment of chronic periodontitis will be evaluated in a randomized, controlled clinical trial. Thirty patients with mild to moderate chronic periodontitis were divided into 2 groups: group 1 (test): will include 15 patients treated with SRP followed by application of Aloe vera gel in the periodontal pockets at day 1 and after 1 and 2 weeks, and group 2 (control) which includes 15 patients treated with SRP only.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals.
* Patients with mild to moderate chronic periodontitis (CAL 1-4mm) according to the American Academy of Periodontology classification

Exclusion Criteria:

* Smoking and alcoholism.
* Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy, conditions leads to xerostomia).
* Patients on any medication affecting the periodontium.
* Lactating, pregnant or menopausal females.
* Patients with parafunctional habits.
* Patients with poor oral hygiene.
Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.

All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment

Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.

Materials and Methods: Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients from both sexes aged 17 - 25 years
* Mild-to-moderate crowding (≤5 mm)
* Optimum oral hygiene
* Maximum of 3 restored teeth
* Absence of defective enamel formation in the form of hypocalcification or hypoplasia
* No salivary gland diseases.

Exclusion Criteria:

* Patients with poor oral hygiene
* Heavily restored teeth
* Sever crowding
* Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.
Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.


Eligibility Criteria:
Inclusion Criteria:

* gastric adenocarcinoma confirmed by gastroscopy and pathology (histologically/cytologically ) ;
* life expectancy of ≥3-month；
* unresectable patients who were initially diagnosed as stage IV (clinical stage, American Joint Committee on Cancer 8th edition);
* Eastern Cooperative Oncology Group performance status: 0-1;
* must have at least 1 of the following unresectable factors indicated by CT, MRI or positron emission tomography(PET)-CT:

  1. N3 lymphatic metastasis;
  2. Extensive or bulky lymph nodes;
  3. T4b;
  4. Hepatic metastasis: ≤5 lesions, total diameter of ≤8cm;
  5. Peritoneal metastasis (CY1, P1);
  6. Kukernburg tumor;
* adequate organ function;
* pregnant test negative of females of childbearing potential , and willing to use adequate contraception;
* written Informed Consensus Form;

Exclusion Criteria:

* prior use of any checkpoint inhibitor treatment, including PD-1, programmed cell death ligand-1(PDL-1), CTLA4 etc;
* Her-2 positive with willing to use herceptin treatment;
* prior active autoimmune disease or history of autoimmune disease;
* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class \> 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) \< 50%;
* not controlled hypertension;
* prior systemic treatment to metastatic disease；
* previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency;
* history of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis ;
* patients who may receive vaccination during study period;
* mental disorders history, or psychotropic drug abuse history;
* unable to orally administration;
Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN

Patients with KCN who undergo cornea transplantation divided to 2 groups:

Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare


Eligibility Criteria:
Inclusion Criteria:

* Patients with KCN who undergo DALK surgery

Exclusion Criteria:

* Penetrating Keratoplasty surgery
* Other corneal diseases
* dystrophies
* Corneal graft rejection
Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

Laparoscopic appendectomy (L-APPE) presents a golden standard in the treatment of acute appendicitis nowadays. However, there are ongoing controversies regarding the ideal technique of appendicular stump closure during L-APPE in the published literature. Several technical modifications of appendicular stump closure are available at the present - closure using endoloop, endostapler or Hem-o-lock clips. The aim of the proposed project (CAS study) is to compare medical and economic outcomes of patients undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop and Hem-o-lock clips).

Acute appendicitis presents one of the most common surgical illnesses which affect approximately 7% of the western population. In the Czech Republic, 11664 patients were hospitalized and operated for the diagnosis of acute appendicitis (K35-K38) during 2016. It might seem that the procedure of appendectomy will be guided by a clear algorithm for its frequency, but it is not so. Because of acute appendicitis, appendectomy may be performed via laparotomy or laparoscopy (minimally invasive surgery). During laparoscopic appendectomy (L-APPE), there are no clear recommendations regarding trocar placement, methods of dividing appendicular mesenteriolum, methods of appendicular stump closure or appendicular stump sinking.

The proposed clinical study is focused on the issue of the appendicular base interruption during L-APPE. At the present, there are several technical modifications of appendicular stump closure - by means of endoloop (the suture loop from absorbable fiber), endostapler or using Hem-o-lock clips. The performed literature search revealed that evidence-based medicine data regarding the optimal way of appendicular stump closure are insufficient. That is why the investigators have decided to conduct a prospective randomized single-center clinical study aimed to compare different technical modifications of appendicular stump closure during L-APPE. Within a study period, all patients undergoing L-APPE at the University Hospital Ostrava will be randomized to one of the technical modifications of appendicular stump closure.

The aim of the project (CAS study) is to compare medical and economic outcomes of patients undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop and Hem-o-lock clips). The operative time, intraoperative and postoperative complications will be the primary outcome measures of the study, economic outcomes will be the secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* acute appendicitis
* laparoscopic approach
* signed informed content

Exclusion Criteria:

- necrosis or advanced inflammatory changes in the area of appendicular stump