cyrilzakka/clinical-trials huggingface dataset:
The Role of Probiotic LH76 in Human Gut Health

This study aims to evaluate the safety and efficacy of the probiotic LH76 as a dietary supplement in healthy adults. The research will assess its effects on gut microbiota composition, intestinal health, and immune function compared to a placebo. Key outcomes include changes in microbial diversity, intestinal barrier integrity, and immune response markers over the intervention period. The findings will contribute to understanding the potential health benefits of LH76 and its role in supporting gut and immune health.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
2. Willing to self-administer probiotic or placebo once a day during the intervention period
3. Good eyesight, can read and write, can wear glasses
4. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria:

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
5. Have received radiation or chemotherapy in the past
6. Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
7. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past Open Contacts/Locations
Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced NSCLC
* Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry.
* Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
* ECOG performance status of ≤ 2.
Lactate Use as Triage Tool in Sepsis : Veinous, Capillary or Arterial?

Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some analyzers (EKF diagnostics Lactate Scout\*) can give results in 15 seconds.

We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect earlier those infections states and we want to find the most accurate site to detect severe sepsis (capillary, venous or arterial sample).

Actually, patients presenting a sepsis with arterial lactate\> 2 mmol.l-1 must be considered as criticals, and if lactate\> 4 mmol.l-1 as septic shock. However, results are usually slow to obtain, especially if we want to respect the Surving Sepsis Campaign, which preconize antibiotic as soon as possible (first hour).

In admission room, arterial sample can't be easily done and usual results need more than 30 minutes. On the contrary, using analyzers like "EKF diagnostics Lactate Scout\*" can give results faster with capillary blood (15 seconds). We will compare this results with both veinous and arterial lactate.

* For primary outcome, we will determine the most accurate value of capillary or veinous lactate that may be able to detect critical patient suspected of infection.
* for secondary outcomes, we will determine if quick capillary lactate test may replace arterial lactate in this indication and be able to predict mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* S.I.R.S : 2 or more criteria (fever \> 38.3°C or hypothermia (core temperature \< 36°C) heart rate \> 90.min-1, tachypnea, altered mental status)
* Suspected infection

Exclusion Criteria:

* Arterial sample by laboratory reference method no available
Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome

Rational: Intellivent is a ventilation mode completely automated which controls ventilation and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated in post operative heart surgery for patient with a controlled ventilation on short period (2 to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit patients from intubation to coming off.

Primary objective : Compare parameters which have been selected by automated mod (Intellivent) to those selected by clinical practitioner in a conventional mode

Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters. Record complications, number of manual adjustments and prognostic signs.

Methodology: Patients in the intensive care unit who need invasive ventilation. They will be included after a detailed information (information note). Oxygenation and ventilation parameters will be recorded 2 times by day from intubation to coming off. The investigator in charge will determine daily at the bedside of the patient the adjustments he should make in a conventional mode. These adjustments will be compared to the IntelliVent automated adjustments.

Experimental study, observational, prospective, comparative, opened, monocentric in an intensive care unit.

Number of patients: 100


Eligibility Criteria:
Inclusion Criteria:

* Patient which needs an invasive ventilation
* Intubation \< 24 hours
* Age ≥ 18 years

Exclusion Criteria:

* Patient which has withdrawal standard in line with the unit coming off procedure (all criteria must be present)
* temperature ≤ 38,5°C
* No pressor drug
* No sedation,
* Motor response to order,
* Cough during bronchoaspiration
* %VM ≤ 130%, FiO2 ≤ 50%, PEEP ≤ 5 cmH2O, Pinsp ≤ 25 cmH2O.
* Patient with non invasive ventilation .
* Dysfunctions of the ventilatory command (ex Cheyne-Stokes).
* Broncho pleural fistula.
* Brain dead status.
* Pregnant woman.
* Adult under guardianship.
* Person deprived of liberty
Intrathecal Analgesia for Normal Labour

Primary outcome: Compare the duration of analgesia. Secondary outcome: analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

The pain of childbirth is the most severe pain any women can endure in their life time. Painful uterine contractions lead to maternal hyperventilation and increased catecholamine concentrations resulting im maternal and fetal hypoxemia.

Labour pain when unrelieved can have adverse effect on the course of labour as well as on the fetal wellbeing. An effective labour analgesia lead to better fetal and maternal outcome.

Although the gold standard in labour analgesia is utilization of epidural services which are widely used to provide pain-free labour in many parts of the world and and have the advantage of providing flexibility to meet the needs of each patient . Epidurals have long been associated with increased oxytocin use, increased fetal malposition, increased rates of instrumental and cesarian delivery, and longer labour .

The use of single-shot intrathecal low dose found to be effective . The advantages of this form of technique include the rapidity of onset and reliability, with minimal hemodynamic changes and motor block. Spinal block is cheaper as well as less technically challenging when compared to epidural and combined spinal epidural block. Intrathecal analgesia alone is useful when duration of labour can be reasonably estimated. Opioid combined with a small dose of local anesthetic provides rapid analgesia and dissipates when no longer needed.

Bupivacaine because of its least placental transfer, due to high protein binding and minimal motor block compared to sensory block in lower doses, has become the popular choice for labor analgesia. Addition of neuraxial lipid soluble opioids permitted reduction in the dose while maintaining effective analgesia and minimizing potential adverse effects on the progress of labor and lower extremity motor block .

Levobupivacaine is the S (-) enantiomer of racemic bupivacaine. Previous studies have shown that it exhibits a clinical profile similar to bupivacaine with the added advantage of less motor impairment .

Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnancies
2. vertex presentation who will be in the active phase of labour with a cervical dilatation \>4cm
3. normal fetal heart rate.

Exclusion Criteria:

* 1-Parturients with systemic diseases 2-Suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia.
* 3 Fetus with known or suspected congenital abnormalities, and 4-Administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.
Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia

Infraclavicular nerve catheter for postoperative analgesia will be included in the 70 adult patients undergoing upper extremity surgery included in the study. These patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the number of pushing the button, the amount of bolus dose given, the total dose given in the patient controlled anesthesia device, the need for additional analgesia and the amount, pain scores, complications will be recorded for three days postoperatively. Records will be compared statistically.

Ethics committee approval was received on 10 December 2019, numbered 19/398. The study was planned to include 70 adult patients undergoing upper extremity surgery at Gulhane Training and Research Hospital between 10 December 2019 and February 2020. Continue infraclavicular nerve catheter for postoperative analgesia will be included in the patients included in the study. These patients will be randomized to the catheter tip configuration as CEMP(closed-ended multiport catheter) group and OESP(open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the patients who have placed an infraclavicular catheter and used the catheter successfully for three days postoperatively, the number of pushing the button, the amount of bolus dose given and the total dose given in the patient controlled anesthesia device,the amounts of need for additional analgesia and pain scores(Numeric rating Scale), complications will be recorded. Records will be compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Score I-III
* upper extremity surgery

Exclusion Criteria:

* emergency surgery,
* secondary surgery,
* chronic pain treatment
* pregnancy,
* any contraindication to peripheral nerve blockade,
* pre-existing peripheral nerve neuropathy,
* allergy to local anesthetics (study medications),
* ASA score ≥ 4,
* neurologic or neuromuscular disease,
* psychiatric disease,
* renal failure,
* hepatic failure,
* NSAID contraindication,
* inability to use a patient controlled analgesia (PCA) device,
* infection at the injection site
* withdrawal of consent.
Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain

The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received at least one dose of dabrafenib or combination with trametinib as part of a compassionate use for the treatment of metastatic melanoma, with deadline the start of treatment the April 30, 2014.

Exclusion Criteria:

* Patients with a history not available.
Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection

In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.

In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.

Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide evidence-based data for

1. estimating of the risk of sexual transmission of ZIKV in the general population
2. antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
3. advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
4. strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
5. advice on gamete cryopreservation
6. optimising investigations for diagnosis of ZIKV in males.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 18-50 years
* ZIKV symptoms within the preceding thirty days
* Confirmed ZIKV infection (WHO criteria)
* Able to ejaculate to produce a semen sample

Exclusion Criteria:

• Current urological malignancy
Accessibility of the World Health Organization's eTB Catalogue of Recommendations

The World Health Organization's Global Tuberculosis Programme (WHO-GTB) issues evidence-informed guideline recommendations on tuberculosis (TB). These recommendations are used by decision-makers, guideline developers and other stakeholders. In an effort to improve the accessibility and usability of these recommendations, a new eTB catalogue of recommendations has been developed. This study aims to compare the accessibility of the new eTB catalogue to the earlier method of accessing recommendations directed through the general WHO website.

This is a two-arm superiority randomized controlled trial. The primary objective is to compare the accessibility of information between the eTB catalogue (intervention) and WHO TB (comparison). Secondary outcomes include understanding of the information, satisfaction of catalogue presentation, and preference toward the catalogue. Current and potential users of TB recommendations will be recruited. Data will be collected using a survey with demographic questions and subsequent 1:1 randomization to the intervention. Superiority will be declared if the mean difference in accessibility is 0.5 or greater for the intervention arm on the seven-point Likert scale.

Eligibility Criteria:
Inclusion Criteria:

* Stakeholders who consider themselves to be users or potential users of tuberculosis (TB) recommendations will be eligible for participation. For the purposes of this trial, a user is defined as someone who has previously accessed TB guidelines, recommendations or policy advice, and a potential user is someone who plans to access TB guidelines, recommendations, or policy advice in the future.
* Participants may be part of any group that has a stake in TB, including the public, healthcare providers, policymakers, or researchers. Participants may be from either low- and middle-income countries (LMIC) or high-income countries (HIC).
* They may also vary in levels of education and previous TB work experience.

Exclusion Criteria:

* Individuals involved in eTB catalogue development.
Chiropractic Manual Therapy in Infantile Colic

Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Excessive crying,
* infant less than 8weeks of age,
* born at gestational age 37 weeks or later, otherwise healthy

Exclusion Criteria:

* Not accepted for chiropractic care
Clinical Performance of Dual-cantilevered Single-implant Bridge

The study aims to evaluate the clinical performance (implant and prosthetic survival/ success rates) of a novel implant-supported fixed dental prosthesis design: the dual-cantilevered single implant bridge (T-Bridge) made out of monolithic zirconia bonded to a titanium base abutment (Variobase abutments)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years
* Willingness to sign an informed consent and participate in the study
* Three missing adjacent teeth in the posterior site.
* Tooth gap of 21-24 mm.
* Presence of natural or artificial opposing dentition
* Sufficient vertical interocclusal space of an implant restoration (7mm)
* Sufficient ridge height to place an implant of 10mm in length
* Sufficient ridge width for the placement of a 4.1mm diameter implant. Simultaneous GBR to achieve a width of 6.5mm will be included.

Exclusion Criteria:

* Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
* Any disorder that would interfere with wound healing or represent a contraindication for implant surgery, such as but not limited to uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates.
* Pregnancy or lactation
* Heavy smoking habit with ≥ 10 cig/d
* Severe bruxism or clenching habits, presence of oro-facial pain
* Insufficient ridge width/height for the study implant
Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children

This study assesses the feasibility of digital data collection for a randomized controlled trial in a quaternary pediatric intensive care unit and the effect of two commonly used mechanical ventilation modes on gas exchange (CO2) in children over 2 days after randomization.

This is a single-center, open-labelled, randomized controlled trial with two parallel 1:1 treatment arms: pressure controlled (PC) vs pressure-regulated volume controlled (PRVC) mechanical ventilation modes.

Use to routine digital data is essential to enable health learning systems and to provide rapid clinical trials readiness, as the pandemic has demonstrated. Despite availability of data to perform digital trials in PICU settings, these are yet scarcely done.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by the participant or the participant's parents or legal guardians. In case of an emergency situation, a physician who is independent of the research project must be consulted prior to inclusion in order to safeguard the interests of the test subject.
* Admission to PICU at the University Children's Hospital Zurich
* Need for mechanical ventilation for \>60 min during PICU hospitalization. Need for mechanical ventilation will be based on clinical decision of the treating physician.
* Need for an arterial line during PICU hospitalization. Need for an arterial line will be based on clinical decision of the treating physician.
* Age \<18 years
* Weight \>2 Kg

Exclusion Criteria:

* Substantial air leaks around the endotracheal tube (\>30%)
* Cyanotic shunt lesions
* Intracranial hypertension (i.e. traumatic brain injury or patients admitted after neurosurgery)
* Pulmonary hypertension under treatment (i.e sildenafil or inhaled nitric oxide)
* Time from start of invasive mechanical ventilation until time of screening is \> 24 hours
* Previous enrolment in the study in the past 30 days
* Inability of the parents or legal guardians to understand the study due to linguistic or cognitive reasons
Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers

The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking

In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12 weeks). The participants are all cigarette smokers who are motivated to quit. They are encouraged to gradually substitute as many cigarettes as possible with study products during the Study Product Test Period and to refrain from all cigarettes at the latest by the first day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The participants are encouraged to cut down on use of study products during the last 3 weeks to avoid a too abrupt ending of nicotine intake.

All subjects are encouraged to continue in the study for clinical follow-up independent of smoking status although use of study products is discontinued during the Follow-Up Phase. If a subject has managed to quit smoking during the Intervention Phase but there is an imminent danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of nicotine replacement therapy or a smokefree tobacco product is a better option in terms of health risks than a smoking relapse.

Eligibility Criteria:
Inclusion Criteria:

* Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
* Daily smoking more than 1 year
* Motivated to quit smoking using a smokefree tobacco product
* Good general health

Exclusion Criteria:

* Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
* Unable to refrain from nicotine replacement therapy during the study
* Current oral condition that could be made worse by study interventions
* History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
* History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
* History of alcohol or substance abuse other than cigarette smoking within the past year
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months