cyrilzakka/clinical-trials huggingface dataset:
Predictive Value of Th1, Th2 and Th17 Cytokines on the Success of Embryo Implantation (ImmuNoFertilité)

Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Embryo implantation depends on two factors: the quality of the embryo and the endometrial receptivity. Although good quality embryos are transferred, implantation may not occur. Changes in the maternal cytokine profile at the time of implantation may result in poor implantation or early abortions. Consequently, a misdirection of the immunological profile could be responsible for repeated implantation failure (RIF). The definition of RIF is not consensual, but most commonly refers to 3 failures after good quality embryo transfer, and would affect between 5 and 10% of patients.

The possibility of defining a predictive immune profile for RIF from a peripheral blood sample is debated. However, after stimulation of immune cells in peripheral blood, patients with RIF show an excessive pro-inflammatory profile.

Our objective is to assess the activation of T cells and innate immune cells (via an anti-CD3 agonist and a TLR7-8 ligand, respectively) from a blood sample to predict implantation success after frozen embryo transfer. This functional test is easy to use and applicable in a clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (aged 18 and above) treated in the Medically Assisted Procreation (MAP) center of the University Hospital of Nice, in the process of a frozen embryo transfer
* Social security affiliation
* Signed consent

Exclusion Criteria:

* Contra-indication to frozen embryo transfer
* Ongoing infection
* Patients under guardianship
Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.

This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The study will assess target engagement of the ventral striatum after LIFU in patients with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age.
2. Documentation of an AUD diagnosis per DSM-5 criteria as evidenced by problematic pattern of alcohol use leading to clinically significant impairment or distress, as manifested by at least two of the DSM-5 criteria, occurring within a 12-month period.
3. Be willing to undergo a brain MRI and follow study protocol.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data.
3. Non-English speaking.
4. Other investigational AUD treatments.
5. Primary psychosis, Bipolar I, or severe personality disorder.
6. Active suicidality or history of suicide attempt in the past 5 years.
7. Cognitive impairment (MoCA \<24)
8. Significant medical or neurological disease, or life expectancy \<12 mos.
9. Significant brain abnormality on brain imaging.
10. Any MRI exclusion criteria.
Nature-based Solutions for Work-related Stress

Although exposure to nature has restorative effects on human health, beneficial effects of nature-based interventions in the working environment have been underexplored. The investigators aim to conduct a randomised controlled pilot study.

During workhours one group participates in a nature-based program, the other group is a control group. The investigators test stress-related parameters including cortisol levels, wellbeing and stress, and neurocognition.

Participants of the intervention group follow a 30-minute stress management course in nature followed by a nature-based activity of 1.5 hours, twice a week for 3 consecutive weeks. The investigators measure neurocognition via neurocognitive tests, emotional status via burnout assessment tool and well-being questionnaires, and asses stress levels via salivary cortisol and smartwatches.

Eligibility Criteria:
Inclusion Criteria:

* work at province of Limburg speak dutch

Exclusion Criteria:

-
The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements

Patients with class II malocclusion and retrognathic mandibles will be treated using functional appliances and asses the remodeling that is expected to occur in the temporomandibular joint (TMJ) using cone-beam computed tomography (CBCT) images and we will register mandibular movements using electronic axiograph ( a specific apparatus used to record jaw movements in three dimensions).

There are three groups :

1. Activator Group
2. Twin block Group
3. Control Group with no treatment.

Patients will be allocated to the three groups randomly.

Data will be collected using three different approaches:

* CBCT images before treatment and 12 months after treatment
* Axiograph registrations before treatment and 12 months after treatment

The main purposes of this project are:

1. to evaluate the remodeling effects that would take place in the bone structures of the temporomandibular joint (TMJ) during functional treatment.
2. to evaluate the possible change that may occur in mandibular movements following functional treatment.
3. to evaluate the possible change in the spatial relationship between centric occlusion (CO) and centric relation (CR) following functional treatment

Eligibility Criteria:
Inclusion Criteria:

Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern

Exclusion Criteria:

Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV colorectal adenocarcinoma.

The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Eligibility Criteria:
Inclusion Criteria:

Histologic diagnosis of colorectal adenocarcinoma

Stage III or IV (Dukes's stage C or D)

One and only one prior cytotoxic chemotherapy regimen which must have included 5-FU

Adult (18 years of age or older) patients

Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)

Serum creatinine less than 2.0 mg/dL

Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values

ECOG performance status of 0 - 2

Bidimensional measurable disease

Patients who have signed an IRB / Ethics Committee approved informed consent

Life expectancy at least 12 weeks

Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)

Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion Criteria:

Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)

Females who are pregnant or lactating

Patients with peripheral neuropathy NCI-CTC grade 2 or greater

Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry

Patients who have had an investigational agent within 4 weeks of study entry

Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes
Fundus Camera Module for Early Detection of Alzheimer's Disease

Alzheimer's Disease (AD) affects tens of millions of people just in Europe. It is typically detected in its late stage when irreversible damage has already occurred, and current treatments are mostly conservative or palliative. Here we developed a device performing high-resolution multispectral imaging of the eye fundus to detect AD in its early stage. After clinical testing, the proposed device has a high potential to become a method for routine population screening, as it is non-invasive and affordable. The possibility of AD detection in an early stage is crucial for developing a new pharmaceutical treatment that would dramatically improve the lives of millions and save the expenses connected to lifelong healthcare assistance to people with AD in later stages.


Eligibility Criteria:
Inclusion Criteria:

* 55 years or older
* Diagnosis:

  1. For AD group: Clinically diagnosed with Alzheimer's disease (mild to moderate stage) based on Mini-Mental State Examination (MMSE) score between 10-26 and confirmed by PET imaging or CSF.
  2. For Control group: No diagnosis of Alzheimer's disease or other neurodegenerative disorders.
* Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician/ neurologist, prior to the initiation of any study specific procedure

Exclusion Criteria:

* Severe cognitive impairment (MMSE \<10) preventing cooperation during the imaging process.
* Inability to remain still during the fundus imaging procedure.
Femtosecond Laser Assisted Cataract Surgery in The NHS

This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
* Patients must be willing to attend for follow-up at 1 month after cataract surgery.
* Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.

Exclusion Criteria:

* Children below the age of 18
* Already enrolled in another study

The principle exclusion criteria relate to clinical contraindications for FLACS, such as:

* Significant corneal opacities
* Small pupils following pharmacological dilatation
* Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.
Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma

The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (\> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.


Eligibility Criteria:
Inclusion Criteria:

Subjects with available baseline and sequential serum samples.

Exclusion Criteria:

Subjects without baseline and sequential serum samples.
Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines
* Patients with a post-bronchodilator FEV1 \< 70% of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70 at run-in (Visit 101).
* Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.

Exclusion Criteria:

* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening (Visit 1).
* Patients who develop a COPD exacerbation between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
* Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1.
* Patients who develop a respiratory tract infection between screening (Visit 1) and treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection.
* Patients requiring long term oxygen therapy prescribed for \>12 hours per day.
* Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply.
Chronic Effect of Fasting

The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.

The participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. This second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. The caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.

Eligibility Criteria:
Inclusion Criteria:

* Females;
* Aged between 18 and 59 years old;
* Body mass index equal or greater 25 kg/m²;
* Agree to sign the informed consent.

Exclusion Criteria:

* Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);
* Thyroid diseases or medications for its treatment;
* Medications known to affect total energy expenditure;
* Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters;
* Previous surgery for weight loss;
* Pregnancy or breast-feeding;
* Smoking;
* Alcohol use (\>2 doses/day).
Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy

The goal of this project is to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study a measurement protocol will be established to subsequently investigate whether SERS allows to diagnose patients infected with typhoid fever as well as to stage the disease.

This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) is composed of two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patients samples, maximizing Raman spectroscopical signatures. Given the complex composition of human blood, which encompasses numerous biological constituents, the study focuses on serum, a component obtained through centrifugation after the removal of cells and clotting factors. Fifteen spectra will be recorded per sample. The raw spectra will be post-processed, including removal of the substrate signal, baseline correction, vector normalization, and smoothing steps.

The SERS measurement protocol established in the first section will subsequently be applied to samples of healthy and typhoid fever patients. The samples from infected patients will be confirmed with the Widal test. Multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and infected patients), allowing patient diagnosis, as well as the severity of the infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Nishtar Medical University
* The age range of the patients was from 18 to 70 years
* Confirmed disease with the Widal test (for typhoid fever groups)

Exclusion Criteria:

* Patients with severe concurrent diseases were excluded from the study
Retrospective Study of iStatis Syphilis Ab Test (POC)

The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification.

The objectives of this study are to establish the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Ab Test. Left-over samples stored at -80ᵒC from the previous trials conducted by Epicentre will be used for this study. The samples are tested in a routine testing environment. Serum samples were tested for evidence of syphilis infection using a non-treponemal Rapid Plasma Reagin (RPR) assay. All reactive samples were further tested quantitatively.

Eligibility Criteria:
Inclusion Criteria:

1. Anti-Tp negative samples:

   -Stored at ≤ -80°C.
2. Anti-Tp negative samples - pregnant women:

   * Samples from pregnant women, 1st and multipara
   * Samples found negative or false reactive for anti-Tp assay with the reference method.
   * Stored at ≤ -80°C.
3. Anti-Tp positive samples:

   * Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
   * Stored at ≤ -80°C.
4. Anti-Tp positive samples - pregnant women:

   * Samples from pregnant women
   * Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
   * Stored at ≤ -80°C.

Exclusion Criteria:

* N/A
Induction in the Dark

This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.

1. darkened room and star projector with parental presence;
2. preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
3. parental presence alone.


Eligibility Criteria:
Inclusion Criteria

* Age 2 to 6 years old
* American Society of Anesthesiologists physical status I-II
* Outpatient elective surgical procedures
* Undergoing general anesthesia
* Parent or guardian willing to be present during induction

Exclusion Criteria

* History of previous surgery
* Fear of the dark
* Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
* Severe developmental delay
* Severe obvious, preoperative anxiety
* Patients currently using psychiatric medications
* Non-English speaking
A Multiple Health Behavior Change Internet Program for College Students

The objective of this Phase II research is to evaluate the effectiveness of a population-based, individually tailored multiple health behavior change program for exercise, healthy eating, and stress management in a randomized trial including approximately 1,500 college students.

Despite the importance of shaping a solid foundation of health behaviors early in life, college students have been understudied as a population for health promotion programs. This study represents innovative research for impacting the promotion of healthy lifestyles among college students. The objective is to develop and test a population-based, multiple health behavior change program for college students, liveWell: A Healthy Foundation for Life.

The multiple behavior multimedia program will offer Transtheoretical Model-based (TTM) computer tailored feedback on regular exercise, fruit and vegetable consumption, and effective stress management, as well as providing access to a stage-matched dynamic web portal. The TTM is a comprehensive model that integrates ideas from several different theories and approaches to change (hence the name "Transtheoretical") to explain and predict how and when individuals end high-risk behaviors or adopt healthy ones. Thirty years of research has consistently demonstrated that change is a process that unfolds over time through a series of stages: Precontemplation, Contemplation, Preparation, Action, and Maintenance. It matches specific principles and processes of change to each person's stage of change and guides individuals through the change process. The TTM has been applied throughout the world to behaviors such as smoking cessation, alcohol reduction, bullying prevention, weight management, and medication adherence.

A primary goal of this Phase II grant is to assess the effectiveness of liveWell in a randomized trial including 1680 students from 2 large universities in the U.S. Students will be recruited via freshman orientation classes and will complete follow-up assessments at 6-and 12-months. Effectiveness will be assessed by comparing improvements in continuous outcome measures and movement to public health criteria for each behavior. This intervention offers a cost-effective, science-based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of college students.

Eligibility Criteria:
Inclusion Criteria:

* enrolled as a freshmen in college
* English speaking

Exclusion Criteria:

-