cyrilzakka/clinical-trials huggingface dataset:
Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

The goal of this placebo-controlled randomized trial is to test the effect of intervention with Bifidobacterium animalis subsp. lactis BLa80 on the composition of the gut microbiota of healthy volunteers. The main question it aims to answer is whether probiotic can effectively regulate intestinal flora. Participants will take a package of probiotics every day, and their weight was recorded once a week using a weight scale. Blood and stool tests were conducted before and after taking probiotics.

This placebo-controlled study aims to investigate the effect of Bifidobacterium animalis subsp. lactis BLa80 supplementation on the status of the gut microbiota of healthy participants. 112 subjects were randomly divided into a placebo group (maltodextrin) and a Bla80 group (maltodextrin + strain BLa80 in 1 × 10 10 colony-forming units/day). The intervention lasted 8 weeks, and 16S rRNA sequencing technology was used to study the changes in gut microbiota between different groups. Simultaneously, clinical indicators such as alanine transaminase (ALT), aspartate aminotransferase (AST), and uric acid (UC) were measured to illustrate the metabolic effects of BLa80.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 21

Exclusion Criteria:

* Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
* People whose daily diet is too light or too greasy are not recommended to participate in the test; People with special dietary structure caused by weight loss or other reasons (such as ketogenic diet, etc.) are not recommended to participate in the test;
* Other people with special circumstances are not recommended to participate, such as those who are allergic to probiotic products; Pregnant women, breastfeeding women and people under 19 years old and over 45 years old should not be tested.
Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study

The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)

In the present study, E4/DRSP will be administered alone (Treatment A) and in combination with VAL (Treatment B) following two sequences A-B or B-A.

Eligibility Criteria:
Inclusion Criteria:

* Healthy premenopausal, aged 18-45 years (inclusive) at the time of signing informed consent.
* For subjects who are sexually active and are of childbearing potential: willing to use a highly effective non-hormonal method of contraception from screening until the follow-up assessment, such as (but not limited to): non-hormonal intra-uterine device (copper IUD), bilateral tubal occlusion, vasectomised partner, or sexual abstinence in a heterosexual relationship; this is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements as stated earlier.
* Body weight ≥45 kg, and a body mass index between 18.0 and 30.0 kg/m² (inclusive).
* Negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1.

Exclusion Criteria:

* The use of:

  * any prescription drugs, including oral or vaginal hormonal contraceptives, from 28 days prior to first dose administration until study completion;
  * any herbal medication or dietary supplements acting on cytochrome P450 3A4 (CYP3A4) functions (i.e., St John's Wort), from 28 days prior to first dose administration until study completion;
  * any over-the-counter medication (including paracetamol or dietary supplements (including vitamins and herbal products ), from 14 days prior to first dose administration until study completion. Limited use (i.e., up to 1200 mg/day) of ibuprofen is allowed;
  * any depot progestogen preparations or an injectable hormonal method of contraception, from 6 months prior to the first dose administration until study completion.
* History of hypersensitivity, serious adverse reaction, or existing contraindication to E4, DRSP or VAL, or excipients.
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of open-angle glaucoma or ocular hypertension
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Under 18
* Pregnant
* Other protocol-defined exclusion criteria may apply
Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.

This cross-sectional study will evaluate the association between sociodemographic, occupational, clinical conditions, psychological (sense of coherence), sleep quality variables and SB diagnosed by PSG, the gold standard exam with audio-visual resources obtained at Pelotas Sleep Institute.

Sleep bruxism is defined as a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and should be considered a risk factor rather than a disorder in otherwise healthy individuals.

The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis.

Included on the questionnaire there is a registration form, which contains: included: age at time of data collection , gender, marital status , and education level ; Occupational: individuals were asked about work outside home, and working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills; respiratory allergy and Psychological: sense of coherence .

Eligibility Criteria:
Inclusion Criteria:

* All adults (aged 20 to 60 years) and elderly (aged \>60 years)

Exclusion Criteria:

* Inadequate cognitive capacity to understand and answer the questionnaires;
* Degraded PSG image quality;
* Questionnaires filled incorrectly;
* Participants who presented a history of epilepsy that could interfere in the results of polysomnography.
Integrative Proteomic Characterization of Pancreatic Ductal Adenocarcinoma

A large-scale, high-throughput, multi-dimensional comprehensive study of PDAC multiomics will be carried out. In this study, clinical specimens of resected PDAC collected by our research group from 2017 to 2019 will be selected as research objects.Tumor tissues and their adjacent non-tumor tissues from more than 200 PDAC patients are expected to be used for genome, transcriptome sequencing and mass spectrometry analysis of proteome and phosphorylated proteome.Combined with the data results of multiomics, bioinformatics analysis and network database information, we will clarify the relationship between multiomics of pancreatic cancer and established the new subtyping of pancreatic cancer proteome. A molecular landscape of the progression of pancreatic cancer at the genome-transcriptome-proteome level provides new therapeutic targets to improve the prognosis of this deadly disease.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of pancreatic cancer was confirmed by histological examination or fine needle aspiration cytology;
2. The tumor was graded according to THE WHO standard, and the tumor stage was graded according to the TNM stage;

Exclusion Criteria:

1. The inclusion criteria of the above groups were not met;
2. There are few tissue specimens, only enough for clinical diagnosis;
3. Patients are unwilling to conduct follow-up study;
4. For the new diagnosed patient, radiotherapy or chemotherapy have been given in the previous three months;
Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors

RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

PRIMARY OBJECTIVES:

I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7.
* ARM II: Patients receive oral lisinopril once daily on days 1-7.
* ARM III: Patients receive oral ramipril twice daily on days 1-7.
* ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms, treatment continues in the absence of unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed solid tumor malignancy AND hypertension, defined as a systolic pressure \> 130 OR a diastolic pressure \> 80
* Patients cannot be on active chemotherapy or radiation therapy; start of treatment with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy or radiation therapy
* Creatinine \< 2.5
* Potassium \< ULN
* Ability to understand and the willingness to sign a written informed consent document
* HIV positive patients are eligible to participate in this study

Exclusion Criteria:

* Patients who are pregnant or nursing due to significant risk to the fetus/infant
* Patients who are unable to take oral medications
* Patients who are currently taking an ACE-Inhibitor or ARB
Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible

To assess the accuracy of the computer assessed guides in horizontal bone augmentation achieved at posterior mandible using guided modified ridge splitting technique versus free hand modified ridge splitting technique

The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide.

The second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.

Eligibility Criteria:
Inclusion Criteria:

* posterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually
* Age range from 25-55 years. No sex predilection.
* Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
* Patients of adequate alveolar bone width.
* Both genders males and females will be included
* Normal vertical dimension with normal inter-arch space. The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent anterior teeth

Exclusion Criteria:

* Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
* Previous grafting procedures in the edentulous area.
* General contraindications to implant surgery.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Immunosuppressed or immunocompromised
* Heavy smokers
* Patients undergo medication interfere with bone healing
Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs

The prospect of effective immunotherapies for the treatment of patients with cancer is now a clinical reality thanks to the approval of monoclonal antibodies (mAbs) specifically blocking immune checkpoints or ligands such as CTLA-4, PD-1 and PD-L1. However, these drugs can also induce inflammatory and/or auto-immune complications (Immune-related Adverse Events; IrAE). IrAE can affect all tissues and sometimes irreversibly. IrAE may be severe or fatal in the absence of timely and adequate care with anti-inflammatory drugs (steroids) or more specific immunosuppressants. Thus, IrAE are a new type of toxicities in oncology and represent one of the major limitations for the development of immunotherapy combination therapies. These IrAE are yet unpredictable. Indeed, the induction of immunity relies on the host's immune status and it differs from one patient to another and so far nobody has identified the underlying mechanisms responsible for irAE outbreaks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients with either liquid (hematological) or solid malignancy, in any line of treatment.
* Patients treated with an immunotherapy based on immune checkpoint targeted monoclonal antibody (mainly anti-PD-1, anti-PD-L1, anti-CTLA-4 monotherapies and combinations)
* Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
* Patients must be affiliated to a social security system or beneficiary of the same
* Patient able to read and write French
* Women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to initiation of treatment
* Sexually active women of childbearing potential must agree to use a highly effective method of birth control supplemented by a barrier method during the trial and for the duration planned in the SmPC or the study protocol after the last administration of each immunotherapy
* Sexually active males patients must agree to use condom during the study and for the duration planned in the SmPC or the study protocol after the last administration of each immunotherapy. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception

Exclusion Criteria:

* Patients treated with immunotherapies that do not contain at least one immunomodulatory drug targeted against a co inhibitory checkpoint molecule
* Known severe hypersensitivity reactions to monoclonal antibodies
* Pregnant or breastfeeding women
* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector

The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).

The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).

* Primary objective:

  o To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation
* Secondary objectives:

  * To evaluate the spherical equivalent refraction one month postoperatively.
  * To evaluate level of astigmatism one month postoperatively.
  * To evaluate the Uncorrected Distance Visual Acuity (UDVA) monocular at 1 day, 1 month and 6 months after IOL implantation
  * To evaluate the Best Corrected Distance Visual Acuity (CDVA) monocular at 1 month, 6 months and 1 year after IOL implantation
  * To evaluate safety features of the lens
  * To evaluate PCO development, Nd:YAG capsulotomy rate

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients who underwent cataract surgery in one or both eyes and who were implanted with Bi-Flex 877PAY IOL mono- or bilaterally.
2. Patients with regular post-operative visits over 12 months period after surgery.
3. Patients of any age above 18 years and any medical history who are eligible according the investigator's decision.

Exclusion Criteria:

1. preoperative corneal astigmatism \> 1.5 D
2. uncontrolled diabetic retinopathy
3. iris neovascularisation
4. serious intraoperative complications
Corneal Thickness Changes in Patient Undergoing Dry Eye Managment

The purpose of this research is to the determine effect of dry eye and to compare the effect of artificial tears on central and peripheral corneal thickness.

In this randomized controlled trial, 96 eyes of females with dry eye will be recruited through random sampling. Dry eye assessments will be done including TBUT, Schirmer test 1, and OSDI questionnaire. 96 eyes will be divided into 3 groups (32 eyes each) and will be provided intervention which is Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. , Dextran 0.1%Hypromellose 0.3%, and placebo(normal saline) through randomization by an unmasked investigator. Changes in central and peripheral corneal thickness will be evaluated by corneal topography. Patients will be evaluated at baseline, after 15 days, after 1 month, and re-evaluated after 1 month of cessation of treatment.

Eligibility Criteria:
Inclusion Criteria:

● Females with ages ranging between 18-40 years and OSDI scores greater than 13, ametropia of up to 1DS of SE with astigmatism of less than 0.5DC, and Emmetropes.

Exclusion Criteria:

* Refractive error of more than ±1 Ds of SE and astigmatism of greater than ±0.5DC.
* Corneal surface disease other than dry eye disease.
* Corneal ectasia.
* Corneal or eyelid infections
* Age \< 18 and \>40 years.
* History of contact lens wears within the past three months.
* Male will be excluded because sex has a large influence on the symptomatology of DED Males have significantly low symptom scores as compared to females.
* Corneal surgeries.
* History of ocular /systemic disease within the past 6 months.
* The patients already receiving any kind of treatment for DED and other ocular diseases.
Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Respiratory failure is a common consequence of chronic obstructive pulmonary disease (COPD). A concurrent metabolic alkalosis may worsen the respiratory failure, as a higher pH in blood (and thus in cerebrospinal fluid) results in a weaker respiratory drive. Use of diuretics is the most common cause of metabolic alkalosis.

When a patient with an acute exacerbation of a respiratory failure is also alkalotic, there are (at least theoretical) reasons to lower the pH in order to increase the respiratory drive. Among other alternatives, the drug acetazolamide can be used for this purpose.

In some hospitals there is a tradition for the use of acetazolamide on this indication, but any evidence for the effect of such a treatment is rather weak.

Thus, the aim of this trial is to evaluate the effect of acetazolamide as an adjuvant treatment for hospitalized patients with acute exacerbation of respiratory failure in combination with metabolic alkalosis.


Eligibility Criteria:
Inclusion Criteria:

* Arterial pO2 8 kPa or lower, and arterial pCO2 7 kPa or higher.
* Base Excess 8 mmmol/l or higher.
* Written informed consent

Exclusion Criteria:

* Acetazolamide treatment regarded as obviously indicated or obviously contraindicated
* Already using acetazolamide
* Moribund patient
* Unable to give fully informed consent
* Allergy towards the tablet content or unable to swallow the tablets
* Pregnant or breast-feeding
Performance Comparison Between Comfilcon A and Senofilcon C Lenses

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 34 years of age (inclusive)
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
* Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Has a contact lens prescription that fits within the available parameters of the study lenses.
* Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; \> 10 hours/day)
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Presents with slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Significant pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (or history in past year)
  * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Is currently wearing daily disposable lenses
Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics

Our aim is to objectively analyze the effects of the non-vascularized autograft taken from the radius and the dorsal and volar surgical approach on the preop and postop wrist kinematics and the movements we use frequently in daily life, and to present the results.

At least 23 working male patients between the ages of 20-50 who do not have active additional diseases will be included in the study, and those who have not previously had trauma or surgical intervention on the same extremity, and who do not have vascular and neurological fields, These patients will be followed-up at the itf orthopedic clinic and the medical faculty orthopedics clinic. their patients will be After the preop and postop union is provided to the patients who will be divided into 2 groups of at least 10 people (in the 12th month postop), the wrist motion analysis will be performed with the XSENS MTw Awinda 17 sensor full body motion capture system in the Bahçeşehir University biomechanics laboratory (separate on the healthy side). In addition to the rum, 5 movements such as personal wc cleaning, drinking coffee from the cup will be stimulated by looking at the healthy side.

Eligibility Criteria:
Inclusion

* healty male
* without any chronic systemic dissease
* must not have drug addiction
* must not have surgical prosedure on affected upper extremity before
* patient shouldnt have VISI DISI DEFOMİTY and radiocarpal arthrosis on affected wrist
* there must be minimum 1 year maximum 10 year between trauma and surgery

Exclusion Criteria:

* Criteria:having vascular and neurological spaces in the same extremity without previous trauma or surgical intervention