cyrilzakka/clinical-trials huggingface dataset:
The Effect of Web Based Genital Hygiene Education Provided to Orthopedically Disabled Women

The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors.

It was a randomized controlled trial. The women in the experimental group were given web-based genital hygiene education that continued for seven weeks. No intervention was applied to the women in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being orthopedically handicapped
* Being literate, being over the age of 18
* Having access to the internet
* Being able to use the internet/computer
* Being able to maintain genital hygiene individually.

Exclusion Criteria:

* The inability to use the internet
* Not being a member of the website
* Having mental retardation
* Being dependent on someone else to maintain genital hygiene (bedridden, with spasticity)
* No willing to complete the study.
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers

The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.

This is a cross-over group, double-blind, randomized clinical trial in healthy volunteers comparing dextromethorphan and inactive control on freeze-induced hyperalgesia, experimental pain, diffuse noxious inhibitory control (DNIC), pupillary reaction and reaction time.

The influence of CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.

The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).

Each study sequence consists of 3 assessment days (Day -1, Day 0 = first treatment administration and Day 1).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Aged between 18 and 45 years
* CYP2D6 Extensive and Intermediate metabolizers
* Body mass index (BMI) between 19 and 30 kg/m2
* Systolic blood pressure between 100 and 150 mmHg, diastolic blood pressure between 50 and 90 mmHg, heart rate between 45 and 90 beats per minute
* Without treatment during the 7 days before inclusion specially no use of analgesic and anti-inflammatory drugs
* Cooperation and understanding enough to conform to the study obligations
* Having given free informed written consent
* Affiliated to the French Social Security
* Inscription or acceptation of inscription in the national register of volunteers involved in trials.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Lactose intolerance
* Hypertension
* History of stroke
* Severe heart failure
* Severe hepatic impairment
* Shortness of breath
* Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
* Association with linezolid
* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
* Diabetes (type I and II)
* CYP2D6 Poor and Ultra-rapid metabolizers
* AST, ALT, total bilirubin twice the average
* Dextromethorphan intake during the 7 days before inclusion
* Medical and surgical history incompatible with the study
* Disease progression during inclusion
* Excessive consumption of alcohol (\> 50g/day), tobacco (≥ 10 cigarettes/day), coffee, tea or drinks with caffeine (equivalent to more than 4 cups a day) or any addiction to drugs
* Subject lacking concentration during tests training and low test results reproducibility
* Subject does not meet the selection criteria for its ability to discriminate sensations to noxious stimuli during psychometric tests
* Subject exclusion period, or the total allowable compensation exceeded
* Subject undergoing a measure of legal protection (guardianship, supervision
Gestational Diabetes Mother-infant Cohort

The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.

Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.

Eligibility Criteria:
Inclusion Criteria:

* Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.

Exclusion Criteria:

* diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;
* neurological and hereditary metabolic diseases; (iv) deaf father/mother.
REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania

Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma
* Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol
* Patients able and willing to provide their written informed consent to participate in the study

Exclusion Criteria:

* The treatment with acalabrutinib was initiated during an interventional clinical trial
* Enrolment performed less than 30 days from start of treatment with acalabrutinib
Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.

This study is being done to compare a modified version of the standard ALA-PDT (Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses, to a modified version in which light exposure begins immediately after application of the Levulan. We hypothesize that this will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause less pain during the light exposure. The study employs a bilateral design in which the left versus right sides of the treatment area are compared in the exact same patient. There are 3 arms of the study, each having a different time duration of light exposure in the modified regimen to determine which one is most efficacious

Eligibility Criteria:
Inclusion Criteria:

* Males or females, at least 18 years of age
* Non-hyperkeratotic actinic keratoses, at least 6 in number (3 on each side of scalp, face or upper extremities)

Exclusion Criteria:

* patient is currently pregnant or are planning to conceive during the course of the study period
* patient is using topical therapy or other treatment for these actinic keratoses
* patient has a known hypersensitivity to 5-aminolevulinic acid
Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma

Exclusion Criteria:

* No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding.
A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus

Comparison of the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus.


Eligibility Criteria:
Inclusion criteria:

* Best corrected visual acuity (BCVA) ≥ 20/20;
* No other eye diseases except myopia and astigmatism;
* The cornea was transparent, and there was no cloud or pannus;

Exclusion Criteria:

* The presence of ocular diseases other than myopia and keratoconus;
* Ocular trauma;
* Previous ocular surgery;
* Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination;
* Pregnant and lactating women;
A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults

The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.

The cure rate will be evaluated at the second visit (14 days after the inclusion visit)


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Recovering of written and dated informed consent form
* Social Security medical cover
* Left Iliac Fossa (LIF) pain
* Moderate fever (\>37.8°C)
* Sensitivity/defence during LIF palpation

Biological results :

* CRP \> 10mg/L
* NFS \> 10G/L
* Neutrophil Granulocytosis \> 75%
* Radiological results - presence to the scan :diverticul \& pericolic infiltration

Exclusion Criteria:

* Patients treated by antibiotherapy in the last 15 days prior inclusion
* Patients treated by morphinic drug
* Patients treated by anticoagulant drug
* Pregnant or breast-feeding women
* Patients presenting allergy to active principal, to galactose
* Patients having taking part in another study in the last 3 months prior inclusion
* Patients unable to comply with the study requirements
* Patients presenting Chronic affection inconsistent with the study
* Patients presenting high fever
* Patients presenting abdominal contracture
* Patients presenting immunosuppression
* Radiological sign of complication (abscess\>3cm)
* Patients presenting Pathology inconsistent with efficacy evaluatio
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting

To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.

To establish the correlation between measurand values as obtained from the Samsung LABGEO PT10 Hepatic Panel at the point of care, and the corresponding measurand values as obtained on a commercial clinical chemistry analyzer, with respect to prospectively collected human serum specimens.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with a history of elevated liver enzymes or symptoms suggestive of elevated liver enzymes
* Presenting to the site and requiring testing for levels of liver enzymes as part of routine care at the site
* Subjects able and willing to provide written informed consent

Exclusion Criteria:

* Subjects unable or unwilling to provide written informed consent
* Subjects with a life-threatening disease or any serious, potentially life-threatening medical illness that may compromise patient safety or study conduct
Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders

This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.

This study employs a randomized double-blind placebo-controlled design, with blinding applied to both the assessors and patients, while the therapists remain unblinded. A total of 40 patients with insomnia disorders meeting the inclusion criteria were recruited from the Shanghai Mental Health Center and randomly assigned to either the tDCS active stimulation group or the tDCS sham stimulation group, with 20 patients in each group. All patients underwent clinical assessments, magnetic resonance imaging (MRI) scans, and high-density electroencephalogram (EEG) parameter collections at baseline. Based on the MRI structural images and high-density EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation sites, stimulation intensity, and electrode placement methods). Detailed modeling methods and selection of stimulation parameters can be found in the intervention methods section. Stimulation was carried out for a total of 2 weeks, with one session per day on weekdays, totaling 10 sessions, each lasting thirty minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years;
2. Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
3. Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
4. Insomnia severity as indicated by an ISI score \> 10;
5. Minimum education level of junior high school or above.

Exclusion Criteria:

1. Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
2. Currently using benzodiazepines as sleep aids;
3. Moderate to severe anxiety or depression (HAMD-17 score \> 16 or HAMA score \> 24);
4. Patients with obstructive sleep apnea syndrome;
5. Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
6. Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
7. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
8. Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
9. Severe negative thoughts or high suicide risk;
10. Pregnant or planning to conceive in the near future.
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.


Eligibility Criteria:
Inclusion Criteria:

* Hallux Valgus with 1st ray hypermobility

Exclusion Criteria:

1. Generalized Ligament laxity
2. Previous foot and ankle surgery
3. Diabetes Mellitus
Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients

Study of ANA001 in Moderate and Severe COVID-19 Patients

This is a 2 part, Phase 2/3 multi-center, double blinded, placebo-controlled study to assess the safety, tolerability, and efficacy of oral niclosamide (ANA001) in moderate and severe hospitalized COVID-19 patients compared to placebo.

Eligibility Criteria:
Key Inclusion Criteria:

1. Provide written informed consent prior to performing study procedures
2. Hospitalized.
3. Male or female ≥18 years of age
4. Positive for severe acute respiratory syndrome coronavirus 2
5. Presence of symptoms of lower respiratory tract infection (LRTI) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath
6. At least 1 of the following: respiratory rate (RR) ≥20 breaths per minute, room air oxygen saturation (SpO2) \<98%, requirement for supplemental oxygen, heart rate (HR) ≥90 beats per minute, or temperature \>38.3°C
7. Women of childbearing potential must agree to abstinent or use at least 1 form of contraception not including hormonal contraception from the day of screening through Day 30

Key Exclusion Criteria:

1. Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
2. Patient is not anticipated to survive \>48 hours OR is under palliative care
3. Evidence of critical illness, defined by at least 1 of the following:

   * Respiratory failure requiring at least 1 of the following:

     1. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
     2. Noninvasive positive pressure ventilation (NIPVV), OR
     3. Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure
   * Shock (defined by systolic blood pressure (BP) \<90 mm Hg, or diastolic blood pressure (BP) \<60 mm Hg or requiring vasopressors), OR
   * Multi-organ dysfunction/failure
4. Severe central nervous system (CNS) conditions
5. Chronic kidney disease requiring dialysis
6. Known allergy to the study drug or salicylate containing medications.
7. Suspected and/or confirmed pregnancy or breastfeeding
8. Current or planned participation in any other clinical trial of a treatment being developed under a US investigational new drug (IND) or emergency use authorization (EUA).
9. Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.
Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.

This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy. All enrolled participants will be placed on HCL insulin therapy for 10 days or until hospital discharge (if less than 10 days) to determine functional operability of the system and its effect on glycemic control in the hospital setting. This study will generate preliminary data to inform the design of a large multi-institution randomized controlled trial to assess superiority of HCL compared to standard inpatient insulin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with insulin-treated T1 or Type 2 diabetes mellitus (T2DM) admitted to general (non-intensive care) medical-surgical hospital service requiring inpatient insulin therapy.

Exclusion Criteria:

* Patients admitted the ICU or anticipated to require ICU transfer
* Anticipated length of hospital stay \<48 hours.
* Evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state) at enrollment
* Severely impaired renal function (eGFR \< 30 ml/min/1.73m2) or clinically significant liver failure
* Severe anemia with hemoglobin \<7 g/dL
* Evidence of hemodynamic instability
* Hypoxia (SpO2 \<95% on supplemental oxygen)
* Pre-admission or inpatient total daily insulin dose \>100 units
* Mental condition rendering the participant unable to consent or answer questionnaires
* Pregnant or breast feeding at time of enrollment
* Unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, Novolog or Apidra) during the study
* Use of hydroxyurea or high-dose ascorbic acid (\>1g/day)
* Coronavirus Disease 2019 (COVID-19) infection or person under investigation (PUI) on isolation precautions
Hypoalgesic Effect of Electrical Current and Cervical Manipulation

This study evaluates the hypoalgesic effect of the TENS application associated with joint manipulation of the cervical region in healthy individuals. One group had both active treatments, the other group received both placebo treatments, the third and fourth group received only one of the two treatments actively and the other placebo

Transcutaneous Electrical Nerve Stimulation (TENS) and Cervical Joint Manipulation (CJM) are often used for pain treatment.

TENS also promotes analgesia by activating a descending pathway, which originates in the periaqueductal grey (PAG) and in the rostroventromedial medulla (RVM) to inhibit the excitability of nociceptive neurons in the dorsal horn of the spinal cord.

Joint manipulation generates a series of stimuli within the central nervous system through the activation of proprioceptors located in the joint capsule or muscles, stimulates the PAG, causing pain inhibition by activation of non-opioid descending inhibitory pathways

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* no pain complaints from the last 90 days

Exclusion Criteria:

* previous spinal surgeries
* spinal canal stenosis
* vertebral fracture
* spondylolisthesis
* cancer
* acute infections
* hemorrhagic disorders
* active tuberculosis
* deep vein thrombosis
* osteoporosis
* diseases rheumatic
* diseases metabolic
* cardiorespiratory diseases
* headache in the last seven days
* smoking
* changes in skin sensitivity
* use of pacemaker
* women in menstrual period
* pregnant women
* use of pain-killers in the last 48 hours
* use of anti-inflammatory drugs in the last 48 hours
* previous electrostimulation
* previous cervical joint manipulation treatments
* hypersensitivity to TENS application
* aversion to cervical joint manipulation
* positive test for vertebral artery.