cyrilzakka/clinical-trials huggingface dataset:
Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients

The purpose of this study is to identify, prior to prescribing, which neuropathic pain patients will benefit from duloxetine more specific the investigators aims are to:

* Verify whether presence of chronic pain alters the pain modulation mechanisms, such as DNIC (diffuse noxious inhibitory control) and TS (temporal summation).
* Investigate whether anti-neuropathic medications such as duloxetine indeed change the pain modulation profile, and whether this profile change is associated with a reduction of clinical pain.

There is no accepted practice for selecting among recommended medications for the individual neuropathic pain patient. Guidelines published to date provided the evidence for their efficacy, however, data is not available on how to choose the right medication for the right patient in order to avoid long 'trial and error's. We hypothesize that medications affecting specific process of pain modulation will be more efficacious in patients expressing dysfunction of that specific process. Therefore, medications that enhance descending inhibition such as SSNRI will be more efficacious in patients with less-efficient pain inhibition. The latter is assessed by the conditioned pain modulation (CPM) paradigm. Accordingly, the aim of this study is to examine this hypothesis in painful diabetic neuropathy patients, using duloxetine, an SSNRI agent assumed to augment descending pain inhibition by reuptake inhibition of noradrenalin and serotonin in the spinal cord dorsal horn synapses. We expect to find better effect of duloxetine in those patients whose pain inhibition capability is less efficient, as expressed by their baseline CPM. Further, we aim to evaluate whether pro-nocieptive pattern of pain modulation indeed reverses in response to treatment. This will be explored by comparing the CPM responses before and after treatment, and by correlating pain alleviation with the possible changes in CPM.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having painful diabetic neuropathy.
* Pain is experienced for more than 3 months.
* Pain severity is ≥ 4 on a 0-10 scale (last month average).

Exclusion Criteria:

* Patient already receiving duloxetine or another SNRI/SSRI.
* Known hypersensitivity to duloxetine or any of the inactive ingredients.
* Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
* Uncontrolled narrow-angle glaucoma
* Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine (Mellaril), Cymbalta and thioridazine should not be co-administered
* Inability to perform psychophysical testing, due to language or perceptual barriers.
Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

The objective of this trial is to determine the effects of citicoline on cognitive performance for attention in healrhy Men and Women compared to a placebo.

This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women. Cognitive assessments will be performed to determine whether citicoline administration improves attention, compared to placebo administration.

\*\*Note: This note is to inform you that the Unique Protocol ID BIO-2104 was unintentionally combined with another Unique Protocol ID, K5-24-01-T0060, resulting in history records that should not be considered as part of the BIO-2104's timeline.

This explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol.

Eligibility Criteria:
Inclusion Criteria:

* male or female, 35-75 years of age
* Scores ≥ 24 on the MMSE, ≤15 on the CESD-R, and scores below the population median (i.e., below 81.25, above 36.8) on the Gradual CPT
* Self-reported poor attention
* no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.

Exclusion Criteria:

* color blindness
* Known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the breakfast meal provided
* major medical or neurological illness
* diagnosis of attention deficit hyperactive disorder (ADHD)
* female who is pregnant, planning to be pregnant during the study period
* requiring treatment with a drug which might obscure the action of the study treatment
Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital
* Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group)

Exclusion Criteria:

-Families who are not able to read and speak English well enough to complete the validated surveys
Early Response Assessment in Diffuse Large B-Cell Lymphoma (DLCL) Patients by 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)

Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma
* Patients must have received no prior anti-lymphoma therapy.
* Age \>18 years.
* Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have known HIV infection.
* Patients who are, in the opinion of their treating oncologist, unable to undergo R/CHOP chemotherapy.
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.

Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
* Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
* Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
* Able to keep accurate seizure diaries

Exclusion Criteria:

* Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
* History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
* Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
* History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
* History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.

Stroke is the third most common cause of disability worldwide and leads to upper limb motor disease in more than half of people affected.

Recent data demonstrate that upper limb rehabilitation can be pursued using techniques such as the observation of action (Action Observation Therapy - AOT) or the stimulation of limb musculature using surface electrodes (Neuromuscular Electrical Stimulation - NMES).

To date, no rehabilitation studies used both the treatments (AOT-NMES) for the rehabilitation of upper limb after stroke.

The goal of this clinical trial is to study the efficacy of this combined approach (AOT-NMES) in people who developed upper limb motor impairment after stroke.

The main question this study aims to answer is if the rehabilitation performed using both action observation and neuromuscular stimulation has an higher efficacy than the use of AOT alone and higher than the observation of non-motor stimuli.

Participants will be people with upper limb impairment after stroke and will perform 15 rehabilitation sessions (5/week, 3 weeks, 60 minutes each).

Each participant will be casually included in one of following three rehabilitation groups:

* Action observation associated with neuromuscular stimulation (AOT-NMES, experimental condition): they will observe upper limb movements while their arm muscles will be stimulated. After the observation phase they will try to perform the same movements with the impaired arm.
* Action observation alone (AOT): subjects will observe upper limb movements and after the observation phase then they will try to execute them with the impaired arm.
* Motor-neutral observation (MNO): subjects will observe non-movement videos and after the observation phase they will try to execute upper limb movements with the impaired arm.

Each participant will be evaluated for motor function before and after rehabilitation treatment and researchers will compare the motion improvement between the groups to assess the efficacy of AOT-NMES over other treatments.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Upper arm motor impairment after unilateral stroke as verified by MRI or CT;
* Two weeks up to 6 months after stroke;
* Grading of upper arm motor impairment\>2 at Medical Research Council scale (MRC).

Exclusion Criteria:

* Neurological/orthopedic issues that would interfere with upper limb exercises;
* Presence of any medical condition that represents a contraindication to Magnetic Resonance Imaging (MRI) examination or to Transcranial Magnetic Stimulation (TMS);
* Presence of dermatologic issues that will interfere with neuromuscular stimulator;
* Presence of electronic subcutaneous implants;
* Presence of peripheral neuropathy;
* Epilepsy;
* Pregnancy;
* Presence of severe cognitive impairment, including language comprehension detected during the neurological evaluation.
The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis CLINICAL TRIAL

From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).

Background: Phytotherapy relies on the use of extracts derived from plants in pharmaceutical form. Herbal products have been effective in reducing periodontal diseases, as stated by many studies. Gingival crevicular fluid volume and concentrations of certain cytokines are precise and objective parameters in evaluating periodontitis treatment.

Aim of the study: Assessment of local application of Salvia officinalis (S. officinalis) gel as an adjunctive to scaling and root surface debridement (RSD) in the management of periodontitis.

Methods: A randomized clinical trial of split-mouth design for twenty-three subjects with periodontitis was assessed in this study. From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone). A highly sensitive enzyme-linked immunosorbent assay (ELISA) was used to determine the concentration of interleukin 17 (IL-17) in gingival crevicular fluid (GCF).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with periodontitis had at least 20 natural teeth, with probing pocket depth (PPD) ≥ 5 mm and attachment loss ≥ 4 mm

Exclusion Criteria:

* Exclusion criteria were pregnancy, lactation, smoking, and any systemic disease that might affect periodontal disease progression or require antibiotic usage. Likewise, patients who had received anti-inflammatory medications or antibiotics in the preceding three months were excluded.
Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars

This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars

The study will include 20 patients, treated with fractional CO2 laser plus PRP fluid on one side of the face and fractional CO2 laser plus PRP gel on the other side.

Choosing which side of the face will be injected with PRP fluid and which side will be injected with PRP gel will be chosen according to a randomization table for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Both genders
* Skin types III - V
* Willingness and ability to comply with the requirements of the protocol
* Atrophic acne scars

Exclusion Criteria:

* Patients with active acne
* Patients with herpes labialis, bacterial infections, other infections such as HBV. HCV or HIV.
* Oral isotretinoin use in the previous 6 months
* Pregnancy
* Tendency to keloid formation
* Patients with severe systemic illness or malignancy
* Patients with connective tissue diseases
* Patients with bleeding tendencies or any other hematological disease
Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)

Study hypothesis:

Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways

Main objective:

(1) To investigate the expression of mucins and antimicrobial peptides in patients with severe COPD and their relationship with the presence of bacteria in the airway

Eligibility Criteria:
Inclusion Criteria:

* COPD

Exclusion Criteria:

* Acute exacerbation in the last 4 weeks
Trans-vaginal Aspiration of Small Ovarian Endometrioma. Comparison of Two Different Techniques Before ICSI

women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI

women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI.

Transvaginal aspiration will be done under ultrasonographic guidance with spinal needle insertion inside the cyst cavity followed by aspiration of the chocolate material from the cyst \& then irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material. The needle will be withdrawn in women in non-Surgicel group while injection of small pieces of surgicel inside the cyst cavity will be done for women in the surgicel group followed by withdrawal of the needle.

Eligibility Criteria:
Inclusion Criteria:

* Subfertile women indicated for ICSI
* having a single endometrioma of less than 5 cm with typical sonographic criteria; a cyst with 1 to 4 locules and ground glass appearance of the cyst fluid with no papillary projections and no or minimal vascularization of the cyst capsule. Since endometriotic cysts measuringmore than 1 cm are readily diagnosed by ultrasound,25 we chose a diameter of 2 cm as the lower limit to declare a cyst as endometrioma.
* All cases had a normal uterine cavity demonstrated by ultrasonography and hysteroscopy.

Exclusion Criteria:

* bilateral or multiple endometriomas, lesions of more than 5 cm or showing atypical sonographic features presence of uterine pathology (eg, polyp or fibroid)
* follicle-stimulating hormone (FSH) of more than 10,
* body mass index of more than 30, age more than 40 years,
* cases who received previous GnRH therapy for treatment of endometriosis within 12 months of the study
* patients who received oral contraceptive pills or any form of hormones for the previous 3 months,
* patients with previous surgical resection of endometrioma
* severe male factor.
Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.

The main question\[s\] it aims to answer are:

• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.

Participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.

After surgery is complete, you will be randomly assigned to receive painkillers Mirogabalin or Pregabalin along with other standard medications.

Surgery by Mirogabalin group: Participants received 5 mg of mirogabalin, taken as half a tablet, every day.

Twice a day, after breakfast and dinner, for 6 weeks. In the pregabalin group: Participants received 50 mg of pregabalin, one tablet taken daily.

Twice a day, after breakfast and dinner, for 6 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Age 50-85 years old
2. Unilateral primary osteoarthritis undergoing primary TKA
3. ASA I-III

Exclusion Criteria:

1. GFR \&lt;60
2. Allergy to drug in this study
3. Cannot underwent spinal anesthesia and adductor canal block
4. Taking gabapentinoid within 3 months before surgery
5. History of previous knee surgery
6. Severe liver disease
Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction

The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.

Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)

patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.

Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.

Eligibility Criteria:
Inclusion Criteria:

* All patients age must range from 60- 70 years old.
* All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
* Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
* All patients must have sufficient inter arch space

Exclusion Criteria:

1. Patients with oral or systemic diseases.
2. Patients with xerostomia or excessive salivation.
3. Patients with parafunctional habits (bruxism or clenching).
4. Heavy smoker or alcoholic patients.
5. Patients with history of temporo-mandibular dysfunction.
6. Patients with brain disorders or psychiatric disorders